舍尼通治疗慢性非细菌性前列腺炎的有效性和安全性

【目的】评价舍尼通（prostat）治疗慢性非细菌性前列腺炎（CNP）的有效性和安全性。【方法】采用随机双盲安慰剂对照临床试验，对80例慢性非细菌性前列腺炎患者进行为期8周的观察：舍尼通组（40例），舍尼通加左氧氟沙星口服共4周，再继续单独口服舍尼通4周；安慰剂组（40倒），安慰剂加左氧氟沙星口服共4周，再继续单独口服安慰剂4周。【结果】治疗前，两组患者的国际慢性前列腺炎评分（NIH—CPSI）总分及症状程度评分均无统计学意义上的差异。治疗4周、8周后舍尼通组NIH—CPSI总分分别较治疗前平均降低了4．77分（21．96％）和9．08分（41．80％），症状程度评分分别较治疗前平均降低了3．32分（25．48％）和5．88分（45．13％），而安慰剂组NIH—CPSI总分分别较治疗前平均降低了1．05分（5．20％）和1．52分（7．53％），症状程度评分分别较治疗前平均降低了0．95分（7．98％）和1．27分（10．67％），治疗4周、8周后舍尼通组NIH-CPSI总分及症状程度评分的下降幅度均较安慰剂组更明显（分别为P〈0．05，P〈0．01）。治疗8周后总有效率舍尼通组为85％（34／40），安慰剂组为17．5％（7／40），两组总有效率差异有统计学意义（P〈0．01）。全组患者在观察过程中未出现任何与药物有关的不良反应。【结论】舍尼通是治疗慢性非细菌性前列腺炎的有效药物，疗效较高，安全性好。

The Efficacy and Safety of Prostat in the Treatment of Chronic Nonbacterial Prostatitis: A Randomized, Double-blind, Placebo-controlled Clinical Trial

[Objective]To evaluate the efficacy and safety of prostat in the treatment of chronic nonbacterial prostatitis(CNP).[Methods]A randomized, double-blind, placebo-controlled clinical trial was conducted between September 2005 and December 2005.A total of 80 CNP patients enrolled in the trial were divided into two groups. The trial group was treated with prostat and levofloxacin for 4 weeks. In the following 4 weeks each patient took only prostat. The control group was given placebo in the same way. The efficacy was evaluated by the National Institutes of Health chronic prostatitis symptom index (NIH-CPSI) after treatment. [Results]The NIH-CPSI overall scores and symptom rating scores of pre-treatment were not different significantly between the trial group and the control group. After 4- and 8- week therapy, the NIH-CPSI overall scores were averagely reduced by 4.77 points (21.96%), 9.08(41.08%) respectively in the trial group and 1.05(5.20%), 1.27(7.53%) respectively in the control group, and the symptom rating scores were averagely reduced by 3.32(25.48%), 5.88(45.13%) respectively in the trial group and 0.95(7.98%), 1.27(10.67%) respectively in the control group, compared with pre-treatment. Significant differences of reduction were found between the two groups after 4-, and 8- week therapy (P<0.05, P<0.01 respectively). The total effective rate was 82.5% in the trial group and 17.5% in the control group after 8- week therapy(P<0.01). No adverse reaction associated with medication was observed.[Conclusion]Prostat is effective and safe for the treatment of chronic nonbacterial prostatitis.