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

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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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9.	刘士立, 赵丽, 苗利辉. 射血分数保留和射血分数降低心衰患者临床资料分析. 中华急诊医学杂志, 2016, 25(10): 1296-1300.
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24.	柳万千, 敖钦, 王新旺, 等. 心脉隆注射液对扩心病患者脑钠肽前体、高敏C反应蛋白影响. 当代医学, 2015, 21(18): 134-135.
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26.	王亚旭. 心脉隆注射液治疗慢性心力衰竭患者的疗效及近期预后的临床研究. 昆明: 昆明医科大学, 2017.
27.	李俊凤. 心脉隆注射液对高龄慢性心力衰竭病人血清胱抑素C及心功能的影响. 中西医结合心脑血管病杂志, 2018, 16(24): 3651-3653.
28.	苏文华, 梁莉雯, 周秀莉, 等. 心脉隆注射液治疗顽固性心力衰竭的疗效研究. 中华心力衰竭和心肌病杂志(中英文), 2018, 2(1): 22-25.
29.	许恩文, 方昱, 张庆斌, 等. 心脉隆注射液联合米力农治疗慢性充血性心力衰竭的临床研究. 现代药物与临床, 2018, 33(9): 2276-2280.
30.	张耀强. 心脉隆注射液辅助治疗慢性心力衰竭的效果及对心功能及B型钠尿肽的影响. 慢性病学杂志, 2018, 19(5): 667-669.
31.	郝骥, 张振, 祁春梅, 等. 心脉隆注射液治疗慢性心力衰竭的效果. 中国卫生标准管理, 2019, 10(20): 96-98.
32.	毛红岩. 心脉隆注射液治疗扩张型心肌病心力衰竭病人的临床疗效观察. 中西医结合心脑血管病杂志, 2019, 17(19): 2996-2997.
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1. 中华医学会心血管病学分会心力衰竭学组, 中国医师协会心力衰竭专业委员会, 中华心血管病杂志编辑委员会. 中国心力衰竭诊断和治疗指南2018. 中华心血管病杂志, 2018, 46(10): 760-789.
2. 邱伯雍. 慢性心力衰竭流行病学及防治研究进展. 中华实用诊断与治疗杂志, 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. 刘红旭, 朱明军, 毛静远, 等. 规范应用心脉隆注射液治疗慢性心力衰竭的专家共识. 中国中西医结合杂志, 2016, 36(3): 280-284.
8. 王华炜, 王路乔, 孟照辉. 心脉隆注射液治疗心血管疾病研究进展. 中国现代应用药学, 2019, 36(23): 2995-3000.
9. 刘士立, 赵丽, 苗利辉. 射血分数保留和射血分数降低心衰患者临床资料分析. 中华急诊医学杂志, 2016, 25(10): 1296-1300.
10. 中华医学会心血管病学分会, 中华心血管病杂志编辑委员会. 2007年中国慢性心力衰竭诊断治疗指南. 中华心血管病杂志, 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. 中华医学会心血管病学分会, 中华心血管病杂志编辑委员会. 中国心力衰竭诊断和治疗指南2014. 中华心血管病杂志, 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. 中华医学会心血管病学分会, 中华心血管病杂志编辑委员会. 慢性收缩性心力衰竭治疗建议. 中华心血管病杂志, 2002, 30(1): 7-23.
15. 中华人民共和国卫生部. 中药新药临床研究指导原则. 北京: 中国医药科技出版社, 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. 吴佳铭, 尹中, 杜立建. 心脉隆联合多巴酚丁胺治疗慢性心功能不全疗效观察. 现代中西医结合杂志, 2012, 21(28): 3091-3092.
18. 汤华, 李健, 黄智慧, 等. 心脉隆对缺血性心脏病心力衰竭患者QT间期离散度及临床疗效的影响. 中国医药, 2013, 8(9): 1211-1213.
19. 彭小静, 李铭辉, 张云娥. 心脉隆注射液对老年慢性心力衰竭患者的影响. 中西医结合心脑血管病杂志, 2014, 12(11): 1401-1402.
20. 姚恩辉, 李世春, 王华军. 心脉隆注射液对老年慢性心力衰竭患者血管内皮功能的影响. 中国医院药学杂志, 2014, 34(23): 2037-2040.
21. 赵楚敏, 宋巧凤, 王希柱, 等. 心脉隆对充血性心力衰竭患者血清基质金属蛋白酶-1水平的影响. 中国老年学杂志, 2014, (12): 3455-3456.
22. 冯玉平, 郑子龙, 钟丽华, 等. 心脉隆注射液对冠心病心衰患者血清hsCRP、BNP及LDL-C的影响. 中西医结合心脑血管病杂志, 2015, 13(9): 1089-1090.
23. 刘冉. 心脉隆注射液治疗扩张型心肌病心力衰竭的临床研究. 济南: 泰山医学院, 2015.
24. 柳万千, 敖钦, 王新旺, 等. 心脉隆注射液对扩心病患者脑钠肽前体、高敏C反应蛋白影响. 当代医学, 2015, 21(18): 134-135.
25. 钟丽华. 心脉隆注射液治疗老年性冠心病心力衰竭临床观察. 饮食保健, 2016, 3(11): 94-95.
26. 王亚旭. 心脉隆注射液治疗慢性心力衰竭患者的疗效及近期预后的临床研究. 昆明: 昆明医科大学, 2017.
27. 李俊凤. 心脉隆注射液对高龄慢性心力衰竭病人血清胱抑素C及心功能的影响. 中西医结合心脑血管病杂志, 2018, 16(24): 3651-3653.
28. 苏文华, 梁莉雯, 周秀莉, 等. 心脉隆注射液治疗顽固性心力衰竭的疗效研究. 中华心力衰竭和心肌病杂志(中英文), 2018, 2(1): 22-25.
29. 许恩文, 方昱, 张庆斌, 等. 心脉隆注射液联合米力农治疗慢性充血性心力衰竭的临床研究. 现代药物与临床, 2018, 33(9): 2276-2280.
30. 张耀强. 心脉隆注射液辅助治疗慢性心力衰竭的效果及对心功能及B型钠尿肽的影响. 慢性病学杂志, 2018, 19(5): 667-669.
31. 郝骥, 张振, 祁春梅, 等. 心脉隆注射液治疗慢性心力衰竭的效果. 中国卫生标准管理, 2019, 10(20): 96-98.
32. 毛红岩. 心脉隆注射液治疗扩张型心肌病心力衰竭病人的临床疗效观察. 中西医结合心脑血管病杂志, 2019, 17(19): 2996-2997.
33. 郝秋艳. 心脉隆注射液治疗射血分数减少型心衰患者的临床研究. 长沙: 湖南师范大学, 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. 心脉隆注射液联合尼可地尔治疗老年低射血分数慢性心力衰竭的疗效观察. 现代药物与临床, 2020, 35(5): 938-941.
36. 席银娟. 心脉隆注射液对中老年扩张型心肌病中晚期患者心力衰竭症状、多巴胺用量及预后的影响. 中国老年学杂志, 2020, 40(9): 1802-1805.
37. 杨静, 陈光辉, 蒋博, 等. 心脉隆注射液治疗110例老年慢性心力衰竭患者的疗效观察. 中国医药导报, 2012, 09(14): 93-94, 99.
38. 张一炎. 心脉隆注射液治疗舒张性心功能不全疗效观察. 中西医结合心脑血管病杂志, 2014, 12(8): 960-962.
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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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