Liu Bian, Tan Yan, Wang Deren, Liu Ming
Department of Neurology, West China Hospital, Sichuan University, No. 37, Guo Xue Xiang, Chengdu, Sichuan, China, 610041.
Cochrane Database Syst Rev. 2016 Feb 18;2:CD004955. doi: 10.1002/14651858.CD004955.pub3.
Puerarin, a form of herbal medicine, is widely used in the treatment of ischaemic stroke in China.
To assess the effects of puerarin in people with ischaemic stroke.
We searched the Cochrane Stroke Group Trials Register and the Chinese Stroke Trials Register (last searched August 2015). In addition, we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (2015, Issue 7), MEDLINE (1948 to August 2015), EMBASE (1980 to August 2015), AMED (the Allied and Complementary Medicine Database, 1985 to August 2015) and the China Biological Medicine Database (CBM-disc 1979 to August 2015). We searched reference lists, relevant clinical trials and research registers and contacted pharmaceutical companies and researchers in an effort to identify further published and unpublished studies.
Randomised controlled trials (RCTs) or quasi-randomised controlled clinical trials comparing puerarin with placebo or open control (no placebo) in people with ischaemic stroke.
Two review authors independently applied the inclusion criteria, assessed trial quality and risk of bias, and extracted the data.
We included 20 RCTs with 1574 participants in this updated review. All trials were published in Chinese language journals. We included 14 trials that we had excluded in the previous version of the review after we added a new outcome in this update. Time windows within which the participants were randomised ranged from 4.5 hours to 10 days. Ischaemic stroke was confirmed by computerised tomography (CT) or magnetic resonance imaging (MRI) in 18 trials. Meta-analysis of two trials with 164 participants showed that treatment with puerarin did not reduce death or dependency at final follow-up (RR 0.79, 95% CI 0.45 to 1.36). One trial with 83 participants reported that the mean value of the Barthel Index in the puerarin group was below that in the control group. Meta-analysis of 16 trials with 1305 participants showed that puerarin reduced the proportion of participants without improvement of neurological deficit at the end of follow-up (RR 0.42, 95% CI 0.33 to 0.55). None of the included trials reported serious adverse effects.The quality of evidence was low due to incomplete reporting of the methods and short-term follow-up.
AUTHORS' CONCLUSIONS: There is not enough evidence to evaluate the effect of puerarin on survival or dependency in people with ischaemic stroke. High quality and large-scale RCTs with long-term follow-up are needed to assess its efficacy.
葛根素作为一种草药制剂,在中国被广泛用于治疗缺血性脑卒中。
评估葛根素对缺血性脑卒中患者的疗效。
我们检索了Cochrane卒中组试验注册库和中国卒中试验注册库(最后检索时间为2015年8月)。此外,我们还检索了Cochrane对照试验中心注册库(CENTRAL,2015年第7期)、MEDLINE(1948年至2015年8月)、EMBASE(1980年至2015年8月)、AMED(联合与补充医学数据库,1985年至2015年8月)以及中国生物医学数据库(CBM-disc,1979年至2015年8月)。我们检索了参考文献列表、相关临床试验和研究注册库,并联系了制药公司和研究人员,以识别更多已发表和未发表的研究。
比较葛根素与安慰剂或开放对照(无安慰剂)治疗缺血性脑卒中患者的随机对照试验(RCT)或半随机对照临床试验。
两位综述作者独立应用纳入标准,评估试验质量和偏倚风险,并提取数据。
在本次更新的综述中,我们纳入了20项RCT,共1574名参与者。所有试验均发表于中文期刊。在本次更新中增加了一项新结局指标后,我们纳入了14项在之前版本综述中被排除的试验。参与者随机分组的时间窗为4.5小时至10天。18项试验通过计算机断层扫描(CT)或磁共振成像(MRI)确诊为缺血性脑卒中。对两项共164名参与者的试验进行的Meta分析表明,葛根素治疗在最终随访时并未降低死亡或依赖风险(RR=0.79,95%CI 0.45至1.36)。一项有83名参与者的试验报告称,葛根素组的Barthel指数平均值低于对照组。对16项共1305名参与者的试验进行的Meta分析表明,葛根素降低了随访结束时神经功能缺损无改善的参与者比例(RR=0.42,95%CI 0.33至0.55)。纳入的试验均未报告严重不良反应。由于方法报告不完整和随访时间短,证据质量较低。
没有足够的证据来评估葛根素对缺血性脑卒中患者生存或依赖的影响。需要高质量、大规模且具有长期随访的RCT来评估其疗效。