Leqephe lena le fana ka lethathamo la li-analogues tsohle tsa Insugen-30/70 (Bifazik) ka sebopeho le sesupo sa tšebeliso. Lethathamo la li-analogues tse theko e tlaase, hape u ka bapisa litheko libakeng tsa meriana.

• Analogue e theko e tlaase ka ho fetisisa ea Insugen-30/70 (Bifazik):Remix ea Humalog
• Analog e tummeng ka ho fetisisa ea Insugen-30/70 (Bifazik):Remix ea Humalog
• Sehlopha sa ATX: Insulin (ea motho)
• Motsoako o sebetsang: insulin ea motho
  

Ha u bala litšenyehelo theko analogue Insugen-30/70 (Bifazik) theko e fokolang e fumanoeng lenaneng la theko e fanoeng ke li-pharmacies e ile ea tsotelloa

E fuoe lenane la lingaka tsa lithethefatsi e ipapisitse le lipalo-palo tsa litlhare tse kopiloeng ka ho fetisisa

Li-analog mabapi le sebopeho le pontšo ea ts'ebeliso

Lethathamo le ka holimo la li-analogues tsa lithethefatsi, tse bontshang Insugen-30/70 (Bifazik), e loketse haholo hobane e na le sebopeho se tšoanang sa lintho tse sebetsang ebile e lumellana ho latela sesupo sa tšebeliso

Li-analoggs ka pontšo le mokhoa oa ts'ebeliso

Moetso o fapaneng o kanna oa lumellana ho bonts'a mokhoa le mokhoa oa ts'ebeliso

U ka fumana analogue e theko e tlaase ea moriana o theko e phahameng?

Ho fumana analogue e theko e phahameng ea moriana, mofuta oa generic kapa lebitso, pele ho tsohle re khothaletsa ho ela hloko sebopeho, e leng lintho le lipontšo tse tšoanang tse sebetsang. Metsoako e tšoanang ea lithethefatsi e tla bonts'a hore lithethefatsi li tsamaisana le lithethefatsi, li ka lekana meriana kapa li ka etsa meriana. Leha ho le joalo, u se ke oa lebala ka likarolo tse sa sebetseng tsa lithethefatsi tse tšoanang, tse ka amang polokeho le ts'ebetso. Se ke la lebala ka litaelo tsa lingaka, ho itlama ho ka lematsa bophelo ba hau, ka hona, etela ngaka ea hau kamehla pele u sebelisa meriana leha e le efe.

Tlhaloso ea lithethefatsi

Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) - The drug Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® ke litokisetso tse kopaneng tse nang le analogue ea soluble ea motho ea amanang le insulin ultra-nako e telele (insulin degludec) le analogue e potlakileng e sebetsang ea insulin ea "insulin" ("insulin"). DNA e sebelisa mofuta oa Saccharomyces cerevisiae.

Insulin degludec le insulin aspart ka mokhoa o ikhethileng e lumellana le "receptor" ea "insulin" ea motho mme o sebetsana le eona, o lemoha phello ea bona ea pharmacological e tšoanang le phello ea insulin ea motho. Kameho ea "insulin" ea "insulin" e bakoa ke ts'ebeliso ea tsoekere ea glucose ke lisele tse kamora ho ts'oaroa ha insulin ho mesifa le mafura a lisele tsa mafura, le phokotso e ts'oanang ka nako e le 'ngoe ea sekhahla sa tlhahiso ea tsoekere ke sebete.

Litlamorao tsa pharmacodynamic tsa likarolo tsa lithethefatsi Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® li fapane ka ho hlaka mme boemo ba kakaretso ba lithethefatsi bo bontša lintlha tsa karolo ea tšebetso ea likarolo tsa motho ka mong: "insulin" e phahameng haholo le "insulin" ea nako e telele e telele.

Karolo ea basal ea lithethefatsi Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ®, e nang le ketso ea nako e telele (insulin degludec), kamora ho kenella ka mefuta ea li-insulin tse ngata tse tsamaeang ka har'a depo ea subcutaneous depo, ho tloha moo ho nang le phallo e tsamaeang butle ea insulinl. boemo bo patehileng ba ts'ebetso le phello e tsitsitseng ea hypoglycemic ea lithethefatsi. Phello ena e bolokiloe hammoho le insulin aspart mme ha e ame boemo ba ho monya ba monomers ba sebetsang ka potlako ea insulin.

Lithethefatsi Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) Penfill ® e qala ho nka khato ka potlako, e fana ka tlhoko ea prandial ea insulin haufinyane kamora ho kenngoa, ha karolo ea basal e na le sephiri se tsitsitseng, se tsitsitseng le sa nako e telele se fanang ka tlhoko ea motheo. ka insulin. Nako ea ts'ebetso ea tekanyetso e le 'ngoe ea lithethefatsi Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® ke lihora tse fetang 24.

Kamano ea marang-rang e pakiloe pakeng tsa ho eketsa tekanyetso ea Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfnill ® le phello ea eona e akaretsang le e phahameng. Khokahano e lekanang ea lithethefatsi Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® e fihlelleha kamora matsatsi a 2-3 a ts'ebetso ea moriana.

Ho ne ho se na phapang lipampiring tsa meriana ea Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® Penfill ® ho bakuli ba tsofetseng le ba senile le bakuli ba banyenyane.

Ts'ebetso ea Kliniki le Polokeho

Ho ile ha etsoa liteko tse hlano tse sa laoloang tsa bongaka tse sa laoloang ka tšohanyetso tsa lithethefatsi Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® kalafong ho ea ho sepheo sa sepheo sa likatiba tse 26 kapa 52 tse kenyelletsang bakuli ba 1360 ba nang le lefu la tsoekere la mellitus (ba 362 ba nang le lefu la tsoekere mellitus) Tlatsa bakuli ba 1 le 998 ba nang le lefu la tsoekere la mofuta oa 2). Lithuto tse peli tsa helm li ile tsa etsoa ho tsamaiso e le 'ngoe ea Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® hammoho le lithethefatsi tsa molomo tsa hypoglycemic (PHGP) le lethal dose le le leng la insulin glargine hammoho le PHGP ho bakuli ba nang le lefu la tsoekere la mofuta oa 2 lefu la tsoekere. Tsamaiso ea Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® habeli ka letsatsi e kopane le PHGP e ne e bapisoa le tsamaiso ea likarolo tse peli tsa insulin 30 habeli ka letsatsi hammoho le PHGP lithutong tse peli ho bakuli ba nang le lefu la tsoekere la mofuta oa 2. . Tsamaiso ea lithethefatsi Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® hang ka letsatsi hammoho le insulin aspart e ne e boetse e bapisoa le tsamaiso ea insulin detemir hanngoe kapa habeli ka letsatsi hammoho le insulin assartate ho bakuli ba mofuta oa 1 lefu la tsoekere. .

Ho haella ha bophahamo ba lihlahisoa tsa papiso ho netefalitsoe ho oela le Insulin avludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® mabapi le ho fokotseha hoa HbA_1c lithutong tsohle tsa kalafo ea bakuli ho ea sepheo.

Ho bakuli ba nang le lefu la tsoekere la mofuta oa 2 ba sa kang ba fumana kalafo ea insulin le bakuli ba kileng ba fumana kalafo ea insulin, Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® hammoho le PHGP e fana ka taolo e tšoanang ea glycemic ha e bapisoa le insulin. Glargin. Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® e fana ka taolo e ntlafalitsoeng ea glycemic ho bapisoa le insulin glargine e nang le frequency e tlase ea nocturnal hypoglycemia (e hlalositsoeng e le likarolo tsa hypoglycemia tse etsahetseng pakeng tsa lihora tse 0 le 6, tse netefalitsoeng ke liphetho. ho lekanya mokokotlo oa plasma glucose e ka tlase ho 3.1 mmol / l kapa bopaki ba hore mokuli o hloka thuso ea batho ba boraro).

Tsamaiso ea lithethefatsi Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® habeli ka letsatsi e fana ka taolo e tšoanang ea glycemic (HbA_1c) bapisoa le biphasic insulin aspart 30, e neng e boetse e fanoa habeli ka letsatsi. The drug Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® e fana ka matla a nepahetseng a ho fokotsa khatello ea tsoekere ho plasma e potlakileng. Ha u sebelisa Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ®, litekanyetso tsa "glucose" tse fumanehang li ne li fumaneha ka potlako ho bapisoa le bakuli ba tšoaroang ke biphasic insulin aspart. (Insulin degludec + Insulin aspart *) ® ha e atise ho baka hypoglycemia (ho kenyeletsoa bosiu). Ho bakuli ba nang le lefu la tsoekere la mofuta oa 1, kalafo e nang le Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® hang ka letsatsi hammoho le insulin aspart pele lijo tse ling li bontša taolo ea glycemic e tšoanang (HbA_1c le glucose e potlakileng ea "plasma glucose" e nang le maemo a sa tloaelehang a nocturnal hypoglycemia ha a bapisoa le "basulin" regimen ea "insulin dstemir" le "insulin" le "" "" li "li" li "li" insulin "kamehla.

Ho latela tlhahlobo ea meta ea liteko tse bulehileng tse libeke tse 26 tse reriloeng ho latela molaoana oa "ho folisa sepheo" o kenyeletsang bakuli ba nang le lefu la tsoekere la 2, sethethefatsi Insulin avludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ®, e tsamaisitsoeng habeli ka letsatsi, e bonts'itse karolo e tlase ea liketsahalo tsa hypoglycemia tse netefalitsoeng le liketsahalo tsa "hypoglycemia" tsa "nocturnal" tse qaqileng ha li bapisoa le biphasic insulin aspart 30. Liphetho li bonts'itse hore Insulin degludec + Insulin aspart * (Insulin Refludec + Insulin aspart *) ® e fokotsehile e na le "khatello ea" glucose ea "glucose" e potlakileng e nang le kotsi e tlase ea hypoglycemia ka bobeli nakong ea thuto le nakong ea paballo ea lethal dose ho tloha libekeng tse 16 (Tafole 1)

Lethathamo la 1. Liphetho tsa tlhahlobo-leseling ea "meta" litsing tsa hypoglycemia e netefalitsoeng ha e fanoa habeli ka letsatsi nakong ea thuto le nakong ea paballo ea lethal dose ho tloha libeke tse 16

Ho ne ho se na sebopeho sa bohlokoa ka ho fetisisa sa li-antibodies ho insulin kamora kalafo le Insulin degludec + Insulin aspart * (Insulin degludec + Insulin aspart *) ® bakeng sa nako e telele.

