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溴西泮、阿米替林与安慰剂治疗焦虑抑郁性神经症的对照比较

Controlled comparison of bromazepam, amitriptyline, and placebo in anxiety-depressive neurosis.

作者信息

Shammas E

出版信息

Dis Nerv Syst. 1977 Mar;38(3):201-7.

PMID:13969
Abstract

Seventy-two private practice patients with moderate or severe anxiety-depressive neurosis received mean daily oral doses of 23.8 mg bromazepam, 94 mg amitriptyline, or 4.6 capsules of placebo in a double-blind four-week study. The patient's condition was assessed initially and at weekly intervals by using the Brief Psychiatric Rating Scale and the Hamilton Psychiatric Rating Scale for Depression. From the first through the fourth week evaluations, a larger proportion of patients improved on bromazepam than on amitriptyline. Bromazepam was also superior to amitriptyline and placebo in the degree of improvement made Statistical significance (p less than 0.05) of the changes noted after one week was even greater after four weeks, particularly in BPRS items of somatic concern, depressive mood, anxiety and tension and in nearly all representative psychic and somatic symptoms on the depression scale, confirmed by global evaluation. Compared to bromazepam patients, amitriptyline patients had significantly severer adverse reactions which were the major cause of the group's higher dropout rate (66% vs 33%). The prompt clinical response to bromazepam contributed to its superior safety and patient progress in that it was possible to carefully titrate dosage and thus help to control adverse reactions and allow patients to maintain alertness and productivity under therapy.

摘要

在一项为期四周的双盲研究中,72名患有中度或重度焦虑抑郁神经症的私人诊所患者,平均每日口服23.8毫克溴西泮、94毫克阿米替林或4.6粒安慰剂胶囊。通过使用简明精神病评定量表和汉密尔顿抑郁量表,在研究初始及每周对患者病情进行评估。从第一周到第四周的评估结果来看,服用溴西泮后病情改善的患者比例高于服用阿米替林的患者。在改善程度方面,溴西泮也优于阿米替林和安慰剂。一周后所记录变化的统计学显著性(p小于0.05)在四周后甚至更大,特别是在简明精神病评定量表中有关躯体关注、抑郁情绪、焦虑和紧张的项目以及抑郁量表上几乎所有代表性的精神和躯体症状方面,整体评估也证实了这一点。与服用溴西泮的患者相比,服用阿米替林的患者不良反应明显更严重,这也是该组更高退出率(66%对33%)的主要原因。溴西泮迅速的临床反应促成了其在安全性和患者病情进展方面的优势,因为可以仔细调整剂量,从而有助于控制不良反应,并使患者在治疗期间保持警觉和工作能力。

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