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

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 in 15(12.50%),5(8.33%),19(31.67%)and 9(15.00%)patients in the Taz/Bp,Bp,Taz and Plb groups respectively.The incidence rate of adverse drug reactions significantly differed among the 4 groups(P=0.004),and was significantly lower in the Taz/Bp group than in the Taz group(P<0.05),but insignificantly different between the Taz/Bp group and Bp or Plb group(both P>0.05).Conclusion Tazarotene 0.05%/betamethasone dipropionate 0.05%cream is effective and safe for the treatment of psoriasis vulgaris.