多沙唑嗪控释片和特拉唑嗪治疗前列腺增生症的对照研究

Efficacy and tolerability of doxazosin-gastrointestinal therapeutic system andterazosin on benign prostatic hyperplasia

目的 评价多沙唑嗪控释片和特拉唑嗪片治疗良性前列腺增生症 (BPH)的临床有效性和安全性。方法 对入选的119名BPH患者进行了前瞻性的随机、双盲和平行对照试验 ,过程分 3个阶段 :第 1阶段为 2周的清洗期 ,第 2阶段为 2周的单盲安慰剂导入期 ,第 3阶段为 12周的双盲药物治疗期。多沙唑嗪控释片和特拉唑嗪片的起始剂量分别为 4mg/d和 1mg/d ,如果治疗 4周后最大尿流率 (Qmax)增加 <3ml/s,国际前列腺症状评分 (IPSS)下降 <30 % ,则将 2种药物按不同方式加量至8mg/d。主要评价指标为从基线到最后 1次随访的IPSS和Qmax的变化值 ,以及治疗中常见不良事件的发生率。结果 多沙唑嗪控释片和特拉唑嗪片均能显著减轻BPH的下尿路梗阻症状 ,增加Qmax(P <0 .0 0 1) ,降低IPSS(P <0 .0 1) ,两组间比较的差异无显著性意义 (P >0 .0 5 )。多沙唑嗪控释片组没有因为与治疗相关的不良事件而退出试验的患者 ,并且在总不良事件的发生率和头晕、恶心、体位性低血压等主要不良事件的发生率与特拉唑嗪片组比较 ,差异有显著性意义 (P <0 .0 5 )。结论 多沙唑嗪控释片和特拉唑嗪片能同样有效缓解BPH的症状 ,但是前者的安全性和耐受性显著提高。

Objective To evaluate the efficacy and safety of doxazosin-gastrointestinal therapeutic system(GITS) and terazosin on benign prostatic hyperplasia(BPH). Methods Data from a prospective randomized double-blind study were analysed, including a two-week washout period, a two-week single-blind placebo run-in phase, and a 12-week double-blind treatment phase. Doxazosin-GITSand terazosin were started at 4 mg/d and 1 mg/d respectively. If the increase inmaximum urinary flow rate (Q max) was less than 3 ml/s or the reduction intotal international prostate symptom score (IPSS) was less than 30% after 4-week therapy, then both drugs increased to 8 mg/d. The primary outcome measures were mean changes from baseline to the final visit according to IPSS and Q maxin the patients. Numerous treatment-related adverse events were assessed. Results Doxazosin-GITS and terazosin significantly improved the symptoms of BPH , increased Q max(P<0.001)and reduced total IPSS (P<0.01)similarly. The difference between two groups had no statistical significance(P>0.05). No patients withdrew because of treatment-related adverse eventswhen receiving doxazosin-GITS. The patients used doxazosin-GITS had fewer dizziness, nausea or postural hypertension than those used terazosin(P<0.05) Conclusion Doxazosin-GITS and terazosin are effective samely in reducing IPSS and improving Q max. Doxazosin-GITS has fewer titration steps and alower incidence of adverse events, which is the first choice within these medicines.