通脉养心丸治疗冠心病心绞痛随机对照试验的系统评价
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摘要
系统评价通脉养心丸治疗冠心病心绞痛的随机对照试验。计算机检索CNKI,WanFang,VIP,SinoMed,PubMed,EMbase,the Cochrane Library数据库,搜集通脉养心丸治疗冠心病心绞痛的随机对照试验(RCT),检索时限均为建库至2018年11月。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险,风险评估参照Cochrane Handbook 5.3推荐的偏倚风险评估工具,采用RevMan 5.3软件进行Meta分析。共纳入9个RCT,Meta分析结果显示:在治疗冠心病心绞痛时,相对于单独使用西药,通脉养心丸与西药联用可增强心绞痛改善率(RR=1.22,95%CI[1.13,1.31])、心电图改善率(RR=1.31,95%CI[1.21,1.42])、中医证候疗效(RR=1.17,95%CI[1.02,1.35])。有1个研究报告空腹服药后发生胃脘不适,6个研究报告未发生不良事件。通脉养心丸治疗冠心病心绞痛时,在心绞痛改善率、心电图改善率、中医证候疗效等方面均有较佳的有效性及良好的安全性。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。
To systematically review the efficacy and safety of Tongmai Yangxin Pills in treatment for angina pectoris of coronary heart disease. CNKI, WanFang, VIP, SinoMed, PubMed, EMbase and the Cochrane Library databases were retrieved online to collect randomized controlled trials(RCTs) of Tongmai Yangxin Pills for angina pectoris of coronary heart disease since the establishment to November 2018. Two investigators screened out literatures independently, extracted data and assessed the risk of bias of included studies. The risk assessment of included references was made according to criteria recommended by Cochrane Handbook 5.3. Meta-analysis was then performed by RevMan 5.3 software. A total of 9 RCTs were included. The results of Meta-analysis showed that compared with the single application of chemotherapy, the combined administration with Tongmai Yangxin Pills and Western medicine could significantly improve the clinical efficacy of angina(RR=1.22, 95%CI[1.13, 1.31]), the improvement rate of electrocardiogram(RR=1.31, 95%CI[1.21, 1.42]), and the clinical efficacy of traditional Chinese medicine(TCM) syndrome(RR=1.17, 95%CI[1.02, 1.35]). Only one study reported adverse events, while 5 studies reported no adverse event. According to current evidences, in the treatment of angina pectoris of coronary heart disease, Tongmai Yangxin Pills has a better clinical efficacy in the treatment of angina pectoris of coronary heart disease in terms of the improvement rate of electrocardiogram and the clinical efficacy of TCM syndrome. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.
To systematically review the efficacy and safety of Tongmai Yangxin Pills in treatment for angina pectoris of coronary heart disease. CNKI, WanFang, VIP, SinoMed, PubMed, EMbase and the Cochrane Library databases were retrieved online to collect randomized controlled trials(RCTs) of Tongmai Yangxin Pills for angina pectoris of coronary heart disease since the establishment to November 2018. Two investigators screened out literatures independently, extracted data and assessed the risk of bias of included studies. The risk assessment of included references was made according to criteria recommended by Cochrane Handbook 5.3. Meta-analysis was then performed by RevMan 5.3 software. A total of 9 RCTs were included. The results of Meta-analysis showed that compared with the single application of chemotherapy, the combined administration with Tongmai Yangxin Pills and Western medicine could significantly improve the clinical efficacy of angina(RR=1.22, 95%CI[1.13, 1.31]), the improvement rate of electrocardiogram(RR=1.31, 95%CI[1.21, 1.42]), and the clinical efficacy of traditional Chinese medicine(TCM) syndrome(RR=1.17, 95%CI[1.02, 1.35]). Only one study reported adverse events, while 5 studies reported no adverse event. According to current evidences, in the treatment of angina pectoris of coronary heart disease, Tongmai Yangxin Pills has a better clinical efficacy in the treatment of angina pectoris of coronary heart disease in terms of the improvement rate of electrocardiogram and the clinical efficacy of TCM syndrome. Due to the limited quality and quantity of the included studies, more high-quality studies are required to verify the above conclusions.
引文
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[16] 任建勋,李磊,尹云泽,等.通脉养心丸对小型猪心肌缺血再灌注损伤后期气阴两虚证的干预作用[J].中草药,2018,49(7):1612.
