I-Trazhenta isidakamizwa esisha esisha sokunciphisa ushukela wegazi kushukela, eRussia yabhaliswa ngo-2012. Isithako esisebenzayo seTrazhenta, linagliptin, singesinye sezigaba eziphephe kakhulu sabenzeli be-hypoglycemic agents - DPP-4 inhibitors. Babekezelelwa kahle, cishe abanayo imiphumela emibi, futhi empeleni akubangeli i-hypoglycemia.
I-trazenta eseqenjini lezidakamizwa elinesenzo esiseduze ime eceleni. ILinagliptin inokusebenza okuphezulu kakhulu, ngakho-ke kwithebhulethi ngu-5 mg kuphela wale nto. Ngaphezu kwalokho, izinso nesibindi azihlanganyeli ekuqothulweni kwalo, okusho ukuthi abanesifo sikashukela ngokungapheleli kwalezi zitho zingathatha i-Trazhentu.
Izinkomba zokusetshenziswa
Umyalo uvumela i-Trazent ukuthi inqunywe kuphela kwabanesifo sikashukela esinesifo sohlobo 2. Njengomthetho, yisidakamizwa 2 somugqa, okungukuthi, singeniswa kwirejimeni yokwelashwa lapho ukulungiswa kokudla okunempilo, ukuzivocavoca, i-metformin esezingeni elifanele noma eliphakeme lesilinganiso sokuyeka ukunikeza isinxephezelo esanele sesifo sikashukela.
Izinkomba zokwamukelwa:
- I-Trazhent ingachazwa njengokuphela kwe-hypoglycemic lapho i-metformin ingabekezelelwa kahle noma ukusetshenziswa kwayo kuphikisiwe.
- Ingasetshenziswa njengengxenye yokwelashwa okuphelele okuphathelene nokuphuma kwe-sulfonylurea, metformin, glitazones, insulin.
- Ingozi ye-hypoglycemia uma usebenzisa i-Trazhenta incane, ngakho-ke, umuthi uncamela iziguli ezithanda ukwehla ushukela oyingozi.
- Omunye wemiphumela emibi kakhulu futhi ejwayelekile yesifo sikashukela ukungasebenzi kwezinso, i-nephropathy ngokuqalwa ukwehluleka kwezinso. Ngokwezinga elithile, lokhu kuhlangana kwenzeka kuma-40% esifo sikashukela, kuvame ukuqala njenge-asymptomatic. Ukwanda kwezinkinga kudinga ukulungiswa kwendlela yokwelashwa, ngoba iningi lezidakamizwa lishiya izitho. Iziguli kufanele zikhansele i-metformin ne-vildagliptin, zinciphise umthamo we-acarbose, sulfonylurea, saxagliptin, sitagliptin. Ngokulahlwa udokotela, kusala ama-glitazones kuphela, ama-glinid nama-Trazhent.
- Imvamisa phakathi kweziguli ezinesifo sikashukela nokungasebenzi kahle kwesibindi, ikakhulukazi i-hepatosis enamafutha. Kulesi simo, iTrazhenta ingukuphela kwomuthi ovela kuma-DPP4 inhibitors, umyalo ovumela ukuwusebenzisa ngaphandle kwemikhawulo. Lokhu kuyiqiniso ikakhulukazi ezigulini esezikhulile ezinobungozi obukhulu be-hypoglycemia.
Ukuqala nge-Trazhenta, ungalindela ukuthi i-hemoglobin ye-glycated izokwehla ngo-0,7%. Ngokuhlanganiswa ne-metformin, imiphumela ingcono - cishe i-0.95%. Ubufakazi bodokotela bukhombisa ukuthi umuthi usebenza ngokulingene ezigulini ezitholakala kuphela ezinesifo sikashukela futhi onesifo seminyaka engaphezu kwemi-5. Ucwaningo olwenziwe ngaphezulu kweminyaka engu-2 luveze ukuthi ukusebenza kwomuthi we-Trazent akunciphi ngokuhamba kwesikhathi.
Isifo sikashukela nokucindezela kuzoba yinto yesikhathi esedlule
- Ukwehlela ushukela -95%
- Ukuqedwa kwe-vein thrombosis - 70%
- Ukuqedwa kokushaya kwenhliziyo okuqinile -90%
- Ukuqeda umfutho wegazi ophakeme - 92%
- Ukwanda kwamandla ngesikhathi sosuku, ngcono ukulala ebusuku -97%
Ngabe umuthi usebenza kanjani?
