Women's health and gender-based clinical trials on etoricoxib: methodological gender bias
Women's health and gender-based clinical trials on etoricoxib: methodological gender bias
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DOI：
10.1093/pubmed/fdp024
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发表时间：
2009-09-01
影响因子：
4.4
通讯作者：
Horga, J. F.
中科院分区：
文献类型：
--
作者：
Chilet-Rosell, E.;Ruiz-Cantero, M. T.;Horga, J. F.
背景 本研究的目的是确定是否遵守已发布的关于性别和使用依托考昔的临床试验的良好实践指南。选择依托考昔的理由是，它被女性广泛使用，并且有证据表明它与避孕药具和激素替代疗法存在潜在相互作用，正如产品特性中所强调的那样。 方法 该研究回顾了 58 项依托考昔已发表的试验（54 篇论文），以确定它们是否符合食品和药物管理局指南（1993 年）和性、性别和疼痛特殊兴趣小组共识工作组报告（2007 年）的性别建议。结果 女性占 70% etoricoxib 试验总共纳入了 49 835 名受试者，但只有 31% 的受试者处于 I 期。约 85.7% 的试验没有显示性别分层数据。分别约 90.6% 和 93.3% 的受访者未提供按性别划分的疗效和不良反应数据。关于专门影响女性的问题的影响的信息很少。讨论 在已发表的依托考昔试验中，特别是在 I 期试验中，女性的代表性不足。在依托考昔试验中，关于疗效和不良反应的性别分层数据很少。再加上缺乏有关女性特有问题的数据，这表明依托考昔可能对女性造成与其他环氧合酶 2 抑制剂相同的潜在问题。
Background The aim of this study was to determine compliance with published good practice guidelines for gender and clinical trials using etoricoxib. The rationale for choosing etoricoxib was that it is widely used by women and there is evidence of potential interaction with contraceptives and hormone replacement therapy as highlighted in the product characteristics.Methods The study reviewed 58 etoricoxib published trials (54 papers) to determine if they met the gender recommendations of the Guidelines of Food and Drug Administration (1993) and the Sex, Gender and Pain Special Interest Group Consensus Working Group Report (2007).Results Women formed 70% of a total of 49 835 subjects included in the etoricoxib trials, but only 31% of the subjects were in Phase I. About 85.7% of trials did not show sex-stratified data. About 90.6 and 93.3% did not provide efficacy and adverse effects data by sex, respectively. There is scarce information about the influence of issues that specifically affect women.Discussion Women are under-represented in the published etoricoxib trials, specifically, in Phase I. Sex-stratified data on efficacy and adverse effects are scarce in etoricoxib trials. Together with the lack of data on women-specific issues, this suggests that etoricoxib may pose the same potential problems for women as other cyclooxygenase-2 inhibitors.