目的 系統(tǒng)評價芪藶強心膠囊聯(lián)合沙庫巴曲纈沙坦治療慢性心力衰竭（chronic heart failure，CHF）的療效及安全性。方法 計算機檢索PubMed、Embase、The Cochrane Library、中國學術期刊全文數(shù)據(jù)庫（CNKI）、中國生物醫(yī)學文獻數(shù)據(jù)庫（CBM）、維普中文期刊全文數(shù)據(jù)庫（VIP）、萬方數(shù)據(jù)庫，收集芪藶強心膠囊聯(lián)合沙庫巴曲纈沙坦治療CHF的臨床隨機對照試驗（RCT）。檢索時限從建庫至2021年8月31日，評價納入文獻的偏倚風險后，采用Revman 5.3軟件進行Meta分析。結果 共納入17篇RCTs，包括患者1 511例。Meta分析結果顯示：芪藶強心膠囊聯(lián)合沙庫巴曲纈沙坦比單純使用沙庫巴曲纈沙坦或芪藶強心膠囊，可以明顯提高總有效率［OR=3.49，95% CI（2.48，4.92），P<0.000 01］，增加6 min步行距離（6MWD）［MD=78.92，95% CI （34.24，123.60），P<0.000 01］，增加左室射血分數(shù)（LVEF）［MD=5.57，95% CI（4.98%，6.17%），P<0.000 01］，減小左心室舒張末期內(nèi)徑（LVEDD）［MD=-4.12，95% CI（-5.49，-2.74），P<0.000 01］，減小左心室收縮末期內(nèi)徑（LVESD）［MD=-3.26，95% CI（-4.46，-2.07），P<0.000 01］，降低N末端腦利鈉肽前體（NT-proBNP）［MD=-534.61，95% CI（-708.82，-360.39），P<0.000 01］，降低生活質(zhì)量評價MLHFQ評分［MD=-13.02，95% CI（-13.99，-12.05），P<0.000 01］，不良事件發(fā)生率無顯著性差異［MD=0.91，95% CI（0.41，1.99），P=0.8］。結論 芪藶強心膠囊聯(lián)合沙庫巴曲纈沙坦在治療CHF的療效優(yōu)于單用沙庫巴曲纈沙坦或芪藶強心膠囊，對于改善CHF患者心功能和提高生活質(zhì)量是安全有效的，上述結論尚需更高質(zhì)量的隨機雙盲對照研究予以驗證。

Objective To systematically evaluate the efficacy and safety of Qili Qiangxin Capsule (QLQX) combined with Sacubitril/Valsartan in the treatment of chronic heart failure (CHF). Methods A literature search was conducted across PubMed, Embase, Cochrane Library, CNKI, CBM, Wanfang, and VIP from the establishment of database to 31 August 2021 to search for randomised controlled trials (RCT) comparing QLQX combined with Sacubitril/Valsartan with Sacubitril/Valsartan in CHF. Literatures were evaluated the risk of bias of included literatures, and Meta-analyses were performed by using Revman 5.3 software. Results A total of 17 studies involving 1 511 participants were included. Meta-analysis results showed that QLQX combined with Sacubitril/Valsartan significantly increased the effective rate[OR=3.49, 95%CI (2.48, 4.92), P < 0.000 01] and increased 6MWD[MD=78.92, 95%CI (34.24, 123.60), P < 0.000 01], increased LVEF[MD=5.57, 95%CI (4.98%, 6.17%), P < 0.000 01], decreased LVEDD[MD=-4.12, 95%CI (-5.49, -2.74), P < 00.000 01], decreased LVESD[MD=-3.26, 95%CI (-4.46, -2.07), P < 0.000 01], decreased serum brain natriuretic peptide[MD=-534.61, 95%CI (-708.82, -360.39), P < 0.000 01], decreased the MLHFQ score[MD=-13.02, 95%CI (-13.99, -12.05), P < 00.000 01], and there was no significant difference in adverse events[MD=0.91, 95%CI (0.41, 1.99), P=0.8]. Conclusion Meta-analysis indicated that QLQX combined with Sacubitril/Valsartan therapy is safe and effective to improve cardiac function and quality in CHF patients, which required more high-quality, multi-center randomized double-blind clinical trials for further validation.

R286.5

新疆維吾爾自治區(qū)藥學會科研基金資助項目（YXH201922）