Ama-hormone we-incretin abandakanyeka ngqo ekwehliseni i-glucose ibe ezingeni lomzimba. Ukuxineka kwabo kukhuphuka ekuphenduleni kokungena kwe-glucose emikhunjini. Umphumela womsebenzi wama-incretins ukwanda kokuhlanganiswa kwe-insulin, ukwehla kweshukela, okubangela ukwehla kwe-glycemia.
Ama-incretin abhujiswa ngokushesha yi-enzymes ekhethekile i-DPP-4. Umuthi iTrazhenta uyakwazi ukubopha kula ma-enzyme, wehlise ukusebenza kwawo, futhi ngenxa yalokho, yandisa impilo yama-insretin futhi ikhuphule ukuphuma kwe-insulin egazini likashukela.
Inzuzo engabazeki yeTrazhenta ukususwa kwento esebenzayo ikakhulukazi nge-bile ngamathumbu. Ngokwemiyalo, hhayi ngaphezu kwe-5% ye-linagliptin engena kumchamo, ingaphansi kakhulu kwesibindi.
Ngokusho kwesifo sikashukela, izinzuzo zeTrazhenty yilezi:
- ukuthatha umuthi kanye ngosuku;
- zonke iziguli zinqunyelwe umthamo owodwa;
- ukulungiswa kwamthamo akudingeki ezifweni zesibindi nezinso;
- azikho ezinye izivivinyo ezengeziwe ezidingekayo ukuqoka iTrazenti;
- umuthi awunobuthi esibindini;
- umthamo awuguquki lapho uthatha iTrazhenty nezinye izidakamizwa;
- ukuxhumana kwezidakamizwa kwe-linagliptin cishe akukunciphisi ukusebenza kwawo. Kwabashukela, lokhu kuyiqiniso, ngoba kufanele baphuze izidakamizwa eziningana ngasikhathi sinye.
Ifomu lomthamo kanye nomthamo
I-Trazhenta yezidakamizwa iyatholakala ngesimo samathebulethi ngombala obomvu ojulile. Ukuvikela ngokumelene nomgunyathi, ngakolunye uhlangothi kufakwa uphawu lwentengiso yomkhiqizi, iqembu lezinkampani iBeringer Ingelheim, ngakolunye uhlangothi - izimpawu ze-D5.
Ithebhulethi igobolondo lefilimu, ukuhlukaniswa kwalo izingxenye ezithile akunikezwanga. Kwiphakethe elithengiswe eRussia, amaphilisi angama-30 (ama-3 ama-malena ama-10 ama-pcs). Ithebhulethi ngayinye yeTrazhenta iqukethe i-5 mg linagliptin, isitashi, i-mannitol, i-magnesium stearate, udayi. Imiyalo esetshenziswayo inikezela ngohlu oluphelele lwezingxenye ezisizayo.
Imiyalo yokusebenzisa
Uma kwenzeka isifo sikashukela mellitus, umthamo wansuku zonke onconywayo yithebhulethi eyi-1. Ungayiphuza nganoma yisiphi isikhathi esikahle, ngaphandle kokuxhunyaniswa nokudla. Uma umuthi kaTrezhent wawumiselwe ngaphezu kwe-metformin, umthamo wawo ushiywe ungashintshiwe.
Uma uphuthelwa iphilisi, ungaliphuza ngosuku olufanayo. Ukuphuza i-Trazhent ngendlela ephindwe kabili yenqatshelwe, noma ngabe ukwamukela bekuphuthelwa ngosuku olwedlule.
Uma isetshenziswa ngokubambisana ne-glimepiride, glibenclamide, gliclazide ne-analogues, i-hypoglycemia kungenzeka. Ukuze uzigweme, iTrazhenta idakwa njengakuqala, kanti umthamo wezinye izidakamizwa uyancishiswa kuze kutholakale i-standardoglycemia. Ezinsukwini ezintathu okungenani kusukela kuqalile ukuthathwa kukaTrazhenta, ukulawula ngokushesha kwe-glucose kuyadingeka, ngoba umphumela wezidakamizwa ukhula kancane kancane. Ngokusho kokubuyekezwa, ngemuva kokukhetha umthamo omusha, imvamisa nobukhali be-hypoglycemia baba ngaphansi kunangaphambi kokuqala kokwelashwa nge-Trazhenta.
