Raine Charles, Stapleton Philip P, Merinopoulos Dimos, Maw Win Win, Achilleos Katerina, Gayford Dawn, Mapplebeck Sarah, Mackerness Craig, Schofield Paul, Dasgupta Bhaskar
Department of Rheumatology, Southend University Hospital NHS Foundation Trust, Westcliff-on-Sea, UK.
Department of Rheumatology, Broomfield Hospital, Mid Essex Hospital Services NHS Trust, Chelmsford, UK.
Int J Rheum Dis. 2018 Jan;21(1):285-291. doi: 10.1111/1756-185X.13149. Epub 2017 Aug 9.
A feasibility study to assess efficacy and safety of modified release (MR) prednisone (Lodotra™) compared to immediate release (IR) prednisolone in patients with newly diagnosed giant cell arteritis (GCA).
Twelve patients with new diagnosis of GCA were initially treated with high-dose prednisolone (40-60 mg) daily for 4 weeks and then randomized to two open arms to continue tapering steroid treatment with either standard IR prednisolone or MR prednisone. Patients were reviewed every 2 weeks either face to face or by telephone, for a total of 26 weeks. Disease activity, steroid-related side effects, sleep disturbance, fatigue scores and blood tests were systematically monitored. The primary endpoint (efficacy) was defined as the proportion of patients achieving persistent clinical disease control (without features of active disease and remaining flare free at 26 weeks) in each arm.
At 26 weeks, 6/7 patients taking MR prednisone were in persistent control, compared with 4/5 receiving IR prednisone. One patient in each group suffered a disease flare necessitating an increased steroid dose. There were no statistically significant differences between the groups in terms of reduction in inflammatory markers, Health Assessment Questionnaire, visual analogue scale, fatigue and improvement in EuroQol 5D scores.
This trial shows that MR prednisone appears to be a safe and effective treatment for GCA with a similar outcome profile to standard IR prednisolone.
进行一项可行性研究，以评估缓释泼尼松（Lodotra™）与速释泼尼松龙相比，在新诊断的巨细胞动脉炎（GCA）患者中的疗效和安全性。
12例新诊断为GCA的患者最初每日接受高剂量泼尼松龙（40 - 60毫克）治疗4周，然后随机分为两个开放组，分别继续用标准速释泼尼松龙或缓释泼尼松逐渐减少类固醇治疗。每2周对患者进行面对面或电话复查，共26周。系统监测疾病活动度、类固醇相关副作用、睡眠障碍、疲劳评分和血液检查。主要终点（疗效）定义为每组中达到持续临床疾病控制（无活动性疾病特征且在26周时无复发）的患者比例。
在26周时，服用缓释泼尼松的7例患者中有6例处于持续控制状态，而接受速释泼尼松龙的5例患者中有4例。每组各有1例患者病情复发，需要增加类固醇剂量。两组在炎症标志物降低、健康评估问卷、视觉模拟量表、疲劳以及欧洲五维健康量表评分改善方面无统计学显著差异。
该试验表明，缓释泼尼松似乎是一种治疗GCA的安全有效的方法，其结果与标准速释泼尼松龙相似。
