Apidra - malangizo azomwe angagwiritsidwe ntchito

Mlingo wa Apidra ndi yankho la subcutaneous (sc) makina: madzi osapaka utoto kapena utoto (10 ml m'mabotolo, botolo 1 mu bokosi la makatoni, 3 ml makatoni, chikhazikitso: ma cartridge 5 a cholembera "OptiPen" kapena 5 makatoni oikidwa mu cholembera chotayika "OptiSet", kapena makatoni 5 a "OptiClick").

Mu 1 ml yankho lili:

• yogwira mankhwala: insulin glulisin - 3,49 mg (wofanana ndi 100 IU ya insulin ya anthu),
• othandizira zigawo: trometamol, m-cresol, polysorbate 20, sodium chloride, wozungulira hydrochloric acid, sodium hydroxide, madzi a jekeseni.

Contraindication

• achina,
• zaka za ana mpaka zaka 6 (zidziwitso zamankhwala pazogwiritsidwa ntchito ndizochepa),
• Hypersensitivity kuti insulin glulisin kapena china chilichonse mankhwala.

Mosamala, Apidra amalimbikitsidwa kuti azigwiritsidwa ntchito panthawi yapakati.

Odwala omwe ali ndi hepatic insuffuffing angafunike kuchepetsedwa kwa insulin chifukwa kuchepa kwa gluconeogeneis komanso kuchepa kwa insulin kagayidwe.

Kuchepetsa kufunika kwa insulini ndikothekanso ndi kulephera kwaimpso komanso kukalamba (chifukwa cha kuwonongeka kwa impso).

Mlingo ndi makonzedwe

Apidra insulin imayendetsedwa musanadye chakudya (kwa mphindi 0 mpaka 15) kapena mukangodya chakudya ndi s.c. jekeseni kapena kulowetsedwa kosalekeza m'mafuta oyambira pogwiritsa ntchito pampu.

Mlingo ndi mtundu wa kaperekedwe ka mankhwala amasankhidwa mosiyanasiyana.

Apidra yankho limagwiritsidwa ntchito mu mitundu yovuta yamankhwala yokhala ndi insulini kapena insulin / insulin / wothandizira wa insulin;

Malo omwe amalimbikitsidwa kuti azigwiritsa ntchito mankhwalawa:

• s / jekeseni - wopangidwa m'mapewa, ntchafu kapena pamimba, pomwe kumayambitsa khoma lam'mimba kumayamwa mofulumira,
• mosalekeza kulowetsedwa - anachita mu subcutaneous mafuta pamimba.

Muyenera kusinthanitsa malo omwe kulowetsedwa ndi jakisoni ndi makonzedwe aliwonse a mankhwalawa.

Popeza njira ya Apidra ndi njira yothetsera vutoli, kupumulirako sikofunikira musanagwiritse ntchito.

Kuchuluka kwa mayamwidwe, motero, kuyambika ndi kutalika kwa mankhwalawa kumatha kusinthika motsogozedwa ndi zochitika zolimbitsa thupi, kutengera malo a jekeseni wankho ndi zina zosintha.

Chisamaliro chiyenera kuthandizidwa popereka mankhwalawo kupatula mwayi womwe ungalowe mwachindunji m'mitsempha yamagazi. Pambuyo pa njirayi, malo a jakisoni sayenera kutenthedwa.

Odwala amafunika kuphunzitsidwa njira za jakisoni.

Mukamapereka mankhwalawa pogwiritsa ntchito pampu yolumirira insulini, yankho lake silingakanikirane ndi mankhwala ena alionse / othandizira.

Apidra yankho siliphatikiza ndi mankhwala ena kupatula is is-insulin yaumunthu. Potere, Apidra imakokedwa mu syringe yoyamba, ndipo jakisoni imachitika nthawi yomweyo ikasakanikirana. Zambiri pakugwiritsa ntchito mayankho osakanikirana kale jakisoni asanapezeke.

Makatoni amayenera kugwiritsidwa ntchito ndi cholembera cha instiPen Pro1 insulin kapena zida zina zofananira molingana ndi malangizo a wopanga kuti atule cartridge, aphatikizepo singano, ndi kubayirira insulin. Musanagwiritse ntchito makatoni, muyenera kuyang'anira mankhwalawa. Jekeseni, yankho lomveka bwino, lopanda utoto lokhalokha lopanda mawonekedwe olimba owoneka. Asanayambe kuyikapo, cartridge iyenera kusungidwa kwa maola awiri kutentha kwa chipinda, ndipo musanalowetse yankho lake, thovu la mpweya liyenera kuchotsedwa pabokosi.

Makatoni ogwiritsira ntchito sangadzazidwe. Cholembera cha SytiPen Pro1 yowonongeka sichingagwiritsidwe ntchito.

Pakapanda kugwira bwino ntchito kwa cholembera, chithandizocho chimatha kutengedwa kuchokera ku kathumba kuti akhale mu syringe ya pulasitiki yoyenera kwa insulin pa nthawi ya 100 IU / ml, kenako ndikupatsidwa kwa wodwalayo.

Cholembera chosinthanso sichingagwiritsidwe ntchito jakisoni wa wodwala m'modzi yekha (kupewa matenda).

Malangizo onse omwe ali pamwambapa akuyenera kuwonedwa mukamagwiritsa ntchito cholembera ndi makina a OptiKlik syringe popereka yankho la Apidra, omwe ali kapu yagalasi yokhala ndi piston, yokhazikitsidwa mchidebe cha pulasitiki chowoneka komanso 3 ml ya glulisin insulin.

Zotsatira zoyipa

Chovuta chosadziwika bwino cha insulin mankhwala ndi hypoglycemia, yomwe nthawi zambiri imagwiritsa ntchito insulin mu Mlingo wokwera kwambiri kuposa momwe umafunikira.

