前列安栓治疗慢性前列腺炎临床研究

Clinical Study of Prostant in Treating Chronic Prostatitis

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,治疗组总有效率为74.14%,对照组总有效率为40.0%,治疗组优于对照组(P=0.006)。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<0.05,P<0.01)。2组治疗前后EPS中WBC计数比较虽有统计学意义(P<0.01),但其下降值差异却无统计学意义(P=0.121)。2组对药物的耐受性差异无统计学意义(P=0.269),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。

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 kindney, electrocardiograph examination and the side effects. Results After 4-week treatment, the total effective rate was 74.14% in the trial group and 40.0% in the control group, the efficacy of Prostant was superior to that of wild chrysanthemum suppository （P =0.006）. There was significant difference in clinical symptoms and NIH-CPSI between pre-treatment and post-treatment in the trial group and the control group （P〈0.05, P〈0.01）. Though there was remarkable difference between pre-treatment and post-treatment in WBC count in the EPS （P〈 0.01）, no difference in decrease value of two groups （P =0.121）. The tolerance to Prostant and wild chrysanthemum suppository showed no significant difference （P =0.269）, and no serious side effects were recorded. Conclusion Prostant is effective and safe in treating chronic prostatitis and has good compliance.