消渴丸对比格列本脲治疗2型糖尿病疗效与安全性的系统评价

摘要

目的:系统评价消渴丸对比格列本脲治疗2型糖尿病的疗效和安全性,以为临床治疗提供循证参考.方法:计算机检索Medline、PubMed、EMBase、Cochrane图书馆、中国生物医学文献数据库、中国期刊全文数据库、万方数据库和中文科技期刊数据库,纳入消渴丸(试验组)对比格列本脲(对照组)治疗2型糖尿病的随机对照试验(RCT),按Cochrane系统评价方法筛选文献、提取资料、评价质量后采用Rev Man 5.2统计软件对数据进行Meta分析.结果:共纳入15项RCT,合计3 319例患者.Meta分析结果显示,试验组患者糖化血红蛋白(HbA1c)水平[MD=-0.39,95%CI(-0.75,-0.02),P=0.04]、空腹血糖(FPG)水平[MD=-0.70,95%CI(-1.27,-0.12),P=0.02]、餐后2 h血糖(2 h PG)水平[MD=-0.87,95%CI(-1.55,-0.20),P=0.01]、口渴喜饮治疗有效率[RR=3.35,95%CI(1.92,5.85),P<0.001]、倦怠乏力治疗有效率[RR=5.74,95%CI(3.52,9.36),P<0.001]均显著优于对照组,低血糖发生率[RR=0.67,95%CI(0.49,0.91),P=0.01]显著低于对照组,差异均有统计学意义.结论:消渴丸治疗2型糖尿病的疗效和安全性均优于格列本脲,可显著改善患者HbA1c、FPG、2 h PG水平和中医症状.%OBJECTIVE:To systematically review the efficacy and safety of Xiaoke pill versus glibenclamide in the treatment of type 2 diabetes mellitus,and provide evidence-based reference for clinical treatment. METHODS:Retrieved from Medline, PubMed,EMBase,Cochrane Library,CBM,CJFD,Wanfang Database and VIP Database,randomized controlled trials (RCT) about the Xiaoke pill(test group)versus glibenclamide(control group)in the treatment of type 2 diabetes mellitus were enrolled. Meta-analysis was performed by using Rev Man 5.2 software after document selection,data extract and quality assessment by Co-chrane systematical evaluation. RESULTS:A total of 15 RCT were included,involving 3 319 patients. Results of Meta-analysis showed the hemoglobin A1c (HbA1c) level [MD=-0.39,95%CI(-0.75,-0.02),P=0.04],fasting plasma glucose (FPG) level [MD=-0.70,95%CI(-1.27,-0.12),P=0.02],2 h PG[MD=-0.87,95%CI(-1.55,-0.20),P=0.01],incidence of thirst with desire for drinks [RR=3.35,95%CI(1.92,5.85),P<0.001],incidence of tiredness and debilitation[RR=5.74,95%CI(3.52, 9.36),P<0.001] and incidence of hypoglycemia [RR=0.67,95%CI(0.49,0.91),P=0.01] in test group were significantly lower than control group,the differences were statistically significant. CONCLUSIONS:Xiaoke pill has better efficacy and safety than glibenclamide in the treatment of type 2 diabetes mellitus,can obviously improve the HbA1c,FPG,2 h PG tevel and TCM symp-toms.