Zotsatira zoyipa zomwe zimakhudzana ndi kayendetsedwe ka mankhwalawa ndi ziwalo ndi machitidwe a odwala omwe adalembetsa panthawi yoyesedwa (mndandandawu umaperekedwa pogwiritsa ntchito njira zotsatirazi pafupipafupi: zoposa 10% - nthawi zambiri, zopitilira 1%, koma zosakwana 10% - nthawi zambiri, zambiri 0.1%, koma ochepera 1% - nthawi zina, ochulukirapo kuposa 0,01%, koma ochepera 0,1% - kawirikawiri, osakwana 0.01% - osowa kwambiri):

• kagayidwe: pafupipafupi - hypoglycemia, limodzi ndi zizindikiro zotsatirazi mwadzidzidzi: thukuta lozizira, khungu la khungu, kutopa, nkhawa, kunjenjemera, kukwiya kwamanjenje, kufooka, kusokonezeka, kugona, kuvutika kuganizira, kusokoneza maonekedwe, nseru, kugona kwambiri, kupweteka kwa mutu, kupweteka kwambiri, zotsatira za kuwonjezereka kwa hypoglycemia kungakhale: kutaya chikumbumtima ndi / kapena kukomoka, kuwonongeka kwakanthawi kapena kosatha kwa ntchito yaubongo, nthawi yayitali, zotsatira zakupha
• khungu ndi subcutaneous minofu: kawirikawiri - matupi awo sagwirizana, monga kutupa, vuto la jekeseni, kuyamwa pamalo a jekeseni, nthawi zambiri kumangopitiliza okha ndi mankhwala omwe amapezeka, kawirikawiri lipodystrophy, makamaka chifukwa chophwanya magawo a insulin makonzedwe aliwonse a madera / kukonzanso kwamankhwala. kumalo amodzi
• Hypersensitivity zimachitika: nthawi zina - kukhathamira, kumva kukakamira pachifuwa, urticaria, kuyabwa, matupi awo sagwirizana, woopsa milandu ya thupi lawo siligwirizana (kuphatikizapo anaphylactic), kuopseza moyo n`zotheka.

Palibe chidziwitso chazomwe zimapangitsa kuti insulini ichuluke kwambiri, koma chifukwa chogwiritsa ntchito nthawi yayitali ya Apidra, kusiyana kosiyanasiyana kwa hypoglycemia kumatheka.

Chithandizo cha matendawo chimatengera miliri ya matendawa:

• magawo a hypoglycemia wofatsa - kuyimitsidwa ndi kugwiritsira ntchito shuga kapena zinthu zokhala ndi shuga, pazomwe odwala omwe ali ndi shuga akulimbikitsidwa kuti nthawi zonse azikhala ndi ma cookie, maswiti, zidutswa za shuga woyengedwa, msuzi wa zipatso wokoma,
• zigawo za kwambiri hypoglycemia (kutayika kwa chikumbumtima) - siyani kuyika intramuscularly (intramuscularly) kapena sc ndi makonzedwe a 0.5-1 mg wa glucagon, kapena iv (mtsempha wa magazi) osagwirizana ndi mayikidwe a glucagon ku kwa mphindi 10-15 Pambuyo pozindikira, wodwalayo amalangizidwa kuti azipereka chakudya cham'mimba mkati pofuna kupewa kubwereza kwa hypoglycemia, pambuyo pake, kuti akhazikitse chomwe chimayambitsa kwambiri hypoglycemia, komanso kupewa kutulutsa kwa nthawi yayitali m'chipatala.

Malangizo apadera

Pankhani yosamutsa wodwala kuti apange insulin kuchokera kwa wopanga wina kapena mtundu wina wa insulin, kuyang'aniridwa mosamalitsa kwachipatala ndikofunikira, popeza kuwongolera kwa chithandizo chonse kungafunike.

Mlingo wosakwanira wa insulin kapena kutha kwa mankhwala osachiritsika, makamaka kwa odwala omwe ali ndi matenda amtundu wa 1, angayambitse matenda a hyperglycemia ndi matenda ashuga a ketoacidosis - oopsa. Nthawi ya kukonzekera kwa hypoglycemia mwachindunji kumatengera kuthamanga kwa insulin yomwe ingagwiritsidwe ntchito motero imatha kusintha ndi kusintha kwa mankhwalawo.

Mikhalidwe yayikulu yomwe ingasinthe kapena kupangitsa kuti zizindikiro za hypoglycemia zitchulidwe pang'ono:

• kupezeka kwa shuga kwa wodwala nthawi yayitali,
• matenda ashuga a m'mimba
• kulimbitsa insulin mankhwala,
• kugwiritsa ntchito munthawi yomweyo mankhwala ena, mwachitsanzo, β-blockers,
• kutembenukira ku insulin ya anthu kuchokera ku insulin ya nyama.

Kuwongolera Mlingo wa insulin kungakhale kofunikira pokhapokha kusintha kwamalamulo othandizira galimoto kapena zakudya. Kuchulukitsa zolimbitsa thupi zomwe zimapezeka mukangodya kungakulitse mwayi wokhala ndi hypoglycemia. Poyerekeza ndi zochita za insulin ya anthu osungunuka, hypoglycemia imatha kukhazikitsidwa posakhalitsa pochita ma insulin analogues.

Zosagwirizana ndi hypo- kapena hyperglycemic zimachitika chifukwa chitha kumatha kukhala chikumbumtima, chikomokere, kapena kufa.

Matenda olimbana ndi nkhawa kapena kuchuluka kwa zinthu m'maganizo kumatha kusinthanso kufunikira kwa insulin.

Kuyanjana kwa mankhwala

Sipanapezeke kafukufuku wokhudzana ndi mankhwala a pharmacokinetic a Apidra, koma potengera deta yomwe ikupezeka pamankhwala ofanana, titha kudziwa kuti kulumikizana kwakukulu kwa pharmacokinetic sikungatheke.

Mankhwala ena / mankhwala amatha kuthana ndi kagayidwe kakang'ono ka glucose, kamene kangafunikire kusintha kwa insulin glulisin ndikuwonetsetsa mozama momwe alili komanso momwe wodwalayo alili.

