MacLean Catherine H, Morton Sally C, Ofman Joshua J, Roth Elizabeth A, Shekelle Paul G
RAND, 1700 Main Street, M-23C, Santa Monica, CA 90407-2138, USA.
J Clin Epidemiol. 2003 Jan;56(1):44-51. doi: 10.1016/s0895-4356(02)00520-6.
The goals of this systematic review and meta-analysis were to ascertain whether studies of nonsteroidal anti-inflammatory drugs (NSAIDs) summarized in the FDA reviews are ultimately published, to compare the methodologic and population characteristics of studies summarized in the FDA reviews with those reported in peer reviewed literature, and to compare the pooled relative risk of dyspepsia from NSAIDs in each data source. Summary measures of risk difference were calculated with a random effects model; meta-regression was used to assess the effect of study covariates. Among 37 studies described in the FDA reviews, one was published. Sample size, gender distribution, indication for drug use, and methodologic quality did not vary significantly between the published and FDA data. The pooled risk ratio for dyspepsia obtained using published data (1.21) or FDA data (1.07) did not differ significantly or practically. Data from FDA reviews may be a viable data source for systematic reviews and meta-analyses but only after being subjected to the same methodologic scrutiny as published data.
本系统评价和荟萃分析的目的是确定美国食品药品监督管理局（FDA）审评中总结的非甾体抗炎药（NSAIDs）研究最终是否发表，比较FDA审评中总结的研究与同行评审文献中报告的研究的方法学和人群特征，并比较每个数据源中NSAIDs引起消化不良的合并相对风险。采用随机效应模型计算风险差异的汇总指标；采用Meta回归评估研究协变量的效应。在FDA审评中描述的37项研究中，有1项已发表。已发表数据与FDA数据在样本量、性别分布、用药指征和方法学质量方面无显著差异。使用已发表数据（1.21）或FDA数据（1.07）获得的消化不良合并风险比在统计学上或实际应用中均无显著差异。FDA审评中的数据可能是系统评价和荟萃分析的一个可行数据源，但前提是要经过与已发表数据相同的方法学审查。
