达格列净治疗心力衰竭合并2型糖尿病的系统评价及序贯分析

Dapagliflozin in the Treatment of Heart Failure with Diabetes Mellitus Type 2:a Systematic Review and Sequential Analysis

目的系统评价达格列净治疗心力衰竭合并2型糖尿病患者的临床疗效。方法检索Embase、PubMed、Web of Science、Cochrane Library、维普、中国知网、万方数据库中关于达格列净治疗心力衰竭合并2型糖尿病的临床试验,时间范围从建库至2022年3月18日。通过使用RevMan5.3软件对各指标进行meta分析,使用TSA 0.9进行序贯分析。结果最终纳入31项符合标准的随机对照研究,涉及患者2906例。Meta分析结果显示,相比于对照组,试验组显著提高了左心室射血分数[MD=4.43,95%CI(3.35,5.50),P<0.00001]、总有效率[MD=4.19,95%CI(2.52,6.99),P<0.00001],降低了N端脑钠肽前体[MD=-451.84,95%CI(-608.09,-295.60),P<0.00001]、左心室舒张末期内径[MD=-2.74,95%CI(-3.67,-1.82),P<0.00001]、糖化血红蛋白[MD=-0.88,95%CI(-1.19,-0.57),P<0.00001]、空腹血糖[MD=-1.10,95%CI(-1.45,-0.75),P<0.00001]、餐后2 h血糖[MD=-2.52,95%CI(-3.37,-1.66),P<0.00001]及不良反应发生率[MD=0.63,95%CI(0.47,0.83),P=0.001]。试验序贯分析表明,达格列净提高心力衰竭合并2型糖尿病患者左心室射血分数疗效确切,排除假阳性可能。结论达格列净治疗心力衰竭合并2型糖尿病患者具有良好疗效,且安全性好,但日后仍有待于纳入更多高质量随机对照研究进一步论证。

OBJECTIVE To systematically evaluate the clinical efficacy of dapagliflozin in the treatment of heart failure with diabetes mellitus type 2.METHODS The clinical trials of dapagliflozin in the treatment of heart failure with diabetes mellitus type 2 were searched in Embase,PubMed,Web of Science,Cochrane Library,VIP,CNKI and Wanfang databases from the establishment of the database to March 18,2022.The RevMan 5.3 software was used for meta-analysis,and the TSA 0.9 software was used for sequential analysis.RESULTS The 31 RCT studies meeting the criteria were finally included,involving 2906 patients.Meta-analysis showed that compared with the control group,the experimental group significantly improved LVEF[MD=4.43,95%CI(3.35,5.50),P<0.00001],total effective rate[MD=4.19,95%CI(2.52,6.99),P<0.00001],and reduced NT-proBNP[MD=-451.84,95%CI(-608.09,-295.60),P<0.00001],LVEDD[MD=-2.74,95%CI(-3.67,-1.82),P<0.00001,Hb1ac[MD=-0.88,95%CI(-1.19,-0.57),P<0.00001],FPG[MD=-1.10,95%CI(-1.45,-0.75),P<0.00001],2hPG[MD=-2.52,95%CI(-3.37,-1.66),P<0.00001]and the incidence of adverse reactions[MD=0.63,95%CI(0.47,0.83),P=0.001].Sequential analysis showed that the effect of dapagliflozin on LVEF in patients with heart failure with type 2 diabetes was accurate,and the possibility of excluding false positive was possible.CONCLUSION The treatment of heart failure with diabetes mellitus type 2 with good efficacy and safety is achieved by dapagliflozin,but it still needs to be included in more high-quality RCT studies for further demonstration.