Comboglizzen, fumana, reka

Lebitso la Khoebo la tokiso: Katoloso ea Komboglize

Lebitso la machabeng le sa sebetseng: Metformin (metformin) + Saxagliptin (saxagliptin)

Foromo ea boholo: Matlapa a koahetsoeng ka filimi

Lintho tse sebetsang: Metformin hydrochloride + saxagliptin

Sehlopha sa Pharmacotherapeutic: Moemeli oa Hypoglycemic bakeng sa tsamaiso ea molomo (dipeptidyl peptidase 4 inhibitor + biguanide).

Sebopeho sa pharmacological:

Combogliz Prolong e kopanya lithethefatsi tse peli tsa hypoglycemic le mekhoa e tlatsanang ea ts'ebetso ho ntlafatsa taolo ea glycemic ho bakuli ba nang le mofuta oa 2 lefu la tsoekere mellitus (DM2): saxagliptin, dipeptidyl peptidase 4 inhibitor (DPP-4), le metformin, moemeli oa sehlopha sa Biguanide.

Ha o arabela ho kenella ha lijo ho tsoa ka mpeng e nyane, lihormone tsa "incretin" li kenngoa maling, joalo ka glucagon-peptide-1 (GLP-1) le "insulinotropic polypeptide" (HIP) ea glucose. Lihormone tsena li khothaletsa ho ntša insulin liseleng tsa "pancreatic beta", tse ipapisitseng le ts'oarello ea glucose maling, empa e sa sebetse ka enzyme ea DPP-4 ka metsotso e 'maloa. GLP-1 e boetse e theola secretion ea tsoekere ho lisele tsa pancreatic alpha, e fokotsa tlhahiso ea glucose ea sebete. Ho bakuli ba nang le lefu la tsoekere la mofuta oa 2, khatello ea GLP-1 e ea theoha, empa karabelo ea insulin ho GLP-1 e ntse e le teng. Saxagliptin, kaha e le inhibitor ea DPP-4, e fokotsa ho kenella ha lihormone tsa "incretin", ka tsela eo, e eketsa tsitsipano ea bona maling mme e lebise ho fokotsehe ha tsoekere e potlakileng ka mor'a ho ja.

Metformin ke sethethefatsi sa hypoglycemic se ntlafatsang mamello ea tsoekere ho bakuli ba nang le lefu la tsoekere la 2, le ho fokotsa khatello ea tsoekere ea postprandial. Metformin e fokotsa tlhahiso ea tsoekere ke sebete, e fokotse ho monya ha tsoekere ka mpeng mme e phahamisa kutloisiso ea insulin, e eketsa ho kenella ka bongata le ts'ebeliso ea tsoekere. Ho fapana le litokisetso tsa sulfonylurea, metformin ha e bake hypoglycemia ho bakuli ba nang le lefu la tsoekere la mofuta oa 2 kapa batho ba phetseng hantle (ntle le maemong a ikhethang, bona likarolo tsa "Boitlhokomelo" le "Litaelo tse Khethehileng"), le hyperinsulinemia. Nakong ea phekolo ea metformin, secretion ea insulin e lula e sa fetohe, leha ho tsepamisa mohopolo oa insulin le ho arabela lijong tsa motšeare ho ka fokotseha.

Matšoao a sebeliso:

Type 2 lefu la tsoekere le kopantsoe le lijo le boikoetliso ho ntlafatsa taolo ea glycemic.

Contraindication:

- Ho eketsa kutloisiso ea motho ka mong ho karolo efe kapa efe ea lithethefatsi,

- Liphetoho tse tebileng tsa hypersensitivity (anaphylaxis kapa angioedema) ho li-inhibitors tsa DPP-4,

- Mofuta oa 1 oa lefu la tsoekere (sebelisa ha o ithute),

- Sebelisa hammoho le insulin (e sa ithutoang),

- Congenital galactose ho hloka mamello, khaello ea lactase le malabsorption ea glucose-galactose,

- Lilemo ho fihlela lilemo tse 18 (polokeho le ts'ebetso ha e so ithutoe),

- Ho senyeha ha lefu la setho sa botšehali (serum creatinine ≥1.5 mg / dl bakeng sa banna, ≥1.4 mg / dl bakeng sa basali kapa ho hlakisoa hoa clearinine), ho kenyelletsa le ho bakoang ke ho se sebetse hantle ha pelo le methapo (sefuba), infrection ea myocardial e mpe le septicemia,

- Maloetse a hlobaetsang moo ho nang le monyetla oa ho ba le bothata ba ho hlaba ka liphio: ho omella (ka ho hlatsa, lets'ollo), feberu, mafu a tšoaetsanoang a matla, maemo a hypoxia (tšohanyetso, sepsis, ts'oaetso ea liphio, mafu a bronchopulmonary),

- Acidosis e mpe kapa e sa foleng ea metabolic, ho kenyeletsoa lefu la tsoekere le lefu la tsoekere, kapa le hlokang komisi,

- Lipontšo tsa kannete tsa mafu a hlobaetsang le a sa foleng a ka lebisang ho nts'etsopele ea hypoxia ea tishu (ho hloleha ho phefumoloha, ho nyekeloa ke pelo, infarction ea myocardial e mpe).

- Ho buoa hampe le ho tsoa likotsi (ha ho bontšoa kalafo ea insulin),

- ts'ebetso ea ho se sebetse hantle ha sebete,

- Bokhoba bo sa foleng ba joala le chefo e matla ea ethanol,

- Lactic acidosis (ho kenyeletsoa le nalane),

- Nako ea bonyane lihora tse 48 pele le ka hare ho lihora tse 48 kamora ho etsa lithuto tsa radioisotope kapa x-ray ka kenyelletso ea baemeli ba phapang e nang le iodine.

