Masumori Naoya, Hashimoto Jiro, Itoh Naoki, Tsukamoto Taiji
Department of Urology, Sapporo Medical University School of Medicine, Sapporo, Japan.
Scand J Urol Nephrol. 2007;41(5):422-9. doi: 10.1080/00365590701226036. Epub 2007 Mar 8.
To evaluate treatment failure during a 4-year follow-up period after administration of naftopidil for patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH) in real-life clinical practice.
A total of 247 patients with LUTS/BPH who had an International Prostate Symptom Score (IPSS) of > or =8 were enrolled in the study. Naftopidil, 50 mg/day, was given to the patients. They were followed for 4 years with periodic evaluation. Treatment failure was defined as conversion to other medical treatment or to surgery.
Of the 247 patients, treatment failure occurred in 42 (17.0%) during the 4-year follow-up period. The 4-year treatment failure rate was on the Kaplan-Meier curve 35.0%. Among parameters assessed at baseline, prostate volume (PV) was the only significant determinant of treatment failure: patients with a PV of > or =35 ml had a 2.1 times higher hazard of treatment failure than those with a PV of <35 ml (95% CI 1.06-4.33; p=0.03). Patients with a severe IPSS at 12 weeks after administration of naftopidil had a 3.5 times higher hazard than those having a mild/moderate IPSS (95% CI 1.34-9.26; p=0.01). After 4 years, 200 patients (81%) had stopped taking naftopidil because of adverse events, treatment failure, loss to follow-up, etc.
There were significant improvements in IPSS and urinary flow rate with naftopidil although it is unknown whether these improvements were significantly larger than the placebo effect as the study was non-randomized. However, only 19% of patients were known to have continued with the same medication for 4 years in real-life clinical practice. Patients who have a large prostate at baseline and a severe IPSS at 12 weeks after treatment are more likely to have treatment failure, although a prospective study is needed to confirm this.
在现实临床实践中，评估萘哌地尔治疗提示良性前列腺增生（BPH）的下尿路症状（LUTS）患者4年随访期内的治疗失败情况。
共纳入247例国际前列腺症状评分（IPSS）≥8分的LUTS/BPH患者。给予患者每日50mg萘哌地尔。对他们进行为期4年的随访并定期评估。治疗失败定义为改用其他药物治疗或手术治疗。
247例患者中，42例（17.0%）在4年随访期内出现治疗失败。根据Kaplan-Meier曲线，4年治疗失败率为35.0%。在基线评估的参数中，前列腺体积（PV）是治疗失败的唯一显著决定因素：PV≥35ml的患者治疗失败风险比PV<35ml的患者高2.1倍（95%可信区间1.06 - 4.33；p = 0.03）。萘哌地尔给药12周后IPSS严重的患者风险比轻度/中度IPSS患者高3.5倍（95%可信区间1.34 - 9.26；p = 0.01）。4年后，200例患者（81%）因不良事件、治疗失败、失访等原因停止服用萘哌地尔。
萘哌地尔使IPSS和尿流率有显著改善，尽管由于该研究非随机，尚不清楚这些改善是否显著大于安慰剂效应。然而，在现实临床实践中，仅19%的患者已知持续使用同一药物达4年。基线前列腺体积大且治疗后12周IPSS严重的患者更可能出现治疗失败，不过需要前瞻性研究来证实这一点。