[17] 刘志超,王哲,唐倩,等.通脉养心丸治疗冠心病作用机制及临床应用研究进展[J].中国中医急症,2018,27(7):1304.
[18] David Moher,Alessandro Liberati,Jennifer Tetzlaff,et al.系统综述和荟萃分析优先报告的条目:PRISMA声明[J].中西医结合学报,2009,7(9):889.
[19] 杨丰文,邹佳涵,王媛,等.中药注射剂治疗心力衰竭的网状Meta分析[J].中国中药杂志,2018,43(6):1247.
[20] 于丹丹,谢雁鸣,张允岭,等.苦碟子注射液治疗冠心病心绞痛的有效性和安全性研究:随机对照试验的系统评价和Meta分析[J].中国中药杂志,2018,43(20):4138.
[21] David M,Sally H,Kenneth F S,et al.CONSORT 2010说明与详述:报告平行对照随机临床试验指南的更新[J].中西医结合学报,2010,8(8):701.
[2] 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.慢性稳定性心绞痛诊断与治疗指南[J].中华心血管病杂志,2007,35(3):195.
[3] 国家卫生计生委合理用药专家委员会,中国药师协会.冠心病合理用药指南[J].2版.中国医学前沿杂志,2018,10(6):1.
[4] 《中国心血管病报告2017》概要[J].中国循环杂志,2018,33(1):1.
[5] 张伯礼.中医内科学[M].北京:人民卫生出版社,2012:81.
[6] 张国骏.基于《伤寒论》炙甘草汤的通脉养心丸方义研究[C].北京:全国仲景学说学术年会,2012.
[7] 程静.通脉养心丸联合美托洛尔治疗冠心病心绞痛的临床疗效分析[J].临床合理用药杂志,2017,10(14):23.
[8] 邓兵安,兰江.通脉养心丸联合阿司匹林、阿托伐他汀及美托洛尔治疗冠心病心绞痛的疗效观察[J].中国医院用药评价与分析,2018,18(4):514.
[9] 李珂,孙兰军,高克俭,等.通脉养心丸治疗冠心病心绞痛(气阴两虚证)多中心临床研究[C].天津:第九次中国中西医结合学会心血管病学术会议,2009.
[10] 李青霜.通脉养心丸联合比索洛尔治疗心绞痛的临床疗效观察[J].世界最新医学信息文摘,2016,16(A0):185.
[11] 孟繁军,展倩丽.通脉养心丸治疗冠心病心绞痛的临床疗效及其对血管内皮功能的影响[J].实用心脑肺血管病杂志,2016,24(5):84.
[12] 吴桂馨.通脉养心丸联合美托洛尔治疗冠心病心绞痛的临床疗效观察[J].中西医结合心脑血管病杂志,2016,14(20):2406.
[13] 徐华.通脉养心丸联合美托洛尔治疗冠心病心绞痛的效果观察[J].大医生,2018,3(5):50.
[14] 尹倚艰,徐贵成,刘坤,等.通脉养心丸治疗冠心病心绞痛的临床研究[J].中西医结合心脑血管病杂志,2016,14(2):161.
[15] 刁艳菲.通脉养心丸联合美托洛尔治疗冠心病心绞痛的临床观察[J].中西医结合心血管病电子杂志,2018,6(2):58.
[16] 任建勋,李磊,尹云泽,等.通脉养心丸对小型猪心肌缺血再灌注损伤后期气阴两虚证的干预作用[J].中草药,2018,49(7):1612.
[17] 刘志超,王哲,唐倩,等.通脉养心丸治疗冠心病作用机制及临床应用研究进展[J].中国中医急症,2018,27(7):1304.
[18] David Moher,Alessandro Liberati,Jennifer Tetzlaff,et al.系统综述和荟萃分析优先报告的条目:PRISMA声明[J].中西医结合学报,2009,7(9):889.
[19] 杨丰文,邹佳涵,王媛,等.中药注射剂治疗心力衰竭的网状Meta分析[J].中国中药杂志,2018,43(6):1247.
[20] 于丹丹,谢雁鸣,张允岭,等.苦碟子注射液治疗冠心病心绞痛的有效性和安全性研究:随机对照试验的系统评价和Meta分析[J].中国中药杂志,2018,43(20):4138.
[21] David M,Sally H,Kenneth F S,et al.CONSORT 2010说明与详述:报告平行对照随机临床试验指南的更新[J].中西医结合学报,2010,8(8):701.
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