Ibigeragezo bya Clinical

Intego: Intego yubu bushakashatsi ni ugusuzuma imiterere ya pharmacokinetic na pharmacodynamic (PK-PD) imyirondoro ya lispro iyobowe na QS-M inshinge zitagira inshinge zidafite inshinge mu masomo yubushinwa.

Igishushanyo mbonera nuburyo: Ubushakashatsi bwateganijwe, bubiri-buhumyi, kabiri-dummy, ubushakashatsi bwambutse.Abakorerabushake 18 bafite ubuzima bwiza bashakishijwe.Lispro (ibice 0.2 / kg) yakoreshwaga na QS-M inshinge zidafite urushinge cyangwa ikaramu isanzwe.Hakozwe amasaha arindwi ya euglycemic clamp.Abakorerabushake cumi n'umunani (abagabo icyenda n'abagore icyenda) bashakishijwe muri ubu bushakashatsi.Ibipimo byo kubishyiramo byari: abatanywa itabi bafite hagati yimyaka 18-40, hamwe numubare rusange wumubiri (BMI) wa 17-24 kg / m2;amasomo afite ibizamini bisanzwe bya biohimiki, umuvuduko wamaraso, na electrocardiograf;ingingo zasinye uruhushya rubimenyeshejwe.Ibipimo byo guhezwa byari: amasomo afite allergie ya insuline cyangwa andi mateka ya allergique;ingingo zifite indwara zidakira nka diyabete, indwara z'umutima-damura, umwijima cyangwa indwara zimpyiko.Ibintu byakoreshaga inzoga nabyo ntibyatanzwe.Ubushakashatsi bwemejwe na komite ishinzwe imyitwarire y’ibitaro bya mbere bishamikiye kuri kaminuza y’ubuvuzi ya Chongqing.

Ibisubizo: Ahantu hanini munsi yumurongo (AUCs) yubushakashatsi bwa insuline nigipimo cya glucose (GIR) muminota 20 yambere nyuma yo guterwa lispro nuwatewe indege ugereranije n'ikaramu ya insuline byagaragaye (24.91 ± 15.25 na 12.52 ± 7.60 mg . kg - 1, P <0.001 kuri AUCGIR, 0–20 min; 0.36 ± 0.24 na 0.10 ± 0.04 U min L - 1, P <0.001 kuri AUCINS, 0–20 min).Gutera inshinge byerekanaga igihe gito cyo kugera kuri insuline ntarengwa (37.78 ± 11.14 na 80.56 ± 37.18 min, P <0.001) na GIR (73.24 ± 29.89 na 116.18 ± 51.89 min, P = 0.006).Nta tandukaniro ryagaragaye muri insuline zose hamwe ningaruka za hypoglycemic hagati yibikoresho byombi.Umwanzuro: Lispro iyobowe na QS-M inshinge zidafite inshinge zitera insuline mbere kandi nyinshi kurenza ikaramu isanzwe, hamwe ningaruka nini yo kugabanya glucose hakiri kare hamwe nubushobozi rusange muri rusange.