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一项关于西酞普兰治疗惊恐障碍的为期1年的对照性前瞻性试验。

A controlled, prospective, 1-year trial of citalopram in the treatment of panic disorder.

作者信息

Lepola U M, Wade A G, Leinonen E V, Koponen H J, Frazer J, Sjödin I, Penttinen J T, Pedersen T, Lehto H J

机构信息

Psychiatric Research Clinic of Kuopio and Universities of Helsinki, Finland.

出版信息

J Clin Psychiatry. 1998 Oct;59(10):528-34. doi: 10.4088/jcp.v59n1006.

Abstract

BACKGROUND

The objective of this study was to evaluate the efficacy and tolerability of citalopram in the long-term treatment of adult outpatients with panic disorder with or without agoraphobia.

METHOD

Patients in this double-blind, parallel-group trial were assigned to 1 of 3 fixed dosage ranges of citalopram (10 or 15 mg/day, 20 or 30 mg/day, or 40 or 60 mg/day), 1 dosage range of clomipramine (60 or 90 mg/day), or placebo. After the completed 8-week acute treatment period, the eligible patients could continue the treatment for up to 1 year. Of the 475 patients who were randomly assigned for the short-term trial, 279 agreed to continue double-blind treatment at their assigned doses. The primary efficacy measure used was the Clinical Anxiety Scale panic attack item, and the response was defined as no panic attacks (score of 0 or 1). The other key measures used were the Physician's Global Improvement Scale, the Patient's Global Improvement Scale, and the Hamilton Rating Scale for Anxiety (HAM-A).

RESULTS

In all drug-treated groups, except the group receiving the lowest citalopram dose, the treatment outcome was generally better than with placebo. As determined by a life table analysis of response, the probability of response during the 12 months was significantly greater with all treatment regimens than with placebo (p < .05), with citalopram 20 or 30 mg/day demonstrating the best response. Panic attacks tended to disappear in all patients remaining in the study until the end of follow-up. Analysis of the difference in the number of patients in different treatment groups remaining in the study (perhaps the best measure of long-term efficacy) also demonstrated that the patients treated with citalopram in dosage ranges of 20 or 30 mg/day and 40 or 60 mg/day had better response than placebo-treated patients (p < .0002 and p < .004, respectively). HAM-A and Global Improvement Scale scores also showed that patients treated with active drug showed greater improvement than placebo-treated patients. All treatment groups showed no new or exceptional adverse event clusters.

CONCLUSION

Citalopram in the dosage range of 20 to 60 mg/day is effective, well tolerated, and safe in the long-term treatment of patients who have panic disorder.

摘要

背景

本研究的目的是评估西酞普兰对伴有或不伴有广场恐惧症的成人惊恐障碍门诊患者的长期治疗效果及耐受性。

方法

在这项双盲、平行组试验中,患者被分配至西酞普兰的3个固定剂量范围(10或15毫克/天、20或30毫克/天、或40或60毫克/天)、氯米帕明的1个剂量范围(60或90毫克/天)或安慰剂中的一种。在完成8周的急性治疗期后,符合条件的患者可继续治疗长达1年。在随机分配参加短期试验的475名患者中,279名同意继续按分配的剂量接受双盲治疗。使用的主要疗效指标是临床焦虑量表惊恐发作项目,反应定义为无惊恐发作(评分为0或1)。使用的其他关键指标是医生整体改善量表、患者整体改善量表和汉密尔顿焦虑量表(HAM-A)。

结果

在所有药物治疗组中,除接受最低西酞普兰剂量的组外,治疗结果总体上优于安慰剂组。通过对反应的生命表分析确定,所有治疗方案在12个月内的反应概率均显著高于安慰剂组(p < 0.05),其中20或30毫克/天的西酞普兰显示出最佳反应。在研究中直至随访结束,所有剩余患者的惊恐发作均趋于消失。对不同治疗组中留在研究中的患者数量差异进行分析(这可能是长期疗效的最佳指标)也表明,接受20或30毫克/天以及40或60毫克/天剂量范围西酞普兰治疗的患者比接受安慰剂治疗的患者反应更好(分别为p < 0.0002和p < 0.004)。HAM-A和整体改善量表评分也显示,接受活性药物治疗的患者比接受安慰剂治疗的患者改善更大。所有治疗组均未出现新的或异常的不良事件聚集。

结论

20至60毫克/天剂量范围的西酞普兰对惊恐障碍患者进行长期治疗有效、耐受性良好且安全。

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