Yokoyama Osamu, Tsujimura Akira, Akino Hironobu, Segawa Naoki, Tamada Satoshi, Oguchi Naoki, Kitagawa Yasuhide, Tsuji Hidenori, Watanabe Akihiko, Inamoto Teruo, Shimizu Nobutaka, Fujiuchi Yasuyoshi, Katsuoka Yoji, Azuma Haruhito, Matsuda Tadashi, Namiki Mikio, Uemura Hirotsugu, Okuyama Akihiko, Nonomura Norio, Fuse Hideki, Nakatani Tatsuya
Department of Urology, Faculty of Medical Science, University of Fukui, Fukui, Japan,
World J Urol. 2015 May;33(5):659-67. doi: 10.1007/s00345-014-1399-x. Epub 2014 Sep 16.
To evaluate the efficacy and safety of imidafenacin (IM), a novel short half-life anticholinergic, as add-on therapy for male LUTS with nocturia and nocturnal polyuria.
This multicenter, prospective, randomized, open-labelled study was conducted and involved men who had frequency, urgency, and nocturia despite receiving a stable dose of α1-blocker for ≥1 month. Subjects were randomised to control (α1-blocker alone), IM twice/day (α1-blocker +0.1 mg imidafenacin twice daily), or IM nightly (α1-blocker plus 0.1 mg imidafenacin nightly) group; the treatment period was 8 weeks. Primary endpoints included improvements in night-time frequency and Nocturia Quality of Life Questionnaire (N-QOL) scores. Secondary endpoints included changes from the baseline in frequency volume chart variables, and post-void residual volume.
Compared with the controls, IM twice/day and IM nightly patients had a significantly lower night-time frequency (changes from baseline: 0.1 ± 0.8 in control, -0.6 ± 0.9 in IM twice/day, and -0.4 ± 1.0 in IM nightly, p = 0.5227, 0.0006 and 0.0143, respectively). The hours of undisturbed sleep and N-QOL score were significantly improved in IM twice/day group, though not IM nightly group. Nocturnal urine volume was significantly reduced in IM nightly group, although total urine volume remained unchanged.
A short half-life anticholinergic is suggested to be safe and effective as an add-on therapy for residual nocturia in patients with male LUTS receiving α1-blocker treatment. Anticholinergic administration nightly could reduce the nocturnal urine volume.
评估新型短半衰期抗胆碱能药物咪达非那新（IM）作为伴有夜尿症和夜间多尿症的男性下尿路症状附加治疗的疗效和安全性。
开展了这项多中心、前瞻性、随机、开放标签研究，纳入了尽管接受稳定剂量α1受体阻滞剂治疗≥1个月仍有尿频、尿急和夜尿症的男性患者。受试者被随机分为对照组（仅使用α1受体阻滞剂）、每日两次IM组（α1受体阻滞剂+每日两次0.1毫克咪达非那新）或每晚IM组（α1受体阻滞剂+每晚0.1毫克咪达非那新）；治疗期为8周。主要终点包括夜间排尿频率改善情况和夜尿症生活质量问卷（N-QOL）评分。次要终点包括频率-尿量图变量相对于基线的变化以及残余尿量。
与对照组相比，每日两次IM组和每晚IM组患者的夜间排尿频率显著更低（相对于基线的变化：对照组为0.1±0.8，每日两次IM组为-0.6±0.9，每晚IM组为-0.4±1.0，p值分别为0.5227、0.0006和0.0143）。每日两次IM组患者的无干扰睡眠时间和N-QOL评分显著改善，而每晚IM组未改善。每晚IM组的夜间尿量显著减少，尽管总尿量保持不变。
对于接受α1受体阻滞剂治疗的男性下尿路症状患者，短半衰期抗胆碱能药物作为残余夜尿症的附加治疗被认为是安全有效的。每晚给予抗胆碱能药物可减少夜间尿量。
