目的 評價芪參益氣滴丸辨證施治對慢性心力衰竭的療效影響。方法 計算機(jī)檢索PubMed、The Cochrane Library、中文學(xué)術(shù)期刊全文數(shù)據(jù)庫（CNKI）、中國生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫（CBM）、萬方數(shù)據(jù)庫（WanFang Data）和維普中文期刊全文數(shù)據(jù)庫（VIP）等，收集有關(guān)芪參益氣滴丸聯(lián)合西藥治療與單純西藥治療慢性心力衰竭的隨機(jī)對照試驗（RCTs），檢索時限為建庫至2020年11月。采用RevMan 5.3軟件和Stata 15.0軟件進(jìn)行Meta分析。結(jié)果 共納入12個RCTs，包括1 946例患者。Meta分析結(jié)果顯示：與單純西藥治療相比，芪參益氣滴丸聯(lián)合西藥治療能改善美國紐約心臟病協(xié)會（NYHA）心功能療效[RR=1.21，95% CI=（1.13，1.30），P<0.01]；提高左心室射血分?jǐn)?shù)[SMD=0.67，95% CI=（0.41，0.93），P<0.01]，且辨證用藥組的合并效應(yīng)量大于非辨證組（P=0.001，I²=90.8%）；降低N末端B型利鈉肽原（NT-proBNP）[SMD=-1.45，95% CI=（-2.00，-1.14），P<0.001]，提高6分鐘步行距離（6-MWD）[SMD=1.33，95% CI=（0.82，1.85），P<0.01]，且辨證用藥組的合并效應(yīng)量大于非辨證組（P=0.02，I²=81.8%）。兩組不良反應(yīng)發(fā)生率無顯著差異[OR=0.93，95% CI=（0.56，1.55），P=0.77]。結(jié)論 無論辨證與否，與單純西藥治療相比，芪參益氣滴丸聯(lián)合西藥治療在改善患者NYHA心功能療效、左心室射血分?jǐn)?shù)、NT-proBNP、6-MWD方面療效更優(yōu)，但是對于左心室射血分?jǐn)?shù)和6-MWD，辨證治療的療效要優(yōu)于非辨證治療。上述研究結(jié)果仍需要更多大樣本、高質(zhì)量的文獻(xiàn)加以驗證。

Objective To systematically evaluate the clinical effects according to syndrome differentiation of Qishen Yiqi Dropping Pills on chronic heart failure. Methods Computer searches of PubMed, The Cochrane Library, CNKI, CBM, WanFang Data and VIP were conducted to collect randomized controlled trials (RCTs) on qisen Yiqi dropping Pills combined with western medicine and western medicine alone for chronic heart failure. The time limit for retrieval is from the establishment of the database to November 2020. RevMan 5.3 software and Stata 15.0 software were used for Meta-analysis. Results A total of 12 RCTS were included, including 1 946 patients. The results of Meta-analysis showed that compared with the treatment with western medicine alone, qishen Yiqi Dropping Pills combined with the treatment with western medicine could improve the efficacy of New York Heart Association (NYHA) heart function[RR=1.2, 95%CI=(1.13, 1.30), P<0.01]; Increase of the left ventricular ejection fraction[SMD=0.67, 95%CI=(0.41, 0.93), P<0.01], and the combined effect amount in the treatment group with syndrome differentiation was greater than that in the no syndrome differentiation group (P=0.001, I²=90.8%); reduction of NT-proBNP[SMD=-1.45, 95%CI=(-2.00, -1.14), P<0.01]; Increase of 6-minutes walking distance (6-MWD)[SMD=1.33, 95%CI=(0.82, 1.85), P<0.01], and the combined effect amount of the drug group with syndrome differentiation was greater than that of the group without syndrome differentiation (P=0.02, I²=81.8). There was no significant difference in the incidence of adverse reactions between the two groups[OR=0.93, 95%CI=(0.56, 1.55), P=0.77]. Conclusion Compared with pure western medicine treatment, Qishen Yiqi Dropping Pills combined with western medicine treatment has better efficacy in improving the efficacy of NYHA heart function, left ventricular ejection fraction, NT-proBNP, and 6-MWD of the patient. Regardless of syndrome differentiation or not, it has good efficacy. However, the curative effect of treatment based on syndrome differentiation is better than treatment without syndrome differentiation on left ventricular ejection fraction and 6-MWD. The above research results still need to be verified by more large samples and high-quality literature.

R972

國家自然科學(xué)基金面上項目（81573647，82074222）；上海市中醫(yī)臨床重點(diǎn)實(shí)驗室項目（14DZ2273200）；上海市科委引導(dǎo)類項目（19401934300）；上海市衛(wèi)健委中醫(yī)藥事業(yè)發(fā)展三年行動計劃[ZY（2018-2020）-CCCX-2003-07]；上海市臨床重點(diǎn)?？祈椖浚╯hslczdzk05301）