癃清片治疗慢性前列腺炎多中心双盲安慰剂对照试验研究

The efficacy and safety of Longqing tablet in the treatment of chronic prostatitis:a multi-center,randomized,double-blind,placebo-controlled clinical trial

目的评价癃清片治疗慢性前列腺炎的有效性和安全性。方法多中心、随机、双盲、安慰剂对照临床设计。480例湿热兼瘀血型慢性前列腺炎患者按3:1的比例随机分为治疗组、安慰剂对照组。治疗组360例,口服癃清片,一次6片,每日2次。安慰剂对照组1 20例,服用安慰剂,一次6片,每日2次,疗程为4周。以美国国立卫生院前列腺炎症状评分(NIH-CPSI)、慢性前列腺炎中医证候评分作为主要疗效评价指标。结果 (1)治疗4周后,治疗组和对照组CPSI评分分别为(11.9±5.04)和(17.66±4.92),(P<0.05)。治疗组和对照组治疗前后CPSI评分差值分别为(10.44±5.91)和(4.1 8±3.50),治疗组降幅大于对照组(P<0.05)。治疗组在降低NIH-CPSI评分疗效优于对照组。(2)治疗4周后,治疗组和对照组中医证候评分分别为(9.87±3.95)和(1 4.43±4.14),治疗组低于对照组(P<0.05);治疗组和对照组治疗前后差值分别为(9.1 7±4.82)和(4.64±4.3 6),治疗组降幅大于对照组(P<0.05)。(3)治疗组总有效率为82.4%,对照组为40.6%,总有效率治疗组优于对照组(P<0.05)。(4)两组间不良事件发生率比较无差异(P>0.05)。结论癃清片治疗慢性前列腺炎安全、有效,值得在临床推广。

Objective To evaluate the efficacy and safety of Longqing tablet in the treatment of chronic prostatitis. Methods A multi-central, randomized double-blind, placebo-controlled clinical trial was conducted. A total of 480 patients diagnosed as chronic prostatitis with the type of damp-heat ＆ blood stasis were divided randomly into 2 groups based on the ratio of 3：1 including the trial group treated with Longqing tablet for 4 weeks（6 pills ,twice a day）and the control group with placebo in the same way. The efficacy was evaluated by the syndrome index of Chinese medicine for prostatitis（SI-CM）, the NIH chronic prostatitis symptom index（NIH-CPSI）. Results （1）After treatment, NIH-CPSI score was （11.9±5.04） in the trial group and （17.66±4.92） in the control group, NIH-CPSI score decreased significantly in the trial group （P〈0.05）. （2）After treatment, SI-CM score was （9.87±3.95） in the trial group and （14.43±4.14） in the control group, SI-CM score decreased significantly （P〈0.05）. （3） The total effective rates were 82.4% in trial group and 40.6% in control group, The total effective rates of the trial group was better than that of the control group（P〈0.05）. （4） Compared with the incidence of adverse events, there was no obvious difference between the two groups. Conclusion Longqing tablet is effective and safe for the treatment of chronic prostatitis.