Gotzsche P C, Johansen H K
The Nordic Cochrane Centre, Rigshospitalet, Blegdamsvej 9, DK-21OO Copenhagen O, Denmark.
Cochrane Database Syst Rev. 2000(2):CD000189. doi: 10.1002/14651858.CD000189.
The effect of low dose corticosteroids, equivalent to 15 mg prednisolone daily or less, in patients with rheumatoid arthritis has been questioned. We therefore performed a systematic review of trials which compared corticosteroids with placebo or non-steroidal, anti-inflammatory drugs.
To determine whether short-term (i.e. as recorded within the first month of therapy), oral low-dose corticosteroids (corresponding to a maximum of 15 mg prednisolone daily) is superior to placebo and nonsteroidal, antiinflammatory drugs in patients with rheumatoid arthritis.
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All randomised studies comparing an oral corticosteroid (not exceeding an equivalent of 15 mg prednisolone daily) with placebo or a nonsteroidal, antiinflammatory drug were eligible if they reported clinical outcomes within one month after start of therapy.
Decisions on which trials to include were made independently by two observers based on the methods sections of the trials only. Standardised effect measures were used for the statistical analyses; the random effects model was used if P<0.10 for the test of heterogeneity.
Ten studies, involving 320 patients, were included in the meta-analysis. Prednisolone had a marked effect over placebo on joint tenderness (standardised effect size 1.31, 95% confidence interval 0.78 to 1.83), pain (standardised effect size 1.75, 0.87 to 2.64) and grip strength (standardised effect size 0.41, 0.13 to 0.69). Measured in the original units, the differences were 12 tender joints (6 to 18) and 22 mm Hg (5 to 40) for grip strength. Prednisolone also had a greater effect than nonsteroidal, antiinflammatory drugs on joint tenderness (standardised effect size 0.63, 0.11 to 1.16) and pain (standardised effect size 1.25, 0.26 to 2.24), whereas the difference in grip strength was not significant (standardised effect size 0.31, -0.02 to 0.64). Measured in the original units, the differences were 9 tender joints (5 to 12) and 12 mm Hg (-6 to 31). The risk of adverse effects, also during moderate- and long-term use, seemed acceptable.
REVIEWER'S CONCLUSIONS: Prednisolone in low doses (not exceeding 15 mg daily) may be used intermittently in patients with rheumatoid arthritis, particularly if the disease cannot be controlled by other means. Since prednisolone is highly effective, short-term placebo controlled trials studying the clinical effect of low-dose prednisolone or other oral corticosteroids are no longer necessary.
低剂量皮质类固醇(相当于每日15毫克或更低剂量的泼尼松龙)对类风湿性关节炎患者的疗效一直受到质疑。因此,我们对比较皮质类固醇与安慰剂或非甾体抗炎药的试验进行了系统评价。
确定短期(即治疗第一个月内记录的)口服低剂量皮质类固醇(相当于每日最多15毫克泼尼松龙)在类风湿性关节炎患者中是否优于安慰剂和非甾体抗炎药。
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所有比较口服皮质类固醇(每日不超过相当于15毫克泼尼松龙)与安慰剂或非甾体抗炎药的随机研究,若其报告了治疗开始后一个月内的临床结果,则符合入选标准。
两名观察者仅根据试验的方法部分独立决定纳入哪些试验。统计分析采用标准化效应量;若异质性检验P<0.10,则使用随机效应模型。
荟萃分析纳入了10项研究,涉及320名患者。泼尼松龙在关节压痛(标准化效应量1.31,95%置信区间0.78至1.83)、疼痛(标准化效应量1.75,0.87至2.64)和握力(标准化效应量0.41,0.13至0.