Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands
Department of Rheumatology, Sint Maartenskliniek, Nijmegen, The Netherlands.
Ann Rheum Dis. 2019 Jan;78(1):83-90. doi: 10.1136/annrheumdis-2018-214104. Epub 2018 Oct 26.
Low-dose radiation therapy (LDRT) for benign disorders such as knee osteoarthritis (OA) is widely used in some parts of the world, despite absence of controlled studies. We evaluated the effect of LDRT on symptoms and inflammation in patients with knee OA.
In this randomised, double-blinded, sham-controlled clinical trial (RCT), we recruited patients with knee OA (clinical ACR criteria) in the Netherlands, aged ≥50 years, pain score ≥5/10 and non-responding to analgesics and exercise therapy. Patients were randomised 1:1 to receive LDRT (1 Gray per fraction) or sham intervention six times in 2 weeks, stratified by pain (<8 versus ≥8/10). Primary outcome was the proportion of OMERACT-OARSI responders, 3 months postintervention. Secondary outcomes included pain, function and inflammatory signs assessed by ultrasound, MRI and serum inflammatory markers.
We randomly assigned 55 patients: 27 (49%) to LDRT and 28 (51%) to sham. At 3 months postintervention, 12/27 patients (44%; 95% CI 26% to 63%) in the LDRT vs 12/28 patients (43%; 95% CI 25% to 61%) in the sham group responded; difference 2% (95% CI 25% to 28%), OR adjusted for the stratifying variable was 1.1 (95% CI 0.4 to 3.2). Also, for clinical and any of the inflammatory signs, no differences were observed.
We found no substantial beneficial effect on symptoms and inflammatory signs of LDRT in patients knee OA, compared with sham treatment. Therefore, based on this RCT and the absence of other high-quality evidence, we advise against the use of LDRT as treatment for knee OA.
NTR4574.
尽管缺乏对照研究，低剂量辐射疗法（LDRT）仍被广泛用于治疗膝关节骨关节炎（OA）等良性疾病。我们评估了 LDRT 对膝关节 OA 患者症状和炎症的影响。
这是一项随机、双盲、假对照临床试验（RCT），我们在荷兰招募了年龄≥50 岁、疼痛评分≥5/10 且对镇痛药和运动疗法无反应的膝关节 OA 患者。患者按疼痛（<8 与≥8/10）分层，1:1 随机分为 LDRT（1 Gray 每次）或假干预组，在 2 周内接受 6 次治疗。主要结局是干预后 3 个月时 OMERACT-OARSI 应答者的比例。次要结局包括超声、MRI 和血清炎症标志物评估的疼痛、功能和炎症征象。
我们随机分配了 55 名患者：27 名（49%）接受 LDRT，28 名（51%）接受假干预。干预后 3 个月，LDRT 组 27 名患者中有 12 名（44%；95%CI 26%至 63%），假干预组 28 名患者中有 12 名（43%；95%CI 25%至 61%）应答；差异 2%（95%CI 25%至 28%），调整分层变量后，OR 为 1.1（95%CI 0.4 至 3.2）。同样，在临床和任何炎症征象方面，也未观察到差异。
与假治疗相比，我们未发现 LDRT 对膝关节 OA 患者症状和炎症征象有实质性的有益作用。因此，基于这项 RCT 和缺乏其他高质量证据，我们不建议将 LDRT 用于治疗膝关节 OA。
NTR4574。
