Shin Yu Seob, Zhang Li Tao, You Jae Hyung, Choi In Sung, Zhao Chen, Park Jong Kwan
Department of Urology, Chonbuk National University and Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute and Medical Device Clinical Trial Center of Chonbuk National University, Jeonju, Republic of Korea.
Department of Urology, Renji Hospital, Shanghai Jiao Tong University School of Medicine, and Shanghai Institute of Andrology, Shanghai, People's Republic of China.
Clin Interv Aging. 2016 Sep 19;11:1301-1307. doi: 10.2147/CIA.S115042. eCollection 2016.
The objective of this study was to evaluate the safety and efficacy of tamsulosin hydrochloride 0.2 mg (TAM) and its combination with solifenacin succinate 5 mg (SOL) after transurethral resection of the prostate (TURP).
The patients were randomized into three groups: TURP (group 1), TURP plus TAM (group 2), and TURP plus TAM + SOL (group 3). Patients in group 2 and group 3 received medication for 4 weeks. The primary efficacy end points were the mean change in total International Prostate Symptom Score (IPSS) and IPSS subscores. The secondary end points included quality-of-life score, Overactive Bladder Symptom Score, and short-form voiding and storage score of International Continence Society.
In total, 37 men (31.8%) in group 1, 37 men (31.8%) in group 2, and 42 men (36.2%) in group 3 completed the study. In total IPSS, no significant improvement was seen from baseline to the end of treatment in groups 2 and 3 compared with group 1. However, in group 2, the decrement in the IPSS storage score was smaller than group 1 (=0.02), and in group 3, the decrement in the IPSS voiding score was smaller than group 1 (=0.05). In groups 2 and 3 compared with group 1, improvements in the quality of life score, total score of Overactive Bladder Symptom Score, and short-form voiding score and storage score of International Continence Society were not statistically significant.
Treatment with TAM and combination of TAM and SOL did not have significant additional benefits for lower urinary tract symptoms during the early recovery period after TURP.
本研究旨在评估盐酸坦索罗辛0.2毫克（TAM）及其与琥珀酸索利那新5毫克（SOL）联合用药在经尿道前列腺电切术（TURP）后的安全性和有效性。
患者被随机分为三组：TURP组（第1组）、TURP加TAM组（第2组）和TURP加TAM+SOL组（第3组）。第2组和第3组患者接受4周的药物治疗。主要疗效终点为国际前列腺症状评分（IPSS）总分及IPSS分项评分的平均变化。次要终点包括生活质量评分、膀胱过度活动症症状评分以及国际尿失禁学会的简短排尿和储尿评分。
第1组37名男性（31.8%）、第2组37名男性（31.8%）和第3组42名男性（36.2%）完成了研究。在IPSS总分方面，与第1组相比，第2组和第3组从基线到治疗结束时未见显著改善。然而，在第2组中，IPSS储尿评分的下降幅度小于第1组（P=0.02），在第3组中，IPSS排尿评分的下降幅度小于第1组（P=0.05）。与第1组相比，第2组和第3组在生活质量评分、膀胱过度活动症症状评分总分以及国际尿失禁学会的简短排尿评分和储尿评分方面的改善无统计学意义。
TAM治疗以及TAM与SOL联合用药在TURP术后早期恢复期间对下尿路症状无显著额外益处。
