Servicio de Farmacia, Hospital Universitario Virgen del Rocío, Sevilla, Spain.
PLoS One. 2021 Sep 23;16(9):e0257765. doi: 10.1371/journal.pone.0257765. eCollection 2021.
Asthma is one of the most common chronic diseases characterized by sex disparities. Gender bias is a well-documented issue detected in the design of published clinical trials (CTs). International guidelines encourage researchers to analyze clinical data by sex, gender, or both where appropriate. The objective of this work was to evaluate gender bias in the published CTs of biological agents for the treatment of severe asthma. A systematic review of randomized controlled CTs of the biological agents (omalizumab, benralizumab, reslizumab, mepolizumab or dupilumab) for the treatment of severe asthma was conducted. The literature search was performed using PubMed and EMBASE without language restrictions. This study followed the corresponding international recommendations. We identified a total of 426 articles, of which 37 were finally included. Women represented 60.4% of patients included. The mean percentage of women in these trials was 59.9%, ranged from 40.8% to 76.7%. The separate analysis by sex of the main variable was only performed in 5 of the 37 publications included, and none of the trials analyzed secondary variables by sex. Only 1 of the articles discussed the results separately by sex. No study included the concept of gender in the text or analyzed the results separately by gender. The proportion of women included in CTs was higher compared to publications of other disciplines, where women were under-represented. The analysis of the main and secondary variables by sex or gender, even the discussion separately by sex, was insufficient. This gives rise to potential gender bias in these CTs.
哮喘是最常见的慢性疾病之一，其特征是存在性别差异。性别偏见是在已发表的临床试验（CT）设计中发现的一个有据可查的问题。国际指南鼓励研究人员在适当的情况下根据性别、性别或两者来分析临床数据。这项工作的目的是评估治疗严重哮喘的生物制剂已发表 CT 中的性别偏见。对生物制剂（奥马珠单抗、贝那鲁单抗、瑞利珠单抗、美泊利珠单抗或度普利尤单抗）治疗严重哮喘的随机对照 CT 进行了系统评价。文献检索使用了无语言限制的 PubMed 和 EMBASE。本研究遵循了相应的国际建议。我们共确定了 426 篇文章，其中 37 篇最终被纳入。纳入的患者中女性占 60.4%。这些试验中女性的平均比例为 59.9%，范围为 40.8%至 76.7%。仅在纳入的 37 篇出版物中的 5 篇中按性别对主要变量进行了单独分析，且没有试验按性别对次要变量进行了分析。仅有 1 篇文章按性别分别讨论了结果。没有研究在文本中包含性别概念，也没有按性别分别分析结果。与其他学科的出版物相比，CT 中纳入的女性比例更高，但女性代表性不足。按性别或性别对主要和次要变量进行分析，甚至分别按性别进行讨论，都不够充分。这使得这些 CT 中存在潜在的性别偏见。
