前列安栓治疗慢性前列腺炎临床研究.doc

前列安栓治疗慢性前列腺炎临床研究
【摘要】目的评价前列安栓治疗慢性前列腺炎(CP)的有效性及安全性。方法采用随机、双盲、阳性药对照临床研究方法,通过临床症状、体征、前列腺按摩液(EPS)检查,筛选出80例CP患者,随机分为试验组(60例)和对照组(20例)。试验组应用前列安栓,对照组用野菊花栓,观察2组患者临床症状、体征、前列腺按摩液(EPS)检查结果、美国国立卫生研究院慢性前列腺炎症状指数评分(NIH-CPSI)等疗效指标,及血、尿、大便常规和心电图、肝、肾功能、药物不良反应等安全性指标。结果治疗4周后,%,%,治疗组优于对照组(P=)。治疗组和对照组临床症状评分、NIH-CPSI评分比较,差异均有统计学意义(P<,P<)。2组治疗前后EPS中WBC计数比较虽有统计学意义(P<),但其下降值差异却无统计学意义(P=)。2组对药物的耐受性差异无统计学意义(P=),无严重不良反应事件发生。结论前列安栓治疗CP有效、安全,患者依从性较好。
【关键词】慢性前列腺炎;前列安栓;野菊花栓
Abstract:Objective To evaluate the efficacy and safety of Prostant in the treatment of chronic prostatitis. Methods A randomized, double-blind, positive drug-controlled clinical trial method was applied in the study. Through clinical symptoms, signs and expressed prostate secretion (EPS) examination, 80 patients with prostatitis were recruited and randomized into a trial group (60 cases) and a control group (20 cases). The trial group was treated with Prostant, and the control group was treated with wild chrysanthemum suppository. After screening, treatment and follow-up, in the trial group and the control group, the observation on clinical efficacy and safety were evaluated, such as the clinical symptoms, signs, EPS examination, the national institute health-chronic prostatits symptom index (NIH-CPSI) and the blood routine, urine routine, stool routine, the function of liver and kin