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奥匹哌醇治疗更年期综合征。一项双盲、安慰剂对照试验。

Opipramol in the climacteric syndrome. A double-blind, placebo-controlled trial.

作者信息

van Lith N D, Motké J C

出版信息

Maturitas. 1983 Jun;5(1):17-23. doi: 10.1016/0378-5122(83)90017-8.

DOI:10.1016/0378-5122(83)90017-8
PMID:6348485
Abstract

In a double-blind trial, 48 women suffering from post-menopausal complaints were randomly allocated to an 8-wk course of treatment with opipramol (50 mg sugar-coated tablets) or an identical placebo. Autonomic nervous system instability (7 target symptoms) and depression (10 target symptoms) were scored at the beginning of the trial and after 1, 2, 4, 6 and 8 wk and a final assessment was made at the end of the trial. A daily record of hot flushes was kept by the patients. Opipramol brought about an approximately 50% reduction in the symptoms, but a considerable placebo effect was noticed also. It was found that opipramol treatment was significantly better than placebo treatment (P less than 0.01) in reducing hot flushes after 2 mth of therapy. The symptoms of depression were significantly reduced in the opipramol group, as compared with the placebo group. No significant reduction could be seen in the vasomotor symptoms. The final assessment at the end of the trial period showed a significant difference (P less than 0.05) in favour of opipramol.

摘要

在一项双盲试验中,48名患有绝经后不适症状的女性被随机分配,接受为期8周的奥匹哌醇(50毫克糖衣片)治疗或相同的安慰剂治疗。在试验开始时、第1、2、4、6和8周后,对自主神经系统不稳定(7项目标症状)和抑郁(10项目标症状)进行评分,并在试验结束时进行最终评估。患者每天记录潮热情况。奥匹哌醇使症状减轻了约50%,但也注意到有相当大的安慰剂效应。结果发现,治疗2个月后,奥匹哌醇治疗在减轻潮热方面明显优于安慰剂治疗(P<0.01)。与安慰剂组相比,奥匹哌醇组的抑郁症状明显减轻。血管舒缩症状未见明显减轻。试验期结束时的最终评估显示,奥匹哌醇具有显著差异(P<0.05)。

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