• 1. 四川大學華西醫(yī)院中國循證醫(yī)學中心,成都,6100412. 四川大學華西臨床醫(yī)學院,成都,610041;

目的  評價和比較特拉唑嗪、非那司提和坦素羅辛,以及其中任意兩藥聯(lián)用與單藥治療良性前列腺增生癥(benign prostatic hyperplasia,BPH)的有效性.
方法  計算機檢索MEDLINE(1966~2004.12)、EMBASE(1984~2004.12)、Cochrane圖書館(2004年第4期)、美國 lt;生物學文摘 gt;光盤數(shù)據(jù)庫(1990~2004.12)和中國生物醫(yī)學文獻光盤數(shù)據(jù)庫(1978~2004.12)等,手檢10種相關(guān)雜志.納入與有效性有關(guān)的隨機對照試驗(RCT)和半隨機對照試驗(CCT),并追索已納入文獻的參考文獻.由至少兩位系統(tǒng)評價員獨立進行文獻篩查、質(zhì)量評價和資料提取,并交叉核對,不同意見請第三者裁決.采用RevMan 4.2軟件進行Meta分析.
結(jié)果  共初檢出656篇文獻,經(jīng)篩選后最后納入12篇原始研究(2 471例)進行分析,包括11篇RCT,1篇CCT.Meta分析結(jié)果顯示:與特拉唑嗪比較,坦素羅辛改善國際前列腺癥狀評分(international prostatic symptom score, IPSS)更明顯[WMD=0.75,95%CI (0.03,1.46),P=0.04],差異有統(tǒng)計學意義,但在平均尿流率(average rate of urine flow, AFR)改善程度 [WMD=0.23,95%CI (-0.39,0.85),P=0.46]、殘余尿量改善程度 [WMD=0.82,95%CI (-2.92,4.57),P=0.67] 以及減小前列腺體積的效果 [WMD=2.20,95%CI (-3.99,8.39),P=0.49] 方面,兩者差異均無統(tǒng)計學意義.非那司提與坦素羅辛比較,兩者在改善IPSS [WMD=0.65,95%CI (-0.45,1.75),P=0.25] 和最大尿流率方面 [WMD=0.39,95%CI (-0.72,1.51),P=0.49],其差異均無統(tǒng)計學意義.僅有兩個研究比較了非那司提與特拉唑嗪對最大尿流率的影響,且結(jié)論各異.僅有1個研究(538例)比較了單用非那司提、特拉唑嗪與聯(lián)用非那司提和特拉唑嗪治療良性前列腺增生癥的有效率,結(jié)果顯示兩藥聯(lián)用的有效率明顯優(yōu)于單用非那司提,但與單用特拉唑嗪無明顯差異.
結(jié)論  非那司提、特拉唑嗪和坦素羅辛治療良性前列腺增生癥的效果差別不大.在改善IPSS和生活質(zhì)量方面,坦素羅辛似乎優(yōu)于特拉唑嗪;非那司提與特拉唑嗪聯(lián)用比單用非那司提有效率高,但不比單用特拉唑嗪效果好.結(jié)合安全性和經(jīng)濟性考慮,推薦臨床短期單用坦素羅辛治療良性前列腺增生癥.長期治療方案目前尚無足夠的證據(jù)支持,有待進一步研究;在新證據(jù)產(chǎn)生之前不推薦聯(lián)合用藥.鑒于有關(guān)臨床研究現(xiàn)狀,呼吁提高國內(nèi)外原始研究質(zhì)量,增大樣本量,開展高質(zhì)量臨床研究.

引用本文: 熊 鷹,葉 璐,任 宇,李 懿,宋 豪,李寧寧,初錚錚,李幼平. 特拉唑嗪、非那司提和坦素羅辛治療良性前列腺增生癥的有效性評價. 中國循證醫(yī)學雜志, 2005, 05(6): 448-454. doi: 復(fù)制

1. 王健, 齊曉漣, 張乃文. 近期良性前列腺增生癥藥物治療及不良反應(yīng)進展[J]. 中國全科醫(yī)學, 2004; 7(11): 823~825.
2. 熊禮生. 前列腺增生癥的藥物治療[J]. 實用醫(yī)學雜志, 2001; 17(1): 6-7.
3. 鄒聲泉, 龔建平. 外科學--前沿與爭論[M]. 第1版. 北京: 人民衛(wèi)生出版社, 2003.
4. 鐘惟德, 蔡岳斌, 胡建波, 王良圣, 魏鴻藹, 余安迪. α1受體阻滯劑治療前列腺增生癥的療效-成本分析[J]. 廣東藥學院學報, 2000; 16(2): 135~137.
5. 許錫榮, 鐘惟德, 王良圣, 魏鴻藹, 余安迪. 特拉唑嗪、高特靈、哈樂治療前列腺增生癥費用療效分析[J]. 實用醫(yī)學雜志, 2000; 16(10): 816~817.
6. 那彥群, 汪迪, 金杰, 郭應(yīng)祿, 薛兆英, 顧方六. 選擇性α1a受體阻斷劑治療前列腺增生癥[J]. 中華泌尿外科雜志, 1996; 6(17): 327-329.
