国产盐酸特拉唑嗪治疗前列腺增生症的临床研究

Clinical Study of Domestic Terazosin on Benign Prostatic Hyperplasia

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 determine the effect of terazosin on benign prostatic hyperplasia (BPH) and its safety. METHODS: 102 patients with BPH were observed in randomized and controlled clinical trials. The patients were given orally terazosin or hytrin 2mg, once daily for 4 weeks. RESULTS: Their primary outcome parameters, including international prostate symptom score(I-PSS), quality of life(QOL), maximum urinary flow rate(MFR) and residual urine(RU) were significantly improved (P<0.01) compared with that in pretreatment. The results showed that there was no significant difference in efficiency between terazosin and Hytrin (66% vs 68%). After 4 weeks of therapy, mean sitting systolic blood pressure and diastolic blood pressure were significantly reduced. However, in the patients with normotensive(BP<140/90 mmHg), terazosin or hytrin induced no clinically significant mean changes in SBP and DBP. In hypertensive(SBP>140 mmHg or DBP>90 mmHg) patients, terazosin or hytrin significantly decreased the blood pressures. One of the patients in each group withdrew the trial due to dizziness. The common adverse effects of both drugs were slight dizziness and thirst, which might become milder and disappear during the period of treatment. CONCLUSION: The results suggest that terazosin is a safe and efficient medicine for BPH in normotensive patients, and may serve as a good antihypertensive effect for BPH with hight blood pressure.