Ukuhlangana kwezidakamizwa okungenzeka ngokuya ngemiyalo:
| Umuthi othathwe neTrazhenta | Umphumela wokucwaninga |
| Metformin, Glitazone | Umphumela wezidakamizwa uhlala ungashintshiwe. |
| Amalungiselelo weSulfonylurea | Iqoqo le-glibenclamide egazini lehla ngesilinganiso se-14%. Lolu shintsho alunawo umthelela obalulekile kushukela wegazi. Kucatshangwa ukuthi iTrazhenta futhi isebenza ngokuhlonipha ama-analogues eqembu le-glibenclamide. |
| I-Ritonavir (isetshenziselwa ukwelapha i-HIV kanye ne-hepatitis C) | Ingeza izinga le-linagliptin ngezikhathi ezingama-2-3. I-overdose enjalo ayithinti i-glycemia futhi ayibangeli umphumela onobuthi. |
| I-Rifampicin (umuthi olwa ne-TB) | Yehlisa ukunqandwa kwe-DPP-4 ngama-30%. Amandla okwehla ushukela weTrazenti angancipha kancane. |
| I-Simvastatin (i-statin, ijwayelekile ukwakheka kwe-lipid kwegazi) | I-simvastatin inyuswa ngo-10%, ukulungiswa kwamthamo akudingeki. |
Kwezinye izidakamizwa, ukuxhumana noTrazhenta akutholakalanga.
Okungalimaza
Imiphumela emibi engaba khona yeTrazenti yaqashwa ngesikhathi sokuhlolwa kwasemtholampilo nangemva kokuthengisa komuthi. Ngokwemiphumela yabo, iTrazhenta ibingomunye wabahlinzeki abaphephe kakhulu be-hypoglycemic. Ubungozi bemiphumela emibi ehambisana nokuphuza amaphilisi lincane.
Kuyamangaza ukuthi eqenjini labanesifo sikashukela abathole i-placebo (amaphilisi ngaphandle kwento esebenzayo), u-4,3% wenqabile ukwelashwa, isizathu kwaba yimiphumela emibi. Eqenjini elithathe iTrazhent, lezi ziguli bezingaphansi, 3.4%.
Emiyalweni yokusetshenziswa, zonke izinkinga zezempilo ezihlangatshezwa ngabanesifo sikashukela ngesikhathi sokufunda ziqoqwa etafuleni elikhulu. Lapha, futhi izifo ezithathelwanayo, futhi ezibangelwa yigciwane, futhi zinjalo. Ngokucabanga okukhulu iTrazenta yayingeyona imbangela yalokhu kwephula umthetho. Ukuphepha kanye ne-monotherapy yeTrazhenta, kanye nokuhlanganiswa kwayo namanye ama-antidiabetesic agents, kwahlolwa. Kuzo zonke izimo, akubanga namiphumela emibi ethile etholakele.
Ukwelashwa nge-Trazhenta kuphephile futhi ngokwemibandela ye-hypoglycemia. Ukubuyekezwa kusikisela ukuthi ngisho nakushukela onesifo sokusobala kumathonsi kashukela (abantu asebekhulile abanezifo zezinso, ukukhuluphala), imvamisa ye-hypoglycemia ayidluli i-1%. I-Trazhenta ayiwuphazamisi kabi umsebenzi wenhliziyo nemithambo yegazi, ayiholeli ekwenyukeni kancane kancane kwesisindo, njenge-sulfonylureas.
Ukweqisa
Umthamo owodwa we-600 mg we-linagliptin (amaphilisi ayi-120 eTrazhenta) ubekezelelwa kahle futhi awubangeli izinkinga zempilo. Imiphumela yemithamo ephezulu emzimbeni ayifundwanga. Ngokusekelwe ezimfanelweni zokwembeswa kwezidakamizwa, isilinganiso esisebenzayo uma kwenzeka kwe-overdose ukususwa kwamathebulethi angakhanyisiwe emgodini we-gastrointestinal (i-gastric lavage). Ukwelashwa okubonakalayo nokuqashwa kwezimpawu ezibalulekile nakho kuyenziwa. Ukudayela ngesifo uma kwenzeka ngokweqile kweTrazhenta akuphumeleli.
Contraindication
Amathebhulethi okubona awasebenzi:
- Uma onesifo sikashukela engenawo amaseli we-beta okwazi ukukhiqiza i-insulin. Imbangela ingaba uhlobo 1 sikashukela noma i-pancreatic resection.
- Uma ungahambisani nanoma yiziphi izingxenye zephilisi.
- Kwezinkinga ezinkulu ze-hyperglycemic zesifo sikashukela. Ukwelashwa okuvunyelwe kwe-ketoacidosis yi-insulin engena ngaphakathi ukuze kuncishiswe i-glycemia ne-saline ukulungisa ukopha. Noma yikuphi ukulungiswa kwethebhulethi kuyakhanselwa kuze kube yilapho isimo sizinza.
- Ngokuncelisa ibele. ILinagliptin iyakwazi ukungena kubisi, umgudu wokugaya ukudla kwengane, iba nomphumela metabolism wayo we-carbohydrate.
