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HIT 研究——羟氯喹治疗年龄相关性黄斑变性患者的疗效:一项随机对照试验。

The HIT Study-The Hydroxychloroquine Effect in the Treatment of Patients with Age-Related Macular Degeneration: A Randomized Controlled Trial.

机构信息

Department of Ophthalmology, Faculty of Health Sciences, Samson Assuta Ashdod Hospital, Ben-Gurion University of the Negev, Beersheba 84105, Israel.

Plastic and Reconstructive Surgery, Rambam Health Care Campus, Haifa 3109601, Israel.

出版信息

Medicina (Kaunas). 2023 Mar 11;59(3):551. doi: 10.3390/medicina59030551.

DOI:10.3390/medicina59030551
PMID:36984552
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10055796/
Abstract

Decreased age-related macular degeneration (AMD) has been reported in individuals with rheumatoid arthritis treated with hydroxychloroquine (HCQ, plaquenil). In a randomized controlled trial with a parallel study design, we assessed visual acuity, central macular thickness measured with macular optical coherence tomography (OCT), and the number and size of drusen, following treatment with HCQ or a placebo in individuals with AMD. The patients received a daily dosage of 400 mg hydroxychloroquine (study group) or placebo (control group) during 12 months, and underwent complete ophthalmic examinations at 3, 6, 9, 12 and 24 months after initiation of treatment. Results: Of the 110 patients who were randomized to the treatment groups, 46 (29 females) in the study group and 50 (29 females) in the control group completed the study. The study group showed less visual acuity deterioration at two-year follow-up than did the control group (-0.03 ± 0.07 vs. -0.07 ± 0.07, = 0.027). At two years after treatment initiation, the mean number of drusen per eye was lower for ARDS2 (8.1 vs. 12.3, = 0.045) in the study group, compared to the control group. Compared to the control group, the proportion of eyes with increased drusen growth was smaller for both ARDS2 and ARDS3 drusen in the study group, and the proportion of the total drusen with growth was smaller for the study group as well: 32/46 eyes (70%) vs. 40/50 eyes (80%). Drusen volume growth, as calculated by the area and height measured with macular OCT, was also more reduced in the study than the control group (0.20 ± 0.15 vs. 0.23 ± 0.16 mm, = 0.05). None of the participants showed HCQ toxicity or adverse effects. Conclusion: Among patients with AMD, visual deterioration, the growth and the amount of drusen formation at two years after treatment initiation was less among those treated with HCQ than with a placebo. In this study, there was a negative association between HCQ treatment and wet AMD development.

摘要

据报道,接受羟氯喹(HCQ,又名氯喹)治疗的类风湿关节炎患者年龄相关性黄斑变性(AMD)的发生率降低。在一项平行研究设计的随机对照试验中,我们评估了接受 HCQ 或安慰剂治疗的 AMD 患者的视力、黄斑光学相干断层扫描(OCT)测量的中心黄斑厚度以及玻璃膜疣的数量和大小。患者在 12 个月内每天接受 400mg 羟氯喹(研究组)或安慰剂(对照组)治疗,并在治疗开始后 3、6、9、12 和 24 个月进行全面眼科检查。结果:在随机分配至治疗组的 110 名患者中,研究组有 46 名(29 名女性),对照组有 50 名(29 名女性)完成了研究。与对照组相比,研究组在两年随访时视力下降程度较小(-0.03 ± 0.07 对 -0.07 ± 0.07,= 0.027)。治疗开始两年后,研究组每只眼的玻璃膜疣数量平均较少(ARDS2 为 8.1 对 12.3,= 0.045)。与对照组相比,研究组 ARDS2 和 ARDS3 玻璃膜疣生长的眼比例较小,并且研究组总玻璃膜疣生长的比例也较小:32/46 眼(70%)对 40/50 眼(80%)。通过黄斑 OCT 测量的面积和高度计算的玻璃膜疣体积增长在研究组也比对照组减少(0.20 ± 0.15 对 0.23 ± 0.16mm,= 0.05)。无参与者出现 HCQ 毒性或不良反应。结论:在 AMD 患者中,与安慰剂相比,接受 HCQ 治疗的患者在治疗开始两年后的视力恶化、玻璃膜疣生长和形成数量更少。在这项研究中,HCQ 治疗与湿性 AMD 发展之间存在负相关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a6b/10055796/2757055e9db9/medicina-59-00551-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a6b/10055796/ce7bc4bee6fa/medicina-59-00551-g001a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a6b/10055796/2dce2e9ec23c/medicina-59-00551-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a6b/10055796/96086271532b/medicina-59-00551-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a6b/10055796/2757055e9db9/medicina-59-00551-g004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a6b/10055796/ce7bc4bee6fa/medicina-59-00551-g001a.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a6b/10055796/2dce2e9ec23c/medicina-59-00551-g002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a6b/10055796/96086271532b/medicina-59-00551-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7a6b/10055796/2757055e9db9/medicina-59-00551-g004.jpg

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