口服索马鲁肽治疗2型糖尿病有效性和安全性的Meta分析

Efficacy and safety of oral semaglutide for type 2 diabetes:a meta-analysis

目的评价口服索马鲁肽治疗2型糖尿病的疗效及安全性。方法计算机检索PubMed、Cochrane Library、Embase、中国知网、万方和维普,检索时间建库至2019年10月,纳入口服索马鲁肽7 mg、14 mg对比安慰剂或阳性药治疗2型糖尿病的随机对照试验(RCT)。采用Cochrane系统评价手册进行文献质量评价,Stata15.0软件对数据进行Meta分析。结果纳入7项RCT,共4832例患者。Meta分析结果显示,治疗26周后口服索马鲁肽可以显著降低患者糖化血红蛋白(与安慰剂比较,WMD=-1.19,95%CI:-1.34^-1.05,P=0.000;与阳性药比较,WMD=-0.40,95%CI:-0.59^-0.21,P=0.000)、体重(与安慰剂比较,WMD=-2.75,95%CI-3.58^-1.92,P=0.000;与阳性药比较,WMD=-1.50,95%CI:-2.39^-0.61,P=0.001)和空腹血糖(与安慰剂比较,WMD=-1.82,95%CI:-2.01^-1.64,P=0.000;与阳性药比较,WMD=-0.49,95%CI:-0.92^-0.06,P=0.026)。安全性方面,索马鲁肽引起的总不良事件、严重不良事件和低血糖发生率与安慰剂或阳性药比较无显著差异(P>0.05)。索马鲁肽引起胃肠道功能紊乱退出(RR=3.51,95%CI:2.02~6.08,P=0.000)、恶心(RR=2.74,95%CI:1.83~4.11,P=0.000)、腹泻(RR=1.85,95%CI:1.55~2.20,P=0.000)、呕吐(RR=2.58,95%CI:2.03~3.29,P=0.000)发生率均高于安慰剂或阳性药。结论口服索马鲁肽可明显降低2型糖尿病患者的糖化血红蛋白、体重、空腹血糖且具有较好的耐受性。

AIM To evaluate the efficacy and safety of oral semaglutide in treatment of type 2 diabetes.METHODS Randomized controlled trials(RCTs)of oral semaglutide 7 mg,14 mg compared with placebo or positive drug in the treatment of type 2 diabetes were selected in PubMed,Cochrane Library,Embase,CNKI,Wanfang and VIP Database from inception to October,2019.Quality assessment was evaluated by the Cochrane handbook,and meta-analysis was conducted by Stata15.0.RESULTS Seven RCTs were enrolled,involving 4832 patients.The results of meta-analysis showed after 26 weeks oral semaglutide significantly decreased the glycosylated hemoglobin in patients(compared to placebo,WMD=-1.19,95%CI:-1.34 to-1.05,P=0.000;compared to positive drugs,WMD=-0.40,95%CI:-0.59 to-0.21,P=0.000),body weight(compared to placebo,WMD=-2.75,95%CI:-3.58 to-1.92,P=0.000;compared to positive drugs,WMD=-1.50,95%CI:-2.39 to-0.61,P=0.001),and fasting blood glucose(compared to placebo,WMD=-1.82,95%CI:-2.01 to-1.64,P=0.000;compared to positive drugs,WMD=-0.49,95%CI:-0.92 to-0.06,P=0.026).In terms of safety,there were no significant difference in the incidence of total adverse events,serious adverse events and hypoglycemia between semaglutide and placebo or positive drugs(P>0.05).The incidences of gastrointestinal adverse events leading to early discontinuation(RR=3.51,95%CI:2.02 to 6.08,P=0.000),nausea(RR=2.74,95%CI:1.83 to 4.11,P=0.000),diarrhea(RR=1.85,95%CI:1.55 to 2.20,P=0.000),and vomit(RR=2.58,95%CI:2.03 to 3.29,P=0.000)of semaglutide were higher than those of placebo or positive drugs.CONCLUSION Oral semaglutide can significantly reduce glycosylated hemoglobin,body weight and fasting blood glucose in patients with type 2 diabetes with favorable tolerability.