益心舒胶囊联合西药治疗慢性心力衰竭的Meta分析及试验序贯分析
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摘要
目的系统评价益心舒胶囊联合西药对慢性心力衰竭(CHF)的临床疗效及安全性。方法检索PubMed、Cochrane library、Embase、SinoMed、中国知网、维普中文期刊全文数据库和万方数据库中自建库至2017年10月13日发表的有关益心舒胶囊联合西药治疗各型CHF的临床随机对照研究。采用改良Jadad评分量表进行质量评价,分别用Stata 14. 0和TSA v0. 9进行Meta分析和试验序贯分析,并依据GRADE标准进行证据质量评价。结果共纳入19项研究包括2291例CHF患者。Meta分析显示,左室射血分数[LVEF,WMD=2. 46,95%CI (2. 25,2. 67),低质量证据]、左室舒张末期内径[LVEDD,WMD=-2. 04,95%CI(-2. 90,-1. 18),极低质量证据]、6分钟步行距离[WMD=29. 99,95%CI (22. 87,37. 11),低质量证据]等比较差异均有统计学意义(P <0. 05),治疗组优于对照组,且亚组分析提示其疗效均与CHF类型有关。治疗组不良反应发生率为8. 65%,对照组为6. 73%。试验序贯分析进一步说明益心舒胶囊提高CHF患者LVEF水平、6分钟步行距离的证据充分,但提示LVEDD结果存在假阳性的可能。结论益心舒胶囊联合西药能显著提高CHF患者LVEF水平、6分钟步行距离,降低LVEDD水平,且不良反应少。
Objective To systematically review the clinical efficacy and safety of Yixinshu Capsule( 益心舒胶囊)( YXS) combined with western medicine( WM) in treatment of chronic heart failure( CHF). Method Databases such as PubMed,Cochrane library,Embase,Sinomed,CNKI,VIP,and Wanfang data were searched to collect literature from the establishment to 13 October,2017 about treatments of Yixinshu Capsule on CHF. The quality of trials was assessed according to the improved Jadad standard. The meta-analysis and trial sequential analysis( TSA) using Stata 14 version and TSA v0. 9 were respectively carried out. In addition,the GRADE profile software was used to evaluate the quality of evidences. Results A total of 19 studies including 2291 cases of CHF patients were included eventually. Meta-analysis showed that there were statistical differences( P < 0. 05) in left ventricular ejection fraction( LVEF,WMD = 2. 46,95% CI [2. 25,2. 67],low quality evidence),left ventricular end diastolic Dimension( LVEDD,WMD =-2. 04,95% CI [-2. 90,-1. 18],extreme low quality evidence),6-minute walking distance( WMD = 29. 99,95% CI [22. 87,37. 11],low quality evidence),and the treatment group was better than control group. Subgroup analysis showed that the clinical efficacy was related to the kinds of CHF. The incidence of adverse reactions was 8. 65% in the treatment group and 6. 73% in the control group. The TSA analysis showed that the evidence of LVEF or 6-minute walking distance was definite,but there was possibly a false positive result of LVEDD. Conclusion YXS combined with WM can increase LVEF and lengthen 6-minute walking distance,reduce the level of LVEDD for CHF with low side effect rate.
Objective To systematically review the clinical efficacy and safety of Yixinshu Capsule( 益心舒胶囊)( YXS) combined with western medicine( WM) in treatment of chronic heart failure( CHF). Method Databases such as PubMed,Cochrane library,Embase,Sinomed,CNKI,VIP,and Wanfang data were searched to collect literature from the establishment to 13 October,2017 about treatments of Yixinshu Capsule on CHF. The quality of trials was assessed according to the improved Jadad standard. The meta-analysis and trial sequential analysis( TSA) using Stata 14 version and TSA v0. 9 were respectively carried out. In addition,the GRADE profile software was used to evaluate the quality of evidences. Results A total of 19 studies including 2291 cases of CHF patients were included eventually. Meta-analysis showed that there were statistical differences( P < 0. 05) in left ventricular ejection fraction( LVEF,WMD = 2. 46,95% CI [2. 25,2. 67],low quality evidence),left ventricular end diastolic Dimension( LVEDD,WMD =-2. 04,95% CI [-2. 90,-1. 18],extreme low quality evidence),6-minute walking distance( WMD = 29. 99,95% CI [22. 87,37. 11],low quality evidence),and the treatment group was better than control group. Subgroup analysis showed that the clinical efficacy was related to the kinds of CHF. The incidence of adverse reactions was 8. 65% in the treatment group and 6. 73% in the control group. The TSA analysis showed that the evidence of LVEF or 6-minute walking distance was definite,but there was possibly a false positive result of LVEDD. Conclusion YXS combined with WM can increase LVEF and lengthen 6-minute walking distance,reduce the level of LVEDD for CHF with low side effect rate.
