吗氯贝胺治疗抑郁症安全有效性的双盲和开放试验

The safety and efficacy of moclobemide in a double-blind, open trial for depressed patients

目的评价吗氯贝胺的抗抑郁疗效和不良反应。方法选用丙米嗪作为对照药，进行多中心的随机双盲对照和开放试验，对共３９６例抑郁症患者（双盲丙米嗪组９６例、双盲吗氯贝胺组１０２例和开放吗氯贝胺组１９８例）作为期４周的治疗。采用汉密尔顿抑郁量表（ＨＡＭＤ）和临床总体印象量表于每周评定１次疗效。采用治疗中的不良反应量表每周评定１次和实验室检查每２周１次评定不良反应。结果吗氯贝胺的抗抑郁疗效与丙米嗪相似，三组的ＨＡＭＤ减分率分别为７１．７％、７５．４％和６８．１％（Ｐ＞０．０５）。显效率分别为７７．０％、８３．３％和７０．７％（Ｐ＞０．０５）。吗氯贝胺的抗胆碱能不良反应明显少于丙米嗪（Ｐ＜０．０５），对血压和肝肾功能也无明显不良影响，治疗抑郁症的有效剂量为３００～６００ｍｇ／ｄ。结论提示吗氯贝胺是一种有效。

Objective This study evaluated the efficacy and safety of moclobemide (MCL). Methods A multicenter, randomized, doubleblind and open trial was designed. MCL was compared with imipramine (IMI) for 4 weeks in the treatment of depressed patients. The therapeutic effects were weekly rated by Hamilton depressive scale (HAMD) and clinical global impressions scale, and adverse reactions were weekly assessed by the treatment emergent symptoms scale and related laboratory tests once two weeks. Total sample of 396 depressed patients treated for four weeks including blindIMI group 96 cases, blindMCL group 102 cases and openMCL group 198 cases, respectively. Results No difference in the treatment response was found between MIL and IMI, the decreased score rates of HAMD among three groups of blindIMI, blindMCL and openMCL were 71.7%, 75.4% and 68.1% (P<0.05), the marked improvement rates of three groups were 77.0%, 83.3% and 70.7%, respectively (P>0.05). MCL produced fewer anticholinergic side effects than IMI and no toxic effect on blood pressure and functions of liver and kidney was observed. The optimal dose of MCL ranged from 300 to 600 mg/day. Conclusion It is suggested that MCL may be a novel, safe and effective antidepressant.