PDF(Pubmed)
Abstract：
UNASSIGNED: Hormonal oral contraceptive (OC) agents such as estrogen or progesterone, either as single agents or in combination, and a non-hormonal drug like ormeloxifene are used for various conditions. However, estrogen and progesterone-containing OC as well as ormeloxifene are seldom associated with hepatotoxicity. We prospectively studied the clinical, demographic, liver injury pattern, complications, and outcome of the hepatotoxicity from OC and ormeloxifene.
UNASSIGNED: We analyzed and compared the aforementioned characteristics among consecutive patients with OC and ormeloxifene-induced drug-induced liver injury (DILI) from two university hospitals in India. Cases fulfilling established DILI criteria and the Roussel Uclaf causality assessment method were identified and followed up until recovery/death.
UNASSIGNED: We identified 43 (3.5%) amongst 1226 patients with DILI; 19 (44%) from estrogen and progesterone combination, 21 (49%) from progesterone monotherapy, and 3 (7%) due to ormeloxifene. Seven cases were identified from 1998 to 2014 and 36 cases from 2015 to 2023. All were due to oral tablets. The mean age was 36 years (range 21-75). Nineteen patients (44%) developed jaundice and 5 (11.6%) developed itching. The liver injury pattern was hepatocellular in 19 (44%), mixed in 13 (30%), and cholestatic in 11 (26%). Four patients (9%) died, three from acute liver failure and one due to acute on chronic liver failure. Liver biochemical tests normalized after a mean of 66 days after stopping the implicated agents. Contrastingly, literature search yielded 24 cases of progesterone DILI reported between 1962 and 2019 with no mortality.
UNASSIGNED: In contrast to published literature on oral contraceptives, a majority of oral contraceptive-induced DILI in our series were from progesterone monotherapy and a smaller number with ormeloxifene, that often resulted in clinically significant jaundice or liver test abnormalities and rarely in fatality.
UNASSIGNED: We analyzed and compared the aforementioned characteristics among consecutive patients with OC and ormeloxifene-induced drug-induced liver injury (DILI) from two university hospitals in India. Cases fulfilling established DILI criteria and the Roussel Uclaf causality assessment method were identified and followed up until recovery/death.
UNASSIGNED: We identified 43 (3.5%) amongst 1226 patients with DILI; 19 (44%) from estrogen and progesterone combination, 21 (49%) from progesterone monotherapy, and 3 (7%) due to ormeloxifene. Seven cases were identified from 1998 to 2014 and 36 cases from 2015 to 2023. All were due to oral tablets. The mean age was 36 years (range 21-75). Nineteen patients (44%) developed jaundice and 5 (11.6%) developed itching. The liver injury pattern was hepatocellular in 19 (44%), mixed in 13 (30%), and cholestatic in 11 (26%). Four patients (9%) died, three from acute liver failure and one due to acute on chronic liver failure. Liver biochemical tests normalized after a mean of 66 days after stopping the implicated agents. Contrastingly, literature search yielded 24 cases of progesterone DILI reported between 1962 and 2019 with no mortality.
UNASSIGNED: In contrast to published literature on oral contraceptives, a majority of oral contraceptive-induced DILI in our series were from progesterone monotherapy and a smaller number with ormeloxifene, that often resulted in clinically significant jaundice or liver test abnormalities and rarely in fatality.
摘要：
■激素口服避孕药（OC），如雌激素或孕激素，无论是作为单一药物还是组合，和非激素药物如奥美洛昔芬用于各种条件。然而,含有雌激素和孕酮的OC以及奥美洛昔芬很少与肝毒性相关。我们前瞻性地研究了临床，人口统计学,肝损伤模式，并发症,以及OC和奥美洛昔芬的肝毒性结果。
■我们分析并比较了来自印度两家大学医院的OC和ormeloxifene诱导的药物性肝损伤（DILI）的连续患者中的上述特征。确定并随访符合已建立的DILI标准和RousselUclaf因果关系评估方法的病例，直至恢复/死亡。
■我们在1226例DILI患者中确定了43例（3.5％）；19例（44％）来自雌激素和孕激素组合，21（49%）来自孕酮单一疗法，和3（7%）归因于奥美洛昔芬。1998年至2014年发现7例，2015年至2023年发现36例。所有这些都是由于口服片剂。平均年龄为36岁（范围21-75）。19例（44％）患者出现黄疸，5例（11.6％）出现瘙痒。肝损伤类型为肝细胞19（44%），混合在13（30%），11例(26%)出现胆汁淤积。4名患者（9%）死亡，3例来自急性肝衰竭，1例来自急性对慢性肝衰竭。停止相关药物平均66天后，肝脏生化测试恢复正常。相反，文献检索在1962年至2019年间报告了24例孕酮DILI，无死亡病例。
■与已发表的关于口服避孕药的文献相反，在我们的系列中，大多数口服避孕药诱导的DILI来自黄体酮单药治疗，少数使用奥美洛昔芬，这通常导致临床上显著的黄疸或肝脏检查异常，很少导致死亡。
■我们分析并比较了来自印度两家大学医院的OC和ormeloxifene诱导的药物性肝损伤（DILI）的连续患者中的上述特征。确定并随访符合已建立的DILI标准和RousselUclaf因果关系评估方法的病例，直至恢复/死亡。
■我们在1226例DILI患者中确定了43例（3.5％）；19例（44％）来自雌激素和孕激素组合，21（49%）来自孕酮单一疗法，和3（7%）归因于奥美洛昔芬。1998年至2014年发现7例，2015年至2023年发现36例。所有这些都是由于口服片剂。平均年龄为36岁（范围21-75）。19例（44％）患者出现黄疸，5例（11.6％）出现瘙痒。肝损伤类型为肝细胞19（44%），混合在13（30%），11例(26%)出现胆汁淤积。4名患者（9%）死亡，3例来自急性肝衰竭，1例来自急性对慢性肝衰竭。停止相关药物平均66天后，肝脏生化测试恢复正常。相反，文献检索在1962年至2019年间报告了24例孕酮DILI，无死亡病例。
■与已发表的关于口服避孕药的文献相反，在我们的系列中，大多数口服避孕药诱导的DILI来自黄体酮单药治疗，少数使用奥美洛昔芬，这通常导致临床上显著的黄疸或肝脏检查异常，很少导致死亡。
