Xinmailong injection in the treatment of heart failure with different types of ejection fraction: a systematic review_Chinese Journal of Evidence-Based Medicine

Authors：

LIN Shanshan ^1,2 , WANG Xianliang ¹ , YANG Ying ^1,3 , LIU Chunxiang ⁴ , GE Zhao ^1,2 , ZHANG Junhua ⁴ ,  MAO Jingyuan ¹

1. First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, P.R.China;
2. Graduate School of Tianjin University of Traditional Chinese Medicine, Tianjin 301617, P.R.China;
3. Tianjin Nankai District Traditional Chinese Medicine Hospital, Tianjin 300199, P.R.China;
4. Evidence-Based Medicine Center, Tianjin University of Traditional Chinese Medicine, Tianjin 301617, P.R.China;

Corresponding?author：

MAO Jingyuan, Email: jymao@126.com

Keywords：

Xinmailong injection; Heart failure; Ejection fraction; Meta-analysis; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.202008145

Video：

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Objective To systematically review the efficacy and safety of Xinmailong injection in the treatment of different types of heart failure with ejection fraction.Methods CNKI, WanFang Data, VIP, CBM, PubMed, EMbase and The Cochrane Library databases were electronically searched to collect randomized controlled trials (RCTs) of Xinmailong injection in the treatment of different types of heart failure with ejection fraction from inception to August 5^th, 2020. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Meta-analysis was then performed using RevMan 5.3 software.Results A total of 25 RCTs involving 2 467 patients were included. The results of meta-analysis showed that Xinmailong injection combined with conventional therapy was superior to conventional therapy alone on NYHA classification efficiency (HFrEF: RR=1.32, 95%CI 1.04 to 1.69, P=0.02), comprehensive clinical efficacy (HFrEF: RR=1.24, 95%CI 1.15 to 1.34, P<0.000 01; HFpEF: RR=1.22, 95%CI 1.15 to 1.30, P<0.000 01), score of life quality (HFrEF: MD=?7.08, 95%CI ?9.34 to ?4.82, P<0.000 01), left ventricular ejection fraction (HFrEF: MD=4.99, 95%CI 3.18 to 6.80, P<0.000 01; HFpEF: MD=5.10, 95% CI 0.62 to 9.58, P=0.03), the level of B-type natriuretic peptide (HFrEF: SMD=?0.96, 95%CI ?1.36 to ?0.56, P<0.000 01; HFpEF: SMD=?1.83, 95%CI?2.35 to ?1.31, P<0.000 01), the level of N-terminal pro-B natriuretic peptide (HFrEF: SMD=?2.98, 95%CI ?4.45 to ?1.51, P<0.000 1), and 6-minute walking distance (HFrEF: MD=52.56, 95%CI 34.22 to 70.90, P<0.000 01). There was no significant difference in drug-related adverse reactions between two groups.Conclusions Current evidence shows that Xinmailong injection combined with conventional therapy have good efficacy and safety in the treatment of heart failure with different ejection fractions. Due to limited quality and quantity of the included studies, more high quality studies are required to verify above conclusions.

Citation： LIN Shanshan, WANG Xianliang, YANG Ying, LIU Chunxiang, GE Zhao, ZHANG Junhua, MAO Jingyuan. Xinmailong injection in the treatment of heart failure with different types of ejection fraction: a systematic review. Chinese Journal of Evidence-Based Medicine, 2021, 21(4): 423-430. doi: 10.7507/1672-2531.202008145 Copy