Litšobotsi tsa dintho Insulin degludec + Insulin aspart

Lithethefatsi tse kopaneng tse kenyang "anulin" insulin ea "insulin" ea insulin (insulin avludec) le "anulin" e sebetsang kapele e hlahisoang ke insulin (insulin aspart) e entsoeng ke recombinant DNA biotechnology e sebelisang bothata. Saccharomyces cerevisiae.

Motsoako oa liphatlalatso tsa insulin tsa motho o na le insulin ea insulin (insulin avludec) e telele le 30% e sebetsang ka potlako ea insulin.

Insulin ea Degludec e fapana le insulin ea motho ka ho se be teng ha threonine amino acid e maemong a B30 le ho ba teng ha ketane ea lehlakore e kenyelletsang glutamic acid le C16 fatty acid, e hlahisoang ke theknoloji ea DNA e kopantsoeng Saccharomyces cerevisiae. Degludec insulin e na le boima ba molek'hule ea 6103.97.

Insulin aspart e thusa haholo ho insulin ea motho, ntle le hore protheine ea amino acid e nkeloe sebaka sa B28 ka asiti ea acid, e hlahisoang ke theknoloji ea DNA e sebelisang mathata. Saccharomyces cerevisiae, boima ba molek'hule 5825.8.

Insulin Aspart, Bifazik le Degludek: theko le litaelo

Lefu la tsoekere ke lefu le tloaelehileng le hlokang kalafo. Ka hona, mofuteng oa pele oa bokuli le maemong a tsoetseng pele ka mofuta oa bobeli oa lefu la tsoekere, bakuli ba hloka taolo ea insulin e sa fetoheng, e thusang ho fokotsa tsoekere, ka potlako ba e fetole matla.

Hangata ka lefu la tsoekere, insulin Aspart e sebelisoa. Ena ke setlhare sa ultrashort.

Sesebelisoa ke analogue ea "insulin" ea motho, e fumanoang ke theknoloji ea DNA e sebetsang hape e sebelisang mofuta oa Saccharomyces cerevisiae, moo proline e maemong a B28 (amino acid) e nkeloang asiti ea "aspartic". Boima ba molek'hule ke 5825.8.

Sebopeho, foromo ea tokollo le phello ea pharmacological

Biphasic insulin e kopanya aspart e qhibilihang le protulin insulin protamine ka karolelano ea 30 ho isa ho 70%.

Sena ke ho emisoa bakeng sa tsamaiso ea sc, ho ba le 'mala o mosoeu. Millilita e le 'ngoe e na le li-unit tse 100,' me e le 'ngoe ea ED e tsamaellanang le 35 mcg ea anulinrous insulin Aspart.

Analogue ea insulin ea motho e hlahisa mochini o nang le insulin receptor e nang le receptor ho membrane ea sele ea cytoplasmic ea ka ntle. Ho qetela ho sebetsa ho hlophisoa ha glycogen synthetase, pyruvate kinase le hexokinase enzymes.

Ho fokotseha ha tsoekere ho etsahala ka keketseho ea lipakeng tsa intracellular le phetoho e kholo ea tsoekere ea tsoekere. Hypoglycemia e boetse e fumanoa ka ho fokotsa nako ea ho lokolloa ha tsoekere ke sebete, glycogenogeneis le ts'ebetso ea lipogenesis.

Biphasic insulin aspart e fumanoa ka ho qhekella ka biotechnological ha molek'hule ea "proline ea" hormone e nkeloa sebaka ke "acid" ea "acid". Li-insulin tse joalo li na le phello e tšoanang ho hemoglobin ea glycosylated, joalo ka insulin ea motho.

Ka bobeli lithethefatsi li sebetsa ka tsela e tšoanang ho molar e lekanang. Leha ho le joalo, Aspart insulin e sebetsa ka potlako ho feta hormone ea motho e qhibilihang. Asiti ea protralline ea protamine e na le phello ea nako e telele.

Ketso e kamora ho tsamaisoa ha sc ha moemeli e fihlella kamora metsotso e 15. Phekolo e phahameng ka ho fetisisa ea moriana e etsahala lihora tse 1-4 kamora ho kenngoa. Nako ea phello e fihla ho lihora tse 24.

Ho serum Cmax, insulin e 50% ho feta ha o sebelisa insulin ea motho ea biphasic. Ho feta moo, nako ea karolelano ea ho fihla Cmax e ka tlase ho halofo.

T1 / 2 - ho fihlela lihora tse 9, e bonts'a lebelo la ho monngoa ha karoloana e tlameletsoeng protamine. Maemo a "insulin" a motheo a bonoa lihora tse 15-18 kamora puso.

Empa ka lefu la tsoekere la mofuta oa 2, katleho ea Cmax e ka ba metsotso e 95. E boloka e le maemong a ka tlase ho 14 le kaholimo ho 0 kamora ho tsamaisoa ha sc. Hore na sebaka sa tsamaiso se ama sebaka sa ho amoheloa ha se na ho ithutoa.

Thutela-litso

Mokhoa oa ketso. Insulin degludec le insulin aspart e tlama ka ho khetheha ho "receptor" ea "insulin" ea motho mme, ha e sebelisana le eona, e hlokomela phello ea bona ea pharmacological ka mokhoa o ts'oanang le phello ea insulin ea motho. Kameho ea "insulin" ea "insulin" e bakoa ke ts'ebeliso ea tsoekere ea glucose ke lisele ka mor'a ho tlama insulin ho mesifa le mafura a lisele tsa mafura le ho fokotseha ho hongata ha sekhahla sa tlhahiso ea tsoekere ke sebete.

Litholoana tsa pharmacodynamic tsa likarolo tsa motsoako oa insulin degludec + insulin aspart li fapane ka ho hlaka, 'me boemo ba kakaretso ba ts'ebeliso ea lithethefatsi bo bontša lintlha tsa ts'ebetso ea likarolo tsa motho ka mong: "insulin" e phahameng haholo e potlakileng ka insulin.

Karolo ea basal ea ho kopanya insulin degludec + insulin aspart, e nang le ts'ebetso ea nako e telele (insulin degludec), kamora ho entoa ka sc, e etsa li-solhele tse ngata tse ngata ka har'a depo ea subcutaneous, moo ho nang le phallo e potlakileng ea insulin degludec ho potoloha, ho fana ka boemo bo tsitsitseng ba ts'ebetso le phello e tsitsitseng ea hypoglycemic. Phello ena e bolokiloe hammoho le insulin aspart mme ha e ame boemo ba ho monya ba monomers ba sebetsang ka potlako ea insulin.

Motsoako oa "insulin degludec + insulin" o qala ho nka khato ka potlako, o fana ka tlhoko ea insulin kapele kamora ho kenngoa, ha karolo ea basal e na le sephiri se tsitsitseng, se tsitsitseng le sa nako e telele se fanang ka tlhoko ea motheo ea insulin. Nako ea ts'ebetso ea tekanyetso e le 'ngoe ea motsoako oa insulin degludec + insulin aspart e feta lihora tse 24.

Kamano e haufi-ufi lipakeng tsa keketseho ea tekanyetso ea motsoako oa insulin degludec + insulin aspart le phello ea eona e akaretsang le e phahameng ea hypoglycemic, C_s fihlellwa kamora matsatsi a 2-3 a tsamaiso.

Ho ne ho se na phapang ho pharmacodynamics ea motsoako oa insulin degludec + insulin aspart ho bakuli ba tsofetseng le bakuli ba banyenyane.

Ts'ebetso ea Kliniki le Polokeho

Liteko tse hlano tse sa laoleheng tsa machabeng tsa insulin avludec + insulin aspart ka mokhoa oa "kalafo ho fihlella" li ile tsa etsoa libeke tse 26 kapa tse 52 le bakuli ba 1360 ba nang le lefu la tsoekere (bakuli ba 362 ba nang le lefu la tsoekere la 1 le bakuli ba 998 ba nang le lefu la tsoekere la mofuta oa 2). ) Ho entsoe liphuputso tse peli tsa lipapiso tsa tsamaiso e le 'ngoe ea motsoako oa insulin degludec + insulin aspart hammoho le lithethefatsi tsa molomo tsa hypoglycemic (PHGP) le tsamaiso e le' ngoe ea "insulin glargine" hammoho le PHGP ho bakuli ba nang le lefu la tsoekere la 2. Tsamaiso e kopaneng ea insulin degludec + insulin aspart makhetlo a 2 ka letsatsi e kopantsoe. le PHGP e ne e bapisoa le tsamaiso ea biphasic insulin aspart 30 habeli ka letsatsi ka kopanelo le PHGP lithutong tse peli ho bakuli ba nang le mofuta oa "mellitus" ea 2 lefu la tsoekere. insulin aspart hang ka letsatsi hammoho le insulin aspart e ne e boetse e bapisoa le tsamaiso ea insulin detemir 1 kapa makhetlo a mabeli ka letsatsi hammoho le insulin aspart ho bakuli ba mofuta oa 1 lefu la tsoekere.

Ho haella ha bophahamo ba lithethefatsi ha li bapisoa le motsoako oa insulin degludec + insulin mabapi le ho fokotseha hoa HbA_1c lithutong tsohle tsa kalafo ea bakuli ho ea sepheo.

