Robinson P, Keenan A-M, Conaghan P G
Leeds Teaching Hospitals, Leeds, UK.
Rheumatology (Oxford). 2007 Feb;46(2):285-91. doi: 10.1093/rheumatology/kel217. Epub 2006 Jul 26.
To assess symptomatic change after intra-articular corticosteroid (IAST) injection at 2 doses in hip osteoarthritis (OA), and to examine dose response and predictors of response.
Patients with hip OA (90 women and 30 men and median age 64 yrs) referred for IAST fluoroscopic injection were included in this longitudinal, clinical trial. WOMAC scores, body mass index (BMI), conventional radiographic grade (Kellgren and Lawrence scoring) and ultrasound measures (including capsular thickness and osteophyte assessments) were recorded at baseline. In the first phase of the study, 75 patients were injected with 40 mg methylprednisolone; another 45 patients were injected with 80 mg in the second phase. Change in WOMAC scores from baseline to weeks 6 and 12 were calculated for each dose and then dose comparisons were made. Clinical responders (>15% reduction in baseline pain score) were identified in order to establish predictors of response.
For the 40 mg dose, there was a statistically significant improvement in pain (P < 0.001) and stiffness (P < 0.001) but not disability at week 6, and only the improvement in stiffness at week 12 was maintained (P = 0.041). For the 80 mg dose, there was significant improvement in pain (P < 0.001), stiffness (P < 0.001) and disability (P < 0.001) at week 6, which was maintained for all domains at week 12 (P = 0.002; P = 0.001; P < 0.001). When the doses were compared, the 80 mg dose demonstrated a significant improvement compared with the 40 mg group for stiffness at week 12 (P = 0.026) and disability at both weeks 6 and 12 (P = 0.026; P = 0.004). Imaging findings did not relate to severity of symptoms or response to IAST.
In these two hip OA cohorts, both the 40 mg and 80 mg IAST doses had a beneficial effect at week 6, while the 80 mg dose maintained this improvement at week 12. Comparison of the two dose groups provided some evidence of a dose response. Randomized controlled trials of IAST for hip OA are now required.
评估髋关节骨关节炎（OA）患者关节腔内注射两种剂量糖皮质激素（IAST）后的症状变化，并研究剂量反应及反应的预测因素。
本纵向临床试验纳入了因IAST透视注射而转诊的髋关节OA患者（90名女性和30名男性，中位年龄64岁）。在基线时记录WOMAC评分、体重指数（BMI）、传统X线分级（Kellgren和Lawrence评分）以及超声测量结果（包括关节囊厚度和骨赘评估）。在研究的第一阶段，75名患者注射40mg甲泼尼龙；在第二阶段，另外45名患者注射80mg。计算每种剂量从基线到第6周和第12周WOMAC评分的变化，然后进行剂量比较。确定临床反应者（基线疼痛评分降低>15%）以建立反应的预测因素。
对于40mg剂量组，在第6周时疼痛（P<0.001）和僵硬（P<0.001）有统计学显著改善，但功能障碍无改善，且仅第12周时僵硬的改善得以维持（P=0.041）。对于80mg剂量组，在第6周时疼痛（P<0.001）、僵硬（P<0.001）和功能障碍（P<0.001）均有显著改善，且在第12周时所有方面的改善均得以维持（P=0.002；P=0.001；P<0.001）。当比较两种剂量时，80mg剂量组在第12周时的僵硬程度（P=0.026）以及第6周和第12周时的功能障碍程度（P=0.026；P=0.004）与40mg组相比有显著改善。影像学检查结果与症状严重程度或IAST反应无关。
在这两个髋关节OA队列中，40mg和80mg的IAST剂量在第6周时均有有益作用，而80mg剂量在第12周时仍维持这种改善。两个剂量组的比较提供了一些剂量反应的证据。现在需要对髋关节OA的IAST进行随机对照试验。
