多沙唑嗪控释片治疗前列腺增生症的对照研究

目的评价多沙唑嗪控释片、特拉唑嗪片和坦索罗辛片等3种α1受体阻滞剂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183例BPH患者进行了一个前瞻性的随机、双盲和平行对照试验,过程分3个阶段:第一阶段为2周的清洗期,第二阶段为2周的单盲安慰剂导入期,第三阶段为12周的双盲药物治疗期。多沙唑嗪控释片、特拉唑嗪片和坦索罗辛片的起始剂量分别为4 mg/d、1 mg/d和0.4 mg/d,如果治疗4周后最大尿流率(Qmax)增加<3 mL/s,国际前列腺症状评分(IPSS)下降<30%,则将3种药物分别加量为8 mg/d、8 mg/d和0.8 mg/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。统计方法采用方差分析和χ2检验。结果多沙唑嗪控释片、特拉唑嗪片和坦索罗辛片均能显著减轻BPH的下尿路梗阻症状,增加Qmax(P<0.01),但是前两种药物对IPSS的降低显著优于坦索罗辛片(P<0.05)。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和坦索罗辛片组比较,差异有统计学意义(P<0.05)。结论α1受体阻滞剂均能有效缓解BPH的下尿路症状。多沙唑嗪控释片作用全面,有效性和安全性显著提高,是这类药物的首选。

A randomized, double-blind trials of the efficacy anti tolerability of doxazosin-gastrointestinal therapeutic system, terazosin and tamsulosin in patients with benign prostatic hyperplasia

Objective To evaluate the efficacy and safety of doxazosin-gastrointestinal therapeutic system(GITS),terazosin and tamsulosin in treating patients with benign prostatic hyperplasia(BPH).Methods Data were analyzed from a prospective,randomized,double-blind study,which included a two-week washout period,a two-week single-blind placebo run-in phase,and a twelve-week double-blind treatment phase.Doxazosin-GITS,terazosin and tamsulosin were started at 4 mg/d,1 mg/d and 0.4 mg/d respectively.If the increase in Qmax was <3 mL/s or the reduction in total IPSS was <30% after 4 weeks of therapy,the dose was titrated to 8 mg/d,8 mg/d and 0.8 mg/d respectively.The primary outcome measures were mean changes from baseline to the final visit for the international prostate symptom score(IPSS) and maximum urinary flow rate(Qmax) in the patients.Numerous treatment-related adverse events were assessed.Analysis of variance and chi-square test were used for data statistical analysis.Result Doxazosin-GITS,terazosin and tamsulosin significantly improved the symptoms of BPH and increased Qmax(P<0.01).However doxazosin-GITS and terazosin produced significantly greater improvements in total IPSS than tamsulosin (P<0.05).No patients withdrew from the study because of treatment-related adverse events when receiving doxazosin-GITS.The patients used doxazosin-GITS had fewer dizziness,nausea or postural hypotension than those used terazosin and tamsulosin.Conclusion α1 adrenoreceptor antagonist is effective in reducing clinical symptoms of BPH and improving Qmax.Doxazosin-GITS has fewer titration steps and a lower incidence of adverse events,which is the first choice within these medicines.