Ho bakuli ba nang le lefu la tsoekere la mofuta oa 2 bao ho seng mohla ba kileng ba amohela kalafo ea insulin le bakuli ba kileng ba fumana kalafo ea insulin, ho kopana ha insulin degludec + insulin aspart hammoho le PHGP ho fana ka taolo e tšoanang ea glycemic ha e bapisoa le insulin glargine. Motsoako oa insulin degludec + insulin aspart o fana ka taolo e ntlafalitsoeng ea gandcemic gandcemic ha e bapisoa le insulin glargine e nang le frequency e tlase ea nocturnal hypoglycemia (e hlalositsoeng e le likarolo tsa hypoglycemia tse etsahetseng pakeng tsa 0 le 6 hoseng, tse netefalitsoeng ka ho lekanya likhahla tsa glucose ea tlase ho 3.1 mmol / l kapa tlhoko ea thuso ea mokuli ke batho ba boraro).

Ho kenngoa ha motsoako oa insulin degludec + insulin aspart makhetlo a 2 ka letsatsi ho fana ka taolo e tšoanang ea glycemic (HbA_1c) bapisoa le biphasic insulin aspart 30, e neng e boetse e tsamaisoa habeli ka letsatsi. Motsoako oa insulin degludec + insulin aspart e fana ka mefuta e metle e matla ea ho fokotsa likhahla tsa glucose e potlakileng. Ha u sebelisa motsoako oa insulin degludec + insulin aspart, boleng ba "glucose" ea "cholel" e fumanoe ka potlako ho bapisoa le bakuli ba tšoaroang ke biphasic insulin aspart 30. Ho kopana ha insulin degludec + insulin aspart hangata ha ho baka hypoglycemia (ho kenyelletsa le bosiu) . Ho bakuli ba nang le lefu la tsoekere la mofuta oa 1 lefu la tsoekere, kalafo e kopaneng le insulin degludec + insulin aspart 1 nako ka letsatsi hammoho le insulin aspart e bontšitse taolo e tšoanang ea glycemic pele ho lijo tse ling (HbA_1c le glucose e potlakileng ea "plasma glucose" e nang le liketsahalo tse sa tloaelehang tsa nocturnal hypoglycemia ha e bapisoa le "basulin regimen" ea "insulin detemir" le "insulin".

Ho latela tlhahlobo ea meta ea liteko tse peli tse bulehileng tsa libeke tse 26 tse entsoeng ho latela "molaoana oa" ho folisa sepheo "o kenyelletsang bakuli ba nang le lefu la tsoekere la 2, ho kopana ha insulin degludec + insulin aspart, e tsamaisoang makhetlo a 2 ka letsatsi, ho bontšitse liketsahalo tse tlase tsa liketsahalo tse netefalitsoeng. hypoglycemia ka kakaretso le liketsahalo tsa "hypoglycemia" tsa bosiu tse sa ts'oaneng ha li bapisoa le insulin ea biphasic aspart 30. Teko ea meta e bontšitse hore ho kopantsoe ha insulin degludec + insulin aspart lowers plasma glucose ho itima lijo ka mali le menyetla e tlase ea hypoglycemia ka bobeli nakong ea thuto le nakong ea tlhokomelo ea litekanyetso ho tloha libeke tse 16. Khafetsa e amanang le setsoalle (95% CI) ea kakaretso ea motsoako oa hypoglycemia o netefalitsoeng oa insulin degludec + insulin aspart (makhetlo a 2 ka letsatsi) / biphasic insulin aspart 30 (makhetlo a 2 ka letsatsi) nakong ea thuto e ne e le 0.81 (0.67, 0.98 ), nakong ea tlhokomelo ea lethal dose - 0.69 (0.55, 0.87), khafetsa khafetsa ea hypoglycemia bosiu - 0.43 (0.31, 0.59) nakong ea thuto le 0,38 (0.25, 0.58) nakong ea tekanyetso ea tlhokomelo.

Ho ne ho se na sebopeho sa bohlokoa ka ho fetisisa sa li-antibodies ho insulin kamora kalafo le motsoako oa insulin avludec + insulin aspart ka nako e telele.

Ho fufuleloa Kamora ho ente ea sc, ho etsoa hoa solulle solidlulin ea insulin ea li-insulin tse ngata, tse hlahisang depo ea insulin ka har'a li-tiske tsa adipose tsa subcutaneous 'me li se ke tsa kena-kenana le ho tsoa ha insulin aspart monomers maling. Li-Multihexamers butle-butle lia ikarola, li lokolla li-monloma tsa "insludec insulin", ka lebaka la tsona butle-butle li kenang maling. C_s karolo ea ketso ea superlong (insulin degludec) ka plasma ea mali e fihlelloa matsatsi a 2-3 kamora ho kenngoa ha motsoako oa insulin degludec + insulin aspart.

Matšoao a tsebahalang a ho kenngoa ka hloko ha insulin aspart a bolokiloe ka har'a motsoako oa insulin avludec + insulin. Boitsebiso ba pharmacokinetic ba insulin aspart bo hlaha metsotso e 14 ka mor'a ente, C_max e bonoe ka mor'a metsotso e 72

Ho fufuleloa Ts'oarello - nako ea ts'ehetso ea nako ka mor'a tekanyo e le 'ngoe ea sc ea 0,4, 0,6, le 0,8 U / kg ea insulin degludec + insulin aspart ho bakuli ba nang le mofuta oa 1 lefu la tsoekere le mofuta oa 2 lefu la tsoekere le bontšitse keketseho ea tlhahiso le tlhahiso e ntseng e eketseha ea lefu la tsoekere. dikarolo ka bobeli tsa motswako.

Insulin aspart e bontšitse keketseho ea tekanyetso ea C_max le keketseho e nyane ho feta ea tekanyetso ea AUC_0–12 kamora ho tsamaisoa ka lehare le le leng la motsoako oa "insulin" ea "insulin" ea "insulin" ho bakuli ba nang le mofuta oa 1 lefu la tsoekere le mofuta oa 2 lefu la tsoekere.

Insulin degludec e bontšitse keketseho ea tekanyo ea C_max le AUC_0–120 ka tsamaiso e le 'ngoe ea ho kopanya insulin degludec + insulin aspart ho bakuli ba nang le mofuta oa 1 lefu la tsoekere le mofuta oa 2 lefu la tsoekere.

Ho qala ha phello bakeng sa motsoako - insulin aspart - karolelano 14 mets ka mor'a ente, C_max - Metsotso e 72 Serum C_s motsoako - insulin degludec - e fihlelitsoe ka Matsatsi a 3-4 kamora tsamaiso ea motsoako oa insulin degludec + insulin aspart.

Tsamaiso. Ho amana ha insludec insulin bakeng sa serum albin ho tsamaisana le bokhoni bo kopanyang ba protheine ea plasma (> 99%) ho plasma ea mali a motho. Ho "insulin aspart", "protein" e tlamang protein e tlase haholo (T_1/2 motsoako oa insulin degludec + insulin aspart ka mor'a ho enteloa ka sc ho khethoa ke sekhahla sa ho huloa ho tsoa ho lithane tsa subcutaneous. T_1/2 Degludec insulin ke lihora tse ka bang 25 mme tekanyetso e ikemetse.

Linearity Phello e akaretsang ea ho kopanya insulin degludec + insulin aspart e lekana le lethal dose le laoloang la motsoako oa basal (insulin degludec) le karolo ea prandial (insulin aspart) ka mofuta oa 1 le mofuta oa 2 lefu la tsoekere.

Lihlopheng tse khethehileng tsa bakuli

Ha ho na phapang e fumanoeng mefuteng ea pharmacokinetic ea ho kopanya insulin degludec + insulin aspart ho latela bong ba bakuli.

Bakuli ba tsofetseng, bakuli ba merabe e fapaneng, bakuli ba nang le bothata ba ho ruruha ba mokokotlo kapa ba hepatic. Ho ne ho se na phapang e kholo litabeng tsa pharmacokinetics ea motsoako oa insulin degludec + insulin aspart pakeng tsa bakuli ba tsofetseng le ba banyenyane, lipakeng tsa bakuli ba merabe e fapaneng, pakeng tsa bakuli ba nang le bothata ba ho opa ha renal le hepatic le bakuli ba phetseng hantle.

Li-Geriatrics Litlamorao tsa pharmacokinetic le pharmacodynamic tsa motsoako oa insulin degludec + insulin aspart li ile tsa ithutoa ho batho ba baholo ba 13 (batho ba lilemo tse 18 ho isa ho 35) le bakuli ba 15 ba tsofetseng (ba lilemo li ≥65) ba nang le mofuta oa 1 lefu la tsoekere ka mor'a litekanyetso tse peli tsa sc U 0.5 ea / kg: E 'ngoe ke motsoako oa "insulin" ea "insulin" ea "insulin"' me e 'ngoe ke "insulin" ea methapo e' meli. Ho pepesetsoa ka botlalo ha motsoako oa "insulin" oa "insulin" ea "insulin" ea insulin (e thehiloeng ho AUC_0–12 insulin aspart) ho bakuli ba tsofetseng ba ne ba tloaetse ho eketseha ha ba bapisoa le batho ba baholo. Pontšo e felletseng ea motsoako oa insulin degludec ea insulin degludec + insulin aspart (e thehiloeng ho AUC_0–120 insulin degludec) le karabelo ea pharmacodynamic ho kopantsoeng ea insulin degludec + insulin aspart (e thehiloeng ho AUC_0–24 insulin degludec) li ne li tšoana ho batho ba baholo le bakuli ba tsofetseng ba nang le lefu la tsoekere la 1, le ha ho fapana ka tsela e tšoanang ho bakuli ba tsofetseng ho ne ho phahame.

