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目的评价丹益片治疗慢性前列腺炎(瘀血阻滞湿热下注证)的有效性和安全性。方法采用随机、双盲双模拟、多中心、阳性药平行对照研究。试验组(丹益片)用丹益片和前列泰颗粒模拟剂,阳性对照组用前列泰颗粒和丹益片模拟剂,疗程为4周。疗效评价指标采用全数据集(FAS)分析和符合方案数据集(PPS)分析;安全指标采用安全集(SS)分析。结果本临床研究实际入组情况:试验组FAS分析341例,PPS集324例,SS分析341例;对照组FAS分析114例,PPS分析109例,SS分析114例。两组基线资料均衡,具有可比性。FAS分析结果显示:经4周治疗后,FAS集分析结果显示:主要疗效指标:试验组(丹益片)NIH-CPSI总积分改善值为11.74±6.59,对照药(前列泰颗粒)为10.09±5.93,非劣效性检验结果显示扣除基线和中心效应,试验组的NIH-CPSI总积分疗效与阳性对照组相比具有非劣效性。中度病情、病程>1年者试验组(丹益片)NIH-CPSI总积分改善值均优于对照组(前列泰颗粒)且有统计学意义(P≤0.05)。次要疗效指标:试验组(丹益片)中医证候综合疗效的临床控制率为10.0%,总显效率为50.5%,总有效率为85.4%;对照组(前列泰颗粒)则为5.3%,35.1%和79%;扣除中心效应,试验组总显效率优于对照组且有统计学意义(P<0.05)。试验组(丹益片)NIH-CPSI疼痛不适总积分、排尿症状总积分改善值均优于阳性对照组(前列泰颗粒)且有统计学意义,(P均<0.05)。前列腺压痛、质地评分的症状消失率试验组(丹益片)均优于对照组(前列泰颗粒)且有统计学意义(P<0.01)。PPS集分析结果与FAS集基本一致。不良事件发生率及不良反应发生率两组间差异均无统计学意义(P>0.05)。结论丹益片治疗慢性前列腺炎瘀血阻滞湿热下注证与阳性对照药前列泰颗粒相比具有非劣效性,疗效确切,用药安全。
Objective To evaluate the effectiveness and safety of Dan Yi Pian in the treatment of chronic prostatitis. Methods Randomized, double-blind double-dummy, multicenter, positive drug parallel control study. The experimental group (Dan Yi tablets) with Dan Yi tablet and the forefront of the particle simulant, the positive control group with the formerly Thai particles and Dan Yi tablets mimic agent, treatment for 4 weeks. Efficacy indicators using full data set (FAS) analysis and compliance program data set (PPS) analysis; safety indicators using safety set (SS) analysis. Results The actual enrollment of the clinical study: 341 cases of experimental group FAS analysis, 324 cases of PPS set, SS 341 cases; control group 114 cases of FAS analysis, PPS analysis of 109 cases, 114 cases of SS analysis. Two sets of baseline data is balanced, comparable. FAS analysis showed that after 4 weeks of treatment, FAS set analysis showed that: The main efficacy indicators: the experimental group (Dan Yi tablets) NIH-CPSI total score improvement was 11.74 ± 6.59, the control drug (the front column particles) 10.09 ± 5.93. The results of non-inferiority test showed that the NIH-CPSI total score of the experimental group had noninferiority compared with the positive control group after deducting the baseline and central effects. The average score of NIH-CPSI in experimental group (Dan Yi tablet) with moderate disease and disease duration> 1 year was better than that of the control group (Qianlie Tai) and had statistical significance (P≤0.05). Secondary efficacy indicators: The clinical control rate of TCM syndrome comprehensive efficacy of trial group (Dan Yi tablets) was 10.0%, the total effective rate was 50.5%, the total effective rate was 85.4%; while the control group (formerly Thai particles) was 5.3% , 35.1% and 79%, respectively. After deducting the central effect, the total effective rate in the experimental group was significantly higher than that in the control group (P <0.05). The experimental group (Dan Yi tablets) NIH-CPSI pain discomfort total score, voiding symptom scores were better than the positive control group (positive and negative particles) and statistically significant (P all <0.05). Prostate tenderness, texture score of the rate of disappearance of the test group (Dan Yi tablets) were superior to the control group (Qianlie Tai particles) and have statistical significance (P <0.01). PPS set analysis results and FAS set basically the same. The incidence of adverse events and the incidence of adverse reactions between the two groups showed no significant difference (P> 0.05). Conclusion Dan Yi tablets treatment of chronic prostatitis stasis block damp-heat injection card positive control drug compared with the front-column particles with non-inferiority, the exact effect, medication safety.