PMID- 34039871
OWN - NLM
STAT- MEDLINE
DCOM- 20210618
LR  - 20220330
IS  - 2542-5641 (Electronic)
IS  - 0366-6999 (Print)
IS  - 0366-6999 (Linking)
VI  - 134
IP  - 12
DP  - 2021 May 19
TI  - A double-blind, double-dummy, randomized controlled, multicenter trial of 
      99Tc-methylene diphosphonate in patients with moderate to severe rheumatoid 
      arthritis.
PG  - 1457-1464
LID - 10.1097/CM9.0000000000001527 [doi]
AB  - 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-naive 
      Chinese patients with moderate to severe RA. METHODS: Eligible patients with 
      moderate to severely active RA were randomized to receive 99Tc-MDP plus MTX 
      (n = 59) vs. MTX (n = 59) alone or 99Tc-MDP (n = 59) 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 
      MTX + 99Tc-MDP combination group (69.5%) than that in the MTX group (50.8%) or 
      99Tc-MDP group (47.5%) (P = 0.03 for MTX + 99Tc-MDP vs. MTX, and MTX + 99Tc-MDP 
      vs.99Tc-MDP, respectively). The participants in the MTX + 99Tc-MDP group and the 
      99Tc-MDP group had significantly less important radiographic progression than the 
      participants in the MTX group over the 48 weeks (MTX + 99Tc-MDP vs. MTX: 
      P = 0.03, 99Tc-MDP vs. MTX: P = 0.03, 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.
CI  - Copyright (c) 2021 The Chinese Medical Association, produced by Wolters Kluwer, 
      Inc. under the CC-BY-NC-ND license.
FAU - Fu, Qiong
AU  - Fu Q
AD  - Department of Rheumatology, Renji Hospital of Shanghai Jiaotong University School 
      of Medicine, Shanghai 200000, China.
FAU - Feng, Ping
AU  - Feng P
AD  - National Medical Products Administration Key Laboratory for Clinical Research and 
      Evaluation of Innovative Drugs, Institute of Clinical Trials, West China 
      Hospital, Sichuan University, Chengdu, Sichuan 610041, China.
FAU - Sun, Ling-Yun
AU  - Sun LY
AD  - Department of Rheumatology, Nanjing Drum Tower Hospital, Nanjing University 
      Medical School, Nanjing, Jiangsu 210008, China.
FAU - Zuo, Xiao-Xia
AU  - Zuo XX
AD  - Department of Rheumatology, Xiangya Hospital, Central South University, Changsha, 
      Hunan 410008, China.
FAU - Zhao, Dong-Bao
AU  - Zhao DB
AD  - Department of Rheumatology and Immunology, Changhai Hospital, Shanghai 200433, 
      China.
FAU - He, Dong-Yi
AU  - He DY
AD  - Department of Rheumatology, Shanghai Guanghua Hospital of Integrated Traditional 
      Chinese and Western Medicine, Shanghai 200052, China.
FAU - Wu, Hua-Xiang
AU  - Wu HX
AD  - Department of Rheumatology, The Second Affiliated Hospital of Zhejiang University 
      School of Medicine, Hangzhou, Zhejiang 310009, China.
FAU - Zhang, Wei
AU  - Zhang W
AD  - Department of Rheumatology, Renji Hospital of Shanghai Jiaotong University School 
      of Medicine, Shanghai 200000, China.
FAU - Zhang, Wei
AU  - Zhang W
AD  - Department of Quality Control, Cheng Fei Hospital, Chengdu, Sichuan 610091, 
      China.
FAU - Du, Fang
AU  - Du F
AD  - Department of Rheumatology, Renji Hospital of Shanghai Jiaotong University School 
      of Medicine, Shanghai 200000, China.
FAU - Bao, Chun-De
AU  - Bao CD
AD  - Department of Rheumatology, Renji Hospital of Shanghai Jiaotong University School 
      of Medicine, Shanghai 200000, China.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20210519
PL  - China
TA  - Chin Med J (Engl)
JT  - Chinese medical journal
JID - 7513795
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Diphosphonates)
RN  - 0 (Technetium-99)
RN  - 73OS0QIN3O (methylene diphosphonate)
RN  - 7440-26-8 (Technetium)
RN  - YL5FZ2Y5U1 (Methotrexate)
SB  - IM
MH  - *Antirheumatic Agents/therapeutic use
MH  - *Arthritis, Rheumatoid/drug therapy
MH  - China
MH  - Diphosphonates
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Humans
MH  - Methotrexate/therapeutic use
MH  - Technetium/therapeutic use
MH  - Treatment Outcome
PMC - PMC8213301
COIS- None.
EDAT- 2021/05/28 06:00
MHDA- 2021/06/22 06:00
PMCR- 2021/06/20
CRDT- 2021/05/27 05:54
PHST- 2021/05/28 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2021/05/27 05:54 [entrez]
PHST- 2021/06/20 00:00 [pmc-release]
AID - 00029330-202106200-00012 [pii]
AID - CMJ-2020-3891 [pii]
AID - 10.1097/CM9.0000000000001527 [doi]
PST - epublish
SO  - Chin Med J (Engl). 2021 May 19;134(12):1457-1464. doi: 
      10.1097/CM9.0000000000001527.