银花泌炎灵片治疗Ⅲ型前列腺炎湿热下注证随机、双盲、安慰剂平行对照、多中心临床试验  

Efficacy and Safety of Yinhua Miyanling Tablets(银花泌炎灵片)for TypeⅢChronic Prostatitis with Damp-Heat Pouring Downward Syndrome:A Randomized,Double-Blinded,Placebo,Parallel-Controlled Multi-center Trial

作　　者：宁克勤[1] 陈磊 欧阳斌[3] 王旭光 韩万峰[5] 王丹[6] NING Keqin;CHEN Lei;OUYANG Bing;WANG Xuguang;HAN Wanfeng;WANG Dan(Jiangsu Province Hospital of TCM,Nanjing 210029,Jiangsu,China;The Second Affiliated Hospital of Tianjin University of TCM,Tianjin 300250,China;The First Affiliated Hospital of Tianjin University of TCM,Tianjin 300193,China;Longhua Hospital of Shanghai,Shanghai 200032,China;The Affiliated Hospital of Changchun University of TCM,Changchun 130000,Jilin,China;The Second Affiliated Hospital of Helongjiang University of TCM,Harbing 130000,Helongjiang,China)

机构地区：[1]江苏省中医院,江苏南京210029 [2]天津中医药大学第二附属医院,天津300250 [3]天津中医药大学第一附属医院,天津300193 [4]上海龙华医院,上海200032 [5]长春中医药大学附属医院,吉林长春130000 [6]黑龙江中医药大学附属第二医院,黑龙江哈尔滨130000

出　　处：《中华中医药学刊》2021年第10期187-190,共4页Chinese Archives of Traditional Chinese Medicine

基　　金：吉林省科技成果转化计划重大科技成果转化项目(原“双十工程”重大科技成果转化项目)(20170301001YY)。

摘　　要：目的评价银花泌炎灵片治疗Ⅲ型前列腺炎(CPPS)湿热下注证的有效性和安全性。方法采用随机、对照、安慰剂平行对照的试验设计,在6个平行中心进行观察。将216例患者随机分为低剂量组、高剂量组和安慰剂组,低剂量组口服银花泌炎灵片和银花泌炎灵片模拟片,各2片/次,3次/d;高剂量组口服银花泌炎灵片,4片/次,3次/d;安慰剂组口服银花泌炎灵片模拟片,4片/次,3次/d。疗程8周。比较临床疗效、前列腺质地及压痛评分和安全性。结果银花泌炎灵片低高剂量组CPPS临床疗效优于安慰剂组,且高剂量组优于低剂量组(P<0.05);银花泌炎灵片低高剂量组中医证侯疗效均优于安慰剂组(P<0.05)。前列腺质地评分及差值低高剂量组相当,均高于安慰剂组(P<0.05);低高剂量组前列腺压痛评分相当(P>0.05),评分差值高剂量组优于低剂量组,均优于安慰剂组(P<0.05)。PPS分析与FAS检验结果一致。3组不良反应发生率无统计学意义(P>0.05)。结论银花泌炎灵片治疗CPPS湿热下注证安全有效。e Objective To observe the clinical effects and safety of Yinhua Miyanling Tablets(银花泌炎灵片)for typeⅢchro-nic prostatitis with damp-heat pouring downward syndrome.s Methods A randomized,controlled,placebo-controlled trial was conducted in 6 parallel centers.A total of 216 patients were randomly divided into low-dose group,high-dose group and pla-cebo group.The low-dose group was given Yinhua Miyanling Tablets,2 tablets/time,3 times/d.The high dose group was giv-en Yinhua Miyanling Tablets,4 tablets/time,3 times/d.The placebo group was treated with simulation tablet of Yinhua Miyan-ling Tablets,4 tablets/time,3 times/d.The course of treatment was 8 weeks.The clinical efficacy,prostate texture,tenderness score and safety were compared.s Results The CPPS efficacy of low and high dose groups of Yinhua Miyanling Tablets,respective-ly.Both were higher than that of the placebo group,and high dose group’s efficacy was higher than that of the low dose group(P<0.05).The low and high dose groups had the similar effects of TCM syndrome efficacy.Both were higher than that of the placebo group(P<0.05).The prostate texture score and difference in the low-dose and high-dose groups were similar,which were higher than those in the placebo group(P<0.05).The prostate tenderness score of the low-dose and high-dose groups was the same(P>0.05),and the score difference of the high-dose group was better than that of the low-dose group,which was better than that of the placebo group(P<0.05).PPS analysis was consistent with FAS test.There was no significant differ-ence in the incidence of adverse events among the three groups(P>0.05).n Conclusion Yinhua Miyanling Tablets are safe and effective on CPPS with damp-heat pouring downward syndrome.

关 键 词：银花泌炎灵片 前列腺炎 湿热下注证 有效性 安全性 临床试验 

分 类 号：R269.973.3[医药卫生—中西医结合]