他扎罗汀倍他米松乳膏治疗斑块状银屑病后两种延长治疗方案的疗效和安全性的多中心临床观察

Efficacy and safety of two prolonged therapeutic regimens in patients with plaque psoriasis after treatment with tazarotene/betamethasone dipropionate cream:a multicenter clinical observation

目的探索使用他扎罗汀倍他米松乳膏治疗斑块状银屑病4周后有效但未达基愈患者的后续用药方案。方法本研究采用多中心、随机、开放、平行、对照设计。232例完成0.05%/0.05%他扎罗汀倍他米松乳膏4周治疗,银屑病面积与严重性指数(PASI评分)改善在50%~90%但未达基愈的斑块状银屑病受试者,在第5周时1∶1随机化进入试验组和对照组,试验组每日1次外用0.05%/0.05%他扎罗汀倍他米松乳膏,对照组每日1次序贯使用0.05%他扎罗汀凝胶、0.05%/0.05%他扎罗汀倍他米松乳膏(工作日使用他扎罗汀凝胶、周末使用他扎罗汀倍他米松乳膏),进行第5~8周的治疗,第6周和第8周时评价两组的疗效和安全性。两组间计量资料的比较采用协方差分析或t检验,计数资料的比较采用卡方检验。结果232例进入第5~8周治疗的患者中,200例完成研究,试验组和对照组的全分析集(FAS)分别为110例、112例,安全性分析集(SAS)均为113例。连续治疗6周和8周后,试验组PASI评分的下降率分别为73.05%±16.69%和78.46%±15.40%,对照组分别下降66.73%±21.77%和67.02%±34.19%,两组比较,均P<0.05。治疗6周后,试验组达到PASI90的受试者比例(14例,12.7%)高于对照组(5例,4.5%,χ^(2)=4.842,P=0.028);治疗8周后,试验组达到PASI75、PASI90的受试者比例(61.8%、23.6%)均高于对照组(48.2%、12.5%,均P<0.05)。连续用药8周后,试验组和对照组的不良反应发生率(15.0%、23.9%)差异无统计学意义(χ^(2)=2.822,P=0.093)。结论使用0.05%/0.05%他扎罗汀倍他米松乳膏治疗银屑病4周后有效但未达基愈的患者,继续进行为期4周的0.05%/0.05%他扎罗汀倍他米松乳膏治疗是一种比序贯使用0.05%他扎罗汀凝胶、0.05%/0.05%他扎罗汀倍他米松乳膏更优的治疗方案。

Objective To explore the prolonged therapeutic regimen for patients with plaque psoriasis,who showed a positive response to 4-week treatment with tazarotene/betamethasone dipropionate cream,but were not completely cured.Methods A multicenter,randomized,open-labelled,parallel-controlled clinical study was conducted.A total of 232 patients with plaque psoriasis were collected,who showed a positive response to previous 4-week treatment with 0.05%/0.05%tazarotene/betamethasone dipropionate cream,but were not completely cured with the psoriasis area and severity index[PASI]improvement rate being 50%-90%.At week 5,they were randomly and equally divided into 2 groups:test group receiving treatment with 0.05%/0.05%tazarotene/betamethasone dipropionate cream once a day,and control group receiving a sequential regimen of 0.05%tazarotene gel on weekdays once a day followed by 0.05%/0.05%tazarotene/betamethasone dipropionate cream on weekends once a day.After 2-and 4-week prolonged treatment,the efficacy and safety of the 2 therapeutic regimens were evaluated and compared.Measurement data were compared between 2 groups by using covariance analysis or t test,and enumeration data were compared by using chi-square test.Results From the 5th to the 8th week,200 out of the 232 patients completed the treatment.Data collected from 110 patients in the test group and 112 in the control group were enrolled into the full analysis set,and those from both 113 patients in the test group and control group were enrolled into safety analysis set.After consecutive 6-and 8-week treatment,the decline rates of the PASI score were 73.05%±16.69%and 78.46%±15.40%respectively in the test group,which were significantly higher than those in the control group(66.73%±21.77%,67.02%±34.19%,respectively,both P<0.05).After 6-week treatment,the proportion of subjects who achieved PASI90 was significantly higher in the test group(14 cases,12.7%)than in the control group(5 cases,4.5%,χ^(2)=4.842,P=0.028);After 8-week treatment,the proportions of subjects who achieved PASI75 and PASI90(61.8%,23.6%,respectively)were significantly higher in the test group than in the control group(48.2%,12.5%,respectively,both P<0.05).During the consecutive 8-week treatment,there was no significant difference in the incidence rate of adverse reactions between the test group(15.0%)and control group(23.9%,χ^(2)=2.822,P=0.093).Conclusion For patients who showed a positive response to 4-week treatment with 0.05%/0.05%tazarotene/betamethasone dipropionate cream,but were not completely cured,the continuous use of 0.05%/0.05%tazarotene/betamethasone dipropionate cream for 4 weeks is a superior therapeutic regimen compared with the sequential regimen of 0.05%tazarotene gel followed by 0.05%/0.05%tazarotene/betamethasone dipropionate cream.