Bana le bacha. Melemo ea pharmacokinetic ea ho kopanya insulin degludec + insulin aspart thutong ho bana (ea lilemo tse 6 ho isa ho tse 11) le bacha (lilemo tse 12-18) ba nang le mofuta oa 1 lefu la tsoekere ba tšoana le bakuli ba baholo ba nang le ente e le 'ngoe.

Kakaretso ea khatello ea maikutlo le C_max insulin aspart e phahame ho bana ho feta ho batho ba baholo, 'me ho joalo le ho bacha le ho batho ba baholo.

Thepa ea pharmacokinetic ea degludec insulin ho bana le bacha ba nang le lefu la tsoekere la mofuta oa 1 ba bapisoa le bakuli ba baholo. Khahlano le semelo sa ente e le 'ngoe ea lethal dose ea degludec insulin ho bakuli ba mofuta oa 1 lefu la tsoekere, ho bontšitsoe hore phello e felletseng ea litekanyetso tsa lithethefatsi ho bana le lilemong tsa bocha e phahame ho feta ho bakuli ba baholo.

Paul Matla a thobalano ho li-pharmacokinetics tsa likarolo tsa motho ka mong tsa motsoako oa insulin degludec + insulin aspart li ile tsa hlahlojoa boithuto ba lithuto tse fapaneng tsa pharmacokinetic le pharmacodynamic. Ka kakaretso, ho ne ho se na phapang e kholo litabeng tsa pharmacokinetic thepa ea insulin degludec kapa insulin aspart pakeng tsa basali le banna.

Ho Nona Haholo Kameho ea index ea boima ba 'mele (BMI) ho li-pharmacokinetics ea likarolo tse ikhethang tsa motsoako oa insulin degludec + insulin aspart e ile ea ithutoa ka tlhahlobo ea lithuto tsa sefapano-pharmacokinetic le pharmacodynamic. Ho bakuli ba nang le lefu la tsoekere la mofuta oa 1 lefu la tsoekere, ha ho kamano e fumanoeng pakeng tsa ho pepesetsoa ke insludec insulin le BMI. Bakeng sa bakuli ba nang le lefu la tsoekere la mofuta oa 2, ho ile ha senoloa tloaelo ea ho fokotseha ha tsoekere ka "glucose-insulin" e nang le keketseho ea BMI. Bakeng sa "insulin", ho ne ho se setsoalle pakeng tsa BMI le ho pepeseha bakuli ba nang le lefu la tsoekere la mofuta oa 2 kapa lefu la tsoekere.

Mofuta le morabe. Kameho ea morabe le morabe ho pharmacokinetics ea motsoako oa insulin degludec + insulin aspart ha e e-so ithutoe. Karolo ea basal ea motsoako ona - insulin degludec - e ithutoe lithutong tsa pharmacokinetic le pharmacodynamic ho batho ba Amerika American of Hispanic kapa Latino origin (n = 18), batho ba letlalo le lesoeu la letlalo la Spain kapa la Spain (n = 22), le batho ba letlalo le tšoeu ba letlalo la Spain le tsoang Spain (n = 23) mofuta oa 2 lefu la tsoekere. Ho ne ho se na phapang ea lipalo pakeng tsa merabe le merabe e ithutileng.

Boimana Kameho ea bokhachane ho pharmacokinetics le pharmacodynamics ea motsoako oa insulin degludec + insulin aspart ha e e-so ithutoe (bona. "Sebelisa ho ima le ho lactation").

Ho hloleha hape Kameho ea ho se sebetse hantle ha re le hantle ho pharmacokinetics ea motsoako oa "insulin" ea insulin ha e e-so ithutoe. Karolo ea basal ea motsoako - insulin degludec (ka ho hlahisoa ha lethal dose le le leng la 0,4 U / kg) - e ile ea ithutoa lithutong tsa pharmacokinetic ho batho ba 32 (n = 4-8 / sehlopha) ka ho se sebetse hantle kapa ho senyeha ha renal / ho qeta ha methapo ea kutlo. . Ts'ebetso ea renal e senyehileng e ne e behiloe ho latela Cl creatinine: ≥90 ml / min (e tloaelehileng), 60-89 ml / min (bonolo), 30-59 ml / min (ka tekano) le tekanyetso ea s / c ea 0.08 U / kg insulin aspart (karolo e sebetsang ka potlako ea motsoako oa insulin degludec + insulin aspart) e ile ea hlahlojoa thutong ho batho ba nang le ts'ebetso e tloaelehileng ea renal, bonolo, e leka-lekaneng kapa e matla (empa e sa hloke hemodialysis) ts'ebetso ea renal e sa sebetseng. Thutong ena, ho ne ho se na phello e hlakileng ea tumello ea creatinine ho AUC le C_max insulin.

Ho hloleha ha sebete. Kameho ea ho hloleha ha sebete ho pharmacokinetics ea motsoako oa insulin degludec + insulin aspart ha e e-so ithutoe. Karolo ea basal ea motsoako - insulin degludec - e ithutile thutong ea pharmacokinetic ho batho ba 24 (n = 6 / sehlopha) ka ts'ebetso ea sebete e sa tloaelehang kapa e senyehileng (e bonolo, e leka-lekaneng le e matla ea hepatic) kamora ho tsamaisoa ha tekanyetso e le 'ngoe ea s / c (0.4 PIECES / kg) insulin degludec. Ha ho phapang pakeng tsa pharmacokinetics ea insulin degludec e fumanoeng pakeng tsa batho ba phetseng hantle le batho ba nang le ts'ebetso ea sebete e sa sebetseng (bona "Precautions").

Phuputsong e bulehileng ea tekanyetso e le 'ngoe ea 0,06 U / kg ea insulin aspart (motsoako o potlakileng oa motsoako oa insulin avludec + insulin aspart) o ile a tsamaisoa ho sc ho bakuli ba 24 (n = 6 / sehlopha) ka maemo a fapaneng a ho hloleha ha sebete (bonolo, bo leka-lekaneng, bo matla). Phuputsong ena, ha ho na ho lumellana ho fumanoeng pakeng tsa tekanyo ea ho hloleha ha sebete le pharmacokinetics ea insulin aspart.

Lithuto tsa polokeho ea pele

Lintlha tse boletsoeng esale pele tse amanang le lithuto tsa polokeho ea meriana Karolelano ea mesebetsi ea metabolism le mitogenic ea insludec insulin e tšoana le ea insulin ea motho.

Bokhachane le pelehi

Ts'ebeliso ea motsoako oa insulin degludec + insulin aspart nakong ea kemolo e tiisitsoe, hobane ha ho na boiphihlelo ba kliniki ka tšebeliso ea eona nakong ea kemaro. Lithuto tsa ts'ebetso ea ho ikatisa ho liphoofolo ha lia ka tsa senola phapang pakeng tsa insludec insulin le insulin ea motho mabapi le embryotoxicity le teratogenicity.

Ts'ebeliso ea motsoako oa insulin degludec + insulin aspart nakong ea kanyeso e kopantsoe, hobane Ha ho na boiphihlelo ba bongaka ba basali ba anyang basali.

Boithuto ba liphoofolo bo bonts'itse hore ho likhoto, "insulin" ea "insludec" e tšeloa lebese la matsoele, ho ts'eloa ha eona lebese la matsoele ho tlase ho plasma ea mali. Ha ho tsejoe hore na insludec ea insulin e pepesitsoe lebeseng la basali.

Melemo. Lithuto tsa liphoofolo ha lia ka tsa fumana litlamorao tse mpe tsa insludec insulin mabapi le kemolo.

Sehlopha sa Ketso ea Ts'oaetso ea FDA C.

Lithuto tse lekaneng le tse laoloang ka tieo tsa tšebeliso ea motsoako oa insulin degludec + insulin aspart ho basali baimana ha li e-so tšoaroe. Ha ba rera ho ima kapa ho e theha, bakuli ba lokela ho buisana le ngaka ea bona ka tšebeliso ea lithethefatsi. Kaha lithuto tsa ho hlahisa liphoofolo li ke ke tsa bolela esale pele litlamorao ho batho, motsoako oa insulin avludec + insulin aspart o lokela ho sebelisoa nakong ea kemolo ha feela phello e lebelletsoeng ea kalafo e feta kotsi e ka bang teng ho lesea. Bakeng sa bakuli ba nang le nalane ea lefu la tsoekere kapa lefu la tsoekere, ho boloka taolo e ntle ea metabolic pele ho kemaro le nakong ea kemaro ho bohlokoa. Tlhokahalo ea insulin e ka fokotseha nakong ea "trimester" ea pele ea kemaro, joalo ka molao, e eketseha nakong ea kotara ea bobeli le ea boraro mme e fokotseha kapele kamora ho beleha. Ho lekola ka hloko maemo a tsoekere ho bohlokoa ho bakuli bana.

Ha ho tsejoe hore na insulin kapa "insulin" ea "insulin" e hloekisoa lebeseng la matsoele. Kaha lintho tse ngata, ho kenyeletsa insulin ea motho, li pepesitsoe lebeseng la matsoele, tlhokomeliso e lokela ho sebelisoa ha ho sebelisoa motsoako oa insulin avludec + insulin aspart ho bo-'mè ba anyesang. Basali ba nang le lefu la tsoekere nakong ea lebone ba ka hloka phetoho ea tekanyetso ea insulin, moralo oa ho fepa, kapa bobeli ba tsona.

Ditlamorao tsa dintho Insulin degludec + Insulin aspart

Litlamorao tse atileng haholo tse tlalehiloeng nakong ea kalafo ke hypoglycemia (bona Tlhaloso ea karabelo e mpe ea motho ka mong).

Litla-morao tsohle tse hlalositsoeng ka tlase, li thehiloe ho datha tse tsoang ho liteko tsa tliliniki, li hlophisitsoe ho latela MedDRA le litsamaiso tsa litho. Tšitiso ea litlamorao e hlalosoa e le khafetsa (≥1 / 10), hangata (≥1 / 100 ho lithethefatsi, e ka beha bophelo ba mokuli kotsing.

