复方地西泮与地西泮抗焦虑的多中心双盲对照研究

为比较复方地西泮片与地西泮片的镇静、催眠、抗焦虑效果及安全性，对２０６例病例随机入组，疗程３周。结果：（１）用复方地西泮治疗可明显减少地西泮用量，疗效更好；（２）观察组（复方地西泮片）总有效率５０．４％，显著高于对照组（地西泮片）的２２．８％；（３）汉米尔顿焦虑量表（ＨＡＭＡ）及抑郁量表（ＨＡＭＤ）总分于治疗后均明显减低，观察组的减分幅度显著大于对照组；（４）ＨＡＭＡ和ＨＡＭＤ混合因子分析结果显示，两药均可改善睡眠障碍、焦虑、抑郁心境、植物神经及全身症状，复方地西泮片对前二组症状的疗效显著优于地西泮片；（５）不良反应量表记录两组治疗不良反应均轻微，且发生率低。观察组偶见倦、头痛等，均不影响治疗。提示复方地西泮片是一种安全、有效的抗焦虑新药。

A multicentre double blind control study between diazepam co. and diazepam in patients with anxiety

In order to compare the anti anxious efficacy and the tolerability between diazepam co. and diazepam in neurotic patients with anxiety, we designed a 3 week randomized, double blind multicentre trail on 206 in and out patients. The symptoms of the patients were assessed with Hamilton Rating Scale for Anxiety (HAMA) and Hamilton Rating Scale for Depression (HAMD), and the side effects of the medications were assessed with Treatment Emergent Symptoms Scale (TESS). The results showed that:(1) The dose of diazepam has been significantly reduced in diazepam co. group; (2) After 3 weeks treatment, the response rate of the patients to diazepam co. and diazepam were 50.4% and 22.8%, respectively, and the difference was statistically significant; (3) The HAMA and HAMD scores were significantly reduced in both groups, the reduction in diazepam co. group was significantly greater than that in diazepam group; (4) It was shown by factor analysis that both of the medications could improve sleep disturbance, anxiety, depressed mood, autonomic as well as general symptoms, while diazepam co. showed favorable results on the first two symptoms; (5) According to the score of TESS, both medications showed only slight adverse effects and with low frequency. Patients taken diazepam co. showed drowsiness, headache, etc. occasionally and did not interfere the treatment process. The results indicate that diazepam co. is a safe and efficacious anxiolytic drug.