Division of Urology, Department of Surgery, Chiangmai University, Chiangmai, Thailand.
Int Braz J Urol. 2011 Jul-Aug;37(4):468-76. doi: 10.1590/s1677-55382011000400005.
Tamsulosin, a superselective subtype alpha 1a and 1d blocker, is used for the treatment of male lower urinary tract symptoms (LUTS) commonly caused by benign prostatic hyperplasia (BPH). This prospective study evaluated the efficacy and safety of a new formulation, Tamsulosin OCAS® (Oral Controlled Absorption System), for LUTS associated with BPH in Thai patients.
Fifty one patients over 40 years old with complaints of LUTS associated with BPH were recruited. Patients received an 8 week course of once daily 0.4 mg tamsulosin OCAS®, and were followed up at 2 (visit 3), 4 (visit 4) and 8 (visit 5) weeks post-treatment. At each visit, patients were assessed using the International Prostate Symptom Score (IPSS), Nocturia Quality of Life (N-QoL) Questionnaire, QoL Assessment Index (IPSS-QoL), and International Index of Erectile Function (IIEF). The primary outcome was efficacy of Tamsulosin. The secondary outcomes included change in the mean number of nocturia episodes, hours of undisturbed sleep (HUS) and uroflowmetry measurements.
Total IPSS significantly decreased at week 8 from baseline (from 19.52 to 6.08; p < 0.001). Similarly, the voiding and storage subscores of IPSS also continued to improve significantly starting from the second and third visits, respectively (p < 0.001 versus baseline). The IPSS-QoL and N-QoL scores significantly improved at visit 3 through end of study. In addition, we observed significant nocturia and HUS improvement in their last clinic visit. Uroflowmetry parameters, Qmax and Qave, improved significantly at 3rd clinic visit. Three patients experienced mild dizziness.
Tamsulosin OCAS® treatment led to significant improvements in LUTS, HUS and QoL in Thai patients with bladder outlet obstruction from BPH with few side effects.
坦索罗辛是一种超选择性α1a 和 1d 阻滞剂，用于治疗良性前列腺增生（BPH）引起的男性下尿路症状（LUTS）。本前瞻性研究评估了新制剂坦索罗辛 OCAS®（口服控释吸收系统）治疗泰国 BPH 患者 LUTS 的疗效和安全性。
招募了 51 名年龄在 40 岁以上、有 LUTS 合并 BPH 症状的患者。患者接受了为期 8 周的每日一次 0.4mg 坦索罗辛 OCAS®治疗，并在治疗后 2 周（访视 3）、4 周（访视 4）和 8 周（访视 5）进行随访。每次就诊时，患者均采用国际前列腺症状评分（IPSS）、夜间排尿质量生活（N-QoL）问卷、生活质量评估指数（IPSS-QoL）和国际勃起功能指数（IIEF）进行评估。主要疗效终点为坦索罗辛的疗效。次要终点包括夜间排尿次数、未受干扰的睡眠（HUS）时间和尿流率测量的平均变化。
与基线相比，第 8 周时总 IPSS 显著下降（从 19.52 降至 6.08；p<0.001）。同样，从第二次就诊开始，IPSS 的排尿和储存子评分也持续显著改善（与基线相比，p<0.001）。在第 3 次就诊时，IPSS-QoL 和 N-QoL 评分显著改善，并持续到研究结束。此外，我们观察到最后一次就诊时夜间排尿和 HUS 显著改善。在第 3 次就诊时，尿流率参数 Qmax 和 Qave 显著改善。3 名患者出现轻度头晕。
坦索罗辛 OCAS®治疗可显著改善泰国 BPH 患者的 LUTS、HUS 和生活质量，且副作用少。
