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| 發表人 | 討論主題 | 發表時間 | 討論數 |
| 連啟舜 | 此臨床試驗(Conduct study)為針對攝護腺肥大導致中等程度下泌尿道症狀且之前無接受過治療的病人,分派兩組 1.給予藥物治療(tamsulosin+Avodart) 2. 先觀察(watch for waiting),若症狀無改善,則給予單一藥物(tamsulosin)治療. 以上兩組均先給予生活方式改善的建議,持續追蹤兩年後,比較兩組之間的藥物效果和安全性的差異 | 2015/8/21 下午 03:43:29 | 0 |
| 原 文 | 題 目 | Efficacy and safety of a fixed-dose combination of dutasteride and tamsulosin treatment (Duodart®) compared with watchful waiting with initiation of tamsulosin therapy if symptoms do not improve, both provided with lifestyle advice, in the management of treatment-naïve men with moderately symptomatic benign prostatitis hyperplasia: 2-year CONDUCT study results |
| 作 者 | Claus G. Roehrborn, Igor Oyarzabal Perez, Erik P.M. Roos†, Nicolae Calomfirescu, Betsy Brotherton, Fang Wang¶, Juan Manuel Palacios, Averyan Vasylyev and Michael J. Manyak | |
| 出 處 | BJU INTERNATIONAL, 2015 Sep;116(3):450-9. | |
| 出版日期 | 2015 September | |
| 評 論 |
攝護腺肥大的治療,傳統上可藉由藥物(alpha-blocker)快速改善病人症狀,讓病患得到滿意的治療效果. 然而,alpha-blocker藥物的藥理作用只能控制症狀,而無法阻止攝護腺肥大持續進展. 臨床上有另一種藥理作用的藥物 (5-alpha reductase inhibitor, Dutasteride),可以使攝護腺體積縮小,然而此藥物至少需持續給予數個月以上才看得出效果. 而此臨床試驗(Conduct study)目的為評估早期同時使用alpha-blocker（Tamsulosin）＋5-alpha reductase inhibitor（Dutasteride)的效果. 其實過去也有類似的臨床試驗(如MTOPS, COMBAT),主要的差異為MTOPS收案的病患攝護腺大小不一,不像COMBAT和CONDUCT有大於30gm的收案標準. 而COMBAT和CONDUCT之間也有所差異,例如COMBAT因攝護腺肥大產生的症狀包括了中等和重度程度症狀的患者,而CONDUCT僅包括中等程度症狀的患者,因此可以說CONDUCT患者的症狀較不嚴重. 目前根據歐洲攝護腺肥大治療指引(EAU guideline), 雖然使用5-ARI藥物可減低攝護腺肥大的進展,降低未來尿滯留或手術的機率. 不過針對中等程度症狀的攝護腺肥大患者,目前建議是如果病患覺得有造成困擾才需要治療. 而此研究(CONDUCT study)乃針對這些中等程度症狀的攝護腺肥大患者,評估早期即給予兩種藥物治療(alpha-blocker+5-ARI)和僅觀察,若生活建議無改善也僅給予(alpha-blocker)之間是否有差異. 研究發現,早期給予兩種藥物治療不管在症狀改善,或追蹤兩年因症狀惡化導致併發症的風險（絕對風險下降11.1%,相對風險下降43.1%）都有明顯降低. 因此根據此研究（CONDUCT study）,在中等程度症狀的攝護腺肥大病患,早期給予兩種藥物治療(alpha-blocker+5-ARI),是可以降低未來併發症或手術風險的,另外兩者藥物安全性也沒有明顯差異. |
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| abstract |
Objective To investigate whether a fixed-dose combination (FDC) of 0.5 mg dutasteride and 0.4 mg tamsulosin is more effective than watchful waiting with protocol-defined initiation of tamsulosin therapy if symptoms did not improve (WW-All) in treatment- naïve men with moderately symptomatic benign prostatic hyperplasia (BPH) at risk of progression. Patients and Methods This was a multicentre, randomised, open-label, parallel-group study (NCT01294592) in 742 men with an International Prostate Symptom Score (IPSS) of 8–19, prostate volume ≥30 mL and total serum PSA level of ≥1.5 ng/mL. Patients were randomised to FDC (369 patients) or WW-All (373) and followed for 24 months. All patients were given lifestyle advice. The primary endpoint was symptomatic improvement from baseline to 24 months, measured by the IPSS. Secondary outcomes included BPH clinical progression, impact on quality of life (QoL), and safety. Results The change in IPSS at 24 months was significantly greater for FDC than WW-All (–5.4 vs −3.6 points, P < 0.001).With FDC, the risk of BPH progression was reduced by 43.1% (P < 0.001); 29% and 18% of men in the WW-All and FDC groups had clinical progression, respectively, comprising symptomatic progression in most patients. Improvements in QoL (BPH Impact Index and question 8 of the IPSS) were seen in both groups but were significantly greater with FDC (P < 0.001). The safety profile of FDC was consistent with established profiles of dutasteride and tamsulosin. Conclusion FDC therapy with dutasteride and tamsulosin, plus lifestyle advice, resulted in rapid and sustained improvements in men with moderate BPH symptoms at risk of progression with significantly greater symptom and QoL improvements and a significantly reduced risk of BPH progression compared with WW plus initiation of tamsulosin as per protocol. |
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