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南非进行的一项关于帕罗西汀治疗社交恐惧症(社交焦虑症)的双盲安慰剂对照试验。

A double-blind placebo-controlled trial of paroxetine in the management of social phobia (social anxiety disorder) in South Africa.

作者信息

Stein D J, Berk M, Els C, Emsley R A, Gittelson L, Wilson D, Oakes R, Hunter B

机构信息

Department of Psychiatry, University of Stellenbosch, Tygerberg, W Cape.

出版信息

S Afr Med J. 1999 Apr;89(4):402-6.

PMID:10341825
Abstract

BACKGROUND

Social phobia, also known as social anxiety disorder, is a highly prevalent disorder with significant morbidity. Patients with social phobia frequently develop co-morbid psychiatric disorders such as depression and substance abuse, and the disorder impacts significantly on social and occupational functioning. It has been suggested that the selective serotonin reuptake inhibitors (SSRIs) are useful in the management of this disorder, but few controlled trials have been undertaken in this regard. There are also few data on the pharmacotherapy of social phobia in South Africa.

METHODS

A double-blind randomised placebo-controlled multi-site flexible-dose trial of paroxetine was undertaken over 12 weeks among patients with a primary diagnosis of social phobia. Primary response measures were the Global Improvement item on the Clinical Global Impression scale (CGI) and mean change from baseline in the patient-rated Liebowitz Social Anxiety Scale (LSAS) total score. Ninety-three patients participated at 9 South African sites; their data are reported here.

RESULTS

There was a significant drug effect on both the CGI Global Improvement score and the LSAS at 12 weeks. In addition, there was no significant difference in overall rate of adverse experiences between those on paroxetine and those on placebo.

CONCLUSIONS

Paroxetine is both effective and safe in the acute treatment of social phobia. The findings here are consistent with those of previous controlled studies of the SSRIs as well as with previous work done in the USA on the use of paroxetine in the treatment of this disorder. Early diagnosis and treatment of social phobia should be encouraged. However, further research on long-term pharmacotherapy of social phobia is needed.

摘要

背景

社交恐惧症,也称为社交焦虑障碍,是一种高发性疾病,发病率很高。社交恐惧症患者经常并发其他精神疾病,如抑郁症和药物滥用,该疾病对社交和职业功能有重大影响。有人认为选择性5-羟色胺再摄取抑制剂(SSRI)对治疗这种疾病有用,但在这方面进行的对照试验很少。关于南非社交恐惧症药物治疗的数据也很少。

方法

对初步诊断为社交恐惧症的患者进行了一项为期12周的双盲随机安慰剂对照多中心灵活剂量帕罗西汀试验。主要反应指标是临床总体印象量表(CGI)上的总体改善项目以及患者自评的利博维茨社交焦虑量表(LSAS)总分相对于基线的平均变化。93名患者参与了南非9个地点的试验;这里报告了他们的数据。

结果

在12周时,药物对CGI总体改善评分和LSAS均有显著效果。此外,服用帕罗西汀的患者与服用安慰剂的患者在不良经历总体发生率上没有显著差异。

结论

帕罗西汀在社交恐惧症的急性治疗中既有效又安全。此处的研究结果与先前关于SSRI的对照研究结果以及美国先前使用帕罗西汀治疗该疾病的研究结果一致。应鼓励对社交恐惧症进行早期诊断和治疗。然而,需要对社交恐惧症的长期药物治疗进行进一步研究。

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