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0.1%他克莫司软膏外用维持治疗成人白癜风的多中心随机对照研究

A Multicenter Randomized Controlled Study on the Maintenance Treatment of Adult Vitiligo with Topical 0.1% Tacrolimus Ointment

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【作者】 盛安琪; 林福全; 周妙妮; 孙秀坤; 洪为松; 贾虹; 李铁男; 傅丽芳; 尉晓冬; 金嵘; 许文; 许爱娥;

【Author】 Sheng Anqi;Lin Fuquan;Zhou Miaoni;Sun Xiukun;Hong Weisong;Jia Hong;Li Tienan;Fu Lifang;Wei Xiaodong;Jin Rong;Xu Wen;Xu Ai′e;Hangzhou Third People′s Hospital;Institute of Dermatology,Chinese Academy of Medical Sciences;Shenyang Seventh People′s Hospital;

【通讯作者】 许爱娥;

【机构】 杭州市第三人民医院; 中国医学科学院皮肤病研究所; 沈阳市第七人民医院;

【摘要】 目的 明确0.1%他克莫司软膏外用维持治疗在预防白癜风复发中的有效性,并探讨其最佳维持治疗方案。方法 选取2022年1月—2024年11月在3家三级转诊医院就诊的102例白癜风患者,按简单排序随机化法分为26周维持治疗组31例(外用0.1%他克莫司软膏1周2次,26周后停止治疗),52周维持治疗组37例(外用0.1%他克莫司软膏1周2次,52周后停止治疗)和空白组34例(无药物治疗)。3组患者每3个月进行1次随访,共随访18个月,观察患者的复发情况和复发时间。结果 26周维持治疗组复发3例,复发率为9.7%,52周维持治疗组复发8例,复发率为21.6%,空白组复发11例,复发率为32.4%。26周维持治疗组的复发率显著低于空白组(P=0.026);52周维持治疗组的复发率与空白组比较差异无统计学意义(P=0.422),而Kaplan-Meier图显示,52周维持治疗组的无复发率在随访9个月之前高于空白组,但9个月后与空白组趋同。此外,维持治疗组(26周和52周)的平均复发时间较空白组有所延长[(32.57±19.65)周比(25.45±12.17)周],但因样本量少,组内方差较大,差异无统计学意义(P>0.05)。结论 外用0.1%他克莫司软膏1周2次外用维持治疗可有效减少白癜风复发,延长复发时间,26周是他克莫司外用维持治疗的最佳时间。

【Abstract】 Objective In order to evaluate the effectiveness of topical 0.1% Tacrolimus ointment maintenance treatment in preventing vitiligo recurrence and determine the optimal maintenance treatment plan. Methods A total of 102 vitiligo patients from three tertiary referral hospitals from January 2022 to November 2024 were randomly divided into three groups:the 26-week maintenance group(31 cases,topical 0.1% Tacrolimus ointment twice weekly,with treatment stopped after 26weeks),the 52-week maintenance group(37 cases,topical 0.1% Tacrolimus ointment twice weekly,with treatment stopped after 52 weeks),and the control group(34 cases,no medication). All patients were followed up every three months for 18months to observe recurrence rates and time to recurrence. Results The recurrence rates were 9.7%(3/31) in the 26-week group,21.6%(8/37) in the 52-week group,and 32.4%(11/34) in the control group. The 26-week group showed a significantly lower recurrence rate than the control group(P =0.026),while the 52-week group exhibited no statistically significant difference compared to the control group(P=0.422). Kaplan-Meier analysis revealed that the 52-week group had a higher recurrence-free rate than the control group before nine months of follow-up,but the rates converged thereafter.Additionally,the mean time to recurrence in the maintenance groups(26-week and 52-week) was prolonged compared to the control group [(32.57±19.65) weeks vs.(25.45±12.17) weeks],though the differences were not statistically significant(P>0.05) due to small sample size and high within-group variance. Conclusion Topical 0.1% Tacrolimus ointment twice weekly is effective in reducing vitiligo recurrence and delaying relapse,with 26 weeks being the optimal duration for maintenance therapy.

【关键词】 白癜风; 维持治疗; 他克莫司;
【Key words】 Vitiligo; Maintenance therapy; Tacrolimus;
【基金】 国家自然科学基金区域创新发展联合基金(成纤维细胞介导CGRP+神经-免疫互作在白癜风中的作用与机制,编号:U22A20310);国家重点研发计划(基于光电免疫调控效应的常见慢性皮肤病临床试验研究和应用,编号:2023YFC2508200)
  • 【文献出处】 中国中西医结合皮肤性病学杂志 ,Chinese Journal of Dermatovenereology of Integrated Traditional and Western Medicine , 编辑部邮箱 ,2025年03期
  • 【分类号】R758.41
  • 【下载频次】46
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