- 期刊
Comparative Study of Compliance, Antitussive Efficacy and Tolerability between Detusiv® Sustained Release Tablet and Medicon-A® Capsule in the Treatment of Acute Cough
比較比較Detusiv®緩釋錠與Medicon-A®在治療急性咳嗽方面之醫囑遵從性、療效以及病患耐受度之研究
摘要
背景：本篇報告的目的在於比較止咳藥Dextromethorphan兩種不同的配方（Detusiv®緩釋錠與Medicon-A®）在治療急性咳嗽方面之醫囑遵從性、療效以及病患耐受度之研究 方法：56位超過18歲患少於三週急性咳嗽的病人，以隨機方式分成兩組。一組接受DetusivO緩釋錠配方，一組接受Medicon-AO配方，用藥時間為七天。研究項目包括咳嗽頻率、咳嗽嚴重度、整體性以及安全性的評估。 結果：56位病人以隨機方式分成兩組（DetusivR緩釋錠:28;Medicon-AR:28）。55位病人列入分析85.2%（23/27）使用Detusiv®緩釋錠病人和85.7%（24/28）使用Medicon-A®病人咳嗽頻率減少。77.8%（21/27）使用DetusivO緩釋錠病人和82.1%（23/28）使用Medicon-A®病人咳嗽嚴重度減少。92.6%（25 of 27）使用Detusiv®緩釋錠病人和82.1%（23of28）使用Medicon-A®病人整體性評估有改善。兩組病人在咳嗽頻率，咳嗽嚴重度，整體性評估上無統計學差異。兩組病人在七天治療內皆有很好醫囑遵從性，也沒有嚴重副作用發生。 結論：Detusiv®緩釋錠在治療急性咳嗽上與Medicon-A®一樣有效，而且安全性和耐受度很好。
並列摘要
Background: The aim of our study was to compare the compliance, efficacy and tolerability of two dosage forms of dextromethorphan [Detusiv® sustained release (Detusiv® S.R.) tablet vs. Medicon-A® capsule] in the treatment of acute cough. Methods: Fifty-six subjects, aged 18 years and above, with a history of acute cough lasting less than 3 weeks, with or without sputum, were enrolled in this randomized, single-blind (subject-blind), active-controlled, parallel study. Subjects were randomized into a Detusiv® S.R. group or a Medicon-A® group for 7 days. Efficacy variables included cough frequency (primary), cough severity, and global evaluation. For safety variables, the adverse events data were listed individually. Results: Fifty-six subjects were enrolled and randomized into the treatment phase (Detusiv® S.R.: 28; Medicon-A®: 28). The intend-to-treat population analysis included fifty-five. At the endpoint, 85.2% (23/27) of the subjects in the Detusiv® S. R. group and 85.7% (24/28) of the subjects in the Medicon-A® group had decreases in cough frequency. Similarly, 77.8% (21/27) and 82.1% (23/28) of the subjects, respectively, had a decrease in cough severity, and 92.6% (25 of 27) and 82.1% (23 of 28) of the subjects, respectively, had improvement in the global evaluation. The difference between the two treatment groups regarding the improvement in cough frequency, cough severity, and global evaluation was not statistically significant. Overall, both treatment groups showed equally good tolerability throughout the 7-day treatment. No serious adverse event was reported. Conclusion: Detusiv® S. R. tablet was at least as effective as Medicon-A® capsule in treating patients with acute cough. Detusiv® sustained release tablet was shown to be safe and well tolerated in treating patient with acute cough.