Since both drugs in the study were kept in at the temperatures required to ensure maximum efficacy of oxytocin, the trial may underestimate the benefit expected with heat-stable carbetocin use in real-life settings where oxytocin may have degraded due to exposure to higher temperatures.
“The development of a drug to prevent postpartum haemorrhage that continues to remain effective in hot and humid conditions is very good news for the millions of women who give birth in parts of the world without access to reliable refrigeration,” says Dr Metin Gülmezoglu, from the Department of Reproductive Health and Research at WHO.
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接下来就要各国开展监管审查并履行批准程序。
The next step is regulatory review and approval by countries.
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世卫组织将随后要求指南制定小组讨论确定，是否应将热稳定卡贝缩宫素列为预防产后出血的推荐药物。
WHO will ask its Guideline Development Group to consider whether heat-stable carbetocin should be a recommended drug for the prevention of postpartum haemorrhage.
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关于本项研究
About the study
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这项世卫组织研究又被称作CHAMPION（Carbetocin HAeMorrhage PreventION，卡贝缩宫素预防出血）试验，它由MSD for Mothers提供资助。
This WHO study, also referred to as the CHAMPION (Carbetocin HAeMorrhage PreventION) trial, was funded by MSD for Mothers.
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热稳定卡贝缩宫素由产品专利持有方辉凌制药提供，研究使用的催产素则由诺华提供。
Heat-stable carbetocin was provided by Ferring Pharmaceuticals, the product innovator and oxytocin was provided by Novartis for the study.
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该研究是根据世卫组织、MSD for Mothers和辉凌制药之间的合作安排进行的。
The study was conducted under a collaborative arrangement between WHO, MSD for Mothers and Ferring Pharmaceuticals.