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作 者:卫晋菲[1] 周亮[1] 王晓青[1] 李翔[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》2015年第5期261-265,共5页Chinese Journal of Drug Application and Monitoring
基 金:"十二五"国家科技支撑计划子课题(2013BAI06B04Y023128)
摘 要:目的:探讨比较瑞格列奈联合二甲双胍与那格列奈联合二甲双胍治疗2型糖尿病的疗效和安全性。方法:检索Pub Med、Medline、Cochrane图书馆、EMbase、VIP、CNKI、万方数据库,按照Cochrane Handbook 5.1.0评价系统评价方法,查找瑞格列奈联合二甲双胍和那格列奈联合二甲双胍治疗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篇RCT文献,437例患者。Meta分析结果显示:在降低患者糖化血红蛋白[MD=–0.61,95%CI(–0.64,–0.58),P<0.000 01]方面,瑞格列奈联合二甲双胍组优于那格列奈联合二甲双胍组;在降低空腹血糖[MD=–0.46,95%CI(–0.97,0.05),P=0.08]和餐后2小时血糖[MD=0.29,95%CI(–0.92,1.50),P=0.64]方面,两组没有统计学差异;在低血糖反应发生率[OR=1.25,95%CI(0.34,4.58),P=0.74]和胃肠道反应发生率[OR=1.02,95%CI(0.31,3.32),P=0.98]方面,两组的差异没有统计学意义。结论:瑞格列奈联合二甲双胍较那格列奈联合二甲双胍在治疗2型糖尿病时,能更有效的降低糖化血红蛋白,同时两组低血糖和胃肠道反应的发生风险相似。由于本研究存在一定的局限性,因此结论的可靠性仍需多中心、大样本、高质量的RCT加以验证。Objective: To evaluate the efficacy and safety of repaglinide plus metformin versus nateglinide plus metformin in the treatment of type 2 diabetes mellitus. Methods: Databases including Pub Med, Medline, Cochrane Library, EMbase, VIP, CNKI and Wanfang were searched. The quality of randomized controlled trial(RCT) found in the above databases was assessed by the Cochrane Handbook 5.1.0 evaluation system and meta-analysis was performed through Rev Man 5.2 software. Results: A total of 5 RCTs including 437 patients met the inclusion criteria. Results of meta-analysis showed that Hb A1 c [MD = – 0.61, 95%CI(– 0.64, – 0.58), P〈0.000 01] was significantly reduced in repaglinide plus metformin group compared with that in nateglinide plus metformin group. FPG [MD = – 0.46, 95%CI(– 0.97, 0.05), P = 0.08] and 2 h PG [MD = 0.29, 95%CI(– 0.92, 1.50), P = 0.64] in both groups showed no significant difference. For the adverse drug reactions such as hypoglycemia [OR = 1.25, 95%CI(0.34, 4.58), P = 0.74] and gastrointestinal reactions [OR = 1.02, 95%CI(0.31, 3.32), P = 0.98], there were also no significant differences between the two groups. Conclusion: Repaglinide plus metformin had better effect on decreasing glycosylated hemoglobin of type 2 diabetes mellitus patients compared with nateglinide plus metformin, and these two therapeutic regimens had similar risk of hypoglycemia and gastrointestinal reactions. While, further multicenter, large samples, high quality RCTs are warranted to verify the results of this article because of the research drawbacks.
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