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日本行政数据库中先前已解决的乙型肝炎病毒检测的有效性。

Validity of administrative database detection of previously resolved hepatitis B virus in Japan.

机构信息

Department of Clinical Data Management and Research, Clinical Research Center, National Hospital Organization Headquarters, Tokyo, Japan.

Department of Drug Safety and Risk Management, School of Pharmacy, Tokyo University of Pharmacy and Life Sciences, Tokyo, Japan.

出版信息

J Med Virol. 2019 Nov;91(11):1944-1948. doi: 10.1002/jmv.25540. Epub 2019 Jul 22.

Abstract

The risk of hepatitis B virus (HBV) reactivation has increased owing to advances in the immunosuppressive therapy field. However, the HBV reactivation incidence among patients with previously resolved HBV (prHBV) infection during immunosuppressive therapy for rheumatoid arthritis (RA) remains unclear. The objective of this work is to describe the validity of detecting prHBV infection from administrative data through comparisons with chart abstraction and determine the incidence of HBV reactivation during immunosuppressive therapy for RA in Japan. In this retrospective cohort study, data on selected patients were extracted from administrative claims data. To identify patients with prHBV infection and de novo hepatitis, and HBsAg carriers, we conducted chart abstraction. The incidence rate of de novo hepatitis was 1.23 of 100 person-years. The positive predictive value (PPV) and its 95% confidence interval (CI) of administrative data for the identification of suspected prHBV infections was 85.8% (95% CI: 81.7%-89.3%). This study evaluated the PPV of the algorithm of HBV-DNA testing with immunosuppressive therapy performed four times or more per year for the detection of prHBV infection from administrative data. Additionally, we determined the incidence rate of HBV reactivation among preHBV infections during immunosuppressive therapy for RA to be 1.23 of 100 person-years.

摘要

由于免疫抑制治疗领域的进步,乙型肝炎病毒(HBV)再激活的风险增加。然而,在类风湿关节炎(RA)的免疫抑制治疗期间,既往已解决 HBV(prHBV)感染患者的 HBV 再激活发生率尚不清楚。本研究的目的是描述通过与图表摘要比较从行政数据中检测 prHBV 感染的有效性,并确定日本 RA 免疫抑制治疗期间 HBV 再激活的发生率。在这项回顾性队列研究中,从行政索赔数据中提取了选定患者的数据。为了确定 prHBV 感染、新发肝炎和 HBsAg 携带者患者,我们进行了图表摘要。新发肝炎的发病率为 1.23/100 人年。行政数据识别疑似 prHBV 感染的阳性预测值(PPV)及其 95%置信区间(CI)为 85.8%(95%CI:81.7%-89.3%)。本研究评估了免疫抑制治疗期间每年进行四次或更多次 HBV-DNA 检测的算法对从行政数据中检测 prHBV 感染的 PPV。此外,我们确定了 RA 免疫抑制治疗期间 prHBV 感染患者的 HBV 再激活发生率为 1.23/100 人年。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/618a/6771469/462b45d0dd94/JMV-91--g001.jpg

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