宁泌泰胶囊治疗Ⅲ型前列腺炎随机双盲安慰剂对照临床研究

Efficacy and safety of Ningmitai Capsule in treatment towards type Ⅲ prostatitis: A randomized, double-blind, placebo-control clinical trial

目的评价宁泌泰胶囊治疗Ⅲ型前列腺炎的有效性和安全性。方法采用随机、双盲以及安慰剂作为对照进行临床试验设计。试验共50例Ⅲ型前列腺炎患者入选,治疗组25例患者口服宁泌泰胶囊,每次4粒,每日3次,4周为1个疗程。对照组25例患者口服安慰剂胶囊,用法用量与治疗组完全一致。治疗有效性以美国国立卫生院前列腺炎症状评分(NIH-CPSI)为主要疗效评价指标;以治疗前后患者尿常规及肝肾功能指标评估其安全性;并记录不良事件。结果治疗组NIH-CPSI总分治疗前为23.96±1.30,经4周治疗后下降为16.04±1.66(P<0.001)。安慰剂组与其不同,同治疗前相比,所有评分在4周治疗后无统计学差异(P>0.05)。治疗组疼痛评分、排尿评分、生活质量评分均显著性降低(P<0.05)。参与本研究完成治疗的全部患者未见明显不良反应发生。结论宁泌泰胶囊治疗Ⅲ型前列腺炎安全有效。

Objective To evaluate the efficacy and safety of Ningmitai Capsule in the treatment towards type Ⅲ prostatitis.Methods A randomized, double-blind, placebo-control clinical trial was conducted. A total of 50 patients diagnosed as type Ⅲ prostatitis were divided into two groups with the ratio of 1∶1. Patients of the trial group were treated with Ningmitai Capsule at the dose of four grain tid for 4 weeks, and patients of the control group were given placebo in the same way. The efficacy was evaluated by the NIH chronic prostatitis symptom index(NIH-CPSI) while safety-evaluation was evaluated by adverse events, results of urine routine examinations and hepatorenal-function tests. Results After 4-week treatment, NIH-CPSI total scores were 23.96 ± 1.30 before treatment, and reduced to 16.04 ± 1.66(P < 0.001). To the contrary, for all these scores, no significant statistical differences exist in placebo-control group. Pain-symptom scores, micturition-symptom scores and QOL scores were all statistically reduced in the trial group. No significant adverse events occurred in all patients who completed the study. Conclusion Ningmitai Capsule is effective and safe in the treatment of type Ⅲ prostatitis.