MAMBO: Measuring ambulation, motor, and behavioral outcomes with post stroke fluoxetine in Tanzania: Protocol of a phase II clinical trial
MAMBO: Measuring ambulation, motor, and behavioral outcomes with post stroke fluoxetine in Tanzania: Protocol of a phase II clinical trial
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DOI：
10.1016/j.jns.2019.116563
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发表时间：
2020-01-15
影响因子：
4.4
通讯作者：
Mateen, Farrah J.
中科院分区：
文献类型：
--
作者：
Vogel, Andre C.;Okeng'o, Kigocha;Mateen, Farrah J.
背景：SSA具有较高的卒中发病率和卒中后发病率。卒中恢复的廉价药物治疗将有利于该地区的患者。氟西汀目前被列入世界卫生组织基本药物清单，有望用于缺血性中风后的运动恢复治疗，但其有效性在SSA中存在争议和未经测试。目的确定氟西汀在急性缺血性中风后14天内每日口服20mg，并连续服用90天，是否耐受性良好且安全，并有足够的依从性，以证明未来在坦桑尼亚联合共和国进行氟西汀的随机对照试验是合理的。方法：开放标签II期临床试验，入组120例患者。参与者将从坦桑尼亚达累斯萨拉姆的Muhimbili国立医院招募，随访90天。主要结局是：1)安全性，包括血清钠和肝酶水平；2)耐受性，通过研究病例报告表格来衡量。次要结果是：1)运动强度的变化，通过Fugl-Meyer运动量表测量；2)粘附性，用电子药瓶测量；3)通过标准问卷测量被试抑郁症状负担。结论：扩大氟西汀治疗撒哈拉以南非洲中风幸存者的证据基础，需要对其安全性、耐受性和依从性进行测试。与先前在法国和英国进行的研究相比，坦桑尼亚的患者特征、卫生基础设施和卒中恢复的常规护理存在很大差异。如果氟西汀显示出有利的终点，则可能在中风后扩大其使用。
Background: SSA has a high stroke incidence and post-stroke morbidity. An inexpensive pharmacological treatment for stroke recovery would be beneficial to patients in the region. Fluoxetine, currently on the World Health Organization Essential Medicines List, holds promise as a treatment for motor recovery after ischemic stroke, but its effectiveness is controversial and untested in this context in SSA.Aim To determine if fluoxetine 20 mg by mouth daily, given within 14 days of acute ischemic stroke, and taken for 90 days, is well-tolerated and safe with adequate adherence to justify a future randomized, controlled trial of fluoxetine in the United Republic of Tanzania.Methods: Open-label, phase II clinical trial enrolling up to 120 patients. Participants will be recruited from the Muhimbili National Hospital in Dar es Salaam, Tanzania, and followed for 90 days.The primary outcomes are: 1) safety, including serum sodium and hepatic enzyme levels; and 2) tolerability, as measured through study case report forms. The secondary outcomes are: 1) change in motor strength, as measured through the Fugl-Meyer Motor Scale; 2) adherence, as measured with electronic pill bottles; and 3) participant depressive symptom burden measured via standard questionnaires.Conclusions: Expanding the evidence base for fluoxetine for Sub-Saharan African stroke survivors requires testing of its safety, tolerability, and adherence. Compared to prior studies in France and the United Kingdom, the patient characteristics, health infrastructure, and usual care for stroke recovery differ substantially in Tanzania. If fluoxetine reveals favorable endpoints, scale up of its use post-stroke is possible.