Ha o sebelisa motsoako oa insulin degludec + insulin aspart, methapo ea hypersensitivity (ho kenyelletsa ho ruruha ha leleme kapa molomo, lets'ollo, ho nyekeloa ke pelo, mokhathala le ho hlohlona ha letlalo) le urticaria li ne li fumaneha seoelo.

Litla-morao. Ha o sebelisa insulin efe kapa efe, ho kenyelletsa motsoako oa insulin degludec + insulin aspart, bophelo bo botle bo ka bang kotsi bo akaretsang bo ka ba teng, ho kenyelletsa anaphylaxis, liphetoho tse akaretsang tsa letlalo, angioedema, bronchospasm, hypotension le makala, liphetoho tsena li ka beha bophelo kotsing (bona "Lits'ireletso") .

Hypersensitivity (e bonahatsoang ke ho ruruha ha leleme le molomo, lets'ollo, ho nyekeloa, ho tepella le ho hlohlona) le urticaria li ile tsa bonoa ka 0.5% bakuli ba fumanang motsoako oa insulin degludec + insulin aspart.

Hypoglycemia Hypoglycemia e ka hlaha haeba tekanyetso ea insulin e phahame haholo ha e bapisoa le tlhoko ea mokuli. Hypoglycemia e matla e ka lebisa ho lahleheloa ke kelello le / kapa ho tsitsipana, ho senyeha hoa nakoana kapa ho sa fetoheng hoa ts'ebetso ea boko, esita le lefu. Matšoao a hypoglycemia, joalo ka molao, a hlaha ka tšohanyetso. Tsena li kenyelletsa ho ruruha ho batang, ho ruruha ha letlalo, ho tepella ho hoholo, ho tšoha kapa ho thothomela, ho tšoenyeha, mokhathala o sa tloaelehang kapa bofokoli, ho ferekana, ho fokotseha ho tsepamisa maikutlo, ho otsela, tlala e matla, pono e fifatsang, ho opeloa ke hlooho, ho nyekeloa ke pelo.

Lipodystrophy. Lipodystrophy (ho kenyelletsa lipohypertrophy, lipoatrophy) e ka ntlafala sebakeng sa ente. Ho lumellana le melao ea ho fetola sebaka sa ente sebakeng se le seng sa anatomical ho thusa ho fokotsa kotsi ea ho fumana karabelo e mpe.

Lipodystrophy. Tšebeliso ea insulin nako e telele, ho kenyelletsa le motsoako oa insulin degludec + insulin aspart, e ka lebisa ho lipodystrophy sebakeng sa liente tsa insulin tse phetoang hangata. Lipodystrophy e kenyelletsa lipohypertrophy (thickening of adipose tiske) le lipoatrophy (tšesaetso ea lisele tsa adipose) mme e ka ama ho koaloa ha insulin. U lokela ho lula u fetola sebaka sa ente ea insulin kahare ho sebaka se ts'oanang sa anatomical ho fokotsa kotsi ea lipodystrophy. Lenaneo la kliniki le tlaleha lipodystrophy ho 0,1% ea bakuli, e tšoaroa ka motsoako oa insulin degludec + insulin aspart.

Likarabelo tsa sebakeng sa ente. Ho bakuli ba fumanang motsoako oa insulin degludec + insulin aspart, maikutlo a ile a bonoa setsing sa ente (hematoma, bohloko, hemorrhage ea lehae, erythema, li-nodules tsa tishu tse hlahang, ho ruruha, ho fifala ha letlalo, ho hlohlona, ​​ho teneha le ho tiisa sebakeng sa ente). Lintho tse ngata tse etsahalang setsing sa ente ena ha li na letho, ke tsa nakoana, 'me hangata li nyamela ka kalafo e tsoelang pele.

Likarabelo tsa sebakeng sa ente. Bakuli ba fumanang motsoako oa insulin avludec + le insulin aspart ba ka ba le karabelo sebakeng sa ente, ho kenyeletsoa hematoma, bohloko, hemorrhage, erythema, marumo, ho ruruha, ho bonahala ha letlalo, ho hlohlona, ​​ho utloa mofuthu, le ho tiisa sebakeng sa ente. Lenaneong la bongaka, maikutlo a teng sebakeng sa ente a ile a bonoa ho 2% ea bakuli, e tšoaroa ka motsoako oa insulin degludec + insulin aspart.

Ho fumana boima. Ho fumana boima ho ka bonoa ka kalafo ea insulin, ho kenyeletsoa ha u sebelisa motsoako oa insulin degludec + insulin aspart, 'me u be pontšo ea litla-morao tsa anabulin. Lenaneong la bakuli, bakuli ba nang le lefu la tsoekere la mofuta oa 1 ba fumaneng insulin degludec + insulin aspart, ba ne ba e-na le boima ba 'mele ba boima ba lik'hilograma tse 2,8,' me bakuli ba nang le lefu la tsoekere la mofuta oa 2 ba amohetseng insulin degludec + insulin aspart ba fumane karolelano ea 1 , 6 kg.

Edema ea Peripheral. Insulin, ho kenyeletsoa ho kopana ha insulin degludec + insulin aspart, ho ka lebisa ho bolokoeng ha sodium le edema. Lenaneong la bongaka, edema ea potoloho e ile ea bonoa ho 2.2% ea bakuli ba nang le lefu la tsoekere la 1 le 1.8% ea bakuli ba nang le lefu la tsoekere la mofuta oa 2 ba amohetseng motswako oa insulin avludec + insulin.

Bana le bacha. Melemo ea pharmacokinetic ea motsoako oa "insulin degludec + insulin" e ithutile ho bana le bacha ba ka tlase ho lilemo tse 18 (bona. Pharmacokinetics). Boithuto ba ho sebetsa hantle le polokeho ho bana le lilemong tsa bocha ha bo e-so tšoaroe.

Lihlopheng tse ikhethang tsa bakuli. Nakong ea liteko tsa tleliniki, ha ho liphapang tse fumanoeng khafetsa, mofuta, kapa ho teba ha maikutlo a lipakeng tsa bakuli ba tsofetseng, bakuli ba nang le mokokotlo oa mokokotlo oa mokokotlo kapa oa hepatic, le bongata ba bakuli ka kakaretso.

Phihlelo ea Patlisiso ea Kliniki

Kaha liteko tsa tleliniki li etsoa ka maemo a fapaneng, liketsahalo tsa maemo a mabe tse bonoang lithutong tsena li ke ke tsa bapisoa ka kotloloho le khafetsa litekong tse ling tsa kliniki le ho bolela esale pele ho ba teng ha litla-morao tsa tleliniki.

Tšireletseho ea motsoako oa insulin degludec + insulin aspart ho bakuli ba mofuta oa 1 le mofuta oa 2 lefu la tsoekere e ile ea hlahlojoa litekong tse 5 tse reriloeng ka molao-motheo oa "ho phekola ho ea ho sepheo", likhoeli tse 6-12 tse sa feleng.

Boithuto ba polokeho ea motsoako oa insulin degludec + insulin aspart ho bakuli ba nang le mofuta oa 1 lefu la tsoekere le kenyelletsa bakuli ba 362, nako e tloaelehileng ea ho pepesetsoa e ne e le libeke tse 43. Karolelano ea bakuli e ne e le lilemo tse 41, mme 1% ea bakuli e ne e le lilemo tse fetang 75. Linoko tse mashome a mahlano a metso e 'meli e ne e le banna, 91% e ne e le letlalo le bosoeu, 3% e le Maafrika-Amerika,' me 3% e le ea Spain. BMI e tloaelehileng e ne e le 26 kg / m 2. Nako e tloaelehileng ea lefu la tsoekere e ne e le lilemo tse 17, mme HbA e tloaelehileng_1c qalong ea thuto - 8,3%. Nalane ea lefu la neuropathy, ophthalmopathy, nephropathy le lefu la pelo qalong ea thuto e tlalehiloe maemong a 19, 25, 6 le 4%, ka ho latellana. Moelelo oa GFR qalong ea thuto e ne e le 88 ml / min / 1.73 m 2, mme 6% ea bakuli ba ne ba na le GFR ka tlase ho 60 ml / min / 1.73 mm 2.

Phuputso e 'ngoe ea polokeho ea motsoako oa insulin degludec + insulin aspart e ne e kenyelletsa bakuli ba 998 ba nang le mofuta oa 2 lefu la tsoekere, nako e telele ea ho pepeseha e ne e le libeke tse 24. Karolelano ea bakuli e ne e le lilemo tse 58, 'me 3% e ne e feta lilemo tse 75. Linoko tse mashome a mahlano a metso e mene e ne e le banna, 44% e ne e le letlalo le bosoeu, 4% African-American, 'me 6% e ne e le Hispanic. BMI e tloaelehileng e ne e le 29 kg / m 2. Nako e tloaelehileng ea lefu la tsoekere ke lilemo tse 12, HbA e tloaelehileng_1c qalong ea thuto - 8,5%. Nalane ea lefu la neuropathy, ophthalmopathy, nephropathy le lefu la pelo qalong ea thuto e tlalehiloe maemong a 15, 21, 10 le 1%, ka ho latellana. Pele, moelelo oa GFR o ne o le 84 ml / min / 1.73 m 2 mme ho 11% ea bakuli ba ka tlase ho 60 ml / min / 1.73 m 2.

Karabelo e akaretsang e mpe (ntle le hypoglycemia) e hlokometsoeng nakong ea liteko tsa tleliniki ho bakuli ba nang le mofuta oa 1 le mofuta oa 2 lefu la tsoekere le phekoloang ka motsoako oa insulin avludec + insulin aspart li fanoa ka tlase. Liphetoho tse akaretsang tse mpe li hlalositsoe e le karabelo e bonoang ho ≥5% ea bakuli ho palo ea batho ba ithutoang. Hypoglycemia ha e bontšoe mme e tšohloa karolong e ikhethang e ka tlase.

