Hickling P, Jacoby R K, Kirwan J R
Mount Gould Hospital, Plymouth.
Br J Rheumatol. 1998 Sep;37(9):930-6. doi: 10.1093/rheumatology/37.9.930.
Prednisolone reduced the progression of joint destruction over 2 yr in early, active rheumatoid arthritis. The response to discontinuation of prednisolone under double-blind conditions is now reported.
A randomized, double-blind, placebo-controlled trial of prednisolone 7.5 mg daily in addition to routine medication over 2 yr in 128 patients with early rheumatoid arthritis, using radiological progression (changes in the Larsen score) and the development of erosions as primary outcome measures. Study medication was blindly discontinued and follow-up maintained for a further year. Other assessments included disability, joint inflammation, pain and the acute-phase response.
Similar results were obtained when all available radiographs were included for each year of assessment (maximum 114) and when only patients with radiographs at all time points were included (75 patients). In these 75, the mean progression in the prednisolone group was 0.21 Larsen units in year 1, 0.04 units in year 2 and 1.01 units in year 3 (P = 0.587, 0.913 and 0.039 for change within each year, respectively). The equivalent placebo group means were 2.34, 1.00 and 1.63 Larsen units (P = 0.001, 0.111 and 0.012; difference between groups: 2.13, 0.96 and 0.67 units, P = 0.082, 0.02 and 0.622). The percentage of hands which had erosions at each time point was: prednisolone group: 27.8, 29.2, 34.7 and 39.2; placebo group: 28.2, 48.7, 59.0 and 66.5. There was little evidence for a flare in clinical symptoms after discontinuation of prednisolone.
Joint destruction resumed after discontinuation of prednisolone. This corroborates the previously reported therapeutic effect and challenges current concepts of disease pathogenesis.
在早期、活动期类风湿关节炎患者中，泼尼松龙可在2年内减缓关节破坏的进展。现将在双盲条件下停用泼尼松龙后的反应报告如下。
一项随机、双盲、安慰剂对照试验，对128例早期类风湿关节炎患者除常规药物治疗外，每日加用7.5mg泼尼松龙，为期2年，以放射学进展（ Larsen评分变化）和骨侵蚀的出现作为主要结局指标。研究药物被盲目停用，并继续随访1年。其他评估包括残疾情况、关节炎症、疼痛和急性期反应。
在每年评估时纳入所有可用X线片（最多114例）以及仅纳入在所有时间点均有X线片的患者（75例）时，均获得了相似的结果。在这75例患者中，泼尼松龙组第1年的平均进展为0.21个Larsen单位，第2年为0.04个单位，第3年为1.01个单位（每年变化的P值分别为0.587、0.913和0.039）。相应安慰剂组的平均值分别为2.34、1.00和1.63个Larsen单位（P值分别为0.001、0.111和0.012；组间差异：2.13、0.96和0.67个单位，P值分别为0.082、0.02和0.622）。各时间点出现骨侵蚀的手部比例为：泼尼松龙组：27.8%、29.2%、34.7%和39.2%；安慰剂组：28.2%、48.7%、59.0%和66.5%。几乎没有证据表明停用泼尼松龙后临床症状会出现 flare。
停用泼尼松龙后关节破坏再次出现。这证实了先前报道的治疗效果，并对当前的疾病发病机制概念提出了挑战。
