Insulin Apidra (Epidera): sake dubawa, umarnin don amfani da glulisin

"Apidra", "Epidera", insulin-glulisin - babban sinadaran kwayoyi shine kwatankwacin maganin insulin mutum, wanda aka samu ta injiniyan kwayoyin.

Ta ƙarfin ƙarfin aikinta, ya yi daidai da insulin ɗan adam mai narkewa. Amma Apidra yana farawa da sauri, kodayake tsawon lokacin da miyagun ƙwayoyi suke da ƙasa kaɗan.

Halayen magunguna

Pharmacodynamics Babban aikin insulin da dukkan analogues dinsa (insulin-glulisin babu banbanci) shine daidaituwar sukarin jini.

Godiya ga insulin gluzulin, yawan glucose a cikin magudanar jini yana raguwa kuma yawanshi yana motsawa ta hanyar kyallen tsinkaye, musamman mai, kasusuwa da tsoka. Bugu da kari, insulin:

• yana hana samar da glucose a cikin hanta;
• yana ƙara haɓakar furotin;
• yana hana proteolysis;
• yana hana lipolysis a cikin adipocytes.

Nazarin da aka gudanar a kan masu ba da agaji lafiya da marasa lafiya tare da ciwon sukari mellitus sun nuna a sarari cewa subcutaneous management of insulin-glulisin ba kawai rage lokacin jira don bayyanuwa ba, amma kuma yana rage tsawon lokacin bayyanuwa ga miyagun ƙwayoyi. Wannan ya bambanta shi da insulin mutum mai narkewa.

Tare da gudanarwa na subcutaneous, sakamakon rage karfin sukari na insulin-glulisin a cikin jini yana farawa bayan mintina 15-20. Tare da allurar ciki, sakamakon insulin-glulisin na jikin mutum yana daidai iri daya.

Na'urar Apidra tana da aiki iri guda na rashin aiki kamar na mutum wanda yai insulin abinci mai narkewa. A cikin gwaji na asibiti a cikin marasa lafiya da masu ciwon sukari na 1, an kimanta tasirin maganin ƙwaƙwalwar ƙwayar jikin mutum da insidly na Apidra.

An gudanar da su duka biyu a cikin kashi na 0.15 U / kg subcutaneously a lokuta daban-daban dangane da abinci na mintina 15, wanda ake ganin daidaitacce.

Sakamakon binciken ya nuna cewa an gudanar da insulin-glulisin na mintina 2 kafin abinci ya samar da ainihin ainihin aikin glycemic saka idanu bayan abinci kamar na insulin mutum, wanda aka allura a mintuna 30 kafin abinci.

Idan ana gudanar da insulin-glulisin mintina 2 kafin cin abinci, miyagun ƙwayoyi suna ba da kyakkyawan kulawar glycemic bayan cin abinci. Fiye da gudanar da insulin ɗan adam na minti 2 kafin abinci.

Insulin-glulisin, wanda aka gudanar da mintina 15 bayan fara abincin, ya samar da kulawar glycemic bayan abincin mai kama da wanda insulin ɗan adam ya bayar, gabatarwar wanda ke faruwa minti 2 kafin fara abincin.

Nazarin kashi na farko, wanda aka gudanar tare da Apidra, insulin-llpro na mutum mai narkewa da insulin-lyspro a cikin rukuni na marasa lafiya tare da kiba da ciwon sukari, ya nuna cewa a cikin waɗannan marasa lafiya insulin-glulisin ba sa rasa halayen sa na saurin-sauri.

A cikin wannan binciken, ratar da ta kai kashi 20% na adadin yanki a ƙarƙashin matakin-lokaci-lokaci (AUC) na insulin-glulisin ya kasance mintuna 114, na insulin-lispro -121 minti kuma na insulin ɗan adam - minti 150.

Kuma AUC (0-2 hours), kuma yana nuna farkon aikin hypoglycemic, ya kasance 427 mg / kg don insulin-glulisin, 354 mg / kg don insulin-lyspro da 197 mg / kg don insulin mutum mai narkewa.

Type 1 ciwon sukari

Karatun asibiti. A nau'in 1 mellitus na ciwon sukari, an kwatanta insulin-lispro da insulin-glulisin.

