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日本免疫介导性炎症性疾病患者接受肿瘤坏死因子拮抗剂治疗前的结核病筛查:一项基于大规模医疗保险索赔数据库的纵向研究。

Tuberculosis screening prior to anti-tumor necrosis factor therapy among patients with immune-mediated inflammatory diseases in Japan: a longitudinal study using a large-scale health insurance claims database.

机构信息

Department of Public Health, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

Department of Clinical Epidemiology and Health Economics, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.

出版信息

Int J Rheum Dis. 2017 Nov;20(11):1674-1683. doi: 10.1111/1756-185X.13190. Epub 2017 Oct 26.

DOI:10.1111/1756-185X.13190
PMID:29076252
Abstract

AIM

Tuberculosis screening is recommended for patients with immune-mediated inflammatory diseases (IMIDs) prior to anti-tumor necrosis factor (TNF) therapy. However, adherence to the recommended practice is unknown in the current clinical setting in Japan.

METHODS

We used a large-scale health insurance claims database in Japan to conduct a longitudinal observational study. Of more than two million beneficiaries in the database between 2013 and 2014, we enrolled those with IMIDs aged 15-69 years who had initiated anti-TNF therapy. We defined tuberculosis screening primarily as tuberculin skin test and/or interferon-gamma release assay (TST/IGRA) within 2 months before commencing anti-TNF therapy. We analyzed the proportions of the patients who had undergone tuberculosis screening and the associations with primary disease, type of anti-TNF agent, methotrexate prescription prior to anti-TNF therapy, and treatment for latent tuberculosis infection (LTBI).

RESULTS

Of 385 patients presumed to have initiated anti-TNF therapy, 252 (66%) had undergone tuberculosis screening by TST/IGRA (22% TST, 56% IGRA, and 12% both TST and IGRA), and 231 (60%) had undergone TST/IGRA and radiography. Patients with psoriasis tended to be more likely to undergo tuberculosis screening than those with other diseases; however, this association was not statistically significant. Treatment for LTBI was provided to 43 (11%) patients; 123 (32%) received neither TST/IGRA nor LTBI treatment.

CONCLUSIONS

Tuberculosis screening was often not performed prior to anti-TNF therapy despite the guidelines' recommendations; thus, patients could be put at unnecessary risk of reactivation of tuberculosis.

摘要

目的

在开始抗肿瘤坏死因子(TNF)治疗之前,建议对患有免疫介导的炎症性疾病(IMIDs)的患者进行结核病筛查。然而,目前在日本的临床环境中,尚不清楚是否遵循了这一推荐实践。

方法

我们使用日本的一个大型医疗保险索赔数据库进行了一项纵向观察性研究。在 2013 年至 2014 年期间,我们从数据库中的 200 多万名受益人中招募了年龄在 15 至 69 岁之间、开始接受抗 TNF 治疗的 IMIDs 患者。我们将结核病筛查主要定义为在开始抗 TNF 治疗前 2 个月内进行结核菌素皮肤试验和/或干扰素-γ释放试验(TST/IGRA)。我们分析了接受结核病筛查的患者比例,并分析了其与主要疾病、抗 TNF 药物类型、抗 TNF 治疗前甲氨蝶呤的使用情况以及潜伏性结核感染(LTBI)治疗之间的关联。

结果

在 385 名被认为开始接受抗 TNF 治疗的患者中,有 252 名(66%)通过 TST/IGRA 进行了结核病筛查(22% TST、56% IGRA 和 12%同时进行 TST 和 IGRA),有 231 名(60%)进行了 TST/IGRA 和影像学检查。患有银屑病的患者比患有其他疾病的患者更有可能接受结核病筛查,但这种关联没有统计学意义。有 43 名(11%)患者接受了 LTBI 治疗;有 123 名(32%)患者既未接受 TST/IGRA 检查,也未接受 LTBI 治疗。

结论

尽管有指南建议,但在开始抗 TNF 治疗之前,结核病筛查往往没有进行;因此,患者可能面临不必要的结核再激活风险。

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