活血化瘀法治疗冠心病心绞痛临床研究系统综述和Meta分析

背景]活血化瘀法是治疗冠状动脉粥样硬化性心脏病的主要方法,疗效评价指标不一,临床研究多为小样本,影响结果可信度,疗效系统综述较少。目的]评价活血化瘀法治疗冠心病心绞痛有效性和安全性。检索策略]以主题词"活血化瘀"、"逐瘀"、"通瘀"、"通脉"、"通络"、"冠心病"、"心绞痛"、"胸痹"和"真心痛",检索中国生物医学文献数据库(CBM)、中国医院数字图书馆(CNKI)的期刊全文数据库、万方数据知识服务平台、维普中文期刊数据库(VIP)、Pubmed数据库、Embase数据库1998年1月至2012年12月文献。纳入标准]随机对照试验(RCT)或半随机对照试验(CCT),病例资料完整;各文献研究假设及研究方法相似,组间均衡性较好。资料提取与分析]采用RevMan5.0软件随机效应模型Meta分析。计数资料用比值比(OR),计量资料用加权均数差(WMD),计算95%可信区间(CI)。纳入文献异质性检验结果P0.05,采用固定效应模型作Meta分析;反之采用随机效应模型;然后采用敏感性分析检测Meta分析结果稳定性,对≥5篇分析结果,采用漏斗图分析发表性偏倚。结果]纳入11篇文献,Meta分析结果:活血化瘀法可以明显改善冠心病心绞痛临床症状OR=3.96,95%CI(2.62,5.98),(P0.001)];心电图改善率OR=2.20,95%CI(1.64,2.95),(P0.001)];硝酸甘油停减率OR=6.11,95%CI(3.68,10.13),(P0.001)];红细胞压积WMD=-5.14,95%CI(-10.35,-0.07),(P0.001)];血液流变学中全血高切黏度WMD=-0.42,95%CI(-0.72,-0.12),(P0.001)];全血低切黏度WMD=-0.13,95%CI(-0.47,-0.22),(P0.001)];血浆黏度WMD=-0.13,95%CI(-0.20,-0.06),(P0.001)];血脂中的甘油三酯WMD=-0.26,95%CI(-0.48,-0.04),(P0.001)];总胆固醇WMD=-0.62,95%CI(-1.58,-0.35),(P0.001)];高密度脂蛋白WMD=0.12,95%CI(0.03,0.22),(P0.001)]。不良反应的发生率较低,症状较轻。结论]活血化瘀法治疗冠心病心绞痛安全,有效。问题与展望]前期研究质量不高,实验结果存在发表偏倚;目前对疗效尚不能得出最终结沦,有待于高质量临床研究,开展更多设计合理、执行严格、随访时间充足的具有中医特色的随机双盲对照试验。

Meta Analysis of Clinical Research Literature on Method of Promoting Blood Circulation and Removing Blood-stasis for Treatment Coronary Heart disease

Background ] Method of promoting blood circulation in treatment of coronary heart disease is the main treatment Method, but have different curative effect evaluation of each index, and the domestic research on the treatment in the treatment of coronary heart disease （ CHD ） are small sample, credibility influence the result of the experiment, clinical less systematically review the efficacy of the treatment. Objiective ] Analysis of clinical trials of promoting blood circulation and removing blood stasis in treating coronary heart disease by Meta analysis Method and evaluate itstreatment effect. Methods ] The related literature retrieval of promoting blood circulation and removing blood stasis in treating coronary heart disease clinical trials in January 1998- December 2012 published was collected, and Analysis by RevMan5.0 software . Inclusion criteria ] Activate blood Method in treatment of coronary atherosclerotic heart disease randomized controlled trial （RCT） or quasi-randomized controlled trials （CCTS）, case data integrity;The literature research hypothesis and research Methods are similar, good balance between groups, comparable. Data extraction and analysis ] Using RevMan5.0 Meta analysis software random effects model.Count data with odds ratio （ OR ）, measurement data using the weighted mean differences （ WMD ）, calculate the 95% confidence interval （ CI ） . When incorporated into literature heterogeneity test Results P〉O.05, by using the fixed effects model as a Meta analysis.On the other hand, using random effect model; And then uses the sensitivity analysis of probing the stability of Meta analysis Results, analysis of 5 or higher as a result, the funnel chart analysis published potential sex bias potential. Results ] A total of 11 studies were included, the Results of Meta analysis suggest that：The Method of promoting blood circulation and removing blood stasis can significantly improve the clinical symptoms in patients with coronary heart disease and angina pectoris RR=1.21, 95%CI （ 1.13, 1.29 ）,（ P〈0.001 ）], electrocardiogram improvement rate RR=1.24, 95%CI （ 1.14, 1.36 ）,（ P〈0.001 ）], withdrawal rate of nitroglycerin RR=1.62, 95%CI （ 1.39, 1.90 ）,（ P〈0.001 ） ], hematocrit SMD=-1.74, 95%CI （ -3.45, -0.03 ）,（P=0.05 ）], the whole blood viscosity of hemorheology SMD=-0.31, 95%CI （ -0.55, -0.08 ）,（ P=0.010 ） ], whole blood low shear viscosity SMD=-0.11, 95%CI （ -0.34, -0.13 ）, （P=0.37） ], plasma viscosity SMD=-0.44, 95%CI （ -0.68, -0.21 ）,（P〈0.001 ） ], triglycerides of blood lipids SMD=-0.25, 95%CI （ -0.46, -0.04 ）,（ P=0.02 ） ], total cholesterol SMD=-0.81, 95%CI （ -1.89, - 0.27 ）,（P=0.14 ） ], high density lipoprotein SMD=0.46, 95%CI （ 0.00, 0.92 ）,（ P=0.05 ） ] . Low incidence rate of adverse reaction, and mild symptoms. Conclusion ] The promoting blood circulation and removing blood stasis in treating coronary heart disease is effective, safe, but the early research quality is not high, the experimental Results of potential publication bias. Problem and Prospect ] The Results of the previous research and the quality is not high, the experiment potential publication bias.Traditional Chinese Medicine of promoting blood circulation to remove blood stasis Method in the treatment of CHD curative effect is not the final knot theory, subject to high quality clinical research Results.The clinical research of Traditional Chinese Medicine, combined Chinese and western medicine also needs to further standardize and improve in terms of research design.More reasonable design, strict execution, follow-up time enough with TCM characteristics, randomized, double-blind controlled trial.