CHINESE JOURNAL OF DRUG EVALUATION >

2026 , Vol. 43 >Issue 1: 68 - 68-73

DOI: https://doi.org/10.2095-3593.2026.030009

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

Fold

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.

Key words： ; font-size:medium; ">Vitiligo； Children； Five Vitamins and Lysine granules； Tacrolimus； Immune function； Adverse effect

Cite this article

WANG Fang, CHEN Lin, LI Huyu, WANG Shengchun . Clinical Study of Tacrolimus Combined with Five Vitamins and Lysine Granules in the Treatment of Pediatric Vitiligo[J]. CHINESE JOURNAL OF DRUG EVALUATION, 2026 , 43(1) : 68 -68-73 . DOI: 10.2095-3593.2026.030009

References

 [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.
Options
Outlines

/

〈 〉

[an error occurred while processing this directive]