OBJECTIVE:To evaluate the efficacy and safety of semaglutide in the treatment of type 2 diabetes mellitus,and to provide evidence-based reference in clinic. METHODS:Retrieved from Wangfang,CNKI,PubMed,Embase,Medline and the Cochrane library,randomized controlled trials(RCTs)about semaglutide alone or combined with other hypoglycemic drugs(trial group)versus placebo or other hypoglycemic medicine alone or combination(control group)in the treatment of type 2 diabetes mellitus were collected. After data extraction and literature quality evaluation,Meta-analysis was performed by using Rev Man 5.3 software. RESULTS:Totally 7 literatures were included,involving 7 708 patients. Results of Meta-analysis showed that compared with control group,the level of glycosylated hemoglobin [vs. placebo:MD＝－1.48,95%CI(－1.68,－1.28),P＜0.001;vs. positive control medicine:MD＝－0.95,95%CI(－1.17,－0.73),P＜0.001],fasting plasma glucose [vs. placebo:MD＝－1.87, 95%CI(－2.25,－1.50),P＜0.001;vs. positive control medicine:MD＝－1.07,95%CI(－1.58,－0.55),P＜0.001],body weight [vs. placebo:MD＝－3.15,95%CI(－3.98,－2.32),P＜0.001;vs. positive control medicine:MD＝－3.64,95%CI (－4.60,－2.69),P＜0.001] and body weight index [vs. placebo:MD＝－1.11,95%CI(－1.40,－0.81),P＜0.001;vs. positive control medicine:MD＝－1.34,95%CI(－1.67,－1.00),P＜0.001] in trial group were decreased significantly. For safety,the incidence of nausea and diarrhea of somaglutide was significantly higher than control group(P＜0.05). CONCLUSIONS:Semaglutide showes superiority in reducing the levels of glycosylated hemoglobin,fasting plasma glucose,body weight and body weight index in patients with type 2 diabetes mellitus,but the occurrence of nausea and diarrhea in patient should be monitored.%目的:系统评价索马鲁肽治疗2型糖尿病的有效性和安全性,为临床提供循证参考.方法:计算机检索万方、中国知网、PubMed、Embase、Medline、Cochrane图书馆等数据库,收集索马鲁肽单用或联用其他降糖药(试验组)对比安慰剂或其他降糖药单用或联用(对照组)治疗2型糖尿病的临床随机对照试验(RCT),提取资料并评价文献质量后,采用Rev Man 5.3软件进行Meta分析.结果:共纳入7篇文献,合计7 708例患者.Meta分析结果显示,相比对照组,试验组能显著降低患者的糖化血红蛋白水平[对比安慰剂:MD＝－1.48,95%CI(－1.68,－1.28),P＜0.001;对比阳性对照药物:MD＝－0.95,95%CI(－1.17,－0.73),P＜0.001]、空腹血糖水平[对比安慰剂:MD＝－1.87,95%CI(－2.25,－1.50),P＜0.001;对比阳性对照药物:MD＝－1.07,95%CI(－1.58,－0.55),P＜0.001]、体质量[对比安慰剂:MD＝－3.15,95%CI(－3.98,－2.32),P＜0.001;对比阳性对照药物:MD＝－3.64,95%CI(－4.60,－2.69),P＜0.001]和体质量指数[对比安慰剂:MD＝－1.11,95%CI(－1.40,－0.81),P＜0.001;对比阳性对照药物:MD＝－1.34, 95%CI(－1.67,－1.00),P＜0.001].安全性方面,索马鲁肽致恶心、腹泻的发生率均显著高于对照组(P＜0.05).结论:索马鲁肽在降低2型糖尿病患者糖化血红蛋白水平、空腹血糖水平、体质量和体质量指数等方面优势显著,但临床应注意监测患者恶心、腹泻的发生情况.
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