红花黄色素注射液治疗脑梗死疗效及安全性的系统评价

 目的 系统评价红花黄色素注射液治疗脑梗死的有效性和安全性。方法 检索电子数据库搜集红花黄色素治疗脑梗死的随机对照试验,同时手工检索纳入的参考文献。经过筛选、提取资料和评估风险偏倚后,采用RevMan5.3软件对符合纳入标准的RCT进行Meta分析。结果 共纳入38个RCT,3454例患者。Meta分析结果显示:(1)红花黄色素+常规治疗组总体有效率优于各对照组(单纯常规、丹参、血栓通、川穹嗪、银杏达莫),且差异具有统计学意义(P<0.05);(2)红花黄色素对神经功能缺损评分改善程度优于对照组,差异具有统计学意义MD=-3.14, 95%CI(-4.04,-2.24), P<0.01];(3)红花黄色素组治疗后的中医症候疗效评分平均低于对照组MD=-3.75, 95%CI(-5.41,-2.09), P<0.01];(4)在血液流变学、出凝血功能指标、血清炎症标记物等方面,红花黄色素治疗组的改善效果同样优于对照组(P<0.05);(5)药物不良反应及毒副作用极少,安全性较高。结论 红花黄色素辅助治疗脑梗死可以有效地提高常规西药治疗效果,且安全性良好,是目前较佳的治疗方案。同时,考虑到纳入研究数量及质量的限制,上述结论尚需更多高质量并采用关键性终点指标的临床试验予以验证。

Safflower yellow for the treatment of cerebral infarction: a systematic review

Objective To evaluate the efficacy and safety of the safflower yellow injection in the treatment of cerebral infarction. Methods Related data published by December 2015 was retrieved from PubMed, EMBASE, the Cochrane Library, VIP, CNKI, CBM and WangFang databases regarding randomized controlled tests (RCTs) about the safflower yellow injection in treating cerebral infarction. At the same time,related literature was retrieved manually. Two reviewers independently selected studies, extracted the data and assessed the risk of bias according to the inclusion and exclusion criteria. Meta-analysis of the included RCTs was performed with software RevMan5.3. Results A total of 38 RCTs involving 3454 patients were included. The results of meta analysis showed that(1)in terms of total efficiency, the safflower yellow injection combined with conventional treatment group was better than any other control group, and the difference was statistically significant (P<0.05); (2)the safflower yellow injection could more effectively improve the National Institute of Health Stroke Scale (NIHSS)than control groups, and the difference was statistically significant MD=-3.14, 95%CI(-4.04,-2.24),P<0.01]; (3)the average TCM syndrome score of the curative effect in the safflower yellow injection group was lower than in control groupsMD=-3.75,95%CI (-5.41,-2.09), P<0.01];(4)the safflower yellow injection was more effective than control groups in the improvement of blood rheology, blood coagulation indexes and serum inflammatory markers (P<0.05); (5)drug adverse reactions and side effects were few. Conclusions Current evidence shows that the safflower yellow injection can improve the effect of conventional treatment of cerebral infarction,and is safe. Therefore, the safflower yellow injection combined with conventional treatment is a preferred option. Considering the quantity and quality of the included studies, clinical trials of better quality are needed.