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恩西拉嗪治疗广泛性焦虑症的安慰剂对照研究:初步报告。

A placebo-controlled study of enciprazine in the treatment of generalized anxiety disorder: a preliminary report.

作者信息

Schweizer E, Rickels K, Csanalosi I, London J, Turner D

机构信息

Psychopharmacology Research Unit, University of Pennsylvania, Philadelphia 19104.

出版信息

Psychopharmacol Bull. 1990;26(2):215-7.

PMID:2236459
Abstract

Enciprazine is a propanolamine derivative with a preclinical profile similar to buspirone but with less affinity for the postsynaptic dopamine receptor (Linden et al. 1988). We report on the outcome, using intent-to-treat data, of a 5-week, double-blind trial comparing three dose strengths of enciprazine (5 mg t.i.d., 10 mg t.i.d., and 20 mg t.i.d.) to placebo. A dose escalation was permitted after 2 weeks of active drug treatment, which 61 percent of patients overall took advantage of. A "last observation carried forward" (LOCF) analysis found a mean improvement in Hamilton Anxiety Scale (HAM-A) scores by Week 5 of -11.0 for the combined enciprazine treatment groups, and -4.4 for the placebo group (p less than .05). Fifty-two percent of enciprazine patients were judged to be "much" or "very much" improved, whereas none of the placebo patients were judged to have comparable improvement. Enciprazine was well-tolerated, with low levels of sedative and asthenic side effects reported. The compound appears to have promise as an anxiolytic agent.

摘要

恩西拉嗪是一种丙醇胺衍生物,其临床前特征与丁螺环酮相似,但对突触后多巴胺受体的亲和力较低(林登等人,1988年)。我们报告了一项为期5周的双盲试验的结果,该试验使用意向性治疗数据,将三种剂量强度的恩西拉嗪(每日三次,每次5毫克、10毫克和20毫克)与安慰剂进行比较。在积极药物治疗2周后允许剂量递增,总体上61%的患者利用了这一点。“末次观察结转”(LOCF)分析发现,恩西拉嗪联合治疗组在第5周时汉密尔顿焦虑量表(HAM-A)评分的平均改善为-11.0,安慰剂组为-4.4(p<0.05)。52%的恩西拉嗪患者被判定“显著”或“非常显著”改善,而安慰剂组患者均未被判定有类似改善。恩西拉嗪耐受性良好,报告的镇静和乏力副作用水平较低。该化合物似乎有望成为一种抗焦虑药物。

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