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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。
Objective To evaluate the efficacy and safety of high selective alpha 1 blockers in the treatment of chronic nonbacterial prostatitis (CNP). Methods A total of 156 patients with CNP were screened out through prostate massage solution (EPS) and NIH-CPSI using a randomized, double-blind and controlled clinical trial. The patients were randomly divided into three groups The patients were given with placebo (group Ⅰ), terazosin (group Ⅱ, 1 mg, qd) and sembuturin (group Ⅲ, 0.2 mg, qd) for 12 weeks. All patients were followed up for NIH-CPSI score and ADR evaluation before enrollment, 4th week, 8th week and 12th week of treatment. Results The total score of NIH-CPSI, pain scores, urination scores and quality of life scores of the three groups were 12 weeks, 12 weeks, 14 days, 14 days, 14 days, 0.75,1.67 ± 0.68,1.41 ± 0.48 and 7.02 ± 1.10,2.86 ± 0.69,2.20 ± 0.69, the difference between before and after treatment in group Ⅱ and group Ⅲ was statistically significant (P <0.01), but there was no difference in group Ⅰ The scores of NIH-CPSI, pain, urination and quality of life in group Ⅱ and group Ⅲ and group Ⅰ at the 4th week, the 8th week and the 12th week were significantly different (P <0.01), while the decrease in group Ⅲ was more obvious . The leukocyte counts in EPS before and after treatment in group Ⅱ and group Ⅲ were significantly different (P <0.01), and decreased compared with group Ⅰ (P <0.01). Ⅲ group of drug tolerance than Ⅱ group, no serious adverse events occurred. CONCLUSION JDB can more effectively relieve pain and urination symptoms of patients, improve the quality of life of patients, reduce the WBC in EPS, and have good tolerance.