【摘要】 为确定马普替林治疗抑郁症的疗效及其耐受性,以抗抑郁药阿米替林为对照进行了由5个单位参加的多中心随机双盲对照试验.共226例病人纳入,马普替林(MT)组117例,阿米替林(AT)组109例.经6周治疗,结果显示两组疗效近似.HDS平均减分率在MT组为80%,AT组为85%;中、重度不良反应的发生率AT组为28%,高于MT组的15%.文章较为详细地讨论了多中心新药临床验证的有关问题.更多还原

【Abstract】 Two hundred and twenty six cases suffering from moderately of severly depressive illness were involved in the double-blind randomised, multicenter comparative clinical trail. The patients were divided into Maprotiline (MT) group(117) and Amitriptyline (AT) group(109). They were assessed with HDS and TESS at days 0, 7, 11, 21 , 28 and 42 for the efficacy and adverse effects. The dose was increased by 25mg/d to 75mg/d on day 3. The doses of poor responders were increased to 150mg/d at day 14 and maintained till the end of study. The results showed that Maprotiline and Amitriptyline produced similar improvement. Both declined rates of HDS of MT group and AT group were 80% and 85% respectively. The number of reported moderate and severe adverse effects in the AT group(28%) was higher than in MT group(15%).更多还原