果糖二磷酸钠治疗急性脑梗死的系统评价

Fructose-1,6 Diphosphate for Cerebral Infarction:A Systematic Review

目的评价果糖二磷酸钠(fructose-1,6 diphosphate,FDP)治疗急性脑梗死的疗效与安全性。方法检索MEDLINE、EMbase、Cochrane系统评价和临床试验数据库、中国生物医学文献光盘数据库、中国期刊全文数据库,收集FDP治疗急性脑梗死的随机或半随机对照试验。所有检索均截至2006年。对纳入研究进行质量评价,并用RevMan 4．2软件进行Meta分析。结果共纳入10个随机对照试验,均为中文,其中9个试验质量评分为C级,1个试验质量评分为A级。所有研究均未对远期效果进行评价。在近期疗效上,8个研究的合并分析显示,FDP可明显改善急性脑梗死患者的神经功能缺损[OR 2．55,95%CI(1．74, 3．74)]。在治疗期间的病死率方面,7个研究的Meta分析显示,FDP组与对照组差异无统计学意义[RD-0．01,95%CI(-0．03,0．01)]。1个研究评价了肌力改善的情况,结果显示FDP组患者肌力改善的比例高于对照组[OR 4．69,95%CI (1．55,1 4．24)]。1个研究结局指标为欧洲卒中量表评分,经治疗后FDP组评分高于对照组[WMD 10．23,95%CI(4．13,16．33)]。1个研究发现FDP组和对照组的安全性差异无统计学意义[OR 1．24,95%CI(0．32,4．75)]。未检索到评价FDP用于急性脑梗死的经济学研究。结论FDP在短期内可能有助于改善急性脑梗死患者的神经功能缺损,但对近期病死率的影响与对照组无差异,对远期生存率、依赖率和神经功能缺损的影响尚不清楚。因此FDP在急性脑梗死中的应用仍需要进行大规模、高质量、随访时间足够的随机对照研究提供证据。

Objective To assess the efficacy and safety of fructose-1,6 diphosphate （FDP） in the treatment of cerebral infarction. Methods We searched MEDLINE, EMbase, Cochrane CENTRAL Register of Controlled Trials, CBM and CNKI in 2006. Randomized controlled trials（RCTs） or quasi-randomized controlled trials involving FDP for cerebral infarction were collected. We assessed the quality of the studies and conducted meta-analyse with The Cochrane Collaboration＇ s RevMan 4.2. Results Ten RCTs were included, 9 of which were of low quality and only one was graded as high quality. None of the trials reported the number of patients who had died or were dependent at the end of long term follow-up. After 7 to 30 days of treatment, improvement of neurological deficiency was associated with FDP compared with placebo or control [OR 2.45, 95%CI （1.91,3.15）]. There was no statistical difference in the death rate between the FDP and control groups at the end of the treatment [RD-0.01, 95%CI （-0.03,0.01）]. One study found that FDP had a similar safety profile [OR 1.24, 95%CI （0.32,4.75）] to the control group. None of the trials compared the costs in the treatment groups. Conclusions The quality of the published clinical trials on FDP in the treatment of cerebral infarction is poor. FDP may improve short-term neurological deficits, but seems unlikely to decrease mortality. Moreover, we found no evidence to support the long-term efficacy of FDP on mortality, dependency and neurological deficit. Large-scale and high quality clinical trials with sufficient follow-ups are needed to evaluate the role of FDP in the treatment of cerebral infarction.