盐酸特拉唑嗪治疗中国人群良性前列腺增生患者的多中心临床研究

目的 评价维持剂量盐酸特拉唑嗪治疗中国人群BPH患者的有效性、安全性和依从性. 方法2007年6月至2008年3月在中国32家泌尿外科中心开展了多中心、前瞻性临床研究,方案为口服盐酸特拉唑嗪1～4 mg,1次/d,共4周.主要评价指标是治疗2、4周时患者IPSS变化值;次要指标是治疗4周时Qmax,QOL变化值,治疗2、4周时血压变化值以及4周内脱落率.并通过对不良事件的分析评估其安全性. 结果共纳入1006例BPH患者(FAS集),资料合格者992例(PP集),合并高血压病344例.FAS集患者IPSS从基线的22.32±6.13降至2周时的16.98±5.92以及4周时的14.00±5.52(P＜0.01);PP集患者IPSS从基线的22.32±6.15降至2周时的16.96±5.93及4周时的13.95±5.52(P＜0.01).以IPSS与基线相比下降＞30%定义为有效,2周末有效率为26.54%,4周末为60.64%.治疗4周后Qmax 和QOL均有显著增高,分别改善32%和45%(P＜0.01).对于血压正常或高血压获得控制的患者,盐酸特拉唑嗪对血压的影响较小;而对伴有未治疗或未能控制血压的高血压患者,盐酸特拉唑嗪能一定程度降低血压(P＜0.05).治疗中不良事件发生率低,最常见为头晕(3.68%).研究结束时960例仍继续服药. 结论盐酸特拉唑嗪能有效改善中国人群BPH患者症状,显著提高生活质量,同时具有良好的安全性和依从性.

A multicenter prospective clinical study on the effectiveness and safety of terazosin in the treatment of Chinese benign prostatic hyperplasia patients

Objective To evaluate the effectiveness and safety of terazosin in the treatment of Chinese benign prostatic hyperplasia (BPH) patients. Methods A multicenter prospective postmarketing observational study was conducted from June 2007 to March 2008 in 32 urologic centers.Patients were given terazosin for 4 weeks according to the routine medical care procedures following instructions. Effectiveness evaluation included the primary endpoint focusing on the changes in IPSS total score at the end of 2nd and 4th week compared with the baseline. The secondary endpoints were the changes in Qmax and QOL at the end of 4th week, diastolic and systolic blood pressures at the end of 2nd and 4th week compared with the baseline and the discontinuation rate of terazosin within the four weeks. Safety was assessed by adverse events. Results There were 1006 patients included in this study (FAS) and 992 patients (PP) completed the study. Among them, there were 344 patients having hypertension. The total IPSS score reduced from 22.32±6. 13 at baseline to 16. 98±5.92 at the end of the 2nd week and to 14.00±5. 52 at the end of the 4th week in FAS population (P＜0. 01).The total IPSS score changed from 22.32±6.15 at baseline to 16. 96±5.93 at the end of the 2nd week and to 13. 95±5.52 at the end of the 4th week in the PP population (P＜0.01). The efficacy rate was 26.54% at the 2-week treatment and 60.64% at the 4-week treatment, which was defined as obtaining improvement by 30% compared with the baseline. Patient's IPSS in different age groups with different prostatic hyperplasia levels and patients combined with or without 5-α reductase inhibitors were all decreased significantly(P＜0.01). With 4-week treatment of terazosin, Qmax and QOL were improved significantly by 32% and 45% (P＜0.01). Terazosin decreased BPH patient blood pressure with untreated or uncontrolled hypertension (P＜0.05), but had little influence on normal blood pressure of those under control. The incidence of adverse reactions was low. The most common adverse event was dizziness (3.68%). At the end of the study, 960 subjects (95%) were taking drug continuously.Conclasions Terazosin can significantly improve the symptoms and quality of life in Chinese BPH patients with good safety and compliance.