Alfuzosin treatment for chronic prostatitis/chronic pelvic pain syndrome:: A prospective, randomized, double-blind, placebo-controlled, pilot study
Alfuzosin treatment for chronic prostatitis/chronic pelvic pain syndrome:: A prospective, randomized, double-blind, placebo-controlled, pilot study
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DOI：
10.1016/s0090-4295(03)00466-7
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发表时间：
2003-09-01
期刊：
影响因子：
2.1
通讯作者：
Helström, PJ
中科院分区：
文献类型：
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作者：
Mehik, A;Alas, P;Helström, PJ
目标.进行一项前瞻性、安慰剂对照研究，比较阿夫唑嗪与安慰剂和标准治疗对慢性前列腺炎/慢性盆腔疼痛综合征（CP/CPPS）患者的长期疗效，因为α受体阻滞剂已被建议用于治疗CP/CPPS。对120名连续诊断为CP/CPPS的男性进行前瞻性筛选，然后要求他们参加前列腺炎治疗试验。同意随机化的患者随后随机分配至阿夫唑嗪5 mg每日两次或安慰剂组，同意参与但未随机分配的患者进入对照或标准（α受体阻滞剂除外）治疗组。患者前瞻性治疗6个月，然后再随访6个月。经验证的芬兰版美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）的总分和领域评分较基线的变化是本研究的主要结局参数。70例受试者同意参加研究。66例患者的数据可用于评价（阿夫唑嗪组17例，安慰剂组20例，对照/标准组29例）。在6个月的活性治疗结束时，与安慰剂组和对照/标准组相比，阿夫唑嗪组的NIH-CPSI总分出现统计学显著性降低（分别降低9.9、3.8和4.3，P = 0.01）。与安慰剂组和对照/标准组相比，阿夫唑嗪组6个月时疼痛评分出现统计学显著性改善（P = 0.01），但三组间排尿或生活质量评分无统计学显著性改善。在阿夫唑嗪组患者中，65%的NIH-CPSI平均总分改善超过33%，而安慰剂组和对照/标准组分别为24%和32%（P = 0.02）。在12个月时（阿夫唑嗪/安慰剂治疗中止后6个月），阿夫唑嗪组和安慰剂组的NIH-CPSI所有领域的症状评分与原始基线评分相比均出现恶化，但对照组/标准组未出现恶化（NIH-CPSI评分分别低于基线3. 5、0. 1和5. 6分）。阿夫唑嗪组分别有1例和4例患者出现胃肠道症状和射精量减少。无患者因不良事件退出研究。与安慰剂和标准/传统治疗相比，阿夫唑嗪治疗CP/CPPS 6个月是安全的，耐受性良好，并导致NIH-CPSI适度但具有统计学显著性的改善，特别是在疼痛领域。有益效果仅在治疗几个月后才明显，并在治疗停止时消失。
Objectives. To perform a prospective, placebo-controlled study to examine the long-term efficacy of alfuzosin compared with placebo and standard therapy in patients with chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), because alpha-blockers have been suggested for the treatment of CP/CPPS.Methods. One hundred twenty consecutive men diagnosed with CP/CPPS were prospectively screened and then asked to participate in a prostatitis treatment trial. Patients who agreed to be randomized were subsequently randomized to alfuzosin 5 mg twice daily or placebo and patients who agreed to participate but not be randomized were entered into a control or standard (except alpha-blockers) therapy group. Patients were prospectively treated for 6 months and then followed up for an additional 6 months. The change from baseline in the total and domain scores of the validated Finnish version of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) was the primary outcome parameter for this study.Results. Seventy subjects agreed to participate in the study. The data from 66 patients were available for evaluation (17 in the alfuzosin, 20 in the placebo, and 29 in the control/standard group). At the end of 6 months of active therapy, the alfuzosin group had had a statistically significant decrease in total NIH-CPSI score compared with the placebo and control/standard groups (9.9, 3.8, and 4.3 decrease, respectively, P = 0.0 1). A statistically significant improvement occurred in the pain score in the alfuzosin group at 6 months compared with the placebo and control/standard groups (P = 0.01), but not in the voiding or quality-of-life score among the three groups. Of the patients in the alfuzosin group, 65% had a greater than 33% improvement in the mean NIH-CPSI total score compared with 24% and 32% of the placebo and control/standard groups, respectively (P = 0.02). At 12 months (6 months after the alfuzosin/placebo treatment was discontinued), the symptom scores in all domains of the NIH-CPSI showed deterioration compared with original baseline score in the alfuzosin and placebo groups but not in the control/standard group (NIH-CPSI score 3.5, 0.1, and 5.6 points below baseline, respectively). Gastrointestinal symptoms and a decrease in ejaculate volume were noted by I and 4 patients, respectively, in the alfuzosin group. No patients dropped out of the study because of an adverse event.Conclusions. Six months of alfuzosin therapy for CP/CPPS is safe and well tolerated and results in a modest, but statistically significant, improvement in the NIH-CPSI, particularly in the pain domain, compared with placebo and standard/traditional treatment. The beneficial effect is only apparent after several months of treatment and disappears when treatment is discontinued.