中华皮肤科杂志 ›› 2023, Vol. 56 ›› Issue (2): 112-117.doi: 10.35541/cjd.20220157

• 论著 • 上一篇    下一篇

生物制剂与甲氨蝶呤治疗儿童重度斑块状银屑病疗效及安全性比较

王召阳    向欣    陈云刘    苗朝阳    赵欣荣    张振华    刘元香    马琳    徐子刚   

  1. 国家儿童医学中心  首都医科大学附属北京儿童医院皮肤科，北京  100045
  • 收稿日期:2022-03-08 修回日期:2022-06-27 发布日期:2023-02-01
  • 通讯作者: 徐子刚 E-mail:zigangxupek@163.com
  • 基金资助:
    北京市自然科学基金（7212037）；北京市医院管理局儿科学科协同发展中心专项（XTZD20180502）；北京市科委“首都临床特色应用研究”专项课题（Z161100000516070）

Comparison of efficacy and safety of biologics versus methotrexate in the treatment of severe pediatric plaque psoriasis

Wang Zhaoyang, Xiang Xin, Chen Yunliu, Miao Chaoyang, Zhao Xinrong, Zhang Zhenhua, Liu Yuanxiang, Ma Lin, Xu Zigang   

  1. Department of Dermatology, Beijing Children′s Hospital, Capital Medical University, National Center for Children′s Health, Beijing 100045, China
  • Received:2022-03-08 Revised:2022-06-27 Published:2023-02-01
  • Contact: Xu Zigang E-mail:zigangxupek@163.com
  • Supported by:
    Beijing Municipal Natural Science Foundation （7212037）; Special Fund of the Pediatric Medical Coordinated Development Center of Beijing Hospitals Authority （XTZD20180502）; Capital Clinical Characteristic Application Research Project of Beijing Municipal Science and Technology Commission （Z161100000516070）

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摘要： 【摘要】 目的 比较生物制剂与甲氨蝶呤治疗儿童重度斑块状银屑病的疗效及安全性。方法 采用回顾性匹配病例对照研究设计，按银屑病皮损面积和严重程度指数（PASI）评分及年龄、以1∶1比例纳入首都医科大学附属北京儿童医院2016年6月至2021年11月接受生物制剂（阿达木单抗或司库奇尤单抗）或甲氨蝶呤治疗的重度斑块状银屑病患儿各10例。治疗第4、8、12周时分别评估PASI、医师对病情整体评分（PGA）及体表受累面积（BSA）评分，并记录药物的不良反应。统计分析主要采用Mann-Whitney U检验、Fisher确切概率法及广义估计方程。结果 治疗第4、8周时，生物制剂组PASI75应答率（7/10、10/10）及PASI90应答率（5/10、9/10）显著高于甲氨蝶呤组（PASI75：1/10、5/10，PASI90：0/10、1/10；均P＜0.05），而第12周时生物制剂组与甲氨蝶呤组PASI75（10/10比8/10）及PASI90应答率（9/10比4/10）差异均无统计学意义（均P > 0.05）。基线时两组PASI、BSA、PGA评分差异均无统计学意义（P > 0.05），而治疗第4、8、12周时生物制剂组PASI、BSA评分及第8周时PGA评分均显著低于甲氨蝶呤组（PASI：Z值分别为2.50、3.56、2.63；BSA：Z值分别为2.87、3.57、2.40；PGA：Z = 2.81，均P＜0.05）。分析各组评分随时间的变化，生物制剂组治疗4、8、12周，PASI、PGA、BSA评分均显著低于各基线评分（均P＜0.01）；除BSA评分外，第8、12周PASI及PGA评分显著低于第4周相应评分（均P＜0.05）；然而，第12周PASI、PGA、BSA评分与第8周相应评分差异无统计学意义（均P＞0.05）。甲氨蝶呤组第4、8、12周PASI、PGA、BSA评分均显著低于前一相邻时间点相应评分（均P＜0.05）。两组不良反应的发生率差异无统计学意义（P = 0.650），且两组均无严重不良反应发生。生物制剂组不良反应以感染为主，甲氨蝶呤组以感染及转氨酶升高为主。结论 生物制剂和甲氨蝶呤治疗儿童重度斑块状银屑病的疗效肯定，安全性好，且生物制剂比甲氨蝶呤能更快达到PASI75、PASI90。