A cikin gwaji na asibiti na uku na dindindin na makonni 26, an ba mutanen da ke da nau'in ciwon sukari na 1 ƙin insulin glulisin ɗan lokaci kaɗan kafin abinci (insulin glargine yana aiki kamar insulin basal a cikin waɗannan marasa lafiya)

A cikin waɗannan mutanen, insulin-glulisin dangane da glycemic iko an kwatanta shi da insulin-lyspro kuma an ƙididdige shi ta hanyar sauya yawan ƙwayar glycosylated hemoglobin (L1L1c) a ƙarshen binciken tare da farawa.

A cikin marasa lafiya, ana lura da dabi'un glucose a cikin jini, wanda aka ƙaddara ta hanyar saka idanu akan kansa. Bambanci tsakanin insulin-glulisin da shiri insulin-lyspro shine lokacin da aka fara gudanar da farkon, babu bukatar kara yawan insulin.

Gwaje-gwaje na asibiti na kashi na uku, na tsawon makonni 12, (nau'in ciwon sukari na 1 wanda ke yin amfani da insulin-glargine kamar yadda aka gayyaci insulin-glargine a matsayin manyan masu ba da agaji) ya nuna cewa basirar allurar insulin-glulisin kai tsaye bayan abinci ya yi kama da na allurar insulin-glisin. kai tsaye kafin abinci (minti 0-15). Ko mintuna 30-45 kafin cin abinci ɗan adam ya narke.

Marasa lafiya waɗanda suka ƙaddamar da gwaje-gwaje sun kasu kashi biyu:

1. Firstungiyoyin farko sun ɗauki insidon insidra kafin abinci.
2. Na biyu rukuni aka gudanar da insulin ɗan adam mai narkewa.

Abubuwan da aka koya a rukunin farko sun nuna raguwa sosai a cikin HL1C fiye da masu sa kai na rukuni na biyu.

Type 2 ciwon sukari

Na farko, gwaje-gwaje na asibiti na kashi na uku ya faru a makonni 26. Binciken lafiya na mako-mako 26, wanda ya wajaba don kwatanta tasirin Apidra (mintuna 0-15 kafin abinci) tare da insulin ɗan adam mai narkewa (minti 30-45 kafin abinci).

Duk waɗannan magunguna an ba su ga marasa lafiya waɗanda ke da nau'in ciwon sukari na 2 a ƙarƙashin ƙasa (waɗannan mutane sun yi amfani da insulin-isofan a matsayin babban insulin). Matsakaicin matsakaicin nauyin jikin mutanen shine yakai 34.55 kg / m².

Game da canji a cikin haɗakar HL1C, bayan watanni shida na jiyya, insulin-glulisin ya nuna daidaituwarsa tare da insulin ɗan adam idan aka kwatanta da ƙimar farko ta wannan hanyar:

• don insulin ɗan adam mai narkewa, 0.30%;
• don insulin-glulisin-0.46%.

Bayan shekara 1 na jiyya, hoton ya canza kamar haka:

1. don insulin ɗan adam mai narkewa - 0.13%;
2. don insulin-glulisin - 0.23%.

Yawancin marasa lafiyar da ke cikin wannan binciken, kai tsaye kafin allura, hade da insulin-isophan tare da insulin-gajeran aiki. A lokacin rarrabuwar, 58% na marasa lafiya sun yi amfani da magungunan hypoglycemic da kuma umarnin umarnin ci gaba da shan su a matakin iri ɗaya.

A cikin gwajin asibiti da aka sarrafa a cikin manya, babu bambance-bambance a cikin inganci da amincin insulin-glulisin yayin nazarin ƙananan ƙungiyoyi da aka gano da jinsi da kabila.

A cikin Apidra, maye gurbin ampara acid na asparagine a matsayin B3 na insulin ɗan adam tare da lysine, kuma ƙari, lysine a matsayi B29 tare da acid glutamic, yana haɓaka ɗaukar hanzari.

