氟马西尼治疗肝硬化并发肝性脑病的随机双盲研究  

Flumazenil in the treatment of cirrhotic patients with hepatic encephalopathy:A randomized doubled-blind clinical trial

作　　者：朱畴文[1] 王吉燿 刘天舒[1] 

机构地区：[1]上海医科大学中山医院,200032

出　　处：《中华消化杂志》1998年第6期355-358,共4页Chinese Journal of Digestion

摘　　要：目的为评价氟马西尼治疗肝硬化患者肝性脑病(HE)的临床疗效,观察其快速改善意识状态的能力以及对患者的脑病病程的影响。方法这是一项随机双盲对照临床试验(RCT),选择符合纳入标准的 HE2～4级的肝硬化患者共25例,随机分配入治疗组13例和对照组12例。在重点观察阶段(IOP,2.5小时),两组患者分别接受氟马西尼(1mg,静脉注射)和等量的生理盐水,并全部随访至出院或在院内死亡时。所有患者自试验治疗开始时均给予常规治疗。结果治疗组的3例呈有效反应,即在 IOP 内 HE 分级由原2～4级改善并维持在0～1级,对照组无1例有如此反应,但两组差异无显著性(P=0.124),把握度仅56%。另外,8例治疗组和1例对照组患者呈阳性反应,即 HE 分级在 IOP 内曾有所改善,两组差异有显著性(P=0.008)。这些阳性反应发生与否与初始 HE 分级或肝功能无关,且始发在20分钟之内,但在 IOP 内并不保持稳定。大多数患者在试验治疗的第2至5灭内回复正常的意识水平。两组的死亡率(治疗组3例,对照组5例)比较,差异无显著性。结论与安慰剂相比,氟马西尼并不能有效地改善 HE 的临床级别,但能在约63%的发生 HE 的肝硬化患者中,引出快速但不稳定的阳性反应。Objective To assess the therapeutic effectiveness of flumazenil in terms of the rapid improvement of mental status of cirrhotic patients with hepatic encephalopathy(HE) and the impact of this drug on the changes of clinical course. Methods In this randomized double-blind controlled clinical trial (RCT) conducted in Zhongshan Hospital,25 consecutive cirrhotic patients with HE of clinical staging of 2 to 4 (Conn's 5-stage grading),diagnosed by clinical,biochemical,histological and psychometric methods,were randomly allocated to treatment(n=13) and control group (n=12).Patients received 1.0mg flumazenil by bolus intravenous injection and normal saline as placebo,respectively,during the observation period (2.5 hours) and followed-up till discharge or death in the ward.All patients received the conventional therapy for HE since the commencement of the trial.Results There was no significant difference (P=0.124,power=56%) between the 2 groups in terms of the response which was defined as improvement of clinical staging of HE mainained at Grade 0 or 1 during the observation period(3 in treated group and none in controls).However,there were 8 and i favorable positive responses in treatment and control group respectively,with the pvalue of 0.008.Most positive changes initiated within 20 minutes but were not maintained throughout the observation period.Most patients regained their consciousness on the 2nd to 5th day of the trial. There was no statistical difference in the death rate between the 2 groups (3 in treatment group and 5 in controls).Conclusion Comparing with placebo, flumazenil dose not improve the clinical staging of HE effectively,but can induce a rapid but unstable positive responses in 63% cirrhotic patients.

关 键 词：肝性脑病 氟马西尼 肝硬化 治疗 

分 类 号：R747.905[医药卫生—神经病学与精神病学] R575.206[医药卫生—临床医学]