关键词: 银屑病, 甲氨蝶呤, 生物制剂, 儿童, 斑块状银屑病

Abstract: 【Abstract】 Objective To compare the efficacy and safety of biologics versus methotrexate in the treatment of severe pediatric plaque psoriasis. Methods A retrospective matched case-control study was carried out. Twenty children with severe plaque psoriasis from Beijing Children′s Hospital, Capital Medical University from June 2016 to November 2021 were included in this study, and the patients treated with biologics （adalimumab or secukinumab） were matched with those treated with methotrexate at a ratio of 1∶1 according to the psoriasis area and severity index （PASI） score and age. PASI, physician′s global assessment （PGA）, and body surface area （BSA） scores were assessed at weeks 4, 8 and 12 after the start of treatment, and adverse drug reactions were recorded. Statistical analysis was mainly carried out by using Mann-Whitney U test, Fisher′s exact test and generalized estimating equations. Results At weeks 4 and 8, the proportions of patients achieving PASI75 and PASI90 were significantly higher in the biologics group （PASI75: 7/10, 10/10, PASI90: 5/10, 9/10, respectively） than in the methotrexate group （PASI75: 1/10, 5/10, PASI90: 0, 1/10, respectively; all P < 0.05）, while there was no significant difference between the biologics group and methotrexate group at week 12 （PASI75: 10/10 vs. 8/10, PASI90: 9/10 vs. 4/10, both P > 0.05）. There were no significant differences in the PASI, BSA or PGA scores between the two groups at baseline （all P > 0.05）, while the biologics group showed significantly decreased PASI and BSA scores at weeks 4, 8 and 12, and significantly decreased PGA score at week 8 compared with the methotrexate group （PASI: Z = 2.50, 3.56, 2.63, respectively; BSA: Z = 2.87, 3.57, 2.40, respectively; PGA: Z = 2.81; all P＜0.05）. Analysis of changes over time showed that the PASI, PGA and BSA scores in the biologics group significantly decreased at weeks 4, 8 and 12 compared with those at baseline （all P＜0.01）; the PASI and PGA scores significantly decreased at weeks 8 and 12 compared with the corresponding scores at week 4 （all P＜0.05）; however, there were no significant differences in the PASI, PGA or BSA scores between week 12 and 8 （all P＞0.05）. In the methotrexate group, the PASI, PGA and BSA scores at weeks 4, 8 and 12 were all significantly lower than the corresponding scores at the previous adjacent time points （all P＜0.05）. There was no significant difference in the incidence of adverse reactions between the two groups （P = 0.650）, and no serious adverse reactions occurred in either group. The main adverse reaction was infection in the biologics group, while infection and elevation of transaminase levels were common in the methotrexate group. Conclusion Biologics and methotrexate were both effective and safe for the treatment of severe pediatricplaque psoriasis, and biologics facilitated rapider achievement of PASI75 and PASI90 compared with methotrexate.

Key words: Psoriasis, Methotrexate, Biological agents, Child, Plaque psoriasis

引用本文

王召阳 向欣 陈云刘 苗朝阳 赵欣荣 张振华 刘元香 马琳 徐子刚. 生物制剂与甲氨蝶呤治疗儿童重度斑块状银屑病疗效及安全性比较[J]. 中华皮肤科杂志, 2023,56(2):112-117. doi:10.35541/cjd.20220157

Wang Zhaoyang, Xiang Xin, Chen Yunliu, Miao Chaoyang, Zhao Xinrong, Zhang Zhenhua, Liu Yuanxiang, Ma Lin, Xu Zigang. Comparison of efficacy and safety of biologics versus methotrexate in the treatment of severe pediatric plaque psoriasis[J]. Chinese Journal of Dermatology, 2023, 56(2): 112-117.doi:10.35541/cjd.20220157