摘要
目的:评价国产Ⅱ类新药扎莱普隆治疗失眠症的有效性和安全性。方法:采用多中心随机双盲双模拟、阳性药平行对照的方法。受试者分别口服扎莱普隆胶囊5mg^10mg·d-1或佐匹克隆片7.5mg^15mg·d-1。疗程14d。结果:意向性(ITT)分析样本患者234例,其中扎莱普隆组115例,佐匹克隆组119例。两组的睡眠障碍量表(SDRS)及 Hamilton焦虑量表(HAMA)评分在治疗结束时均较基线显著减少(P＜0.01)。有效率扎莱普隆为67.8%,佐匹克隆为71.4%,无显著性差异。两组常见药物不良反应为嗜睡、口干、头晕、头痛及厌食。但扎莱普隆的嗜睡与厌食发生率显著少于佐匹克隆(P＜0.05)。结论:扎莱普隆与佐匹克隆具有类似的疗效,药物不良反应相对较佐匹克隆要少。为治疗睡眠障碍的安全而有效的新药。
OBJECTIVE:TO evaluate the efficacy and safety of new agent zaleplonin treatment of insomnia. METHODS: A multicenter,randomized and double-blind controlled clinical trial was conducted for treating insomnia, the testgroup was given with zaleplon 5mg^l0mg.d-1and the control group given withzopicolone 7.5mg^l5mg.d-1 during l4 days treatment period. RESULTS: 234cases with insomnia were enrolled by intention-to-treat analysis, of which ll5cases were in the test group and ll9 cases in the control group. The scores ofsleep dysfunction rating scale and Hamilton anxiety rating scale in endpointwere significantly reduced comparison with baseline in both groups(P<0.0l).The effcacy rates of test and control group were 67.8% and 7l.4% respectively,there was no significant difference between two groups(P>0.05). The commonadverse reactions of both groups were drowsiness, dry mouth, headache andloss of appetite, but the incidence of drowsiness and loss of appetite in testgroup were less than in control group(P<0.05).CONCLUSION.Zaleplon hassimilar efficacy and less side effects compared with zopiclone,it is an effectiveand safe new agent for treatment insomnia.
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2002年第2期87-89,共3页
The Chinese Journal of Clinical Pharmacology
