Thompson C, Peveler R C, Stephenson D, McKendrick J
Department of Mental Health, University of Southampton, England.
Am J Psychiatry. 2000 Mar;157(3):338-43. doi: 10.1176/appi.ajp.157.3.338.
Many claims have been made for superior compliance with selective serotonin reuptake inhibitors (SSRIs) compared with tricyclic antidepressants, but to date meta-analyses have not confirmed reduced dropouts in randomized controlled trials. The authors used a randomized study design to evaluate differential compliance with antidepressant medications in a primary care setting.
A total of 152 patients treated in 10 primary care practices in the United Kingdom were included in a randomized, open-label, parallel-group study of fluoxetine and dothiepin at therapeutic doses for 12 weeks. Compliance was assessed by using pill count, patient questionnaires, and the Medication Event Monitoring System.
The level of compliance with fluoxetine was numerically higher than the level of compliance with dothiepin on all three primary outcome measures, although the differences were not significant. In a secondary analysis using data from the Medication Event Monitoring System, both a survival analysis for length of time without a gap in medicine taking and a derived compliance index showed a significant advantage to fluoxetine. Patients in the fluoxetine group reported superior response on the health transition scale of the 36-item Short-Form Health Survey Questionnaire and numerically greater improvement on the Hamilton Depression Rating Scale. In both treatment arms patients with a superior compliance index were more likely to have improved in Hamilton depression scale scores by the last study visit.
This study supports recent meta-analyses of SSRIs versus tricyclic antidepressants in finding no significant differences in crude indices of compliance between fluoxetine and dothiepin, despite marked differences in side effect profile and dose regimen. However, both a survival analysis and a new measure that takes account of prolonged periods of noncompliance distinguished between the treatments and was associated with improvement in both groups.
与三环类抗抑郁药相比,许多人声称选择性5-羟色胺再摄取抑制剂(SSRI)具有更好的依从性,但迄今为止的荟萃分析尚未证实随机对照试验中的脱落率降低。作者采用随机研究设计来评估在初级保健机构中抗抑郁药物的差异依从性。
在英国10家初级保健机构接受治疗的152名患者被纳入一项随机、开放标签、平行组研究,该研究使用治疗剂量的氟西汀和多塞平治疗12周。通过清点药片、患者问卷和药物事件监测系统来评估依从性。
在所有三项主要结局指标上,氟西汀的依从水平在数值上均高于多塞平的依从水平,尽管差异不显著。在使用药物事件监测系统数据进行的二次分析中,对服药无间断时间的生存分析和得出的依从性指数均显示氟西汀具有显著优势。氟西汀组的患者在36项简短健康调查问卷的健康转变量表上报告了更好的反应,并且在汉密尔顿抑郁量表上的改善在数值上更大。在两个治疗组中,依从性指数较高的患者在最后一次研究访视时汉密尔顿抑郁量表评分更有可能得到改善。
本研究支持近期对SSRI与三环类抗抑郁药的荟萃分析,即尽管氟西汀和多塞平在副作用特征和剂量方案上存在显著差异,但在依从性的粗略指标上未发现显著差异。然而,生存分析和一种考虑到长期不依从情况的新测量方法均区分了两种治疗方法,并且与两组的改善情况相关。