Rukunin Masu haƙuri na Musamman

• Marasa lafiya tare da raunin koda A cikin binciken asibiti da aka gudanar a cikin mutane masu ƙoshin lafiya tare da ɗimbin yawa na matsayin kamfani na aiki (keɓantaccen keɓaɓɓen (CC)> 80 ml / min, 30¬50 ml / min, <30 ml / min), an kiyaye yawan fara aikin insulin-glulisin. Koyaya, a gaban gazawar koda, ana iya rage buƙatar insulin.
• Marasa lafiya tare da cututtukan cututtukan hanta. A cikin wannan rukuni na marasa lafiya, ba a yi nazarin sigogin magani ba.
• Tsofaffi mutane. Ga wannan rukuni na marasa lafiya, bayanan pharmacokinetic akan tasirin insulin-glulisin yana da iyaka.
• Yara da matasa. Abubuwan da ke cikin Pharmododynamic da magunguna na insulin-glulisin a cikin matasa (12-16 years) da kuma a cikin yara (shekaru 7-1) tare da nau'in ciwon sukari na 1 an bincika. Magungunan insulin-glulisin miyagun ƙwayoyi suna cikin sauri a cikin duka shekaru biyu tare da Stax da Tmax masu kama da waɗanda ke cikin tsofaffi marasa lafiya da ke da nau'in ciwon sukari na 1 da masu lafiya. Lokacin da aka gudanar da shi nan da nan gabanin gwajin tare da abinci, insulin-glulisin, kamar yadda yake a cikin ƙungiyar masu haƙuri, yana ba da ingantaccen sarrafa sukari na jini bayan cin abinci idan aka kwatanta da insulin na ɗan adam. Increasearuwar yawan sukarin jini bayan cin abinci (awanni na AUC 0-6 - yanki a ƙarƙashin ɓarna "sukari na jini - lokaci" 0-6 hours) shine 641 mg / (h'dl) don Apidra da 801 mg / (h ' d) don insulin mutum mai narkewa.

Alamu da magunguna

Wani nau'in ciwon sukari na insulin-in-1 a cikin yara bayan shekaru 6, da matasa da manya.

Ya kamata a gudanar da insulin-glulisin jim kadan ko kuma nan da nan tare da abinci. Ya kamata a yi amfani da Apidra a cikin tsarin kulawa da suka haɗa da insulins masu aiki na tsaka-tsaki ko analogues.

Bugu da kari, za'a iya amfani da Apidra a hade tare da magungunan baka na tsotsar jini. An zabi sashi na miyagun ƙwayoyi koyaushe daban-daban.

Hanyar Gudanarwa

Ana gudanar da maganin ta hanyar allurar subcutaneous ko ta hanyar ci gaba cikin kitsen cikin bututun ta amfani da famfan insulin. Subcutaneous injections na miyagun ƙwayoyi an sanya su a cikin ciki, cinya ko kafada. Hakanan ana yin allurar ciki a ciki.

Wuraren jiko da allura tare da kowane sabon allurar insulin ya kamata ya canza. A farkon aiwatarwa, lokacinsa da kuma yawan tallarsa, aikin jiki da kuma yankin gudanarwa na iya yin tasiri. Gudun ƙarƙashin ƙasa zuwa cikin ciki yana samar da adsorption da sauri fiye da injections zuwa wasu sassan jiki.

Don hana kwayoyi daga shiga cikin hanyoyin jini kai tsaye, yakamata a yi taka tsantsan. Nan da nan bayan an sha maganin, ba za a gaurayar wurin allurar ba.

An ba shi izinin haɗa Apidra tare da insulin-isophan na mutum.

Fulin insulin don ci gaba da jiko na subcutaneous

Idan ana amfani da Apidra ta hanyar famfo don ci gaba da haɓakar insulin, ba a hana shi haɗa shi da sauran magunguna ba.

Don samun ƙarin bayani game da aiki na miyagun ƙwayoyi, ya zama dole a yi nazarin umarnin da ya rattaba hannu a kansa. Tare da wannan, duk shawarwari game da amfani da ciken alkalann ya kamata a bi su.

Groupsungiyoyi na musamman na marasa lafiya sun haɗa da marasa lafiya waɗanda ke da:

• ƙarancin aikin na yara (tare da irin waɗannan cututtukan, buƙatar allurar insulin na iya raguwa);
• aiki mara nauyi na hepatic (kamar yadda a baya ya gabata, buƙatar insulin shirye-shirye na iya raguwa saboda raguwa a cikin ikon gluconeogenesis da raguwar metabolism).

Bayanai game da karatun likitancin magunguna na tsofaffi har yanzu basu isa ba. Bukatar insulin a cikin tsofaffi marasa lafiya na iya raguwa saboda rashin isasshen aikin renal.

Ana iya ba da magani ga yara bayan shekaru 6 da matasa. Ba a samun bayanai kan tasirin miyagun ƙwayoyi kan yara 'yan ƙasa da shekaru 6 ba.

