复方丹参滴丸联合胺碘酮治疗心律失常效果的Met a分析
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摘要
目的对复方丹参滴丸联合胺碘酮治疗心律失常的临床效果和安全性进行系统评价。方法检索Cochrane Library、中国生物医学文献光盘数据库(CBM)、Clinicaltrials.gov、PubMed、Embase、Medline、CNKI、万方数据库、维普全文电子期刊(VIP),收集从建库至2018年9月关于复方丹参滴丸联合胺碘酮治疗心律失常的临床随机对照试验,依据纳入及排除标准由2名研究员独立完成检索与文献的资料提取,采用RevMan5.3软件进行Meta分析。结果最终纳入13篇研究文献,共涉及1178例受试者其中590例患者采用复方丹参滴丸联合胺碘酮治疗,588例患者采用胺碘酮治疗。复方丹参滴丸联合胺碘酮与单纯应用胺碘酮治疗心律失常比较,其临床疗效[RR=1.21,95%CI(1.16,1.27),P <0.00 001]更好,且室性早搏[MD=-178.09,95%CI(-201.94,-154.25),P <0.00 001]、房性早搏[MD=-119.14,95%CI(-134.21,-104.06),P <0.00 001]、交界性早搏[MD=-54.88,95%CI(-68.61,-41.59),P <0.00 001]次数均减少,不良反应发生率更低[RR=0.28,95%CI(0.13,0.60),P <0.00 001],差异有统计学意义(P <0.05)。结论与单用胺碘酮比较,应用复方丹参滴丸联合胺碘酮治疗心律失常的临床效果更加显著,安全性更高。但由于纳入的文献质量普遍偏低,上述结论仍需更多高质量的随机对照实验作为论据加以证实。
Objective To systematically evaluate the clinical efficacy and safety of Compound Danshen Dropping Pills combined with Amiodarone in the treatment of arrhythmia. Methods Cochrane Library, CBM, Clinicaltrials.gov,PubMed, Embase, Medline, CNKI, Wanfang database, VIP full-text electronic journals(VIP) were searched by computer, and randomized controlled trials of Compound Danshen Dropping Pills combined with Amiodarone in the treatment of arrhythmia were collected from the database to September 2018. Randomized controlled trials of arrhythmias were performed by two researchers independently according to inclusion and exclusion criteria. Meta analysis was performed by RevMan 5.3 software. Results Finally, 13 studies were included, involving 1178 subjects including 590 patients of Compound Danshen Dripping Pills combined with Amiodarone trenatment and 588 patients of Amiodarone treatment.Compared with Amiodarone alone, Compound Danshen Dripping Pills combined with Amiodarone has better clinical efficacy [RR = 1.21,95%CI(1.16,1.27),P < 0.00 001] and ventricular premature beats [MD =-178.09,95%CI(-201.94,-154.25),P < 0.00 001], atrial premature beats [MD =-119.14,95%CI(-134.21,-104.06),P < 0.00 001], borderline.Sexual premature beats [MD =-54.88, 95%CI(-68.61,-41.59),P < 0.00 001] frequency were reduced, the incidence of adverse reactions was lower [RR = 0.28,95%CI(0.13,0.60),P < 0.00 001], the difference was statistically significant(P < 0.05). Conclusion Compared with Amiodarone alone, Compound Danshen Dropping Pills combined with Amiodarone has more significant clinical effect and higher safety in the treatment of arrhythmia. However, due to the low quality of the included literature, the above conclusions still need to be supported by more high quality randomized controlled trials.
