1,6-二磷酸果糖注射液(瑞安吉)治疗急性脑梗死的多中心、随机、双盲、安慰剂对照临床研究

The clinical efficacy and safety of fructose-1,6-diphosphate (Ruianji) in treating acute cerebral infarction

目的评价1,6-二磷酸果糖注射液(FDP)治疗急性缺血性卒中的临床有效性及安全性。方法多中心、随机、双盲、安慰剂对照研究。症状发生在72h以内的颈内动脉系统的急性脑梗死患者,被随机分配至FDP或安慰剂2个治疗组,治疗10d。除研究用药外,两组均同时应用治疗急性脑梗死常用的药物。有效性终点为治疗11d及21d时的卒中神经功能缺损评分。安全性及耐受性评价指标为实验室检查、不良事件发生率及病死率。结果自2001年11月至2002年7月在4个中心共入选200例患者,FDP组101例,安慰剂组99例。治疗11d时两组神经功能缺损评分差异无显著性(P=0.062)。21d时FDP治疗组神经功能改善优于安慰剂组(P=0.0438)。FDP组除5例发生注射部位相关的疼痛外,无其他不良反应发生。结论初步研究结果显示:FDP治疗症状发生在72h以内的急性脑梗死是有效安全的药物。

Objective To study the efficacy and safety of fructose-1,6-diphosphate （FDP） in treatment of acute cerebral infarction. Methods A multicenter, randomized, double-blind, placebo-controlled study was carried ont. The patients with acute cerebral infarction within 72 hours of onset of symptoms were randomly allocated to receive either FDP or placebo treatment for 10 days. The routine treatment for acute cerebral infarction was used simultaneously in both FDP and placebo groups in addition to the trial agents. The efficacy end points were Chinese Stoke Neurological Functional Deficits Scale （CSNFDS） Score on days 11 and 21. The variables of safety and tolerance were laboratory test, adverse reaction and mortality. Results A total of 200 patients were enrolled at 4 centers from November 2001 to July 2002, and 101patients were randomly assigned to receive FDP and 99 to receive placebo. There was no significant difference in CSNFDS Score between two groups on day 11, but much greater proportion of improvement in neurological function on day 21 was seen in FDP group than in placebo group （ P = 0. 0438）. No severe adverse reactions were observed except injection related pain in 5 patients. Conclnsion The present study showed that FDP was effective and safe with a good tolerance in treatment of acute cerebral infarction within 72 hours of onset of symptoms.