解释复发性多发性硬化症随机对照试验中安慰剂组年复发率的时间趋势：系统回顾和荟萃回归
Explaining temporal trends in annualized relapse rates in placebo groups of randomized controlled trials in relapsing multiple sclerosis: systematic review and meta-regression
摘要：
背景资料：最近的研究表明，复发性多发性硬化症（RMS）的随机对照试验（RCT）中安慰剂组的年复发率（ARR）降低。方法：我们对RMS的RCT进行了系统的文献检索。提取了合格标准和基线特征数据，并检验了随时间推移的显著趋势。进行了一项荟萃回归，以估计其对试验ARR随时间降低的贡献。结果：我们确定了56项研究。基线时患者年龄（p < 0.001），基线时多发性硬化（MS）的平均持续时间（p = 0.048），治疗组规模（p = 0.003），牛津质量量表评分（p = 0.021），以及合格标准的数量（p<0.001）显著增加，而试验前ARR（p = 0.001），计算试验前ARR的时间跨度（p < 0.001），安慰剂对照随访的持续时间（p = 0.006）随时间显著减少。在试验安慰剂ARR的荟萃回归中，发现时间趋势不显著，主要因素解释了变异：试验前ARR、用于计算试验前ARR的年数和研究持续时间。结论：观察到的试验ARR下降可能是由于试验前ARR下降和计算试验前ARR的时间较短所致。增加患者年龄和疾病持续时间也可能有贡献。
英文摘要：
Background: Recent studies have shown a decrease in annualised relapse rates (ARRs) in placebo groups of randomised controlled trials (RCTs) in relapsing multiple sclerosis (RMS). Methods: We conducted a systematic literature search of RCTs in RMS. Data on eligibility criteria and baseline characteristics were extracted and tested for significant trends over time. A meta-regression was conducted to estimate their contribution to the decrease of trial ARRs over time. Results: We identified 56 studies. Patient age at baseline (p < 0.001), mean duration of multiple sclerosis (MS) at baseline (p = 0.048), size of treatment groups (p = 0.003), Oxford Quality Scale scores (p = 0.021), and the number of eligibility criteria (p<0.001) increased significantly, whereas pre-trial ARR (p = 0.001), the time span over which pre-trial ARR was calculated (p < 0.001), and the duration of placebo-controlled follow-up (p = 0.006) decreased significantly over time. In meta-regression of trial placebo ARR, the temporal trend was found to be insignificant, with major factors explaining the variation: pre-trial ARR, the number of years used to calculate pre-trial ARR and study duration. Conclusion: The observed decline in trial ARRs may result from decreasing pre-trial ARRs and a shorter time period over which pre-trial ARRs were calculated. Increasing patient age and duration of illness may also contribute.
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