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題名 | Comparison of Patanol[feb9] (Olopatadine Hydrochloride 0.1%) with Loratadine in Alleviating the Symptoms/Signs of Allergic Conjunctivitis of Taiwanese--An Observer-Masked, Parallel-Group, Randomized, Seven-Day Environmental Study=Patanol[feb9]與Loratadine對於減緩臺灣人過敏性結膜炎療效之比較 |
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作者 | 陳喬鴻; 楊美娟; 呂大文; 林素玲; 周秉義; | 書刊名 | Journal of Medical Sciences |
卷期 | 23:1 2003.02[民92.02] |
頁次 | 頁35-40 |
分類號 | 418.2323 |
關鍵詞 | 過敏性結膜炎; Allergic conjunctivitis; Loratadine; Olopatadine; |
語文 | 英文(English) |
英文摘要 | This study was conducted to evaluate the use of PATANOL® eye drops (olopatadine ophthalmic solution 0.1%) compared with loratadine 10 mg tablets for treating the occular signs and symptoms of patients with moderate to severe allergic conjunctivitis in Asian patients from Taiwan. Methods: Patients who met all inclusion/exclusion criteria and had a positive reaction to at least one common allergen in Taiwan (n=45) were randomized to receive one drop of PATANOL b.i.d. (n=22) or 1 tablet of loratadine 10 mg q.d. (n=23) for 7 days. The onset of action for treating signs and symptoms of allergic conjunctivitis was evaluated on Day 0, prior to dosing and 3, 10, and 20 minutes post dosing. Ocular itching, redness and nasal signs and symptoms were scored for both eyes on both Day 3 and Day 7 for evaluation of the duration of action. Dedicated site personnel dispensed the medication outside the view of the investigator in order to ensure that observer-masking was maintained. Results: On Day 0, PATANOL was significantly (p≦0.05) more effective than loratadine in allerviating itching and redness at 10, 20 mins after treatment. Itching score reductions of 2.2 and 2.5 units were achieved after 3 and 7 days of PANTANOL and loratadine treatments, respectively. On Day 3, the mean score for ocular redness was 1.0 in the PATANOL group versus 1.5 for the loratadine group (p=0.012). There were no serious or drug related ocular or nonocular adverse events in this study. Conclusions: The findings demonstrate that PATANOL is statistically superior to loratadine in alleviating the signs and symptoms of ocular itching and redness with a more rapid onset of action at 10, 20 mins after initial treatment. Over a 7-day treatment period, PATANOL demonstrated a trend towards greater score reductions of itching and redness. |
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