Objective To systematically evaluate the clinical efficacy and safety of Compound Danshen Dropping Pills combined with Amiodarone in the treatment of arrhythmia. Methods Cochrane Library, CBM, Clinicaltrials.gov,PubMed, Embase, Medline, CNKI, Wanfang database, VIP full-text electronic journals(VIP) were searched by computer, and randomized controlled trials of Compound Danshen Dropping Pills combined with Amiodarone in the treatment of arrhythmia were collected from the database to September 2018. Randomized controlled trials of arrhythmias were performed by two researchers independently according to inclusion and exclusion criteria. Meta analysis was performed by RevMan 5.3 software. Results Finally, 13 studies were included, involving 1178 subjects including 590 patients of Compound Danshen Dripping Pills combined with Amiodarone trenatment and 588 patients of Amiodarone treatment.Compared with Amiodarone alone, Compound Danshen Dripping Pills combined with Amiodarone has better clinical efficacy [RR = 1.21,95%CI(1.16,1.27),P < 0.00 001] and ventricular premature beats [MD =-178.09,95%CI(-201.94,-154.25),P < 0.00 001], atrial premature beats [MD =-119.14,95%CI(-134.21,-104.06),P < 0.00 001], borderline.Sexual premature beats [MD =-54.88, 95%CI(-68.61,-41.59),P < 0.00 001] frequency were reduced, the incidence of adverse reactions was lower [RR = 0.28,95%CI(0.13,0.60),P < 0.00 001], the difference was statistically significant(P < 0.05). Conclusion Compared with Amiodarone alone, Compound Danshen Dropping Pills combined with Amiodarone has more significant clinical effect and higher safety in the treatment of arrhythmia. However, due to the low quality of the included literature, the above conclusions still need to be supported by more high quality randomized controlled trials.
引文
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[2]郑蕊,陈静,樊官伟,等.潜在恶性心律失常治疗进展及中医药防治特点与前景[J].中医杂志,2015,56(18):1615-1618.
[3]黄妹丹,韦勤将,何凤珍,等.心脏钠离子通道基因突变与心律失常关系的研究进展[J].医学综述,2018,24(8):1463-1467.
[4]李倩.复方丹参滴丸研究进展及临床应用[J].中华中医药杂志,2018,33(7):2989-2991.
[5]黄迎春.不同厂家、不同剂型胺碘酮治疗心律失常的临床疗效评价[J].海峡药学,2013,25(4):248-249.
[6]曹克将,陈明龙,江洪,等.室性心律失常中国专家共识[J].中国心脏起搏与心电生理杂志,2016,20(4):283-325.
[7]郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002.
[8]常见心律失常病因、严重程度及疗效参考标准(1979年)[J].医学研究通讯,1979,12:18-19.
[9]朱帮云.复方丹参滴丸治疗冠心病心律失常的临床分析[J].按摩与康复医学:中旬刊,2011,2(2):125.
[10]侯丽雅.复方丹参滴丸联合胺碘酮治疗冠心病心律失常的疗效观察[J].医药论坛杂志,2012,33(12):38-39.
[11]刘红军.复方丹参滴丸治疗冠心病心律失常60例疗效观察[J].中国医药指南,2013,11(8):277-278.
[12]高艳红.盐酸胺碘酮联合复方丹参滴丸治疗冠心病并快速型心律失常临床疗效观察[J].中国实用医药,2015,10(2):6-8.
[13]刘启寿.盐酸胺碘酮联合复方丹参滴丸治疗冠心病伴快速型心律失常的观察[J].江西医药,2015,50(7):683-685.
[14]栾岚.心衰合并心律失常病患的临床治疗体会[J].中国卫生标准管理,2015,6(15):106-107.
[15]王秋娜.复方丹参滴丸联合胺碘酮治疗冠心病并快速型心律失常的疗效观察[J].中西医结合心血管病电子杂志,2015,3(16):103-104.
[16]刘雪雁.中西联合用药治疗冠心病并快速型心律失常的临床疗效观察[J].世界最新医学信息文摘,2016,16(43):189-193.
[17]袁清茹.心力衰竭合并心律失常患者的临床治疗体会[J].中国医药指南,2016,14(20):65.
[18]蒋德琴.中西医结合治疗室性早搏临床经验[J].实用中西医结合临床,2017,17(2):50-51.
