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題 名 | Anti-Ischemic and Anti-Anginal Effects of Controlled-Release and Conventional Isosorbide-5-Mononitrate in Stable Angina Pectoris=Isosorbide-5-Mononitrate之緩慢釋放劑型與傳統型對穩定性心絞痛患者之療效比較 |
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作 者 | 陳嬰華; 丁予安; 王石補; | 書刊名 | 中華醫學雜誌 |
卷 期 | 61:10 1998.10[民87.10] |
頁 次 | 頁577-583 |
分類號 | 415.3161 |
關鍵詞 | 心絞痛; 緩慢釋放劑型; Angina pectoris; Controlled-release formulation; Isosorbide-5-mononitrate; |
語 文 | 英文(English) |
中文摘要 | 背景 Isosorbide-5-mononitrate 之緩慢釋放劑型作用時間長,可保持穩定的 血中濃度,這樣白天可達到有效之血漿濃度,晚上血漿濃度降低則可避免藥物耐受性的產生 ,它每天只需給予 1 次,較傳統劑型更為使用方便。 方法 此為一公開、隨機、交叉對照之研究。 44 位穩定性心絞痛患者,在停用硝酸鹽類藥 物後 1 周, 分別給予 isosorbide-5-mononitrate 緩慢釋放型 60 mg 每天 1 次與傳統 劑型 20mg 每天 2 次各 2 周(之間相隔 1 周以待藥物代謝),以比較其療效。 每位患者 在給藥前及給藥後 2 周,均接受運動心電圖測試, 並記錄胸痛發作次數及舌下硝化甘油之 消耗量。 結果 39 位患者完成研究並進入統計分析。與對照組比較,兩種 isosorbide-5- mononitrate 劑型均可有效增長患者的運動時間及延緩運動時出現 1-mm ST 間節下的時間 。但只有緩慢釋放型可有效延緩運動時胸痛發作的時間。此外在改善患者運動時間方面,緩 慢釋放劑型亦較傳統劑型更為顯著。 在給藥期間,兩種劑型皆有 5 位患者主訴不適,主要 是頭痛及頭暈。 結論 Isosorbide-5-mononitrate 60mg 每天 1 次之緩慢釋放劑型比 20mg 每天 2 次之 傳統劑型,在改善患者運動時間及延緩運動時胸痛發作時間方面更為有效,且其副作用少, 使用方便。 |
英文摘要 | Backguound. A controlled-release formulation of isosorbide-5- mononitrate (5-ISMN) can be administered once daily to lower the peak plasma concentration of 5-ISMN to avoid peak-related side-effects, prolong duration of action and produce predictable and reproducible plasma concentrations of 5-ISMN. This study was undertaken to compare the anti-anginal and anti-ischemic efficacy of controlled-release 5-ISMN 60 mg administered once daily and conventional 5-ISMN 20 mg given twice daily in patients with stable angina pectoris. Methods. In 44 patients with stable angina pectoris, controlled-release 5-ISMN and the conventional formulation of 5-ISMN were tested in an open, randomized, cross-over study. The study started with a one-week run-in period, during which nitrates were withdrawn. Patients were then randomly allocated to two-week treatment with controlled-release 5-ISMN 60 mg each morning followed by a one - week placebo washout and then a two-week treatment with the conventional formulation of 5-ISMN 20 mg twice daily, or vice versa. Treadmill exercise testing was performed at the end of the placebo run-in and washout periods and at the end of both active treatment periods. Results. Thirty-nine patients completed the study and were included in the statistical evaluation. Total exercise duration and time to appearance of 1-mm ST depression increased significantly after two weeks of treatment with both drugs compared with ploacebo. However, the time to onset of chest pain increased significantly only after therapy with controlled-release 5-ISMN. Moreover, controlled-release 5-ISMN produced a more pronounced improvment in total exercise duration than the conventional formulation of 5-ISMN after two weeks of therapy. Adverse events were reported by five (13%)patients receiving controlled-release 5-ISMN and by the same percentage of patients receiving conventional 5-ISMN therapy; most of these events were headache and /or dizziness. Conclusions. Treatment with 5-ISMN in the controlled-release formulation of 60 mg administered once daily appears more effective in improving total exercise duration and increasing the time to onset of chest pain than the conventional formulation of 5-ISMN in patients with stable angina pectoris. Once-daily administration of controlled- release 5-ISMN is well tolerated and convenient. |
本系統中英文摘要資訊取自各篇刊載內容。