中成药对缺血性卒中的荟萃分析
Title: Meta-Analysis of Traditional Chinese Patent Medicine for Ischemic Stroke.Author: Wu B, Liu M, Liu H, Li W, Tan S, Zhang S, Fang Y.
Resource: Stroke. 2007 Apr 26; [Epub ahead of print]
Abstract: BACKGROUND AND PURPOSE: A large number of traditional Chinese patent medicine (TCPM) are widely used for ischemic stroke in China. The aim of this study was to systematically review the existing clinical evidence on TCPM for ischemic
stroke. METHODS: We identified all TCPM that were listed in the Chinese National
Essential Drug list of 2004 and those commonly used TCPM in current clinical
practice for ischemic stroke. Fifty-nine TCPM were identified for further
evaluation. We applied Cochrane systematic review methods. We searched for
reports of randomized controlled trials and controlled clinical trials on any of
the 59 TCPM for ischemic stroke comparing one TCPM with control. Primary
outcomes included death or dependency at the end of follow-up (at least 3
months) and adverse events. Effects on neurological impairments were a secondary
outcome. RESULTS: One-hundred ninety-one trials (19 338 patients) on 22 TCPM
were available and included, of which 120 were definite or possible randomized
controlled trials and 71 were controlled clinical trials. The methodological
quality of included trials was generally "poor." Few trials reported methods of
randomization. Three trials were randomized, double blind, and
placebo-controlled. Primary outcomes: one trial on Puerarin and one trial on
Shenmai injection assessed death or dependency at the end of long-term follow-up
(at least 3 months) and found no statistically significant difference between 2
groups. The reported adverse events including allergic reaction, headache,
nausea, diarrhea, bellyache, blood pressure change, and subcutaneous ecchymosis.
Most of the adverse events were not severe. Secondary outcomes: analysis of the
secondary outcome, "marked improvement in neurological deficit," showed apparent
benefits of about the same magnitude for all the TCPM studied. Of the 22 TCPM, 8
drugs (Milk vetch, Mailuoning, Ginkgo biloba, Ligustrazine, Danshen agents,
Xuesetong, Puerarin, and Acanthopanax) had relatively more studies and patient
numbers. CONCLUSIONS: There was insufficient good quality evidence on the
effects of TCPM in ischemic stroke on the primary outcome (death or dependency).
We considered the apparent benefit on neurological impairment was as likely to
be attributable to bias from poor methodology as to a real treatment effect.
However, because the agents assessed appeared potentially beneficial and
nontoxic, further randomized controlled trials are justified. Eight drugs could
be further research priorities.
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