目的运用循征医学方法,对中药防治冠状动脉介入治疗后再狭窄随机对照试验进行系统评价。方法全面收集2007年12月以前中药防治冠状动脉介入治疗后再狭窄的随机对照试验文献,采用Jadad质量标准对文献进行评分;利用RevMan4.2软件对多个研究结果的总体效应进行Meta分析;进行敏感性分析;用漏斗图分析发表性偏倚;报道药物不良反应。结果17篇文献符合纳入标准,只有2篇双盲试验被评为高质量文献。中药防治冠状动脉介入治疗后再狭窄和心绞痛复发率的疗效分析中,试验组发生率均低于对照组,且差异有统计学意义(P〈0.01)。敏感性分析显示评价结果较为稳定;漏斗图图形不对称,考虑存在发表性偏倚。结论中药在防治冠状动脉介入治疗后再狭窄及心绞痛复发率方面有一定疗效。
OBJECTIVE: To evaluate the randomized controlled trials on preventing and treating restenosis after percutaneous coronary intervention (PCI) with Chinese medicine adopting the principle of evidence-based medicine (EBM). METHODS: Pertinent literatures were retrieved roundly, and scored depending on Jadad Quality Scale. Meta-analysis was applied on the total effect of outcomes reported using RevMan 4. 2 software. Moreover, the sensitivity was analyzed, the publication bias was identified with funnel-plot and the adverse reaction of medicine was reported. RESULTS: Among the 17 literatures met the inclusion criteria, only two double-blinded trials were appraised as high quality. The analysis on the recurrence rates of restenosis post-PCI and angina pectoris in patients treated with Chinese medicine illustrated that the rates in the treatment group were all lower than those in the control group with statistical significance (P < 0.01). Sensitivity analysis revealed a relatively stable result of the evaluation. Funnel-plot displayed an asymmetrical figure, indicating the possible existence of publication bias. CONCLUSION: TCM has definite therapeutic effect on preventing and treating restenosis after PCI and reducing the recurrence rate of angina pectoris in patients.