改良德尔菲法构建《雷公藤多苷片治疗慢性肾脏病合理用药指南》的临床问题
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国家中医药管理局中医药创新团队及人才支持计划项目(ZYYCXTD-C-202005)


Identifying Clinical Questions of Guidelines for Rational Use of Tripterygium Glycosides Tablet in the Treatment of Chronic Kidney Disease with Modified Delphi Method
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    摘要:

    目的:确定纳入《雷公藤多苷片治疗慢性肾脏病合理用药指南》临床问题与结局指标。方法:通过文献检索和专家头脑风暴会议形成临床问题与结局指标清单,经3轮改良德尔菲法调查问卷进行重要性评分和排序,最后召开专家共识投票会确认。由专家积极系数、权威系数以及变异系数进行问卷质量控制。结果:13个临床问题达成共识,主要涉及雷公藤多苷片单独使用或与治疗慢性肾脏病的常规西药联合使用时,与单独使用常规西药比较,是否有额外的获益;使用雷公藤多苷片期间出现肝功能异常时,是否需要停药;有生育需求的人群,使用雷公藤多苷片后需要停药多长时间。纳入结局指标51个,疗效性指标26个,包括蛋白尿改善、肾功能评价、远期预后、生命质量、免疫功能5方面。安全性指标25个,主要为系统性毒性,还包括血浆白蛋白降低、血尿酸升高、血糖以及血脂异常等。结论:通过改良德尔菲法确定了临床问题与结局指标,初步形成指南的结构体系,为指南的后续制定奠定了工作基础。

    Abstract:

    To determine the clinical questions and outcome indicators of the Guidelines for Rational Use of Tripterygium Glycosides Tablet in the Treatment of Chronic Kidney Disease.Methods:Literature retrieval and expert brainstorming meetings were applied to set up a list of clinical questions and outcome indicators.Three rounds of questionnaire survey based on the modified Delphi method were employed for importance rating and ranking.Final clinical questions and outcome indicators were confirmed by an expert consensus voting meeting.Questionnaire quality control was based on an expert positivity coefficient,an authority coefficient,and the coefficient of variation.Results:Consensus was reached on 13 clinical questions,including if there is additional benefit when Tripterygium Glycosides Tablet is used alone or in combination with conventional Western medicine for the treatment of chronic kidney disease compared to the efficacy when conventional Western medicine is used alone; if it is necessary to halt taking Tripterygium Glycosides Tablet when abnormal liver function occurs; for people with fertility needs,how long is suitable regarding the withdrawal time.A total of 51 outcome indicators were determined,including 26 efficacy indicators and 25 safety indicators.The efficacy indicators comprised improvement in proteinuria,renal function evaluation,long-term prognosis,quality of life,and immune function.The safety indicators mainly included systemic toxicity,as well as decreased plasma albumin,elevated blood uric acid,abnormal blood glucose and lipid levels,etc.Conclusion:The clinical questions and outcome indicators of the Guidelines for Rational Use of Tripterygium Glycosides Tablet in the Treatment of Chronic Kidney Disease were determined through the modified Delphi method.The structural system of the guidelines was initially formed,which lays a foundation for the follow-up development of the guidelines.

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文玉敏,柳芳,卢建东,费宇彤,李平.改良德尔菲法构建《雷公藤多苷片治疗慢性肾脏病合理用药指南》的临床问题[J].世界中医药,2024,(16).

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  • 收稿日期:2023-08-03
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  • 在线发布日期: 2024-09-13
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