两种丹参类中药注射剂治疗冠心病心绞痛的系统评价及其药物经济学分析

Two Kinds of Radix Salviae Miltiorrhizae Injection for Angina Pectoris: A Systematic Review and Pharmacoeconomics Analysis

目的系统评价注射用丹参多酚酸盐与丹参注射液治疗冠心病心绞痛的有效性和安全性，并分析其药物经济性。方法计算机检索PubMed、CENTRAL（2013年第4期）、CNKI、VIP和WanFangData，查找有关注射用丹参多酚酸盐与丹参注射液比较治疗冠心病心绞痛的随机对照试验（RCT），检索时限均为2004年1月～2013年5月。同时手检相关期刊与会议论文。由2位评价员根据纳入与排除标准独立进行文献筛选、资料提取和质量评价后，采用RevMan5．2软件进行Meta分析。结果共纳入10个RCT，包括患者1196例。Meta分析结果显示：注射用丹参多酚酸在治疗冠心病心绞痛方面的有效性[OR=3．79，95％CI（2．78，5．17），P〈0．00001]和安全性[OR=0．24，95％CI（0．09，0．64），P=0．004]明显优于丹参注射液，但缺乏经济学优势。结论现有证据表明，注射用丹参多酚酸盐为治疗冠心病心绞痛的安全、有效方案，丹参注射液为较经济方案。受限于纳入研究的数量和质量，上述结论尚需今后开展更多大样本、高质量的RCT加以验证。

Objective To systematically review the effectiveness and safety ofsalvianolate injection and Danshen injec- tion for patients with angina pectoris, and evaluate the cost of drug. Methods We electronically searched databases includ- ing PubMed, CENTRAL （Issue 4, 2013）, CNKI, VIP and WanFang Data （2004.1 to 2013.5） for the randomized controlled trials （RCTs） on the comparison between salvianolate injection and Danshen injection for angina pectoris from January 2004 to May 2013. Relevant journals and conference proceedings were also manually retrieved. Two reviewers independently screened literature in accordance with the inclusion and exclusion criteria, extracted the data and assess the methodological quality of included studies. Then, meta-analysis was performed using RevMan 5.2 software. Results A total of 10 RCTs in- volving 1 196 patients were included. The results of meta-analysis showed that, salvianolate injection was obviously superior to Danshen injection in the effectiveness （OR=3.79, 95%CI 2.78 to 5.17, P〈0.000 01） and safety （OR=0.24, 95%CI 0.09 to 0.64, P=0.004）, but lack of economic advantages in the treatment of the angina pectoris diseases. Conclusion Current evidence indicates that, salvianolate injection is a safe and effective scheme for angina pectoris, and Danshen injection is considered as a economic method. Because of the limited quantity and quality of currently-available research, the aforementioned conclu- sion should be verified by strictly-designed and large-scale sample RCTs.