口腔扁平苔藓临床干预研究的核心结局指标集解读与思考  

Interpretation and consideration of core outcome set in clinical intervention study of oral lichen planus

作　　者：魏子豪 王志勇 陈谦明 Wei Zihao;Wang Zhiyong;Chen Qianming(Oral Medicine Center,Stomatology Hospital,School of Stomatology,Zhejiang University School of Medicine&Clinical Research Center for Oral Diseases of Zhejiang Province&Key Laboratory of Oral Biomedical Research of Zhejiang Province&Cancer Center of Zhejiang University,Hangzhou 310006,China;Department of Scientific Research,Stomatology Hospital,School of Stomatology,Zhejiang University School of Medicine&Clinical Research Center for Oral Diseases of Zhejiang Province&Key Laboratory of Oral Biomedical Research of Zhejiang Province&Cancer Center of Zhejiang University,Hangzhou 310006,China)

机构地区：[1]浙江大学医学院附属口腔医院口腔内科中心·浙江大学口腔医学院、浙江省口腔疾病临床医学研究中心浙江省口腔生物医学研究重点实验室、浙江大学癌症研究院,杭州310006 [2]浙江大学医学院附属口腔医院科研部·浙江大学口腔医学院、浙江省口腔疾病临床医学研究中心、浙江省口腔生物医学研究重点实验室、浙江大学癌症研究院,杭州310006

出　　处：《中华口腔医学杂志》2024年第10期998-1003,共6页Chinese Journal of Stomatology

基　　金：国家卫生健康委科学研究基金(WKJ-ZJ-2212);浙江省科学技术厅“尖兵领雁+X”研发攻关计划(2024C03193);浙江省科学技术厅中央引导地方科技发展资金项目(2024ZY01032);国家自然科学基金(82370952);浙江省口腔疾病临床医学研究中心开放课题(2024-KFKT-01)。

摘　　要：口腔扁平苔藓(OLP)是口腔黏膜慢性炎症性疾病,尚无法治愈。OLP病情易反复,影响患者生活质量且有癌变风险。制订OLP临床管理循证方案并规范执行可缓解OLP患者的临床症状,降低癌变风险,提升其生活质量。但已有的OLP临床干预研究,研究者报告的结局指标种类繁多,缺乏统一标准,无法对不同研究进行循证分析并为临床诊疗提供循证意见。为此,第8届世界口腔医学工作组于2022年3月至2023年1月间分3个步骤确定了OLP核心结局指标集(COS),以降低OLP临床干预研究数据的异质性,形成可用于循证分析的数据池,为制订OLP临床管理循证方案提供必要条件。本文对本次COS的制订过程进行介绍,并对OLP COS进行解读,明确COS的意义与不足。同时帮助国内学者理解并使用OLP COS,以进一步提升我国OLP临床研究质量和循证价值。Oral lichen planus(OLP),as a chronic inflammatory disease of oral mucosa,cannot be completely cured at present.OLP can develop into oral squamous cell carcinoma and reduce the life quality of patients.The development of high-quality evidence-based strategies for OLP clinical management can effectively alleviate the clinical symptoms and reduce the risk of cancerization,thus to improve the life quality of patients.However,there is a wide variety of outcomes and a lack of uniform standards in previous OLP clinical intervention studies.Therefore,evidence-based analysis of relevant studies cannot be conducted to provide more convincing guidance for clinical diagnosis and treatment.To reduce the heterogeneity of clinical intervention studies,form a data pool for meta-analysis,and provide higher quality evidence-based OLP clinical management protocols,the World Workshop on Oral MedicineⅧidentified a core outcome set(COS)for OLP in three steps from March 2022 to January 2023.This article introduces the process of COS formulation,interprets OLP COS,and puts forward the advantages and drawback of OLP COS in this paper.We encourage researchers to use this COS in their future OLP clinical studies for improving the clinical significance and evidence-based value of studies.

关 键 词：扁平苔藓 口腔 循证医学 临床研究 核心结局指标集 专家共识 

分 类 号：R781.5[医药卫生—口腔医学]