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基于美国FAERS的新型口服抗凝药物致女性生殖系统异常出血风险的数据分析
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| 篇名： | 基于美国FAERS的新型口服抗凝药物致女性生殖系统异常出血风险的数据分析 |
| TITLE： | Data Analysis of the Risks of Abnormal Female Reproductive System Haemorrhages Induced by Novel Oral An- ticoagulants Based on FAERS |
| 摘要： | 目的：评价新型口服抗凝药（NOACs）致女性生殖系统异常出血的风险。方法：收集2004年1月1日－2019年5月31日美国FDA不良事件报告系统（FAERS）数据库中收录的以“达比加群酯“”利伐沙班“”阿哌沙班“”依度沙班”等4种NOACs为首要怀疑药物的女性生殖系统异常出血的不良事件（ADE）报告，采用报告比值比法（ROR）对NOACs致女性生殖系统异常出血事件进行信号检测。结果：FAERS数据库中共收录涉及NOACs致女性生殖系统异常出血的ADE报告2658份，其中达比加群酯330份、利伐沙班2049份、阿哌沙班267份、依度沙班12份。达比加群酯、阿哌沙班、依度沙班诱发女性生殖系统异常出血的患者均以≥75岁为主，分别占37.27％、36.70％、58.33％；利伐沙班以45～64岁为主，占33.04％。达比加群酯、利伐沙班、阿哌沙班、依度沙班致严重的不良事件的发生率分别为96.36％、84.53％、47.19％、58.33％，均以住院/住院时间延长为主（分别占64.78％、90.01％、86.51％、71.43％）。共检测到12个可疑信号，涉及出血部位包括宫颈、输卵管、卵巢、盆腔、子宫、阴道、尿路等。其中，利伐沙班的可疑信号有11个，出血事件主要表现为阴道血肿[ROR＝12.07，95％CI（8.51，17.12）]、绝经后出血[ROR＝9.89，95％CI（8.31，11.77）]、盆腔血肿[ROR＝7.68，95％CI（5.66，10.43）]等；达比加群酯、阿哌沙班、依度沙班的可疑信号分别有4、4、2个，阿哌沙班[ROR＝5.18，95％CI（1.81，5.85）]和依度沙班[ROR＝48.19，95％CI（6.76，343.77）]均以阴道血肿为主；达比加群酯以盆腔血肿[ROR＝12.56，95％CI（8.92，17.70）]信号最强，其次为尿路出血[ROR＝5.41，95％CI（3.34，8.76）]和盆腔出血[ROR＝2.53，95％CI（1.88，3.40）]。结论：4种NOACs均可诱发女性生殖系统异常出血，且严重的不良事件发生率较高，常需住院治疗或延长住院时间。利伐沙班的出血风险最高，表现为阴道血肿、绝经后出血及盆腔血肿；达比加群酯以盆腔血肿为主，阿哌沙班和依度沙班均为阴道血肿为主。 |
| ABSTRACT： | OBJECTIVE：To eva luate the risk of abno rmal female reproductive system haemorrhage induced by novel oral anticoagulants （NOACs）. METHODS ：The abnormal female reproductive system haemorrhage reports induced by 4 kinds of NOACs as “dabigatran etexilate ”，“rivaroxaban”，“apixaban”and“edoxaban”were used as the first suspected dugs to collected from FDA adverse event reporting system （FAERS）database during Jan. 1st，2004-May 31st，2019. The report odd ratio （ROR） method was used to detect the signal of abnormal female reproductive system haemorrhage induced by NOACs. RESULTS ：A total of 2 658 adverse events related to abnormal female reproductive system haemorrhage were collected from FAERS database ， involving 330 reports of dabigatran etexilate ，2 049 reports of rivaroxaban ，267 reports of apixaban ，and 12 reports of edoxaban. The abnormal female reproductive system haemorrhage caused by dabigatran etexilate ，apixaban and edoxaban mainly occurred in patients aged 75 and older ，accounting for 37.27％，36.70％ and 58.33％ respectively；that of rivaroxaban mainly occurred in patients with 45-64 years old ，accounting for 33.04％. The incidence of severe adverse events （SAE）induced by dabigatran etexilate，rivaroxaban，apixaban and edoxaban were 96.36％，84.53％，47.19％ and 58.33％，respectively. All of patients in the included reports were mainly hospitalized and hospitalization stay wa s prolonged ，accounting for 64.78％，90.01％，86.51％ and 71.43％ ，respectively. A total of 12 suspected signals were detected，involving cervix uteri ，fallopian tube ，ovary，pelvis cavity，uterus，vagina，urinary tract ，etc. Among them ，there were 11 positive signals of rivaroxaban ，and the bleeding events were concentrated in vaginal hematoma [ROR ＝12.07， 药。95％CI（8.51，17.12）]，postmenopausal hemorrhage [ROR ＝ 9.89，95％CI（8.31，11.77）]，pelvic hematoma [ROR ＝7.68，95％CI（5.66，10.43）]. There were 4，4 and 2 suspicious signals for dabigatran etexilate ，apixaban and edoxaban. The main bleeding events of both apixaban [ ROR＝5.18，95％CI（1.81，5.85）] and edoxaban [ROR ＝48.19，95％CI（6.76，343.77）] were vaginal hematoma ；dabigatran etexilate-induced pelvic hematoma [ROR ＝ 12.56，95％CI（8.92，17.70）] had the strongest signal ，followed by urinary tract bleeding [ROR ＝5.41，95％CI（3.34，8.76）] and pelvic hemorrhage [ ROR＝2.53，95％CI（1.88，3.40）]. CONCLUSIONS ：Totally 4 kinds of NOACs can cause abnormal female reproductive system haemorrhage ，and the incidence of SAE is high ，of requiring hospitalization or prolonging hospitalization time. The risk of haemorrhage in rivaroxaban is the highest ，usually manifesting as vaginal hematoma ，postmenopausal hemorrhage and pelvic hematoma. Dabigatran etexilate mainly induce pelvic hematoma ，while apixaban and edoxaban are mainly cause vaginal hematoma. |
| 期刊： | 2020年第31卷第14期 |
| 作者： | 田晓江，贾运涛，王柯静，陈琳 |
| AUTHORS： | TIAN Xiaojiang ，JIA Yuntao ，WANG Kejing ，CHEN Lin |
| 关键字： | 新型口服抗凝药；女性；生殖系统异常出血；信号检测；不良事件；用药安全；美国FDA不良反应报告系统 |
| KEYWORDS： | Novel oral anticoagulants ；Female；Abnormal female reproductive system haemorrhage ；Signal detection ；Adverse |
| 阅读数： | 356 次 |
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