谭雨晴 田盼盼 吴晓博 陈恒文 李军

摘要 目的：系統评价加味四逆汤治疗慢性心力衰竭的疗效。方法：检索CNKI、PubMed、WANFANG Data、VIP、EMbase、SinoMed、The Cochrane Library、Web of science自建库以来至2019年3月18日公开发表的与四逆汤治疗慢性心力衰竭相关的随机对照试验。由2名研究者根据纳排标准对相关文献进行筛选，完成资料提取、质量评价，运用Revman5.3对纳入文献进行Meta分析。结果：纳入22篇文献，共计1 597例患者。Meta分析结果显示：加味四逆汤联合常规西药治疗慢性心力衰竭有效率优于单用常规西药观察组[RR=1.25，95%CI（1.19，1.32），P<0.000 01]，加味四逆汤联合常规西药改善左室射血分数（LVEF%）较常规西药更明显[MD=6.84，95%CI（3.30，10.37），P=0.000 1]。结论：常规西药合加味四逆汤治疗可以提高慢性心力衰竭临床有效率，在提高患者每搏输出量及EF%、降低脑钠肽（BNP）、缩小左心室舒张/收缩期末内径（LVEDD/LVESD）、延长6 min步行距离、减低Lee心衰评分及减低中医证候评分等方面优于单纯应用西药治疗。由于纳入研究样本量和质量的限制，还需更多高质量临床试验提供证据支持。

关键词  四逆汤;慢性心力衰竭;系统评价;Meta分析;循证医学;联合用药;心功能;随机对照试验

Systematic Review on Efficacy of Jiawei Sini Decoction in the Treatment of Chronic Heart Failure

TAN Yuqing^1，2，TAN Panpan^1，2，WU Xiaobo^1，2，CHEN Hengwen¹，LI Jun¹

（1 Guang′anmen Hospital，China Academy of Chinese Medicine Science，Beijing 100053，China; 2 Beijing University of Chinese Medicine，Beijing 100029，China）

Abstract Objective：To systematically review the efficacy of Jiawei Sini Decoction in the treatment of chronic heart failure.Methods：Randomized controlled trials（RCTs）related to treatment of chronic heart failure with Sini Decoction in the database of CNKI，WANFANG Data，VIP，EMbase，SinoMed，the Cochrane Library and Web of Science were searched online from the establishment of the database to March 18th 2019.A total of 2 researchers independently screened literature according to inclusion and exclusion criteria，and the extracted data and quality evaluation were finished.Meta-analysis of the included papers was performed with Revman5.3.Results：A total of 22 papers were included，totally 1 597 cases of patients.The results of Meta-analysis showed that Jiawei Sini Decoction combined with conventional Western medicine was more effective than conventional Western medicine（RR=1.25，95% CI（1.19，1.32），P<0.000 01）.Jiawei Sini Decoction combined with conventional Western medicine could significantly improve left ventricular ejection fraction than conventional Western medicine（MD=6.84，95% CI（3.30，10.37），P=0.000 1）.Conclusion：On the basis of conventional Western medicine treatment，Jiawei Sini Decoction has better efficacy，which is more effective in improving stroke output and ejection fraction（EF%），reducing brain natriuretic peptide（BNP），reducing left ventricular end-diastolic/systolic inner diameter（LVEDD/LVESD），extending 6-minute walking distance，reducing Lee heart failure score and traditional Chinese medicine syndrome scores and other aspects than pure Western medicine.Due to the limitations of the sample sizes and quality of the included study，more high-quality clinical trials are needed to provide evidence.

Keywords Sini Decoction; Chronic heart failure; Systematic review; Meta-analysis; Evidence-based medicine; Drug combination; Cardiac function; Randomized controlled trial

中图分类号：R256.2 文献标识码：A doi：10.3969/j.issn.1673-7202.2020.08.011

慢性心力衰竭（Chronic Heart Failure，CHF）是一个多种因素引起的复杂的临床综合征，是各种心脏疾病发展的最终阶段[1]。随着冠心病和高血压的发病率逐渐上升、人口老龄化加速及各种危险因素的增加，我国心力衰竭的数量也在增加[2]。CHF治疗指南[3]将β受体阻滞剂、血管紧张素转换酶抑制劑（ACEI）/血管紧张素受体（ARB）、醛固酮受体拮抗剂列为治疗心力衰竭的“金三角”。根据CHF的临床症状，可以将其归于中医“心悸”“心痹”“喘证”“水肿”等范畴。四逆汤出自《伤寒论》，有回阳救逆之功，现代药理学研究[4]表明，四逆汤可改善心肌缺血，改善心肌细胞代谢，提高心肌收缩力，减少再灌注损伤。本研究对以四逆汤为主方治疗CHF的随机对照试验进行系统评价，评价加味四逆汤联合常规西药治疗CHF的临床有效性及安全性。

1 资料与方法

1.1 文献检索 以计算机检索为主，配合以手工检索，检索自建库以来至2019年3月18日发表的文献。……