目的 系统评价沙库巴曲缬沙坦联合芪参益气滴丸治疗慢性心力衰竭的临床疗效。方法 计算机检索PubMed、Embase、Web of Science、The Cochrane library、中国知网、万方数据知识服务平台、维普中文期刊全文数据库中随机对照试验，检索时间限定为建库始至2026年1月29日。采用偏倚风险评估工具进行文献质量评价，使用RevMan 5.3、Stata 15.0软件进行Meta分析，通过TSA 0.9.5.10 Beta软件进行试验序贯分析，并按照GRADE标准进行证据质量评价。结果 最终共纳入7个随机对照试验，共计589例患者，纳入研究的整体方法学质量较低。Meta分析结果显示，沙库巴曲缬沙坦联合芪参益气滴丸可显著地提高总有效率，减慢心率，升高血压，包括收缩压、舒张压，降低B型利钠肽前体和氨基末端脑钠肽前体浓度，改善心功能指标，包括提高射血分数、每搏量和心输出量，降低左室收缩末期容积、左室收缩末期血容量和左室舒张末期血容量，改善血管内皮细胞功能，包括增加一氧化氮浓度、降低内皮素-1表达，提高6 min步行距离，降低明尼苏达心力衰竭生活质量问卷（MLHFQ）评分。试验序贯分析进一步肯定了沙库巴曲缬沙坦联合芪参益气滴丸治疗慢性心力衰竭的疗效。GRADE证据质量分级显示总有效率、MLHFQ评分为中等质量证据，心率、收缩压等14项结局指标均为低质量证据，其余均为极低质量证据。结论 沙库巴曲缬沙坦联合芪参益气滴丸能显著提高临床疗效，然而证据等级不高，期待开展更多高质量、大样本、多中心的随机对照试验。

Objective To systematically evaluate the efficacy of sacubitril valsartan combined with Qishen Yiqi Dropping Pills in treatment of chronic heart failure. Methods RCTs were retrieved from PubMed, Embase, Web of Science, The Cochrane Library, CNKI, Wanfang Data Knowledge Service Platform, and VIP Chinese Journal Full-text Database. The search period was from the establishment of the databases to January 29, 2026. The risk of bias assessment tool was used to evaluate the quality of the literature. Meta-analysis was conducted using RevMan 5.3 and Stata 15.0 software. Trial sequential analysis (TSA) was performed using TSA 0.9.5.10 Beta software, and the quality of evidence was evaluated according to the GRADE standard. Results A total of 7 RCTs involving 589 patients were included. The overall methodological quality of the included studies was low. The results of the Meta-analysis showed that the combination of sacubitril/valsartan and Qishen Yiqi Dropping Pills significantly increased the total effective rate, slowed heart rate, increased blood pressure, including systolic blood pressure and diastolic blood pressure, reduced proBNP concentration and NT-proBNP concentration, improved cardiac function indicators, including increasing LVEF, SV and CO, reducing LVESD, ESV and EDV, and improving vascular endothelial cell function, including increasing NO concentration and reducing ET-1 expression, and increasing 6 min walking distance, and it reduced the MLHFQ score. The TSA further confirmed the efficacy of sacubitril valsartan combined with Qishen Yiqi Dropping Pills in patients with chronic heart failure. The GRADE evidence quality classification showed that the total effective rate and MLHFQ score were moderate quality evidence, while the 14 outcome indicators such as heart rate and systolic blood pressure were low quality evidences, and the rest were very low quality evidences. Conclusion The combination of sacubitri valsartan and Qishen Yiqi Dropping Pills can significantly improve the clinical efficacy. However, the evidence level is not high, looking forward to conducting more high-quality, large sample, multicenter randomized controlled trials.

R972

国家中医优势专科建设项目（国中医药医政函[2024]90号）