引文
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[5]翁鸿,李胜,曾宪涛,等.试验序贯分析软件在Meta分析中的应用[J].中国循证医学杂志,2016,16(5):604-611.
[6]阿吉木·吾布力哈斯木,阿吉古力·巴吾东,曲曼古丽·亚逊.益心舒胶囊联合坎地沙坦治疗冠心病并慢性心力衰竭患者的临床疗效[J].实用心脑肺血管病杂志,2017,25(4):77-80.
[7]陈守宏,刘振,武海若.益心舒胶囊治疗慢性心力衰竭102例临床观察[J].中西医结合心脑血管病杂志,2010,8(1):14-15.
[8]程颐,高军毅,高怀民.阿托伐他汀片联合益心舒胶囊治疗冠心病慢性心力衰竭的疗效观察[J].现代药物与临床,2013,28(6):911-914.
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[11]韩敏,江蓓湖,丘洪,等.益心舒胶囊治疗慢性心力衰竭的临床研究[J].中西医结合心脑血管病杂志,2009,7(7):763-764.
[12]华宁,唐发宽,唐雪正,等.益心舒胶囊对老年充血性心力衰竭患者利钾尿肽、心房钠尿肽的影响[J].中西医结合心脑血管病杂志,2010,8(5):515-517.
[13]简新闻,季汉华.益心舒胶囊治疗冠心病慢性舒张功能不全临床分析[J].中西医结合心脑血管病杂志,2012,10(7):799-801.
[14]蒋周田.益心舒胶囊治疗扩张型心肌病慢性心力衰竭的临床疗效观察[J].广西医科大学学报,2013,30(5):765-767.
[15]李麟,王永莉,丁弘,等.益心舒胶囊治疗老年充血性心力衰竭的疗效观察[J].心理医生(下半月版),2012(8):283.
[16]刘川玉,唐建红,苏涵,等.益心舒胶囊对慢性心力衰竭患者心功能及AngⅡ和TNF-α的影响研究[J].中国药房,2009,20(30):2385-2387.
[17]刘强,徐智,毛威.益心舒胶囊治疗心房颤动合并舒张性心力衰竭患者的疗效[J].中国新药与临床杂志,2011,30(10):766-770.
[18]裴娟慧,李茂荣,甘丰.益心舒胶囊对冠心病致舒张性心功能不全的临床疗效观察及心率变异性的影响[J].中华心脏与心律电子杂志,2016,4(4):228-230.
[19]宋海萍,赵国定.益心舒胶囊治疗慢性充血性心力衰竭的临床研究[J].中西医结合心脑血管病杂志,2009,7(2):133-134.
[20]王慧,王万粮,杨蕾,等.益心舒胶囊对慢性充血性心力衰竭患者心功能及血浆脑钠肽的影响[J].中西医结合心脑血管病杂志,2014,12(4):409-410.
[21]吴刚勇,宗刚军,陈景开,等.益心舒治疗冠心病慢性心力衰竭临床观察[J].心血管康复医学杂志,2009,18(3):295-297.
[22]邢玉龙,王用,史云桃.益心舒胶囊治疗慢性心力衰竭的临床观察[J].中西医结合心脑血管病杂志,2012,10(10):1163-1164.
[23]遇准,冯建莉,丛春蕾.益心舒胶囊治疗气阴两虚挟瘀型慢性充血性心力衰竭的疗效观察[J].中西医结合心脑血管病杂志,2013,11(2):158-159.
[24]张颖莉,朱雪梅.益心舒胶囊治疗舒张性心力衰竭的临床观察[J].中西医结合心脑血管病杂志,2011,9(3):287-289.
[25]杨元庆,陈玲.加味血府逐瘀汤合并西药治疗慢性充血性心力衰竭60例临床观察[J].中医杂志,2011,52(1):39-41.
[26]BITTNER V,WEINER DH,YUSUF S,et al. Prediction of mortality and morbidity with a 6-minute walk test in patients with left ventricular dysfunction[J]. JAMA,1993,270(14):1702-1707.
[27]高建步,李玉东,杨守忠,等.益心舒胶囊对经皮冠状动脉介入术后患者生活质量和焦虑、抑郁情绪的影响[J].中国新药杂志,2017,26(10):1148-1151.
[2]HOBBS FD,ROALFE AK,DAVIS RC,et al. Prognosis of all-cause heart failure and borderline left ventricular systolic dysfunction:5 year mortality follow-up of the Echocardiographic Heart of England Screening Study(ECHOES)[J]. Eur Heart J,2007,28(9):1128-1134.
[3]毛静远,朱明军.慢性心力衰竭中医诊疗专家共识[J].中医杂志,2014,55(14):1258-1260.
