临床视角下抗肿瘤药物特殊用法的合理性研究进展

目的 评价芪参益气滴丸辨证施治对慢性心力衰竭的疗效影响。方法 计算机检索PubMed、The Cochrane Library、中文学术期刊全文数据库（CNKI）、中国生物医学文献数据库（CBM）、万方数据库（WanFang Data）和维普中文期刊全文数据库（VIP）等，收集有关芪参益气滴丸联合西药治疗与单纯西药治疗慢性心力衰竭的随机对照试验（RCTs），检索时限为建库至2020年11月。采用RevMan 5.3软件和Stata 15.0软件进行Meta分析。结果 共纳入12个RCTs，包括1 946例患者。Meta分析结果显示：与单纯西药治疗相比，芪参益气滴丸联合西药治疗能改善美国纽约心脏病协会（NYHA）心功能疗效RR=1.21，95% CI=（1.13，1.30），P<0.01]；提高左心室射血分数SMD=0.67，95% CI=（0.41，0.93），P<0.01]，且辨证用药组的合并效应量大于非辨证组（P=0.001，I²=90.8%）；降低N末端B型利钠肽原（NT-proBNP）SMD=-1.45，95% CI=（-2.00，-1.14），P<0.001]，提高6分钟步行距离（6-MWD）SMD=1.33，95% CI=（0.82，1.85），P<0.01]，且辨证用药组的合并效应量大于非辨证组（P=0.02，I²=81.8%）。两组不良反应发生率无显著差异OR=0.93，95% CI=（0.56，1.55），P=0.77]。结论 无论辨证与否，与单纯西药治疗相比，芪参益气滴丸联合西药治疗在改善患者NYHA心功能疗效、左心室射血分数、NT-proBNP、6-MWD方面疗效更优，但是对于左心室射血分数和6-MWD，辨证治疗的疗效要优于非辨证治疗。上述研究结果仍需要更多大样本、高质量的文献加以验证。

Advance in the rationality of unconventional application of anti-tumor drugs from clinical perspective

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 functionRR=1.2, 95%CI=(1.13, 1.30), P<0.01]; Increase of the left ventricular ejection fractionSMD=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-proBNPSMD=-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 groupsOR=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.