Nickel J Curtis, Roehrborn Claus G, O'Leary Michael P, Bostwick David G, Somerville Matthew C, Rittmaster Roger S
Department of Urology, Queen's University, Kingston General Hospital, Kingston, ON, Canada.
Eur Urol. 2008 Dec;54(6):1379-84. doi: 10.1016/j.eururo.2007.11.026. Epub 2007 Nov 20.
The ongoing REDUCE trial is a 4-yr, phase 3, placebo-controlled study to determine if daily dutasteride 0.5mg reduces the risk of biopsy detectable prostate cancer. Prostate biopsies performed in all men prior to entry were centrally reviewed, thus allowing an examination of the relationship between inflammatory changes and lower urinary tract symptoms (LUTS).
Eligible men were aged 50-75 yr, with serum prostate-specific antigen >or=2.5 ng/ml and <or=10 ng/ml (50-60 yr), or >or=3.0 ng/ml and <or=10 ng/ml (>60 yr) and an International Prostate Symptom Score (IPSS)<25 (or <20 if already on alpha-blocker therapy). Acute prostatitis was an exclusion criterion. For a given individual, inflammation was assessed across all cores and the amount of inflammation scored as none (0), mild (1), moderate (2), or marked (3). LUTS was assessed with the use of the IPSS. The relationship between inflammation scores (averaged over all cores) and total IPSS; grouped IPSS (0-3, 4-7, 8-11, 12-15, 16-19, >/=20); and irritative, obstructive, and nocturia subscores was determined by Spearman rank correlations. The relative contribution of inflammation, age, and body mass index was then examined with the use of linear regression analyses.
Data were available for 8224 men. Statistically significant but relatively weak correlations were found between average and maximum chronic inflammation and IPSS variables (correlation coefficients, 0.057 and 0.036, respectively; p < 0.001 for total IPSS). Both age and average chronic inflammation were significant in the linear regression after adjustment for other covariates; for both variables, more severe inflammation was associated with higher IPSS scores.
In the REDUCE population, there is evidence of a relationship between the degree of LUTS and the degree of chronic inflammation. Study entry criteria that selected older men and decreased enrolment of men with a greater degree of inflammation and LUTS may have limited the strength of this relationship. The impact of baseline prostate inflammation on progression of LUTS and/or associated complications will be determined during 4-yr longitudinal follow-up.
正在进行的REDUCE试验是一项为期4年的3期安慰剂对照研究，旨在确定每日服用0.5mg度他雄胺是否能降低活检可检测到的前列腺癌风险。对所有入组前男性进行的前列腺活检进行了集中审查，从而能够研究炎症变化与下尿路症状（LUTS）之间的关系。
符合条件的男性年龄在50至75岁之间，血清前列腺特异性抗原在50至60岁时≥2.5 ng/ml且≤10 ng/ml，或在60岁以上时≥3.0 ng/ml且≤10 ng/ml，国际前列腺症状评分（IPSS）<25（如果已经接受α受体阻滞剂治疗则<20）。急性前列腺炎为排除标准。对于给定个体，对所有活检组织核心区域的炎症情况进行评估，并将炎症程度分为无（0）、轻度（1）、中度（2）或重度（3）。使用IPSS评估LUTS。通过Spearman等级相关性确定炎症评分（所有核心区域的平均值）与总IPSS、分组IPSS（0 - 3、4 - 7、8 - 11、12 - 15、16 - 19、≥20）以及刺激性、梗阻性和夜尿亚评分之间的关系。然后使用线性回归分析研究炎症、年龄和体重指数的相对贡献。
8224名男性的数据可用。发现平均和最大慢性炎症与IPSS变量之间存在统计学上显著但相对较弱的相关性（相关系数分别为0.057和0.036；总IPSS的p < 0.001）。在对其他协变量进行调整后的线性回归中，年龄和平均慢性炎症均具有显著性；对于这两个变量，更严重的炎症与更高的IPSS评分相关。
在REDUCE研究人群中，有证据表明LUTS程度与慢性炎症程度之间存在关联。选择老年男性且减少炎症和LUTS程度较高男性入组的研究纳入标准可能限制了这种关联的强度。基线前列腺炎症对LUTS进展和/或相关并发症的影响将在4年的纵向随访中确定。
