Leeb B F, Bird H A, Nesher G, Andel I, Hueber W, Logar D, Montecucco C M, Rovensky J, Sautner J, Sonnenblick M
Lower Austrian Centre for Rheumatology, Humanis Klinikum Lower Austria, Stockerau, Austria.
Ann Rheum Dis. 2003 Dec;62(12):1189-94. doi: 10.1136/ard.2002.002618.
To develop response criteria for polymyalgia rheumatica (PMR) for monitoring treatment and comparing alternative treatments regimens.
76 patients, mean (SD) age 68.7 (7.7) years, were enrolled. Corticosteroids, and non-steroidal anti-inflammatory drugs (NSAIDs) were the only drugs allowed during the observation period. Erythrocyte sedimentation rate (ESR), C reactive protein (CRP), alpha(2) globulin, serum iron, pain, physician's global assessment (PGA), morning stiffness (MST), muscle tenderness (MT), myalgia, and the elevation of upper limbs (EUL) were determined regularly. The daily corticosteroid and NSAID doses as the corticosteroid response time were recorded. To ensure evaluation of an adequate number of patients (n = 57) week 24 was chosen for final analysis.
ESR, CRP, alpha(2) globulin, pain, PGA, MST, myalgia, MT, and EUL showed significant improvement (p<0.0001) at week 24 compared with week 0. Multiple regression analysis showed that changes of ESR (p = 0.08), CRP (p = 0.41), alpha(2) globulin (p = 0.13), MST (p = 0.1), and MT (p = 0.07) were independent of pain, but myalgia (p<0.001) and EUL (p = 0.003) were pain dependent. Consequently, a core set of PMR response criteria, comprising ESR or CRP, pain, PGA, MST, and EUL was established. Assessment of treatment responses with this core set resulted in 90%, 70%, 50%, and 20% improvement in 31/57 (54%), 46/57 (81%), 51/57 (89%), and 54/57 (95%) of the patients, respectively.
These PMR response criteria are a promising tool for better monitoring of disease activity and treatment in PMR. It is proposed that these criteria should be used in clinical trials in the near future to explore alternative treatment options for PMR.
制定风湿性多肌痛(PMR)的反应标准,用于监测治疗效果并比较不同的治疗方案。
纳入76例患者,平均(标准差)年龄68.7(7.7)岁。观察期间仅允许使用皮质类固醇和非甾体抗炎药(NSAIDs)。定期测定红细胞沉降率(ESR)、C反应蛋白(CRP)、α₂球蛋白、血清铁、疼痛程度、医生整体评估(PGA)、晨僵(MST)、肌肉压痛(MT)、肌痛以及上肢抬高(EUL)情况。记录每日皮质类固醇和NSAIDs剂量以及皮质类固醇反应时间。为确保对足够数量的患者(n = 57)进行评估,选择第24周进行最终分析。
与第0周相比,第24周时ESR、CRP、α₂球蛋白、疼痛程度、PGA、MST、肌痛、MT和EUL均有显著改善(p<0.0001)。多元回归分析显示,ESR(p = 0.08)、CRP(p = 0.41)、α₂球蛋白(p = 0.13)、MST(p = 0.1)和MT(p = 0.07)的变化与疼痛无关,但肌痛(p<0.001)和EUL(p = 0.003)与疼痛相关。因此,建立了一套PMR反应核心标准,包括ESR或CRP、疼痛程度、PGA、MST和EUL。使用该核心标准评估治疗反应,结果显示31/57(54%)、46/57(81%)、51/57(89%)和54/57(95%)的患者分别有90%、70%、50%和20%的改善。
这些PMR反应标准是更好地监测PMR疾病活动和治疗效果的有前景的工具。建议在不久的将来将这些标准用于临床试验中探索PMR的替代治疗方案。