Meta analysis on cinepazide maleate in treatment of diabetic peripheral neuropath
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摘要: 目的 对马来酸桂哌齐特治疗糖尿病周围神经病变(DPN)的疗效和安全性进行系统评价。 方法 检索Medline(1977~2011.11)、CNKI(1994~2011.11)、万方(1989~2011.11)、VIP(1989~2011.11)等数据库,收集有关马来酸桂哌齐特治疗糖尿病周围神经病变的随机临床对照试验研究(RCT)。通过文献质量评价,对纳入文献进行Meta分析。 结果 有11个试验982例患者纳入分析,纳入研究的文献经质量评价,均为C级。Meta分析显示:1有效率:马来酸桂哌齐特明显高于对照组,合并效应量OR及95%CI为5.91[3.71,9.43](P< 0.000 01)2神经功能改善:腓神经SNCV合并效应值WMD=2.52,95%CI(1.92,3.13);腓神经MNCV合并效应值WMD=3.07,95%CI(1.59,4.55);正中神经MNCV合并效应值WMD=3.97,95%CI(1.87,6.07);正中神经SNCV合并效应值WMD=2.94,95%CI(1.43,4.46);以上效应值均明显高于对照组;3不良反应:主要表现为轻度头痛、头晕、消化道不适。 结论 马来酸桂哌齐特治疗DPN可能有一定疗效,但由于尚缺乏高质量的RCT证据支持,马来酸桂哌齐特治疗DPN尚不能作出最后结论,还需进行更多高质量的 RCT才能得出肯定性结论。Abstract: Objective To assess the efficacy and safety of Cinepazide Maleate(CPZD) in the treatment of diabetic peripheral neuropath(DPN),with evidence-based medicine methods. Methods By retrieving related database,such as Medline(1977~2011.11), CNKI(1994~2011.11), WANFANG(1989~2011.11), VIP(1989~2011.11), the randomized controlled trials on DPN treatment by CPZD were included and analyzed according to the inclusion criteria.Meta analysis was used in this study. Results There were 982 cases of 11 trials were included in the analysis, the methodological quality of all studies included were rated as C-class. Meta-analysis showed that: 1Efficient: CPZD group was significantly higher than control group[OR and 95% CI=4.33 (2.45,7.66)]2Improvement of neurological function: The combined effect size of common peroneal nerve(CPN) SNCV and MNCV, median nerve(MN) SNCV and MNCV were as follows, CPN-SNCV:WMD=2.52,95%CI(1.92,3.13);CPN-MNCV:WMD=3.07,95%CI(1.59,4.55);MN-MNCV: WMD=3.97,95%CI(1.87,6.07);MN-SNCV:WMD=2.94,95%CI(1.43,4.46), the above-mentioned value were significantly higher than control group. 3Adverse reactions were less, mainly showed mild headache, dizziness, gastrointestinal discomfort. Conclusions Cinepazide Maleate might have positive effect on DPN. However,the evidence was not strong enough due to the general low methodological quality.A reliable conclusion about the effects of CPZD on DPN could not be summarized at the moment. Further large high-quality randomized controlled trials should be done.
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