复方丹参滴丸治疗冠心病无症状心肌缺血疗效和安全性的Meta分析
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摘要
目的评价复方丹参滴丸治疗冠心病无症状心肌缺血的有效性和安全性。方法检索Cochrane Library、PubMed、Embase、中国知网(CKNI)、万方数据库(WanFang)、维普数据库(VIP)、中国生物医学文献数据库(CBM),检索时间为建库至2017年8月20日。根据既定纳入和排除标准选取复方丹参滴丸治疗冠心病无症状心肌缺血病人为研究对象的随机对照临床试验,提取纳入文献资料后对文献质量进行评价,最后将资料信息录入至RevMan 5.3软件进行数据分析。结果纳入10项随机对照试验研究,共735例冠心病无症状心肌缺血病人。复方丹参滴丸治疗无症状心肌缺血在心电图疗效[OR=2.59,95%CI(1.38,4.86),P=0.003]、临床症状及心电图合并疗效[OR=3.05,95%CI(1.62,5.76),P=0.000 6]、动态心电图疗效[OR=2.58,95%CI(1.14,5.85),P=0.02]、舒张压(DBP)疗效[MD=-1.36,95%CI(-2.20,-0.51),P=0.002]、收缩压(SBP)疗效[MD=-2.89,95%CI(-4.07,-1.71),P<0.000 01]、心率(HR)疗效[MD=-6.05,95%CI(-10.51,-1.58),P=0.008]、减少ST段持续压低次数[MD=-29.91,95%CI(-46.55,-13.27),P=0.000 4]及ST段持续压低时间[MD=-42.04,95%CI(-56.96,-27.11),P<0.000 01]方面优于对照组,差异均具有统计学意义。未报道严重不良事件及肝肾功能损害。结论复方丹参滴丸治疗冠心病无症状心肌缺血在心电图改善、动态心电图疗效、降低心肌耗氧量指标等方面较对照组有优势,但由于纳入文献质量偏低,Meta分析结果存在偏倚。
Objective To evaluate efficacy and safety of compound Danshen dripping pills in the treatment of silent myocardial ischemia of coronary heart disease.Methods The Cochrane Library,PubMed,Embase,CNKI,Wang Fang Database,VIP and CBM were searched for collecting the RCT about compound Danshen dripping pills in the treatment of coronary heart disease of silent myocardial ischemia.The retrieval time was from the setup time of the databases to August 20,2017.The quality of literatures for the eligible articles was assessed,the meta-analysis was performed using Rev Man5.3 software.Results A total of 845 patients with silent myocardial ischemia of coronary heart disease were enrolled in 11 randomized controlled clinical trials.The results of Meta analysis showed that compound Danshen dripping pills had some advantages in the ECG effect [OR=2.59,95%CI(1.38,4.86),P=0.003],the combined effects of clinical symptoms and ECG [OR=3.05,95%CI(1.62,5.76),P=0.000 6],dynamic electrocardiographic efficacy [OR=2.58,95%CI(1.14,5.85).P=0.02],the DBP curative effect [MD=-1.36,95%CI(-2.20,-0.51),P=0.002],and the SBP curative effect[MD=-2.89,95%CI(-4.07,-1.71),P<0.000 01],the HR effect[MD=-6.05,95%CI(-10.51,-1.58),P=0.008],the frequency of ST-segment depression [MD=-29.91,95%CI(-46.55,-13.27),P=0.000 4],the duration of ST-segment depression [MD=-42.04,95%CI(-56.96,-27.11),P<0.000 01],and the differences between the two groups were all statistically significant.No serious adverse events or liver and kidney dysfunction were reported.Conclusion Compared with the control group,compound Danshen dripping pills has advantages in improving electrocardiogram,improving effect of dynamic electrocardiogram and reducing indexes of myocardial oxygen consumption in the treatment of silent myocardial ischemia of coronary heart disease,However,due to the low quality of the original research literature and the bias risk existing in the Meta analysis,the reliability of the conclusions is affected.
