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使用日本健康保险数据库的流行病学研究:类风湿关节炎患者使用肿瘤坏死因子抑制剂和非肿瘤坏死因子抑制剂并无增加带状疱疹风险

No increased risk of herpes zoster in TNF inhibitor and non-TNF inhibitor users with rheumatoid arthritis: epidemiological study using the Japanese health insurance database.

作者信息

Sakai Ryoko, Kasai Shoko, Hirano Fumio, Harada Sayoko, Kihara Mari, Yokoyama Waka, Tsutsumino Michi, Nagasaka Kenji, Koike Ryuji, Yamanaka Hisashi, Miyasaka Nobuyuki, Harigai Masayoshi

机构信息

Division of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases, Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan.

Department of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, Tokyo, Japan.

出版信息

Int J Rheum Dis. 2018 Sep;21(9):1670-1677. doi: 10.1111/1756-185X.13300. Epub 2018 Apr 17.

DOI:10.1111/1756-185X.13300
PMID:29667330
Abstract

OBJECTIVE

It is controversial whether the use of biological disease-modifying antirheumatic drugs (DMARDs) increases the risk of herpes zoster (HZ). We aimed to evaluate the risks of HZ in tumor necrosis factor inhibitor (TNFI) and non-TNFI users with rheumatoid arthritis (RA) over 3 years in Japan.

METHOD

Using the Japanese health insurance database, we assigned patients with at least one RA diagnostic code and one prescription for any DMARDs (RA cases) recorded between January 2005 and December 2013 to the RA group. We randomly selected five age-, sex-, calendar year- and observation length-matched non-RA cases for each RA case (non-RA group), and assessed associations between RA and HZ. To evaluate the risks of HZ in TNFI and non-TNFI users, we conducted a nested case-control study (NCC) in the RA group.

RESULTS

The RA group (n = 6712) had a significantly higher crude incidence rate of HZ than the non-RA group (n = 33 560) (14.2 vs. 8.3/1000 patient-years), and the adjusted odds ratio (95% confidence interval) of the RA versus non-RA groups was 1.43 (1.17-1.75). The NCC demonstrated that use of TNFI, non-TNFI, methotrexate, or immunosuppressive DMARDs did not increase the risks of HZ. Use of corticosteroid ≥ 5 mg/day conveyed a significant risk of HZ in patients with RA.

CONCLUSIONS

Rheumatoid arthritis was significantly associated with the development of HZ, and use of corticosteroids ≥ 5 mg/day was identified as a significant risk factor, whereas either TNFI or non-TNFI use were not.

摘要

目的

使用生物性改善病情抗风湿药(DMARDs)是否会增加带状疱疹(HZ)的风险存在争议。我们旨在评估在日本,肿瘤坏死因子抑制剂(TNFI)使用者和非TNFI使用者中类风湿关节炎(RA)患者3年内发生HZ的风险。

方法

利用日本医疗保险数据库,我们将2005年1月至2013年12月期间记录有至少一个RA诊断代码且有任何DMARDs处方(RA病例)的患者归入RA组。我们为每个RA病例随机选择5名年龄、性别、日历年份和观察时长匹配的非RA病例(非RA组),并评估RA与HZ之间的关联。为评估TNFI使用者和非TNFI使用者发生HZ的风险,我们在RA组中进行了一项巢式病例对照研究(NCC)。

结果

RA组(n = 6712)的HZ粗发病率显著高于非RA组(n = 33560)(14.2对8.3/1000患者年),RA组与非RA组的调整优势比(95%置信区间)为1.43(1.17 - 1.75)。NCC表明,使用TNFI、非TNFI、甲氨蝶呤或免疫抑制性DMARDs不会增加HZ的风险。使用≥5 mg/天的皮质类固醇会使RA患者发生HZ的风险显著增加。

结论

类风湿关节炎与HZ的发生显著相关,且使用≥5 mg/天的皮质类固醇被确定为一个显著的风险因素,而使用TNFI或非TNFI则不是。

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