Abstract：
Adverse drug reactions (ADRs) are known to show sex-specific differences in occurrence and phenotype. The aim of this study was to analyse sex-specific differences in ADR-drug combinations that required hospitalization based on two different datasets.
We performed a complementary analysis of (i) spontaneously reported (n = 12 564, female = 51.7%) and (ii) systematically collected ADR reports from a prospective multicentre observational study (ADRED, n = 2355, female = 48.2%) from Germany in the ADR database EudraVigilance (EV). Both datasets were analysed separately concerning the suspected drugs, ADRs and ADR-drug combinations more frequently reported for females or males by calculating reporting odds ratios (ROR) with 95% confidence intervals. ADR-drug combinations more frequently reported for either females or males in EV reports were related to prescription data. Finally, the results from both datasets were discussed with regard to their (dis-)concordance.
In both datasets, some antineoplastic agents and nervous system drugs were found to be reported more often for females than males (RORs ranging from 1.5 [1.1-2.1] for quetiapine in spontaneous reports to 41.3 [13.1-130.0] for trastuzumab in spontaneous reports). ADRs of the respiratory system, and haemorrhages were described predominantly for males in both datasets. In spontaneous reports the ADR-drug combination self-injurious behaviour-quetiapine was more often reported for females without and with consideration of drug prescriptions (ROR: 3.8 [1.3-11.0]). Quetiapine and psychiatric disorders (superordinate level) was exclusively reported for females in ADRED reports.
Our results can contribute to raise awareness and further knowledge regarding sex-specific ADRs. The findings require further in-depth investigation.
We performed a complementary analysis of (i) spontaneously reported (n = 12 564, female = 51.7%) and (ii) systematically collected ADR reports from a prospective multicentre observational study (ADRED, n = 2355, female = 48.2%) from Germany in the ADR database EudraVigilance (EV). Both datasets were analysed separately concerning the suspected drugs, ADRs and ADR-drug combinations more frequently reported for females or males by calculating reporting odds ratios (ROR) with 95% confidence intervals. ADR-drug combinations more frequently reported for either females or males in EV reports were related to prescription data. Finally, the results from both datasets were discussed with regard to their (dis-)concordance.
In both datasets, some antineoplastic agents and nervous system drugs were found to be reported more often for females than males (RORs ranging from 1.5 [1.1-2.1] for quetiapine in spontaneous reports to 41.3 [13.1-130.0] for trastuzumab in spontaneous reports). ADRs of the respiratory system, and haemorrhages were described predominantly for males in both datasets. In spontaneous reports the ADR-drug combination self-injurious behaviour-quetiapine was more often reported for females without and with consideration of drug prescriptions (ROR: 3.8 [1.3-11.0]). Quetiapine and psychiatric disorders (superordinate level) was exclusively reported for females in ADRED reports.
Our results can contribute to raise awareness and further knowledge regarding sex-specific ADRs. The findings require further in-depth investigation.
摘要：
目的：已知药物不良反应（ADR）在发生和表型上显示出性别差异。这项研究的目的是根据两个不同的数据集分析需要住院治疗的ADR药物组合的性别差异。
方法：我们对i）自发报告（n=12,564，女性=51.7％）和ii）系统收集的前瞻性多中心观察性研究的ADR报告（ADRED，n=2,355，女性=48.2％），来自德国的ADR数据库EudraVigilance（EV）。两个数据集分别就可疑药物进行了分析，通过计算95％置信区间（CI）的报告优势比（ROR），女性或男性更频繁地报告了ADR和ADR药物组合。在EV报告中，女性或男性更频繁报告的ADR-药物组合与处方数据有关。最后,对两个数据集的结果进行了讨论。
结果：在两个数据集中，发现一些抗肿瘤药和神经系统药物在女性中的报告频率高于男性(ROR范围为1.5[1.1-2.1](喹硫平EV)至41.3[13.1-130.0](曲妥珠单抗EV)).呼吸系统的不良反应，在两个数据集中，出血主要是男性。在EV中，ADR-药物组合的自我伤害行为-喹硫平在没有和考虑药物处方的情况下更常见（ROR：3.8[1.3-11.0]）。在ADRED报告中，女性仅报告了喹硫平和精神疾病（上级）。
结论：我们的研究结果有助于提高对性别特异性不良反应的认识和进一步了解。这些发现需要进一步深入调查。
方法：我们对i）自发报告（n=12,564，女性=51.7％）和ii）系统收集的前瞻性多中心观察性研究的ADR报告（ADRED，n=2,355，女性=48.2％），来自德国的ADR数据库EudraVigilance（EV）。两个数据集分别就可疑药物进行了分析，通过计算95％置信区间（CI）的报告优势比（ROR），女性或男性更频繁地报告了ADR和ADR药物组合。在EV报告中，女性或男性更频繁报告的ADR-药物组合与处方数据有关。最后,对两个数据集的结果进行了讨论。
结果：在两个数据集中，发现一些抗肿瘤药和神经系统药物在女性中的报告频率高于男性(ROR范围为1.5[1.1-2.1](喹硫平EV)至41.3[13.1-130.0](曲妥珠单抗EV)).呼吸系统的不良反应，在两个数据集中，出血主要是男性。在EV中，ADR-药物组合的自我伤害行为-喹硫平在没有和考虑药物处方的情况下更常见（ROR：3.8[1.3-11.0]）。在ADRED报告中，女性仅报告了喹硫平和精神疾病（上级）。
结论：我们的研究结果有助于提高对性别特异性不良反应的认识和进一步了解。这些发现需要进一步深入调查。