Boitšoaro bo bobe bo bonoang ho ≥5% ea bakuli ba nang le mofuta oa 1 lefu la tsoekere kalafong kalafo ea insulin degludec + insulin aspart (N = 362)

Ho opeloa ke hlooho 9.7%.

Likokoana-hloko tsa phepelo e phahameng ea phefumoloho li 9.1%.

Liphetoho tse mpe tse bonoang ho ≥5% ka mofuta oa 2 lefu la tsoekere kalafong kalafo ea "insulin" le "insulin" (N = 998)

Ts'oaetso ea phepelo ea "phepelo e phahameng" ea 5.7%.

Bohloko ba hlooho ea 5.6%.

Hypoglycemia ke karabelo e atisang ho hlahella ho bakuli ba sebelisang insulin, ho kenyelletsa le motsoako oa insulin avludec + insulin aspart (bona "Precautions"). Khafetsa ea hypoglycemia e tšoaeang e ipapisitse le moelelo o sebelisoang mohopolo oa hypoglycemia, joalo ka lefu la tsoekere, lethal dose la insulin, matla a taolo ea tsoekere, kalafo ea ka morao le lintlha tse ling tsa ka hare le kantle ho mokuli. Bakeng sa mabaka ana, ho bapisa liketsahalo tsa hypoglycemia litekong tsa kliniki tsa motsoako oa insulin degludec + insulin aspart le ts'oaetso ea hypoglycemia le basebeletsi ba bang e ka ba e khelosang mme e kanna ea se be moemeli oa tlhahlobo ea hypoglycemia e hlokometsoeng ts'ebetsong ea bongaka.

Se latelang ke boemo ba hypoglycemia lithutong ho bakuli ba nang le lefu la tsoekere la mofuta oa 2 le ileng la amohela motsoako oa insulin avludec + insulin aspart. Hypoglycemia e matla e hlalositsoe e le ketsahalo e hlokang thuso ea motho e mong ho kenella lik'habohaedreite, tsoekere kapa mofuta o mong oa ho tsosa hape

Lithutong tsa bongaka, ho kopana ha insulin degludec + insulin aspart hypoglycemia ho hlalositsoe e le ketsahalo ea "hypoglycemia" e matla, kapa ketsahalo eo glucose ea "laboratori kapa" e neng e le ka tlase ho 56 mg / dl kapa glucose eohle ea mali e neng e le ka tlase ho 50 mg / dl (i.e nang le matšoao a hypoglycemic kapa ntle le ona) - (2).

Peresente ea bakuli ba nang le lefu la tsoekere la mofuta oa 1 ba nang le bonyane karolo e le 'ngoe ea hypoglycemia (1) kapa hypoglycemia (2) litekong tsa bakuli ba baholo.

Thutong ea A, bakuli ba fumane motsoako oa insulin degludec + insulin aspart (nako e le 1 ka letsatsi) le insulin aspart (makhetlo a 2 ka letsatsi) bakeng sa libeke tse 52 (N = 362).

Hypoglycemia (1) 13.3%.

Hypoglycemia (2) 95%.

Peresente ea bakuli ba nang le lefu la tsoekere la mofuta oa 2 ba nang le bonyane karolo ea 1 ea hypoglycemia (1) kapa hypoglycemia (2) litekong tsa bakuli ba baholo.

Thutong ea B, bakuli ba fumane motsoako oa insulin degludec + insulin aspart (nako e 1 ka letsatsi), insulin e bonolo mme pele ho 2 kapa ho feta PHGP (N = 265).

Thutong ea C, bakuli ba fumane motsoako oa insulin degludec + insulin aspart (nako e le 1 ka letsatsi), insulin ea preal (1 nako ka letsatsi), le 1 kapa ho feta PHGP (N = 230).

Thutong ea D, bakuli ba amohela motsoako oa insulin degludec + insulin aspart (makhetlo a 2 ka letsatsi), pejana ka makhetlo a 1-2 ka letsatsi, pele / ho ikopanya, le / ntle le PHGP (N = 224).

Thutong ea E, bakuli ba ile ba amohela motsoako oa insulin degludec + insulin aspart (makhetlo a 2 ka letsatsi), pejana makhetlo a 1-2 ka letsatsi basal / pre / boithati bo kopaneng, le / ntle le PHGP (N = 279).

Hypoglycemia (1) 0.4, 0, 3.1 le 1.4%.

Hypoglycemia (2) 49.8, 52.6, 66.1 le 73.5%.

Tšebelisano

Hona le lithethefatsi tse 'maloa tse amang tlhokahalo ea insulin.

Tlhokahalo ea insulin e ka fokotsoa: lithethefatsi tsa molomo tsa hypoglycemic, li-glucagon-peptide-1 receptor agonists (GLP-1), li-inhibitors tsa MAO, li-beta-blocker tse sa khethang, li-inhibitors tsa ACE, salicylates, anabolic steroid le sulfonamides.

Tlhokahalo ea insulin e ka eketseha: lithibela-pelehi tsa molomo tsa lihormone tsa molomo, li-thiazide diuretics, li-corticosteroids, lihormone tsa qoqotho, sympathomimetics, somatropin le danazole.

Beta-blockers li ka pata matšoao a hypoglycemia.

Octreotide / lanreotide ka bobeli li ka eketsa le ho fokotsa tlhoko ea mmele ea insulin.

Ethanol e ka ntlafatsa le ho fokotsa phello ea hypoglycemic ea insulin.

Lithethefatsi tse ling, ha li eketsoa hammoho le insulin degludec + insulin aspart, li ka baka tšenyo ea insulin degludec le / kapa insulin. Motsoako oa insulin degludec + insulin aspart ha oa lokela ho eketsoa ka tharollo ea infusion. U ke ke oa kopanya sethethefatsi sena le lithethefatsi tse ling.

Mekhahlelo ea bohlokoa ea ts'ebelisano ea insulin degludec + insulin aspart

Lithethefatsi tse ka eketsang kotsi ea hypoglycemia:lithethefatsi tsa antidiabetes Li-inhibitors tsa ACE Angiotensin II receptor blockers, li-disopyramides, li-fibrate, fluoxetine, MAO inhibitors pentoxifylline, pramlintide, propoxypheneli-salicylates somatostatin analogues (mohlala, octreotide), sulfonamides, Li-agonists tsa GLP-1, dipeptidyl peptidase-4 inhibitors; mofuta oa li-inhibitors tse tšehelitsoeng ke sodium-glucose glucose transporter mofuta oa 2 inhibitors (SGLT-2 inhibitors).

Ka ts'ebeliso e kopanetsoeng ea motsoako oa insulin degludec + insulin aspart le lithethefatsi tsena, phokotso ea litekanyetso le keketseho ea khafetsa ea ho lekola maemo a tsoekere e ka hlokahala.

Lithethefatsi tse ka fokotsang phello ea ho kopana ha insulin degludec + insulin aspart (ho theola tsoekere ea mali):antiypych antipsychotic (olanzapine le clozapine), corticosteroids, danazol diuretics, estrogens, glucagon, isoniazid, nicotinic acid, lithibela-pelehi tsa molomo phenothiazines, progesterones (ho kenyeletsoa e le karolo ea lithibela-pelehi tsa molomo), liprotheine tsa thibelo ea mafu, somatropin, sympathomimetics (ho kenyelletsa salbutamol, epinephrine, terbutaline), lihormone tsa qoqotho.

Ka tšebeliso e kopaneng ea motsoako oa insulin degludec + insulin aspart le lithethefatsi tsena, keketseho ea tekanyetso le khafetsa ea ho lekola maemo a tsoekere e ka hlokahala.

Lithethefatsi tse ka eketsang le ho fokotsa phello ea ho kopana ha insulin degludec + insulin aspart (ho theola tsoekere ea mali): joala beta-blockers, clonidine, litsi tsa letsoai. Pentamidine e ka baka hypoglycemia, eo ka linako tse ling e ka tsamaeang le hyperglycemia.

Ka tšebeliso e kopaneng ea motsoako oa insulin degludec + insulin aspart le lithethefatsi tsena, ho ka fetoloa litekanyetso le keketseho ea sekhahla sa ho lekola maemo a tsoekere.

Lithethefatsi tse ka thibelang matšoao le matšoao a hypoglycemia: beta blockers, clonidine, guanethidine le reserpine. Ka tšebeliso e kopaneng ea motsoako oa insulin degludec + insulin aspart le lithethefatsi tsena, keketseho ea sekhahla sa ho lekola maemo a tsoekere e ka hlokahala.

Bongata

Tekanyetso e tobileng e bakang insulin e ngata ha e e-so theoe, empa hypoglycemia e ka hlaha butle butle haeba tekanyetso ea lithethefatsi e phahame haholo ha e bapisoa le tlhoko ea mokuli (bona "Precautions"). Mokuli a ka felisa hypoglycemia e bonolo ka ho nka lihlahisoa tsa glucose kapa tsoekere tse nang le tsoekere ka molomo. Ka hona, ho khothalletsoa hore bakuli ba nang le lefu la tsoekere ba lule ba nkile lihlahisoa tse nang le tsoekere.

Maemong a hypoglycemia e matla, ha mokuli a sa tsebe letho, o lokela ho kenngoa ka glucagon (ho tloha ho 0.5 ho isa ho 1 mg) i / m kapa s / c (e ka tsamaisoa ke motho ea koetlisitsoeng) kapa ka / ka tharollo ea dextrose (glucose) (e ka tsamaisoa feela mosebeletsi oa bongaka). Ho hlokahala hape ho tsamaisa dextrose iv haeba mokuli a sa hlaphoheloe kelellong metsotso e leshome le metso e mehlano ka mor'a ts'ebetso ea glucagon. Kamora ho hlaphoheloa kelellong, mokuli o eletsoa ho nka lijo tse nang le lik'habohaedreite ho thibela ho khutla ha hypoglycemia.