Chifukwa chikagwiritsidwa ntchito limodzi ndi yankho la Apidra:

• m`kamwa hypoglycemic mankhwala, angiotensin kutembenuza enzyme zoletsa, disopyramides, fluoxetine, fibrate, monoamine oxidase inhibitors, propoxyphene, pentoxifylline, sulfonamide antimicrobials, salicylates - akhoza kupititsa patsogolo hypoglycemic zotsatira za insulin ndikuwonjezera hypoglycemia,
• glucocorticosteroids, diuretics, danazol, diazoxide, isoniazid, somatropin, phenothiazine zotumphukira, sympathomimetics (epinephrine / adrenaline, terbutaline, salbutamol), estrogens, mahomoni a chithokomiro, propsinsin, antipsychot Kuchepetsa hypoglycemic zotsatira za insulin,
• clonidine, β-blockers, Mafuta amchere a lithiamu - amatha kapena kufooketsa mphamvu ya insulin,
• pentamidine - imatha kuyambitsa hypoglycemia, kenako hyperglycemia,
• Mankhwala okhala ndi chisoni pantchito (β-blockers, guanethidine, clonidine, reserpine) - ndi hypoglycemia, amatha kuchepetsa kuuma kapena kutsitsa zizindikiro za reflex adrenergic activation.

Kafukufuku wokhudza kuphatikiza kwa insulin glulisin sanachitike, chifukwa chake, Apidra sayenera kusakanikirana ndi mankhwala ena aliwonse, kupatula ndi isofan-insulin.

Pankhani yoyambitsa yankho pogwiritsa ntchito pampu kulowetsedwa, Apidra sayenera kusakanikirana ndi mankhwala ena.

Zofanizira za Apidra ndi: Vozulim-R, Actrapid (NM, MS), Gensulin R, Biosulin R, Insuman Rapid GT, Insulin MK, Insulin-Fereyn CR, Gansulin R, Humalog, Pensulin (SR, CR), Monosuinsulin (MK, MP ), Humulin Regular, NovoRapid (Penfill, FlexPen), Humodar R, Monoinsulin CR, Insuran R, Rinsulin R, Rosinsulin R.

Migwirizano ndi magwiritsidwe akusungidwa

Sungani makatoni awoawo, osapeza kuwala, kutentha kwa 2-8 ° C. Osamawuma. Musayandikire ana!

Mutatsegula phukusi, sungani pamalo otetezedwa ndi kuwala kutentha mpaka 25 ° C. Alumali moyo wa mankhwalawa atagwiritsidwa ntchito koyamba ndi milungu 4 (tikulimbikitsidwa kuti muike chizindikiro tsiku loyambirira la yankho pazomwe zalembedwa).

Mankhwala

Chofunikira kwambiri cha insulin ndi insulin analogues, kuphatikizapo insulin glulisin, ndikuwongolera kwa kagayidwe ka glucose. Insulin imachepetsa kuchuluka kwa shuga m'magazi, ndikulimbikitsa kufatsa kwa glucose mwa zotumphukira, makamaka minofu yamatumbo ndi minyewa ya adipose, komanso kuletsa mapangidwe a shuga mu chiwindi. Insulin imachepetsa lipolysis mu adipocytes, linalake ndipo tikulephera kuphatikiza mapuloteni. Kafukufuku wopangidwa mwa odzipereka athanzi komanso odwala matenda a shuga aonetsa kuti chifukwa cha insulin glulisin imayamba kuchita zinthu mwachangu ndipo imakhala ndi nthawi yofupikirapo kuposa kusungunuka kwa insulin yamunthu. Ndi subcutaneous makonzedwe, kutsitsa kuchuluka kwa shuga m'magazi, ntchito ya insulin glulisin imayamba mu 10-20 mphindi. Mothandizidwa ndi mtsempha wa magazi, mphamvu ya insulin glulisin ndi sungunuka wa munthu amakhala ndi mphamvu. Gawo limodzi la insulin glulisin limakhala ndi ntchito yofanana yotsitsa shuga monga gawo limodzi la insulin yaumunthu.

Mu gawo lomwe ndimaphunzirira odwala omwe ali ndi matenda a shuga 1, ma glucose omwe amachepetsa ma protein a insulin glulisin ndi insulle ya anthu amasungunuka mosalekeza pamankhwala a 0,15 U / kg panthawi zosiyanasiyana pokhudzana ndi chakudya chokwanira cha mphindi 15. Zotsatira za phunziroli zidawonetsa kuti insulini glulisin yoyendetsedwa mphindi 2 asanadye chakudya chimapereka chiwonetsero chofananira cha glycemic pambuyo chakudya pambuyo poti munthu amasungunuka ndi insulin mphindi 30 asanadye. Pakaperekedwa mphindi ziwiri asanadye, insulin glulisin imapereka chiwongolero chabwinoko pakatha chakudya kuposa chakudya chosungunuka chomwe munthu amakhala nacho pakadutsa mphindi 2 asanadye. Glulisin insulin kutumikiridwa mphindi 15 chakudya chitayamba kupereka chiwonetsero chofananira cha glycemic pambuyo chakudya monga munthu wosungunuka wa insulin, kutumikiridwa mphindi 2 chakudya chisanachitike.

Gawo lomwe ndimaphunzira ndi insulin glulisin, insulin lispro ndi insulin ya insulin ya anthu omwe ali m'gulu la onenepa kwambiri adawonetsa kuti mwa odwalawa, insulin glulisin imakhalabe ndi machitidwe omwe amathandizira. Phunziroli, nthawi yoti ifike 20% ya AUC yonse inali ma mineral 114 a insulini glulisin, 121 mphindi ya insulin lispro ndi ma 150 mphindi a insulle ya insulle ya anthu, ndi AUQ_{(0-2 h)}ndikuwonetsanso ntchito yoyambirira yotsitsa glucose, motero, inali 427 mg / kg ya insulin glulisin, 354 mg / kg ya insulin lispro, ndi 197 mg / kg ya insulin ya anthu osungunuka.

