Massachusetts General Hospital, Department of Neurology, 165 Cambridge St. #627, Boston, MA 02114, USA.
Muhimbili National Hospital, Neurology Unit, Dar es Salaam, Tanzania.
J Neurol Sci. 2020 Jan 15;408:116563. doi: 10.1016/j.jns.2019.116563. Epub 2019 Nov 6.
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.
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.
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.
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.
SSA 中风发病率和中风后发病率都很高。一种廉价的治疗中风的药物对该地区的患者将是有益的。氟西汀目前被世界卫生组织基本药物清单收录，有望成为治疗缺血性中风后运动功能恢复的一种药物，但在 SSA 背景下，其在这方面的疗效尚存在争议，尚未得到验证。
确定在急性缺血性中风后 14 天内口服氟西汀 20mg 每天一次，连续服用 90 天，是否具有良好的耐受性和安全性，同时确保足够的依从性，从而为氟西汀在坦桑尼亚联合共和国进行未来的随机对照试验提供依据。
开放性、2 期临床试验，最多纳入 120 名患者。参与者将从坦桑尼亚达累斯萨拉姆的穆希比利国家医院招募，并随访 90 天。主要结局指标为：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进行评估。次要结局指标为：1）运动力量的变化，通过 Fugl-Meyer 运动量表进行测量；2）通过电子药瓶测量的依从性；3）通过标准问卷评估患者的抑郁症状负担。
为了扩大氟西汀在撒哈拉以南非洲中风幸存者中的证据基础，需要对其安全性、耐受性和依从性进行测试。与法国和英国的先前研究相比，坦桑尼亚的患者特征、卫生基础设施和中风后康复的常规护理有很大的不同。如果氟西汀显示出有利的结果，可以扩大其在中风后的使用。
