EPIPHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products - ANSM, French National Health Insurance - CNAM), Saint-Denis, France; Université Paris-Saclay, Faculté de pharmacie, Orsay 91400, France.
EPIPHARE Scientific Interest Group in Epidemiology of Health Products (French National Agency for the Safety of Medicines and Health Products - ANSM, French National Health Insurance - CNAM), Saint-Denis, France.
Vaccine. 2024 Oct 24;42(24):126252. doi: 10.1016/j.vaccine.2024.126252. Epub 2024 Sep 2.
COVID-19 vaccination has been inconsistently associated with an increased risk of heavy menstrual bleeding in previous studies. This study aimed to assess the risk of heavy menstrual bleeding requiring hospital care following COVID-19 vaccination according to the number of doses received and the time elapsed since vaccination.
Using comprehensive data of the French National Health Data System, we carried out a case-control study. Non-pregnant 15-50 years old women who had a hospital discharge diagnosis of heavy menstrual bleeding between May 12, 2021, and August 31, 2022 (cases) were randomly matched to up to 30 controls of same age, place of residence, social deprivation index, and contraceptive use profile at the date of case hospital admission (index date). Conditional logistic regression models were used to estimate the risk of hospital care for heavy menstrual bleeding associated with primary or booster doses and delay since last COVID-19 vaccination at index date, adjusting for socio-demographic characteristics, comorbidities, healthcare use indicators, and recent SARS-CoV-2 infection.
A total of 4610 cases and 89,375 matched controls were included (median age, 42 years). Compared to unvaccinated women, the risk of hospital care for heavy menstrual bleeding was increased in those having received a last dose of primary vaccination in the preceding 1-3 months (Odds Ratio, 1.20 [95% confidence interval, 1.07-1.35]). This association was marked among women residing in the most deprived municipalities (1.28 [1.07-1.52]) and those who were not using hormonal contraception (1.28 [1.11-1.48]). Assuming a causal relationship, a total of 103 cases [54-196] were estimated to be attributable to primary vaccination in France.
These findings provide evidence of an increased risk of heavy menstrual bleeding during the three-month period following primary COVID-19 mRNA vaccination. No increased risk was found beyond 3 months after primary vaccination nor following booster doses.
之前的研究表明，COVID-19 疫苗接种与月经大出血风险增加之间的关联并不一致。本研究旨在根据接种疫苗的剂次和接种后时间，评估 COVID-19 疫苗接种后因月经大出血而需要住院治疗的风险。
使用法国国家健康数据系统的综合数据，我们进行了一项病例对照研究。2021 年 5 月 12 日至 2022 年 8 月 31 日期间，因月经大出血在医院接受治疗的非妊娠 15-50 岁女性（病例），按年龄、居住地、社会剥夺指数和病例入院日期（索引日期）的避孕方法，随机匹配至多 30 名相同年龄、居住地、社会剥夺指数和避孕方法的对照者。采用条件逻辑回归模型，调整社会人口学特征、合并症、医疗保健使用指标和近期 SARS-CoV-2 感染后，估计与索引日期上次 COVID-19 疫苗接种后 1-3 个月内的初级或加强剂量以及延迟接种相关的因月经大出血而住院治疗的风险。
共纳入 4610 例病例和 89375 名匹配对照者（中位年龄 42 岁）。与未接种疫苗的女性相比，最近 1-3 个月内接种最后一剂初级疫苗的女性因月经大出血住院治疗的风险增加（比值比 1.20 [95%置信区间 1.07-1.35]）。这种关联在居住在最贫困城市的女性（1.28 [1.07-1.52]）和未使用激素避孕的女性（1.28 [1.11-1.48]）中更为明显。假设存在因果关系，法国估计有 103 例（54-196 例）因初级疫苗接种而导致月经大出血。
这些发现提供了 COVID-19 mRNA 疫苗初级接种后 3 个月内月经大出血风险增加的证据。在初级疫苗接种后 3 个月以上或加强接种后，未发现风险增加。