Maphunziro azachipatala
Mtundu woyamba wa shuga.
M'masabata makumi awiri ndi awiri oyesa gawo lachitatu la III, lomwe limayerekezera ndi insulin glulisin ndi insulin lispro, yomwe imayendetsedwa mosakhalitsa asanadye (0-15 mphindi), odwala omwe ali ndi matenda a shuga 1 omwe amagwiritsa ntchito insulin glargine monga insulin insulini, insulin glulisin inali yofanana ndi inspro insulin yoletsa glycemic, yomwe idayesedwa ndi kusintha kwa ndende ya glycated hemoglobin (HbA_1s) panthawi yakumapeto kwa phunziroli poyerekeza ndi mtengo woyambira. Pamene insulin idaperekedwa, glulisin, mosiyana ndi mankhwala a lyspro insulin, sanafunike kuchuluka kwa basulin insulin.

Kafukufuku wotsatira wa milungu iwiri wachitatu kwa odwala omwe ali ndi matenda a shuga 1 omwe adalandira insulin glargine monga chithandizo choyambira adawonetsa kuti kugwira ntchito kwa insulin glulisin atangomaliza kudya kunali kofanana ndi kwa insulin glulisin musanadye chakudya (0 -15 min) kapena insulin ya anthu sungunuka (30-45 mphindi musanadye).

Mu gulu la odwala omwe adalandira insulin glulisin asanadye, kuchepa kwakukulu kwa HbA kunawonedwa_1s poyerekeza ndi gulu la odwala omwe amalandila insulin yaumunthu.

Type 2 shuga
Kuyesedwa kwamankhwala kwa gawo la 26 la milungu yachitatu yotsatiridwa ndikutsatiridwa kwa masabata a 26 mu mawonekedwe a kafukufuku wachitetezo adachitidwa kuti afanize insulin glulisin (0-15 mphindi musanadye) ndi insulin ya insulle ya anthu (30-45 mphindi asanadye), omwe adalowetsedwa m'mankhwala odwala omwe ali ndi matenda a shuga 2, kuwonjezera insulin-isophan monga basal insulin. Insulin glulisin yawonetsedwa kuti ingafanane ndi insulin ya anthu osungunuka posintha masinthidwe a HbA_1s pambuyo 6 miyezi ndipo pambuyo 12 miyezi chithandizo poyerekeza ndi mtengo woyamba.

Popitirira kulowetsedwa kwa insulin yogwiritsira ntchito chipangizo cha mtundu wa pampu (cha mtundu 1 wa matenda a shuga) mwa odwala 59 omwe amathandizidwa ndi Apidra ® kapena insulin aspart m'magulu onse azachipatala, zochitika zotsika za catheter occlusion zimawonedwa (maumboni a 0.08 pamwezi pogwiritsa ntchito mankhwala Apidra ® ndi ma miclusions a 0.15 pamwezi pogwiritsa ntchito insulin aspart, komanso mawonekedwe amodzimodzi omwe amapezeka pamalo a jakisoni (10,3% mukamagwiritsa ntchito Apidra ® ndi 13.3% mukamagwiritsa ntchito insulin aspart).

Mwa ana ndi achinyamata omwe ali ndi matenda a shuga 1 amisellitus, omwe amalandila insulin kamodzi patsiku madzulo, insulin glargine, kapena kawiri tsiku lililonse m'mawa ndi madzulo, isulin insulin, poyerekeza mphamvu ndi chitetezo cha mankhwala ndi insulin glulisin ndi insulin lispro ndi kwa makonzedwe a mphindi 15 asanadye chakudya, adawonetsedwa kuti kuwongolera glycemic, kuchuluka kwa hypoglycemia, komwe kumafunikira kulowererapo kwa anthu ena, komanso zochitika zamasewera a hypoglycemic omwe anali ofanana m'magulu onse awiri azachipatala. Komanso, pakatha milungu 26 ya chithandizo, odwala omwe amalandira chithandizo cha insulini ndi glulisin kuti akwaniritse kuwongolera kwa glycemic ofanana ndi lispro insulin amafunikira kuwonjezeka kocheperako pa tsiku lililonse la insulin insulin, kuchita insulin mwachangu komanso kuchuluka kwa insulin.

Mtundu ndi jenda
M'mayeso azachipatala olamulidwa mwa achikulire, kusiyana pakubwera ndi chitetezo cha insulin glulisin sikunawonetsedwe pakupendedwa kwamagulu osiyanitsidwa ndi mtundu ndi jenda.

Pharmacokinetics
Mu insulin, glulisin, m'malo mwa amino acid katsitsumzukwa wa munthu insulin pamalo B3 ndi lysine ndi lysine pamalo B29 ndi glutamic acid amalimbikitsa kuyamwa mwachangu.

Mayamwidwe ndi Bioavailability
Ma cell a nthawi ya pharmacokinetic atsekera odzipereka athanzi komanso odwala omwe ali ndi mtundu wa 2 ndi mtundu wa 2 matenda osokoneza bongo adawonetsa kuti kuyamwa kwa insulini glulisin poyerekeza ndi insulle ya insulin yaumunthu kunali pafupifupi kawiri nthawi yayikulu ndipo kuchuluka kwakukulu kwa plasma (Cmax) kunali pafupifupi 2 nthawi zina.

Mu kafukufuku yemwe wachitika kwa odwala omwe ali ndi matenda a shuga 1, pambuyo pa insulin glulisin pa 0,15 U / kg, T_max (nthawi yoyambira ndende yozama ya plasma) inali mphindi 55, ndi C_max anali 82 ± 1.3 μU / ml poyerekeza ndi T_maxndikupanga mphindi 82, ndi C_maxwa 46 ± 1.3 mcU / ml ya insulin yaumunthu. Nthawi yomwe amakhala munthawi yogwiritsira ntchito insulin glulisin inali yocheperako (mphindi 98) kusiyana ndi insulle ya munthu (161 mphindi).

