Cohort experience in 39 psychiatric outpatients with high doses of an enteric-coated weekly formulation of fluoxetine
Cohort experience in 39 psychiatric outpatients with high doses of an enteric-coated weekly formulation of fluoxetine
复制标题
DOI：
10.2165/00044011-200222030-00004
复制
发表时间：
2002-01-01
影响因子：
3.2
通讯作者：
Wilson, MG
中科院分区：
文献类型：
--
作者：
Buongiorno, PA;Plewes, JM;Wilson, MG
背景：临床试验表明，每周服用一次 90 毫克的肠溶口服氟西汀新制剂具有良好的耐受性、安全性、有效性，并且具有很高的依从性。它已获得监管机构批准在抗抑郁治疗的持续阶段上市。然而，关于每周一次制剂在临床实践中的经验的文献报道很少，特别是在患有严重内科和精神共病的患者中。方法：在临床环境中，向 39 名确诊为重度抑郁症的精神科门诊患者（年龄 18 至 78 岁）提供肠溶氟西汀 90 毫克。 45.8% 的女性和 42.9% 的男性存在共病医疗或精神疾病；这些患者中的大多数都在同时服用药物。七名患者此前未曾因抑郁症接受治疗。利用患者图表中的数据，对每周一次氟西汀（90 至 540 毫克）的耐受性、疗效和依从性进行了评估。结果：在已接受氟西汀治疗的 32 名患者中，31 人成功从每日单剂量转换为每周单剂量（90 至 540 毫克），一名患者转换为分次剂量（每周两次）。其余 7 名患者开始每周重新服用氟西汀。目前，所有 39 名患者的抑郁症均处于缓解状态，情感、共病状况或依从性没有变化。迄今为止的剂量调整后，该队列已受到监测，每周氟西汀给药的累积暴露量为 7.2 患者年。没有患者停止肠溶氟西汀治疗。没有报告严重不良事件或住院治疗。没有关于恶心、头痛或性功能障碍的查询事件的新报告。没有出现新的神经质、虚弱、腹泻、思维异常或嗜睡的自发报告。结论：根据我们的临床经验，肠溶氟西汀以较高剂量每周一次或两次给药，对于重度抑郁症的短期维持治疗是有效的且耐受性良好。对于一些长期治疗抑郁症的患者来说，简单的每周一次或两次给药可能是一种方便的选择。
Background: A new formulation of enteric-coated oral fluoxetine given at a dose of 90mg once weekly has been shown in clinical trials to be well tolerated, safe, effective and associated with very high compliance. It has been approved by regulatory agencies for marketing in the continuation phase of antidepressant therapy. However, literature reports on experience with the once-weekly formulation in clinical practice, especially in patients with substantial medical and psychiatric co-morbidities, are sparse.Methods: Enteric-coated fluoxetine 90mg was provided in a clinic setting to 39 psychiatric outpatients (aged 18 to 78 years) with a confirmed diagnosis of major depression. A co-morbid medical or psychiatric condition was present in 45.8% of the women and 42.9% of the men; most of these patients were on concomitant medication. Seven patients were previously untreated for depression. The tolerability, efficacy and compliance of once-weekly fluoxetine (90 to 540mg) were evaluated in this patient population utilising data from patient charts.Results: Of the 32 patients already receiving fluoxetine, 31 were successfully converted from a single daily dose to a single weekly dose (90 to 540mg) and one patient was converted to a divided dosage (twice weekly). The remaining seven patients were started on weekly fluoxetine administration de novo, Presently, all 39 remain in remission from depression, with no changes in affect, co-morbid conditions or compliance. After dosage adjustments to date, this cohort has been monitored and has a cumulative exposure of weekly fluoxetine administration of 7.2 patient-years. No patient has discontinued enteric-coated fluoxetine therapy. No serious adverse events or hospitalisations were reported. There were no new reports of queried events of nausea, headache or sexual dysfunction. There were no new spontaneous reports of nervousness, asthenia, diarrhoea, abnormal thinking or somnolence.Conclusions: In our clinical experience, enteric-coated fluoxetine, administered at higher doses once or twice weekly, was effective and well tolerated for short-term maintenance treatment of major depressive disorder. The simple once- or twice-weekly administration could be a convenient alternative for some patients during long-term treatment of depression.