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1. 中華醫學會心血管病學分會心力衰竭學組, 中國醫師協會心力衰竭專業委員會, 中華心血管病雜志編輯委員會. 中國心力衰竭診斷和治療指南2018. 中華心血管病雜志, 2018, 46(10): 760-789.
2. 邱伯雍. 慢性心力衰竭流行病學及防治研究進展. 中華實用診斷與治療雜志, 2017, 31(6): 619-621.
3. Zhang Y, Zhang J, Butler J, et al. Contemporary epidemiology, management, and outcomes of patients hospitalized for heart failure in China: results from the China heart failure (China-HF) registry. J Card Fail, 2017, 23(12): 868-875.
4. Benjamin EJ, Muntner P, Alonso A, et al. Heart disease and stroke statistics-2019 update: a report from the American Heart Association. Circulation, 2019, 139(10): e56-e528.
5. Cook C, Cole G, Asaria P, et al. The annual global economic burden of heart failure. Int J Cardiol, 2014, 171(3): 368-376.
6. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure. Kardiol Pol, 2016, 74(10): 1037-1147.
7. 劉紅旭, 朱明軍, 毛靜遠, 等. 規范應用心脈隆注射液治療慢性心力衰竭的專家共識. 中國中西醫結合雜志, 2016, 36(3): 280-284.
8. 王華煒, 王路喬, 孟照輝. 心脈隆注射液治療心血管疾病研究進展. 中國現代應用藥學, 2019, 36(23): 2995-3000.
9. 劉士立, 趙麗, 苗利輝. 射血分數保留和射血分數降低心衰患者臨床資料分析. 中華急診醫學雜志, 2016, 25(10): 1296-1300.
10. 中華醫學會心血管病學分會, 中華心血管病雜志編輯委員會. 2007年中國慢性心力衰竭診斷治療指南. 中華心血管病雜志, 2007, 35(12): 1-29.
11. Jessup M, Abraham WT, Casey DE, et al. 2009 focused update: ACCF/AHA guidelines for the diagnosis and management of heart failure in adults: a report of the American College of Cardiology Foundation/American Heart Association task force on practice guidelines: developed in collaboration with the international society for heart and lung transplantation. Circulation, 2009, 119(14): 1977-2016.
12. 中華醫學會心血管病學分會, 中華心血管病雜志編輯委員會. 中國心力衰竭診斷和治療指南2014. 中華心血管病雜志, 2014, 42(2): 98-122.
13. Ponikowski P, Voors AA, Anker SD, et al. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The task force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail, 2016, 18(8): 891-975.
14. 中華醫學會心血管病學分會, 中華心血管病雜志編輯委員會. 慢性收縮性心力衰竭治療建議. 中華心血管病雜志, 2002, 30(1): 7-23.
15. 中華人民共和國衛生部. 中藥新藥臨床研究指導原則. 北京: 中國醫藥科技出版社, 2002: 69.
16. Higgins JPT, Green S, Higgins J. Cochrane handbook for systematic reviews of interventions (version 5.1.0). The Cochrane Collaboration. Avaliable at: http://handbook-5-1.cochrane.org/.
17. 吳佳銘, 尹中, 杜立建. 心脈隆聯合多巴酚丁胺治療慢性心功能不全療效觀察. 現代中西醫結合雜志, 2012, 21(28): 3091-3092.
18. 湯華, 李健, 黃智慧, 等. 心脈隆對缺血性心臟病心力衰竭患者QT間期離散度及臨床療效的影響. 中國醫藥, 2013, 8(9): 1211-1213.
19. 彭小靜, 李銘輝, 張云娥. 心脈隆注射液對老年慢性心力衰竭患者的影響. 中西醫結合心腦血管病雜志, 2014, 12(11): 1401-1402.
20. 姚恩輝, 李世春, 王華軍. 心脈隆注射液對老年慢性心力衰竭患者血管內皮功能的影響. 中國醫院藥學雜志, 2014, 34(23): 2037-2040.
21. 趙楚敏, 宋巧鳳, 王希柱, 等. 心脈隆對充血性心力衰竭患者血清基質金屬蛋白酶-1水平的影響. 中國老年學雜志, 2014, (12): 3455-3456.
22. 馮玉平, 鄭子龍, 鐘麗華, 等. 心脈隆注射液對冠心病心衰患者血清hsCRP、BNP及LDL-C的影響. 中西醫結合心腦血管病雜志, 2015, 13(9): 1089-1090.
23. 劉冉. 心脈隆注射液治療擴張型心肌病心力衰竭的臨床研究. 濟南: 泰山醫學院, 2015.
24. 柳萬千, 敖欽, 王新旺, 等. 心脈隆注射液對擴心病患者腦鈉肽前體、高敏C反應蛋白影響. 當代醫學, 2015, 21(18): 134-135.
25. 鐘麗華. 心脈隆注射液治療老年性冠心病心力衰竭臨床觀察. 飲食保健, 2016, 3(11): 94-95.
26. 王亞旭. 心脈隆注射液治療慢性心力衰竭患者的療效及近期預后的臨床研究. 昆明: 昆明醫科大學, 2017.
27. 李俊鳳. 心脈隆注射液對高齡慢性心力衰竭病人血清胱抑素C及心功能的影響. 中西醫結合心腦血管病雜志, 2018, 16(24): 3651-3653.
28. 蘇文華, 梁莉雯, 周秀莉, 等. 心脈隆注射液治療頑固性心力衰竭的療效研究. 中華心力衰竭和心肌病雜志(中英文), 2018, 2(1): 22-25.
29. 許恩文, 方昱, 張慶斌, 等. 心脈隆注射液聯合米力農治療慢性充血性心力衰竭的臨床研究. 現代藥物與臨床, 2018, 33(9): 2276-2280.
30. 張耀強. 心脈隆注射液輔助治療慢性心力衰竭的效果及對心功能及B型鈉尿肽的影響. 慢性病學雜志, 2018, 19(5): 667-669.
31. 郝驥, 張振, 祁春梅, 等. 心脈隆注射液治療慢性心力衰竭的效果. 中國衛生標準管理, 2019, 10(20): 96-98.
32. 毛紅巖. 心脈隆注射液治療擴張型心肌病心力衰竭病人的臨床療效觀察. 中西醫結合心腦血管病雜志, 2019, 17(19): 2996-2997.
33. 郝秋艷. 心脈隆注射液治療射血分數減少型心衰患者的臨床研究. 長沙: 湖南師范大學, 2019.
34. Xue J, Xu Y, Deng Y, et al. The efficacy and safety of Xinmailong Injection in patients with chronic heart failure: a multicenter randomized double-blind placebo-controlled trial. J Altern Complement Med, 2019, 25(8): 856-860.
35. 李雪. 心脈隆注射液聯合尼可地爾治療老年低射血分數慢性心力衰竭的療效觀察. 現代藥物與臨床, 2020, 35(5): 938-941.
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Xinmailong injection in the treatment of heart failure with different types of ejection fraction: a systematic review

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