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| 發表人 | 討論主題 | 發表時間 | 討論數 |
| 姜秉均 | Tadalafil在男性下泌尿道症狀的作用: 四個雙盲隨機分配臨床試驗的整合分析 | 2015/6/26 下午 02:19:27 | 0 |
| 原 文 | 題 目 | Effect of tadalafil on male lower urinary tract symptoms: an integrated analysis of storage and voiding international prostate symptom subscores from four randomised controlled trials. |
| 作 者 | Christopher R. Chapple, Claus G. Roehrborn, Kevin McVary, Dapo Ilo, Carsten Henneges, Lars Viktrup | |
| 出 處 | European Urology | |
| 出版日期 | 2015 | |
| 評 論 | 泌尿科醫師常利用國際攝護腺症狀評分(IPSS)來評估男性下泌尿路症狀，其症狀包括三個儲存型障礙(刺激型症狀)，包括頻尿、夜尿、和急尿，與四個排尿型障礙(阻塞型症狀)，包括排尿不濟、排尿斷續、尿流無力、和排尿費力，近年來的Tadalafil (商品名:Cialis, 犀利士) 針對排尿障礙的臨床試驗中發現，除了可以改善患者的性功能障礙之外，也可以有效的改善男性下泌尿路症狀，合併四個重要的臨床試驗的整合分析發現：1. 大多數病人的症狀刺激型和阻塞型症狀的分數比例約為4比6；2. 使用Tadalafil改善最大的病人，其起始刺激型與阻塞型症狀的比例也約4比6，反而症狀太偏向刺激型或阻塞型的患者，使用Tadalifil改善的效果並不好，這也暗示著明顯有刺激型或阻塞型的症狀患者有更適合的藥物與治療；3. Tadalafil針對刺激型症狀可以改善2.0分，針對阻塞型症狀可以改善3.2分，其改善的比例也約為4比6，所以Tadalafil可以同時改善刺激型與阻塞型的症狀，且與患者的治療前的症狀成等比例(4:6)的關係，故無論患者是否以刺激型症狀較多或阻塞型症狀較多，皆可以嘗試使用Tadalafil來改善下泌尿路症狀，但患者的症狀太偏向刺激型或阻塞型症狀者，可以考慮嘗試找出其可能罹患的病理機制，使用其他的藥物或治療方式。 | |
| abstract |
BACKGROUND: The international prostate symptom score (IPSS) evaluates lower urinary tract symptoms (LUTS) in men with suspected benign prostatic hyperplasia (BPH); the total score does not differentiate between storage and voiding and is unevenly weighted (four questions [57%] on voiding, three questions [43%] on storage). OBJECTIVE: To evaluate the relative contributions of storage and voiding IPSS subscores to total IPSS at baseline and in response to treatment with tadalafil. DESIGN, SETTING, AND PARTICIPANTS: Integrated analysis of data from four placebo-controlled, 12-wk studies of tadalafil (5mg once daily) in 1499 men with LUTS/BPH. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Relationships between total IPSS and the storage and voiding subscores were assessed using graphical exploration and linear regression modelling. Linear modelling was performed for the baseline and endpoint and for changes in subscores. The optimal storage subscore to total IPSS (S:T) ratio for IPSS improvement was identified using nonparametric regression and gradient-descent optimisation. RESULTS AND LIMITATIONS: The contribution of storage and voiding subscores at baseline and endpoint was 38.8% and 61.2%, and 39.2% and 60.7%, respectively. This intuitive 40:60 storage-to-voiding ratio was similar at baseline and endpoint by treatment group and for changes in subscores, but spanned the entire range for individuals. Changes in total IPSS were greatest for a storage subscore percentage contribution to total IPSS of 42.7%. There was no statistical association between S:T ratio (≥ 40% vs < 40%) at baseline and response to tadalafil. The main limitation was the use of unvalidated storage and voiding IPSS subscores. CONCLUSIONS: A constant S:T ratio of 4:10 was observed at baseline and endpoint. The greatest effect on total IPSS was noted for an S:T percentage contribution of 42.7%. Tadalafil efficacy was unaffected by the level of storage dysfunction at baseline. PATIENT SUMMARY: This analysis shows that for men with BPH, improvements during treatment with tadalafil apply to both storage and voiding symptoms at a constant ratio. The extent of storage dysfunction before treatment did not affect the response to treatment. |
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