含锌复方制剂对不同分型痤疮的功效与安全性分析  

Efficacy and Safety of Zinc-Containing Compound Preparation for Different Types of Acne

作　　者：徐驰 项蕾红 何黎[1,3] 许爱娥 黄玲[5] 涂颖 左麻迈[1] 李佳熹 向昱衡 欧阳晶 吴典[1] XU Chi;XIANG Leihong;HE Li;XU Ai′e;HUANG Ling;TU Ying;ZUO Mamai;LI Jiaxi;XIANG Yuheng;OUYANG Jing;WU Dian(Department of Dermatology,the First Affiliated Hospital of Kunming Medical University,Kunming 650032,China;Department of Dermatology,Huashan Hospital Affiliated to Fudan University,Shanghai 200000,China;Skin Health Research Center,Yunnan Characteristic Plant Extraction Laboratory,Kunming 650032,China;Department of Dermatology,Hangzhou Third People′s Hospital,Hangzhou 310000,China;Dermatology Department,the First Affiliated Hospital of Dali University,Dali 671000,China)

机构地区：[1]昆明医科大学第一附属医院皮肤科,云南昆明650032 [2]复旦大学附属华山医院皮肤科,上海200000 [3]云南特色植物提取实验室皮肤健康研究院,云南昆明650032 [4]杭州市第三人民医院皮肤科,浙江杭州310000 [5]大理大学第一附属医院皮肤科,云南大理671000

出　　处：《中国皮肤性病学杂志》2025年第4期394-403,共10页The Chinese Journal of Dermatovenereology

基　　金：国家自然科学基金项目(81960563);国家重点研发计划“常见多发病防治研究”重点专项(2023YFC2509000);教育部高原光皮肤疾病机制及综合防治研究创新团队(IRT17-R49)。

摘　　要：目的评估含锌的复方制剂对不同分型痤疮患者的功效及安全性。方法采用随机、开放性、多中心平行对照试验的方法,纳入170例痤疮患者,分为3组,其中1组皮损为粉刺,2组皮损为浅粉红色丘疹及红色丘疹或脓疱,3组皮损为结节或囊肿;含锌的复方制剂Ⅰ、Ⅱ、Ⅲ、Ⅳ型适用于不同皮损。每组随机分为试验组A,对照组B;1A组外用Ⅰ型制剂,1B组外用阿达帕林;2组联合口服药物,2A组浅粉红色丘疹外用Ⅱ型制剂(2A-Ⅱ组),红色丘疹或脓疱外用Ⅲ型制剂(2A-Ⅲ组),2B组浅粉红色丘疹(2B-Ⅱ组)及红色丘疹或脓疱(2B-Ⅲ组)均外用夫西地酸;3组联合口服药物,3A组外用Ⅳ型产品,3B组外用夫西地酸。在试验前后对各组进行相关指标评估:包括皮损计数及皮损处红度(a*值)、经表皮失水率(TEWL)、皮肤角质层含水量(SCH),同时记录主观不适症状并进行安全性评估。结果①各组皮损数量试验后均有明显下降(均P<0.001),各试验组的皮损改善均优于各对照组(均P<0.05);②2A、2B、3A组试验后a*值明显下降(均P<0.05);③2A、3A组试验后TEWL值明显下降、SCH值明显上升(均P<0.05),2B-Ⅱ、2B-Ⅲ组SCH值明显上升(均P<0.05)后下降,2A-Ⅱ组SCH值明显高于2B-Ⅱ组(P<0.05);2A-Ⅲ组TEWL值明显低于2B-Ⅲ组(P<0.05),SCH值明显高于2B-Ⅲ组(P<0.05);3A组SCH值明显高于3B组(P<0.05);④1A组发生不良反应率明显低于1B组(P<0.05)。结论含锌的复方制剂可有效改善痤疮皮损,可抑制粉刺进一步向炎性发展,改善炎性皮损处炎症及皮肤屏障,且安全性良好,同时根据痤疮不同分型治疗的理念值得临床推广。Objective To evaluate the efficacy and safety of compound preparation containing zinc in patients with different types of acne.Methods A randomized,open,multicenter parallel controlled trial was conducted.A total of 170 acne patients were included and divided into 3 groups.Group 1 were the patients with comedo,group 2 were patients with light pink papules and red papules or pustules,and group 3 were the patients with nodules or cysts.Compound preparation containing zinc typeⅠ,Ⅱ,Ⅲ,Ⅳare suitable for different skin lesions.Each group was randomly divided into test group A and control group B,group 1A was treated with typeⅠpreparation externally,group 1B was treated with adapalene externally,group 2A was treated with typeⅡpreparation externally on light pink papules(group 2A-Ⅱ),typeⅢpreparationt externally on red papules or pustules(group 2A-Ⅲ),group 2B was treated with fusidic acid externally on light pink papules(group 2B-Ⅱ)and red papules or pustules(group 2B-Ⅲ);group 3A was treated with typeⅣpreparation externally,group 3B treated with fusidic acid externally.Each group was evaluated after treatment included lesions count,a*value,TEWL and SCH value.At the same time,discomfort symptoms and safety assessment were recorded during follow-up.Results The number of skin lesions in each group decreased obviously after treatment(P<0.001),the therapeutic effect of all treatment group was better than that of control group(P<0.05).There was an obvious decrease in the a*value in groups 2A,2B and 3A after treatment(P<0.05).SCH value in groups 2B-Ⅱand 2B-Ⅲwas obviously increased firstly(P<0.05)and then decreased,the SCH value of group 2A-Ⅱwas obviously higher than that of group 2B-Ⅱ(P<0.05).The TEWL value of group 2A-Ⅲwas obviously lower than that of group 2B-Ⅲ(P<0.05),and the SCH value was obviously higher than that of group 2B-Ⅲ(P<0.05).The SCH value of group 3A was obviously higher than that of group 3B(P<0.05).The adverse reaction rate of group 1A was obviously lower than that of group

关 键 词：痤疮 分型 外用药物 复方制剂 锌 

分 类 号：R758.733[医药卫生—皮肤病学与性病学]