Pakufufuza kwa odwala omwe ali ndi matenda a shuga 2 pambuyo pa mankhwala a insulin glulisin pa 0,2 PIECES / kg C_max anali 91 μED / ml wokhala ndi malo amtundu wa 78 mpaka 104 μED / ml.

Pamene s / c ya insulin idaperekedwa, glulisin m'chigawo cha khomo lamkati lakumbuyo, ntchafu, kapena phewa (m'chigawo chofiyira cha minofu), kuyamwa kunafulumira mukaulowetsedwa m'chigawo cha khomo lamkati lakumbuyo poyerekeza ndi kuyamwa kwa mankhwalawa m'dera la ntchafu. Kuchuluka kwa mayamwidwe kudera lotetemera kunali kwapakatikati. Mtheradi wa bioavailability wa insulin glulisin pambuyo pa kukonzekera anali pafupifupi 70% (73% kuchokera kukhoma lakumbuyo kwam'mimba, 71 kuchokera ku minofu yolumikizana ndi 68% kuchokera m'chiuno) ndipo anali ndi kusiyana kochepa kwa odwala osiyanasiyana.

Kugawa ndi Kuchotsa
Kugawika ndi kutulutsa kwa insulin glulisin ndi madzi osungunuka pakhungu pambuyo pamitsempha yama cell ndi ofanana, ndikugawa mavitamini 13 malita ndi malita 21 ndi theka la moyo wamphindi 13 ndi 17, motsatana. Pambuyo pakuyamwa kwa insulin, glulisin imachotsedwa mofulumira kuposa insulin yaumunthu, ndikumakhala ndi moyo wamphindi 42, poyerekeza ndi theka la moyo wosasungunuka wamunthu wamphindi 86. Pakufufuza kwapadera kwamaphunziro a insulin glulisin mwa onse athanzi komanso omwe ali ndi matenda amtundu wa 2 komanso mtundu wa 2, kuwonongerako theka la moyo kumachokera pa mphindi 37 mpaka 75.

Pharmacokinentics pamagulu apadera a odwala
Odwala omwe ali ndi vuto la impso
Mu kafukufuku wazachipatala omwe amapangidwa mu odwala omwe alibe matenda a shuga omwe ali ndi magwiridwe antchito osiyanasiyana a impso (creatinine clearance (CC)> 80 ml / min, 30-50 ml / min, ® mwa amayi apakati. Kachulukidwe kochepa ka data kamene kamapezeka pa ntchito ka insulin glulisin mu azimayi oyembekezera (zotsatira zosakwana 300 zapakati) zidafotokoza), sizikuwonetsa kuyipa kwake pakubala, kulera kwa mwana wosabadwa kapena khanda lobadwa chatsopano. lichy pakati insulin glulisine ndi insulin anthu za mimba, embryonic / chitukuko yoopsa, pobereka ndi chitukuko positi-Natal.

Kugwiritsa ntchito Apidra ® mwa amayi apakati kumafunikira kusamala. Kusamala mosamala za kuchuluka kwa shuga m'magazi ndikukhala ndi vuto lokwanira la glycemic ndikofunikira.

Odwala omwe ali ndi pakati asanabadwe kapena matenda ashuga ayenera kukhala ndi vuto lokwanira la glycemic musanabadwe komanso panthawi yonse yomwe ali ndi pakati. Munthawi yoyamba kubereka, kufunika kwa insulini kumatha kuchepa, ndipo panthawi yachiwiri komanso yachitatu, imatha kuchuluka. Pambuyo pobadwa, insulini imafuna kuchepa mwachangu.

Odwala omwe ali ndi matenda ashuga ayenera kudziwitsa dokotala ngati ali ndi pakati kapena akufuna kukhala ndi pakati.

Nthawi yoyamwitsa
Sizikudziwika ngati insulin glulisin imadutsa mkaka wa m'mawere, koma ambiri, insulini simalowa mkaka wa m'mawere ndipo samatengedwa ndi makonzedwe amkamwa.

Amayi pakuyamwitsa, kuwongolera kwa insulin dosing regimen ndi zakudya kungafunike.

Mlingo ndi makonzedwe

Apidra ® iyenera kugwiritsidwa ntchito pazamankhwala omwe amaphatikiza insulin, kapena insulin yayitali, kapena analogue ya insulin yayitali. Kuphatikiza apo, Apidra ® ikhoza kugwiritsidwa ntchito limodzi ndi mankhwala amkamwa a hypoglycemic (PHGP).

Mlingo wa Apidra ® mlingo umasankhidwa payekha malinga ndi malingaliro a dokotala mogwirizana ndi zosowa za wodwala. Odwala onse omwe ali ndi matenda ashuga amalangizidwa kuti azitsatira ndende yawo ya shuga.

Gwiritsani ntchito m'magulu a wodwala apadera
Ana ndi achinyamata
Apidra ® ikhoza kugwiritsidwa ntchito mwa ana opitirira zaka 6 ndi achinyamata. Zambiri zamankhwala pazokhudza kugwiritsa ntchito mankhwalawa kwa ana osakwana zaka 6 ndizochepa.

Odwala okalamba
Zambiri zomwe zimapezeka mu pharmacokinetics mwa odwala okalamba omwe ali ndi matenda osokoneza bongo ndi osakwanira.
Kugwedezeka kwa impso muukalamba kungachititse kuchepa kwa insulin.

Odwala omwe ali ndi vuto la impso
Kufunika kwa insulini pakukanika kwa impso kumatha kuchepa.

Odwala omwe ali ndi vuto la chiwindi
Odwala omwe ali ndi vuto la chiwindi, vuto la insulin lingathe kuchepa chifukwa cha kuchepetsedwa kwa gluconeogeneis komanso kuchepa kwa insulin metabolism.

Kupanga ndi mawonekedwe a kumasulidwa

m'miyala 10 ml kapena ma cartridge atatu a 3 ml, mu paketi ya makatoni 1 vial kapena chovala chaching'ono chonyamula ma cartridge 5 a cholembera kapena makatoni a OptiPen kapena cholembera m'miyala ya OptiSet yotayika kapena pulogalamu ya OptiClick cartridge .

