Efficacy of Corticosteroid Therapy for HTLV-1-Associated Myelopathy: A Randomized Controlled Trial (HAMLET-P).
Efficacy of Corticosteroid Therapy for HTLV-1-Associated Myelopathy: A Randomized Controlled Trial (HAMLET-P).
复制标题
DOI：
10.3390/v14010136
复制
发表时间：
2022-01-12
期刊：
影响因子：
--
通讯作者：
Yamano Y
中科院分区：
文献类型：
--
作者：
Yamauchi J;Tanabe K;Sato T;Nakagawa M;Matsuura E;Tsuboi Y;Tamaki K;Sakima H;Ishihara S;Ohta Y;Matsumoto N;Kono K;Yagishita N;Araya N;Takahashi K;Kunitomo Y;Nagasaka M;Coler-Reilly A;Hasegawa Y;Araujo A;Jacobson S;Grassi MFR;Galvão-Castro B;Bland M;Taylor GP;Martin F;Yamano Y
皮质类固醇最常用于治疗HTLV-1相关性脊髓病（HAM）;然而，其临床疗效尚未在随机临床试验中进行测试。这项随机对照试验包括8名和30名HAM患者，分别患有快速和缓慢进展的行走障碍。快速进展者被分配（1：1）接受或不接受3天的静脉注射甲泼尼龙治疗，除了口服泼尼松龙治疗。同时，缓慢进展者被分配（1：1）接受口服泼尼松龙或安慰剂。主要结局是快速进展者第2周Osame运动障碍评分改善≥1级或10 m步行时间（10 mWT）改善≥30%，缓慢进展者第24周10 mWT较基线变化的复合终点。在快速进展试验中，所有4名患者，但只有一个没有静脉注射甲泼尼龙四个实现了主要结果（p = 0.14）。在缓慢进展试验中，泼尼松龙和安慰剂组10 mWT的中位变化分别为−13.8%（95% CI：−20.1-−7.1; p < 0.001）和−6.0%（95% CI：−12.8-1.3; p = 0.10）（组间差异p = 0.12）。尽管主要终点未达到统计学显著性，但总体数据表明皮质类固醇治疗的获益。（注册号：UMIN 000023798、UMIN 000024085）
Corticosteroids are most commonly used to treat HTLV-1-associated myelopathy (HAM); however, their clinical efficacy has not been tested in randomized clinical trials. This randomized controlled trial included 8 and 30 HAM patients with rapidly and slowly progressing walking disabilities, respectively. Rapid progressors were assigned (1:1) to receive or not receive a 3-day course of intravenous methylprednisolone in addition to oral prednisolone therapy. Meanwhile, slow progressors were assigned (1:1) to receive oral prednisolone or placebo. The primary outcomes were a composite of ≥1-grade improvement in the Osame Motor Disability Score or ≥30% improvement in the 10 m walking time (10 mWT) at week 2 for rapid progressors and changes from baseline in 10 mWT at week 24 for slow progressors. In the rapid progressor trial, all four patients with but only one of four without intravenous methylprednisolone achieved the primary outcome (p = 0.14). In the slow progressor trial, the median changes in 10 mWT were −13.8% (95% CI: −20.1–−7.1; p < 0.001) and −6.0% (95% CI: −12.8–1.3; p = 0.10) with prednisolone and placebo, respectively (p for between-group difference = 0.12). Whereas statistical significance was not reached for the primary endpoints, the overall data indicated the benefit of corticosteroid therapy. (Registration number: UMIN000023798, UMIN000024085)
登录
查看更多内容
影响因子：
2.1
作者：
Abraham, L;Hareendran, A;Noble, JG
通讯作者：
Noble, JG
影响因子：
4.4
作者：
KIRA, J;FUJIHARA, K;HASUO, K
通讯作者：
HASUO, K
DOI：
10.1097/00042560-199504120-00006
发表时间：
1995-04-15
期刊：
JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES AND HUMAN RETROVIROLOGY
影响因子：
--
作者：
HARRINGTON, WJ;UCAR, A;POIESZ, B
通讯作者：
POIESZ, B
影响因子：
4.4
作者：
KURODA, Y;YUKITAKE, M;MATSUI, M
通讯作者：
MATSUI, M
影响因子：
3.2
作者：
Nakagawa, M;Nakahara, K;Osame, M
通讯作者：
Osame, M