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目的：对盐酸特拉唑嗪治疗前列腺增生症患者的疗效与安全性进行临床评价。方法：采用随机平行对照试验方法，对比研究受试药盐酸特拉唑嗪和高特灵对102例前列腺增生症（BPH）患者的疗效及药物不良反应。特拉唑嗪和对照药高特灵分别每日1次口服2mg，疗程4周。结果：治疗后患者国际前列腺症状评分（I-PSS）、生活质量评分（QOL）、最大尿流率（MFR）及残尿量（RU）与用药前比较，均有明显改善（均P<0.01），两药无显著差异(P>0.05)。两药综合疗效评价的有效率分别为66%及68%。两药使患者的收缩压（SBP）和舒张压（DBP）均有统计意义的降低，但对基础血压正常（BP<140/90 mmHg）的患者SBP和DBP无明显影响，而对基础血压异常(SBP>140 mmHg或（和） DBP>90 mmHg)的患者血压降低幅度显著，两者均有显著差异（分别P<0.01；P<0.05）。两组各有1例因头昏而退出试验。药物不良反应发生率分别为15.7 %和19.6 %，主要症状为轻微头昏、口干等，勿需任何处理，于2～3d内逐渐减轻和消失。结论：特拉唑嗪片治疗前列腺增生症疗效确切，药物不良反应轻，耐受性好，对伴有高血压的前列腺增生症患者更为有益。
Objective: To evaluate the efficacy and safety of terazosin hydrochloride in patients with benign prostatic hyperplasia. Methods: Randomized controlled trials were conducted to compare the efficacy and side effects of terazosin and gortolol hydrochloride on 102 BPH patients. Terazosin and the control drug Gotthard were oral 2mg daily for 4 weeks. Results: After treatment, I-PSS, QOL, MFR and residual urine (RU) were significantly improved in both groups (all P <0.01) ), No significant difference between the two drugs (P> 0.05). The overall efficacy of the two drugs were 66% and 68%, respectively. Both drugs reduced both SBP and DBP, but had no significant effect on SBP and DBP in patients with basal BP (BP <140/90 mmHg), but no effect on basal BP (SBP> 140 mmHg or (and) DBP> 90 mmHg) had significant reductions in BP (P <0.01, P <0.05, respectively). One patient in each group quit due to dizziness. Adverse drug adverse reactions were 15.7% and 19.6%, the main symptoms are mild dizziness, dry mouth, etc., without any treatment, gradually reduce and disappear in 2 ~ 3d. Conclusion: Terazosin tablets in the treatment of benign prostatic hyperplasia is effective, light adverse drug reactions, tolerability is good for hypertensive patients with benign prostatic hyperplasia.