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EFFICACY OF CORTICOSTEROID THERAPY FOR HTLV-1-ASSOCIATED MYELOPATHY: A RANDOMIZED CONTROLLED TRIAL (HAMLET-P)
Prednisolona
Metilprednisolona
Ensaio Clínico Controlado Aleatório
Prednisolona
Metilprednisolona
Ensayo Clínico Controlado Aleatorio
Author
Yamauchi, Junji
Tanabe, Kenichiro
Sato, Tomoo
Nakagawa, Masanori
Matsuura, Eiji
Tsuboi, Yoshio
Tamaki, Keiko
Sakima, Hirokuni
Ishihara, Satoshi
Ohta, Yuki
Matsumoto, Naoki
Kono, Kenichi
Yagishita, Naoko
Araya, Natsumi
Takahashi, Katsunori
Kunitomo, Yasuo
Nagasaka, Misako
Reilly, Ariella Coler
Hasegawa, Yasuhiro
Araujo, Abelardo
Jacobson, Steven
Grassi, Maria Fernanda Rios
Castro, Bernardo Galvão
Bland, Martin
Taylor, Graham P
Martin, Fabiola
Yamano, Yoshihisa
Tanabe, Kenichiro
Sato, Tomoo
Nakagawa, Masanori
Matsuura, Eiji
Tsuboi, Yoshio
Tamaki, Keiko
Sakima, Hirokuni
Ishihara, Satoshi
Ohta, Yuki
Matsumoto, Naoki
Kono, Kenichi
Yagishita, Naoko
Araya, Natsumi
Takahashi, Katsunori
Kunitomo, Yasuo
Nagasaka, Misako
Reilly, Ariella Coler
Hasegawa, Yasuhiro
Araujo, Abelardo
Jacobson, Steven
Grassi, Maria Fernanda Rios
Castro, Bernardo Galvão
Bland, Martin
Taylor, Graham P
Martin, Fabiola
Yamano, Yoshihisa
Affilliation
"Múltipla ver em Notas"
Abstract
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.
Keywords in Portuguese
Vírus Linfotrópico T Tipo 1 HumanoPrednisolona
Metilprednisolona
Ensaio Clínico Controlado Aleatório
Keywords in Spanish
Virus Linfotrópico T Tipo 1 HumanoPrednisolona
Metilprednisolona
Ensayo Clínico Controlado Aleatorio
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