• 中国核心期刊(遴选)数据库收录期刊
  • 中文科技期刊数据库收录期刊
  • 中国期刊全文数据库收录期刊
  • 中国学术期刊综合评价数据库统计源期刊等
药品评价

他克莫司联合五维赖氨酸颗粒治疗儿童白癜风的临床研究

展开
  • 1.郑州大学附属儿童医院,河南省儿童医院,郑州儿童医院, 河南 郑州 450000;
    2.河南科技大学第二附属医院, 河南 洛阳 471000;
    3.黄河水利委员会黄河中心医院, 河南 郑州 450000
王芳,女,硕士,主治医师,研究方向:特应性皮炎、白癜风、血管瘤

收稿日期: 2025-11-25

  修回日期: 2025-12-15

  录用日期: 2026-04-01

  网络出版日期: 2026-04-01

基金资助

2023年度河南省医学科技攻关计划项目(LHGJ20230842)

Clinical Study of Tacrolimus Combined with Five Vitamins and Lysine Granules in the Treatment of Pediatric Vitiligo

Expand
  • 1.Children′s Hospital Affiliated to Zhengzhou University/Henan Children′s Hospital/Zhengzhou Children′s Hospital,
         Henan Zhengzhou 450000, China;
    2.The Second Affiliated Hospital of Henan University of Science and Technology, Henan Luoyang 471000, China;
    3.Yellow River Conservancy Commission Yellow Reiver Central Hospital, Henan Zhengzhou 450000, China

Received date: 2025-11-25

  Revised date: 2025-12-15

  Accepted date: 2026-04-01

  Online published: 2026-04-01

摘要

目的:探讨他克莫司软膏外用联合五维赖氨酸颗粒口服治疗儿童白癜风的临床疗效及安全性。方法:选取2022年6月至2024年6月于郑州大学附属儿童医院就诊的80例白癜风患儿,采用随机数字表法分为对照组与观察组,每组各40例。对照组单用0.03%他克莫司软膏外涂治疗,观察组在对照组基础上加服五维赖氨酸颗粒。比较两组患儿的临床疗效、不良反应发生率,以及治疗前后白癜风面积评分指数(VASI)、体液免疫指标(IgG、IgA、IgM)、细胞免疫指标(CD3+、CD4+、CD8+)、炎症因子(IL-17、TNF-α)水平及皮肤病生活质量指数(DLQI)。结果:观察组治疗总有效率高于对照组,VASI评分低于对照组(P<0.05)。治疗后,观察组CD3+、CD4+水平高于对照组,CD8+、IgG、IgA、IgM及IL-17、TNF-α水平均低于对照组(P<0.05)。两组不良反应发生率差异无统计学意义(P>0.05)。观察组DLQI评分改善亦优于对照组(P<0.05)。结论:他克莫司联合五维赖氨酸颗粒治疗儿童白癜风疗效显著,能有效促进白斑复色、调节免疫功能、减轻炎症反应,且安全性良好。

本文引用格式

王芳, 陈琳, 李虎羽, 王胜春 . 他克莫司联合五维赖氨酸颗粒治疗儿童白癜风的临床研究[J]. 中国药物评价, 2026 , 43(1) : 68 -68-73 . DOI: 10.2095-3593.2026.030009

Abstract

Objective: To evaluate the clinical efficacy and safety of topical tacrolimus ointment combined with oral Five Vitamins and Lysine granules in the treatment of pediatric vitiligo. Methods: Eighty children with vitiligo admitted to the Children′s Hospital Affiliated to Zhengzhou University from June 2022 to June 2024 were selected and randomly divided into the control group and the observation group using the random number table method, with 40 cases in each group. The control group was treated with 0.03% tacrolimus ointment alone, while the observation group received additional oral Five Vitamins and Lysine granules on the basis of the control group. The clinical efficacy, incidence of adverse reactions, Vitiligo Area Scoring Index (VASI), humoral immune indicators (IgG, IgA, IgM), cellular immune indicators (CD3+,CD4+,CD8+), inflammatory factor levels (IL-17, TNF-α), and Dermatology Life Quality Index (DLQI) were compared between the two groups before and after treatment. Results: The total effective rate was higher and the VASI score was lower in the observation group compared to the control group (P<0.05). After treatment, the observation group showed higher levels of CD3+ and CD4+, and lower levels of CD8+, IgG, IgA, IgM, IL-17, and TNF-α compared to the control group (P<0.05). There was no statistically significant difference in the incidence of adverse reactions between the two groups (P>0.05). Improvement in DLQI score was also greater in the observation group (P<0.05). Conclusion: The combination of tacrolimus and Five Vitamins and Lysine granules demonstrates significant efficacy in the treatment of pediatric vitiligo, effectively promoting repigmentation, regulating immune function, reducing inflammatory response, and has farorable safety profile.

