鲁格列净治疗2型糖尿病疗效及安全性的Meta分析

Efficacy and safety of luseogliflozin in treatment of type 2 diabetes mellitus: a Meta-analysis

目的系统评价鲁格列净治疗2型糖尿病的疗效及安全性。方法计算机检索Cochrane图书馆、PubMed、EMBase、CBM、CNKI、万方数据库、维普数据库,收集鲁格列净治疗2型糖尿病的随机对照试验(RCT),提取资料并进行质量评价后,采用Rev Man5. 3统计软件进行Meta分析。结果共纳入5项RCT,均来源于英文数据库,合计764例患者。Meta分析结果显示与安慰剂组相比,鲁格列净组糖化血红蛋白[WMD=-0. 94,95%CI(-1. 02,-0. 87),P <0. 01]、空腹血糖[WMD=-33. 09,95%CI(-35. 93,-30. 25),P <0. 01]下降;药物不良反应发生率[RR=1. 92,95%CI(1. 30,2. 83),P <0. 01]、尿频发生率[RR=2. 41,95%CI(1. 09,5. 37),P=0. 03]增多;不良事件发生率[RR=1. 01,95%CI (0. 88,1. 15),P=0. 91]、低血糖发生率[RR=1. 36,95%CI(0. 76,2. 42),P=0. 30]、泌尿系统感染发生率[RR=2. 50,95%CI(0. 30,21. 11),P=0. 40]、生殖系统感染发生率[RR=1. 72,95%CI(0. 50,5. 89),P=0. 39]、肾功能异常发生率[RR=1. 18,95%CI(0. 69,2. 02),P=0. 53]和体积减少相关不良反应发生率[RR=1. 34,95%CI(0. 47,3. 80),P=0. 59]差异无统计学意义。结论在2型糖尿病不同治疗周期,鲁格列净均能有效改善患者的糖化血红蛋白和空腹血糖,不会导致严重不良事件以及特殊不良反应发生,一般不良反应轻微可耐受,用药较为安全。

Objective To systematically evaluate the efficacy and safety of luseogliflozin in treatment of type2 diabetes mellitus(T2DM).Methods The randomized controlled trials(RCTs)of luseogliflozin for T2DM were searched from Cochrane Library,PubMed,EMBase,CBM,CNKI,Wanfang and VIP databases using a computer.The data were extracted and the quality of the included studies was assessed.RevMan5.3 statistical software was used for Meta-analysis.Results A total of 764 cases in 5 RCTs were included,which were from English databases.Compared with those in the placebo group,HbA1c[WMD=-0.94,95%CI(-1.02,-0.87),P<0.01]and fasting plasma glucose[WMD=-33.09,95%CI(-35.93,-30.25),P<0.01]in the luseogliflozin group were decreased;The incidence of adverse reactions[RR=1.92,95%CI(1.30,2.83),P<0.01]and frequency of urinary frequency[RR=2.41,95%CI(1.09,5.37),P=0.03]in the luseogliflozin group were increased.There were no significant differences in the incidence rates of adverse events[RR=1.01,95%CI(0.88,1.15),P=0.91],hypoglycemia[RR=1.36,95%CI(0.76,2.42),P=0.30],urinary tract infections[RR=2.50,95%CI(0.30,21.11),P=0.40],reproductive system infections[RR=1.72,95%CI(0.50,5.89),P=0.39],abnormal renal function[RR=1.18,95%CI(0.69,2.02),P=0.53]and volume reduction related adverse reactions[RR=1.34,95%CI(0.47,3.80),P=0.59]between the two groups.Conclusion In different treatment cycles of T2DM,luseogliflozin can effectively improve HbA1c and fasting plasma glucose,but leads to no serious adverse events and special adverse reactions.The adverse reactions are common,mild and tolerable,and the medication is safe.