7. 金蘭. 兩種選擇性α受體阻斷劑在治療前列腺增生癥中的療效比較[J]. 江蘇藥學與臨床研究, 1999; 7(1): 31~32.
8. 王彥, 苑記清. 不同藥物治療前列腺增生癥[J]. 中國藥事, 2003; 17(8): 525~526.
9. 蔡岳斌. 前列腺增生癥三種藥物治療方案的費用效果分析[J]. 廣州醫(yī)學院學報, 2001; 29(2): 85~86.
10. 李鳳閣, 王素如. 非那雄胺治療前列腺增生癥47例[J]. 醫(yī)藥導報, 1999; 18(5): 324.
11. Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age[J]. J Urol, 1984; 132(3): 474-479.
12. Wang J, Qi XL, Zhang NW. Advancement of drug treatment for benign prostatic hyperplasia[J]. Chinese General Practice, 2004; 7(11): 823-825.
13. Xiong LS. Drug treatment for benign prostatic hyperplasia[J]. The Journal of Practical Medicine, 2001; 17(1): 6-7.
14. Zou SQ, Gong JP. Surgery-front and argument[M]. 1st ed. Beijing: People’s Medical Publishing House, 2003.
15. Okada H, Kamidono S, Yoshioka T, Okuyama A, Ozono S, Hirao Y, Okajima E, Yamamoto K, Kishimoto T, Park Y, Kurita T. A comparative study of terazosin and tamsulosin for symptomatic benign prostatic hyperplasia in Japanese patients[J]. BJU Int, 2000; 85(6): 676-681.
16. Lee E, Lee C. Clinical comparison of selective and non-selective alpha 1A-adrenoreceptor antagonists in benign prostatic hyperplasia: studies on tamsulosin in a fixed dose and terazosin in increasing doses[J]. Br J Urol, 1997; 80(4): 606-611.
17. Tsujii T. Comparison of prazosin, terazosin and tamsulosin in the treatment of symptomatic benign prostatic hyperplasia: a short-term open, randomized multicenter study. BPH Medical Therapy Study Group. Benign prostatic hyperplasia[J]. Int J Urol, 2000; 7(6): 199-205.
18. Zhong WD, Cai YB, Hu JB, Wang LS, Wei HA, Yu AD. Effective-cost analysis of alpha 1-adrenoceptor antagonist for benign prostatic hyperplasia[J]. Academic Journal of Guangdong College of Pharmacy, 2000; 16(2): 135-137.
19. Xu XR, Zhong WD, Wang LS, Wei HA, Yu AD. Effective-cost analysis of terazosin, hytrin and harnal for benign prostatic hyperplasia[J]. The Journal of Practical Medicine, 2000; 16(10): 816-817.
20. Na YQ, Wang D, Jin J, Guo YL, Xue ZY, Gu FL. Selective alpha 1a-adrenoceptor antagonist for benign prostatic hyperplasia[J]. Chinese Journal of Urology, 1996; 6(17): 327-329.
21. Jin L. Effective of two selective alpha-adrenoceptor antagonist for benign prostatic hyperplasia[J]. Jiangsu Pharmaceutical and Clinical Research, 1999; 7(1): 31-32.
22. Lee E. Comparison of tamsulosin and finasteride for lower urinary tract symptoms associated with benign prostatic hyperplasia in Korean patients[J]. J Int Med Res. 2002; 30(6): 584-590.
23. Wang Y, Wan JQ. Different drugs for benign prostatic hyperplasia[J]. Chinese Pharmaceutical Affairs, 2003; 17(8): 525-526.
24. Cai YB. Cost-effectiveness analysis of three therapeutic schemes for benign prostatic hypertrophy[J]. Academic Journal of Guangzhou Medical College, 2001; 29(2): 85-86.
25. Li FG, Wang SR. Finasteride for benign prostatic hyperplasia-47 cases reports[J]. Herald of Medicine, 1999; 18(5): 324.
26. Lepor H, Williford WO, Barry MJ, Brawer MK, Dixon CM, Gormley G, Haakenson C, Machi M, Narayan P, Padley RJ. The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group[J]. N Engl J Med, 1996; 335(8): 533-539.
  1. 1. 王健, 齊曉漣, 張乃文. 近期良性前列腺增生癥藥物治療及不良反應(yīng)進展[J]. 中國全科醫(yī)學, 2004; 7(11): 823~825.
  2. 2. 熊禮生. 前列腺增生癥的藥物治療[J]. 實用醫(yī)學雜志, 2001; 17(1): 6-7.
  3. 3. 鄒聲泉, 龔建平. 外科學--前沿與爭論[M]. 第1版. 北京: 人民衛(wèi)生出版社, 2003.
  4. 4. 鐘惟德, 蔡岳斌, 胡建波, 王良圣, 魏鴻藹, 余安迪. α1受體阻滯劑治療前列腺增生癥的療效-成本分析[J]. 廣東藥學院學報, 2000; 16(2): 135~137.
