Weill Cornell Medical College, Cornell University, New York, New York 10065, USA.
Urology. 2010 May;75(5):1144-8. doi: 10.1016/j.urology.2009.12.010. Epub 2010 Mar 5.
To assess safety and efficacy of 4 mg tolterodine extended release (TER) with 0.5 mg dutasteride (DUT) in men with persistent overactive bladder (OAB) symptoms and lower urinary tract symptoms (LUTS) unsuccessfully treated with DUT alone. TER is indicated for OAB and DUT is indicated for LUTS from benign prostatic hyperplasia.
A total of 51 men treated with DUT for >or=6 months with persistent OAB symptoms enrolled in a 12-week, open-label study, and given TER (4 mg q.h.s.). Inclusion criteria were international prostate symptom score (IPSS) >or=12, IPSS quality-of-life item >or=3, significant bother, frequency (>or=8 voids/24 h), and urgency (>or=3 episodes/24 h). Visits occurred at 4, 8, and 12 weeks. Efficacy was assessed by changes in diary endpoints and IPSS (total, storage, and voiding). Safety was assessed by changes in postvoid residual, peak flow rate (Q(max.)), adverse events, and retention.
Baseline prostate volume was 54.3 mL. TER significantly reduced frequency and urgency: 24-hour micturition frequency (-3.2, P <.02), OAB episodes (19.2%, P <.03), severe OAB episodes (71.4%, P <.05), and nighttime voiding (-0.9, P <.003). IPSS decreased with DUT (19.3-14.3) and decreased with addition of TER to 7.1 (P <.001). Storage symptoms decreased from 9.8 to 4.5 (P <.001). Dry mouth occurred in 4 (7.5%) subjects, constipation in 1 (2%), and decreased sexual function in 2 (3.9%) subjects. Postvoid residual increased by 4.2 mL, Q(max.) decreased by 0.2 mL/s, and no patients went into retention.
The combination TER and DUT was effective, safe, and well-tolerated in men with large prostates (>or=30 mL) with persistent OAB symptoms and LUTS secondary to benign prostatic hyperplasia.
评估 4 毫克托特罗定延长释放剂（TER）联合 0.5 毫克度他雄胺（DUT）治疗单用 DUT 治疗失败的持续性膀胱过度活动症（OAB）症状和下尿路症状（LUTS）的男性的安全性和疗效。TER 适用于 OAB，DUT 适用于良性前列腺增生引起的 LUTS。
51 名接受 DUT 治疗>或=6 个月且持续存在 OAB 症状的男性入组一项为期 12 周的开放标签研究，并给予 TER（4 毫克 q.h.s.）。纳入标准为国际前列腺症状评分（IPSS）>或=12、IPSS 生活质量评分>或=3、有明显困扰、频率（>或=8 次/24 小时）和紧迫性（>或=3 次/24 小时）。访视时间为 4、8 和 12 周。通过日记终点和 IPSS（总评分、存储评分和排尿评分）的变化评估疗效。通过残余尿量、最大尿流率（Q（max.））、不良事件和保留的变化评估安全性。
基线前列腺体积为 54.3 毫升。TER 显著减少了频率和紧迫性：24 小时排尿频率（-3.2，P <.02）、OAB 发作次数（19.2%，P <.03）、严重 OAB 发作次数（71.4%，P <.05）和夜间排尿次数（-0.9，P <.003）。DUT 治疗后 IPSS 下降（19.3-14.3），联合 TER 治疗后下降至 7.1（P <.001）。存储症状从 9.8 降至 4.5（P <.001）。4 名（7.5%）患者出现口干，1 名（2%）患者出现便秘，2 名（3.9%）患者出现性功能下降。残余尿量增加 4.2 毫升，最大尿流率降低 0.2 毫升/秒，无患者发生潴留。
在前列腺体积较大（>或=30 毫升）、持续存在 OAB 症状和良性前列腺增生引起的 LUTS 的男性中，TER 和 DUT 联合治疗有效、安全且耐受良好。