[4]HIGGINS JPT,GREEN S. Cochrane Handbook for Systematic Reviews of Interventions Version 5. 1. 0[Z/OL].(2011-03)[2017-10-27]. http://www. cochranehandbook. org.
[5]翁鸿,李胜,曾宪涛,等.试验序贯分析软件在Meta分析中的应用[J].中国循证医学杂志,2016,16(5):604-611.
[6]阿吉木·吾布力哈斯木,阿吉古力·巴吾东,曲曼古丽·亚逊.益心舒胶囊联合坎地沙坦治疗冠心病并慢性心力衰竭患者的临床疗效[J].实用心脑肺血管病杂志,2017,25(4):77-80.
[7]陈守宏,刘振,武海若.益心舒胶囊治疗慢性心力衰竭102例临床观察[J].中西医结合心脑血管病杂志,2010,8(1):14-15.
[8]程颐,高军毅,高怀民.阿托伐他汀片联合益心舒胶囊治疗冠心病慢性心力衰竭的疗效观察[J].现代药物与临床,2013,28(6):911-914.
[9]葛海柱,程耀南,覃焕艺.益心舒胶囊治疗慢性充血性心力衰竭的临床观察[J].白求恩军医学院学报,2010,8(1):24-25.
[10]顾宁,黄燕,汪静,等.益心舒胶囊对冠心病心功能不全患者心功能的影响[J].中西医结合心脑血管病杂志,2010,8(2):142-144.
[11]韩敏,江蓓湖,丘洪,等.益心舒胶囊治疗慢性心力衰竭的临床研究[J].中西医结合心脑血管病杂志,2009,7(7):763-764.
[12]华宁,唐发宽,唐雪正,等.益心舒胶囊对老年充血性心力衰竭患者利钾尿肽、心房钠尿肽的影响[J].中西医结合心脑血管病杂志,2010,8(5):515-517.
[13]简新闻,季汉华.益心舒胶囊治疗冠心病慢性舒张功能不全临床分析[J].中西医结合心脑血管病杂志,2012,10(7):799-801.
[14]蒋周田.益心舒胶囊治疗扩张型心肌病慢性心力衰竭的临床疗效观察[J].广西医科大学学报,2013,30(5):765-767.
[15]李麟,王永莉,丁弘,等.益心舒胶囊治疗老年充血性心力衰竭的疗效观察[J].心理医生(下半月版),2012(8):283.
[16]刘川玉,唐建红,苏涵,等.益心舒胶囊对慢性心力衰竭患者心功能及AngⅡ和TNF-α的影响研究[J].中国药房,2009,20(30):2385-2387.
[17]刘强,徐智,毛威.益心舒胶囊治疗心房颤动合并舒张性心力衰竭患者的疗效[J].中国新药与临床杂志,2011,30(10):766-770.
[18]裴娟慧,李茂荣,甘丰.益心舒胶囊对冠心病致舒张性心功能不全的临床疗效观察及心率变异性的影响[J].中华心脏与心律电子杂志,2016,4(4):228-230.
[19]宋海萍,赵国定.益心舒胶囊治疗慢性充血性心力衰竭的临床研究[J].中西医结合心脑血管病杂志,2009,7(2):133-134.
[20]王慧,王万粮,杨蕾,等.益心舒胶囊对慢性充血性心力衰竭患者心功能及血浆脑钠肽的影响[J].中西医结合心脑血管病杂志,2014,12(4):409-410.
[21]吴刚勇,宗刚军,陈景开,等.益心舒治疗冠心病慢性心力衰竭临床观察[J].心血管康复医学杂志,2009,18(3):295-297.
[22]邢玉龙,王用,史云桃.益心舒胶囊治疗慢性心力衰竭的临床观察[J].中西医结合心脑血管病杂志,2012,10(10):1163-1164.
[23]遇准,冯建莉,丛春蕾.益心舒胶囊治疗气阴两虚挟瘀型慢性充血性心力衰竭的疗效观察[J].中西医结合心脑血管病杂志,2013,11(2):158-159.
[24]张颖莉,朱雪梅.益心舒胶囊治疗舒张性心力衰竭的临床观察[J].中西医结合心脑血管病杂志,2011,9(3):287-289.
[25]杨元庆,陈玲.加味血府逐瘀汤合并西药治疗慢性充血性心力衰竭60例临床观察[J].中医杂志,2011,52(1):39-41.
[26]BITTNER V,WEINER DH,YUSUF S,et al. Prediction of mortality and morbidity with a 6-minute walk test in patients with left ventricular dysfunction[J]. JAMA,1993,270(14):1702-1707.
[27]高建步,李玉东,杨守忠,等.益心舒胶囊对经皮冠状动脉介入术后患者生活质量和焦虑、抑郁情绪的影响[J].中国新药杂志,2017,26(10):1148-1151.