[19]叶勇,倪金波.盐酸胺碘酮联合复方丹参滴丸治疗冠心病并快速型心律失常临床研究[J].中国保健营养,2017,27(31):126-127.
[20]帕提古力·苏力坦.心衰合并心律失常患者的临床治疗体会[J].当代医学,2017,23(13):32-34.
[21]王再强.复方丹参滴丸结合胺碘酮对快速型心律失常的临床效果研究[J].北方药学,2018,15(8):42-43.
[22]Donahu JK.Current state of the art for cardiac arrhythmia gene therapy[J].Pharmacol Ther,2017,176:60-65.
[23]孔建晓.冠心病心律失常中药联合治疗与护理[A].中国转化医学和整合医学研究会、中华高血压杂志社.中国转化医学和整合医学学术交流会(上海站)论文汇编[C]//中国转化医学和整合医学研究会、中华高血压杂志社,2015:1.
[24]复方丹参滴丸临床应用中国专家建议写作组.复方丹参滴丸临床应用中国专家建议[J].中华老年医学杂志,2017,37(1):17-22.
[25]Jang SI,Kim HJ,Kim YJ,et al.TanshinoneⅡA inhibits LPS-in-duced NF-κB activation in RAW 264.7cells:Prossible involvement of the NIK-IKK,ERK1/2,p38and JNK pathways[J].Eur J Phar-macol,2006,542(1/3):1-7.
[26]寿健,赵焕昌,徐斌.复方丹参滴丸对冠心病病人早搏的抑制效应[J].中国基层医药,2001,8(5):37-38.
[27]肖铃.复方丹参滴丸药理作用及临床应用的研究进展[J].世界中医药,2015,10(7):1117-1119,1123.
[28]常虹,李正国,杨庆国,等.复方丹参滴丸药理作用及代谢研究进展[J].中国药物警戒,2016,13(11):682-685,690.
[29]Writing Group of Recommendations of Expert Panel from Chinese Geriatrics Society on the Clinical Use of Compound Danshen Dripping Pills;Recommendations on the Clinical Use of Compound Danshen Dripping Pills[J].Chin Med J(Engl),2017,130(8):972-978.
[30]吴翠珊,王善萍,王君隆,等.比较复方丹参滴丸与地奥心血康胶囊治疗心绞痛随机对照临床试验的系统评价和meta分析[J].中西医结合学报,2012,10(1):25-34.
[31]郭玉明,张弛,查清林,等.复方丹参滴丸治疗冠心病的系统评价[J].上海中医药大学学报,2012,26(3):24-31.
[32]程伟.复方丹参滴丸治疗稳定型心绞痛随机对照试验的系统评价[J].山东中医药大学学报,2012,36(4):287-291.
[2]郑蕊,陈静,樊官伟,等.潜在恶性心律失常治疗进展及中医药防治特点与前景[J].中医杂志,2015,56(18):1615-1618.
[3]黄妹丹,韦勤将,何凤珍,等.心脏钠离子通道基因突变与心律失常关系的研究进展[J].医学综述,2018,24(8):1463-1467.
[4]李倩.复方丹参滴丸研究进展及临床应用[J].中华中医药杂志,2018,33(7):2989-2991.
[5]黄迎春.不同厂家、不同剂型胺碘酮治疗心律失常的临床疗效评价[J].海峡药学,2013,25(4):248-249.
[6]曹克将,陈明龙,江洪,等.室性心律失常中国专家共识[J].中国心脏起搏与心电生理杂志,2016,20(4):283-325.
[7]郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002.
[8]常见心律失常病因、严重程度及疗效参考标准(1979年)[J].医学研究通讯,1979,12:18-19.
[9]朱帮云.复方丹参滴丸治疗冠心病心律失常的临床分析[J].按摩与康复医学:中旬刊,2011,2(2):125.
[10]侯丽雅.复方丹参滴丸联合胺碘酮治疗冠心病心律失常的疗效观察[J].医药论坛杂志,2012,33(12):38-39.
