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行动呼吁:系统审查未能在药物治疗酒精使用障碍的临床试验中纳入女性和少数族裔成员

A Call to Action: A Systematic Review Examining the Failure to Include Females and Members of Minoritized Racial/Ethnic Groups in Clinical Trials of Pharmacological Treatments for Alcohol Use Disorder.

机构信息

From the, PATHS Lab, Department of Psychology, University of Rhode Island, Kingston, Rhode Island.

出版信息

Alcohol Clin Exp Res. 2020 Oct;44(10):1933-1951. doi: 10.1111/acer.14440. Epub 2020 Sep 30.

DOI:10.1111/acer.14440
PMID:32997374
Abstract

Alcohol use disorder (AUD) presents a significant public health concern given the high prevalence estimates and numerous deleterious-associated consequences. The FDA currently has approved 3 pharmacological treatments for alcohol use disorder: acamprosate, naltrexone, and disulfiram. Previous research suggests that there may exist differences in the prevalence of and outcomes related to AUD across sex and racial/ethnic groups. Other work indicates that there may be differences in the efficacy of existing pharmacological treatments for AUD across demographic groups. The purpose of the present study was to examine the inclusion of women and members of minoritized racial/ethnic groups in published randomized clinical trials of pharmacological treatments for alcohol use disorder since 1994, in accordance with the NIH Revitalization Act of 1993. PubMed was systematically searched using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The initial search located 842 articles. After exclusion of ineligible articles, 102 remained for analysis. Of those included in the review, only 11.8% reported full sex and racial/ethnic characteristics of their study participants. Of the total sample, 6 articles were specifically examining 1 racial/ethnic group, and 11 were specifically examining 1 sex. Two articles (2.2%) did not report information regarding the sex breakdown of their participants, while 47 (49.0%) did not report any information regarding the racial/ethnic breakdown of their sample. Despite guidelines set forth by NIH, only 5.9% of articles conducted subgroup analyses to examine differences in treatment outcomes by sex or race/ethnicity, and only 16.7% of articles included considerations related to cultural inclusion when discussing study limitations. These results varied by medication type. Results suggest that considerably greater efforts must be put forth by the larger scientific community regarding the inclusion, analysis, and reporting of data focused on women and non-White racial and ethnic groups.

摘要

酒精使用障碍(AUD)是一个重大的公共卫生问题,因为其患病率估计值较高,且与许多有害后果相关。美国食品和药物管理局(FDA)目前已批准了 3 种用于治疗酒精使用障碍的药理学药物:安非他酮、纳曲酮和双硫仑。先前的研究表明,性别和种族/民族群体之间可能存在 AUD 的患病率和相关结果的差异。其他研究表明,在不同的人口统计学群体中,用于治疗 AUD 的现有药理学药物的疗效可能存在差异。本研究的目的是根据 1993 年美国国立卫生研究院(NIH)复兴法案,检查自 1994 年以来,在关于药理学治疗酒精使用障碍的已发表随机临床试验中,女性和少数族裔群体的纳入情况。使用系统评价和荟萃分析的首选报告项目(PRISMA)声明对 PubMed 进行了系统搜索。最初的搜索共找到了 842 篇文章。在排除不符合条件的文章后,有 102 篇文章被纳入分析。在综述中包括的文章中,只有 11.8%报告了其研究参与者的完整性别和种族/民族特征。在总样本中,有 6 篇文章专门研究了 1 个种族/民族群体,11 篇文章专门研究了 1 个性别。有 2 篇文章(2.2%)没有报告其参与者的性别分类信息,而 47 篇(49.0%)没有报告其样本的种族/民族分类信息。尽管 NIH 制定了指导方针,但只有 5.9%的文章进行了亚组分析,以检查性别或种族/民族对治疗结果的影响,只有 16.7%的文章在讨论研究局限性时考虑了文化包容性。这些结果因药物类型而异。结果表明,更大的科学界必须更加努力地关注女性和非白人和少数民族群体的数据纳入、分析和报告。

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