J Tradit Chin Med. 2013 Dec;33(6):715-20. doi: 10.1016/s0254-6272(14)60002-9.
To evaluate the medium- to long-term efficacy of ligustrazine plus conventional medicine treating ischemic stroke.
Randomized controlled trials (RCTs) testing ligustrazine in the treatment of acute ischemic stroke were retrieved from Cochrane Library, PubMed, Excerpta Medica Database, Chinese Medical Journal Database, Chinese Biomedical Database, China National Knowledge Infrastructure Database, and Chinese Clinical Trial Register, and then identified by the inclusive and exclusive criteria. The quality of trials was assessed with the Cochrane Handbook 5.1, a risk of bias assessment tool. RevMan 5.1 was used for meta-analysis.
Three RCTs involving 643 patients were included. Compared to conventional medicine treatment alone, ligustrazine plus conventional medicine treatment showed significant difference in reduction of stroke recurrence either at the end of 1-year follow-up [RR = 0.42, 95% CI (0.18, 0.94), P < 0.05] or 3-years observation [RR = 0.48, 95% CI (0.27, 0.83), P < 0.05]. The ligustrazine group also showed higher survival rate [RR =1.67, 95% II (1.02, 0.2.71), P <0.05] and significantly better effective rate [R R= 1.28, 95% II (1.10, 1.50), P <0.05] than that of the control group at the end of 1 year visit. Only one trial conducted safety assessment and no adverse events were reported. The methodological quality of all the trials included was generally poor.
The findings provided evidence that the combination of ligustrazine and conventional medication was medium- and long-term beneficial to the patients suffering ischemic stroke. But more RCTs of high quality are needed to further prove the efficacy and safety of using ligustrazine for ischemic stroke.
评价川芎嗪联合常规药物治疗缺血性脑卒中的中远期疗效。
计算机检索 Cochrane 图书馆、PubMed、Embase、中国生物医学文献数据库、中国知网、维普及中国临床试验注册中心，纳入川芎嗪治疗急性缺血性脑卒中的随机对照试验（RCT），按纳入和排除标准筛选文献、提取资料并评价纳入研究的偏倚风险后，采用 RevMan5.1 软件进行 Meta 分析。
共纳入 3 个 RCT，包含 643 例患者。与常规药物治疗相比，川芎嗪联合常规药物治疗可降低 1 年随访时 [RR＝0.42，95%CI（0.18，0.94），P＜0.05] 和 3 年观察时 [RR＝0.48，95%CI（0.27，0.83），P＜0.05] 的卒中复发率；1 年随访时 [RR＝1.67，95%CI（1.02，0.27），P＜0.05] 联合组的生存率更高，有效率 [RR＝1.28，95%CI（1.10，1.50），P＜0.05] 亦显著优于对照组。仅 1 个研究报道了安全性，未发生不良反应。纳入研究方法学质量普遍较低。
现有证据表明，川芎嗪联合常规药物治疗可改善缺血性脑卒中患者的预后，但仍需要更多高质量 RCT 进一步验证其疗效和安全性。
