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Human papillomavirus vaccine-associated premature ovarian insufficiency and related adverse events: data mining of Vaccine Adverse Event Reporting System.
Scientific Reports ( IF 4.6 ) Pub Date : 2020-07-01 , DOI: 10.1038/s41598-020-67668-1
Li Gong 1, 2 , Huan-Huan Ji 1 , Xue-Wen Tang 3 , Ling-Yun Pan 4 , Xiao Chen 5 , Yun-Tao Jia 1
Affiliation  

We detected disproportionate reports of premature ovarian insufficiency (POI) and related events, including amenorrhea, menstruation irregular, FSH increased, and premature menopause, following human papillomavirus (HPV) vaccine from FDA Vaccine Adverse Event Reporting System (VAERS). The signal was detected by the methods of Bayesian Confidence Propagation Neural Network (BCPNN) and Multi-item Gamma Poisson Shrinker (MGPS). When both methods detected a positive result, a signal was generated. Besides, time-scan map is drawn based on the IC value and 95%CI of BCPNN, if the IC curve showed a steady upward trend and the 95%CI narrowed, the signal was stable and strong association.The results showed that there were not POI reports of HPV vaccine, but VAERS received a total of 2, 389, 27 POI related events for HPV2, HPV4, HPV9 respectively from the year of marketed to 2018. No signal was detected for HPV2. HPV4-POI ralated events were all detected as signals by two methods. There was only one signal of menstruation irregular for HPV9. Time scan of HPV4-POI ralated events showed those signals were stability and strong association, but not for HPV9. Our results only represent statistical association between HPV vaccine and POI related events, causal relationship needs further investigation.



中文翻译:

人乳头瘤病毒疫苗相关的卵巢早衰和相关不良事件:疫苗不良事件报告系统的数据挖掘。

在FDA疫苗不良事件报告系统(VAERS)接种人乳头瘤病毒(HPV)疫苗后,我们检测到了不成比例的卵巢早衰(POI)及其相关事件的报告,包括闭经,月经不调,FSH升高和更年期提前。通过贝叶斯置信度传播神经网络(BCPNN)和多项目伽玛泊松收缩器(MGPS)的方法检测信号。当两种方法均检测到阳性结果时,就会产生信号。此外,根据BCPNN的IC值和95%CI绘制时间扫描图,如果IC曲线显示稳定的上升趋势且95%CI变窄,则信号是稳定且强关联的,结果表明存在并非关于HPV疫苗的POI报告,但VAERS总共收到了与HPV2,HPV4,从上市年份到2018年,HPV9分别存在。未检测到HPV2的信号。HPV4-POI相关事件均通过两种方法检测为信号。HPV9只有一个月经不调的信号。对HPV4-POI相关事件的时间扫描显示,这些信号具有稳定性和强关联性,但对于HPV9则不是。我们的结果仅代表HPV疫苗与POI相关事件之间的统计关联,因果关系需要进一步调查。

更新日期:2020-07-01
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