Danish Multiple Sclerosis Registry, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Department of Gynecology, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Eur J Neurol. 2022 Jun;29(6):1753-1762. doi: 10.1111/ene.15299. Epub 2022 Mar 7.
Sex differences in multiple sclerosis (MS) prevalence and disease course are thought to be driven by hormones. Exogenous exposure to estrogens may affect MS disease course. Thus, our aim was to investigate the association between hormone therapy (HT) and disease activity and disability accrual among women with MS.
A register-based cohort study was conducted with prospectively enrolled cases from the Danish MS registry. Information on hormone exposure was retrieved from the National Prescription Registry. Outcomes were relapse rate, relapse rate ratio, recurrent relapses, 6-month confirmed and sustained Expanded Disability Status Scale (EDSS) milestones 4 and 6, and recurrent EDSS worsening.
In all, 3325 women were eligible for analyses, of whom 333 (10%) were ever on HT at some time during follow-up. We found no association between HT and disability accrual, although a trend for increasing risk with increasing length of use was seen. The risk of reaching 6-month confirmed and sustained EDSS 4 among users was 0.6 (95% confidence interval [CI] = 0.3-1.2) after <1 year of use and 1.4 (95% CI = 0.9-2.2) after >5 years of HT compared to never use. The risk of recurrent relapse was increased by 20% (95% CI = 1.0-1.4) among current users of HT compared to nonusers. However, the risk of recurrent relapses was driven by the first calendar period (1996-2005) before the introduction of high-efficacy disease-modifying therapy.
Our findings from this nationwide MS population suggest that HT does not affect disability accrual in women with MS, especially if used for <5 years.
多发性硬化症（MS）的发病率和疾病进程存在性别差异，据认为这是由激素驱动的。外源性雌激素暴露可能会影响 MS 的疾病进程。因此，我们的目的是调查激素治疗（HT）与 MS 女性患者疾病活动度和残疾累积之间的关系。
本研究开展了一项基于登记的队列研究，病例来自丹麦 MS 登记处前瞻性纳入的患者。激素暴露信息从国家处方登记处获取。结局指标包括复发率、复发率比值、复发性复发、6 个月时确诊和持续扩展残疾状况量表（EDSS）4 分和 6 分的里程碑，以及 EDSS 恶化的复发性。
共有 3325 名女性符合分析条件，其中 333 名（10%）在随访期间的某个时间点接受过 HT。我们没有发现 HT 与残疾累积之间存在关联，尽管随着使用时间的延长，风险呈增加趋势。与从未使用过 HT 的患者相比，使用 HT <1 年的患者达到 6 个月确诊和持续 EDSS 4 的风险为 0.6（95%置信区间 [CI] = 0.3-1.2），而使用 HT >5 年的患者风险为 1.4（95% CI = 0.9-2.2）。与未使用者相比，HT 的当前使用者的复发风险增加了 20%（95% CI = 1.0-1.4）。然而，复发性复发的风险是由高效疾病修正治疗引入之前的第一个日历期间（1996-2005 年）驱动的。
本项全国性 MS 人群研究结果表明，HT 不会影响 MS 女性患者的残疾累积，尤其是使用时间<5 年的情况下。
