吗氯贝胺治疗抑郁症双盲对照和开放研究

A DOUBLE-BLIND CONTROLLED AND OPEN TRIAL ON THE EFFICACY OF MOCLOBEMIDE IN TREATMENT OF DEPRESSIONS

目的 :探讨国产吗氯贝胺的抗抑郁疗效和安全性。方法 :以抗抑郁药阿米替林为对照 ,进行吗氯贝胺双盲对照和开放性研究。采用汉密尔顿抑郁量表、汉密尔顿焦虑量表、临床大体印象量表、不良反应量表于治疗前、治疗后每周各评定 1次疗效和不良反应 ,并进行相应的体格检查 (包括卧、立位血压 )和化验室检查。结果 :全部入选病例 (抑郁症 99例 ,抑郁性神经症 47例 ,其中双盲对照各 30例 ,开放治疗 86例 )均完成了 4周临床试验 ,完成 6周和 8周试验的病例分别为 142和 12 8例。量表评分和临床评价均表明吗氯贝胺抗抑郁疗效肯定且见效快 ,研究组、对照组及开放组在治疗第 4,6 ,8周时的显效率分别是 46 .7% ,5 3.3 % ,46 .5 % ;86 .2 % ,88.9% ,75 .3% ;89.7% ,82 .6 % ,85 .3%。三组间无显著性差异 (P >0 .0 5 )。吗氯贝胺还显示出抗焦虑作用。吗氯贝胺的不良反应明显轻于阿米替林 ,对肝、肾功能和血压无明显影响。结论

OBJECTIVE:To investigate the clinical efficacy and safety of moclobemide.METHODS:Totally 146 patients were recruited into the study.30 were randomized to blind moclobemide group,30 to blind amitriptyline group,and 86 to moclobemide open group. After 4 weeks treatment the therapeutic effects were rated weekly by HDRS(Hamilton Depression Rating Scale),HARS(Hamilton Anxiety Rating Scale),CGI(Clinical Global Impresssion),and TESS (Treatment Emergent Symptom Scale).RESULTS:The effective rate for blind moclobemide group,blind amitriptyline group,and open moclobemide group were 46.4%,53.3%,46.5%(4 weeks);86.2%,88.9%,75.3%(8 weeks);and 89.7%,82.6%,85.3%(8 weeks)respectively. No significant difference was observed between moclobemide and amitriptyline groups and fewer side effect with moclobemide group. CONCLUSION:The efficacy of domestic moclobemide has been confirmed by this study with mild and fewer side effects.