Litlhokomelo tsa dintho Insulin degludec + insulin

Hypoglycemia Haeba u ja lijo kapa u ikoetlisa ka matla ka tsela e sa reroang, mokuli a ka ba le hypoglycemia. Hypoglycemia e ka boela ea hlaha haeba tekanyetso ea insulin e phahame haholo ha e bapisoa le litlhoko tsa mokuli (bona "Litla-morao" le "Overdose").

Kamora ho lefa tefo ea metabolism ea carbohydrate (ka mohlala, kalafo ea insulin e matlafalitsoeng), matšoao a bakuli a tloaelehileng ho bona a ka fetoha - ba tlang pele ho hypoglycemia, eo bakuli ba lokelang ho tsebisoa ka eona. Matšoao a tloaelehileng - pele ho nako a ka nyamela ka tsela e telele ea lefu la tsoekere.

Mafu a khahlang, haholo a tšoaetsanoang le feberu, hangata a eketsa tlhoko ea mmele ea insulin. Phetoho ea mori le eona e ka hlokahala haeba mokuli a e-na le mathata a liphio, a sebete, kapa a adrenal gland, pituitary kapa mathata a qoqotho.

Joalo ka litokisetso tse ling tsa basulin tsa insulin kapa litokisetso tse nang le karolo ea basal, ho hlaphoheloa ka mor'a hypoglycemia ka motsoako oa insulin avludec + insulin aspart ho ka lieha.

Lintho tse ka behang kotsing ea hypoglycemia. Kotsi ea hypoglycemia e eketseha ka taolo e matla ea glycemic. Kotsi ea hypoglycemia kamora ho kenngoa ka ente e amahanngoa le nako ea ts'ebetso ea insulin mme hangata e phahame haholo ha phello e thellang ea "glucose" e le matla haholo. Joalo ka litokisetso tsohle tsa insulin, phello ea ho fokotsa tsoekere ea motsoako oa insulin degludec + insulin aspart e ka fapana ka nako ho batho ba fapaneng kapa ka linako tse fapaneng ho batho ba tšoanang mme ho latela maemo a mangata, ho kenyelletsa le sebaka sa ente, hammoho le phallo ea mali le mocheso sebakeng sa ente. .

Lintho tse ling tse ka eketsang kotsi ea hypoglycemia li kenyelletsa liphetoho phepong (mohlala, litaba tsa macronutrients kapa linako tsa lijo), liphetoho maemong a ho ikoetlisa, kapa liphetoho ha li nooa ka molomo le lithethefatsi tse ling (bona "Ho sebelisana '). Bakuli ba nang le bothata ba ho phekola renal kapa hepatic ba ka ba kotsing e kholo ea ho ba le hypoglycemia.

Maano a ho fokotsa kotsi ea hypoglycemia. Bakuli le bahlokomeli ba lokela ho tseba matšoao a hypoglycemia mme ba nke mehato e nepahetseng. Ho itlhahloba ha tsoekere ea mali e bapala karolo ea bohlokoa ho thibela le ho phekola hypoglycemia. Ho bakuli ba nang le menyetla e eketsehileng ea hypoglycemia le ho bakuli ba nang le matla a fokotsehileng a ho utloa matšoao a hypoglycemia, ho khothalletsoa keketseho ea khafetsa ea ho lekola tsoekere ea mali.

Hyperglycemia Tekanyo e sa lekaneng ea kalafo kapa ho khaotsa ho phekoloa ho ka lebisa ho nts'etsopele ea hyperglycemia kapa lefu la tsoekere. Ho feta moo, mafu a kopaneng, haholo-holo a tšoaetsanoang, a ka kenya letsoho kholisong ea maemo a hyperglycemic, ka hona, a eketsa tlhoko ea mmele ea insulin.

E le molao, matšoao a pele a hyperglycemia a hlaha butle butle, ho feta lihora tse 'maloa kapa matsatsi. Matšoao ana a kenyelletsa lenyora, ho ntša metsi kapele, ho nyekeloa ke pelo, ho hlatsa, ho otsela, ho otsela le ho omella ha letlalo, molomo o omileng, ho felloa ke takatso ea lijo, monko oa acetone moeeng o tsoang. Mofuta oa 1 lefu la tsoekere mellitus, ntle le kalafo e nepahetseng, hyperglycemia e lebisa nts'etsopele ea lefu la tsoekere la ketoacidosis mme e ka lebisa lefung.

Bakeng sa kalafo ea hyperglycemia e matla, ho khothalletsoa insulin e potlakileng.

Fetisetsa mokuli ho tsoa litokisetsong tse ling tsa insulin. Ho fetisoa ha mokuli ho ea ho mofuta o mocha kapa ho hlophisoa ha insulin ea mofuta o mocha kapa moetsi e mong ho tlameha ho etsahala tlasa tlhokomelo ea bongaka e matla. Ha o fetolela, ho ka hlokahala phetoho ea tekanyetso.

Hyperglycemia kapa hypoglycemia e nang le liphetoho ho regimen ea insulin. Liphetoho litšobotsing tsa insulin, moetsi, mofuta kapa tsela ea tsamaiso li ka ama taolo ea glycemic le predispose ho hypoglycemia kapa hyperglycemia. Liphetoho tsena li lokela ho etsoa ka hloko mme e le tlasa taolo ea ngaka feela, khafetsa ea ho lekanya tsoekere ea mali e lokela ho eketsoa. Bakeng sa bakuli ba nang le lefu la tsoekere la mofuta oa 2 lefu la tsoekere, ho ka hlokahala phetoho ea litekanyetso ka kalafo e tšoanang ea PHGP. Ha o tloha ho tse ling tse ling tsa insulin kalafo ho ea kalafo e kopaneng le insulin degludec + insulin aspart, ho ka hlokahala hore o fetole lethal dose.

Ts'ebeliso e tšoanang ea lithethefatsi tsa sehlopha sa thiazolidinedione le litokisetso tsa insulin. Litaba tsa ho ntlafala ha ho se sebetse ha pelo li tlalehiloe kalafong ea bakuli ba thiazolidinediones hammoho le litokisetso tsa insulin, haholo haeba bakuli ba joalo ba na le mabaka a kotsi a ho ba le ho nyekeloa ke pelo. Ntlha ena e lokela ho tsotelloa ha bakuli ba beoa kalafo e kopantsoeng le thiazolidinediones le motsoako oa insulin avludec + insulin. Ka ho khethoa ha phekolo e joalo e kopaneng, ho bohlokoa ho etsa tlhahlobo ea bongaka ea bakuli ho bona matšoao le matšoao a ho hloleha ha pelo, ho eketsa boima ba 'mele le boteng ba edema ea pherekano. Haeba matšoao a ho hloleha ha pelo a mpefala ho bakuli, kalafo e nang le thiazolidinediones e tlameha ho khaotsa.

Ho boloka mokelikeli le nts'etsopele ea ho nyekeloa ke pelo le tšebeliso e tšoanang ea li-agmaists tsa gamma receptor tse qalileng ke proliferator ea peroxisome (peroxisome proliferator-activated receptor-gamma, PPAR gamma). Li-Thiazolidinediones tse agonists PPARgamma e kanna ea baka ho bolokoa ha metsi haholo ha e sebelisoa hammoho le insulin. Ho boloka mokelikeli ho ka lebisa ho hola kapa ho mpefala le ho feta ha nako ea ho hloleha ha pelo. Bakuli ba fumanang insulin, ho kenyeletsoa motsoako oa insulin degludec + insulin aspart, le agonists PPARgamma e lokela ho hlahlojoa bakeng sa matšoao le matšoao a ho hloleha ha pelo. Haeba CHF e hlaha, ho hlokahala hore u tsamaise kalafo ho latela litekanyetso tsa hona joale tsa tlhokomelo ea bongaka mme u nahane ka ho khaotsa kapa ho fokotsa lethal dose ea agonist PPARgamma.

Tlolo ea setho sa pono. Ho matlafatsoa ha kalafo ea insulin ka ntlafatso e matla taolong ea metabolism ea carbohydrate ho ka lebisa ho senyeha ha nakoana maemong a lefu la tsoekere, ha ntlafatso ea nako e telele taolong ea glycemic e fokotsa kotsi ea tsoelo-pele ea lefu la tsoekere.

Thibelo ea ho ferekanya ka phoso ea litokisetso tsa insulin. Mokuli o lokela ho laeloa ho lekola lengolo le ngotsoeng ka mongolo o mong le o mong pele ho ente e 'ngoe le e' ngoe ho qoba ho ferekanya ka phoso ho kopanya ha insulin degludec + insulin aspart le litokisetso tse ling tsa insulin. Bakuli ba lokela ho lekola lethal dose ho kontinent ea ente ea injector. Hoa hlokahala ho tsebisa bakuli ba foufetseng kapa batho ba nang le bothata ba ho bona hore ba lula ba hloka thuso ea batho ba se nang mathata a pono le ba koetliselitsoeng ho sebetsa le injector.

Li-antibodies ho insulin. Ha o sebelisa insulin, ho ka etsoa ka antibody. Maemong a sa tloaelehang, sebopeho sa antibody se ka hloka tokiso ea tekanyetso ea insulin ho thibela linyeoe tsa hyperglycemia kapa hypoglycemia.

Immunogenicity Joalo ka liprotheine tsohle tsa kalafo, tsamaiso ea insulin e ka etsa hore ho thehoe li-insulin. Ho fumanoa ha motho ea ts'oaetso ho itšepa haholo ho latela kutloisiso le ho khetholoha ha mokhoa oa ho sekaseka mme e ka ba ka lebaka la lintlha tse 'maloa, joalo ka mokhoa oa mokhoa oa tlhahlobo, ts'ebetso ea mehlala, nako ea pokello ea sampole, kalafo e kopaneng, le lefu le tlasa. Ka mabaka ana, ho bapisa karolo ea li-antibodies le motsoako oa insulin degludec + insulin aspart le boemo ba li-antibodies lithutong tse ling kapa linthong tse ling li ka u khelosa.