- Ho tsamaisana le lijo tsa hypocaloric (5% ea bakuli ba fumaneng metformin e lokisitsoeng e lokisitsoeng le ho ntlafala khafetsa ho feta sehlopheng sa placebo ba ne ba e-na le lets'ollo le ho nyekeloa le pelo / ho hlatsa.

Litlamorao tse latelang li tlalehiloe nakong ea ts'ebeliso ea morao-rao ea saxagliptin: pancreatitis e matla le karabelo ea hypersensitivity, ho kenyelletsa anaphylaxis, angioedema, rash le urticaria. Ho ke ke ha khoneha ho hakanya khafetsa khafetsa ea tsoelo-pele ea liketsahalo tsena, hobane melaetsa e ile ea amoheloa ka boithatelo ho tsoa ho baahi ba boholo bo sa tsejoeng (bona likarolo "Contraindication" le "Litaelo tse Khethehileng").

Palo e felletseng ea li-lymphocyte

Ha u sebelisa saxagliptin, ho fokotseha ha tekanyo e thehiloeng ho litekanyetso ho palo e felletseng ea li-lymphocytee ho hlokometsoe. Ha ho hlahlojoa lintlha tse kopaneng tsa lithuto tse hlano tse lahleloang ka beke, 24, ho fokotseha ha palo ea lisele tse ka bang 100 le tse 120 / / tsa palo e felletseng ea li-lymphocyte tse tsoang ho palo ea pele ea lisele tsa 2200 / μl li ile tsa bonoa ka ts'ebeliso ea saxagliptin ka tekanyo ea 5 mg le 10 mg, ka ho bapisoa, ha ho bapisoa ka placebo. Phello e ts'oanang e ile ea bonoa ha ho nooa saxagliptin ka tekanyetso ea 5 mg ka kopanong ea pele le metformin ha ho bapisoa le metformin monotherapy. Ho ne ho se na phapang lipakeng tsa 2,5 mg saxagliptin le placebo. Karolo ea bakuli eo palo ea li-lymphocyte e neng e le ≤ 750 lisele / μl e ne e le 0.5%, 1.5%, 1.4%, le 0.4% lihlopheng tsa kalafo tsa saxagliptin ka tekanyo ea 2,5 mg, ka tekanyo ea 5 mg , ka tekanyetso ea 10 mg le placebo, ka ho latellana. Ho bakuli ba bangata ba sebelisang saxagliptin khafetsa, ha ho na ho khutlisetsoa hape ho sena, le hoja ho bakuli ba bang palo ea li-lymphocyte e ile ea fokotseha hape ka ts'ebetso ea kalafo ka saxagliptin, e ileng ea lebisa ho feliseng saxagliptin. Ho fokotseha ha palo ea li-lymphocyte ho ne ho sa tsamaisane le lipontšo tsa bongaka.

Mabaka a ho fokotseha ha palo ea li-lymphocyte nakong ea kalafo ea saxagliptin ha a bapisoa le placebo ha a tsejoe. Haeba ho na le ts'oaetso e sa tloaelehang kapa ea nako e telele, ho hlokahala ho lekanya palo ea li-lymphocyte. Matla a saxagliptin palong ea li-lymphocyte ho bakuli ba nang le mahlaba ka bongata ka palo ea li-lymphocyte (mohlala, vaerase ea immunodeficiency virus) ha e tsejoe.

Saxagliptin e ne e se na phello ea bohlokoa tlhatlhobong kapa ho latela tatellano ea palo ea liplatelese maemong a ts'eletseng a mahlo a tšeletseng, a laoloang tleliniking ea ts'ireletso le ho sebetsa hantle.

Tlhatlhobo ea Vitamin B12

Lithutong tsa bongaka tse laoloang tsa metformin tse tšoarellang libeke tse 29, bakuli ba ka bang 7% ba ile ba fokotseha ha maemo a serum pele ho ketelo e tloaelehileng ea vithamine B12 ho boleng bo botle ntle le lipontšo tsa kliniki. Leha ho le joalo, ho fokotseha ho joalo hangata ha ho tsamaisane le nts'etsopele ea phokolo ea mali 'me e fola kapele ka mor'a ho khaotsa metformin kapa tšebeliso e eketsehileng ea vithamine B12.

Bongata

Ka tšebeliso ea nako e telele ea lithethefatsi ho tekanyetso ho fihla ho makhetlo a 80 ho feta ho buelloa, matšoao a botahoa ha a hlalosoe. Haeba ho na le overdose, kalafo ea matšoao e lokela ho sebelisoa. Saxagliptin le metabolite ea eona e ka sehloohong li hlahisoa ke hemodialysis (tekanyo ea excretion: 23% ea lethal dose ka lihora tse 4).

Ho bile le linyeoe tsa overdose ea metformin, ho kenyelletsa le ho nka li-g tse fetang 50. Hypoglycemia e ntlafalitsoe hoo e ka bang 10% ea linyeoe, empa kamano ea eona ea mabaka le metformin ha e so theoe. Ho 32% ea linyeoe tse ngata tsa metformin e ngata, bakuli ba ne ba na le lactic acidosis. Metformin e hloekisoa nakong ea dialysis, ha tumello e fihla ho 170 ml / min.

Letsatsi la ho felloa ke nako: Lilemo tse 3

Maemo a ho abjoa ho tsoa litlolong tsa litlama: Ka lengolo la ngaka.

Moetsi: Bristol Myers squibb, USA

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