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2000 - 2021年孕产妇保健药品研发数据库分析:预防和治疗胎儿生长受限的新候选药物

Analysis of a maternal health medicines pipeline database 2000-2021: New candidates for the prevention and treatment of fetal growth restriction.

作者信息

Lim Shao, McDougall Annie R A, Goldstein Maya, Tuttle Andrew, Hastie Roxanne, Tong Stephen, Ammerdorffer Anne, Rushwan Sara, Ricci Christina, Gülmezoglu A Metin, Vogel Joshua P

机构信息

Maternal, Child and Adolescent Health Program, Burnet Institute, Melbourne, Victoria, Australia.

Policy Cures Research, Sydney, New South Wales, Australia.

出版信息

BJOG. 2023 May;130(6):653-663. doi: 10.1111/1471-0528.17392. Epub 2023 Feb 5.

DOI:10.1111/1471-0528.17392
PMID:36655375
Abstract

OBJECTIVE

The Accelerating Innovation for Mothers project established a new database of candidate medicines under development between 2000 and 2021 for five pregnancy-related conditions, including fetal growth restriction. The objective was to assess medicines for fetal growth restriction and their potential for clinical use globally.

DESIGN

Landscape analysis.

SETTING

Global (focus on low- and middle-income countries, LMICs).

SAMPLE

Drugs, dietary supplements and biologics under investigation for prevention or treatment of fetal growth restriction.

METHODS

A research pipeline database of medicines was created through searching AdisInsight, PubMed and various grant and clinical trial databases. Analysis of clinical and preclinical candidates were descriptive.

MAIN OUTCOMES MEASURES

Fetal growth restriction candidates in clinical development were identified and ranked as high, medium or low potential based on prespecified criteria, including efficacy, safety and accessibility.

RESULTS

Of the 444 unique candidates in the database across all five pregnancy-related conditions, 63 were for fetal growth restriction. Of these, 31 were in clinical development (phases I, II or III) and 32 were in preclinical development. Three candidates, aspirin, l-arginine and vitamin D, were ranked as having high potential as preventive agents. There were no high-potential candidates for treating fetal growth restriction, although five candidates were ranked as having medium potential: allylestrenol, dalteparin, omega-3 fatty acids, tadalafil, and United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP).

CONCLUSIONS

l-Arginine, aspirin and vitamin D are promising, high-potential preventative agents for fetal growth restriction. Based on the medicines pipeline, new pharmacological agents for fetal growth restriction are unlikely to emerge in the near future.

摘要

目的

“加速母亲创新”项目建立了一个新数据库,收录了2000年至2021年间正在研发的、针对包括胎儿生长受限在内的五种与妊娠相关病症的候选药物。目的是评估用于胎儿生长受限的药物及其在全球临床应用的潜力。

设计

态势分析。

背景

全球范围(重点关注低收入和中等收入国家)。

样本

正在研究用于预防或治疗胎儿生长受限的药物、膳食补充剂和生物制品。

方法

通过检索阿迪斯洞察数据库、医学期刊数据库以及各种资助和临床试验数据库,创建了一个药物研究管线数据库。对临床和临床前候选药物的分析采用描述性方法。

主要观察指标

确定处于临床开发阶段的胎儿生长受限候选药物,并根据预先设定的标准(包括疗效、安全性和可及性)将其潜力分为高、中、低三个等级。

结果

在该数据库中,针对所有五种与妊娠相关病症的444种独特候选药物中,有63种是针对胎儿生长受限的。其中,31种处于临床开发阶段(I期、II期或III期),32种处于临床前开发阶段。三种候选药物,即阿司匹林、L-精氨酸和维生素D,被列为具有作为预防药物的高潜力。虽然有五种候选药物被列为具有中等潜力:烯丙雌醇、达肝素、ω-3脂肪酸、他达拉非和联合国国际产前多种微量营养素制剂(UNIMMAP),但没有治疗胎儿生长受限的高潜力候选药物。

结论

L-精氨酸、阿司匹林和维生素D是用于胎儿生长受限的、有前景的高潜力预防药物。基于药物研发管线,近期不太可能出现用于胎儿生长受限的新型药物。

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