M halayen

Mafi kyawun mummunan sakamako wanda ke faruwa yayin maganin insulin lokacin da kashi ya wuce shine hypoglycemia.

Akwai wasu halayen masu illa waɗanda ke da alaƙa da amfani da miyagun ƙwayoyi kuma an lura da su a cikin gwaji na asibiti, yawan abubuwan da suke faruwa a teburin.

Rashin hankali daga metabolism da fata

Mafi yawan lokuta cututtukan jini na haɓaka. Bayyanar cututtuka na wannan yanayin galibi yakan faru ba zato ba tsammani. Bayyanannun bayyanannun sunada alamu ga cututtukan neuropsychiatric:

1. Gajiya, jin gajiya, rauni.
2. Rage ikon mayar da hankali.
3. Rushewar gani.
4. Damuwa.
5. Ciwon kai, tashin zuciya.
6. Ruɗarwar hankali ko cikakkiyar asararsa.
7. Ciwon ciki.

Amma mafi yawancin lokuta, alamun neuropsychiatric suna zuwa da alamun adrenergic counter-regulation (martani ga rashin lafiyar tsarin na juyayi)

1. Erarin tashin hankali, rashin damuwa.
2. Girgiza kai, damuwa.
3. Jin yunwa.
4. Pallor na fata.
5. Tachycardia.
6. Gumi mai sanyi.

Mahimmanci! Maimaitawa mai zurfi na hypoglycemia na iya haifar da lalacewar tsarin juyayi. Abubuwan da ke tattare da mummunan rauni da tsawan lokaci suna haifar da mummunar haɗari ga rayuwar mai haƙuri, tunda koda sakamako mai mutuwa yana yiwuwa tare da ƙara haɓaka.

A wuraren allurar miyagun ƙwayoyi, ana samun alamun bayyanar cututtukan ciki na gida sau da yawa:

• itching
• kumburi;
• hyperemia.

Ainihin, waɗannan halayen suna da ɗan lokaci kuma galibi sukan ɓace tare da ƙarin ilimin.

Irin wannan amsawa daga ƙwayar subcutaneous, kamar lipodystrophy, yana da wuya sosai, amma yana iya bayyana saboda cin zarafin canji a wurin allurar (ba za ku iya shiga insulin a cikin yanki ɗaya ba).

Janar cuta

Bayyananniyar tsararraki ta hanyar rashin hankali abu ne mai wuya, amma idan sun bayyana, to alamu masu zuwa:

1. urticaria;
2. sara;
3. kirji
4. itching
5. rashin lafiyan cuta mai narkewa.

Akwai wasu maganganu na musamman game da cututtukan da ke cikin jiki (wannan ya hada da bayyanar cutar anaphylactic) haifar da barazana ga rayuwar mai haƙuri.

Ciki

Ba a samun bayani game da amfani da insulin-glulisin ta mata masu ciki. Gwajin dabbobi na dabbobi bai nuna wani bambance-bambance tsakanin insulin-narkewar mutum da insulin-glulisin dangane da ciki, ci gaban tayin, haihuwa da ci gaban haihuwa.

Koyaya, mata masu juna biyu ya kamata su tsara maganin sosai. A lokacin kulawa, ya kamata a sa ido kan sukari na jini akai-akai.

Marasa lafiya waɗanda suka kamu da ciwon sukari kafin samun juna biyu ko kuma waɗanda suka kamu da cutar sukari a cikin mata masu juna biyu suna buƙatar kula da ƙwayar cutar glycemic a duk tsawon lokacin.

A cikin farkon lokacin ciki, bukatar haƙuri ga insulin na iya raguwa. Amma, a matsayin mai mulkin, a cikin watanni masu zuwa, yana ƙaruwa.

Bayan haihuwa, bukatar insulin ya ragu kuma. Mata masu shirin daukar ciki ya kamata su sanar da mai kula da lafiyar su game da hakan.

Har yanzu ba a san ko insulin-glulisin zai iya shiga cikin madara ba. Mata yayin shayarwa na iya buƙatar daidaita sashi na ƙwayoyi da abinci.

Yara da matasa

Ana iya amfani da insulin-glulisin a cikin yara bayan shekaru 6 da matasa. Ga yara 'yan kasa da shekaru 6, ba a sanya maganin ba, tunda babu bayanan asibiti.