他克莫司治疗白癜风一年的临床疗效观察

Evaluation of efficacy of tacrolimus in the one-year treatment of vitiligo

目的观察长期使用他克莫司软膏治疗白癜风的疗效。方法收集2016年1月至2018年2月在义乌市皮肤病医院及杭州市第三人民医院皮肤科白癜风门诊首诊并持续随访的白癜风患者156例,男70例,女86例;成年患者114例,6~18岁患儿42例。外用他克莫司软膏2次/d治疗6个月,每月随访1次,观察并记录色素开始再生时间、患者白癜风面积及严重程度评分(VASI),计算VASI改善率。治疗6个月时,将显效的患者随机分为常规治疗组(2次/d)和间隔治疗组(每3日1次),继续观察6个月,比较两种方法对最终疗效的影响。采用Mauchly球形检验法、随机区组的方差分析法分析治疗前及治疗1~6个月的VASI评分差异。结果156例患者治疗前、治疗1~6个月的VASI值[M(P25,P75)]分别为2(0.6,5)、2(2,5)、1.6(0.575,4.5)、1.2(0.5,4.0)、0.4(1.15,3.5)、0.75(0.3,2.575)、0.6(0.2,2.2),不同治疗时间点的VASI值差异有统计学意义(F=6.14,P<0.05),VASI值总体呈下降趋势。在6个月治疗期内,平均起效时间(2.2±0.6)个月。98例(62.8%)显效,达显效时间为(5.2±0.6)个月。显效患者中46例完成6个月的后续治疗,治疗第12个月,常规治疗组复色率(73.3%±18.2%)与间隔治疗组(72.0%±16.2%)间差异无统计学意义(t=0.42,P>0.05)。结论使用他克莫司治疗白癜风6个月时疗效显著,皮损治疗显效后每3日1次或2次/d的长期疗法均可维持较好疗效。

Objective To evaluate the efficacy of long-term treatment with tacrolimus ointment in patients with vitiligo.Methods A total of 156 patients with vitiligo(70 males and 86 females)were enrolled into this study,who were firstly diagnosed with vitiligo and continuously followed up in Department of Dermatology,Yiwu Dermatology Hospital and the Third People′s Hospital of Hangzhou between January 2016 and February 2018.Of the 156 patients,114 were adults,and 42 were children aged 6-18 years.All the patients received 6-month treatment with tacrolimus ointment twice a day.They were followed up once a month,the time to initial repigmentation and vitiligo area severity index(VASI)were recorded,and VASI improvement rate was calculated.After 6-month treatment,the patients achieving marked improvement were divided into conventional treatment group and interval treatment group to be treated with tacrolimus ointment twice a day and once every 3 days respectively for another 6 months,and final efficacy of the 2 protocols was compared.Mauchly′s test of sphericity,randomized block analysis of variance and Bonferroni method were used to analyze differences among pre-treatment VASI scores,and 1-to 6-month post-treatment VASI scores.Results Among the 156 patients,the pre-treatment,and 1-,2-,3-,4-,5-and 6-month post-treatment VASI scores[M(P25,P75)]were 2(0.6,5),2(2,5),1.6(0.575,4.5),1.2(0.5,4.0),0.4(1.15,3.5),0.75(0.3,2.575),0.6(0.2,2.2)respectively.Additionally,there was a significant difference in the VASI score among the above time points(F=6.14,P<0.05),and the VASI score showed a gradual decreasing trend over time.During the initial 6-month treatment,the average time to initial repigmentation was 2.2±0.6 months.Of the 156 patients,98(62.8%)received marked improvement,and the time to marked improvement was 5.2±0.6 months.Of the 98 patients who received marked improvement,46 completed another 6-month treatment.After 12-month treatment,there was no significant difference in the repigmentation rate between the conventional treatment group(73.3%±18.2%)and interval treatment group(72.0%±16.2%,t=0.42,P>0.05).Conclusions The initial 6-month topical tacrolimus therapy showed marked efficacy for vitiligo.After the marked improvement of skin lesions,good efficacy can be maintained by long-term treatment with topical tacrolimus once every 3 days or twice a day.