Cheah Phaik Yeong, Liong Men Long, Yuen Kah Hay, Teh Chu Leong, Khor Timothy, Yang Jin Rong, Yap Hin Wai, Krieger John N
University of Science Malaysia School of Pharmaceutical Sciences, Penang, Malaysia.
Urology. 2004 Nov;64(5):881-6. doi: 10.1016/j.urology.2004.06.041.
To evaluate the initial, long-term, and durable response rates to terazosin, placebo, or other therapies in patients with chronic prostatitis/chronic pelvic pain syndrome.
A total of 100 subjects, aged 20 to 50 years, who met the National Institutes of Health criteria for chronic prostatitis/chronic pelvic pain syndrome and had not previously been treated with alpha-blockers, were entered in a 14-week, double-blind comparison of terazosin or placebo therapy. Nonresponders and responders with subsequent relapse were treated with terazosin or other medications (open label). The criterion for response was a score of 0 to 2 on the National Institutes of Health Chronic Prostatitis Symptom Index quality-of-life item. The initial response was evaluated at week 14, and the long-term response was evaluated after a median of 38 weeks (range 34 to 42), regardless of any additional treatment. A durable response was defined as an initial response without additional treatment.
Of the 43 patients in the terazosin group, 24 (56%) had an initial response compared with 14 (33%) of 43 subjects in the placebo group (P = 0.03). Long-term responses were noted in 23 (56%) of 41 assessable subjects treated with terazosin initially compared with 12 (32%) of 38 assessable subjects treated with placebo (P = 0.03). Of the nonresponders and initial responders with relapse, 7 (41%) of 17 subjects responded to terazosin compared with 7 (21%) of 34 given other treatment (P = 0.12). Durable responses occurred in 18 (44%) of the 41 assessable patients treated initially with terazosin and in 6 (16%) of 38 treated initially with placebo (P = 0.01).
Patients treated with terazosin were more likely to have initial, long-term, and durable responses than those treated with placebo.
评估慢性前列腺炎/慢性盆腔疼痛综合征患者对特拉唑嗪、安慰剂或其他疗法的初始、长期和持久缓解率。
共有100名年龄在20至50岁之间、符合美国国立卫生研究院慢性前列腺炎/慢性盆腔疼痛综合征标准且此前未接受过α受体阻滞剂治疗的受试者，进入为期14周的特拉唑嗪或安慰剂治疗双盲对比试验。无反应者及后续复发的反应者接受特拉唑嗪或其他药物治疗（开放标签）。反应标准为美国国立卫生研究院慢性前列腺炎症状指数生活质量项目评分为0至2分。在第14周评估初始反应，无论是否接受额外治疗，在中位时间38周（范围34至42周）后评估长期反应。持久反应定义为无需额外治疗的初始反应。
特拉唑嗪组的43名患者中，24名（56%）有初始反应，而安慰剂组的43名受试者中有14名（33%）有初始反应（P = 0.03）。最初接受特拉唑嗪治疗的41名可评估受试者中有23名（56%）有长期反应，相比之下，接受安慰剂治疗的38名可评估受试者中有12名（32%）有长期反应（P = 0.03）。在无反应者及复发的初始反应者中，17名受试者中有7名（41%）对特拉唑嗪有反应，而接受其他治疗的34名受试者中有7名（21%）有反应（P = 0.12）。最初接受特拉唑嗪治疗的41名可评估患者中有18名（44%）出现持久反应，最初接受安慰剂治疗的38名患者中有6名（16%）出现持久反应（P = 0.01）。
与接受安慰剂治疗的患者相比，接受特拉唑嗪治疗的患者更有可能出现初始、长期和持久反应。
