[关键词]
[摘要]
目的 评价急性心肌梗死(AMI)后早期(住院期或出院后≤14 d)在沙库巴曲缬沙坦背景治疗基础上加用达格列净的疗效与安全性。方法 系统检索中外文数据库[中国学术期刊全文数据库(CNKI)、万方、维普、SinoMed、CochraneLibrary、PubMed、Embase、Web of Science,检索截止至2025年11月1日],纳入随机对照试验(RCT)。采用RoB 2评估偏倚;按1/3/6个月预设时间分层;连续结局采用均数差(MD),二分类结局采用相对危险比(RR),并报告95%置信区间(95% CI)。据异质性选用随机或固定效应并评估发表偏倚。结果 纳入20项RCT(n=1 856)。与仅用沙库巴曲缬沙坦相比,加用达格列净显著改善心肌结构和功能,具体为左心室射血分数上升(MD 4.68,95% CI 3.91–5.44),左心室舒张末期容积、左心室舒张末期内径与左心室收缩末期内径下降(分别为MD=-3.80,95% CI: -5.33~-2.28; MD=-2.80,95% CI:-4.35~-1.24; MD=-3.95,95% CI: -5.03~-2.88),6 min步行距离增加(6MWD,MD=49.73,95% CI: 30.87~68.59),N端脑利钠肽前体(NT-proBNP)降低(MD=-155.31,95% CI: -202.90~-107.72);临床事件方面,主要不良心血管事件(RR=0.30,95% CI: 0.20~0.45)与心力衰竭再住院(RR=0.42,95% CI: 0.22~0.79)风险降低。部分连续结局存在较高异质性,但效应方向一致。主要安全性结局未观察到统计学显著增加;糖尿病酮症酸中毒事件极少且总体中性。结论 在AMI后早期(≤14 d)启动达格列净与沙库巴曲缬沙坦联合治疗,可在随后的1~6个月随访期内显著改善心肌结构和功能,并降低主要不良心血管事件和心力衰竭再住院风险,安全性总体可接受;仍需高质量、长随访RCT验证其对硬结局与远期重构的影响。
[Key word]
[Abstract]
Objective To evaluate the efficacy and safety of adding dapagliflozin to background sacubitril valsartan therapy in the early period after acute myocardial infarction (AMI)—defined as during hospitalization or ≤14 d after discharge. Methods We systematically searched Chinese and international databases [China National Knowledge Infrastructure (CNKI), Wanfang, VIP, SinoMed, Cochrane Library, PubMed, Embase, and Web of Science) through 1st Nov 2025 and included randomized controlled trials (RCT). Risk of bias was assessed with RoB 2. Predefined time strata were 1/3/6 months. Mean difference (MD) was used for continuous outcomes and risk ratio (RR) for dichotomous outcomes, each with 95% confidence intervals (CI). Random- or fixed-effects models were applied according to heterogeneity, and publication bias was assessed. Results Twenty RCTs (n = 1 856) were included. Compared with sacubitril valsartan alone, add-on dapagliflozin significantly improved cardiac structure and function: left ventricular ejection fraction (LVEF) increased (MD 4.68, 95% CI 3.91 to 5.44); Left ventricular end-diastolic volume (LVEDV), left ventricular end-diastolic diameter (LVEDD), and left ventricular end-systolic diameter (LVESD) decreased (MD -3.80, 95% CI -5.33 to -2.28; MD -2.80, 95% CI -4.35 to -1.24; MD -3.95, 95% CI -5.03 to -2.88, respectively). Six-min walk distance (6MWD) increased (MD 49.73, 95% CI 30.87 to 68.59), and N-terminal pro-B-type natriuretic peptide (NT-proBNP) decreased (MD -155.31, 95% CI -202.90 to -107.72). For clinical events, risks of major adverse cardiovascular events (MACE) and heart-failure rehospitalization (HFH) were reduced (RR 0.30, 95% CI 0.20 to 0.45; RR 0.42, 95% CI 0.22 to 0.79). Some continuous outcomes showed substantial heterogeneity, though effect directions were consistent. No statistically significant increases were observed in key safety outcomes; Rare-event estimates were imprecise, and diabetic ketoacidosis events were very infrequent with an overall neutral signal. Conclusion In early post-AMI care (≤14 d), adding dapagliflozin to sacubitril valsartan yields 1–6-months improvements in cardiac structure and function and reduces MACE and HFH, with an overall acceptable safety profile; High-quality, longer-term RCTs are warranted to confirm effects on hard endpoints and adverse remodeling.
[中图分类号]
R965
[基金项目]
国家自然科学基金地区基金项目(81960861);广西重点研发计划(2018AB58103);广西研究生教育创新计划项目(YCBXJ2025012)