[关键词]
[摘要]
【目的】构建维吾尔医治疗进展期白癜风的核心结局指标集,规范同类研究的结局指标选择与报告。 【方法】基于现有 的白癜风随机对照试验核心结局指标域,补充开发体现维吾尔医治疗白癜风优势和特色的结局指标集合。通过文献梳理和 半结构化问卷调查收集维吾尔医治疗进展期白癜风的相关指标,汇总形成指标清单;采用德尔菲调查和共识会议筛选核心 指标。 【结果】文献研究共纳入54项研究,问卷调查共收回86份问卷。通过文献研究及问卷调查整理形成的指标遴选清单共 包含28个指标;通过2轮德尔菲调查及1次共识会议最终确定了7个指标域的12个结局指标,包括白斑面积、复色、病情控 制时间、复色的维持、复发率、免疫指标、心理健康、生活质量、不良事件、不良反应发生率、肝肾功能监测、维医异常 黏液质分型,并推荐了部分指标的测量工具。 【结论】该核心指标集的研制有助于全面评价维医药的疗效,并为建立符合少 数民族医药特色的疗效评价方法提供了示范。
[Key word]
[Abstract]
Objective To develop a core outcome set (COS) for treatment of progressive vitiligo in Uyghur medicine,and to standardize the selection and reporting of outcome measures in relevant studies. Methods Based on the existing core outcome domain set of randomized controlled trials for vitiligo,additional outcome indicators reflecting the advantages and characteristics of Uyghur medical treatment were developed. Specific indicators for Uyghur medical treatment of progressive vitiligo were collected through literature review and semi-structured questionnaire surveys,and then a list of indicators were formed. The Delphi survey and consensus meetings were used to select core indicators. Results A total of 54 studies were included,and 86 questionnaires were collected. Through literature review and questionnaire surveys,a list of 28 indicators were obtained. After two rounds of Delphi survey and one consensus meeting,12 outcome indicators in 7 domains were finally determined,including vitiligo lesion area, repigmentation, disease control time, maintenance of repigmentation, recurrence rate, immune indicators,psychological health,patients’ quality of life,adverse events,adverse reaction incidence, liver and kidney function monitoring,and Uyghur medicine syndrome differentiation of mucus. Additionally,some measurement tools for certain indicators were recommended. Conclusion The development of the COS for vitiligo treatment in Uyghur medicine helps to comprehensively evaluate the efficacy of Uyghur medicine,and will provide a model for establishing efficacy evaluation methods that conform to the characteristics of ethnic minority medicine.
[中图分类号]
R275.9
[基金项目]
国家重点研发计划项目 (编号:2022YFC3501001) ;新疆维吾尔自治区重点研发计划项目 (编号:2022B03012-1)