Objective To evaluate efficacy and safety of compound Danshen dripping pills in the treatment of silent myocardial ischemia of coronary heart disease.Methods The Cochrane Library,PubMed,Embase,CNKI,Wang Fang Database,VIP and CBM were searched for collecting the RCT about compound Danshen dripping pills in the treatment of coronary heart disease of silent myocardial ischemia.The retrieval time was from the setup time of the databases to August 20,2017.The quality of literatures for the eligible articles was assessed,the meta-analysis was performed using Rev Man5.3 software.Results A total of 845 patients with silent myocardial ischemia of coronary heart disease were enrolled in 11 randomized controlled clinical trials.The results of Meta analysis showed that compound Danshen dripping pills had some advantages in the ECG effect [OR=2.59,95%CI(1.38,4.86),P=0.003],the combined effects of clinical symptoms and ECG [OR=3.05,95%CI(1.62,5.76),P=0.000 6],dynamic electrocardiographic efficacy [OR=2.58,95%CI(1.14,5.85).P=0.02],the DBP curative effect [MD=-1.36,95%CI(-2.20,-0.51),P=0.002],and the SBP curative effect[MD=-2.89,95%CI(-4.07,-1.71),P<0.000 01],the HR effect[MD=-6.05,95%CI(-10.51,-1.58),P=0.008],the frequency of ST-segment depression [MD=-29.91,95%CI(-46.55,-13.27),P=0.000 4],the duration of ST-segment depression [MD=-42.04,95%CI(-56.96,-27.11),P<0.000 01],and the differences between the two groups were all statistically significant.No serious adverse events or liver and kidney dysfunction were reported.Conclusion Compared with the control group,compound Danshen dripping pills has advantages in improving electrocardiogram,improving effect of dynamic electrocardiogram and reducing indexes of myocardial oxygen consumption in the treatment of silent myocardial ischemia of coronary heart disease,However,due to the low quality of the original research literature and the bias risk existing in the Meta analysis,the reliability of the conclusions is affected.
引文
[1] CHANG C,YE B,XIE W,et al.The diagnosis of silent myocardial ischemia.Motion-Frozen (or morphing) myocardial perfusion imaging[J].Hellenic Journal of Nuclear Medicine,2016,19(3):196.
[2] ZHANG Z M,RAUTAHARJU P M,PRINEAS R J,et al.Race and sex differences in the incidence and prognostic significance of silent myocardial infarction in the Atherosclerosis Risk in Communities (ARIC) study[J].Circulation,2016,133(22):2141.
[3] 彭林玉.复方丹参滴丸在心血管方面的药理与临床研究[J].中国卫生产业,2013,2(19):186-188.
[4] ZHANG J H,SHANG H C,GAO X M,et al.Compound salvia droplet pill,a traditional Chinese medicine,for the treatment of unstable angina pectoris:a systematic review[J].Med Sci Monit,2008,14(1):A1-A7.
[5] 国际心脏病学会和协会及WHO临床命名标准化联合专题组.缺血性心脏病的命名及诊断标准[J].中华心血管病杂志,1981,9(1):75-76.
[6] STERN S,COHN P F,PEPINE C J.Silent myocardial ischemia[J].Curr Probl Cardiol,1993,185:301-359.
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[8] 刘明,姜莉芸.复方丹参滴丸治疗无症状性心肌缺血70例临床疗效观察[J].云南中医中药杂志,2002,23(6):20.
[9] 牛守智.复方丹参滴丸治疗无症状心肌缺血的疗效观察(附24例报告)[J].哈尔滨医药,2006,26(5):61-62.
[10] 孟贞.无症状心肌缺血临床治疗63例疗效分析[J].中国实用医药,2008,3(12):119-120.
[11] 邵启峰.复方丹参滴丸治疗老年无症状心肌缺血30例临床分析[J].当代医学,2009,15(7):136-137.
[12] 刁幼华,孙传良.阿司匹林联合复方丹参滴丸治疗无症状性冠心病的疗效观察[J].中国药房,2009,20(14):1082-1084.
