A double-blind, double-dummy, randomized controlled, multicenter trial of 99Tc-methylene diphosphonate in patients with moderate to severe rheumatoid arthritis.
Chin Med J (Engl)
; 134(12): 1457-1464, 2021 May 19.
Article
en En
| MEDLINE
| ID: mdl-34039871
ABSTRACT
BACKGROUND:
Clinical observational studies revealed that 99Tc-methylene diphosphonate (99Tc-MDP) could reduce joint pain and swollenness in rheumatoid arthritis (RA) patients. This multicenter, randomized, double-blind, double-dummy study aimed to evaluate the effects of 99Tc-MDP plus methotrexate (MTX) vs. MTX alone or 99Tc-MDP alone on disease activity and structural damage in MTX-naïve Chinese patients with moderate to severe RA.METHODS:
Eligible patients with moderate to severely active RA were randomized to receive 99Tc-MDP plus MTX (nâ=â59) vs. MTX (nâ=â59) alone or 99Tc-MDP (nâ=â59) alone for 48 weeks from six study sites across four provinces in China. The primary outcomes were the American College of Rheumatology 20% improvement (ACR20) response rates at week 24 and changes in modified total Sharp score at week 48.RESULTS:
At week 24, the proportion of participants achieving ACR20 was significantly higher in the MTXâ+â99Tc-MDP combination group (69.5%) than that in the MTX group (50.8%) or 99Tc-MDP group (47.5%) (Pâ=â0.03 for MTXâ+â99Tc-MDP vs. MTX, and MTXâ+â99Tc-MDP vs.99Tc-MDP, respectively). The participants in the MTXâ+â99Tc-MDP group and the 99Tc-MDP group had significantly less important radiographic progression than the participants in the MTX group over the 48âweeks (MTXâ+â99Tc-MDP vs. MTX Pâ=â0.03, 99Tc-MDP vs. MTX Pâ=â0.03, respectively). There was no significant difference in terms of adverse events (AEs) among the groups. No serious AEs were observed.CONCLUSIONS:
This study demonstrated that the combination of 99Tc-MDP with MTX inhibited structural damage and improved disease activity in RA patients compared with MTX and 99Tc-MDP monotherapies, without increasing the rate of AEs. Additional clinical studies of 99Tc-MDP therapy in patients with RA are warranted. TRIAL REGISTRATION Chictr.org, ChiCTR-IPR-14005684; http//www.chictr.org.cn/showproj.aspx?proj=10088.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Contexto en salud:
1_ASSA2030
Problema de salud:
1_doencas_nao_transmissiveis
Asunto principal:
Artritis Reumatoide
/
Antirreumáticos
Tipo de estudio:
Clinical_trials
/
Observational_studies
Límite:
Humans
País/Región como asunto:
Asia
Idioma:
En
Revista:
Chin Med J (Engl)
Año:
2021
Tipo del documento:
Article
País de afiliación:
China