复方黄柏液涂剂治疗急性和亚急性湿疹多中心随机双盲安慰剂对照临床疗效及安全性分析  

Efficacy and safety analysis of acute and subacute eczema patients treated with compound Huangbai liquid application: a multicenter, randomized, double-blind and placebo-controlled clinical trial

作　　者：曾碧君[1,2] 刘毅[3] 王禹毅[3] 闫小宁 张晓杰[5] 曹毅[6] 杨志波[1] ZENG Bi-jun;LIU Yi;WANG Yu-yi;YAN Xiao-ning;ZHANG Xiao-jie;CAO Yi;YANG Zhi-bo(Department of Dermatology,the Second Affiliated Hospital of Hunan University of Chinese Medicine,Changsha 410005,China;Hunan University of Traditional Chinese Medicine Hunan Provincial Medical and Food Homologous Functional Food Engineering Technology Research Center,Changsha 410208,China;Dermatology Department of Chongqing Traditional Chinese Medicine Hospital,Chongqing 400021,China;Department of Dermatology,Shanxi Provincial Hospital of Traditional Chinese Medicine,Xian 710003,China;Department of Dermatology,Affiliated Hospital of Shandong University of Traditional Chinese Medicine,Jinan 250011,China;Department of Dermatology,Zhejiang Provincial Hospital of Traditional Chinese Medicine,Hangzhou 310006,China)

机构地区：[1]湖南中医药大学第二附属医院皮肤科,长沙410005 [2]湖南中医药大学湖南省药食同源功能性食品工程技术研究中心,长沙410208 [3]重庆市中医院皮肤科,重庆400021 [4]陕西省中医院皮肤科,西安710003 [5]山东中医药大学附属医院皮肤科,济南250011 [6]浙江省中医院皮肤科,杭州310006

出　　处：《中国新药杂志》2024年第23期2489-2494,共6页Chinese Journal of New Drugs

基　　金：湖南省中医药管理局重点课题项目(A2023056)。

摘　　要：目的:观察复方黄柏液涂剂治疗急性、亚急性湿疹患者的临床疗效。方法:纳入就诊于湖南中医药大学第二附属医院等5家中心符合入排标准的湿疹患者120例,随机分为试验组(n=60)和对照组(n=60),试验组采用复方黄柏液涂剂湿敷治疗,对照组采用复方黄柏液涂剂安慰剂湿敷治疗,疗程1周。对两组的症状总积分(total symptom score,TSS)、湿疹面积及严重程度评分(eczema area and severity index,EASI)、视觉模拟评分量表(visual analogue scale,VAS)、中医症状评分、有效性和安全性进行评价。结果:最终纳入101例,试验组50例、对照组51例。治疗后d 4,d 7,试验组TSS,EASI,VAS的改善及中医症状改善率显著优于同时期对照组(P<0.05);试验组的瘙痒、红斑、丘疹、糜烂、渗液等症状改善显著优于对照组(P<0.05);试验组总有效率(78%)明显高于对照组(9.8%,P<0.05)。两组患者的不良事件发生率比较无统计学差异(P>0.05)。结论:复方黄柏液涂剂能加快缓解急性、亚急性湿疹患者的症状,疗效确切且安全可靠。Objective: To observe the efficacy and safety of compound Huangbai liquid for the patients with acute and subacute eczema. Methods: A hundred and twenty patients with acute and subacute eczema, who met the inclusion and exclusion criteria and were admitted to 5 centers including the Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine, were enrolled in the randomized clinical trial which concluded a treatment group(n=60) and a control group(n=60). The patients in treatment group received compound Huangbai liquid, while the control group was given compound Huangbai liquid placebo. After one week of treatment, the total symptom score(TSS), eczema area and severity index(EASI), visual analogue scale(VAS), traditional Chinese medicine symptom score, and safety were evaluated in the two groups. Results: Finally, 101 cases, 50 cases in experimental group and 51 cases in control group, were included. On the 4th and 7th days after treatment, TSS, EASI and VAS were improved and the rate of traditional Chinese medicine symptoms in treatment group were significantly higher than that in control group at the same period(P<0.05). The symptoms such as itching, erythema, papules, erosion, and exudation in treatment group were significantly improved compared to those in control group(P<0.05). The total effective rate of treatment group(78%) was significantly higher than that of control group(9.8%, P<0.05). There was no statistically significant difference in the incidence of adverse events between the patients of two groups(P>0.05). Conclusion: Compound Huangbai liquid can accelerate the relief of various symptoms in patients with acute and subacute eczema, and has a definite and safe and reliable therapeutic effect.

关 键 词：复方黄柏液涂剂 湿疹 糜烂 渗液 

分 类 号：R969.4[医药卫生—药理学]