除湿丸治疗湿重于热型亚急性湿疹的疗效和安全性评价  

Efficacy and safety of Chusi,.pellets in patients with subacute eczema of more dampness less heat type

作　　者：曹洋[1] 蔡念宁[1] 张广中[1] 张苍[1] 

机构地区：[1]首都医科大学附属北京中医医院皮肤科,100010

出　　处：《中华皮肤科杂志》2012年第12期897-899,共3页Chinese Journal of Dermatology

基　　金：北京市“十一五”中医药51510科技工程重大项目：（NO.JJX-2006-63）

摘　　要：目的评价除湿丸治疗湿重于热型亚急性湿疹的疗效及安全性。方法2010年5月至2011年10月在首都医科大学附属北京中医医院皮肤科门诊选取亚急性湿疹患者129例，采用随机、双盲、双模拟、阳性平行对照临床研究，治疗组（66例）口服除湿丸及胶囊安慰剂，对照组（63例）口服湿毒清胶囊及水丸安慰剂，疗程4周，于治疗前及治疗后第4周各随访1次，以皮疹面积、颜色、形态、瘙痒程度及实验室检查结果为观察指标，对疗效和安全性进行评价。疗前疗后积分比较采用t检验或Wilcoxon秩和检验。两组间各项及总体疗效比较采用Peamonr检验或Fisher精确概率法。结果共123例亚急性湿疹患者纳入疗效分析，治疗结束时，治疗组和对照组总有效率分别为69．3％（43／62）和59．0％（36／61），两组差异无统计学意义（r=1．43，P〉0．05）。瘙痒程度评分比较，治疗组优于对照组（r=4．05，P〈0．05）。相关不良反应发生率治疗组为13．6％（9／66），对照组为11．1％（7／63），主要表现为大便溏稀、胃脘部不适。治疗后两组实验室指标未见明显变化。结论除湿丸治疗湿重于热型亚急性湿疹安全有效，总体疗效与湿毒清胶囊相当，在改善患者瘙痒程度上效果更佳。Objective To evaluate the clinical efficacy and safety of Chushi pellets in patients with subacute eczema of more dampness less heat type. Methods A randomized,double blind, double-dummy and positive parallel-controlled study was performed. Totally, 129 patients with subacute eczema were collected at the dermatology clinic in Beijing Hospital of Traditional Chinese Medicine from May 2010 to October 2011, and classified into two groups to he treated with Chushi pellets and placebo capsules （n = 66, experiment group） or Shiduqing capsules and placebo watered pills （n = 63, control group） for 4 weeks. Follow-up visits were scheduled on day 1 （baseline）, and 4 weeks after the beginning of treatment. Clinical endpoints included skin rash area, color, morphology, degree of pruritus and laboratory examination results. The therapeutic effect and safety of Chushi pellets were evaluated. The differences in clinical parameters were assessed by using t test and Wilcoxon rank-sum test between pre- and post-treatment, and by Pearson chi-square test or Fisher＇s exact test between the experiment and control group. Results Finally, the treatment outcome of 123 patients were assessed for the efficacy of Chushi pellets. At the end of the treatment, the total response rate was 69.3% （43/62） in the experiment group, and 59.0% （36/61） in the control group （X2 = 1.43, P 〉 0.05）. The improvement in pruritus was greater in the experiment group than in the control group （x2 = 4.05, P 〈 0.05）. Side effects mainly included loose stool and stomach upset, with an incidence of 13.6% （9/66） in the experiment group, and 11.1% （7/63） in the control group. No marked changes were observed in laboratry parameters after treatment in either of the groups. Conclusions Chushi pellets are safe and effective for the treatment of subacute eczema of more dampness less heat type. Compared with Shiduqing capsules, Chushi pellets shows an equivalent overall efficacy but a stronger antipruritic effect.

关 键 词：亚急性湿疹 安全性评价 总体疗效 治疗组 除湿丸 热型 湿重 湿毒清胶囊 

分 类 号：R259[医药卫生—中西医结合]