[13] 钱伟玲,贾连旺.复方丹参滴丸改善心肌梗死后无症状心肌缺血及血管内皮依赖性舒张功能的效果评价[J].中国中医急症,2009,18(7):1089-1091.
[14] 温运昌.复方丹参滴丸治疗无症状心肌缺血的疗效[J].中国现代药物应用,2011,5(5):157-158.
[15] 高彦,蔡舸,吕云.复方丹参滴丸治疗无症状心肌缺血疗效观察[J].航空航天医学杂志,2013,24(11):1381-1382.
[16] 武鸿燕.复方丹参滴丸治疗老年无症状性心肌缺血的效果分析[J].吉林医学,2013,34(29):6037-6038.
[17] 陈宁,于虹.复方丹参滴丸治疗无症状心肌缺血疗效观察[J].现代中西医结合杂志,2006,15(14):1925-1926.
[18] 刘鸣.系统评价、Meta-分析设计与实施方法[M].北京:人民卫生出版社,2011:1.
[2] ZHANG Z M,RAUTAHARJU P M,PRINEAS R J,et al.Race and sex differences in the incidence and prognostic significance of silent myocardial infarction in the Atherosclerosis Risk in Communities (ARIC) study[J].Circulation,2016,133(22):2141.
[3] 彭林玉.复方丹参滴丸在心血管方面的药理与临床研究[J].中国卫生产业,2013,2(19):186-188.
[4] ZHANG J H,SHANG H C,GAO X M,et al.Compound salvia droplet pill,a traditional Chinese medicine,for the treatment of unstable angina pectoris:a systematic review[J].Med Sci Monit,2008,14(1):A1-A7.
[5] 国际心脏病学会和协会及WHO临床命名标准化联合专题组.缺血性心脏病的命名及诊断标准[J].中华心血管病杂志,1981,9(1):75-76.
[6] STERN S,COHN P F,PEPINE C J.Silent myocardial ischemia[J].Curr Probl Cardiol,1993,185:301-359.
[7] 胡大一.全国心肌缺血再灌注损伤和无症状性心肌缺血专题讨论会纪要[J].中华心血管病杂志,1992,20(2):17.
[8] 刘明,姜莉芸.复方丹参滴丸治疗无症状性心肌缺血70例临床疗效观察[J].云南中医中药杂志,2002,23(6):20.
[9] 牛守智.复方丹参滴丸治疗无症状心肌缺血的疗效观察(附24例报告)[J].哈尔滨医药,2006,26(5):61-62.
[10] 孟贞.无症状心肌缺血临床治疗63例疗效分析[J].中国实用医药,2008,3(12):119-120.
[11] 邵启峰.复方丹参滴丸治疗老年无症状心肌缺血30例临床分析[J].当代医学,2009,15(7):136-137.
[12] 刁幼华,孙传良.阿司匹林联合复方丹参滴丸治疗无症状性冠心病的疗效观察[J].中国药房,2009,20(14):1082-1084.
[13] 钱伟玲,贾连旺.复方丹参滴丸改善心肌梗死后无症状心肌缺血及血管内皮依赖性舒张功能的效果评价[J].中国中医急症,2009,18(7):1089-1091.
[14] 温运昌.复方丹参滴丸治疗无症状心肌缺血的疗效[J].中国现代药物应用,2011,5(5):157-158.
[15] 高彦,蔡舸,吕云.复方丹参滴丸治疗无症状心肌缺血疗效观察[J].航空航天医学杂志,2013,24(11):1381-1382.
[16] 武鸿燕.复方丹参滴丸治疗老年无症状性心肌缺血的效果分析[J].吉林医学,2013,34(29):6037-6038.
[17] 陈宁,于虹.复方丹参滴丸治疗无症状心肌缺血疗效观察[J].现代中西医结合杂志,2006,15(14):1925-1926.
[18] 刘鸣.系统评价、Meta-分析设计与实施方法[M].北京:人民卫生出版社,2011:1.
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