{"title":"视谱神经脊髓炎患者严重感染的发生率和危险因素：日本索赔数据库研究","authors":"Noriko Isobe, Tetsuro Oda, Tomohiro Yamaguchi, Yuta Kamei, Takahiko Tsumuraya, Akinori Yuri, Ayako Nakasone, Keiko Asao, Shinichi Matsuda","doi":"10.1007/s40120-025-00794-y","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Serious infection is a leading cause of mortality in patients with neuromyelitis optica spectrum disorder (NMOSD). We assessed the incidence of and risk factors for serious infections in patients with NMOSD.</p><p><strong>Methods: </strong>This observational, retrospective cohort study included patients with a first NMOSD diagnosis (index date) between January 2016 and August 2022 in Japan. Data were extracted between April 2008 and August 2022 from the Medical Data Vision database. A serious infection was defined as an infection diagnosed during hospitalization. We described the incidence rate, cumulative incidence, and estimated hazard ratios (HRs) of potential risk factors using a Cox proportional hazard model with time-fixed and time-varying covariates.</p><p><strong>Result: </strong>In this study (n = 4231), the incidence rate of serious infections was 5.77 [95% confidence interval (CI) 5.23-6.35] per 100 person-years, and the cumulative incidence ranged from 2.87% (95% CI 2.33-3.49%) at 6-month follow-up to 12.48% (95% CI 10.62-14.50%) at 5-year follow-up. Age [≥ 75 years (ref. 18-35 years); HR 2.48, 95% CI 1.36-4.53], cancer (HR 1.91, 95% CI 1.11-3.29), diabetes mellitus (HR 1.43, 95% CI 1.04-1.96), neurogenic bladder (HR 1.97, 95% CI 1.46-2.66), urolithiasis (HR 1.97, 95% CI 1.02-3.78), the number of NMOSD relapses (HR 1.27, 95% CI 1.03-1.56) and a low daily dose of oral glucocorticoid (> 0 mg and < 5 mg [ref. 0 mg]; HR 1.80, 95% CI 1.21-2.69) were associated with an increased risk of serious infections.</p><p><strong>Conclusion: </strong>The incidence of serious infections in the NMOSD population, including those mainly treated with conventional therapies in real-world settings, was comparable to that reported in clinical trials or observational studies under specific treatments. Various potential risk factors for serious infections were identified. 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Age [≥ 75 years (ref. 18-35 years); HR 2.48, 95% CI 1.36-4.53], cancer (HR 1.91, 95% CI 1.11-3.29), diabetes mellitus (HR 1.43, 95% CI 1.04-1.96), neurogenic bladder (HR 1.97, 95% CI 1.46-2.66), urolithiasis (HR 1.97, 95% CI 1.02-3.78), the number of NMOSD relapses (HR 1.27, 95% CI 1.03-1.56) and a low daily dose of oral glucocorticoid (> 0 mg and < 5 mg [ref. 0 mg]; HR 1.80, 95% CI 1.21-2.69) were associated with an increased risk of serious infections.</p><p><strong>Conclusion: </strong>The incidence of serious infections in the NMOSD population, including those mainly treated with conventional therapies in real-world settings, was comparable to that reported in clinical trials or observational studies under specific treatments. Various potential risk factors for serious infections were identified. 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引用次数: 0
摘要
简介：严重感染是视神经脊髓炎谱系障碍（NMOSD）患者死亡的主要原因。我们评估了NMOSD患者严重感染的发生率和危险因素。方法：这项观察性、回顾性队列研究纳入了2016年1月至2022年8月期间日本首次诊断为NMOSD的患者（指标日期）。数据从2008年4月至2022年8月从医疗数据视觉数据库中提取。严重感染定义为住院期间确诊的感染。我们使用具有时间固定和时变协变量的Cox比例风险模型描述了潜在危险因素的发病率、累积发病率和估计风险比（hr）。结果：本研究（n = 4231）中，严重感染的发生率为5.77[95%可信区间（CI） 5.23-6.35] / 100人年，6个月随访时的累计发病率为2.87% (95% CI 2.33-3.49%)， 5年随访时的累计发病率为12.48% （95% CI 10.62-14.50%）。年龄[≥75岁（参考18-35岁）；风险比2.48,95% CI 1.36-4.53]，癌症（风险比1.91,95% CI 1.11-3.29），糖尿病（风险比1.43,95% CI 1.04-1.96），神经源性膀胱（风险比1.97,95% CI 1.46-2.66），尿石症（风险比1.97,95% CI 1.02-3.78）， NMOSD复发次数（风险比1.27,95% CI 1.03-1.56），低日口服糖皮质激素剂量（> - 0 mg）和NMOSD人群中严重感染的发生率，包括那些在现实环境中主要接受常规治疗的人群，与临床试验或观察性研究中报告的特定治疗的发生率相当。确定了严重感染的各种潜在危险因素。这些结果可以帮助患者和临床医生更好地制定治疗方案。试验注册：大学医院医学信息网临床试验注册中心（UMIN-CTR: UMIN000051151）。