  5. 5. 許錫榮, 鐘惟德, 王良圣, 魏鴻藹, 余安迪. 特拉唑嗪、高特靈、哈樂治療前列腺增生癥費用療效分析[J]. 實用醫(yī)學雜志, 2000; 16(10): 816~817.
  6. 6. 那彥群, 汪迪, 金杰, 郭應(yīng)祿, 薛兆英, 顧方六. 選擇性α1a受體阻斷劑治療前列腺增生癥[J]. 中華泌尿外科雜志, 1996; 6(17): 327-329.
  7. 7. 金蘭. 兩種選擇性α受體阻斷劑在治療前列腺增生癥中的療效比較[J]. 江蘇藥學與臨床研究, 1999; 7(1): 31~32.
  8. 8. 王彥, 苑記清. 不同藥物治療前列腺增生癥[J]. 中國藥事, 2003; 17(8): 525~526.
  9. 9. 蔡岳斌. 前列腺增生癥三種藥物治療方案的費用效果分析[J]. 廣州醫(yī)學院學報, 2001; 29(2): 85~86.
  10. 10. 李鳳閣, 王素如. 非那雄胺治療前列腺增生癥47例[J]. 醫(yī)藥導報, 1999; 18(5): 324.
  11. 11. Berry SJ, Coffey DS, Walsh PC, Ewing LL. The development of human benign prostatic hyperplasia with age[J]. J Urol, 1984; 132(3): 474-479.
  12. 12. Wang J, Qi XL, Zhang NW. Advancement of drug treatment for benign prostatic hyperplasia[J]. Chinese General Practice, 2004; 7(11): 823-825.
  13. 13. Xiong LS. Drug treatment for benign prostatic hyperplasia[J]. The Journal of Practical Medicine, 2001; 17(1): 6-7.
  14. 14. Zou SQ, Gong JP. Surgery-front and argument[M]. 1st ed. Beijing: People’s Medical Publishing House, 2003.
  15. 15. Okada H, Kamidono S, Yoshioka T, Okuyama A, Ozono S, Hirao Y, Okajima E, Yamamoto K, Kishimoto T, Park Y, Kurita T. A comparative study of terazosin and tamsulosin for symptomatic benign prostatic hyperplasia in Japanese patients[J]. BJU Int, 2000; 85(6): 676-681.
  16. 16. Lee E, Lee C. Clinical comparison of selective and non-selective alpha 1A-adrenoreceptor antagonists in benign prostatic hyperplasia: studies on tamsulosin in a fixed dose and terazosin in increasing doses[J]. Br J Urol, 1997; 80(4): 606-611.
  17. 17. Tsujii T. Comparison of prazosin, terazosin and tamsulosin in the treatment of symptomatic benign prostatic hyperplasia: a short-term open, randomized multicenter study. BPH Medical Therapy Study Group. Benign prostatic hyperplasia[J]. Int J Urol, 2000; 7(6): 199-205.
  18. 18. Zhong WD, Cai YB, Hu JB, Wang LS, Wei HA, Yu AD. Effective-cost analysis of alpha 1-adrenoceptor antagonist for benign prostatic hyperplasia[J]. Academic Journal of Guangdong College of Pharmacy, 2000; 16(2): 135-137.
  19. 19. Xu XR, Zhong WD, Wang LS, Wei HA, Yu AD. Effective-cost analysis of terazosin, hytrin and harnal for benign prostatic hyperplasia[J]. The Journal of Practical Medicine, 2000; 16(10): 816-817.
  20. 20. Na YQ, Wang D, Jin J, Guo YL, Xue ZY, Gu FL. Selective alpha 1a-adrenoceptor antagonist for benign prostatic hyperplasia[J]. Chinese Journal of Urology, 1996; 6(17): 327-329.
  21. 21. Jin L. Effective of two selective alpha-adrenoceptor antagonist for benign prostatic hyperplasia[J]. Jiangsu Pharmaceutical and Clinical Research, 1999; 7(1): 31-32.
  22. 22. Lee E. Comparison of tamsulosin and finasteride for lower urinary tract symptoms associated with benign prostatic hyperplasia in Korean patients[J]. J Int Med Res. 2002; 30(6): 584-590.
  23. 23. Wang Y, Wan JQ. Different drugs for benign prostatic hyperplasia[J]. Chinese Pharmaceutical Affairs, 2003; 17(8): 525-526.
  24. 24. Cai YB. Cost-effectiveness analysis of three therapeutic schemes for benign prostatic hypertrophy[J]. Academic Journal of Guangzhou Medical College, 2001; 29(2): 85-86.
  25. 25. Li FG, Wang SR. Finasteride for benign prostatic hyperplasia-47 cases reports[J]. Herald of Medicine, 1999; 18(5): 324.
  26. 26. Lepor H, Williford WO, Barry MJ, Brawer MK, Dixon CM, Gormley G, Haakenson C, Machi M, Narayan P, Padley RJ. The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. Veterans Affairs Cooperative Studies Benign Prostatic Hyperplasia Study Group[J]. N Engl J Med, 1996; 335(8): 533-539.