de Klerk E
AARDEX Ltd, Maastricht, The Netherlands.
J Clin Psychiatry. 2001;62 Suppl 22:43-7.
A once-weekly enteric-coated formulation of fluoxetine represents a new, effective option for the long-term treatment of clinically diagnosed depression. This study assessed compliance with the new once-weekly fluoxetine as compared with once-daily fluoxetine treatment.
Adult patients from the United Kingdom who had responded to fluoxetine treatment for a current episode of depression (DSM-IV criteria) were monitored for compliance with daily and weekly dose administration of fluoxetine. The study consisted of 2 study phases. Study phase I was a baseline assessment of 20 mg of fluoxetine daily dosing for 4 weeks (N = 117). The second phase of the study consisted of randomly assigning patients to either once-weekly (90 mg/wk) or once-daily (20 mg/day) fluoxetine for 3 months (weekly, N = 56; daily, N = 53). Compliance with the dosing regimen was measured using an electronic Drug Exposure Monitor (eDEM, AARDEX Ltd., Zug, Switzerland).
For those patients randomly assigned to weekly fluoxetine, compliance was 85.4% during study period I while on treatment with daily fluoxetine and then 87.5% while on treatment with weekly fluoxetine. This difference was not significant. For once-daily dosing, however, compliance declined from 87.3% during period I to 79.4% during period II (p < .001). After adjusting for compliance during study period I, weekly compliance during study period II was 87.8% and daily compliance was 79.0%, a statistically significant difference (p = .006).
Compliance with once-weekly fluoxetine was better than that with once-daily fluoxetine. Compliance decreased over time when patients remained on daily dosing; however, when patients switched from daily dosing to weekly dosing, compliance did not decrease. The results of this study allay concerns about inferior compliance with a once-weekly regimen compared with the conventional once-daily regimen.
一种每周一次的氟西汀肠溶制剂是临床诊断抑郁症长期治疗的一种新的有效选择。本研究评估了与每日一次氟西汀治疗相比，新的每周一次氟西汀的依从性。
对来自英国、对当前抑郁发作（符合《精神疾病诊断与统计手册》第四版标准）接受氟西汀治疗有反应的成年患者进行监测，观察其对氟西汀每日和每周剂量给药的依从性。该研究包括2个研究阶段。研究阶段I是对每日服用20mg氟西汀进行4周的基线评估（N = 117）。研究的第二阶段包括将患者随机分配至每周一次（90mg/周）或每日一次（20mg/天）氟西汀治疗3个月（每周治疗组，N = 56；每日治疗组，N = 53）。使用电子药物暴露监测仪（eDEM，瑞士楚格的AARDEX有限公司）测量给药方案的依从性。
对于那些随机分配至每周一次氟西汀治疗的患者，在研究阶段I接受每日一次氟西汀治疗时依从性为85.4%，而在接受每周一次氟西汀治疗时为87.5%。这种差异不显著。然而，对于每日一次给药，依从性从阶段I的87.3%降至阶段II的79.4%（p < 0.001）。在对研究阶段I的依从性进行校正后，研究阶段II的每周依从性为87.8%，每日依从性为79.0%，差异有统计学意义（p = 0.006）。
每周一次氟西汀的依从性优于每日一次氟西汀。当患者持续每日给药时，依从性随时间下降；然而，当患者从每日给药改为每周给药时，依从性并未下降。本研究结果消除了对每周一次给药方案相较于传统每日一次给药方案依从性较差的担忧。
