中华皮肤科杂志 ›› 2020, Vol. 53 ›› Issue (5): 335-339.doi: 10.35541/cjd.20190701

• 论著 • 上一篇    下一篇

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

陈浩1    杨海珍2    顾军3    温海4    李明5    刘晓明6    郝飞7    娄冬华8    孙建方1   

  1. 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 刘晓明现在香港大学深圳医院皮肤科  518053；郝飞现在重庆医科大学附属第三医院皮肤科  401120

  • 收稿日期:2019-06-26 修回日期:2020-03-09 发布日期:2020-04-30
  • 通讯作者: 孙建方 E-mail:fangmin5758@aliyun.com
  • 基金资助:
    “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）

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

Chen Hao1, Yang Haizhen2, Gu Jun3, Wen Hai4, Li Ming5, Liu Xiaoming6, Hao Fei7, Lou Donghua8, Sun Jianfang1   

  1. 1Hospital for Skin Diseases, Chinese Academy of Medical Sciences and Peking Union Medical College, Nanjing 210042, China;  2Department of Dermatology, Peking University First Hospital, Beijing 100034, China;  3Department of Dermatology, Changhai Hospital, The Second Military Medical University, Shanghai 200072, China;  4Department of Dermatology, Changzheng Hospital, The Second Military Medical University, Shanghai 200003, China;  5Department of Dermatology, Zhongshan Hospital, Fudan University, Shanghai 200032, China;  6Department of Dermatology, The First Affiliated Hospital of Dalian Medical University, Dalian 116011, China; 7Department of Dermatology, The First Hospital Affiliated to AMU, Chongqing 400038, China;  8Department of Biostatistics, Nanjing Medical University, Nanjing 211166, China Liu Xiaoming is working on the Department of Dermatology, The University of Hong Kong-Shenzhen Hospital, Shenzhen 518053, China; Hao Fei is working on the Department of Dermatology, The Third Affiliated Hospital of Chongqing Medical University, Chongqing 401120, China
  • Received:2019-06-26 Revised:2020-03-09 Published:2020-04-30
  • Contact: Sun Jianfang E-mail:fangmin5758@aliyun.com
  • Supported by:
    Subproject of "Chongqing Innovative Drug Incubation Base" of National Science and Technology Major Projects for "Key New Drug Innovation" （2010ZX09401-306-2-17）

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摘要： 【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χ2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 = 0.016 7，P > 0.016 7）；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 < 0.016 7）。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。

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

Abstract: 【Abstract】 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 = 0.016 7, P > 0.016 7）; 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 < 0.016 7）. 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.

Key words: Psoriasis, Betamethasone, Randomized controlled trial, Tazarotene/betamethasone dipropionate cream