Gwajin asibiti

Makasudi: Manufar wannan binciken shine a kimanta bayanan martabar pharmacokinetic da pharmacodynamic (PK-PD) na lispro wanda allurar jet mara amfani da QS-M a cikin batutuwan Sinanci.

Tsarin bincike da hanyoyin: An yi bazuwar, makafi biyu, dummy biyu, binciken giciye.An dauki ma'aikatan sa kai sha takwas lafiyayyu.Lispro (0.2 raka'a/kg) an gudanar da shi ta hanyar allurar jet na QS-M ko ta alkalami na al'ada.An yi gwajin manne euglycemic na awa bakwai.An dauki masu aikin sa kai goma sha takwas (maza tara da mata tara) a cikin wannan binciken.Sharuɗɗan haɗawa sune: marasa shan taba masu shekaru 18-40 shekaru, tare da ƙididdigar jiki (BMI) na 17-24 kg / m2;batutuwa masu gwaje-gwajen kwayoyin halitta na al'ada, hawan jini, da electrocardiograph;batutuwa waɗanda suka sanya hannu kan yarda da aka sanar.Sharuɗɗan keɓancewar sune: batutuwa masu ciwon insulin ko wasu tarihin rashin lafiyan;masu fama da cututtuka na yau da kullun kamar ciwon sukari, cututtukan zuciya, hanta ko cutar koda.Abubuwan da suka yi amfani da barasa kuma an cire su.Kwamitin da'a na Asibitin Farko na Jami'ar Kiwon Lafiya ta Chongqing ya amince da binciken.

Sakamako: Babban yanki mafi girma a ƙarƙashin lanƙwasa (AUCs) na maida hankali na insulin da adadin jiko na glucose (GIR) a cikin mintuna 20 na farko bayan allurar lispro ta hanyar injector jet idan aka kwatanta da alkalami na insulin (24.91 ± 15.25 vs. 12.52 ± 7.60 mg). . kg-1, P <0.001 don AUCGIR,0-20 min; 0.36 ± 0.24 vs. 0.10 ± 0.04 U min L-1, P <0.001 don AUCINS, 0-20 min).Allurar da ba ta da allura ta nuna ɗan gajeren lokaci don isa matsakaicin adadin insulin (37.78 ± 11.14 vs. 80.56 ± 37.18 min, P <0.001) da GIR (73.24 ± 29.89 vs. 116.18 ± 51.89 min, P = 0.06).Babu bambance-bambance a cikin jimlar bayyanar insulin da tasirin hypoglycemic tsakanin na'urorin biyu.Ƙarshe: Lispro wanda QS-M mai allura mara allura ke gudanarwa yana haifar da farkon bayyanar insulin fiye da alkalami na al'ada, da mafi girman tasirin rage yawan glucose na farko tare da irin wannan ƙarfin gabaɗaya.