红花注射液治疗不稳定型心绞痛的疗效与安全性评价.doc

红花注射液治疗不稳定型心绞痛的疗效与安全性评价 吴逢波，徐珽，李健，唐尧（四川大学华西医院药剂科成都 610041） 摘要 目的：评价红花注射液治疗不稳定型心绞痛的疗效与安全性。 方法：检索红花注射液治疗不稳定型心绞痛的随机和半随机对照试验，根据纳入和排除标准筛选文献、提取资料和进行质量评价，并采用RevMan5.0.0软件进行Meta分析。 结果：共纳入6个研究，包括436例患者。仅有1个研究描述具体的随机方法，其余研究均未描述具体的随机方法、分配隐藏和盲法。Meta分析结果显示：红花注射液+常规治疗的总有效率优于常规治疗[RR=1.18, 95%CI(1.09,1.27)]；红花注射液+常规治疗的血浆粘度改善优于常规治疗[RR=0.35, 95%CI(0.23,0.46)]。 结论：红花注射液治疗不稳定型心绞痛患者有效，其效果优于对照组。但由于纳入研究数量少、质量低，上述结果尚需高质量大样本的随机双盲对照试验的验证。 关键词 红花注射液；不稳型心绞痛；有效性；安全性；Meta分析；随机对照试验 Efficacy and Safety of Safflower Injection in the Treatment of Unstable Angina Pectoris: A Systematic Review WU Feng-bo, Xu Ting,LI Jian, TANG Yao (Department of Pharmacy, West China Hospital, Sichuan University, Cheng du 610041, China) ABSTRACT Objective：To evaluate the efficacy and safety of safflower injection in the treatment of unstable angina pectoris. Methods：We searched for randomized controlled trials of safflower injection in the treatment of UAP. We screened the retrieved studies according to the predefined inclusion and exclusion criteria, evaluated the quality of included studies, and performed meta-analyses with The Cochrane Collaboration’s Revman 5.5.0 software. Results：Six studies involving 436 participants were included.Only one study reports randomization,the other included studies were inadequate at reporting randomization,concealment of allocation and blinding.Meta-analysis based on the included studies showed that the total effective rate of safflower injection with conventional therapy was better than conventional therapy in UAP(RR=1.18,95%CI 1.09,1.27). the plasma viscosity of safflower injection with conventional therapy was better than conventional therapy in UAP(RR=0.35,95%CI0.23,0.46). Conclusion：Safflower injection is effective and safe for UAP.However,due to the limited quantity and quality of the included studies,The result suggest that larger-scale and high quality RCTs are needed. KEY WORDS SafflowerInjection;UAP;Efficacy;Safety;Meta-analysis;RCT 作者简介：吴逢波，男，药师，从事临床药学工作。E-mail:wufen