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王炯珵 使用dutasteride或tamsulosin和合併治療男性有下泌尿症狀和攝護腺肥大四年的研究 2011/3/5 上午 07:05:35 0
原 文 題  目 The effects of dutasteride or tamsulosin alone and in combination on storage and voiding symptoms in men with lower urinary tract symptoms and benign prostatic hyperplasia: a 4-year data from combination of avodart and tamsulosin study
作  者 Montorsi F, Roehrborn C, Garcia-Penit J, Borre M, Roeleveld TA, Alimi JC, Gagnier P, Wilson TH
出  處 BJU Int
出版日期 2011 Feb 23. on pubmed
評 論 這是由GSK所主導的一個叫「戰鬥(combat)」的研究,主要是將4844位大於50歲,IPSS≧12,攝護腺大於30毫升,最大尿流速介於5和15毫升/每秒的男生納入,第一組服用Tamsulosin 0.4mg,第二組Dutasteride 0.5mg,第三組合併使用後四年的研究報告。
合乎預期的,合併使用組當然比單獨使用組改善來多,有趣的是,單獨使用Tamsulosin比起Dutasteride在前12個月IPSS改善較多,在第12個月至第24個月兩組不分軒輊,但第24個月後,Dutasteride則「後發先至」,領先Tamsulosin。
如果以攝護腺大小做區分的話,介於30至58mL的攝護腺,合併使用最有效,但超過58公克以上的攝護腺,單獨使用Dutasteride和合併使用組的IPSS差不多,需要手術和AVR的機會也差不多,但服用Tamsulosin則比這兩組高。
其他的因子如IPSS≧20,餘尿≧40毫升,PSA≥3,最大尿流速小於10毫升/每秒等.都是BPH會惡化的因子,這些在臨床上可以理解,有趣的是,BMI≧26.8的病人,也是危險因子,意思是說較胖的病人容易需要TUR-P,看起來肥胖、代謝症候群和BHP真的有些相關性。
本篇論文有篇姐妹作.刊登在2010的European Urology,上面有進一步說明Dutasteride治療組,攝護腺平均大約會縮小27%,IPSS平均大約會縮小27%,IPSS平均減少5~6分.最大尿流速平均增加2.0~2.5毫升/每秒也比單獨使用Tamsulosin好。
或許我們可以得到這樣的結論嗎? ∝-blocker作用比較快,5ARI的作用比較久但比較慢發生效果,所以對於較大的攝護腺,開始使用合併治療,等治療約2年後使用Dutasteride單獨治療,這樣的結論,老實說和我過去的用藥習慣不同,我總以為停Dutasteride病人比較不會感覺到症狀惡化,所以可以停,因為臨床上的發現也是如此,很多人一停∝-blocker,症狀立即很明顯復發,不是嗎?

abstract OBJECTIVE: •To assess the effects of combined therapy with dutasteride and tamsulosin on voiding and storage symptoms compared with those of dutasteride or tamsulosin alone, using 4-year data from the Combination of Avodart and Tamsulosin (CombAT) study.

PATIENTS AND METHODS: • Men (n = 4844) aged ≥50 years with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostate hyperplasia (BPH), a prostate volume of ≥30 mL, and a serum prostate-specific antigen level of 1.5-10 ng/mL. • CombAT was a multicentre, double-blind, parallel-group study. • Oral dutasteride (0.5 mg) or tamsulosin (0.4 mg) alone or in combination was taken daily for 4 years. • Mean changes from baseline in storage and voiding symptoms at 4 years were assessed using subscales of the International Prostate Symptom Score.

RESULTS: • At 4 years, the mean reduction in the storage subscore was significantly greater in the combined therapy group vs the dutasteride (adjusted mean difference -0.43) and tamsulosin (adjusted mean difference -0.96) monotherapy groups (P < 0.001). • Also at 4 years, the mean reduction in the voiding subscore was significantly greater in the combined therapy group vs the dutasteride (adjusted mean difference -0.51) and tamsulosin (adjusted mean difference -1.60) monotherapy groups (P < 0.001). • The improvement in the storage subscore with combined therapy was significantly better (P < 0.001) than dutasteride and tamsulosin from 3 months and 12 months, respectively. Similarly, the improvement in the voiding subscore with combined therapy was significantly better than dutasteride (P < 0.001) and tamsulosin (P ≤ 0.006) from 3 months and 6 months, respectively. • Improvements in the storage and voiding symptom subscores with combined therapy were achieved irrespective of prostate volume, although in men with the highest baseline prostate volumes (≥58 mL), combined therapy was not better than dutasteride.

CONCLUSION: • In men with a prostate volume of ≥30 mL, combined therapy with dutasteride plus tamsulosin provided better long-term (up to 4 years) control of both storage and voiding LUTS compared with tamsulosin monotherapy. • Combined therapy was better than dutasteride monotherapy in men with prostate volumes of ≥30 to <58 mL, but not in men with a prostate volume of ≥58 mL.

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