Nickel J Curtis, Krieger John N, McNaughton-Collins Mary, Anderson Rodney U, Pontari Michel, Shoskes Daniel A, Litwin Mark S, Alexander Richard B, White Paige C, Berger Richard, Nadler Robert, O'Leary Michael, Liong Men Long, Zeitlin Scott, Chuai Shannon, Landis J Richard, Kusek John W, Nyberg Leroy M, Schaeffer Anthony J
Department of Urology, Queen's University, Kingston, ON, Canada.
N Engl J Med. 2008 Dec 18;359(25):2663-73. doi: 10.1056/NEJMoa0803240.
In men with chronic prostatitis-chronic pelvic pain syndrome, treatment with alpha-adrenergic receptor blockers early in the course of the disorder has been reported to be effective in some, but not all, relatively small randomized trials.
We conducted a multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy of alfuzosin, an alpha-adrenergic receptor blocker, in reducing symptoms in men with chronic prostatitis-chronic pelvic pain syndrome. Participation in the study required diagnosis of the condition within the preceding 2 years and no previous treatment with an alpha-adrenergic receptor blocker. Men were randomly assigned to treatment for 12 weeks with either 10 mg of alfuzosin per day or placebo. The primary outcome was a reduction of at least 4 points (from baseline to 12 weeks) in the score on the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) (range, 0 to 43; higher scores indicate more severe symptoms). A 4-point decrease is the minimal clinically significant difference in the score.
A total of 272 eligible participants underwent randomization, and in both study groups, 49.3% of participants had a decrease of at least 4 points in their total NIH-CPSI score (rate difference associated with alfuzosin, 0.1%; 95% confidence interval, -11.2 to 11.0; P=0.99). In addition, a global response assessment showed similar response rates at 12 weeks: 33.6% in the placebo group and 34.8% in the alfuzosin group (P=0.90). The rates of adverse events in the two groups were also similar.
Our findings do not support the use of alfuzosin to reduce the symptoms of chronic prostatitis-chronic pelvic pain syndrome in men who have not received prior treatment with an alpha-blocker. (ClinicalTrials.gov number, NCT00103402.)
据报道，在一些（但并非全部）相对较小的随机试验中，对于患有慢性前列腺炎-慢性盆腔疼痛综合征的男性，在疾病病程早期使用α-肾上腺素能受体阻滞剂进行治疗是有效的。
我们进行了一项多中心、随机、双盲、安慰剂对照试验，以评估α-肾上腺素能受体阻滞剂阿夫唑嗪在减轻慢性前列腺炎-慢性盆腔疼痛综合征男性症状方面的疗效。参与研究要求在之前2年内确诊该病且未曾接受过α-肾上腺素能受体阻滞剂治疗。男性被随机分配接受为期12周的治疗，每日服用10毫克阿夫唑嗪或安慰剂。主要结局是美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）评分（范围为0至43分；分数越高表明症状越严重）从基线到12周至少降低4分。4分的降低是该评分中临床上最小的显著差异。
共有272名符合条件的参与者进行了随机分组，在两个研究组中，49.3%的参与者NIH-CPSI总分降低了至少4分（阿夫唑嗪相关的率差为0.1%；95%置信区间为-11.2至11.0；P = 0.99）。此外，一项整体反应评估显示12周时的反应率相似：安慰剂组为33.6%，阿夫唑嗪组为34.8%（P = 0.90）。两组的不良事件发生率也相似。
我们的研究结果不支持在未接受过α受体阻滞剂治疗的男性中使用阿夫唑嗪来减轻慢性前列腺炎-慢性盆腔疼痛综合征的症状。（ClinicalTrials.gov编号，NCT00103402。）