参考文献

 [1] Leung AKC, Lam JM, Leong KF, et al. Vitiligo: an updated narrative review[J]. Curr Pediatr Rev, 2021, 17(2):76-91.
     [2] 郭琳雯,张丽,蒋滟蕲,等.973例儿童和成人白癜风患者流行病学及临床特征分析[J]. 现代预防医学, 2019, 46(24):4518-4522.
     [3] Frisoli ML, Essien K, Harris JE. Mechanisms of pathogenesis and treatment[J]. Ann Rev Immunol, 2020, 38: 621-648.
     [4] Alshiyab D, Al-Qarqaz F, Ba-Shammakh S, et al.Comparison of the efficacy of tacrolimus 0.1% ointment vs calcipotriol/betamethasone in combination with NBUVB in treatment of vitiligo[J]. J Dermatolog Treat, 2023, 34(1):2252119.
     [5] 中国中西医结合学会皮肤性病专业委员会色素病学组. 白癜风诊疗共识(2018版)[J]. 中华皮肤科杂志, 2018, 51(4):247-250.
     [6] 杜紫微, 宋晋贤, 郑树茂, 等. 四君子汤加减口服联合0.03%他克莫司软膏外用治疗儿童进展期白癜风脾胃虚弱型临床观察[J]. 河北中医, 2021, 43(4):617-620.
     [7] 高明, 常远, 姚新瑞, 等. 维生素D辅助复方甘草酸苷片治疗白癜风的效果[J]. 河南医学研究, 2023, 32(18):3356-3360.
     [8] 钱莹莹, 李巍, 吴亚芬, 等. 792例儿童白癜风临床分析[J]. 中国麻风皮肤病杂志, 2021, 37(2):72-75.
     [9] 王禹毅,王小琴(综述),刁庆春,等.白癜风与自身免疫性共病的研究进展[J]. 重庆医学,2022,51(11):1973-1976.
     [10] 赵艳霞, 鲁娜, 王璇, 等. 白癜风免疫学发病机制的探讨[J]. 中国中西医结合皮肤性病学杂志, 2022, 21(4):381-383.
     [11] 鲁慧, 钱华, 李巍, 等. 308准分子激光联合他克莫司软膏治疗对白癜风患儿血清免疫球蛋白和IL-17、IL-22的影响[J]. 现代生物医学进展, 2020, 20(3):511-514.
     [12] 中国中西医结合学会皮肤性病专业委员会色素病学组. 白癜风诊疗共识(2021版)[J]. 中华皮肤科杂志, 2021, 54(2):105-109.
     [13] 杨谦, 何荣国, 邬运学, 等. 二氧化碳点阵激光联合他克莫司对白癜风患者血清炎性因子表达的影响[J]. 赣南医学院学报, 2020, 40(1):69-71, 80.
     [14] 徐永平,胡文婷,许爱娥.他克莫司治疗白癜风一年的临床疗效观察[J]. 中华皮肤科杂志,2020,53(1):36-39.
     [15] Khaitan BK, Sindhuja T. Autoimmunity in vitiligo: therapeutic implications and opportunities[J]. Autoimmun Rev, 2022, 21(1):102932.
     [16] 任虎. 毫火针辅助308nm准分子光联合他克莫司软膏对白癜风患者疗效及免疫功能的影响[J]. 中国美容医学, 2021, 30(3):102-105.
     [17] 郭园. 血清免疫球蛋白及补体C3、C4水平变化与白癜风患者疾病分期的关联性分析[J]. 黑龙江中医药, 2020, 49(4):97-98.
     [18] 朱飞飞. 血清免疫球蛋白及C3、C4与白癜风疾病分期的关联性分析[J]. 实用中西医结合临床, 2019, 19(9):120-121, 127.
     [19] 王春爽, 苏晨琳, 刘春景, 等. 308 nm准分子光结合他克莫司治疗儿童白癜风临床效果及安全性观察[J]. 中华生物医学工程杂志, 2024, 30(2):119-123.
     [20] Bargiela D, Cunha PP, Velica P, et al. Vitamin B6 metabolism determines T cell anti-tumor responses[J]. Front Immunol, 2022, 13: 837669.
     [21] 欧阳经鑫, 李秋粉, 周华, 等. 维生素B_(6)的生物学功能及其抗炎作用机制[J]. 动物营养学报, 2023, 35(5):2738-2747.
文章导航

/