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.
Objective To assess the effectiveness and safety of fructose 1,6-diphosphate （FDP） in the treatment of hypoxic ischemic encephalopathy （HIE）patients. Methods Biomedical databases, including MEDLINE （1977 -2004 ）, EMBASE（1989- 2004） ,Cochrane Injuries Group trials register, Cochrane Controlled Trials Register, CBMdisk and CNKI （1994- 2005 ）were searched. Chnical trials were collecte＆Quality assessments of chnical trials were carried out. Randomized controlled trials （RCTs） with mortality and the incidence of cerebral palsy, epilepsy and mental defect were selected for meta-analysis. Results Nine RCTs were included, and all were done in China. None of the 9 RCTs described the method of randomization or allocation concealment. None of the 9 RCTs mentioned wether blindness was use＆ In Jadad score, 5 trials were scored by 2 and 4 trials were 1. Seven trials were included in the meta-analysis of death, which showed that the obsolute risk （OR） [95% confidence interval （CI）] of death following FDP administration was 0. 50 （95% CI 0. 21 to 1.16）. Five RCTs reported the results of follow-up. When intention to treat （ITT） analysis was adopted, the OR of FDP on cerebral palsy was 0. 36 （95% CI 0. 19 to 0. 89）, on epilepsy was 0.74 （95% CI 0. 29 to 1.88）, and on dementia was 0. 21 （95% CI 0. 06 to 0.70）. We didn＇t conduct sensitivity analysis because no RCTs were of high quality. We didn＇t identify clinical trials compared with adverse reactions between the two groups. Conclusions The quality of RCTs on FDP for HIE is poor. Because there were no RCTs of high quality available, we can＇t draw a conlusion. Well-designed RCTs with economic evaluation are urgently needed to evaluate the value of FDP in the treatment of HIE.