穴位敷贴治疗稳定性心绞痛的临床随机对照试验的系统评价

Randomized controlled trials of the point application therapy for stable angina pectoris:a systematic analysis

目的：评价穴位敷贴治疗稳定性心绞痛的疗效及安全性。方法：检索Pub Med、Cochrane图书馆、Clinical trials、MEDLINE等英文数据库,以及万方数字化期刊全文数据库、中国生物医学文献期刊数据库（CBM）、中国期刊全文数据库（CNKI）、中文科技期刊数据库（VIP）。根据纳入、排除标准筛选并纳入符合穴位敷贴辅助治疗稳定性心绞痛的随机对照试验,进行质量评价,Meta分析采用Rev Man 5.2软件。结果：共纳入9篇研究,虽都提到随机,仅1篇明确随机方法,所有纳入文献的分配隐藏及盲法等都不清楚。分析结果显示,穴位敷贴疗法与药物疗法改善心绞痛症状的比较,有统计学差异（RR=1.13,95%CI=1.07~1.20,P=0.000）;穴位敷贴组与西药组改善心电图疗效比较,结果显示差异有统计学意义（RR=1.12,95%CI=1.04~1.20,P=0.002）;穴位敷贴组与药物组对改善中医证候的疗效比较,结果显示差异有统计学意义（RR=1.14,95%CI=1.05~1.25,P=0.004）。其中3篇研究报道不良反应,包括皮疹、胃肠道不良反应等,组间无差别。结论：穴位敷贴疗法对改善稳定性心绞痛患者的心绞痛症状及中医症候疗效方面可能有效,但是纳入研究数量偏少、质量偏低,结论尚需慎重。

Objective：To evaluate the effectiveness and safety of point application therapy in treating table angina pectoris（SAP）.Methods：An extensive search of 4 English medical databases（Pub Med,Cochrane Library,Clinicaltrials,MEDLINE）,and 4 Chinese medical databases（Wan Fang,CBM,CNKI,VIP） was conducted. Randomized controlled trials（RCTs） in accordance with inclusion and exclusion criteria were included. And quality of enrolled studies was assessed. A Meta-analysis was performed by Review Manager5.2 software. Results：After researching,a total of 9 RCTs were included. Only one of the included RCTs had a clear random method.The allocation concealment and blinding of all included studies were not sure. There were statistical differences in relieving angina symptoms between point application therapy group and drug therapy group（RR=1.13,95%CI=1.07-1.20,P=0.000）. There were statistical differences in ECG effect between point application group and western medicine group（RR=1.12,95%CI=1.04-1.20,P=0.002）.There were statistical differences in traditional Chinese medicine（TCM）syndrome between two groups（RR=1.14,95%CI=1.05-1.25,P=0.004）. In addition,3 trials reported adverse effects such as skin rash,gastrointestinal adverse reactions. Conclusion：The point application therapy appears to have beneficial effects on relieving angina symptoms and TCM syndromes in participants with SAP.However,the findings should be interpreted with caution due to the poor methodological quality and small sample of the included trials.