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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 effectiveness and safety of Qinglian Tablet in the treatment of chronic prostatitis. Methods Multi-center, randomized, double-blind, placebo-controlled clinical design. 480 patients with damp-heat and stasis-type chronic prostatitis were randomly divided into treatment group and placebo control group according to the ratio of 3: 1. The treatment group of 360 cases, orally Qing tablets, a 6, 2 times a day. Placebo control group of 120 cases, taking placebo, a 6, 2 times a day, treatment for 4 weeks. The National Institutes of Health prostatitis symptom score (NIH-CPSI), chronic prostatitis TCM syndrome score as the main efficacy evaluation index. Results (1) After 4 weeks of treatment, the CPSI scores of the treatment group and the control group were (11.9 ± 5.04) and (17.66 ± 4.92), respectively (P <0.05). The differences of CPSI score before and after treatment in the treatment group and control group were (10.44 ± 5.91) and (4.1 8 ± 3.50), respectively. The treatment group decreased more significantly than the control group (P <0.05). The treatment group was better than the control group in reducing the NIH-CPSI score. (2) After 4 weeks of treatment, the scores of TCM syndromes in the treatment group and the control group were (9.87 ± 3.95) and (4.43 ± 4.14) respectively, lower in the treatment group than in the control group (P <0.05); The treatment group and the control group Before and after the difference was (9.17 ± 4.82) and (4.64 ± 4.36), the treatment group decreased more than the control group (P <0.05). (3) The total effective rate was 82.4% in the treatment group and 40.6% in the control group, and the total effective rate in the treatment group was better than that in the control group (P <0.05). (4) There was no difference in the incidence of adverse events between the two groups (P> 0.05). Conclusion 癃 clear tablets for the treatment of chronic prostatitis safe and effective, it is worth in the clinical promotion.