摘要
目的:系统评价复方丹参滴丸的安全性和有效性,为临床应用和深入研究提供依据。方法:检索复方丹参滴丸治疗冠心病的随机对照试验(randomized controlled trials,RCTs),无盲法和语言限制;筛选符合纳入标准的RCTs,依据Jadad评分法进行文献的质量评价,并采用RevMan 5.0软件进行Meta分析。结果:共纳入254篇文献,有4篇为高质量文献,占所有纳入研究的1.57%。按干预措施和疗效评价分组进行Meta分析,结果显示:在改善心绞痛症状方面,以复方丹参滴丸作为干预药物,与对照药消心痛比较,第1组其疗效差异无统计学意义[RR=1.07,95%CI(0.96,1.20)],第2组和第3组复方丹参滴丸的疗效均优于消心痛[RR=1.28,95%CI(1.12,1.45);RR=1.48,95%CI(1.22,1.78)];与对照药复方丹参片比较,复方丹参滴丸的疗效优于复方丹参片[RR=1.29,95%CI(1.15,1.46)]。在改善心电图方面,复方丹参滴丸与消心痛比较,第1组其疗效差异无统计学意义[RR=1.22,95%CI(1.00,1.50)],第2组复方丹参滴丸的疗效优于消心痛[RR=1.58,95%CI(1.20,2.06)];复方丹参滴丸与复方丹参片比较,复方丹参滴丸的疗效优于复方丹参片[RR=1.27,95%CI(1.07,1.50)]。结论:复方丹参滴丸治疗冠心病,其缓解心绞痛和改善心电图的疗效相对优于消心痛和复方丹参片,且不良反应少,耐受性好;虽然近年来RCTs研究的数量和质量有逐年提高的趋势,但仍需从临床试验设计的科学性、报告的规范性等诸多环节来提高研究水平。
Objective： To systematically review the efficacy and safety of ＂Compound Salvia Droplet Pill＂ （CSDP） for coronary heart disease （CHD）, and provide the information for further research and clinical application. Methods： The clinical randomized controlled trials （RCTs） of CSDP for CHD were searched without language or blinding restriction. The quality of RCTs was evaluated with Jadad scores. RevMan 5.0 software was used for meta-analysis. Results： Two hundred and fifty- four RCTs were reviewed, and four RCTs were high quality studies. The results of meta-analysis were as follows： On the aspects of improving angina, there was no statistical difference between CSDP and isosorbide dinitrate in the 1st group [ RR ： 1.07,95 % （71（0.96,1.20） ] , the clinical effects of CSDP were better than isosorbide dinitrate in the 2nd and 3rd groups [ RR = 1.28,95 % CI（ 1. 12, 1. 45 ） ;RR = 1.48,95% CI（ 1.22,1.78 ） ] ; the clinical effects of CSDP were better than ＂Compound Salvia Tablet＂ （CST） [ RR - 1.29,95 % CI（1.15,1.46） 1. On the aspects of improving electrocardiogram （ ECG）, there was no statistical difference between CSDP and isosorbide dinitrate in the I st group [ RR = 1.22,95 % CI（ 1.00, l. 50） ], the clinical effects of CSDP were better than isosorbide dinitrate in the 2nd group [ RR = 1.58,95% CI（1.20,2.06） ] ; the clinical effects of CSDP were better than CST [ RR = 1.27,95% CI（1.07,1.50） ]. Conclusion ： The clinical effects of CSDP is better than isosorbide dinitrate and CST on relieving angina and improving ECG with less adverse reaction and good tolerance. The quantity and quality of RCTs are higher lhan before, but we still have to boost the research level through scientific design and normative report.
出处
《上海中医药大学学报》
CAS
2012年第3期24-31,共8页
Academic Journal of Shanghai University of Traditional Chinese Medicine
基金
国家"十一五"科技支撑计划资助项目(2006BAI04A10)
国家自然科学基金资助项目(30825047)
国家科技部创新方法工作专项项目(2008IM020900)
关键词
复方丹参滴丸
冠心病
系统评价
META分析
＂Compound Salvia Droplet Pill＂
coronary heart disease
systematic review
meta-analysis
