0.05%/0.05%他扎罗汀倍他米松乳膏治疗轻中度寻常型银屑病多中心疗效观察  

Efficacy of tazarotene 0.05%/betamethasone dipropionate 0.05%cream in the treatment of mild to moderate psoriasis vulgaris:a multicenter clinical observational study

作　　者：陈浩 杨海珍[2] 顾军[3] 温海[4] 李明 刘晓明[6,9] 郝飞 娄冬华 孙建方[1] Chen Hao;Yang Haizhen;Gu Jun;Wen Hai;Li Ming;Liu Xiaoming;Hao Fei;Lou Donghua;Sun Jianfang(Hospital for Skin Diseases,Chinese Academy of Medical Sciences and Peking Union Medical College,Nanjing 210042,China;Department of Dermatology,Peking University First Hospital,Beijing 100034,China;Department of Dermatology,Changhai Hospital,The Second Military Medical University,Shanghai 200072,China;Department of Dermatology,Changzheng Hospital,The Second Military Medical University,Shanghai 200003,China;Department of Dermatology,Zhongshan Hospital,Fudan University,Shanghai 200032,China;Department of Dermatology,The First Affiliated Hospital of Dalian Medical University,Dalian 116011,China;Department of Dermatology,The First Hospital Affiliated to AMU,Chongqing 400038,China;Department of Biostatistics,Nanjing Medical University,Nanjing 211166,China;Department of Dermatology,The University of Hong Kong-Shenzhen Hospital,Shenzhen 518053,China;Department of Dermatology,The Third Affiliated Hospital of Chongqing Medical University,Chongqing 401120,China)

机构地区：[1]中国医学科学院北京协和医学院皮肤病医院,南京210042 [2]北京大学第一医院皮肤科,100034 [3]第二军医大学长海医院皮肤科,上海200072 [4]第二军医大学长征医院皮肤科,200003 [5]复旦大学附属中山医院皮肤科,上海200032 [6]大连医科大学附属第一医院皮肤科,大连116011 [7]陆军军医大学第一附属医院皮肤科,重庆400038 [8]南京医科大学生物统计学系,211166 [9]香港大学深圳医院皮肤科,518053 [10]重庆医科大学附属第三医院皮肤科,401120

出　　处：《中华皮肤科杂志》2020年第5期335-339,共5页Chinese Journal of Dermatology

基　　金：“重大新药创制”科技重大专项“重庆创新药物孵化基地”子课题(2010ZX09401-306-2-17)。

摘　　要：目的初步评价0.05%/0.05%他扎罗汀倍他米松乳膏治疗寻常型银屑病的临床疗效及安全性。方法采用多中心、随机、盲法、单模拟、平行对照临床试验,寻常型银屑病受试者被随机分配(2∶1∶1∶1)进入0.05%/0.05%他扎罗汀倍他米松乳膏(Taz/Bp)组、0.05%二丙酸倍他米松乳膏(Bp)组、0.05%他扎罗汀凝胶(Taz)组和乳膏基质对照(Plb)组,连续用药4周。在用药开始后第1、2、4周分别评价各组药物的疗效和安全性。连续性指标的比较采用中心效应的两因素方差分析,并用LSD-t检验进行两两比较。分类指标的比较采用χ^2检验或Fisher精确检验法。结果7个研究中心共纳入300例受试者,Taz/Bp组120例,Bp组60例,Taz组60例,Plb组60例,用药4周后,达PASI75的比例分别为35.83%、20.00%、18.33%和6.67%,差异有统计学意义(P<0.05);Taz/Bp组PASI75比例高于Plb组(α=0.05,P<0.05)和Taz组(α=0.025,P<0.025),与Bp组相比差异无统计学意义(α=0.0167,P>0.0167);4组达PASI90的比例分别为25.00%、8.33%、5.00%、1.67%,差异有统计学意义(P<0.05),Taz/Bp组高于Plb组(P<0.05)、Taz组(P<0.025)及Bp组(P<0.0167)。各试验组药物耐受性良好,4组分别有15例(12.50%)、5(8.33%)例、19(31.67%)例、9(15.00%)例发生药物不良反应,不良反应发生率差异有统计学意义(P=0.004),Taz/Bp组发生率低于Taz组(P<0.05),与Bp组和Plb组比较差异无统计学意义(P>0.05)。结论0.05%/0.05%他扎罗汀倍他米松乳膏治疗寻常型银屑病具有良好的疗效和安全性。Objective To preliminarily evaluate clinical efficacy and safety of tazarotene 0.05%/betamethasone dipropionate 0.05%cream in the treatment of psoriasis vulgaris.Methods A multicenter,randomized,double-blinded,single-dummy,parallel-controlled clinical trial was conducted.Subjects with mild to moderate psoriasis vulgaris were randomized into 4 groups at a ratio of 2∶1∶1∶1,including tazarotene 0.05%/betamethasone dipropionate 0.05%cream(Taz/Bp)group,betamethasone dipropionate 0.05%cream(Bp)group,tazarotene 0.05%gel(Taz)group and cream vehicle control(Plb)group.The treatment lasted 4 weeks.After 1,2 and 4 weeks of treatment,efficacy and safety of drugs were evaluated in the above groups.Two-way analysis of variance model with main effects was used to compare continuous indices,least significant difference t-test was used for multiple comparisons,and chi-square test or Fisher′s exact test for comparisons of categorical data.Results A total of 300 subjects were enrolled from 7 research centers,including 120 in the Taz/Bp group,60 in the Bp group,60 in the Taz group and 60 in the Plb group.After 4 weeks of treatment,proportions of patients achieving a 75%reduction in PASI(PASI75)were 35.83%,20.00%,18.33%and 6.67%in the Taz/Bp,Bp,Taz and Plb groups respectively,and there was a significant difference among the 4 groups(P<0.05);the proportion of patients achieving PASI75 was significantly higher in the Taz/Bp group than in the Plb group(α=0.05,P<0.05)and Taz group(α=0.025,P<0.025),but there was no significant difference between the Taz/Bp group and Bp group(α=0.0167,P>0.0167);the proportions of patients achieving PASI90 were 25.00%,8.33%,5.00%and 1.67%in the Taz/Bp,Bp,Taz and Plb groups respectively,which significantly differed among the 4 groups(P<0.05),and the Taz/Bp group showed a significantly increased proportion of patients achieving PASI90 compared with the Plb group(P<0.05),Taz group(P<0.025)and Bp group(P<0.0167).All the tested drugs were well tolerated in the 4 groups.Adverse drug reactions occurred i

关 键 词：银屑病 倍他米松 随机对照试验 他扎罗汀倍他米松乳膏 

分 类 号：R75[医药卫生—皮肤病学与性病学]