心脉隆注射液治疗冠心病心力衰竭有效性与安全性的系统评价Systematic review of efficacy and safety of Xinmailong Injection in treatment of coronary heart disease complicated with heart failure
卫靖靖;朱明军;王永霞;李彬;彭广操;王新陆;于瑞;
WEI Jing-jing;ZHU Ming-jun;WANG Yong-xia;LI Bin;PENG Guang-cao;WANG Xin-lu;YU Rui;Henan University of Chinese Medicine;the First Affiliated Hospital of Henan University of Chinese Medicine;
摘要(Abstract):
为系统评价心脉隆注射液治疗冠心病心力衰竭的有效性与安全性。计算机检索国内外7个数据库(CNKI,VIP,WanFang,SinoMed,PubMed,EMbase,Cochrane Library)建库至2020年2月,收集心脉隆注射液治疗冠心病心力衰竭的随机对照研究。2名研究者按照纳入和排除标准独立筛选文献、提取资料并进行质量评价。运用RevMan 5.3软件进行Meta分析。共纳入19项符合标准的研究,总样本量1 922例,其中治疗组967例,对照组955例,所纳入研究总体质量一般。Meta分析显示,冠心病心力衰竭患者在常规治疗基础上加用心脉隆注射液后,进一步降低患者血浆B型利钠肽水平(BNP)(SMD=-3.34,95%CI[-4.06,-2.63])或氨基末端B型利钠肽前体(NT-proBNP)水平,提高心功能疗效(RR=1.23,95%CI[1.18,1.29])和左室射血分数(LVEF)(MD=6.85,95%CI[4.93,8.76]),增加6 min步行距离测试(6MWT)(MD=24.34,95%CI[16.05,32.64])与血管内皮生长因子水平(VEGF)(MD=26.39,95%CI[24.30,28.49]),降低左心室舒张末期内径(LVEDD)(MD=-4.06,95%CI[-6.33,-1.80]),且亚组分析提示疗程可能与增加LVEF相关。该研究发现,心脉隆注射液治疗冠心病心力衰竭可进一步改善临床症状及相关指标,且无严重不良反应的发生,但仍需更多设计严谨、实施规范的多中心、大样本的研究来支持。
To systematically evaluate the efficacy and safety of Xinmailong Injection in the treatment of coronary heart disease complicated with heart failure. Seven databases,namely CNKI, VIP,WanFang,SinoMed,PubMed,EMbase,Cochrane Library, were retrieved by computer for collecting the randomized controlled trials about Xinmailong Injection in the treatment of coronary heart disease complicated with heart failure. The literatures were screened out, data was extracted, and the methodological quality evaluation was conducted by 2 researchers independently according to inclusion and exclusion criteria. RevMan 5.3 software was used for Meta-analysis and corresponding description analysis. A total of 19 studies involving 1 922 patients were included, including 967 cases in the trial group and 955 cases in the control group. All the clinical studies showed a low quality. Meta-analysis results showed that Xinmailong Injection combined with conventional treatment could better reduce the BNP level(SMD=-3.34, 95%CI[-4.06,-2.63]) in patients of coronary heart disease complicated with heart failure or NT-proBNP level, improve the cardiac function(RR=1.23,95%CI[1.18,1.29]) and LVEF(MD=6.85,95%CI[4.93,8.76]),increase 6 MWT(MD=24.34, 95%CI[16.05, 32.64]) and VEGF(MD=26.39,95%CI[24.30,28.49]),and decreased LVEDD(MD=-4.06, 95%CI[-6.33,-1.80]). And subgroup analysis suggested that the course of treatment may be related to the increase of LVEF. This study found that Xinmailong Injection for coronary heart disease complicated with heart failure can further alleviate clinical symptoms and relevant indicators, with no serious adverse reaction. However, it still needs the support of well-designed multicenter, double-blind and high-quality clinical trials.
关键词(KeyWords):
心脉隆注射液;冠心病;心力衰竭;系统评价;随机对照试验;Meta分析
Xinmailong Injection;coronary heart disease;heart failure;systematic review;randomized controlled trial;Meta-analysis
基金项目(Foundation): 国家重点研发计划项目(2019YFC1710000,2019YFC1710003);; 国家中医药管理局中医药循证能力建设项目(2019XZZX-XXG003);; 河南省创新型科技团队项目(C20130050)
作者(Author):
卫靖靖;朱明军;王永霞;李彬;彭广操;王新陆;于瑞;
WEI Jing-jing;ZHU Ming-jun;WANG Yong-xia;LI Bin;PENG Guang-cao;WANG Xin-lu;YU Rui;Henan University of Chinese Medicine;the First Affiliated Hospital of Henan University of Chinese Medicine;
Email:
DOI: 10.19540/j.cnki.cjcmm.20200302.505
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- 心脉隆注射液
- 冠心病
- 心力衰竭
- 系统评价
- 随机对照试验
- Meta分析
Xinmailong Injection - coronary heart disease
- heart failure
- systematic review
- randomized controlled trial
- Meta-analysis
- 卫靖靖
- 朱明军
- 王永霞
- 李彬
- 彭广操
- 王新陆
- 于瑞
WEI Jing-jing- ZHU Ming-jun
- WANG Yong-xia
- LI Bin
- PENG Guang-cao
- WANG Xin-lu
- YU Rui
- Henan University of Chinese Medicine
- the First Affiliated Hospital of Henan University of Chinese Medicine
- 卫靖靖
- 朱明军
- 王永霞
- 李彬
- 彭广操
- 王新陆
- 于瑞
WEI Jing-jing- ZHU Ming-jun
- WANG Yong-xia
- LI Bin
- PENG Guang-cao
- WANG Xin-lu
- YU Rui
- Henan University of Chinese Medicine
- the First Affiliated Hospital of Henan University of Chinese Medicine