Furuya Ryoji, Masumori Naoya, Furuya Seiji, Ogura Hiroshi, Mutoh Masatoshi, Kobayashi Ko, Hisasue Shin-ichi, Tsukamoto Taiji
Urology Service, Furuya Hospital.
Nihon Hinyokika Gakkai Zasshi. 2010 Jan;101(1):13-7. doi: 10.5980/jpnjurol.101.13.
We retrospectively evaluated patients who received silodosin for lower urinary tract symptoms suggestive of benign prostatic hyperplasia (BPH/LUTS) in our hospital, to investigate its efficacy, adverse events and continuance rate.
From the release of silodosin (July 2006) through October 2008, 256 patients received silodosin for BPH/LUTS in our hospital. Of these 256, we evaluated 195, as 61 were excluded due to conditions such as prostate cancer. We evaluated the International Prostate Symptom Score (IPSS), quality of life (QOL) index, uroflowmetry and postvoid residual urine volume before and after medication. We calculated the continuance rate of the drug by the Kaplan-Meier method.
The patients' mean age was 68.1 years and the mean medicated period was 3.1 months. Overall severity at baseline estimated by the criteria for severity of BPH was mild in 0%, moderate in 69%, and severe in 31%. Silodosin significantly improved the IPSS, QOL index, maximum urinary flow rate and postvoid residual urine volume in 90 patients whose data were available for analysis of the efficacy. Improvements were observed both in voiding symptoms and in storage symptoms. However, 45.6% of the overall efficacy was insufficient. Adverse events were observed in 56 of the 195 cases (28.7%). The most common adverse event was abnormal ejaculation (10.8%). The patients who reported adverse events were significantly younger in age and had lower IPSS and QOL index values after treatment than those without adverse events (mean age: 65.4 vs. 69.2 years old; mean IPSS: 7.7 vs. 13.1, mean QOL index: 2.9 vs. 3.6). The continuance rate for the drug was 12.0% at 1 year on the Kaplan-Meier curve. The development of adverse events was involved in the low continuance rate of silodosin.
Modification of treatment such as dose reduction is necessary to continue silodosin.
我们回顾性评估了我院因提示良性前列腺增生的下尿路症状（BPH/LUTS）而接受西洛多辛治疗的患者，以研究其疗效、不良事件及持续用药率。
自西洛多辛上市（2006年7月）至2008年10月，我院有256例患者因BPH/LUTS接受西洛多辛治疗。在这256例患者中，我们评估了195例，另外61例因前列腺癌等情况被排除。我们评估了用药前后的国际前列腺症状评分（IPSS）、生活质量（QOL）指数、尿流率及排尿后残余尿量。我们采用Kaplan-Meier法计算药物的持续用药率。
患者的平均年龄为68.1岁，平均用药时间为3.1个月。根据BPH严重程度标准，基线时总体严重程度为轻度的占0%，中度的占69%，重度的占31%。在90例可获得疗效分析数据的患者中，西洛多辛显著改善了IPSS、QOL指数、最大尿流率及排尿后残余尿量。排尿症状和储尿症状均有改善。然而，总体疗效不足的比例为45.6%。195例中有56例（28.7%）出现不良事件。最常见的不良事件是射精异常（10.8%）。报告有不良事件的患者年龄显著更小，治疗后IPSS和QOL指数值低于无不良事件的患者（平均年龄：65.4岁对69.2岁；平均IPSS：7.7对13.1，平均QOL指数：2.9对3.6）。根据Kaplan-Meier曲线，该药物1年时的持续用药率为12.0%。不良事件的发生与西洛多辛的低持续用药率有关。
为继续使用西洛多辛，有必要调整治疗方案，如减少剂量。
