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作 者:卫晋菲[1] 周亮[1] 王晓青[1] 张鑫[1] 王心慧[1] 王明媚[1]
机构地区:[1]解放军总医院第一附属医院药剂药理科,北京100048
出 处:《中国药物应用与监测》2016年第5期263-267,共5页Chinese Journal of Drug Application and Monitoring
基 金:"十二五"国家科技支撑计划课题项目(2013BAI06B04)
摘 要:目的:探讨比较瑞格列奈与米格列奈治疗2型糖尿病的疗效和安全性。方法:计算机检索Pub Med、Medline、EMbase、Cochrane图书馆、万方、维普、CNKI、中国医院知识总库。按照Cochrane Handbook 5.1.0评价系统评价方法查找瑞格列奈和米格列奈治疗2型糖尿病的随机对照试验(RCT),进行数据提取和质量评价后,采用Rev Man 5.2软件进行Meta分析。结果:共纳入5个RCT的文献,390例患者。Meta分析结果显示:在降低患者糖化血红蛋白[MD=0.02,95%CI(–0.43,0.48),P=0.92]和空腹血糖[MD=0.33,95%CI(0.00,0.66),P=0.05]方面,瑞格列奈组和米格列奈组的差异无统计学意义;在降低餐后2小时血糖[MD=0.91,95%CI(0.42,1.39),P=0.000 3]方面,米格列奈组优于瑞格列奈组。两组在胃肠道反应发生率[OR=0.61,95%CI(0.15,2.48),P=0.49]方面的差异没有统计学意义,但瑞格列奈组低血糖反应[OR=5.71,95%CI(2.16,15.10),P=0.000 4]的发生风险高于米格列奈组。结论:米格列奈在降低餐后2小时血糖方面的效果优于瑞格列奈,同时其低血糖反应的发生率更低。由于受到纳入研究质量与样本数量的限制,此结论有待设计严谨、长期随访的大样本临床随机对照试验进一步给予验证。Objective: To evaluate the efficacy and safety of repaglinide versus mitiglinide in type 2 diabetes (T2DM). Methods: PubMed, Medline, EMbase, Cochrane Library, Wanfang, VIP, CNKI and CHKD databases were retrieved. The data about randomized controlled trials (RCTs) of repaglinide and mitiglinide in type 2 diabetes treatment was collected and assessed by Cochrane Handbook 5.1.0 collaboration system, and then meta-analysis was performed using RevMan 5.2 software. Results: A total of 5 RCTs including 390 patients met the inclusion criteria. The results of meta-analysis showed that the effects of repaglinide in lowering HbAlc [MD = 0.02, 95%CI(- 0.43, 0.48), P = 0.92] and FPG [MD = 0.33, 95%CI (0.00, 0.66), P = 0.05] were similar to those of mitiglinide. Mitiglinide significantly reduced 2 hPG [MD = 0.91, 95%CI(0.42, 1.39), P = 0.000 3] comparing with repaglinide. No significant difference was observed in gastrointestinal discomfort [OR = 0.61, 95%CI(0.15, 2.48), P = 0.49] between the two groups, but the risk of hypoglycemia [OR = 5.71, 95%CI(2.16, 15.10), P = 0.000 4] in repaglinide group was higher than that of mitiglinide group. Conclusion: In the treatment of T2DM, mitiglinide showed more effective in 2 hPG and lower risk of hypoglycemia than repaglinide. Limited by the methodological quality and sample amount of included studies, this conclusion needs to be verified by large sample, strict design and long-term follow-up RCTs.
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