脑苷肌肽治疗急性缺血性脑卒中对照试验评价

Systematic Review of Cerebroside Carnosine for Acute Ischemic Stroke

目的:系统评价脑苷肌肽治疗急性缺血性卒中的疗效与安全性。方法:计算机检索MEDLINE、Cochrane图书馆、中国生物医学文献数据库、中文科技期刊全文数据库、万方数据库和维普医药信息资源系统,全面收集国内外发表的脑苷肌肽用于急性缺血性卒中治疗的随机和半随机对照试验,按Cochrane系统评价方法,评价纳入研究的方法学质量并提取有效数据进行Meta分析。结果:共纳入了14个RCTs,1 524例急性缺血性脑卒中患者。其中只有2项研究质量评分为B级,其他均为C级。对提供神经功能缺损改善率的10项研究和3个月随访的2项研究进行Meta分析显示,脑苷肌肽可明显改善急性缺血性脑卒中患者的神经功能缺损,分别为[0R3.62, 95%CI(2.52,5.19)]和[OR2.38,95%CI(1.28,4.40)],NIHSS评分和ESS评分结果均表明治疗组疗效优于对照组,分别为[WMD-3.22,95%CI(-3.60,-2.84)]和[WMD 17.64,95%CI(11.37,33.90)]。日常生活活动能力评分比较的Meta分析,结果表明治疗组优于对照组[WMD14.43,95%CI(0.16,28.69)]。结论:脑苷肌肽可能有助于改善急性缺血性卒中患者的神经功能缺损,但对远期生存率、残疾率的影响尚不清楚。仍需高质量、大样本、长期随访的随机对照试验进一步证实其有效性和安全性。

Objective： To assess the efficacy and safety of cerebroside carnosine for acute ischemic stroke. Method： Searches were performed in the MEDLINE,.Cochrane library, CBM, CNKI, Wanfang and VMIS up to 2007. Randomized controlled trials （RCTs） or quasi- randomized controlled trials were collected. The quality of the studies Was assessed and the meta-analysis was conducted according to the methods of Cochrane Collaboration＇s RevMan 4.2. Result： 14 RCTs and 1 524 cases of acute ischemic stroke were included, only 2 were graded as high quality, and the others were graded as low quality. The meta-analysis of 10 trials involving the improvement of neurological deficit and 2 follow-up trials in 3 monthes indicated that the cerebroside carnosine could improve neurologic impairmenst significantly, [ OR3.62,95% CI （2.52,5.19） ] and [ OR2.38,95% CI（1.28,4.40） ] respectively. The meta-analysis of all the scores of NIHSS and ESS indicated that the cerebroside camosine was more effective than those in the controlled group, [ WMD - 3.22,95% CI （ - 3.60, - 2.84） ] and [ WMD17.64,95% CI（11. 37,33. 90） ] respectively. The meta-analysis of the scores of ADL also indicated that the treatment group had an advantage, [ WMD14. 43 ,95% CI （0.16,28.69） ]. Conclusion： The cerebroside camosine might improve the neurological deficit of patients with acute ischemic stroke, but seem unlikely to the long-term survival rate and disability rate. A high quality,large sample and long term randomized controlled follow-up trials are needed to evaluate the role of cerebroside camosine for acute ischemic stroke.