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氟西汀与分级运动治疗慢性疲劳综合征的随机、双盲、安慰剂对照试验

Randomised, double-blind, placebo-controlled treatment trial of fluoxetine and graded exercise for chronic fatigue syndrome.

作者信息

Wearden A J, Morriss R K, Mullis R, Strickland P L, Pearson D J, Appleby L, Campbell I T, Morris J A

机构信息

University of Manchester, Department of Psychiatry, Withington Hospital.

出版信息

Br J Psychiatry. 1998 Jun;172:485-90. doi: 10.1192/bjp.172.6.485.

DOI:10.1192/bjp.172.6.485
PMID:9828987
Abstract

BACKGROUND

The Joint Working Group of the Royal Colleges of Physicians, Psychiatrists and General Practitioners (1996) recommended graded exercise and antidepressants for patients with chronic fatigue syndrome. We assessed efficacy and acceptability of these treatments.

METHOD

Six-month prospective randomised placebo and therapist contact time controlled trial with allocation to one of four treatment cells: exercise and 20 mg fluoxetine, exercise and placebo drug, appointments only and 20 mg fluoxetine, appointments and placebo drug. Drug treatment was double blind and patients were blind to assignment to exercise or appointments.

RESULTS

Ninety-six (71%) of 136 patients completed the trial. Patients were more likely to drop out of exercise than non-exercise treatment (P = 0.05). In an intention to treat analysis, exercise resulted in fewer patients with case level fatigue than appointments only at 26 weeks (12 (18%) v. 4 (6%) respectively P = 0.025) and improvement in functional work capacity at 12 (P = 0.005) and 26 weeks (P = 0.03). Fluoxetine had a significant effect on depression at week 12 only (P = 0.04). Exercise significantly improved health perception (P = 0.012) and fatigue (P = 0.028) at 28 weeks.

CONCLUSIONS

Graded exercise produced improvements in functional work capacity and fatigue, while fluoxetine improved depression only.

摘要

背景

皇家内科医师学院、精神科医师学院和全科医师学院联合工作组(1996年)建议对慢性疲劳综合征患者采用分级运动和抗抑郁药治疗。我们评估了这些治疗方法的疗效和可接受性。

方法

进行为期六个月的前瞻性随机安慰剂和治疗师接触时间对照试验,将患者分配到四个治疗组之一:运动加20毫克氟西汀、运动加安慰剂、仅接受预约加20毫克氟西汀、预约加安慰剂。药物治疗采用双盲,患者对被分配到运动组或预约组不知情。

结果

136名患者中有96名(71%)完成了试验。与非运动治疗相比,患者退出运动治疗的可能性更大(P = 0.05)。在意向性分析中,运动组在26周时疲劳程度处于病例水平的患者比仅接受预约组少(分别为12名(18%)对4名(6%),P = 0.025),并且在12周(P = 0.005)和26周(P = 0.03)时功能工作能力有所改善。氟西汀仅在第12周对抑郁有显著影响(P = 0.04)。运动在28周时显著改善了健康认知(P = 0.012)和疲劳(P = 0.028)。

结论

分级运动改善了功能工作能力和疲劳,而氟西汀仅改善了抑郁。

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