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两种药物的故事:孕产妇保健药物研发与引进所需的自主权、端到端规划及执行

A Tale of Two Medicines: The Need for Ownership, End-to-End Planning and Execution for Development and Introduction of Maternal Health Medicines.

作者信息

Gülmezoglu Metin, Chinery Lester, Rushwan Sara, Ammerdorffer Anne

机构信息

Concept Foundation, Avenue de Sécheron, Geneva, Switzerland.

出版信息

Int J MCH AIDS. 2024 Sep 23;13(Suppl 1):S9-S14. doi: 10.25259/IJMA_21_2024. eCollection 2024 Sep.

DOI:10.25259/IJMA_21_2024
PMID:39629307
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11583814/
Abstract

Postpartum hemorrhage (PPH) persists as the leading direct cause of maternal mortality in low- and middle-income countries (LMICs) and is a major global health challenge. Following favorable evidence from pivotal efficacy clinical trials, the World Health Organization (WHO) recommends the use of heat-stable carbetocin to prevent PPH as a viable substitute in settings where maintaining a cold chain for thermosensitive uterotonics is compromised, and tranexamic acid as an adjunct therapy for PPH treatment. However, the implementation of these drugs has been hindered by several challenges, such as decentralized and disorganized procurement, poor quality assurance, inadequate supply chain management, and limited access in many LMICs. While including maternal health drugs in the essential medicines list and adopting updated global recommendations are necessary steps forward, they are not enough to guarantee access unless there is end-to-end (E2E) thinking, planning, and execution for essential maternal health commodities. We describe distinct access challenges between the two drugs, both having compelling safety and efficacy data and normative recommendations around the same time; one patent protected and owned by a pharmaceutical company and another with multiple generic manufacturers. We highlight the need for coordinated action to facilitate access to evidence-based maternal health commodities.

摘要

产后出血(PPH)仍然是低收入和中等收入国家(LMICs)孕产妇死亡的主要直接原因,也是一项重大的全球卫生挑战。鉴于关键疗效临床试验的有力证据,世界卫生组织(WHO)建议使用热稳定的卡贝缩宫素在维持热敏宫缩剂冷链存在困难的环境中作为预防产后出血的可行替代药物,并建议使用氨甲环酸作为产后出血治疗的辅助疗法。然而,这些药物的实施受到了若干挑战的阻碍,如采购分散和无序、质量保证不佳、供应链管理不足以及许多低收入和中等收入国家的可及性有限。虽然将孕产妇保健药物列入基本药物清单并采纳最新的全球建议是向前迈出的必要步骤,但除非对基本孕产妇保健商品进行端到端(E2E)的思考、规划和执行,否则这些措施不足以确保药物的可及性。我们描述了这两种药物在获取方面面临的不同挑战,这两种药物都有令人信服的安全性和有效性数据以及同时期的规范性建议;一种受制药公司专利保护并由其生产,另一种有多个仿制药制造商。我们强调需要采取协调行动,以促进获取基于证据的孕产妇保健商品。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e14/11583814/b320a21fc66b/IJMA-13-S1-9-g1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e14/11583814/b320a21fc66b/IJMA-13-S1-9-g1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/2e14/11583814/b320a21fc66b/IJMA-13-S1-9-g1.jpg

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本文引用的文献

1
The drug drought in maternal health: an ongoing predicament.孕产妇健康领域的药物短缺:一个持续存在的困境。
Lancet Glob Health. 2024 Jul;12(7):e1174-e1183. doi: 10.1016/S2214-109X(24)00144-X.
2
Factors influencing the participation of pregnant and lactating women in clinical trials: A mixed-methods systematic review.影响孕妇和哺乳期妇女参与临床试验的因素:一项混合方法系统评价。
PLoS Med. 2024 May 30;21(5):e1004405. doi: 10.1371/journal.pmed.1004405. eCollection 2024 May.
3
The compatibility of oxytocin and tranexamic acid injection products when mixed for co-administration by infusion for the treatment of postpartum haemorrhage: An in vitro investigation.
缩宫素和氨甲环酸注射液混合用于产后出血治疗时输注的相容性:一项体外研究。
BJOG. 2023 Jun;130(7):741-749. doi: 10.1111/1471-0528.17398. Epub 2023 Feb 14.
4
Tranexamic acid at cesarean delivery: drug-error deaths.氨甲环酸在剖宫产中的应用:药物错误导致的死亡。
BJOG. 2023 Jan;130(1):114-117. doi: 10.1111/1471-0528.17292. Epub 2022 Oct 27.
5
Quality of oxytocin and tranexamic acid for the prevention and treatment of postpartum hemorrhage in Kenya, Nigeria, South Africa, and Tanzania.肯尼亚、尼日利亚、南非和坦桑尼亚用于预防和治疗产后出血的缩宫素和氨甲环酸的质量。
Int J Gynaecol Obstet. 2022 Jun;158 Suppl 1(Suppl 1):46-55. doi: 10.1002/ijgo.14197.
6
Challenges in updating national guidelines and essential medicines lists in Sub-Saharan African countries to include WHO-recommended postpartum hemorrhage medicines.在撒哈拉以南非洲国家更新国家指南和基本药物清单以纳入世卫组织推荐的产后出血药物方面面临的挑战。
Int J Gynaecol Obstet. 2022 Jun;158 Suppl 1(Suppl 1):11-13. doi: 10.1002/ijgo.14269.
7
Uterotonics for prevention of postpartum haemorrhage: EN-BIRTH multi-country validation study.预防产后出血的宫缩剂:EN-BIRTH 多国家验证研究。
BMC Pregnancy Childbirth. 2021 Mar 26;21(Suppl 1):230. doi: 10.1186/s12884-020-03420-x.
8
Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth.卡贝缩宫素与缩宫素预防阴道分娩后出血的比较。
N Engl J Med. 2018 Aug 23;379(8):743-752. doi: 10.1056/NEJMoa1805489. Epub 2018 Jun 27.
9
Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial.氨甲环酸早期给药对产后出血妇女死亡率、子宫切除术和其他并发症的影响(WOMAN):一项国际、随机、双盲、安慰剂对照试验。
Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26.
10
The UN Commission on Life Saving Commodities 3 years on: global progress update and results of a multicountry assessment.联合国拯救生命商品委员会成立三周年:全球进展更新和多国评估结果。
Lancet Glob Health. 2016 Apr;4(4):e276-86. doi: 10.1016/S2214-109X(16)00046-2.