Morita Tatsuo, Kubo Kenji Komatsu Taro, Fujisaki Akira, Natsui Shinsuke, Nukui Akinori, Kobayashi Minoru, Kurokawa Shinsuke
Department of Urology, Jichi Medical University, Tochigi, Japan.
Res Rep Urol. 2013 Apr 9;5:83-90. doi: 10.2147/RRU.S42583. eCollection 2013.
To determine if switching from one brand of the α1-adrenoceptor antagonist naftopidil (Avishot™) to another brand (Flivas™) under the same conditions causes the same changes in lower urinary tract symptoms (LUTS) and quality of life (QOL) as the perceived placebo effect, and if ambient temperature as a nonspecific factor is related to those changes in benign prostatic hyperplasia (BPH) patients.
A retrospective study was carried out on 217 BPH patients who had received Avishot™ for more than 6 months and then were switched to Flivas™ at the same dose and timing. The two drugs contain the same principal ingredient and display the same pharmacokinetic properties. The International Prostate Symptom Score (IPSS), QOL score, and average monthly ambient temperature at the patients' residence area from the Automated Meteorological Data Acquisition System in Japan were used for the evaluation.
A significant change in urinary storage symptoms (P = 0.006), and especially in nighttime frequency (P< 0.001), was observed by switching drugs, suggesting the perceived placebo effect. There was significant improvement of daytime frequency (P< 0.05), nighttime frequency (P< 0.001), storage symptoms (P< 0.001), and total IPSS (P< 0.05) when the magnitude of ambient temperature change from before and 3 months after switching drugs was higher than 10°C, while no significant improvement was noted in any of the parameters examined when the same was lower than 10°C.
The present study showed the nonspecific effect of magnitude of ambient temperature change was involved in the perceived placebo effect on LUTS, especially on storage symptoms, by switching drugs. The nonspecific effect on LUTS with BPH needs to be considered when evaluating subjective treatment efficacy of drugs for LUTS with BPH in routine clinical practice. The present study supports the lifestyle advice "avoid exposing the lower body to cold temperature" or "keep warm when it is cold" for LUTS with BPH.
确定在相同条件下从一种品牌的α1-肾上腺素能受体拮抗剂萘哌地尔（阿维舒™）转换为另一种品牌（弗利瓦斯™）是否会引起与感知到的安慰剂效应相同的下尿路症状（LUTS）和生活质量（QOL）变化，以及环境温度作为一个非特异性因素是否与良性前列腺增生（BPH）患者的这些变化相关。
对217例接受阿维舒™治疗超过6个月，然后在相同剂量和时间转换为弗利瓦斯™的BPH患者进行了一项回顾性研究。这两种药物含有相同的主要成分，并显示出相同的药代动力学特性。使用国际前列腺症状评分（IPSS）、QOL评分以及来自日本自动气象数据采集系统的患者居住地区的月平均环境温度进行评估。
换药后观察到储尿期症状有显著变化（P = 0.006），尤其是夜尿症（P < 0.001），提示存在感知到的安慰剂效应。当换药前后3个月的环境温度变化幅度高于10°C时，白天尿频（P < 0.05）、夜尿症（P < 0.001）、储尿期症状（P < 0.001）和总IPSS（P < 0.05）有显著改善，而当变化幅度低于10°C时，所检查的任何参数均未观察到显著改善。
本研究表明，环境温度变化幅度的非特异性效应参与了换药时对LUTS，尤其是对储尿期症状的感知到的安慰剂效应。在常规临床实践中评估治疗BPH的LUTS药物的主观治疗效果时，需要考虑对BPH的LUTS的非特异性效应。本研究支持针对BPH的LUTS给出“避免下半身暴露于低温”或“寒冷时注意保暖”的生活方式建议。