- Ngesikhathi sokukhulelwa. Akukho bufakazi bokuthi kungenzeka ukuthi kungene i-linagliptin nge-placenta.
- Kwisifo sikashukela esingaphansi kweminyaka engu-18. Umphumela emzimbeni wezingane awucwaningwanga.
Ngokuncike ekunakekelweni okuthe xaxa kwezempilo, iTrazhent ivunyelwe ukuqoka iziguli ezingaphezulu kweminyaka engu-80, nge-pancreatitis ebabayo futhi engamahlalakhona. Sebenzisa ngokuhlangana ne-insulin ne-sulfonylurea kudinga ukulawulwa kwe-glucose, ngoba kungadala i-hypoglycemia.
Imaphi ama-analogues angenziwa amanye
I-Trazhenta ingumuthi omusha, ukuvikelwa kwe-patent kusasebenza kuyo, ngakho-ke kuyenqatshelwe ukukhiqiza ama-analogues eRussia ngesakhiwo esifanayo. Ngokuphathelene nokusebenza kahle, ukuphepha kanye nendlela yokusebenza, ukuqondana kweqembu kusondele kakhulu kweTrazent - DPP4 inhibitors, noma ama-gliptins. Zonke izinto ezivela kuleli qembu zivame ukubizwa ngokuthi ukuphela nge-gliptin, ngakho-ke zingahlukaniswa kalula kwamanye amaphilisi amaningi antidiabetes.
Izici eziqhathanisayo zama-gliptins:
| Imininingwane | I-Linagliptin | I-Vildagliptin | I-Saxagliptin | I-Sitagliptin |
| Uphawu lwentengiso | I-Trazenta | UGalvus | Onglisa | UJanuvia |
| Umkhiqizi | Beringer Ingelheim | I-Novartis Pharma | U-Astra Zeneka | Merk |
| Ama-analog, izidakamizwa ezinento efanayo esebenzayo | I-Glycambi (+ empagliflozin) | - | - | I-Xelevia (i-analogue ephelele) |
| Inhlanganisela yeMetformin | E-Gentadueto | UGalvus Met | Ukwanda Kwe-Combogliz | IYanumet, iVelmetia |
| Intengo yenyanga yokwamukelwa, rub | 1600 | 1500 | 1900 | 1500 |
| Imodi yokwamukela, kanye ngosuku | 1 | 2 | 1 | 1 |
| Kunconywe umthamo owodwa, mg | 5 | 50 | 5 | 100 |
| Ukuzala | 5% - umchamo, 80% - indle | 85% - umchamo, 15% - indle | 75% - umchamo, 22% - indle | 79% - umchamo, 13% - indle |
| Ukulungiswa kwedosi kokuhluleka kwezinso | - (Akudingeki) | + (kuyadingeka) | + | + |
| Ukuqapha okwengeziwe kwezinso | - | - | + | + |
| Ukushintshwa kwedose ukwehluleka kwesibindi | - | + | - | + |
| Ukubalwa kwemali ekusebenzisaneni nezidakamizwa | - | + | + | + |
Amalungiselelo weSulfonylurea (PSM) angama-analogues ashibhile eTrazhenta. Zibuye futhi zithuthukise i-insulin synthesis, kepha indlela esebenza ngayo kumaseli we-beta ihlukile. I-Trazenta isebenza kuphela ngemuva kokudla. I-PSM igqugquzela ukukhishwa kwe-insulin, noma ngabe ushukela wegazi ujwayelekile, ngakho-ke kuvame ukudala i-hypoglycemia. Kunobufakazi bokuthi i-PSM isithinta kabi isimo samaseli we-beta. I-drug Trazhenta kulokhu iphephile.
I-PSM yanamuhla futhi engenabungozi kakhulu yi-glimepiride (Amaryl, Diameride) ne-glycazide ende (Diabeteson, UGlidiab namanye ama-analogues). Inzuzo yale mishanguzo yintengo ephansi, inyanga yokuphatha izobiza ama-ruble ayi-150-350.
Imithetho yokubeka kanye nentengo
Ukupakisha iTrazhenty kubiza ama-ruble ayi-1600 - 1950. Ungayithenga ngebhizinisi kuphela. ILinagliptin ifakiwe ohlwini lwezidakamizwa ezibalulekile (i-Vital and Essential Izidakamizwa), ngakho-ke uma kunezinkomba, abanesifo sikashukela ababhaliswe ne-endocrinologist bangayithola mahhala.
Usuku lokuphela kweTrazenti yiminyaka emi-3, izinga lokushisa endaweni yokubeka akufanele lidlule ama-25 degrees.
