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肌肉内氯屈膦酸盐治疗症状性膝骨关节炎的长期疗效:一项随机对照研究。

Intramuscular Clodronate in Long-Term Treatment of Symptomatic Knee Osteoarthritis: A Randomized Controlled Study.

机构信息

Institute of Rheumatology, University of Siena, Siena, Italy.

Unit of Rheumatology, San Pietro Fatebenefratelli Hospital, Rome, Italy.

出版信息

Drugs R D. 2020 Mar;20(1):39-45. doi: 10.1007/s40268-020-00294-4.

Abstract

BACKGROUND AND OBJECTIVE

Clodronate is a nitrogen-free bisphosphonate that is widely and effectively used in the treatment of many osteo-metabolic disorders. The objective of our study was to evaluate the effectiveness of clodronate in reducing pain and bone marrow edema in knee osteoarthritis.

METHODS

In total, 74 patients were included in the study. Group 1 received intramuscular clodronate 200 mg daily for 15 days and then once weekly for the next 11.5 months; group 2 received intramuscular clodronate 200 mg daily for 15 days and then once weekly for the next 2.5 months. Visual analog scale (VAS) scores were recorded at baseline (T0) and after 30 days (T1), 3 months (T2), 6 months (T3), 9 months (T4), and 12 months (end of study; T5). We also evaluated functional status and use of paracetamol (T0, T1, T2, T3, T4, and T5) and changes in Whole Organ Magnetic Resonance Imaging Score (WORMS; T0, T2, and T5).

RESULTS

Both groups had a statistically significant reduction in VAS score until 3 months. Group 1 then experienced further VAS reductions, whereas VAS scores for group 2 progressively increased. Pain, stiffness, and physical function also showed the same trend, as did bone marrow edema extension, which was evaluated with WORMS.

CONCLUSION

Our study indicates that intramuscular administration of a therapeutic dose of clodronate followed by a maintenance dose is effective in the management of symptomatic knee osteoarthritis, improving functional outcomes and reducing pain and bone marrow edema. Prolonged treatment increases the long-term efficacy of clodronate compared with the shorter schedule.

摘要

背景与目的

氯膦酸二钠是一种不含氮的双膦酸盐,广泛且有效地用于治疗多种骨代谢疾病。本研究旨在评估氯膦酸二钠在减轻膝关节骨关节炎疼痛和骨髓水肿方面的疗效。

方法

本研究共纳入 74 例患者。第 1 组接受肌肉注射氯膦酸二钠 200mg,每日 1 次,连用 15 天,之后每周 1 次,共 11.5 个月;第 2 组接受肌肉注射氯膦酸二钠 200mg,每日 1 次,连用 15 天,之后每周 1 次,共 2.5 个月。在基线(T0)、第 30 天(T1)、第 3 个月(T2)、第 6 个月(T3)、第 9 个月(T4)和第 12 个月(研究结束;T5)时记录视觉模拟评分(VAS)。我们还评估了功能状态和对扑热息痛的使用(T0、T1、T2、T3、T4 和 T5)以及全器官磁共振成像评分(WORMS;T0、T2 和 T5)的变化。

结果

两组患者的 VAS 评分均在 3 个月时出现统计学显著下降。第 1 组随后 VAS 评分进一步下降,而第 2 组 VAS 评分逐渐升高。疼痛、僵硬和身体功能也呈现出相同的趋势,WORMS 评估的骨髓水肿扩展也是如此。

结论

我们的研究表明,肌肉注射治疗剂量的氯膦酸二钠后再维持剂量治疗膝关节骨关节炎有症状患者是有效的,可改善功能结局并减轻疼痛和骨髓水肿。与较短的疗程相比,延长治疗可增加氯膦酸二钠的长期疗效。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7326/7067929/93f489a259e2/40268_2020_294_Fig1_HTML.jpg

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