双时相门冬胰岛素50注射液治疗2型糖尿病的临床研究

Clinical trial of biphasic insulin aspart 50 injection in the treatment of type 2 diabetes mellitus

目的比较双时相门冬胰岛素50注射液与双时相人胰岛素50注射剂治疗2型糖尿病的临床疗效及安全性。方法将112例口服二甲双胍血糖控制不达标的2型糖尿病患者随机分为对照组56例和试验组56例。对照组予以0.4U·kg^(-1)双时相人胰岛素50,bid(早、晚餐前5 min),皮下注射;试验组予以双时相门冬胰岛素50,早餐前30 min予以0.4 U·kg^(-1),晚餐前30 min予以0.2U·kg^(-1),皮下注射。2组患者均治疗36周。比较2组患者的餐后2 h血糖(2 h PG)、可溶性细胞间黏附分子1(s ICAM^(-1))、可溶性血管细胞间黏附分子1(s VCAM^(-1))、单核细胞趋化蛋白^(-1)(MCP^(-1))和肿瘤坏死因子(TNF-α)的水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的2 h PG分别为(8.31±2.43),(11.08±2.43)mmol·L^(-1),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的s ICAM^(-1)分别为(229.82±7.61)和(249.45±8.05)μg·L^(-1),s VCAM^(-1)分别为(531.58±11.45)和(559.82±15.42)μg·L^(-1),MCP^(-1)分别为(371.46±9.76)和(399.64±12.85)μg·L^(-1);TNF-α分别为(12.05±1.18)和(15.81±1.76)μg·L^(-1),差异均有统计学意义(均P<0.05)。2组患者的药物不良反应均以低血糖为主,试验组和对照组的药物不良反应发生率分别为5.36%和14.29%,差异无统计学意义(P>0.05)。结论与双时相人胰岛素50注射剂相比,双时相门冬胰岛素50注射液可显著降低患者的2 h PG和血清s ICAM^(-1)、s VCAM^(-1)、MCP^(-1)、TNF-α的水平,且不增加药物不良反应的发生率。

Objective To compare the clinical efficacy and safety of biphasic insulin aspart 50 injection and biphasic human insulin 50 injection in the treatment of type 2 diabetes mellitus（ T2DM）. Methods A total of 112 patients with T2 DM whoes glycemic did not control by oral metformin,were randomly divided into control group and treatment group with 56 cases per group. Control group received 0. 4 U · kg^-1biphasic human insulin 50,bid（ 5 min before breakfast and dinner）,subcutaneous injection. Treatment group received biphasic insulin aspart 50 injection,30 min before breakfast at 0. 4 U·kg^-1,30 min before dinner at0. 2 U · kg^-1,subcutaneous injection. Two groups were treated for 36 weeks. The 2 h-postprandial blood glucose（ 2 h PG）, solubleintercellular adhesion molecule-1（ s ICAM-1）,soluble vascular cell adhesionmolecula-1（ s VCAM-1）,monocyte chemotactic protein 1（ MCP-1）,tumor necrosis factor-α（ TNF-α） and adverse drug reactions were compared between two groups. Results After treatment,the 2 h PG of treatment and control groups were（ 8. 31 ± 2. 43）,（ 11. 08 ± 2. 43） mmol·L^-1with significant difference（ P〈0. 05）. After treatment,the main indexes in treatment and control groups were compared： s ICAM-1 were（ 229. 82 ± 7. 61）,（ 249. 45 ± 8. 05） μg · L^-1; s VCAM-1 were（ 531. 58 ± 11. 45）,（ 559. 82 ± 15. 42） μg·L^-1; MCP-1 were（ 371. 46 ± 9. 76）,（ 399. 64 ± 12. 85） μg·L^-1;TNF-α were（ 12. 05 ± 1. 18）,（ 15. 81 ± 1. 76） μg · L^-1, the differences were statistically significant（ all P〈0. 05）. The adverse drug reactions of two groups were based on hypoglycemia,the incidences of treatment and control groups were 5. 36% and 14. 29% without significant difference（ P〈0. 05）. Conclusion Compared with biphasic human insulin 50 injection,biphasic insulin aspart 50 injection can reduce the 2 h PG and serum levels of s ICAM-1,s VCAM-1,MCP-1 and TNF-α,without increasing the incidence of adverse drug reactions.