Incidence and Risk Factors for Serious Infections in Patients with Neuromyelitis Optica Spectrum Disorder: A Claims Database Study in Japan.
Introduction: Serious infection is a leading cause of mortality in patients with neuromyelitis optica spectrum disorder (NMOSD). We assessed the incidence of and risk factors for serious infections in patients with NMOSD.
Methods: This observational, retrospective cohort study included patients with a first NMOSD diagnosis (index date) between January 2016 and August 2022 in Japan. Data were extracted between April 2008 and August 2022 from the Medical Data Vision database. A serious infection was defined as an infection diagnosed during hospitalization. We described the incidence rate, cumulative incidence, and estimated hazard ratios (HRs) of potential risk factors using a Cox proportional hazard model with time-fixed and time-varying covariates.
Result: In this study (n = 4231), the incidence rate of serious infections was 5.77 [95% confidence interval (CI) 5.23-6.35] per 100 person-years, and the cumulative incidence ranged from 2.87% (95% CI 2.33-3.49%) at 6-month follow-up to 12.48% (95% CI 10.62-14.50%) at 5-year follow-up. Age [≥ 75 years (ref. 18-35 years); HR 2.48, 95% CI 1.36-4.53], cancer (HR 1.91, 95% CI 1.11-3.29), diabetes mellitus (HR 1.43, 95% CI 1.04-1.96), neurogenic bladder (HR 1.97, 95% CI 1.46-2.66), urolithiasis (HR 1.97, 95% CI 1.02-3.78), the number of NMOSD relapses (HR 1.27, 95% CI 1.03-1.56) and a low daily dose of oral glucocorticoid (> 0 mg and < 5 mg [ref. 0 mg]; HR 1.80, 95% CI 1.21-2.69) were associated with an increased risk of serious infections.
Conclusion: The incidence of serious infections in the NMOSD population, including those mainly treated with conventional therapies in real-world settings, was comparable to that reported in clinical trials or observational studies under specific treatments. Various potential risk factors for serious infections were identified. These results may assist patients and clinicians in better decision-making regarding treatment options.
Trial registration: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR: UMIN000051151).
期刊介绍：
Aims and Scope
Neurology and Therapy aims to provide reliable and inclusive, rapid publication for all therapy related research for neurological indications, supporting the timely dissemination of research with a global reach, to help advance scientific discovery and support clinical practice.
Neurology and Therapy is an international, open access, peer reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world and health outcomes research around the discovery, development, and use of neurological and psychiatric therapies, (also covering surgery and devices). Studies relating to diagnosis, pharmacoeconomics, public health, quality of life, and patient care, management, and education are also welcomed.
The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, case reports, trial designs, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Neurology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.
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