摘要
目的比较不同种类药物治疗良性前列腺增生(BPH)的疗效与差异,确定不同药物对不同患者的最佳适应证。方法采用随机平行对照、多中心临床研究方法,对2002年9月至2003年12月906例 BPH 患者,随机进入选择性α-受体阻滞剂特拉唑嗪、多沙唑嗪、坦索罗辛与萘哌地尔;5α-还原酶抑制剂非那雄胺与爱普列特以及植物制剂舍尼通等7种治疗药物组。每3个月随访一次,国际前列腺症状评分(IPSS)与生活质量评分(QOL),最大尿流率(Qmax)与平均尿流率(Qave),前列腺总体积(TPV)与前列腺移行带体积以及残余尿量为观察指标进行疗效评价。根据不同指标基线水平将患者进行分层,比较各治疗组患者主观指标 IPSS 和客观指标 Qmax 的改善情况。结果基线指标分析显示,全组主观指标 IPSS 评分和客观指标 Qmax 水平与 TPV 以及移行带体积呈明显相关性(P<0.01)。至随访6个月时各类药物均使 BPH 患者的主观指标 IPSS 与 QOL 评分及客观指标 Qmax与残余尿量有明显改善。各种药物对主客观指标的影响程度的组间比较显示,对 IPSS 的改善无显著差异;5α-还原酶抑制剂类药物爱普列特与非那雄胺可以使 TPV 和移行带体积均明显缩小(P<0.05)。将患者以前列腺体积<35.5 cm^3和≥35.5 cm^3分为两层,在非那雄胺治疗的患者中 Qmax 平均增加5.7 ml/s 和2.2 ml/s(P<0.01),在舍尼通、萘哌地尔及多沙唑嗪治疗组,≥35.5 cm^3者症状改善更为明显(P<0.05)。以 IPSS<20分和≥20分进行分层,各种药物的疗效均在≥20分时更为明显(P<0.01)。结论各种药物均可明显改善 BPH 患者的主、客观症状,各种药物的疗效均对基线IPSS 评分较高的患者疗效更为明显。5α-还原酶抑制剂能明显减小前列腺体积,对于前列腺体积≥35.5 cm^3者有更为明显的主客观疗效。
Objective To compare the differences of the efficacy and different therapeutic drugs on the treatment of benign prostatic hyperplasia （BPH） in order to ensure the optimal indication for different BPH patients. Methods A randomized, parallel-controlled, multicentral clinical trial was conducted. From September 2002 to December 2003 906 BPH patients were enrolled into 7 therapeutic groups, including selective-adrenoceptor antagonist （terazosin, doxazosin tamsulosin and naftopidil ）, 5α-reductase inhibitor （ finasteride and epristeride） and natural product （cernihon）. International Prostate Symptom Score （IPSS） and Quality of Life （QOL）, urofiowmetry, total prostatic volume （TPV）and transitional zone volume and residual urine were used as efficacy criteria. Results According to the baseline, the IPSS and Qmax were significantly correlated to the prostatic volume and transitional zone volume （ P 〈 0. 01 ）. At average followup of 6 months, significant improvements in IPSS, QOL, Qmax and residual urine volume were observed in each therapeutic group, and no difference in IPSS improvement was found among the groups. Prostatic volume and transitional zone volume were significant decreased in 5α-reductase inhibitor groups （ P 〈 0. 05 ）. In patients with baseline TPV greater than 35. 5 cm^3 , the improvement of Qmax was more significant than that in patients with TPV less than 35. 5 cm^3 in finasteride group （ P 〈 0. 01 ） （ 5.7 mL/s and 2. 2 mL/s respectively）, and more significant symptomatic improvements were also found in cernilton, doxazosin and naftopidil group. In each group, the improvement of symptom were more significant in patients with IPSS higher than 20 points （ P 〈 0. 01 ）. Conclusions Each drug observed in this study can improve the subjective and objective symptoms significantly for BPH patients, especially for patients with higher IPSS baseline. When using 5α-reductase inhibitor, prostatic volume can be decreased significantly and more obviously sub
出处
《中华外科杂志》
CAS
CSCD
北大核心
2007年第14期947-950,共4页
Chinese Journal of Surgery
基金
国家"十五"科技攻关资助项目[2001BA702B04(B)]
关键词
前列腺增生
药物疗法
临床方案
Prostatic hyperplasia
Drug therapy
Clinical protocols
