防风通圣颗粒治疗亚急性湿疹的随机、安慰剂对照研究  

A randomized,placebo controlled study on Fangfeng Tongsheng granule in treatment of sub-acute eczema

作　　者：赵婷[1] 刘瓦利[2] 吴萍[1] 刘永俊 闫雨荷[2] 王静[1] 张弛金 李广瑞[5] 李刚[6] 王福胜[7] 樊敏 

机构地区：[1]中国中医科学院广安门医院国家药物临床试验机构,北京100053 [2]中国中医科学院广安门医院皮肤科,北京100053 [3]山东省烟台天正药业有限公司,山东烟台264003 [4]天津中医药大学第一附属医院,天津300193 [5]中国中医科学院望京医院,北京100102 [6]济南市中医医院,山东济南250012 [7]烟台毓璜顶医院,山东烟台264000 [8]烟台市中医医院,山东烟台264000

出　　处：《中国中药杂志》2015年第7期1415-1418,共4页China Journal of Chinese Materia Medica

基　　金：国家"重大新药创制"科技重大专项(2013ZX09303301)

摘　　要：为进一步评价防风通圣颗粒治疗亚急性湿疹(表寒里热、表里俱实证)的有效性和安全性开展临床试验。将符合纳入标准的108例患者采用按照中心分层、区组随机的方法,按照2∶1分为试验组和安慰剂对照组。试验组服用防风通圣颗粒,3 g/次,2次/日;对照组服用防风通圣颗粒模拟剂,3 g/次,2次/日,疗程14 d。观察2组中医证候疗效、皮肤症状疗效等,并观察在用药过程中的不良事件及不良反应。试验结果显示共入组108例病例,1例因违反方案退出试验。其中试验组71例,对照组36例,107例病例均全部完成临床试验。中医证候疗效:用药2周后试验组愈显率33.81%(24/71),对照组愈显率0%(0/36),试验组优于对照组,2组比较差异有统计学意义。中医证候积分:用药2周后试验组下降(12.82±7.96),对照组下降(3.67±4.12),试验组下降幅度大于对照组,2组比较差异有统计学意义。皮肤症状疗效:用药2周后试验组愈显率25.35%(18/71),对照组愈显率0%(0/36),试验组优于对照组,2组比较差异有统计学意义。皮肤症状积分:用药2周后试验组下降(10.04±7.17),对照组下降(2.33±3.57),试验组下降幅度大于对照组,2组比较差异有统计学意义。试验过程中无明显与药物有关的不良事件。说明防风通圣颗粒治疗亚急性湿疹(表寒里热、表里俱实证)安全、有效。The clinical study was conducted to further evaluation the effectiveness and safety of Fangfeng Tongsheng granule in the treatment of sub-acute eczema （superficial cold and interior heat syndrome, exterior and interior sthenic syndrome）. In the block randomized, multi-centered study, totally 108 patients were enrolled and assigned to two groups：72 patients in the test group and 36 patients in the placebo control group. Those in the test group took Fangfeng Tongsheng granule with the dose of 3 g, twice a day, while those in the control group were give simulated agent granules with the same dose. The therapeutic course lasted for 14 days. Their efficacies in TCM syndrome, dermal symptoms and adverse events were observed. According to the test results, except for the one exit case, all of the remaining 108 cases, including 71 in the test group, and 36 in the control group, completed the clinical trial. As for the efficacy of TCM syndrome, after the medication for 2 weeks, the cure rate was 33.81% （24/71） in the test group and 0% （0/36） in the control group （P〈0.01）, with a statistical difference between the two groups. Regarding the TCM score, after the medication for 2 weeks, the test group decreased by （12.82±7.96）, while the control group decreased by （3.67±4.12）, indicating a statistical difference between the two groups. As for the efficacy of dermal symptoms, after the medication for 2 weeks, the cure rate was 25.35% （18/71） in the test group and 0% （0/36） in the control group, with a statistical difference between the two groups. Regarding the dermal symptom score, after the medication for 2 weeks, the test group decreased by （10.04±7.17）, while the control group decreased by （2.33±3.57）, indicating a statistical difference between the two groups. There was no significant adverse event caused by Fangfeng Tongsheng granule. In conclusion, Fangfeng Tongsheng granule was effective and safe in treating sub-acute eczema （superficial cold and interior heat syndrome,

关 键 词：防风通圣颗粒 亚急性湿疹 随机 安慰剂对照 

分 类 号：R275.9[医药卫生—中西医结合]