Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial
Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial
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DOI：
10.1016/s1474-4422(20)30207-6
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发表时间：
2020-08-01
期刊：
影响因子：
48
通讯作者：
Yi, Qilong
中科院分区：
文献类型：
--
作者：
Hankey, Graeme J.;Hackett, Maree L.;Yi, Qilong
背景：氟西汀治疗卒中后康复的试验报告结果相互矛盾。氟西汀在中风恢复(亲和力)试验中的评估旨在表明中风后6个月的每日口服氟西汀是否改善了不同种族人群的功能结果。方法亲和力是一项随机、平行分组、双盲、安慰剂对照试验，在澳大利亚(n=29)、新西兰(4)和越南(10)的43个卒中医院进行。符合条件的患者为成人(年龄=18岁)，在过去的2-15天内被临床诊断为急性中风，脑成像与缺血性或出血性中风相一致，并且持续的神经功能缺陷导致改良兰金量表(MRS)评分为1或更高。患者通过基于网络的系统使用最小化算法被随机分配为1：1，每天一次，口服氟西汀20 mg胶囊或匹配的安慰剂，为期6个月。患者、护理者、研究人员和结果评估员被掩盖在治疗分配中。主要结果是6个月时的功能状态，由MRS测量。主要分析是对6个月时的MRS进行有序Logistic回归，并对最小化变量进行了调整。根据患者的治疗分配情况进行初步和安全性分析。该试验在澳大利亚-新西兰临床试验注册中心注册，ACTRN12611000774921。2013年1月11日至2019年6月30日期间，1280名患者在澳大利亚(n=532)、新西兰(n=42)和越南(n=706)招募，其中642人随机分配给氟西汀，638人随机分配给安慰剂。平均试用期为167天(SD48中心点1)。6个月后，氟西汀组有624名患者(97%)有MRS数据，安慰剂组有632名患者(99%)有MRS数据。氟西汀组和安慰剂组的MRS分类分布相似(调整后的共同优势比0中心点94，95%CI 0中心点76-1中心点15；p=0中心点53)。与安慰剂组相比，氟西汀组患者有更多的跌倒(20[3%]比7[1%]；p=0中心点018)，骨折(19[3%]比6[1%]；p=0中心点014)，以及癫痫发作(10[2%]比2[
Background Trials of fluoxetine for recovery after stroke report conflicting results. The Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial aimed to show if daily oral fluoxetine for 6 months after stroke improves functional outcome in an ethnically diverse population. Methods AFFINITY was a randomised, parallel-group, double-blind, placebo-controlled trial done in 43 hospital stroke units in Australia (n=29), New Zealand (four), and Vietnam (ten). Eligible patients were adults (aged >= 18 years) with a clinical diagnosis of acute stroke in the previous 2-15 days, brain imaging consistent with ischaemic or haemorrhagic stroke, and a persisting neurological deficit that produced a modified Rankin Scale (mRS) score of 1 or more. Patients were randomly assigned 1:1 via a web-based system using a minimisation algorithm to once daily, oral fluoxetine 20 mg capsules or matching placebo for 6 months. Patients, carers, investigators, and outcome assessors were masked to the treatment allocation. The primary outcome was functional status, measured by the mRS, at 6 months. The primary analysis was an ordinal logistic regression of the mRS at 6 months, adjusted for minimisation variables. Primary and safety analyses were done according to the patient's treatment allocation. The trial is registered with the Australian New Zealand Clinical Trials Registry, ACTRN12611000774921. Findings Between Jan 11, 2013, and June 30, 2019, 1280 patients were recruited in Australia (n=532), New Zealand (n=42), and Vietnam (n=706), of whom 642 were randomly assigned to fluoxetine and 638 were randomly assigned to placebo. Mean duration of trial treatment was 167 days (SD 48 center dot 1). At 6 months, mRS data were available in 624 (97%) patients in the fluoxetine group and 632 (99%) in the placebo group. The distribution of mRS categories was similar in the fluoxetine and placebo groups (adjusted common odds ratio 0 center dot 94, 95% CI 0 center dot 76-1 center dot 15; p=0 center dot 53). Compared with patients in the placebo group, patients in the fluoxetine group had more falls (20 [3%] vs seven [1%]; p=0 center dot 018), bone fractures (19 [3%] vs six [1%]; p=0 center dot 014), and epileptic seizures (ten [2%] vs two [