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全身冷冻疗法治疗类风湿性关节炎:一项单中心、单盲、随机对照试验。

Whole-body cryotherapy for the treatment of rheumatoid arthritis: a monocentric, single-blinded, randomised controlled trial.

机构信息

Department of Rheumatology, Clinical Immunology, Osteology and Physical Medicine, Campus Kerckhoff, Justus-Liebig-University Gießen, Bad Nauheim, Germany.

Department of Medical Statistics, University Medical Center Göttingen, Germany.

出版信息

Clin Exp Rheumatol. 2022 Nov;40(11):2133-2140. doi: 10.55563/clinexprheumatol/lrff6k. Epub 2022 Mar 1.

DOI:10.55563/clinexprheumatol/lrff6k
PMID:35238767
Abstract

OBJECTIVES

To evaluate effects of whole-body cryotherapy (WBC) in rheumatoid arthritis (RA).

METHODS

Patients with active RA undergoing a 16-day multimodal rheumatologic complex treatment were randomly assigned to either WBC (6 applications in 14 days at -130°C for 3 min) or no treatment. The primary outcome was the difference between groups in pain on a numerical rating scale after intervention. Secondary outcomes assessed effects on i) disease activity, ii) functional capacity, iii) cytokine levels, and iv) use of analgesics.

RESULTS

A total of 56 RA patients completed the trial (intervention group [IG]: 31 patients, control group [CG]: 25 patients). The mean change (± standard error) in pain after intervention was -2 in the IG (95% confidence interval [CI] -2.75 to -1.31, p<0.001) and -0.88 (95% CI -1.43 to -0.33, p=0.003) in the CG, with a baseline-adjusted between-group difference of -1.31 ± 0.4 (95% CI -2.1 to -0.53; p=0.002). Pain at the 12-week follow-up visit remained significantly below baseline values in the IG. Disease activity and functional capacity showed statistically and clinically meaningful improvement after intervention but were not significant at the 12-week follow up. TNF and IL-6 levels changed significantly in the IG. Eighteen of 31 (58%) patients of the IG reduced or discontinued analgesics at the 12-week follow-up. No WBC-related side effects were reported.

CONCLUSIONS

WBC in RA reduces pain and disease activity significantly and in a clinically meaningful manner, resulting in a reduction of analgesics. These effects are potentially based on a change in cytokine levels.

摘要

目的

评估全身冷冻疗法(WBC)在类风湿关节炎(RA)中的疗效。

方法

接受 16 天多模式风湿科综合治疗的活动期 RA 患者被随机分为 WBC 组(在 14 天内接受 6 次治疗,每次 3 分钟,温度为-130°C)或对照组(不接受治疗)。主要结局是干预后两组患者数字评分量表上疼痛的差异。次要结局评估对以下方面的影响:i)疾病活动度,ii)功能能力,iii)细胞因子水平,以及 iv)镇痛药的使用。

结果

共有 56 例 RA 患者完成了试验(干预组 [IG]:31 例,对照组 [CG]:25 例)。干预后疼痛的平均变化(±标准误差)在 IG 为-2(95%置信区间 [CI] -2.75 至-1.31,p<0.001),在 CG 为-0.88(95% CI -1.43 至-0.33,p=0.003),组间差异为-1.31 ± 0.4(95% CI -2.1 至-0.53;p=0.002)。IG 在 12 周随访时疼痛仍明显低于基线值。疾病活动度和功能能力在干预后均有显著改善,但在 12 周随访时无统计学意义。IG 中 TNF 和 IL-6 水平发生显著变化。IG 中有 18 例(58%)患者在 12 周随访时减少或停用了镇痛药。未报告与 WBC 相关的不良反应。

结论

WBC 可显著减轻 RA 患者的疼痛和疾病活动度,且具有临床意义,从而减少镇痛药的使用。这些效果可能基于细胞因子水平的变化。

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