Maximos Mira, Brabete Andreea, Lê Mê-Linh, Greaves Lorraine
, PharmD, MSc, ACPR, was, at the time of this study, with Woodstock Hospital, Woodstock, Ontario, and the Centre of Excellence for Women's Health, Vancouver, British Columbia. She is now with Women's College Hospital and the Leslie Dan Faculty of Pharmacy, University of Toronto, Toronto, Ontario. During the study period, Dr Maximos was a PhD student with the School of Pharmacy, University of Waterloo, and those studies are still in progress.
, PhD, is with the Centre of Excellence for Women's Health, Vancouver, British Columbia.
Can J Hosp Pharm. 2023 Jul 5;76(3):239-245. doi: 10.4212/cjhp.3299. eCollection 2023 Summer.
Biological sex-related factors influence pharmacokinetic, pharmacodynamic, and disease processes that may affect the predictability of drug dosing and adverse effects, which may in turn have clinical consequences for patients' lives. Nonetheless, sex-related factors are not always taken into account in clinical trial design or clinical decision-making, for multiple reasons, including a paucity of studies that clearly and objectively study and measure sex-disaggregated and sex-related outcomes, as well as gaps in regulatory and policy structures for integrating these considerations.
To complete a narrative review and use a case study to understand available evidence, inform future research, and provide policy considerations that incorporate information on sex- and gender-related factors into clinician-facing resources.
A comprehensive review of available literature was conducted using a sex- and gender-based analysis plus (SGBA Plus) approach to identify sex- and/or gender-disaggregated information for gilteritinib, a chemotherapeutic agent. Systematic searches were performed in MEDLINE (Ovid), Embase (Ovid), CENTRAL (Wiley), International Pharmaceutical Abstracts (Ovid), Scopus, and ClinicalTrials.gov, from inception to March 18, 2021. The information was then summarized and compared with the Canadian product monograph for this drug.
Of 311 records screened, 3 provided SGBA Plus information as a component of outcomes, rather than just as categories or demographic characteristics. Of these, 2 were case studies, and 1 was a clinical trial. No studies from the ClinicalTrials.gov database that were in progress at the time of this review provided details about sex-disaggregated outcomes. The Canadian product monograph did not include sex-disaggregated outcome data.
The available evidence from clinical trials, other published literature, and guidance documents does not provide details about sex-disaggregated outcomes for gilteritinib. This paucity of available evidence may create a challenge for clinicians who are making decisions about the efficacy and safety of prescribed therapies in sex-specific populations that have not been well studied.
生物性别相关因素会影响药代动力学、药效学及疾病进程，这可能会影响药物剂量预测性及不良反应，进而可能对患者生命产生临床影响。然而，由于多种原因，性别相关因素在临床试验设计或临床决策中并不总是被考虑在内，包括缺乏清晰客观地研究和测量按性别分类及与性别相关结果的研究，以及整合这些考量因素的监管和政策结构存在缺陷。
进行叙述性综述并通过案例研究来了解现有证据，为未来研究提供信息，并提供政策考量，将与性别相关因素的信息纳入面向临床医生的资源中。
采用基于性别分析加（SGBA Plus）方法对现有文献进行全面综述，以确定化疗药物吉列替尼按性别和/或性别的分类信息。从数据库建立至2021年3月18日，在MEDLINE（Ovid）、Embase（Ovid）、CENTRAL（Wiley）、国际药学文摘（Ovid）、Scopus和ClinicalTrials.gov中进行系统检索。然后对信息进行总结，并与该药物的加拿大产品说明书进行比较。
在筛选的311条记录中，有3条提供了SGBA Plus信息作为结果的一个组成部分，而不仅仅是作为类别或人口统计学特征。其中，2条是案例研究，1条是临床试验。在本次综述时，ClinicalTrials.gov数据库中正在进行的研究均未提供按性别分类结果的详细信息。加拿大产品说明书未包括按性别分类的结果数据。
临床试验、其他已发表文献和指导文件中的现有证据未提供吉列替尼按性别分类结果的详细信息。这种现有证据的匮乏可能给临床医生在对研究不足的特定性别群体中规定治疗的疗效和安全性做出决策时带来挑战。
