- 期刊
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Timoptol-XE(上標 ®)及Timoptol(上標 ®)用於青光眼或高眼壓症病人之比較性研究
Comparative Study of Timoptol-XE(superscript ®) Versus Timoptol(superscript ®) in Patients with Open-Angle Glaucoma or Ocular Hypertension
摘要
目的：本臨床試驗目的在比較新投予劑型藥物0.5% Timoptol-XE(上標 ®)每日一次與傳統0.5% Timoptol(上標 ®)每日二次之間的降眼壓效果，以及對於病人心率、血壓的影響。 方法：將四十名青光眼或高眼壓症病人隨機分為兩組，接受為期十二週的隨機、開放、兩階段交叉(cross-over)試驗，各階段皆為六週。A組二十人先使用Timoptol-XE(上標 ®)六週後再使用Timoptol(上標 ®)六週，B組二十人則先使用Timoptol(上標 ®)六週後再使用Timoptol-XE(上標 ®)六週。在使用此二種藥物之前以及各階段結束時均需測量病人的眼壓、血壓、心率，並詢問病人使用藥物的不良反應以及偏好使用何種眼藥。 結果：此二種藥物對於降眼壓的效果，以及對血壓、心率的改變，均沒有達到統計上有意義的差異，對於病人主觀的不良反應以及偏好性也沒有顯着的不同。 結論：雖然Timoptol-XE(上標 ®)每日一次與Timoptol(上標 ®)每日兩次的效果與反應均無差異，但就減少投予總劑量以及病人用藥的方便性與順從性，Timoptol-XE(上標 ®)仍是種值得一用的降眼壓藥。
關鍵字
無資料並列摘要
Topical beta-blockers are widely used anti-glaucoma drugs, and usually they are considered the first line drug for various types of glaucoma. Decrease the frequency of instillation without damping the drug effect is a good idea for most of the glaucoma patients who almost need to take these medicines for life. So we decided to perform this clinical trial to evaluate the responses of the topical beta-blocker that was used once a day. Of course, the responses we had concened included favored (reduction of intraocular pressure) and disfavored (bradycardia, hypotension). A 12-week, randomized, open-labeled, two-period cross-over (6 weeks each period) study was designed; 40 subjects with ocular hypertension, primary open-angle glaucoma, or chronic angle-closure glaucoma were included and treated topically with either timolol maleate 0.5% in Gelrite (Timoptol-XE(superscript ®)) once a day or aqueous timolol maleate 0.5% (Timoptol(superscript ®)) twice a day in a random order of drug use for each 6-week period. There was no statistically significant difference in intraocular pressure, blood pressure, and heart rate between these different groups of treatment; neither is in the different sequence and phases. There was also no difference in adverse effects and preference between these two formulations.