Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China.
Centre for Evidence-Based Chinese Medicine, Beijing University of Chinese Medicine, Beijing 100029, China; The National Research Center in Complementary and Alternative Medicine (NAFKAM), Department of Community Medicine, Faculty of Health Science, the Arctic University of Norway, 9037 Tromsø, Norway.
Complement Ther Med. 2018 Feb;36:82-89. doi: 10.1016/j.ctim.2017.12.004. Epub 2017 Dec 9.
The existing eligible randomized controlled trials (RCTs) were critically appraised for the effectiveness and safety of Chinese herbal medicine Dengzhan Shenmai for ischemic stroke.
Systematic review and meta-analysis (CRD42016042914, http://www.crd.york.ac.uk/PROSPERO).
Six electronic databases were searched from inception to May 2016. Risk ratio (RR) and mean difference (MD) with a 95% confidence interval (CI) were used as effect estimates using RevMan 5.3. Meta-analysis was performed where data were available. A summary of finding table was generated by the GRADEpro (version 3.6).
We identified 14 RCTs involving 5206 participants. Majority of the included trials were of high risk of bias in methodological quality. For acute ischemic stroke, adding DZSM capsule to conventional therapy achieved higher Barthel Index scores (MD 22.37, 95% CI 21.34-23.40), lower neurological function deficit scores (MD - 3.73, 95% CI -5.27 to -2.19) and lower recurrence rate (RR 0.22, 95% CI 0.10, 0.46). For patients in their convalescence (or sequelae) stage of ischemic stroke, DZSM capsule was superior in improving quality of life (MD 28.8, 95% CI 7.10-50.50) and recurrence rate (RR 0.71, 95% CI 0.51-0.99) compared to placebo. No trials reported serious adverse events.
DZSM capsule appears to improve neurological function, quality of life, and reduce recurrence rate based on conventional therapy for ischemic stroke. DZSM capsule seems generally safe for clinical application. However, the findings of benefit are inconclusive due to generally weak evidence, and further large, rigorous trials are still warranted.
对现有的合格随机对照试验（RCT）进行批判性评价，以评估中药灯盏细辛治疗缺血性中风的有效性和安全性。
系统评价和荟萃分析（CRD42016042914，http://www.crd.york.ac.uk/PROSPERO）。
从成立到 2016 年 5 月，我们在六个电子数据库中进行了检索。使用 RevMan 5.3 软件，采用风险比（RR）和均数差值（MD）及其 95%置信区间（CI）作为效应估计值。如果数据可用，则进行荟萃分析。通过 GRADEpro（版本 3.6）生成汇总结局表格。
我们共纳入 14 项 RCT，涉及 5206 名参与者。大多数纳入的试验在方法学质量方面存在较高的偏倚风险。对于急性缺血性中风，在常规治疗的基础上加用灯盏细辛胶囊可使巴塞尔指数评分更高（MD 22.37，95%CI 21.34-23.40），神经功能缺损评分更低（MD-3.73，95%CI-5.27 至-2.19），复发率更低（RR 0.22，95%CI 0.10-0.46）。对于处于中风恢复期（或后遗症期）的患者，与安慰剂相比，灯盏细辛胶囊可显著提高生活质量（MD 28.8，95%CI 7.10-50.50）和降低复发率（RR 0.71，95%CI 0.51-0.99）。没有试验报告严重不良事件。
与常规疗法相比，灯盏细辛胶囊可改善缺血性中风患者的神经功能、生活质量并降低复发率。灯盏细辛胶囊在临床应用中似乎是安全的。但是，由于证据总体较弱，获益的发现并不确定，仍需要进一步开展大规模、严格的试验。
