CAJ | 학술논문

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Pearson x2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(x2=1.43,P＞0.05).瘙痒程度评分比较,治疗组优于对照组(x2=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.
목적 평개제습환치료습중우열형아급성습진적료효급안전성.방법 2010년5월지2011년10월재수도의과대학부속북경중의의원피부과문진선취아급성습진환자129례,채용수궤、쌍맹、쌍모의、양성평행대조림상연구,치료조(66례)구복제습환급효낭안위제,대조조(63례)구복습독청효낭급수환안위제,료정4주,우치료전급치료후제4주각수방1차,이피진면적、안색、형태、소양정도급실험실검사결과위관찰지표,대료효화안전성진행평개.료전료후적분비교채용t검험혹Wilcoxon질화검험,량조간각항급총체료효비교채용Pearson x2검험혹Fisher정학개솔법.결과 공123례아급성습진환자납입료효분석,치료결속시,치료조화대조조총유효솔분별위69.3％(43/62)화59.0％(36/61),량조차이무통계학의의(x2=1.43,P＞0.05).소양정도평분비교,치료조우우대조조(x2=4.05,P＜ 0.05).상관불량반응발생솔치료조위13.6％(9/66),대조조위11.1％(7/63),주요표현위대편당희、위완부불괄.치료후량조실험실지표미견명현변화.결론 제습환치료습중우열형아급성습진안전유효,총체료효여습독청효낭상당,재개선환자소양정도상효과경가.
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 be 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.