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热稳定卡贝缩宫素用于低收入和中等收入国家产后出血的管理:临床证据、成本效益、实施挑战及采用策略的综合综述

Heat-Stable Carbetocin in the Management of Postpartum Haemorrhage in Low- and Middle-Income Countries: A Comprehensive Review of Clinical Evidence, Cost-Effectiveness, Implementation Challenges and Adoption Strategies.

作者信息

Adnani Qorinah Estiningtyas Sakilah, Adepoju Victor Abiola, Jamil Safayet

机构信息

Department of Public Health, Faculty of Medicine, Universitas Padjadjaran, Bandung, West Java, Indonesia.

Jhpiego Nigeria, affiliate of Johns Hopkins University, Abuja, Nigeria.

出版信息

Int J Womens Health. 2025 Jun 3;17:1615-1630. doi: 10.2147/IJWH.S515252. eCollection 2025.


DOI:10.2147/IJWH.S515252
PMID:40487679
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12145113/
Abstract

INTRODUCTION: Postpartum haemorrhage (PPH) remains a leading global cause of maternal deaths, with over 70,000 annual deaths. Low- and middle-income countries disproportionately bear this burden, often due to compromised cold chains for oxytocin and insufficient staff training. METHODS: This review synthesized thirty publications on heat stable carbetocin (HSC) published from January 2018-March 2025. Eligible studies include randomized trials, systematic and narrative reviews, cost or economic evaluations, and implementation studies. Study findings were categorized into clinical efficacy and safety of HSC, cost-effectiveness, and adoption barriers and facilitators from field implementation, and sustainability strategies. RESULTS: Several large-scale trials, especially the CHAMPION trial, demonstrated that HSC is clinically non-inferior to oxytocin. In a pilot study from Nigeria (n = 18,364 deliveries), 56% of women received HSC for PPH prevention and PPH incidence dropped to 0.8%. Cost models from India estimated that HSC could prevent about 5,500 additional PPH cases and save five maternal lives per 100,000 births when priced comparably to oxytocin. Programs in Kenya and conflict-affected South Sudan achieved >90% coverage of HSC by implementing WHO policy updates, pooled procurement, simulation drills for frontline health workers, and appointing "PPH champions". Awareness of uterotonics and PPH danger signs among postpartum women increased from 48% to 81% after community-based intervention in Kenya. The thermostability of HSC (up to three years without refrigeration at a temperature of ≤30°C) addresses gaps in cold chain associated with oxytocin and reduces wastage from degradation. Integrating HSC with tranexamic acid and other postpartum haemorrhage bundle elements further improved maternal outcomes. CONCLUSION: Heat-stable carbetocin offers a viable, cost-effective uterotonic strategy in LMIC settings. Consistent training, supportive supervision, regulatory oversight, and domestic funding, including private sector investment, are critical to achieving widespread adoption of HSC in LMIC. Expanding HSC across resource-limited settings could substantially reduce PPH-related deaths and accelerate maternal survival goals.

摘要

引言:产后出血(PPH)仍然是全球孕产妇死亡的主要原因,每年有超过70000例死亡。低收入和中等收入国家承受着不成比例的负担,这通常是由于催产素冷链受损和工作人员培训不足。 方法:本综述综合了2018年1月至2025年3月发表的30篇关于热稳定卡贝缩宫素(HSC)的出版物。符合条件的研究包括随机试验、系统评价和叙述性综述、成本或经济评估以及实施研究。研究结果分为HSC的临床疗效和安全性、成本效益、实地实施中的采用障碍和促进因素以及可持续性策略。 结果:几项大规模试验,特别是CHAMPION试验,表明HSC在临床上不劣于催产素。在尼日利亚的一项试点研究(n = 18364例分娩)中,56%的妇女接受HSC预防产后出血,产后出血发生率降至0.8%。印度的成本模型估计,当HSC定价与催产素相当时,每10万例分娩中HSC可额外预防约5500例产后出血病例并挽救5名孕产妇生命。肯尼亚和受冲突影响的南苏丹通过实施世界卫生组织的政策更新、集中采购、为一线卫生工作者进行模拟演练以及任命“产后出血冠军”,实现了HSC超过90%的覆盖率。在肯尼亚进行社区干预后,产后妇女对宫缩剂和产后出血危险信号的知晓率从48%提高到了81%。HSC的热稳定性(在≤30°C温度下无需冷藏可达三年)解决了与催产素相关的冷链问题,并减少了降解造成的浪费。将HSC与氨甲环酸及其他产后出血综合措施相结合可进一步改善孕产妇结局。 结论:热稳定卡贝缩宫素在低收入和中等收入国家提供了一种可行、具有成本效益的宫缩剂策略。持续培训、支持性监督、监管以及包括私营部门投资在内的国内资金,对于在低收入和中等收入国家广泛采用HSC至关重要。在资源有限的环境中推广HSC可大幅减少与产后出血相关的死亡,并加速实现孕产妇生存目标。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e00b/12145113/1f39a87a34c6/IJWH-17-1615-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e00b/12145113/33391fce2e3e/IJWH-17-1615-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e00b/12145113/1f39a87a34c6/IJWH-17-1615-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e00b/12145113/33391fce2e3e/IJWH-17-1615-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e00b/12145113/1f39a87a34c6/IJWH-17-1615-g0002.jpg

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本文引用的文献

[1]
Carbetocin Is More Effective in Stabilizing Hemodynamic Parameters Compared to Oxytocin During Cesarean Section.

Biomedicines. 2025-3-11

[2]
The Role of Oxytocin versus Carbetocin in Prevention of Postpartum Hemorrhage in Cesarean Section: A Randomized Control Trial.

Ann Afr Med. 2025-4-1

[3]
Establishing Sustainable Access to Quality Uterotonics in Kano, Lagos and Niger States-A Supply Chain Perspective.

Int J Health Plann Manage. 2025-5

[4]
A systematic review and meta-analysis of randomized trials comparing carbetocin to oxytocin in prevention of postpartum hemorrhage after cesarean delivery in low-risk women.

J Obstet Gynaecol Res. 2025-1

[5]
Special Collection: Implementation Research Evidence for Prevention and Treatment of Postpartum Hemorrhage in High-Burden Low- and Middle-Income Countries.

Int J MCH AIDS. 2024-9-23

[6]
Empowering Midwives in Humanitarian Settings: Integrating Heat-Stable Carbetocin and Tranexamic Acid into Postpartum Hemorrhage Training.

Int J MCH AIDS. 2024-9-23

[7]
Introduction of Heat-Stable Carbetocin through a Public-Private Partnership Model in India: A Retrospective Study to Determine Feasibility and Its Optimal Use in Public Health Settings.

Int J MCH AIDS. 2024-9-23

[8]
A Tale of Two Medicines: The Need for Ownership, End-to-End Planning and Execution for Development and Introduction of Maternal Health Medicines.

Int J MCH AIDS. 2024-9-23

[9]
Feasibility, Acceptability, and Appropriate Use of Novel and Lesser-Used Medicines for Prevention and Treatment of Postpartum Hemorrhage: Evidence from Implementation Research.

Int J MCH AIDS. 2024-9-23

[10]
An Implementation Research Study on Uterotonics Use Patterns and Heat-stable Carbetocin Acceptability and Safety for Prevention of Postpartum Hemorrhage in Nigeria.

Int J MCH AIDS. 2024-9-23

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