Department of Gynaecology-Obstetrics, CHU St Pierre. Université Libre De Bruxelles, Vrije Universiteit Brussel, Brussels, Belgium.
Department of Gynaecology-Obstetrics, CHU St Pierre. Université Libre De Bruxelles, Vrije Universiteit Brussel, Brussels, Belgium.
Eur J Obstet Gynecol Reprod Biol. 2020 Sep;252:300-302. doi: 10.1016/j.ejogrb.2020.06.064. Epub 2020 Jun 27.
EMA decided that with ulipristal acetate (UPA) treatment for uterine fibroids, should be discontinued due to the associated risk of hepatic failure, We analyzed whether the risk of recurrent symptoms due to fibroids may lead to an increased risk of Covid -19 infection and death, that would exceed the former risk of hepatic failure and transplantation.
STUDY DESIGN, SIZE, DURATION: We used a Markov model to generate probabilities.
PARTICIPANTS/MATERIALS, SETTING, METHODS: There are currently about 36,250 treated patients in Europe. We estimated bleeding probabilities, while using or discontinuing UPA, which may induce a need of medical or surgical management in symptomatic patients, and increase the risk of acquiring a Covid-19 infection, and die from it. We also estimated the risk of suffering a hepatic failure and hepatic transplantation.
Based on our assumptions, ceasing UPA during a Covid 19 pandemic may be associated with a fatality ratio between 4 and 18, due to the Pandemic, whereas pursuing UPA would be associated with a fatality rate due to the pandemic between 1-2, and an added fatality rate due to hepatic impairment of 1. The added risk of stopping UPA may range between 2 and 15 additional deaths. Our calculations suggest that the decision to stop UPA in the middle of the Covid- 19 pandemic may be untimely, since it may result in an increased risk of Covid-19 infection, due to the recurrence of symptoms and the need for medical and surgical treatment.
A decision, like the one EMA took need to be taken in a wider health context of a population, than simply analyzing its role as regulating agent for medications.
EMA 决定停止使用屈螺酮（UPA）治疗子宫肌瘤，因为其与肝衰竭风险相关。我们分析了由于肌瘤症状复发导致的感染 COVID-19 风险和死亡风险是否会超过肝衰竭和肝移植的风险。
研究设计、规模和持续时间：我们使用马尔可夫模型生成概率。
参与者/材料、设置、方法：目前欧洲约有 36250 名接受治疗的患者。我们估计了出血的概率，同时考虑了使用或停止 UPA 的情况，这可能会导致有症状的患者需要进行医疗或手术管理，并增加感染 COVID-19 和死亡的风险。我们还估计了发生肝衰竭和肝移植的风险。
根据我们的假设，在 COVID-19 大流行期间停止使用 UPA 可能会导致死亡率在 4 到 18 之间，这是由于大流行造成的，而继续使用 UPA 则与大流行期间因 COVID-19 导致的死亡率在 1 到 2 之间，以及因肝损伤导致的额外死亡率在 1 之间。停止 UPA 的额外风险可能在 2 到 15 例额外死亡之间。我们的计算表明，在 COVID-19 大流行期间停止使用 UPA 的决定可能为时过早，因为这可能会由于症状复发以及需要医疗和手术治疗而导致感染 COVID-19 的风险增加。
EMA 做出的决定需要在更广泛的人群健康背景下做出，而不仅仅是分析其作为药物监管机构的作用。
