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台湾长期服用羟氯喹患者的当前筛查实践:一项基于全国人群的队列研究。

Current screening practice in patients under long-term hydroxychloroquine medication in Taiwan: A nationwide population-based cohort study.

作者信息

Yen Chu-Yu, Lee Pei-Hsuan, Yen Ju-Chuan, Chen Chun-Chen, Hu Hsiao-Yun, Tseng Po-Chen

机构信息

Department of Ophthalmology, Taipei City Hospital, Renai Branch, Taipei, Taiwan.

Graduate Institute of Biomedical Informatics, College of Medical Science and Technology, Taipei Medical University.

出版信息

Medicine (Baltimore). 2019 Apr;98(14):e15122. doi: 10.1097/MD.0000000000015122.

DOI:10.1097/MD.0000000000015122
PMID:30946384
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6455786/
Abstract

Hydroxychloroquine (HCQ), an analog of chloroquine, is widely used in various rheumatologic and dermatologic disorders. However, it may cause severe retinopathy with long-term use. The guidelines proposed by the American Academy of Ophthalmology suggested a baseline fundus examination and an annual screening after 5 years by using automated visual fields (VF) plus spectral-domain optical coherence tomography (SD-OCT). Both multifocal electroretinogram (mfERG) and fundus autofluorescence (FAF) can also be used to improve the accuracy of diagnosis. The purpose of this study was to examine if the current HCQ screening practice in Taiwan was sufficient according to the guidelines to prevent severe macular complications.This study could remind every doctor to explain visual side effects thoroughly to every patient using HCQ, and refer patients for the ophthalmologic survey to eliminate potential visual impairment caused by this medicine.This nationwide population-based cohort study included all patients who started taking HCQ (n = 5826) from January 1, 1997, to December 31, 2007, in the Longitudinal Health Insurance Database 2000. The ICD codes used for HCQ retinopathy were 362.10, 362.55, 362.89, and 362.9. Patients previously diagnosed these retinal disorders were excluded. Demographic data including sex, age, diagnostic tools used, and the date of the initial diagnosis of the subsequent HCQ-related retinal disorder were collected. Patients were divided into 2 groups. The patients taking HCQ <5 years were defined as group 1, and >5 years as group 2. The risk of developing retinal diseases between these 2 groups was compared with a 2-sample t-test for continuous variables, and Fisher's exact test for discrete variables. Multiple logistic regressions were used for odds ratio calculation.The baseline examination ratio of the automated VF, SD-OCT scans, and multifocal electroretinograms (mfERGs) in the first 3 months were only 0.2% in both groups. The screening ratio of the 3 examination tools after 5 years were 1.1% in group 1 and 1.2% in group 2. 2.5% and 3.9% of patients developed a retinal disorder after HCQ use in group 1 and 2, respectively. The risk of developing retinal disorder was significantly higher in group 2 (relative risk = 1.53, P = .006). The odds ratio (OR) was also significantly higher in group 2 (1.67 with 95% cumulative incidence 1.20-2.30)The examination ratio according to the guidelines was very low in Taiwan. Thus, it is very important for doctors who prescribe HCQ to schedule both baseline and annual ophthalmology screening tests and inform patients of possible severe ocular complications, even in the patient taking HCQ <5 years. It is also important for ophthalmologists to review medical history carefully to find out the causes of retinotoxicity. Medications should be stopped, if possible when toxicity is recognized or strongly suspected.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f2b/6455786/bf0762ed7086/medi-98-e15122-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f2b/6455786/bf0762ed7086/medi-98-e15122-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5f2b/6455786/bf0762ed7086/medi-98-e15122-g001.jpg
摘要

羟氯喹(HCQ)是氯喹的类似物,广泛用于各种风湿性和皮肤病。然而,长期使用可能会导致严重的视网膜病变。美国眼科学会提出的指南建议进行基线眼底检查,并在5年后每年使用自动视野检查(VF)和光谱域光学相干断层扫描(SD-OCT)进行筛查。多焦视网膜电图(mfERG)和眼底自发荧光(FAF)也可用于提高诊断准确性。本研究的目的是根据指南检查台湾目前的HCQ筛查实践是否足以预防严重的黄斑并发症。本研究可以提醒每位医生向每位使用HCQ的患者充分解释视觉副作用,并将患者转诊进行眼科检查,以消除这种药物引起的潜在视力损害。这项基于全国人群的队列研究纳入了2000年纵向健康保险数据库中从1997年1月1日至2007年12月31日开始服用HCQ(n = 5826)的所有患者。用于HCQ视网膜病变的国际疾病分类代码为362.10、362.55、362.89和362.9。先前诊断为这些视网膜疾病的患者被排除在外。收集了人口统计学数据,包括性别、年龄、使用的诊断工具以及随后HCQ相关视网膜疾病的初次诊断日期。患者分为两组。服用HCQ<5年的患者定义为第1组,>5年的患者定义为第2组。使用两样本t检验比较连续变量,使用Fisher精确检验比较离散变量,比较这两组发生视网膜疾病的风险。使用多元逻辑回归计算比值比。两组在前3个月自动VF、SD-OCT扫描和多焦视网膜电图(mfERG)的基线检查率仅为0.2%。5年后,这三种检查工具在第1组的筛查率为1.1%,在第2组为1.2%。第1组和第2组分别有2.5%和3.9%的患者在使用HCQ后发生视网膜疾病。第2组发生视网膜疾病的风险显著更高(相对风险 = 1.53,P = 0.006)。第2组的比值比(OR)也显著更高(1.67,95%累积发病率为1.20 - 2.30)。台湾地区按照指南的检查率非常低。因此,对于开具HCQ处方的医生来说,安排基线和年度眼科筛查测试并告知患者可能的严重眼部并发症非常重要,即使是服用HCQ<5年的患者。眼科医生仔细回顾病史以找出视网膜毒性的原因也很重要。如果在认识到或强烈怀疑毒性时,尽可能停用药物。

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