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匈牙利生物时代新诊断克罗恩病患者的治疗偏好与结局:一项基于国家健康保险基金数据库的全国性研究

Therapeutic preferences and outcomes in newly diagnosed patients with Crohn's diseases in the biological era in Hungary: a nationwide study based on the National Health Insurance Fund database.

作者信息

Kurti Zsuzsanna, Ilias Akos, Gonczi Lorant, Vegh Zsuzsanna, Fadgyas-Freyler Petra, Korponay Gyula, Golovics Petra A, Lovasz Barbara D, Lakatos Peter L

机构信息

1st Department of Medicine, Semmelweis University, Budapest, H-1083, Hungary.

Strategic Analysis Department, National Health Insurance Fund (OEP), Budapest, H-1139, Hungary.

出版信息

BMC Gastroenterol. 2018 Jan 30;18(1):23. doi: 10.1186/s12876-018-0746-6.

Abstract

BACKGROUND

Accelerated treatment strategy, including tight disease control and early aggressive therapy with immunosuppressives (IS) and biological agents have become increasingly common in inflammatory bowel disease (IBD). The aim of the present study was to estimate the early treatment strategy and outcomes in newly diagnosed patients with Crohn's disease (CD) between 2004 and 2008 and 2009-2015 in the whole IBD population in Hungary based on the administrative database of the National Health Insurance Fund (OEP).

METHODS

We used the administrative database of the OEP, the only nationwide state-owned health insurance provider in Hungary. Patients were identified through previously reported algorithms using the ICD-10 codes for CD in the out-, inpatient (medical, surgical) non-primary care records and drug prescription databases between 2004 and 2015. Patients were stratified according to the year of diagnosis and maximum treatment steps during the first 3 years after diagnosis.

RESULTS

A total of 6173 (male/female: 46.12%/53.87%) newly diagnosed CD patients with physician-diagnosed IBD were found in the period of 2004-2015. The use of 5-ASA and steroids remained common in the biological era, while immunosuppressives and biologicals were started earlier and became more frequent among patients diagnosed after 2009. The probability of biological therapy was 2.9%/6.4% and 8.4%/13.7% after 1 and 3 years in patients diagnosed in 2004-2008/2009-2015. The probability of hospitalization in the first 3 years after diagnosis was different before and after 2009, according to the maximal treatment step (overall 55.7%vs. 47.4% (p = 0.001), anti-TNF: 73%vs. 66.7% (p = 0.103), IS: 64.6% vs. 56.1% (p = 0.001), steroid: 44.2%vs. 36.8% (p < 0.007), 5-ASA: 32.6% vs. 26.7% p = 0.157)). In contrast, surgery rates were not significantly different in patients diagnosed before and after 2009 according to the maximum treatment step (overall 16.0%vs.15.3%(p = 0.672) anti-TNF 26.7%vs.27.2% (p = 0.993), IS: 24.1%vs22.2% (p = 0.565), steroid 8.1%vs.7.9% (p = 0.896), 5-ASA 10%vs. 11% (p = 0.816)).

CONCLUSIONS

IS and biological exposure became more frequent, while hospitalization decreased and surgery remained low but constant during the observation period. Use of steroids and 5-ASA remained high after 2009. The association between the maximal treatment step and hospitalization/surgery rates suggests that maximal treatment step can be regarded as proxy severity marker in patients with IBD.

摘要

背景

加速治疗策略,包括严格的疾病控制以及早期积极使用免疫抑制剂(IS)和生物制剂,在炎症性肠病(IBD)中越来越普遍。本研究的目的是基于匈牙利国家健康保险基金(OEP)的管理数据库,评估2004年至2008年以及2009年至2015年期间匈牙利IBD患者群体中,新诊断的克罗恩病(CD)患者的早期治疗策略和治疗结果。

方法

我们使用了OEP的管理数据库,它是匈牙利唯一的全国性国有健康保险提供商。通过先前报告的算法,利用2004年至2015年期间门诊、住院(医疗、外科)非初级护理记录和药物处方数据库中CD的ICD - 10编码来识别患者。根据诊断年份和诊断后前3年的最大治疗步骤对患者进行分层。

结果

在2004年至2015年期间,共发现6173例(男性/女性:46.12%/53.87%)新诊断的CD患者,这些患者均由医生诊断为IBD。在生物制剂时代,5 - ASA和类固醇的使用仍然普遍,而免疫抑制剂和生物制剂在2009年后诊断的患者中更早开始使用且使用频率更高。2004 - 2008年/2009 - 2015年诊断的患者在1年和3年后接受生物治疗的概率分别为2.9%/6.4%和8.4%/13.7%。根据最大治疗步骤,2009年前后诊断的患者在诊断后前3年的住院概率有所不同(总体55.7%对47.4%(p = 0.001),抗TNF:73%对66.7%(p = 0.103),IS:64.6%对56.1%(p = 0.001),类固醇:44.2%对36.8%(p < 0.007),5 - ASA:32.6%对26.7%,p = 0.157)。相比之下,根据最大治疗步骤,2009年前后诊断的患者手术率无显著差异(总体16.0%对15.3%(p = 0.672),抗TNF 26.7%对27.2%(p = 0.993),IS:24.1%对22.2%(p = 0.565),类固醇8.1%对7.9%(p = 0.896),5 - ASA 10%对11%(p = 0.816))。

结论

在观察期内,免疫抑制剂和生物制剂的使用频率增加,住院率下降,手术率虽低但保持稳定。2009年后类固醇和5 - ASA的使用仍然较多。最大治疗步骤与住院率/手术率之间的关联表明,最大治疗步骤可被视为IBD患者病情严重程度的替代指标。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ed28/5789702/42733c422c65/12876_2018_746_Fig1_HTML.jpg

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