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題 名 | Effects of Latanoprost 50 ug/ml on Chinese Patients with Primary Open-Angle Glaucoma and Ocular Hypertension=評估以Latanoprost治療原發隅角開放性青光眼及高眼壓的中國病患之效果 |
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作 者 | 劉瑞玲; 周清光; 許紋銘; 劉榮宏; | 書刊名 | 中華醫學雜誌 |
卷 期 | 62:10 1999.10[民88.10] |
頁 次 | 頁703-709 |
分類號 | 416.748 |
關鍵詞 | 青光眼; 眼壓; 高眼壓; 前列腺素; Glaucoma; Intraocular pressure; Latanoprost; Ocular hypertension; Prostaglandin; |
語 文 | 英文(English) |
中文摘要 | 背景 評估以latanoprost治療罹患原發隅角開放性青光眼及高眼壓之中國病患的 有效性及安全性。 方法 第一階段是為期14天的隨機雙盲平行研究,以比較latanoprost和安慰劑的治療 效果。第二階段是為期10週的latanoprost單臂開放標籤臨床試驗,評估病患在沒有藥物作 用的基準日及開始臨床試驗後為1、7、14、15天及第6、12週覆診日的眼壓、視覺功能、 眼部表徵及各種不良反應。 結果 共有26位病患參與試驗。在第一階段,安慰劑組的眼壓與基準值相比,沒有顯著 差異;而latanoprost組眼壓卻明顯下降(p值在第1天為0.003,第7天為0.004,第14天 則<0.001)。兩組相比,latanoprost組的眼壓明顯比安慰劑組低(p值在第1天為0.03,第7 及14天則<0.001)。兩組病患的眼壓,在第二階段都明顯下降,平均下降6.12mmHg(27 %)。在試驗全程此降壓效果維持穩定。使用latanoprost最常見的不良反應為結膜充血,26 位病患中,有16位發生此現象;沒有任何病患因無法忍受latanoprost的副作用而退出試驗。 結論 以局部latanprost眼藥水治療原發隅角開放性青光眼及高眼壓病患,可以有效降 低眼壓。此降壓效果在單次點藥後,至少可以維持24小時;且在12週點藥期間,藥效維持 穩定。輕微的結膜充血為最常見的副作用,此現象在停藥後即告緩解。 |
英文摘要 | Background. This study was designed to determine the efficacy and safety of latanoprost 50 μg/ml in Chinese patients with primary open-angle glaucoma (POAG) and ocular hypertension (OH). Methods. A 14-day randomized, double-masked, paralledl-group study comparing topical latanoprost with placebo was followed by a 10-week, one-armed, open-labeled latanoprost treatment study. Intraocular pressure (IOP), visual function, coular manifestations and miscellaneous adverse effects were evaluated at baseline, and days 1, 7, 14, 15, week 6 and week 12 visits. Results. Twenty-six eligible patients were enroleed in the study. The mean IOP was significantly reduced from baseline only in the lataanoprost-treated eyes during the first study period (p=0.003 on day 1; p=0.004 on day 7; p<0.001 on day 14). Meanwhile, the mean IOP was significantly lower in the latanoprost-treated eyes than that in the placebo-treated eyes (p=0.03 on day 1; p=0.001 on day 7 and 14). Eyes in both groups showed significantly reduced IOP at each visit of the secondary 10-week latanoprost treatment period, with a mean decrease of 6.12 mmHg. The IOP-lowering effect showed no diminution throughout the study course. Conjunctival hyperemia occurred in 16 of all patients who underwent latanoprost treatment and was the most frequent adverse effect observed. No patient withdrew from the study because of intolerable side-effects. Conclusions. Topical latanoprost is effective in reducing IOP form patients with POAG and OH. The pressure-lowering effect lasts for at least 24 hours after 1 drop instillation and no drift of effect is noted during this 12-week study. Conjunctival hyperemia was the most common side-effect. Which was mild in degree and recovered after discontinuation of the medication. medication. |
本系統中英文摘要資訊取自各篇刊載內容。