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放射性滑膜切除术联合钐-153 颗粒羟基磷灰石治疗膝关节炎类风湿关节炎患者的疗效:一项对照、随机、双盲试验。

Effectiveness of radiation synovectomy with samarium-153 particulate hydroxyapatite in rheumatoid arthritis patients with knee synovitis: a controlled randomized double-blind trial.

机构信息

Division of Rheumatology, Universidade Federal de São Paulo, Escola Paulista de Medicina (UNIFESP) - São Paulo/SP, Brazil.

出版信息

Clinics (Sao Paulo). 2009;64(12):1187-93. doi: 10.1590/S1807-59322009001200008.

Abstract

OBJECTIVES

The aim of the present study was to investigate the effectiveness of Samarium(153)-particulate hydroxyapatite radiation synovectomy in rheumatoid arthritis patients with chronic knee synovitis.

METHODS

Fifty-eight rheumatoid arthritis patients (60 knees) with chronic knee synovitis participated in a controlled double-blinded trial. Patients were randomized to receive either an intra-articular injection with 40 mg triamcinolone hexacetonide alone (TH group) or 40 mg triamcinolone hexacetonide combined with 15 mCi Samarium(153)-particulate hydroxyapatite (Sm/TH group). Blinded examination at baseline (T0) and at 1 (T1), 4 (T4), 12 (T12), 32 (T32), and 48 (T48) weeks post-intervention were performed on all patients and included a visual analog scale for joint pain and swelling as well as data on morning stiffness, flexion, extension, knee circumference, Likert scale of improvement, percentage of improvement, SF-36 generic quality of life questionnaire, Stanford Health Assessment Questionnaire (HAQ), Lequesne index, use of non-steroidal anti-inflammatory drugs or oral corticosteroids, events and adverse effects, calls to the physician, and hospital visits.

RESULTS

The sample was homogeneous at baseline, and there were no withdrawals. Improvement was observed in both groups in relation to T0, but no statistically significant differences between groups were observed regarding all variables at the time points studied. The Sm/TH group exhibited more adverse effects at T1 (p<0.05), but these were mild and transitory. No severe adverse effects were reported during follow-up.

CONCLUSION

Intra-articular injection of Samarium(153)-particulate hydroxyapatite (15 mCi) with 40 mg of triamcinolone hexacetonide is not superior to triamcinolone hexacetonide alone for the treatment of knee synovitis in patients with rheumatoid arthritis at 1 y of follow-up.

摘要

目的

本研究旨在探讨钐(153)-颗粒羟基磷灰石放射性滑膜切除术治疗慢性膝关节滑膜炎类风湿关节炎患者的疗效。

方法

58 例慢性膝关节滑膜炎的类风湿关节炎患者(60 膝)参与了一项对照性双盲试验。患者随机分为关节内注射 40mg 曲安奈德己酮(TH 组)或 40mg 曲安奈德己酮联合 15mCi 钐(153)-颗粒羟基磷灰石(Sm/TH 组)。所有患者在基线(T0)和 1 周(T1)、4 周(T4)、12 周(T12)、32 周(T32)和 48 周(T48)时进行盲法检查,包括关节疼痛和肿胀的视觉模拟评分,以及晨僵、关节活动度、膝关节周长、改善的 Likert 量表、改善百分比、SF-36 通用生活质量问卷、斯坦福健康评估问卷(HAQ)、莱塞恩指数、非甾体抗炎药或口服皮质类固醇的使用、事件和不良反应、医生电话咨询和就诊次数。

结果

基线时样本具有同质性,且无退出。两组患者在 T0 时均有改善,但在研究的各时间点,两组间所有变量均无统计学差异。Sm/TH 组在 T1 时不良反应更多(p<0.05),但均为轻度和短暂性的。在随访期间未报告严重不良反应。

结论

在 1 年的随访中,关节内注射 40mg 曲安奈德己酮联合 15mCi 钐(153)-颗粒羟基磷灰石(15mCi)并不优于单独使用曲安奈德己酮治疗类风湿关节炎患者的膝关节滑膜炎。

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