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| 發表人 | 討論主題 | 發表時間 | 討論數 |
| 陳順郎 | 每日服用五毫克犀利士對於男性患者因攝護腺肥大造成之下泌尿道症候群最大尿流速的影響 | 2014/6/27 下午 02:07:42 | 0 |
| 原 文 | 題 目 | Effects of Tadalafil Once Daily on Maximum Urinary Flow Rate in Men with Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia |
| 作 者 | Claus G. Roehrborn 、 Christopher Chapple 、Matthias Oelke、, David Cox、 Anne Esler and Lars Viktrup | |
| 出 處 | The Journal of urology 2014 Vol 191 1045—1050 | |
| 出版日期 | April , 2014 | |
| 評 論 |
臨床實驗上已經證實Tadalafil(Cialis:犀利士)能在統計及實證上改善因攝護腺肥大的造成之儲尿性(storage ) 及排尿性(voiding) 下泌尿道症候群症狀，然而在平均最大尿流速有效改善的研究並不多見，這篇作者包括許多大師級人物如Claus G. Roehrborn 、 Christopher Chapple等等，從為期12週，以四個國際性且隨機分派有安慰劑作為控制族群針對下泌尿道症候群而被推測有攝護腺肥大的男性使用每天一次5mg犀利士整合研究中，來檢視對最高尿流速上的影響。 在總共1371位平均63.1歲的男性族群中，比起安慰劑，5mg犀利士有意義增加最高尿流速(每秒分別增加0.4和1.1ml)。在731位其原始排尿量基準值125到250ml的族群中，其最高尿流速分別有每秒0.9和1.2ml的變化。而在428位其原始排尿量基準值250到450ml的族群中，其最高尿流速分別有-0.3和0.7ml的變化。而在原始排尿量基準值大於450ml的38位男性裡，其最高尿流速分別有每秒-0.2和2.0ml的改變。其中只有原始排尿量基準值250到450ml的族群中，兩組才有統計學上意義。文獻上也顯示出原始排尿量基準值250到450ml 能有最佳最高尿流速率。 另外5mg犀利士在128位原始最高尿流速率基準值大於每秒15ml的男性中，分別改變了每秒-2.1和-0.8ml。在522位原始最高尿流速率基準值落在每秒10-15ml的男性中，分別改變了每秒0.2和0.8ml。在547位原始最高尿流速率基準值低於10ml的男性中，分別改變了每秒1.2和1.8ml。其中只有原始高尿流速率基準值落在每秒10-15ml的男性族群中，兩組才有統計學上意義。 這個綜合分析顯示，比起安慰劑，犀利士有一個小但是明顯的最高尿流速率的改善。比起安慰劑，使用犀利士的族群在最高尿流速和IPSS得到的更多的改善。犀利士在一定的排尿量之最高尿流速率影響機制仍不清楚，只是本研究再次顯示判讀尿流速時，當次排尿量仍是重要的考量因素。 |
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| abstract |
Purpose: Tadalafil significantly improves lower urinary tract symptoms sug-gestive of benign prostatic hyperplasia. We post hoc characterized changes in the maximum urinary flow rate using integrated data from 4 international,placebo controlled studies of tadalafil once daily for lower urinary tract symp-toms suggestive of benign prostatic hyperplasia. Materials and Methods: After a 4-week placebo lead-in period 1,500 men were randomized totadalafil5 mg or placebo for 12 weeks. Data were analyzed using ANCOVA. Maximum urinary flow rate values were rank transformed for analysis. Results: Baseline maximum urinary flow rate data were available on 1,371 men with a mean age of 63.1 years and end point data were available on 1,197.Tadalafil5 mg significantly increased maximum urinary flow vs placebo(median 1.1 vs 0.4 ml per second, p ¼ 0.003). At a baseline voided volume of 125 to less than 250 ml the median change in the maximum urinary flow rate was 0.9 and 1.2 ml per second(p ¼ 0.142)in 731 patients, at a baseline of250to 450 ml the change was e 0.3 and 0.7 ml per second (p ¼ 0.011)in 428,and at a baseline of greater than 450 ml the change was e 0.2 and 2.0 ml per second (p ¼ 0.186)in 38 for placebo and tadalafil, respectively. The difference was 0.3,1.0 and 2.2 ml per second, respectively. At a baseline maximum urinary flow rate of greater than 15 ml per second in 128 patients the median flow rate change was e 2.1 and e 0.8 ml per second(p ¼ 0.246),at a maximum of10 to 15 ml per second in 522 the change was 0.2 and 0.8 ml per second (p ¼ 0.044),and at a maximum of less than 10 ml per second in 547 the change was 1.2 and 1.8 ml per second (p ¼ 0.189) for placebo and tadalafil,respectively. Tadalafilimproved I-PSS(International Prostate Symptom Score) voiding subscores significantly vs placebo across all baseline maximum urinary flow subgroups(each p < 0.001). Conclusions: This integrated analysis revealed a small but statistically signifi-cant median maximum urinary flow rate improvement for tadalafil vs placebo.The numerical difference in the maximum urinary flow change from baseline between tadalafil and placebo increased with increased voided volume. |
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