Miner Cherri M, Brown Eileen B, Gonzales Jill S, Munir Reema
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Ind. 46285, USA.
J Clin Psychiatry. 2002 Mar;63(3):232-40. doi: 10.4088/jcp.v63n0310.
Major depressive disorder is frequently a chronic, recurrent condition necessitating maintenance treatment. For some patients, compliance with daily pharmacotherapy is difficult over time. As an alternative approach, a once-weekly administered formulation of fluoxetine has recently been made available. This raises the important question of whether once-weekly enteric-coated fluoxetine, 90 mg, is effective for maintenance of response in patients whose depressive symptoms have responded to daily dosing with selective serotonin reuptake inhibitors (SSRIs) such as citalopram, paroxetine, or sertraline.
Patients had met DSM-IV criteria for major depressive disorder prior to beginning treatment for their current episode, had received 6 to 52 weeks of treatment with citalopram (20-40 mg/day [N = 83]), paroxetine (20 mg/day [N = 77]), or sertraline (50-100 mg/day [N = 86]), and had responded to that treatment (Clinical Global Impressions-Severity of Illness [CGI-S] score < or = 2, modified 17-item Hamilton Rating Scale for Depression [HAM-D-17] score < or = 10). Patients meeting these criteria (N = 246) continued treatment with their current SSRI for 1 week, then were switched to open-label enteric-coated fluoxetine, 90 mg, taken once weekly for 12 weeks. Safety measures were comparisons of spontaneously reported and solicited treatment-emergent adverse events. Efficacy measures were percentages of patients who discontinued the study for relapse and lack of efficacy and comparison of change from baseline to endpoint in scores on the modified HAM-D-17, subscales of the HAM-D-28, and the CGI-S. Quality of life measures were assessed with the MOS 36-Item Short-Form Health Survey (SF-36). We hypothesized that the once-weekly administration of fluoxetine could be safely and effectively initiated among subjects who had been stabilized on daily SSRI treatment.
Seventy-nine percent of patients successfully completed a switch to enteric-coated fluoxetine, 90 mg, with 9.3% discontinuing due to relapse or lack of efficacy. Enteric-coated fluoxetine at a once-weekly dose of 90 mg was well tolerated in all groups. No significant increases were found in the HAM-D-17 total, HAM-D-28 subscores, or CGI-S score. Patients showed improvement from baseline to endpoint in most of the SF-36 health concepts.
Enteric-coated fluoxetine taken once weekly appears to be well tolerated and efficacious in patients who responded to acute therapy with other SSRIs and were subsequently switched to fluoxetine once weekly for continuation/maintenance therapy.
重度抑郁症常常是一种慢性复发性疾病,需要维持治疗。随着时间推移,对一些患者而言,坚持每日药物治疗存在困难。作为一种替代方法,最近已推出了每周给药一次的氟西汀制剂。这就引出了一个重要问题,即对于那些抑郁症状对诸如西酞普兰、帕罗西汀或舍曲林等选择性5-羟色胺再摄取抑制剂(SSRI)每日给药有反应的患者,每周一次服用90毫克肠溶包衣氟西汀对于维持疗效是否有效。
患者在开始本次发作的治疗前符合重度抑郁症的DSM-IV标准,曾接受过6至52周的西酞普兰(20 - 40毫克/天 [N = 83])、帕罗西汀(20毫克/天 [N = 77])或舍曲林(50 - 100毫克/天 [N = 86])治疗,且对该治疗有反应(临床总体印象-疾病严重程度 [CGI-S] 评分≤2,改良17项汉密尔顿抑郁量表 [HAM-D-17] 评分≤10)。符合这些标准的患者(N = 246)继续用其当前的SSRI治疗1周,然后换用开放标签的90毫克肠溶包衣氟西汀,每周服用一次,共12周。安全措施是比较自发报告和主动询问的治疗中出现的不良事件。疗效指标是因复发和缺乏疗效而中断研究的患者百分比,以及改良HAM-D-17、HAM-D-28各分量表和CGI-S评分从基线到终点的变化比较。生活质量指标用MOS 36项简短健康调查(SF-36)进行评估。我们假设在每日SSRI治疗已稳定的受试者中可以安全有效地开始每周一次服用氟西汀。
79%的患者成功换用90毫克肠溶包衣氟西汀,9.3%的患者因复发或缺乏疗效而中断治疗。所有组中,每周一次服用90毫克剂量的肠溶包衣氟西汀耐受性良好。HAM-D-17总分、HAM-D-28各分量表评分或CGI-S评分均未发现显著升高。在大多数SF-36健康概念方面,患者从基线到终点均有改善。
对于那些对其他SSRI急性治疗有反应、随后换用每周一次氟西汀进行延续/维持治疗的患者,每周服用一次肠溶包衣氟西汀似乎耐受性良好且有效。