特拉唑嗪、非那司提和坦素罗辛治疗良性前列腺增生症的有效性评价

目的评价和比较特拉唑嗪、非那司提和坦素罗辛,以及其中任意两药联用与单药治疗良性前列腺增生症(benign prostatic hyperplasia,BPH)的有效性.方法计算机检索MEDLINE(1966～2004.12)、EMBASE(1984～2004.12)、Cochrane图书馆(2004年第4期)、美国<生物学文摘>光盘数据库(1990～2004.12)和中国生物医学文献光盘数据库(1978～2004.12)等,手检10种相关杂志.纳入与有效性有关的随机对照试验(RCT)和半随机对照试验(CCT),并追索已纳入文献的参考文献.由至少两位系统评价员独立进行文献筛查、质量评价和资料提取,并交叉核对,不同意见请第三者裁决.采用RevMan 4.2软件进行Meta分析.结果共初检出656篇文献,经筛选后最后纳入12篇原始研究(2 471例)进行分析,包括11篇RCT,1篇CCT.Meta分析结果显示:与特拉唑嗪比较,坦素罗辛改善国际前列腺症状评分(international prostatic symptom score, IPSS)更明显WMD＝0.75,95%CI (0.03,1.46),P=0.04],差异有统计学意义,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]、残余尿量改善程度 WMD=0.82,95%CI (-2.92,4.57),P=0.67] 以及减小前列腺体积的效果 WMD=2.20,95%CI (-3.99,8.39),P=0.49] 方面,两者差异均无统计学意义.非那司提与坦素罗辛比较,两者在改善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],其差异均无统计学意义.仅有两个研究比较了非那司提与特拉唑嗪对最大尿流率的影响,且结论各异.仅有1个研究(538例)比较了单用非那司提、特拉唑嗪与联用非那司提和特拉唑嗪治疗良性前列腺增生症的有效率,结果显示两药联用的有效率明显优于单用非那司提,但与单用特拉唑嗪无明显差异.结论非那司提、特拉唑嗪和坦素罗辛治疗良性前列腺增生症的效果差别不大.在改善IPSS和生活质量方面,坦素罗辛似乎优于特拉唑嗪;非那司提与特拉唑嗪联用比单用非那司提有效率高,但不比单用特拉唑嗪效果好.结合安全性和经济性考虑,推荐临床短期单用坦素罗辛治疗良性前列腺增生症.长期治疗方案目前尚无足够的证据支持,有待进一步研究;在新证据产生之前不推荐联合用药.鉴于有关临床研究现状,呼吁提高国内外原始研究质量,增大样本量,开展高质量临床研究.

Evaluation of the Effectiveness of Terazosin, Tamsulosin and Finasteride for Benign Prostatic Hyperplasia

Objective To evaluate the effectiveness of terazosin, tamsulosin and fin asteride for benign prostatic hyperplasia (BPH). Methods We searched the related original studies all over the world , and only included randomized controlled trials (RCT) and quasi-randomized con trolled trials (CCT). MEDLINE (1966Dec. 2004), EMBASE (1984Dec . 2004), The Cochrane Library (Issue 4, 2004) and four Chinese databases were electronically searched and 10 related journals were handsearched . The studies included in the references of eligible studies were additionally searched. Two reviewers independently screened the studies for eligibility, eva luated the quality and extracted the data from the eligible studies, with confir mation by cross-checking. Divergences of opinion were consulted by a third part y. Meta-analysis was performed by using RevMan 4.2 software. Results Twelve original studies involving 2 471 participants met inclusion criteria. Compared with terazosin, tamsulosin could improve inter national prostatic symptom score, with WMD 0.75, 95% confidence interval (CI) 0.03 to 1 .46, P=0.04. There was no statistical difference between teraz osin and tamsulosin in improving the average rate of urine flow (WMD 0.23, 95%C I -0.39 to 0.85, P= 0.46), the residual urine volume (WMD 0.82, 95%CI -2.92 to 4.57, P =0.67) and in diminishing the volume of prostate (WMD=2.20, 95%CI -3 .99 to 8.39, P=0.49). There was no statistical difference bet ween finasteride and tamsulosin in improving the international prostatic symptom score (WMD 0.65, 95%CI -0.45 to 1.75, P=0.25) or the max r ate of urine flow (WMD 0.39, 95%CI -0.72 to 1.51, P=0.49). Only two studies compared finasteride with terazosin and had different conclusio ns. Only one study compared finasteride or terazosin with a combination of these drugs suggested that the combination had higher effective power than finasterid e alone but no difference with terazosin alone. Conclusions Although the effectiveness in some aspects is higher in the tamsul osin group, there is not enough evidence to show which one is the best among the se three drugs. The combination of finasteride and terazosin does not show more effectiveness than terazosin alone. This review suggests that tamsulosin alone s hould be used for the treatment of BPH and the combination needs to be identifie d by better evidence. It is important to improve the quality of original studies .