【摘要】 目的 分析评估索格列净治疗2型糖尿病患者的疗效和安全性。方法 检索PubMed、Embase、Web ofScience、Medline、Cochrane Library、美国临床试验注册平台、CNKI、万方、维普、SinoMed等数据库，检索时间为建库起至2023年10月31日，收集有关索格列净与安慰剂(或其他口服降糖药)对照治疗2型糖尿病的随机对照试验(RCT),提取文献有效数据及质量评价后，应用RevMan 5.3软件进行meta分析。结果 共纳入14篇RCT,共计16959例患者。Meta分析结果显示：疗效方面，与对照组相比，索格列净能显著降低糖尿病患者糖化血红蛋白[MD=-0.45,95%CI(-0.58,-0.33),P<0.01]、空腹血糖[MD=-0.66,95%CI(-1.01,-0.31),P=0.0002]和餐后2 h血糖[MD=-1.01,95%CI(-1.58,-0.44),P=0.0005]、提高糖化血红蛋白<7%达标率[RR=1.88,95%CI(1.64,2.15),P<0.01];与对照组相比索格列净可降低收缩压[MD=-2.13,95%CI(-2.81,-1.45),P<0.01]和体质量[MD=-1.40,95%CI(-1.63,-1.17),P<0.01];但在降低舒张压方面差异无统计学意义。安全性方面，索格列净组与对照组低血糖事件发生率相似[RR=1.00,95%CI(0.92,1.09),P=0.97];但索格列净组不良反应发生率更低[RR=0.92,95%CI(0.88,0.96),P<0.01]。按照索格列净使用剂量不同进行亚组分析显示，与对照组相比，索格列净200 mg和400 mg组均可显著降低患者的糖化血红蛋白、空腹血糖水平，提高糖化血红蛋白<7%达标率，降低收缩压、体质量等指标(P<0.05);且均未增加低血糖事件风险(P>0.05)。结论 索格列净可显著降低2型糖尿病患者的糖化血红蛋白、空腹血糖、餐后2 h血糖、收缩压和体质量，同时不增加低血糖风险以及不良反应发生率。更多还原

【Abstract】 Objective To evaluate the efficacy and safety of sotagliflozin in the treatment of type 2 diabetes mellitus（T2DM）. Methods Randomized controlled trials（RCTs） involving sotagliflozin versus placebo（or other oral hypoglycemic agents） in the treatment of T2DM pulished before October 31, 2023 were retrieved in PubMed, Embase, Web of science, Medline, Cochrane Library, the North American Clinical Trial Register, CNKI, Wanfang, VIP, SinoMed and other databases. The extracted Valid data were performed for quality evaluation, and a meta-analysis was conducted using RevMan 5.3 software. Results Fourteen RCTs representing 16, 959 patients were included. The results of meta-analysis showed: In terms of efficacy, compared with the control group, sotagliflozin group presented significantly decreased glycated hemoglobin（HbA₁c, MD=-0.45, 95%CI[-0.58,-0.33]; P<0.01） and fasting blood glucose（FBG, MD=-0.66, 95%CI[-1.01,-0.31]; P=0.0002） and 2-h postprandial glucose（2hPG, MD=-1.01, 95%CI[-1.58,-0.44]; P=0.0005）, and improved compliance rate of HbA₁c <7%（RR=1.88, 95%CI[1.64, 2.15], P<0.01）. Compared with control group, sotagliflozin group had decreased systolic blood pressure（SBP, MD=-2.13, 95%CI[-2.81,-1.45], P<0.01） and body mass（BM, MD=-1.40, 95%CI[-1.63,-1.17], P<0.01）, but there was no statistical significance in reducing diastolic blood pressure（DBP）. In terms of safety, the incidence of hypoglycemic events was similar between the sotagliflozin group and the control group（RR=1.00, 95%CI[0.92, 1.09], P=0.97）. However, the incidence of adverse reactions was significantly lower in sotagliflozin group（RR=0.92, 95%CI[0.88, 0.96], P<0.01）. Subgroup analysis according to different doses of sotagliflozin showed that compared with the control group, sotagliflozin 200 mg and 400 mg groups could significantly reduce the HbA₁c and FBG, improve the compliance rate of HbA₁c<7%, and reduce SBP, BM and other indexes（P<0.05）, and without increasing the risk of hypoglycemia events（P>0.05）. Conclusion Sotagliflozin can significantly reduce HbA₁c, FBG, 2hPG, SBP, and BM in T2DM patients without increasing the risk of hypoglycemia or the incidence of adverse reactions.更多还原