机构地区:[1]复旦大学附属华山医院内分泌科,上海200040
出 处:《复旦学报(医学版)》2023年第5期670-682,共13页Fudan University Journal of Medical Sciences
基 金:国家自然科学基金(81970711)。
摘 要:目的采用Meta分析方法综合分析国内外相关文献,系统评价钠-葡萄糖协同转运蛋白2(sodium-glucose cotransporter 2,SGLT-2)抑制剂治疗对1型糖尿病(type 1 diabetes mellitus,T1DM)患者心血管系统影响。方法全面检索PubMed、Cochrane Library、Embase、Web of Science、中国知网、万方及维普数据库,检索时间均为从建库至2022年8月31日,收集SGLT-2抑制剂对T1DM患者心血管系统影响的随机对照研究(randomized controlled trial,RCT),依照纳入和排除标准进行文献筛选、数据提取以及质量评价,采用Revman 5.3软件进行Meta分析。结果共有14篇文献(15个RCTs)纳入研究。结果显示:与安慰剂组相比,SGLT-2抑制剂联合胰岛素治疗可显著降低T1DM患者的糖化血红蛋白(MD=-0.36,95%CI:-0.40~-0.31,P<0.05)、体重(MD=-2.72,95%CI:-3.02~-2.43,P<0.05)、收缩压(MD=-3.17,95%CI:-3.69~-2.66,P<0.05)、舒张压(MD=-1.38,95%CI:-1.27~-1.04,P<0.05),显著升高总胆固醇(MD=0.32,95%CI:0.05~0.58,P=0.02)、低密度脂蛋白(MD=0.41,95%CI:0.17~0.66,P<0.05),但两组间心血管事件发生率(RR=0.82,95%CI:0.47~1.42,P=0.47)、心梗发生率(RR=1,95%CI:0.43~2.32,P=0.99)、卒中发生率(RR=0.45,95%CI:0.10~2.03,P=0.30)、甘油三酯(MD=0.01,95%CI:-0.31~0.32,P=0.97)、高密度脂蛋白(MD=0.01,95%CI:-0.09~0.10,P=0.89)差异无统计学意义。结论与安慰剂相比,SGLT-2抑制剂联合胰岛素治疗可改善T1DM患者心血管相关指标,提示其对心血管的保护作用,但不能降低心血管事件的发生率。Objective To systematically evaluate the effects of sodium-glucose cotransporter 2(SGLT-2)inhibitors on the cardiovascular system of patients with type 1 diabetes mellitus(T1DM)by reviewing and integrating relevant domestic and foreign literature by meta analysis.Methods PubMed,Cochrane Library,Embase,Web of Science,CNKI,Wanfang data,VIP database were searched to collect the randomized controlled trials(RCT)that reported the effects of SGLT-2 inhibitors on the cardiovascular system of patients with T1DM from the earliest available date to Aug 31,2022.We carried out literature screening,data extraction and quality evaluation based on the inclusion,then exclusion criteria and statistical analysis was performed by RevMan 5.3 software.Results A total of 14 articles(15 RCTs)were included in the meta-analysis.Pooled analysis showed that compared with the placebo group,SGLT-2 inhibitors combined with insulin treatment significantly decreased the glycosylated hemoglobin(MD=-0.36,95%CI:-0.40,-0.31,P<0.05),body weight(MD=-2.72,95%CI:-3.02,-2.43,P<0.05),systolic blood pressure(MD=-3.17,95%CI:-3.69,-2.66,P<0.05),diastolic blood pressure(MD=-1.38,95%CI;-1.27,-1.04,P<0.05),and significantly increased total cholesterol(MD=0.32,95%CI:0.05,0.58,P=0.02)and low-density lipoprotein(MD=0.41,95%CI:0.17,0.66,P<0.05).There were no significant differences between the two groups in the incidence of cardiovascular events(RR=0.82,95%CI:0.47,1.42,P=0.47),the incidence of myocardial infarction(RR=1,95%CI:0.43,2.32,P=0.99),the incidence of stroke(RR=0.45,95%CI:0.10,2.03,P=0.30),triglycerides(MD=0.01,95%CI:-0.31,0.32,P=0.97)and high-density lipoprotein(MD=0.01,95%CI:-0.09,0.10,P=0.89).Conclusion Compared with placebo,SGLT-2 inhibitors combined with insulin therapy could improve cardiovascularrelated indicators in patients with T1DM,suggesting its protective effect on the cardiovascular system,but could not reduce the incidence of cardiovascular events.
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