Efficacy of Corticosteroid Therapy for HTLV-1-Associated Myelopathy: A Randomized Controlled Trial (HAMLET-P)
| العنوان: | Efficacy of Corticosteroid Therapy for HTLV-1-Associated Myelopathy: A Randomized Controlled Trial (HAMLET-P) |
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| المؤلفون: | Junji Yamauchi, Kenichiro Tanabe, Tomoo Sato, Masanori Nakagawa, Eiji Matsuura, Yoshio Tsuboi, Keiko Tamaki, Hirokuni Sakima, Satoshi Ishihara, Yuki Ohta, Naoki Matsumoto, Kenichi Kono, Naoko Yagishita, Natsumi Araya, Katsunori Takahashi, Yasuo Kunitomo, Misako Nagasaka, Ariella Coler-Reilly, Yasuhiro Hasegawa, Abelardo Araujo, Steven Jacobson, Maria Fernanda Rios Grassi, Bernardo Galvão-Castro, Martin Bland, Graham P. Taylor, Fabiola Martin, Yoshihisa Yamano |
| المصدر: | Viruses, Vol 14, Iss 136, p 136 (2022) Viruses Viruses; Volume 14; Issue 1; Pages: 136 |
| بيانات النشر: | MDPI AG, 2022. |
| سنة النشر: | 2022 |
| مصطلحات موضوعية: | Male, Human T-lymphotropic virus 1, Motor Disorders, prednisolone, Middle Aged, Microbiology, Article, Paraparesis, Tropical Spastic, human T-lymphotropic virus type 1, methylprednisolone, QR1-502, Infectious Diseases, Treatment Outcome, Adrenal Cortex Hormones, Virology, randomized controlled trial, Humans, Disabled Persons, Female, Prospective Studies, HTLV-1-associated myelopathy, Aged |
| الوصف: | 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) |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 1999-4915 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::9e4481974ca3f88ee2a15d5ab3e18037Test https://www.mdpi.com/1999-4915/14/1/136Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....9e4481974ca3f88ee2a15d5ab3e18037 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 19994915 |
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