Mankhwala

Insulin glulisin ndi analogue yobwerezabwereza ya insulin ya anthu, yofanana ndi mphamvu kwa insulin wamba ya anthu. Insulin glulisin imayamba kuchita zinthu mwachangu ndipo imakhala ndi nthawi yofupikirapo kuposa insulin ya munthu wosungunuka. Chofunikira kwambiri cha insulin ndi insulin analogues, kuphatikizapo insulin glulisin, ndikuwongolera kwa kagayidwe ka glucose. Insulin imachepetsa kuchuluka kwa shuga m'magazi, ndikulimbikitsa kufatsa kwa glucose mwa zotumphukira, makamaka minofu yamatumbo ndi minyewa ya adipose, komanso kuletsa mapangidwe a shuga mu chiwindi. Insulin imalepheretsa adipocyte lipolysis ndi proteinolysis komanso imathandizira kaphatikizidwe ka mapuloteni. Kafukufuku wopangidwa mwa odzipereka athanzi komanso odwala matenda a shuga aonetsa kuti chifukwa cha insulin glulisin imayamba kuchita zinthu mwachangu ndipo imakhala ndi nthawi yofupikirapo kuposa kusungunuka kwa insulin yamunthu. Mukamayambitsa kukhazikitsidwa kwa shuga m'magazi, ntchito ya insulin glulisin imayamba pakadutsa mphindi 10-20. Ndi makina a iv, zotsatira za kutsitsa shuga m'magazi a insulin glulisin ndi insulle ya insulin yamunthu ndiyofanana mu mphamvu. Gawo limodzi la insulin glulisin limakhala ndi ntchito yofanana yotsitsa shuga monga gawo limodzi la insulin yaumunthu.

Mu gawo lomwe ndimaphunzira odwala omwe ali ndi vuto la matenda ashuga a mtundu 1, kutsitsa kwa glucose-insulin glulisin ndi insulle human insulin, amayesedwa s.c. pa mlingo wa mayunitsi a 0,15 / kg panthawi zosiyanasiyana malinga ndi chakudya chokwanira cha mphindi 15.

Zotsatira za phunziroli zidawonetsa kuti insulin glulisin, yomwe idapangidwira mphindi 2 asanadye chakudya, idapereka chiwonetsero chofananira cha glycemic pambuyo chakudya monga insulin ya munthu wosungunuka, kutumikiridwa mphindi 30 asanadye. Pakaperekedwa mphindi ziwiri asanadye, insulin glulisin imapereka chiwongolero chabwinoko pakatha chakudya kuposa chakudya chosungunuka chomwe munthu amakhala nacho pakadutsa mphindi 2 asanadye. Glulisin insulin, yoyendetsedwa pakatha mphindi 15 chakudya chitayamba, anaperekanso chiwonetsero chofananira cha glycemic pambuyo chakudya mukamalimbitsa thupi insulin, amasungunuka mphindi 2 chakudya chisanachitike.

Kunenepa kwambiri Gawo loyamba lomwe ndimaphunziro a insulin glulisin, insulin lispro ndi insulin ya insulin ya anthu omwe ali m'gulu la onenepa kwambiri adawonetsa kuti mwa odwalawa, insulin glulisin imakhalabe ndi machitidwe omwe amathandizira. Phunziroli, nthawi yoti ifike 20% ya AUC yonse inali ma mineral 114 a insulini glulisin, 121 mphindi ya insulin lispro ndi ma 150 mphindi a insulle ya insulle ya anthu, komanso AUC (maola 0-2), yomwe imawonetseranso ntchito zomwe zimachepetsa shuga. mg · kg -1 - kwa insulin glulisin, 354 mg · kg -1 - wa insulin lispro ndi 197 mg · kg -1 - wosungunuka wa insulin wa anthu, motero.

Mtundu woyamba wa shuga. M'masabata a 26 oyesedwa ndi gawo lachitatu la magawo atatu, omwe insulin glulisin imayerekezedwa ndi inspro insulin, yoyendetsedwa s.c. asanadye (0 mpaka mphindi 15), odwala omwe ali ndi matenda a shuga 1, amagwiritsa ntchito insulin glargine, insulin glulisin ngati basulin insulini anali ofanana ndi lyspro insulin pankhani ya kayendedwe ka glycemic, komwe adayesa kusintha kwa kuchuluka kwa glycosylated hemoglobin (HbA_1C) panthawi yakumapeto kwa kafukufukuyu poyerekeza ndi zotsatira zake. Miyezo yamtengo wapatali yamagazi inawonedwa, yodziwunikira. Ndi makonzedwe a insulin glulisin, mosiyana ndi mankhwala a insulin, lyspro sanafune kuwonjezeka kwa mlingo wa basal insulin.

Kafukufuku wotsatira wa milungu iwiri wachitatu kwa odwala omwe ali ndi matenda a shuga 1 omwe adalandira insulin glargine monga chithandizo choyambira adawonetsa kuti kuyamwa kwa insulini glulisin atangodya chakudya kumakhala kofanana ndi kwa insulin glulisin musanadye chakudya (0 -15 min) kapena kusungunuka kwa insulin ya anthu (30-45 mphindi musanadye).

Mwa kuchuluka kwa odwala omwe anamaliza phunziroli, pagulu la odwala omwe adalandira insulin glulisin asanadye, kuchepa kwakukulu kwa HbA kunawonedwa_1C poyerekeza ndi gulu la odwala omwe amalandila insulin yaumunthu.

