Zheng Qing-Hua, Li Xiao-Li, Mei Zhi-Gang, Xiong Li, Mei Qing-Xian, Wang Jin-Feng, Tan Ling-Jing, Yang Song-Bai, Feng Zhi-Tao
Third-Grade Pharmacological Laboratory on Chinese Medicine Approved by State Administration of Traditional Chinese Medicine, Medical College of China Three Gorges University Yichang Hospital of Traditional Chinese Medicine, Clinical Medical College of Traditional Chinese Medicine, China Three Gorges University, Yichang, Hubei Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, China.
Medicine (Baltimore). 2017 Jan;96(1):e5803. doi: 10.1097/MD.0000000000005803.
Previous studies indicated that the puerarin injection has been widely employed in China for the treatment of acute ischemic stroke. We aim to evaluate the efficacy and safety of the puerarin injection for the treatment of acute ischemic stroke.
A systematic literature search was performed in PUBMED, EMBASE, SPRINGER LINK, Scopus, Cochrane Library, China National Knowledge Infrastructure (CNKI), VIP Journals Database, Wanfang database and the China Biological Medicine database before November 2016, randomized controlled clinical trials (RCTs) of puerarin injection treating acute ischemic stroke were included. In addition, we searched reference lists of relevant retrieved articles. Two authors extracted data independently. The effective rate, the neurologic deficit score, the blood rheology indexes, and fibrinogen were assessed and analyzed by the Review Manager 5.3 software. The continuous variables were expressed as MD with 95% CI and dichotomous data used RR or ORs. Adverse reactions related to the puerarin injection were also examined.
Thirty-five RCTs with a total of 3224 participants were identified in the meta-analysis. The combined results of 32 trials indicated that the puerarin injection was better than control drugs at the clinical effective rate (RR 1.22, 95% CI 1.17 to 1.28, P < 0.001) and 16 studies showed the neurological deficit was significantly improved (MD -3.69, 95% CI -4.67 to -2.71, P < 0.001); the hemorheology index and fibrinogen were much lower with the puerarin injection when compared with western conventional medicines (WCM) or other control drugs (the whole blood viscosity: MD -0.89, 95% CI -1.37 to -0.41, P < 0.001; the HCT: MD -0.04, 95% CI -0.06 to -0.02, P < 0.001; the fibrinogen: MD -0.64, 95% CI -0.96 to -0.31, P < 0.001). Eleven trials reported that the adverse reactions related to the puerarin injection included facial flushing, dizziness, vomiting, nausea, and other mild gastrointestinal discomfort and allergic reaction. No serious adverse drug reactions were reported.
Puerarin injection may be more effective and relatively safe in clinic for treating acute ischemic stroke. However, the current evidence is insufficient due to the poor methodological quality and lack of adequate safety data. Further RCTs are required to examine its efficacy.
先前的研究表明，葛根素注射液在中国已被广泛用于治疗急性缺血性中风。我们旨在评估葛根素注射液治疗急性缺血性中风的疗效和安全性。
于2016年11月之前在PUBMED、EMBASE、SPRINGER LINK、Scopus、Cochrane图书馆、中国知网（CNKI）、维普期刊数据库、万方数据库和中国生物医学数据库中进行系统的文献检索，纳入葛根素注射液治疗急性缺血性中风的随机对照临床试验（RCT）。此外，我们还检索了相关检索文章的参考文献列表。两名作者独立提取数据。通过Review Manager 5.3软件评估和分析有效率、神经功能缺损评分、血液流变学指标和纤维蛋白原。连续变量以MD表示，并伴有95%置信区间，二分数据则使用RR或ORs。还检查了与葛根素注射液相关的不良反应。
在荟萃分析中确定了35项RCT，共有3224名参与者。32项试验的综合结果表明，葛根素注射液在临床有效率方面优于对照药物（RR 1.22，95%置信区间1.17至1.28，P＜0.001），16项研究表明神经功能缺损有显著改善（MD -3.69，95%置信区间-4.67至-2.71，P＜0.001）；与西药（WCM）或其他对照药物相比，葛根素注射液治疗后血液流变学指标和纤维蛋白原水平更低（全血粘度：MD -0.89，95%置信区间-1.37至-0.41，P＜0.001；红细胞压积：MD -0.04，95%置信区间-0.06至-0.02，P＜)。11项试验报告称，与葛根素注射液相关的不良反应包括面部潮红、头晕、呕吐、恶心以及其他轻度胃肠道不适和过敏反应。未报告严重的药物不良反应。
葛根素注射液在临床上治疗急性缺血性中风可能更有效且相对安全。然而，由于方法学质量较差且缺乏足够的安全性数据，目前的证据不足。需要进一步的随机对照试验来检验其疗效。
