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ArthroRad 试验:低剂量放射治疗对骨关节炎疼痛的随机多中心单盲试验-12 个月随访的最终结果。

ArthroRad trial: randomized multicenter single-blinded trial on the effect of low-dose radiotherapy for painful osteoarthritis-final results after 12-month follow-up.

机构信息

Department of Radiotherapy and Radiooncology, Saarland University Medical Center Homburg/Saar, Homburg/Saar, Germany.

, Mühlstraße 28, 66894, Bechhofen, Germany.

出版信息

Strahlenther Onkol. 2024 Feb;200(2):134-142. doi: 10.1007/s00066-023-02152-z. Epub 2023 Oct 10.

DOI:10.1007/s00066-023-02152-z
PMID:37815599
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10806033/
Abstract

OBJECTIVE

Updated report about the randomized comparison of the effect of radiotherapy on painful osteoarthritis (OA) applying a standard dose vs. a very low dose regime after a follow-up of 1 year.

PATIENTS AND METHODS

Patients presenting with OA of the hand/finger and knee joints were included. After randomization (every joint region was randomized separately) the following protocols were applied: (a) standard arm: total dose 3.0 Gy, single fractions of 0.5 Gy twice a week; (b) experimental arm: total dose 0.3 Gy, single fractions of 0.05 Gy twice a week. The dosage was blinded for the patients. For evaluation the scores after 1‑year visual analog scale (VAS), Knee Injury and Osteoarthritis Outcome Score-Short Form (KOOS-PS), Short Form Score for the Assessment and Quantification of Chronic Rheumatic Affections of the Hands (SF-SACRAH) and 12-item Short-Form Health Survey (SF-12) were used (for further details: see [1]).

RESULTS

The standard dose was applied to 77 hands and 33 knees, the experimental dose was given to 81 hands and 30 knees. After 12 months, the data of 128 hands and 45 knees were available for evaluation. Even after this long time, we observed a favorable response of pain to radiotherapy in both trial arms; however, there were no reasonable statistically significant differences between both arms concerning pain, functional, and quality of life scores. Side effects did not occur. The only prognostic factor was the pain level before radiotherapy.

CONCLUSIONS

We found a favorable pain relief and a limited response in the functional and quality of life scores in both treatment arms. The possible effect of low doses such as 0.3 Gy on pain is widely unknown.

摘要

目的

报道应用标准剂量与极低剂量放射疗法治疗手部/手指和膝关节骨关节炎疼痛的随机比较结果,随访时间为 1 年。

患者和方法

纳入患有手部/手指和膝关节骨关节炎的患者。随机分组后(每个关节区域单独随机分组),应用以下方案:(a)标准组:总剂量 3.0Gy,单次剂量 0.5Gy,每周 2 次;(b)实验组:总剂量 0.3Gy,单次剂量 0.05Gy,每周 2 次。剂量对患者设盲。治疗 1 年后采用视觉模拟评分(VAS)、膝关节损伤和骨关节炎结果评分-短表(KOOS-PS)、慢性风湿性手部疾病评估和量化短表(SF-SACRAH)和 12 项简明健康调查量表(SF-12)评估评分。(更多详细信息,请参见[1])。

结果

标准剂量组应用于 77 只手和 33 个膝关节,实验组应用于 81 只手和 30 个膝关节。治疗 12 个月后,128 只手和 45 个膝关节的数据可用于评估。即使经过这么长时间,我们观察到两组患者的疼痛对放射治疗均有良好的反应;然而,两组之间在疼痛、功能和生活质量评分方面没有合理的统计学差异。未出现副作用。唯一的预后因素是放射治疗前的疼痛水平。

结论

我们发现两组治疗均能缓解疼痛,且在功能和生活质量评分方面有一定的反应。0.3Gy 等低剂量对疼痛的可能作用尚不清楚。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/680a/10806033/59af450b3045/66_2023_2152_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/680a/10806033/4cc9ad31de74/66_2023_2152_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/680a/10806033/59af450b3045/66_2023_2152_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/680a/10806033/4cc9ad31de74/66_2023_2152_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/680a/10806033/59af450b3045/66_2023_2152_Fig2_HTML.jpg

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