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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 double-phase aspart-insulin 50 injection with double-phase insulin 50 injection in the treatment of type 2 diabetes mellitus. Methods A total of 112 patients with type 2 diabetes who did not receive metformin oral glucose control were randomly divided into control group (56 cases) and experimental group (56 cases). The control group received 0.4 U · kg -1 double-phase human insulin 50 d, bid (5 min before breakfast and dinner), and injected subcutaneously. The experimental group received double-phase insulin aspart 50 at 30 min before breakfast and 0.4 U · Kg ~ (-1), 0.2U · kg ~ (-1) 30 min before dinner, subcutaneous injection. Two groups of patients were treated for 36 weeks. After 2 h of postprandial blood glucose (2 h PG), soluble intercellular adhesion molecule 1 (s ICAM -1), soluble vascular cell adhesion molecule 1 (s VCAM -1) The level of MCP-1 and TNF-α, as well as the incidence of adverse drug reactions, were measured. Results After treatment, the 2 h PG levels in the experimental and control groups were (8.31 ± 2.43) and (11.08 ± 2.43) mmol·L -1, respectively, with significant difference (P <0.05). After treatment, the ICAM -1 of the test group and the control group were (229.82 ± 7.61) and (249.45 ± 8.05) μg · L -1, respectively, and the VCAM -1 sVCAM -1 were (531.58 ± 11.45) and (559.82 ± 15.42) μg · L -1, MCP -1 were (371.46 ± 9.76) and (399.64 ± 12.85) μg · L -1, respectively (12.05 ± 1.18) and (15.81 ± 1.76) μg · L -1, respectively (all P <0.05). Adverse reactions were mainly hypoglycemia in both groups. The incidences of adverse drug reactions in the two groups were 5.36% and 14.29%, respectively, with no significant difference (P> 0.05). Conclusion Compared with double-phase human insulin 50 injection, double-phase aspart insulin 50 injection can significantly reduce 2 h PG and serum s ICAM -1, s VCAM -1, MCP ~ (-1) -1), TNF-α levels, and does not increase the incidence of adverse drug reactions.