한국인 정상안압녹내장에서 브린졸라미드 1%와 브리모니딘 0.2% 혼합제제의 임상 효과
Clinical Effectiveness of a Brinzolamide 1%-Brimonidine 0.2% Fixed Combination for Normal Tension Glaucoma in South Koreans
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목적: 한국인 정상안압녹내장 환자들을 대상으로 하여 브린졸라미드 1%와 브리모니딘 0.2% 혼합제제(brinzolamide 1%-brimonidine 0.2% fixed combination, BBFC)의 안압 하강 효과와 안정성에 대해 알아보고자 한다. 대상과 방법: 2016년 1월부터 2016년 12월까지 정상안압녹내장을 처음 진단받고 BBFC를 점안 시작한 45명의 환자를 대상으로 하였다. 모든 환자의 녹내장안 중 단안이 연구에 포함되었다. 양안에 녹내장이 있는 경우 녹내장성 변화가 더 심한 눈이 선택되었고, 비슷한 경우에는 우안이 선택되었다. 모든 환자는 BBFC를 하루에 두 번 점안하였다. BBFC 점안 전과 6개월 점안 후, 일중 안압을 오전 9시부터 오후 4시 30분까지 매 2시간 30분마다 측정하였고, 체위변동안압을 확인하였다. 연구 전반에 걸쳐 모든 부작용은 연구자에 의해 기록되고 모니터링되었다. 결과: 10명의 환자가 알레르기 반응 또는 추적관찰이 되지 못하여 제외되었고, 총 35명이 연구에 포함되었다. 평균 안압은 BBFC 점안 전 15.32 ± 4.00 mmHg, 6개월 점안 후 13.38 ± 3.30 mmHg였다(p<0.001). 또한 안압 변화량은 BBFC 점안 후 3.33 ± 3.10 mmHg 에서 2.35 ± 1.40 mmHg로 감소를 보였으나 통계적 유의성은 없었고(p=0.150), 평균 체위변동안압의 차이는 16.94 ± 3.18 mmHg에서 14.80 ± 3.27 mmHg로 통계적으로 유의한 감소를 보였다(p=0.025). 3건의 약물 알레르기 이외에 약제를 중단할 만한 심각한 부작용은 나타나지 않았다. 결론: 정상안압녹내장 환자들에게 브린졸라미드 1%와 브리모니딘 0.2% 혼합제제(BBFC)는 평균 안압, 체위변동안압을 감소시키는 데 효과적이었다.
Abstract
Purpose: This study evaluated the efficacy and safety of a brinzolamide 1%-brimonidine 0.2% fixed combination (BBFC) for normal tension glaucoma (NTG) in a South Korean population. Methods: This study included 45 patients who were newly diagnosed with NTG and treated with BBFC as the first therapy from January 2016 through December 2016. The unilateral eye of NTG eyes of all patients were enrolled. If both eyes were eligible, the eye with the more severe glaucomatous change was selected. If the glaucomatous change was similar in both eyes, the right eye was selected. The patients received the BBFC twice a day. Diurnal intraocular pressure (IOP) was measured every 2 and 1/2 hours between 09:00 am and 04:30 pm. The IOP change with respect to body position (positional IOP) was measured at baseline and at 6 months after eyedrop instillation. Throughout the study, all side effects were recorded and monitored by the investigators. Results: Ten patients were excluded due to an allergic reaction or follow-up loss. A total of 35 patients were enrolled in this study. The mean IOP was 15.32 ± 4.00 mmHg at baseline and 13.38 ± 3.30 mmHg at 6 months after BBFC instillation (p < 0.001). The IOP fluctuation decreased from 3.33 ± 3.10 to 2.35 ± 1.40 mmHg after BBFC instillation; however, the difference was not statistically significant (p = 0.150). The mean change in positional IOP showed a statistically significant reduction from 16.94 ± 3.18 to 14.80 ± 3.27 mmHg (p = 0.025). There was no serious adverse drug reaction except in three cases of allergic reaction. Conclusions: BBFC is effective for the reduction of mean IOP and positional IOP in NTG patients.
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