摘要
目的:评价国产二类新药扎来普隆治疗失眠症的临床疗效及安全性。方法:采用随机、双盲双模拟、平行对照方法。受试者分别每晚口服扎来普隆或唑吡坦10～20mg,疗程14d。结果:扎来普隆组24例,唑吡坦组23例,两组治疗后的睡眠障碍评定量表评分(SDRS)均较治疗前显著降低,两组间SDRS总分(F=0.1416,P=0.8880)、SDRS下降率(F=1.3172,P=0.1944)差异均无显著性意义。治疗总有效率分别为扎来普隆组72%,唑吡坦组58%,两组差异无显著性意义(χ2=0.9150,P=0.3602)。两组的不良反应主要有头昏、恶心、头痛,发生率差异无显著性意义。结论:扎来普隆可明显改善失眠症状,其疗效及不良反应与唑吡坦相似,是一种安全、有效的治疗成人失眠的药物。
AIM:To evaluate the clinical effect and safety of domestic new medicine zaleplon in the treatment of insomnia. METHODS:It was a randomized,double blind,double model,parallel controlled clinical trial.Patients were given zaleplon or zolpidem(StiLnox) 10-20 mg per day,with the treatment course of 14 days. RESULTS:A total of 24 patients were in zaleplon group,and 23 in zolpidem group.The scores of sleep dysfunction rating scale(SDRS) after treatment were significantly reduced as compared with those before treatment.The total scores of SDRS(F=0.141 6,P=0.888 0)and the rate of score reductions(F=1.317 2,P=0.194 4)of both groups had no remarkable difference.The total efficient rate of zaleplon and zolpidem group was 72%and 58%respectively(χ2=0.915 0,P=0.360 2).There was no significant difference between the two groups.The main adverse reactions of both groups were dizziness,nausea and headache,and the occurrence rate had no significant difference. CONCLUSION:Zaleplon can ameliorate insomnia,with the similar effect and adverse reaction with zolpidem.It is an effective and safe new agent for treatment of adult insomnia.
出处
《中国临床康复》
CSCD
2004年第18期3488-3490,共3页
Chinese Journal of Clinical Rehabilitation
