妊娠期药物警戒研究、暴露和结果确定以及中低收入国家的研究结果:范围综述》。

IF 4 2区 医学 Q1 PHARMACOLOGY & PHARMACY Drug Safety Pub Date : 2024-10-01 Epub Date: 2024-06-21 DOI:10.1007/s40264-024-01445-1
Jenine Shafi, Maneet K Virk, Emma Kalk, James G Carlucci, Audrey Chepkemoi, Caitlin Bernard, Megan S McHenry, Edwin Were, John Humphrey, Mary-Ann Davies, Ushma C Mehta, Rena C Patel
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引用次数: 0

摘要

简介药物警戒(PV),即药物获得许可后的持续安全性监测,在妊娠期发挥着至关重要的作用,因为临床试验通常将孕妇排除在外。了解妊娠药物警戒项目在中低收入国家(LMICs)的运行情况非常重要,这些国家的药物警戒数据非常缺乏,但妊娠不良结局的负担却很重。我们进行了一次范围界定审查,以评估最近发表的中低收入国家妊娠风险评估项目是如何测量暴露和结果的:方法:我们利用搜索字符串、二次审查和团队知识审查了关于低收入国家孕妇治疗或疫苗暴露的出版物。在进行全文审阅之前,我们对摘要进行了相关性筛选,并记录了对暴露和结果(分为孕产妇、出生或新生儿/婴儿)的测量,以及其他因素,包括研究主题、环境和设计、比较组和资金来源:我们确定了 31 篇 PV 出版物,涵盖至少 24 个低收入和中等收入国家,所有这些出版物都关注传染病的治疗或疫苗,包括 HIV(17 篇)、肺结核(9 篇)、疟疾(7 篇)、百日咳、破伤风和白喉(1 篇)以及流感(3 篇)。在结果方面,分别有 15、31 和 20 篇出版物涉及孕产妇、新生儿和婴儿的结果。在针对艾滋病病毒的出版物中,主要的暴露-结果关系是孕产妇抗逆转录病毒疗法暴露与不良结果的关系。在结核病特异性出版物中,主要关注的暴露是二线耐药结核病和以异烟肼为基础的艾滋病病毒感染孕妇预防疗法。对于疟疾特异性出版物,主要关注的暴露-结果关系是孕期抗疟药物暴露和不良后果。在以疫苗为重点的出版物中,评估的是孕期特定时间的暴露情况,总体关注点是疫苗的安全性和/或有效性。研究背景通常来自非洲,设计从队列或横断面研究到临床试验各不相同,资金来源主要来自高收入国家:结论:已发表的妊娠 PV 项目主要集中在非洲,并与传染病有关。这可能反映了低收入与中等收入国家的疾病负担,但也反映了高收入国家的优先资助重点。随着非传染性疾病在低收入与中等收入国家发病率的增加,妊娠期保健项目必须扩大其范围。报告最多的是出生和新生儿/婴儿的结果,而关于产妇结果的报告较少,没有关于儿童长期结果的报告;此外,在具体措施的定义和确定方面也存在差异。值得注意的是,几乎所有的项目都只涉及单一的治疗暴露,错失了利用其项目来涵盖更多暴露、增加科学严谨性、在医疗服务中建立统一性以及支持现有医疗系统的机会。对于许多出版物来说,暴露的时间,特别是三个月的暴露时间,对于孕产妇和新生儿的安全至关重要。虽然目前发表的妊娠期母婴风险文献为了解低收入和中等收入国家的母婴风险状况提供了深入的见解,但还需要进一步开展工作,以实现定义和测量的标准化,整合各医疗服务机构的母婴风险项目,并建立更长期的监测。
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Pharmacovigilance in Pregnancy Studies, Exposures and Outcomes Ascertainment, and Findings from Low- and Middle-Income Countries: A Scoping Review.

Introduction: Pharmacovigilance (PV), or the ongoing safety monitoring after a medication has been licensed, plays a crucial role in pregnancy, as clinical trials often exclude pregnant people. It is important to understand how pregnancy PV projects operate in low- and middle-income countries (LMICs), where there is a disproportionate lack of PV data yet a high burden of adverse pregnancy outcomes. We conducted a scoping review to assess how exposures and outcomes were measured in recently published pregnancy PV projects in LMICs.

Methods: We utilized a search string, secondary review, and team knowledge to review publications focusing on therapeutic or vaccine exposures among pregnant people in LMICs. We screened abstracts for relevance before conducting a full text review, and documented measurements of exposures and outcomes (categorized as maternal, birth, or neonatal/infant) among other factors, including study topic, setting, and design, comparator groups, and funding sources.

Results: We identified 31 PV publications spanning at least 24 LMICs, all focusing on therapeutics or vaccines for infectious diseases, including HIV (n = 17), tuberculosis (TB; n = 9), malaria (n = 7), pertussis, tetanus, and diphtheria (n = 1), and influenza (n = 3). As for outcomes, n = 15, n = 31, and n = 20 of the publications covered maternal, birth, and neonatal/infant outcomes, respectively. Among HIV-specific publications, the primary exposure-outcome relationship of focus was exposure to maternal antiretroviral therapy and adverse outcomes. For TB-specific publications, the main exposures of interest were second-line drug-resistant TB and isoniazid-based prevention therapeutics for pregnant people living with HIV. For malaria-specific publications, the primary exposure-outcome relationship of interest was antimalarial medication exposure during pregnancy and adverse outcomes. Among vaccine-focused publications, the exposure was assessed during a specific time during pregnancy, with an overall interest in vaccine safety and/or efficacy. The study settings were frequently from Africa, designs varied from cohort or cross-sectional studies to clinical trials, and funding sources were largely from high-income countries.

Conclusion: The published pregnancy PV projects were largely centered in Africa and concerned with infectious diseases. This may reflect the disease burden in LMICs but also funding priorities from high-income countries. As the prevalence of non-communicable diseases increases in LMICs, PV projects will have to broaden their scope. Birth and neonatal/infant outcomes were most reported, with fewer reporting on maternal outcomes and none on longer-term child outcomes; additionally, heterogeneity existed in definitions and ascertainment of specific measures. Notably, almost all projects covered a single therapeutic exposure, missing an opportunity to leverage their projects to cover additional exposures, add scientific rigor, create uniformity across health services, and bolster existing health systems. For many publications, the timing of exposure, specifically by trimester, was crucial to maternal and neonatal safety. While currently published pregnancy PV literature offer insights into the PV landscape in LMICs, further work is needed to standardize definitions and measurements, integrate PV projects across health services, and establish longer-term monitoring.

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来源期刊
Drug Safety
Drug Safety 医学-毒理学
CiteScore
7.60
自引率
7.10%
发文量
112
审稿时长
6-12 weeks
期刊介绍: Drug Safety is the official journal of the International Society of Pharmacovigilance. The journal includes: Overviews of contentious or emerging issues. Comprehensive narrative reviews that provide an authoritative source of information on epidemiology, clinical features, prevention and management of adverse effects of individual drugs and drug classes. In-depth benefit-risk assessment of adverse effect and efficacy data for a drug in a defined therapeutic area. Systematic reviews (with or without meta-analyses) that collate empirical evidence to answer a specific research question, using explicit, systematic methods as outlined by the PRISMA statement. Original research articles reporting the results of well-designed studies in disciplines such as pharmacoepidemiology, pharmacovigilance, pharmacology and toxicology, and pharmacogenomics. Editorials and commentaries on topical issues. Additional digital features (including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations) can be published with articles; these are designed to increase the visibility, readership and educational value of the journal’s content. In addition, articles published in Drug Safety Drugs may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand important medical advances.
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