中国临床药理学杂志2026，Vol.42Issue(1)：15-21,7.DOI:10.13699/j.cnki.1001-6821.2026.01.003
肤乐霜治疗儿童皮肤病的临床研究
Clinical trial of fule cream for pediatric skin diseases
摘要
Abstract
Objective To observe the effectiveness and hepatorenal safety of Fule Cream alone or in combination with topical corticosteroids(TCS)/calcineurin inhibitors(TCI)in treating pediatric skin diseases.Methods Children prescribed Fule cream in our hospital were enrolled and categorized into monotherapy cohort(Fule Cream alone)and combination cohort(Fule cream with TCS/TCI)based on medication use.The changes in liver and kidney function indicators,the incidence of drug-induced liver injury(DILI),acute kidney injury(AKI)and clinical effectiveness were compared between the two cohorts.Outcome variables for effectiveness were constructed by extracting efficacy descriptions from medical record texts.Results A total of 2 439 children were included for safety analysis and 741 for effectiveness analysis.Effectiveness analysis showed that the combination cohort had a significantly higher response rate of 77.93％(505 cases/648 cases)than the monotherapy cohort 56.99％(53 cases/93 cases)with an odds ratio(OR)of 0.38(95％CI:0.24-0.59).Regarding safety,after treatment,The levels of alanine aminotransferase(ALT),aspartate aminotransferase(AST)and alkaline phosphatase(ALP)in cohort 1 and cohort 2 were significantly decreased after treatment(all P＜0.05).The incidence of DILI and AKI was low.Data quality analysis revealed a high missing rate for follow-up laboratory tests and a lack of standardized efficacy evaluations.Conclusion The Fule Cream combined with TCS/TCI regimen demonstrated not only superior effectiveness but also no increased clinically significant hepatorenal risk in a real-world setting.Although data missingness may affect the precision of effect estimates,sensitivity analyses support the robustness of the primary conclusions.These findings provide real-world evidence supporting the clinical use of Fule Cream and highlight the necessity of enhancing data governance to generate higher-quality real-world evidence.关键词
肤乐霜/儿童皮肤病/药物安全性/真实世界研究/电子病历/数据质量Key words
Fule Cream/pediatric skin diseases/drug safety/real-world study/electronic medical record/data quality分类
医药卫生引用本文复制引用
刘毅,程毅菁,房婧雅,高莹..肤乐霜治疗儿童皮肤病的临床研究[J].中国临床药理学杂志,2026,42(1):15-21,7.基金项目
北京市属医院科研培育计划基金资助项目(PZ20231302) （PZ20231302）
北京市中医药科技发展基金资助项目(BJZYYB-2023-20) （BJZYYB-2023-20）