[11]刘红军.复方丹参滴丸治疗冠心病心律失常60例疗效观察[J].中国医药指南,2013,11(8):277-278.
[12]高艳红.盐酸胺碘酮联合复方丹参滴丸治疗冠心病并快速型心律失常临床疗效观察[J].中国实用医药,2015,10(2):6-8.
[13]刘启寿.盐酸胺碘酮联合复方丹参滴丸治疗冠心病伴快速型心律失常的观察[J].江西医药,2015,50(7):683-685.
[14]栾岚.心衰合并心律失常病患的临床治疗体会[J].中国卫生标准管理,2015,6(15):106-107.
[15]王秋娜.复方丹参滴丸联合胺碘酮治疗冠心病并快速型心律失常的疗效观察[J].中西医结合心血管病电子杂志,2015,3(16):103-104.
[16]刘雪雁.中西联合用药治疗冠心病并快速型心律失常的临床疗效观察[J].世界最新医学信息文摘,2016,16(43):189-193.
[17]袁清茹.心力衰竭合并心律失常患者的临床治疗体会[J].中国医药指南,2016,14(20):65.
[18]蒋德琴.中西医结合治疗室性早搏临床经验[J].实用中西医结合临床,2017,17(2):50-51.
[19]叶勇,倪金波.盐酸胺碘酮联合复方丹参滴丸治疗冠心病并快速型心律失常临床研究[J].中国保健营养,2017,27(31):126-127.
[20]帕提古力·苏力坦.心衰合并心律失常患者的临床治疗体会[J].当代医学,2017,23(13):32-34.
[21]王再强.复方丹参滴丸结合胺碘酮对快速型心律失常的临床效果研究[J].北方药学,2018,15(8):42-43.
[22]Donahu JK.Current state of the art for cardiac arrhythmia gene therapy[J].Pharmacol Ther,2017,176:60-65.
[23]孔建晓.冠心病心律失常中药联合治疗与护理[A].中国转化医学和整合医学研究会、中华高血压杂志社.中国转化医学和整合医学学术交流会(上海站)论文汇编[C]//中国转化医学和整合医学研究会、中华高血压杂志社,2015:1.
[24]复方丹参滴丸临床应用中国专家建议写作组.复方丹参滴丸临床应用中国专家建议[J].中华老年医学杂志,2017,37(1):17-22.
[25]Jang SI,Kim HJ,Kim YJ,et al.TanshinoneⅡA inhibits LPS-in-duced NF-κB activation in RAW 264.7cells:Prossible involvement of the NIK-IKK,ERK1/2,p38and JNK pathways[J].Eur J Phar-macol,2006,542(1/3):1-7.
[26]寿健,赵焕昌,徐斌.复方丹参滴丸对冠心病病人早搏的抑制效应[J].中国基层医药,2001,8(5):37-38.
[27]肖铃.复方丹参滴丸药理作用及临床应用的研究进展[J].世界中医药,2015,10(7):1117-1119,1123.
[28]常虹,李正国,杨庆国,等.复方丹参滴丸药理作用及代谢研究进展[J].中国药物警戒,2016,13(11):682-685,690.
[29]Writing Group of Recommendations of Expert Panel from Chinese Geriatrics Society on the Clinical Use of Compound Danshen Dripping Pills;Recommendations on the Clinical Use of Compound Danshen Dripping Pills[J].Chin Med J(Engl),2017,130(8):972-978.
[30]吴翠珊,王善萍,王君隆,等.比较复方丹参滴丸与地奥心血康胶囊治疗心绞痛随机对照临床试验的系统评价和meta分析[J].中西医结合学报,2012,10(1):25-34.
[31]郭玉明,张弛,查清林,等.复方丹参滴丸治疗冠心病的系统评价[J].上海中医药大学学报,2012,26(3):24-31.
[32]程伟.复方丹参滴丸治疗稳定型心绞痛随机对照试验的系统评价[J].山东中医药大学学报,2012,36(4):287-291.