肤乐霜治疗儿童皮肤病的临床研究OA

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.