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本文引用的文献

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Gaps in Ambulatory Patient Safety for Immunosuppressive Specialty Medications.免疫抑制专科药物门诊患者安全方面的差距。
Jt Comm J Qual Patient Saf. 2019 May;45(5):348-357. doi: 10.1016/j.jcjq.2018.12.003. Epub 2019 Jan 25.
2
Using health-system-wide data to understand hepatitis B virus prophylaxis and reactivation outcomes in patients receiving rituximab.利用全卫生系统数据了解接受利妥昔单抗治疗的患者的乙肝病毒预防及再激活情况。
Medicine (Baltimore). 2017 Mar;96(13):e6528. doi: 10.1097/MD.0000000000006528.
3
Rheumatology Informatics System for Effectiveness: A National Informatics-Enabled Registry for Quality Improvement.风湿性疾病疗效信息系统:一个基于信息学的全国质量改进登记系统。
Arthritis Care Res (Hoboken). 2016 Dec;68(12):1866-1873. doi: 10.1002/acr.23089.
4
Development of the American College of Rheumatology's Rheumatoid Arthritis Electronic Clinical Quality Measures.美国风湿病学会类风湿关节炎电子临床质量指标的制定。
Arthritis Care Res (Hoboken). 2016 Nov;68(11):1579-1590. doi: 10.1002/acr.22984.
5
Implementation of treat-to-target in rheumatoid arthritis through a Learning Collaborative: Rationale and design of the TRACTION trial.通过学习协作组在类风湿关节炎中实施达标治疗:TRACTION试验的原理与设计
Semin Arthritis Rheum. 2016 Aug;46(1):81-7. doi: 10.1016/j.semarthrit.2016.02.009. Epub 2016 Mar 8.
6
Gastroenterologists Have Suboptimal Hepatitis B Virus Screening Rates in Patients Receiving Immunosuppressive Therapy.胃肠病学家对接受免疫抑制治疗的患者进行乙型肝炎病毒筛查的比例不理想。
Dig Dis Sci. 2016 Aug;61(8):2236-2241. doi: 10.1007/s10620-016-4118-1. Epub 2016 Mar 18.
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Poor recognition of risk factors for hepatitis B by physicians prescribing immunosuppressive therapy: a call for universal rather than risk-based screening.开具免疫抑制疗法的医生对乙型肝炎风险因素认识不足:呼吁进行普遍筛查而非基于风险的筛查。
PLoS One. 2015 Apr 15;10(4):e0120749. doi: 10.1371/journal.pone.0120749. eCollection 2015.
8
Preventing hepatitis B reactivation due to immunosuppressive drug treatments.预防免疫抑制药物治疗导致的乙型肝炎再激活。
JAMA. 2015 Apr 28;313(16):1617-8. doi: 10.1001/jama.2015.2571.
9
Screening prior to biological therapy in Crohn's disease: adherence to guidelines and prevalence of infections. Results from a multicentre retrospective study.克罗恩病生物治疗前的筛查:指南依从性与感染患病率。一项多中心回顾性研究的结果
Dig Liver Dis. 2014 Oct;46(10):881-6. doi: 10.1016/j.dld.2014.07.006. Epub 2014 Jul 28.
10
Assessing process of care in rheumatoid arthritis at McGill University hospitals.评估麦吉尔大学附属医院类风湿关节炎的治疗过程。
J Clin Rheumatol. 2013 Jun;19(4):175-9. doi: 10.1097/RHU.0b013e3182937094.

RISE 注册研究揭示了生物制剂和靶向合成 DMARDs 新使用者在药物安全方面的潜在差距。

RISE registry reveals potential gaps in medication safety for new users of biologics and targeted synthetic DMARDs.

机构信息

University of California - San Francisco - Division of Rheumatology, Department of Medicine, 3333 California St San Francisco, CA 94118, United States; Philip R. Lee Institute for Health Policy Research, University of California - San Francisco, 3333 California St San Francisco, CA 94118, United States; San Francisco VA Medical Center, 4150 Clement St 111R, San Francisco, CA 94121, United States.

University of California - San Francisco - Division of Rheumatology, Department of Medicine, 3333 California St San Francisco, CA 94118, United States.

出版信息

Semin Arthritis Rheum. 2020 Dec;50(6):1542-1548. doi: 10.1016/j.semarthrit.2020.03.003. Epub 2020 Mar 19.

DOI:10.1016/j.semarthrit.2020.03.003
PMID:32234243
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7501140/
Abstract

OBJECTIVE

Immunosuppressant drugs can increase the risk of hepatitis B virus (HBV) and hepatitis C virus (HCV) and tuberculosis (TB) reactivation. Using the American College of Rheumatology's Rheumatology Informatics System for Effectiveness (RISE) registry, we examined pre-treatment screening among new users of biologic or targeted synthetic disease modifying drugs (DMARDs).

METHODS

Data, derived from RISE, included patients ≥ 18 years old who were new users of biologic or targeted synthetic DMARDs. We developed quality measures related to pre-treatment screening for HBV, HCV, and TB in addition to a "composite" measure for all applicable tests. We assessed patient-level screening rates, practice-level variation among practices reporting on ≥ 20 patients, and the frequency of positive results.

RESULTS

We included 26,802 patients across 213 rheumatology practices nationwide. Patients were 58 (14) years old, 75.9% female; 59.6% had rheumatoid arthritis, and TNFi were the most common index DMARDs (64.9%). Overall, 44.8% and 40.5% patients had any documented HBV or HCV screening, respectively, prior to the index date; 29.7% had TB screening in the year prior to drug start. Only 15.5% had documentation of screening for all appropriate infections prior to drug start. Practice-level performance on the composite measure was low (range 0 to 48.3%). 2.4% of screening tests were positive.

CONCLUSION

We found gaps in documentation of key safety measures among practices participating in RISE. Given the small but significant number of patients with active or latent infections that pose safety risks, developing standardized and reliable strategies to capture safety screening measures is paramount.

摘要

目的

免疫抑制剂会增加乙型肝炎病毒(HBV)、丙型肝炎病毒(HCV)和结核(TB)再激活的风险。我们利用美国风湿病学会的风湿病信息系统(RISE)登记处,检查了新使用生物制剂或靶向合成疾病修正药物(DMARD)的患者的治疗前筛查情况。

方法

RISE 数据库的数据包括≥18 岁、新使用生物制剂或靶向合成 DMARD 的患者。我们制定了与 HBV、HCV 和 TB 治疗前筛查相关的质量指标,以及所有适用检测的“综合”指标。我们评估了患者层面的筛查率、报告患者数≥20 的实践层面的差异,以及阳性结果的频率。

结果

我们纳入了全国 213 个风湿病实践中的 26802 名患者。患者的年龄为 58(14)岁,女性占 75.9%;59.6%患有类风湿关节炎,肿瘤坏死因子抑制剂(TNFi)是最常见的起始 DMARD(64.9%)。总体而言,分别有 44.8%和 40.5%的患者在索引日期前有任何记录的 HBV 或 HCV 筛查,29.7%在开始药物治疗前的一年中进行了 TB 筛查。只有 15.5%的患者在开始药物治疗前有所有适当感染筛查的记录。实践层面在综合指标上的表现较低(范围 0 至 48.3%)。2.4%的筛查检测呈阳性。

结论

我们发现参与 RISE 的实践在关键安全措施的记录方面存在差距。鉴于存在具有安全风险的活动性或潜伏性感染的患者数量虽小但意义重大,制定标准化和可靠的策略来获取安全筛查措施至关重要。

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