前列安栓治疗慢性前列腺炎:多中心双盲随机安慰剂对照试验

The efficacy and safety of Prostant^(TM) in the treatment of chronic prostatitis:a multi center, randomized, double blinded, placebo controlled trial

目的 评估前列安栓治疗慢性前列腺炎各种疼痛和不适感等症状的有效性、安全性和依从性。 方法 安慰剂对照随机双盲试验。 72例慢性前列腺炎患者随机分为两组。治疗组 36例 ,每晚前列安栓 1粒纳肛 ,连续 1个月 ;对照组 36例 ,安慰剂治疗 1个月。根据前列腺按摩液 (EPS)和美国国立卫生院 (NIH)前列腺炎症状评分评估疗效。 结果 治疗组痊愈 1例 (2 .8% ) ,显效 7例(2 0 .0 % ) ,有效 16例 (45 .7% ) ,总显效率 2 2 .8% ,总有效率 6 8.6 %。对照组无痊愈病例 ,显效 2例(5 .7% ) ,有效 8例 (2 2 .8% ) ,总显效率 5 .7% ,总有效率 2 8.6 %。两组各有 1例在治疗 2周内退出试验。两组相比 ,总有效率和总显效率差别均有显著性意义 (P <0 .0 5 ) ;不良反应发生率差别无显著性意义 (P >0 .0 5 )。 结论 前列安栓治疗慢性前列腺炎安全、有效 。

Objective To evaluate the efficacy and safety of Prostant TM in the treatment of chronic prostatitis. Methods A multi center, randomized, double blinded, placebo controlled trial was carried out during March 2001 and May 2001. 72 cases of patients who had been diagnosed as chronic prostatitis were separated into tow groups: 36 cases in the trial group treated with Prostant TM and the other 36 cases in the controlled group using placebo. The efficacy was evaluated by the WBC in EPS and NIH Chronic Prostatitis Symptom Index after a one month follow up. The efficacy of the therapy was divided into four levels:cure,the symptom index score being reduced over 90%, and the number of WBC in the EPS less than 10/HP; effective, the symptom index score being reduced 60%～89% and the number of WBC in the EPS lowered over 50% or less than 15/HP;improved,the symptom index score being reduced 30%～59% and the number of WBC in the EPS lowered over 25%; no effect, the symptom index score being reduced less than 30% or the number of WBC in the EPS lowered no more than 25%. Results All but two cases had completed the follow up.One case (2.8%) was completely cured,remarkable effective in 7 cases (20.0%) of the trial group;and improred in 16 cases (45.7%).Only 2 cases (5.7%)seemed effective and 8 cases (22.8%) improved in the controlled group. The efficacy showed significant difference between these two groups ( P <0.05). Conclusions Prostant TM is effective and safe for treating chronic prostatitis.