Type 2 shuga. Kuyesedwa kwamankhwala kwa milungu 26 ya III kwatsatiridwa ndikutsatiridwa kwa sabata la 26 mwanjira yophunzirira zachitetezo kunachitika kuti ayerekeze insulin glulisin (0-15 mphindi musanadye) ndi insulin ya munthu wosungunuka (30-45 mphindi musanadye) omwe adayendetsedwa ndi sc odwala omwe ali ndi matenda a shuga 2, kuwonjezera pa insulin-isophan ngati basal. Mtundu wa wodwala wowonda anali 34,55 kg / m 2. Insulin glulisin yawonetsedwa kuti ingafanane ndi insulin ya anthu osungunuka posintha masinthidwe a HbA_1C Pambuyo pa miyezi 6 ya mankhwala poyerekeza ndi zotsatira zake (-0.46% ya insulini glulisin ndi -0.30% ya insulin ya anthu sungunuka, p = 0.0029) ndipo pambuyo pa miyezi 12 ya chithandizo poyerekeza ndi zotsatira zake (-0.23% - kwa insulin glulisin ndi -0.13% ya insulle ya anthu sungunuka, kusiyana sikofunika kwambiri. Phunziroli, odwala ambiri (79%) adasakaniza insulin yawo yochepa ndi isulin insulin nthawi yomweyo asanalowe. Panthawi yodziwika bwino, odwala 58 adagwiritsa ntchito mankhwala a hypoglycemic ndipo adalandira malangizo kuti apitirize kugwiritsa ntchito mlingo womwewo.

Chiyambo ndi mtundu. M'mayeso azachipatala olamulidwa mwa achikulire, kusiyana pakubwera ndi chitetezo cha insulin glulisin sikunawonetsedwe pakupendedwa kwamagulu osiyanitsidwa ndi mtundu ndi jenda.

Pharmacokinetics

Mu insulin glulisine, kulowetsedwa kwa amino acid asparagine wa insulin yaumunthu pamalo B3 ndi lysine ndi lysine pamalo B29 ndi glutamic acid amalimbikitsa kuyamwa mwachangu.

Mayamwidwe ndi bioavailability. Pharmacokinetic ndende nthawi yopindulitsa mwa odzipereka athanzi komanso odwala omwe ali ndi mtundu woyamba wa 2 ndi 2 matenda osokoneza bongo adawonetsa kuti kuyamwa kwa insulini glulisin poyerekeza ndi insulle ya insulin yaumunthu kunali pafupifupi nthawi 2, kufikira kuwirikiza kawiri C_max .

Mu kafukufuku yemwe wachitika kwa odwala omwe ali ndi matenda a shuga 1, pambuyo pa insulin glulisin pa 0,15 u / kg T_max (nthawi ya C_max ) anali 55 mphindi ndi C_max mu plasma anali (82 ± 1.3) μed / ml poyerekeza ndi T_max kuphatikiza 82 mphindi ndi C_max chigawo chimodzi (46 ± 1,3) μed / ml, cha insulin ya anthu. Nthawi yomwe amakhala munthawi yogwiritsira ntchito insulin glulisin inali yochepa (98 min) kuposa ya insulin wamba (161 min).

Pakufufuza kwa odwala omwe ali ndi matenda a shuga 2 pambuyo pa mankhwala a insulin glulisin pa 0,2 u / kg C_max anali 91 μed / ml wokhala ndi malo amtunda wa 78 mpaka 104 μed / ml.

Ndi subcutaneous makonzedwe a insulin glulisin kukhoma kwam'mimba khoma, ntchafu kapena phewa (dera louma), mayamwidwe anali mwachangu pamene adalowetsedwa mu khoma lakunja lamkati poyerekeza ndi kuyendetsa kwa mankhwalawa m'chiuno. Kuchuluka kwa mayamwidwe kudera lotetemera kunali kwapakatikati. Mtheradi wa bioavailability wa insulin glulisin (70%) m'malo osiyanasiyana jakisoni anali ofanana ndipo anali ndi kusiyana kochepa pakati pa odwala osiyanasiyana. Coeffanele of variation (CV) - 11%.

Kugawa ndi kusiya. Kugawa ndi kutulutsa kwa insulin glulisin ndi madzi sungunuka wa munthu pambuyo pa utsogoleri wa iv ndi ofanana, ndi magawo a 13 ndi 22 L, ndi T_1/2 ndikupanga 13 ndi 18 min, motsatana.

Pambuyo pakuyambitsa insulini, glulisin imachotsedwako mwachangu kuposa insulin yaumunthu, chifukwa chowoneka ngati T_1/2 Mphindi 42 poyerekeza ndi T_1/2 sungunuka wa insulin ya anthu, wopangidwa ndi 86 min. Pakufufuza kwapadera kwamaphunziro a insulin glulisin mwa onse athanzi komanso omwe ali ndi matenda amtundu woyamba 1, 2_1/2 kuyambira 37 mpaka 75 Mphindi.

Magulu Opatsa Odwala

Kulephera kwina. Pakafukufuku wazachipatala omwe amapangidwa mwa anthu opanda matenda a shuga omwe ali ndi magwiridwe osiyanasiyana a impso (creatinine Cl> 80 ml / min, 30-50 ml / min, T_max ndi C_max chimodzimodzi ndi akulu. Monga mwa akulu, mukamaperekera zakudya musanayesedwe, insulin glulisin imapatsa shuga shuga wamagazi pambuyo pakudya kuposa kusungunuka kwa insulin. Kuwonjezeka kwa ndende ya magazi pambuyo podya (AUC 0-6 h - m'dera lomwe kumapeto kwa magazi glucose - kuyambira 0 mpaka 6 h) anali 641 mg · h · dl -1 - chifukwa cha insulini glulisin ndi 801 mg · h · dl -1 - sungunuka wa insulin wa anthu.

Mimba komanso kuyamwa

Mimba Zambiri zomwe sizipezeka pakugwiritsa ntchito insulin glulisin mwa amayi apakati.

Kafukufuku wolera nyama sanawonetse kusiyana kulikonse pakati pa insulin glulisin ndi insulin yaumunthu pokhudzana ndi kutenga pakati, fetal / fetal, kubereka mwana ndi chitukuko cha pambuyo pake.

Popereka mankhwala kwa amayi apakati, chisamaliro chikuyenera kuthandizidwa. Kuwunikira mosamala kuchuluka kwa shuga m'magazi kumafunika.

