高选择性α_1受体阻滞剂治疗慢性非细菌前列腺炎的随机对照临床试验

Tamsulosin therapy for chronic nonbacterial prostatitis:a randomized double-blind placebo controlled clinical trial

目的评价高选择性α_1受体阻滞剂治疗慢性非细菌性前列腺炎(CNP)的有效性及安全性。方法采用随机、双盲、对照临床试验方法,通过前列腺按摩液(EPS)及美国国立卫生院慢性前列腺炎症状评分(NIH-CPSI),筛选出156例CNP患者,随机均分为三组,分别给与安慰剂(Ⅰ组)、特拉唑嗪(Ⅱ组,1mg,qd)和积大本特(盐酸坦洛新缓释片)(Ⅲ组,0.2mg,qd),连服12周。所有患者均有入组前、治疗第4周、第8周和第12周随访并行NIH-CPSI评分及药物不良反应的评估。结果治疗12周,三组NIH-CPSI总分、疼痛评分、排尿评分和生活质量评分分别为24.14±3.31、11.10±1.62、9.24±1.90,12.10±1.97、6.57±1.15、5.67±1.44,5.04±0.75、1.67±0.68、1.41±0.48和7.02±1.10、2.86±0.69、2.20±0.69,Ⅱ组和Ⅲ组治疗前后对比差异具统计学意义(P<0.01),而Ⅰ组无差异;组间比较,Ⅱ组和Ⅲ组与Ⅰ组第4周、第8周和第12周NIH-CPSI总分、疼痛、排尿和生活质量评分差异均有统计学意义(P<0.01),Ⅲ组下降更明显。Ⅱ组和Ⅲ组治疗前后EPS中白细胞计数差异有统计学意义(P<0.01),与Ⅰ组相比减少,差异也具统计学意义(P<0.01)。Ⅲ组对药物的耐受性较Ⅱ组好,无严重不良反应事件发生。结论积大本特能更有效地缓解患者的疼痛不适症状和排尿症状,改善患者的生活质量,减少EPS中WBC,耐受性好。

Abstract Objective To evaluate the efficacy and safety of tamsulosin in the treatment of chronic nonbacterial prostatitis （CNP）. Methods A prospective randomized, double-blind, contrasted method was applied in the study. By the expressed prostate secretion （EPS） examination and the national institute health-chronic prostatits symptom index （NIH-CPSI） evaluation, 156 patients with CNP were recruited and randomly divided into Group I treated with placebo, group Ⅲ treated with terazosin and group III treated with tamsulosin. After 12 weeks treatment, the patients were followed-up and evaluated by NIH-CPSI, EPS, and side effects. Results After 12-week treatment, NIH-CPSI total scores, pain index, voiding index and quality of life index of patients in three groups were 24.14±3.31, 11.10±1.62, 9.24±1.90, 12.10±1.97, 6.57±1.15, 5.67±1.44, 5.04±0.75, 1.67±0.68, 1.41±0.48 and 7.02±1.10, 2.86±0.69, 2.20±0.69 respectively. Compared with that in groupI, NIH-CPSI total scores, pain index, voiding index and quality of life index was decresed significantly in group II and group III. There were significant differences in WBC counting in EPS between pre-treatment and post-treatment in both group II and group III （P〈0.01）, The number of WBC numberin EPS was significantly lower in both group II and group III than that in group I . No serious side effects were found for all patientss. Patients treated with terazosin, tamsulosin showed better tolerance. Conclusion Tamsulosin can effectively relieve the pain and voiding symptoms, improve the life quality and reduce WBC number in the EPS of patients with chronic nonbacterial prostatitis, and was worth to be recommended in clinic.