Lithutong tsa bakuli ba nang le lefu la tsoekere la mofuta oa 1 lefu la tsoekere, 95,9% ea bakuli ba fumanang motsoako oa insulin avludec + insulin aspart hang ka letsatsi ba ne ba le tlhahlobo e ntle ea li-antibodies tsa bonyane hanngoe nakong ea thuto. sephetho se nepahetseng, ha 13% ea bakuli bana bonyane nako ea 1 nakong ea thuto e fane ka phello e ntle bakeng sa li-antibodies ho insulin aspart, ho kenyelletsa le 6.4% ea bakuli ba bileng le sephetho se nepahetseng. Lithutong tsa bakuli ba nang le lefu la tsoekere la mofuta oa 2 lefu la tsoekere, 67,5% ea bakuli ba fumanang motsoako oa insulin degludec + insulin aspart hang ka letsatsi ba bile le litlamorao tse ntle tsa tlhahlobo ea li-antibodies ho isa insulin bonyane nako ea 1 nakong ea thuto. ba bileng le litholoana tse ntle qalong ea thuto, ha ba 17.1% ea bakuli bana bonyane nako e le 'ngoe nakong ea thuto ba ile ba fumana liteko tsa hore na li-antibodies li lokela ho sebelisa insulin aspart, ho kenyelletsa 12,3%, e bileng le sephetho se nepahetseng. Maemo a antibody kalafong ea lefu la tsoekere la mofuta oa 2 a kanna a fokotsoa ka lebaka la tšitiso e ka bang teng tlhahlobisong e teng ka lebaka la boteng ba insulin ea methapo ho liseleng tsena ho bakuli. Ho ba teng hoa li-antibodies tse amang ts'ebetso ea bongaka ho ka hloka phetoho ea tekanyetso ho tloaela tloaelo ea hyper- kapa hypoglycemia. Ho ba teng ha li-antibodies ho degludec insulin ha ho so thehiloe.

Hypersensitivity le allergic reaction. Mekhatlo e matla e sokelang bophelo bohle, ho kenyelletsa le anaphylaxis, e ka hlaha ka ts'ebeliso ea litokisetso tsa insulin, ho kenyeletsa metsoako ea insulin degludec + insulin aspart. Mabakeng a karabelo ea hypersensitivity, ho hlokahala hore o emise ho sebelisa motsoako oa insulin degludec + insulin aspart, tsamaisa kalafo ho latela maemo a kalafo ea tlhokomelo ea bongaka le ho shebella ho fihlela matšoao le matšoao a rarollotsoe. Ts'ebeliso ea motsoako oa insulin degludec + insulin aspart e hanoa ho bakuli ba bileng le maikutlo a hypersensitivity ho insulin degludec kapa insulin aspart (bona "Contraindication").

Hypokalemia. Li-insulin tsohle, ho kenyelletsa le ho kopana ha insulin degludec + insulin aspart, ho baka phetoho ea potasiamo e tsoang sebakeng se kantle ho sele, e ka lebisang ho hypokalemia. Hypokalemia e sa phekoloang e ka baka ho holofala ha moea, arrhythmias ea moea le lefu. Hoa hlokahala ho hlokomela boemo ba potasiamo ho bakuli ba kotsing ea hypokalemia, haeba ho bontšitsoe (ka mohlala, bakuli ba sebelisang lithethefatsi tse nang le litekanyetso tse tlase tsa potasiamo, hammoho le bakuli ba noang lithethefatsi tse amehileng ka khatello ea potasiamo).

Lihlopheng tse khethehileng tsa bakuli

Bakuli ba tsofetseng (ba fetang lilemo tse 65). Motsoako oa insulin degludec + insulin aspart o ka sebelisoa ho bakuli ba tsofetseng. Ts'oaetso ea glucose ea mali e lokela ho beoa leihlo ka hloko 'me lethal dose la insulin le lokisoe ka mokhoa o le mong (bona "Pharmacokinetics").

Sebelisa ho li-geriatrics. Litekong tsa bongaka, kakaretso ea bakuli ba 9 (2,5) ea batho ba 362 ba nang le lefu la tsoekere la mofuta oa 1 ba ileng ba phekoloa ka motsoako oa insulin avludec + insulin aspart ba ne ba le lilemo li 65 kapa ho feta mme ba 4 (1.1%) ba ne ba le lilemo li 75 le e felile. Kakaretso ea bakuli ba 256 (25,7%) ea bakuli ba 998 ba nang le lefu la tsoekere la mofuta oa 2 ba neng ba sebelisa motsoako oa insulin degludec + insulin aspart ba ne ba le lilemo tse 65 kapa ho feta mme ba 32 (3.2%) ba ne ba le lilemo tse 75 kapa ho feta. Tlhahlobo e bapisoang ha ea ka ea senola liphapang tsa polokeho kapa katleho ho bakuli ba lilemo tse fetang 65 ha ba bapisoa le bakuli ba banyenyane.

Leha ho le joalo, ha e sebelisoa ho bakuli ba li-geriatric, ho hlokahala hore ho sebelisoe tlhokomeliso e khōloanyane, hobane kutloelo-bohloko e kholo ho litlamorao tsa ho kopana ha insulin degludec + insulin aspart ho batho ba bang ba tsofetseng e ke ke ea qheleloa ka thoko. Tekanyetso ea pele, lethal dose le litheko tsa tlhokomelo ha ea lokela ho fokotsoa ho qoba hypoglycemia. Hypoglycemia e kanna ea thatafalloa ho e tseba ho batho ba baholo.

Bakuli ba nang le mathata a ho renal le hepatic. Motsoako oa "insulin degludec + insulin" o ka sebelisoa ho bakuli ba nang le bothata ba ho ruruha le ho senyeha hoa hepatic. Ts'oaetso ea glucose ea mali e lokela ho beoa leihlo ka hloko 'me lethal dose la insulin le lokisoe ka mokhoa o le mong (bona "Pharmacokinetics").

Ho hloleha hape Litekong tsa bongaka, bakuli ba 18 (5%) ba nang le lefu la tsoekere la mofuta oa 1 ba amohetseng mofuta oa insulin degludec + insulin aspart ba ne ba na le GFR ea ka tlase ho 60 ml / min / 1.73 m 2 kapa ka tlase ho mokuli a le 1 (0.3%). GFR e ne e le ka tlase ho 30 ml / min / 1,73 m 2 kapa ka tlase. Kakaretso ea bakuli ba 111 (11%) ba bakuli ba 998 ba nang le lefu la tsoekere la mofuta oa 2 ba amohetseng motsoako oa insulin degludec + insulin aspart ba nang le GFR ea ka tlase ho 60 ml / min / 1.73 m 2, 'me ha ho na bakuli ba neng ba na le GFR ea ka tlase ho 30 ml / min / 1.73 m 2.

Ho ne ho se na phapang lipolotiking tsa likarolo tsa motho ka mong tsa motsoako oa insulin degludec + insulin aspart lithutong tse ikemetseng ha li bapisoa le ho batho ba phetseng hantle le batho ba nang le ts'ebetso ea ho ruruha ea mokokotlo. Leha ho le joalo, joalo ka li-insulin tsohle, ho bakuli ba nang le ho se sebetse ha renal, tlhahlobo ea tsoekere e lokela ho ntlafatsoa, ​​'me litekanyetso tsa motsoako oa insulin avludec + insulin aspart li lokela ho fetoloa ka bomong.

Ho hloleha ha sebete. Ho ne ho se na phapang lipolotiking tsa likarolo tsa motho ka mong tsa motsoako oa insulin degludec + insulin aspart lithutong tse ikemetseng ha li bapisoa lithutong tse phetseng hantle le lihloohong ka ho hloleha ha sebete (ho fokola, ho leka-lekana le ho se sebetse hantle ha sebete). Leha ho le joalo, joalo ka li-insulin tsohle, tlhaiso ea tsoekere e lokela ho matlafatsoa le litekanyetso tsa "insulin" ea "insulin" e kopantsoeng le motho ka mong ho bakuli ba nang le ts'ebetso ea sebete.

Bana le bacha. Lintlha tse teng tsa pharmacokinetic li hlahisoa karolong ea Pharmacokinetics, leha ho le joalo, ts'ebetso le polokeho ea motsoako oa insulin degludec + insulin aspart ho bana le bacha ba ka tlase ho lilemo tse 18 ha ba e-so ithutoe, litlhahiso mabapi le tekanyetso ea lithethefatsi ho bana ha li e-so hlahisoe.

Le ka mohla u se ke oa fetisetsa pente ea syringe ho bakuli ba bang. Pene ha ea lokela ho fetisetsoa ho motho e mong, le haeba nale e fetotsoe. Tšebeliso ea pene ea setho e le 'ngoe ke mokuli e mong e beha kotsing ea phetiso ea tšoaetso ea hemato native.

Tšusumetso ho bokhoni ba ho khanna makoloi le mekhoa. Bokhoni ba bakuli ba ho tsepamisa mohopolo le sekhahla sa karabelo se ka senyeha nakong ea hypoglycemia, e ka bang kotsi maemong ao bokhoni bona bo hlokahalang haholo (mohlala, ha o khanna makoloi kapa o sebetsa le mechini).

Bakuli ba lokela ho eletsoa hore ba nke mehato ea ho thibela nts'etsopele ea hypoglycemia ha u ntse u khanna.Sena se bohlokoa haholo ho bakuli ba nang le matšoao a sieo kapa a fokotsehileng - tse tlang pele ho nts'etsopele ea hypoglycemia kapa liketsahalo tse etsahalang khafetsa hypoglycemia. Maemong ana, ho tšoaneleha ho lekana ha ho khanna koloi.