Pilot randomized active-placebo-controlled trial of low-dose ketamine for the treatment of multiple sclerosis-related fatigue.
Pilot randomized active-placebo-controlled trial of low-dose ketamine for the treatment of multiple sclerosis-related fatigue.
复制标题
DOI：
10.1177/1352458520936226
复制
发表时间：
2021-05
期刊：
影响因子：
--
通讯作者：
Nourbakhsh B
中科院分区：
文献类型：
--
作者：
Fitzgerald KC;Morris B;Soroosh A;Balshi A;Maher D;Kaplin A;Nourbakhsh B
疲劳是MS最常见的症状，目前尚无有效的药物治疗方法。确定小剂量氯胺酮输注治疗多发性硬化症相关性疲劳的耐受性、安全性和有效性。在这项双盲、随机、积极的安慰剂对照试验中，18名患有多发性硬化症并报告疲劳的受试者接受了一次性静脉输注氯胺酮(0.5 mg/kg)或咪达唑仑(0.05 mg/kg)。主要结果是在注射后7天内每日疲劳严重程度(DFS)的变化。次要结果包括直到注射后第28天测量的疲劳严重程度量表(FSS)和修改后的疲劳影响量表(MFIS)。我们使用混合效应模型分析了所有结果的变化。18名参与者入选；67%的参与者接受了氯胺酮治疗。氯胺酮的副作用是短暂的。7天后无明显变化(−0.10分；95%CI：−0.32，0.12；p=0.40)。我们观察到在治疗1周时FSS评分下降的趋势(−5.2分；95%CI：−10.4，0.14；p=0.0 6)和第28天MFIS评分的临床和统计学显著下降(−13.5分；95%CI：−2 5.0，−1.98；p=0.0 4)。氯胺酮输注是安全的，耐受性良好。虽然在七天后没有观察到DFS的变化，但二次分析表明，输注氯胺酮对减少MS患者的长期疲劳严重程度有好处。
Fatigue is the most common symptom of MS and has no effective pharmacotherapy. To determine the tolerability, safety, and efficacy of low-dose ketamine infusion for MS-related fatigue. In this double-blind, randomized, active placebo-controlled trial, 18 subjects with MS and reported fatigue received a single intravenous infusion of ketamine (0.5 mg/kg) or midazolam (0.05 mg/kg). The primary outcome was change in Daily Fatigue Severity (DFS) for seven days following the infusion. Secondary outcomes included fatigue severity scale (FSS), and Modified Fatigue Impact Scale (MFIS) measured up to day 28 post-infusion. We analyzed changes in all outcomes using mixed-effect models. 18 participants were enrolled; 67% participants received ketamine. Side effects of ketamine were transient. No change in the DFS was observed after seven days (−0.10 point; 95%CI: −0.32,0.12; p=0.40). We observed a trend in reduced FSS scores at 1-week (−5.2 points; 95%CI: −10.4,0.14; p=0.06) and a clinically and statistically significant reduction in MFIS score at day 28 (−13.5 point; 95%CI: −25.0,−1.98; p=0.04). Ketamine infusions were safe and well-tolerated. While no change in DFS after seven days was observed, secondary analyses suggest a benefit of ketamine infusion for reduction of longer-term fatigue severity in people with MS.
登录
查看更多内容
影响因子：
11
作者：
Heesen, C;Nawrath, L;Gold, SM
通讯作者：
Gold, SM
影响因子：
5.8
作者：
Flachenecker, P;Kümpfel, T;Toyka, K
通讯作者：
Toyka, K
影响因子：
5.8
作者：
Smith, MM;Arnett, PA
通讯作者：
Arnett, PA
影响因子：
3.7
作者：
Powell, Daniel J. H.;Moss-Morris, Rona;Schlotz, Wolff
通讯作者：
Schlotz, Wolff
影响因子：
6.6
作者：
Riva-Posse, Patricio;Reiff, Collin M.;McDonald, William M.
通讯作者：
McDonald, William M.