Odwala omwe ali ndi pakati asanabadwe kapena matenda ashuga ayenera kusamalira kagayidwe koyenera panthawi yonse yomwe ali ndi pakati. Munthawi yoyamba kubereka, kufunika kwa insulini kumatha kuchepa, ndipo panthawi yachiwiri komanso yachitatu, imatha kuchuluka. Pambuyo pobadwa, insulini imafuna kuchepa mwachangu.

Kuchepetsa. Sizikudziwika ngati insulin glulisin imadutsa mkaka wa m'mawere, koma insulini sichilowa mkaka wa m'mawere ndipo sichimalowetsedwa ndi ingestion.

Amayi oyamwitsa angafunikire kusintha kwa insulin ndi zakudya.

Bongo

Zizindikiro ndi kuchuluka kwa mankhwala a insulin mokhudzana ndi kufunika kwake, komwe kumatsimikiziridwa ndi kudya ndi mphamvu zamagetsi, hypoglycemia imatha kukhazikika.

Palibe zambiri zachidziwikire zokhudzana ndi kuchuluka kwa insulin glulisin. Komabe, ndi bongo wake, hypoglycemia imatha kukula mofatsa kapena mwamphamvu.

Chithandizo: magawo a hypoglycemia wofatsa amatha kuyimitsidwa ndi shuga kapena zakudya zomwe zili ndi shuga. Chifukwa chake, tikulimbikitsidwa kuti odwala matenda ashuga nthawi zonse azikhala ndi shuga, maswiti, makeke kapena mandimu okoma zipatso.

Zolemba za hypoglycemia yayikulu, pomwe wodwalayo atha kuzindikira, zitha kuyimitsidwa ndi makina a minyewa kapena a subcutaneous a 0.5-1 mg wa glucagon, omwe amachitidwa ndi munthu yemwe adalandira malangizo oyenera, kapena jekeseni wa dextrose (glucose) ndi katswiri wazachipatala. Wodwala ngati sakuyankha ku glucagon kwa mphindi 10-15, ndikofunikira kupereka iv dextrose.

Pambuyo pozindikira, ndikulimbikitsidwa kuti wodwalayo amapatsidwa chakudya chamkati kuti alepheretse kubwereranso kwa hypoglycemia.

Pambuyo pokonzekera glucagon, wodwalayo amayenera kuthandizidwa kuchipatala kuti adziwe zomwe zimayambitsa hypoglycemia yayikulu ndikuletsa kutulutsa kwa zina.

Zokhudza mphamvu pakutha kuyendetsa magalimoto ndi zida

Odwala ayenera kulangizidwa kuti asamale ndikupewa kukhala ndi hypoglycemia poyendetsa magalimoto kapena makina. Izi ndizofunikira kwambiri kwa odwala omwe achepetsa kapena osatha kuzindikira zizindikiro zomwe zikuwonetsa kukula kwa hypoglycemia, kapena omwe ali ndi zochitika zapafupipafupi za hypoglycemia. Mwa odwalawa, funso loti akhoza kuwayendetsa ndi magalimoto kapena njira zina ayenera kusankha payekha.

Malangizo ogwiritsira ntchito ndi kuwongolera

Mbale
Mbale za Apidra ® zimapangidwa kuti zigwiritsidwe ntchito ndi ma insulin omwe ali ndi muyeso woyenera wa gawo ndikugwiritsira ntchito pulogalamu ya insulin pump.

Yenderani botolo musanagwiritse ntchito. Iyenera kugwiritsidwa ntchito pokhapokha yankho likakhala lomveka, lopanda utoto ndipo lilibe zinthu zophatikizika.

Kupitiliza kwa sc kupitilira pogwiritsa ntchito pampu.

Apidra ® itha kugwiritsidwa ntchito popitilira kulowetsedwa kwa insulin (NPII) pogwiritsa ntchito pampu yoyenera kulowetsedwa ndi insulin ndi ma catheters oyenera komanso malo osungira.

Zomwe zimayikidwa ndikusungiramo zosungirako ziyenera kusinthidwa maola 48 aliwonse motsatira malamulo a aseptic.

Odwala omwe amalandila Apidra ® kudzera ku NPI ayenera kukhala ndi insulin ina m'malo mwake ngati kulephera kwa pampu.

Makatoni
Makatoni amayenera kugwiritsidwa ntchito limodzi ndi cholembera cha insulin, AllStar, komanso mogwirizana ndi malingaliro omwe ali m'Malangizo Ogwiritsira Ntchito Opangira chidacho. Sayenera kugwiritsidwa ntchito ndi zolembera zina zanenjenjemera, popeza kulondola kwa dosing kudakhazikitsidwa kokha ndi cholembera ichi.

Malangizo a wopanga ogwiritsa ntchito cholembera cha sySinge ya AllStar okhudza katiriji, kuphatikiza singano, ndi jakisoni wa insulin uyenera kutsatiridwa ndendende. Yenderani cartridge musanagwiritse ntchito. Iyenera kugwiritsidwa ntchito pokhapokha yankho likakhala lomveka bwino, lopanda utoto, lopanda zinthu zolimba zowoneka. Tisanayike katiriji mu cholembera chosakanizira, katirijiyu ayenera kukhala otentha kwa maola awiri. Pamaso pa jekeseni, thovu ndi mpweya ziyenera kuchotsedwa mu katoni (onani malangizo ogwiritsira ntchito cholembera). Malangizo ogwiritsira ntchito cholembera uyenera kutsatiridwa mosamalitsa. Makatoni opanda kanthu sangakwaniritsidwe. Ngati cholembera cha syringe "OlStar" (AllStar) chawonongeka, sichitha kugwiritsidwa ntchito.

Ngati cholembera sichigwira ntchito moyenera, yankho lake limatha kutengedwa kuchokera ku cartridge kupita ku syringe ya pulasitiki yoyenera kwa insulin pakuchitika kwa 100 PIECES / ml ndikupatsidwa kwa wodwala.

Popewa matenda, cholembera chobwezeretsanso chikuyenera kugwiritsidwa ntchito mwa wodwala yemweyo.