Article(id=1292126391009566742, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126377440989952, articleNumber=null, orderNo=null, doi=10.13699/j.cnki.1001-6821.2026.01.003, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=1764000000000, receivedDateStr=2025-11-25, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1785996538164, onlineDateStr=2026-08-06, pubDate=1768579200000, pubDateStr=2026-01-17, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1785996538164, onlineIssueDateStr=2026-08-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1785996538164, creator=13701087609, updateTime=1785996538164, updator=13701087609, issue=Issue{id=1292126377440989952, tenantId=1146029695717560320, journalId=1246415772164075586, year='2026', volume='42', issue='1', pageStart='1', pageEnd='147', issueExtLink='null', onlineDate='null', pubDate='1768579200000', pubDateStr='2026-01-17', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1785996534929, creator='13701087609', updateTime=1786014708731, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1292202603945947673, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126377440989952, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1292202603950141978, tenantId=1146029695717560320, journalId=1246415772164075586, issueId=1292126377440989952, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=15, endPage=21, ext={EN=ArticleExt(id=1292126391244447767, articleId=1292126391009566742, tenantId=1146029695717560320, journalId=1246415772164075586, language=EN, title=Clinical trial of fule cream for pediatric skin diseases, columnId=1246531407326105792, journalTitle=Chinese Journal of Clinical Pharmacology, columnName=Clinical and Basic Bridging Research, runingTitle=null, highlight=null, articleAbstract=
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.
, authors=Yi LIU
1a, Yi-jing CHENG
2, Jing-ya FANG
3, ying GAO
1b, authorsList=Yi LIU, Yi-jing CHENG, Jing-ya FANG, ying GAO, authorCompany=null, correspAuthors=ying GAO, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1292126391470940184, articleId=1292126391009566742, tenantId=1146029695717560320, journalId=1246415772164075586, language=CN, title=肤乐霜治疗儿童皮肤病的临床研究, columnId=1246531407485489349, journalTitle=中国临床药理学杂志, columnName=临床与基础桥接研究, runingTitle=null, highlight=null, articleAbstract=
目的 观察肤乐霜单用或联合外用糖皮质激素（TCS）/钙调磷酸酶抑制剂（TCI）治疗儿童皮肤病的有效性与肝肾功能安全性。
方法 将本院使用肤乐霜的患儿纳入为研究对象。根据用药情况分为单药队列（肤乐霜单用）和联合队列（肤乐霜联用TCS/TCI）。比较2组患儿的肝肾功能指标变化、药物性肝损伤（DILI）及急性肾损伤（AKI）发生率和临床疗效，并通过提取病历文本中的疗效描述构建结局变量。
结果 共纳入2 439例患儿分析安全性，741例分析有效性。有效性分析显示，联用队列临床治疗有效率为77.93%（505例/648例），显著高于单药队列的56.99%（53例/93例），优势比为0.38（95% CI：0.24~0.59）。在安全性方面，治疗后，队列1与队列2的丙氨酸氨基转移酶（ALT）、天冬氨酸氨基转移酶（AST）和碱性磷酸酶（ALP）水平在用药后均显著下降（均P<0.05）。DILI与AKI发生率较低。数据质量分析揭示随访实验室检查缺失率较高，且存在标准化疗效评价缺失等问题。
结论 肤乐霜联合TCS/TCI治疗方案在真实世界中不仅显示出更优的有效性，且未增加有临床意义的肝肾功能风险。尽管数据缺失等局限性可能对效应估计的精确性产生影响，但敏感性分析支持主要结论的稳健性。本研究结果为肤乐霜的临床应用提供了真实世界证据支持，同时提示加强数据治理以生成更高质量真实世界证据的必要性。
, authors=刘毅
1a, 程毅菁
2, 房婧雅
3, 高莹
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刘毅（1984-），男，副主任药师，硕士研究生，主要从事儿童医学产品临床试验及转化工作和研究
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