基于德尔菲法的温胆汤精准临床定位研究
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国家自然科学基金面上项目(82173699);中央高校基本科研业务费专项(YG2021ZD02);上海交通大学医工交叉研究基金重点项目


Precise Clinical Positioning of Wendan Decoction Based on Delphi Method
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    摘要:

    目的:基于德尔菲专家咨询法探究温胆汤的临床应用经验,为其新药开发的精准临床定位提供依据。方法:遴选全国范围内的中西医临床医生45名,采用德尔菲专家咨询法围绕温胆汤治疗疾病的证候、症状、疗程及安全性等开展研究,并对结果进行统计分析。结果:2轮德尔菲专家咨询均发放问卷45份,有效回收43份,统计专家积极系数均为95.56%。温胆汤临床应用情况、临床适用人群、药物安全性等是专家比较关注的问题。在中医适用疾病方面,90.70%的专家认为不寐的患者适合使用温胆汤,86.04%的专家认为痰热内扰证是温胆汤的最佳中医证候。在干预疗程方面,48.84%的专家认为温胆汤最优干预疗程为14 d。在药物安全性方面,88.37%的专家认为严重肝、肾功能损伤的患者不宜使用温胆汤,44.19%的专家认为用药15~30 d应当关注药物安全性问题。结论:专家普遍认为温胆汤的优势治疗病种为失眠,中医证候表现为痰热内扰型,症状表现是痰多胸闷,消化不良,口苦伴恶心嗳气等。同时,临床使用不宜久服,肝肾功能严重受损为其禁忌证。

    Abstract:

    To explore the clinical application experience of Wendan Decoction using the Delphi expert consultation method,providing a basis for its precise clinical positioning in the development of new drugs.Methods:A total of 45 clinical doctors from both traditional Chinese medicine(TCM) and Western medicine in China were selected.The Delphi expert consultation method was used to conduct research on the symptoms,syndromes,treatment duration,and safety of Wendan Decoction in treating diseases.The results were statistically analyzed.Results:Two rounds of the Delphi expert consultation were conducted,distributing 45 questionnaires,of which 43 were validly returned,with a response rate of 95.56%.The experts focused on issues such as the clinical application of Wendan Decoction,the patient populations,and its drug safety.Regarding the diseases applicable to TCM,90.70% of the experts believed that Wendan Decoction was suitable for patients with insomnia,while 86.04% considered phlegm-heat internal disturbance syndrome as the most appropriate TCM syndrome for Wendan Decoction.Regarding the intervention duration,48.84% of the experts suggested that the optimal intervention period for Wendan Decoction was 14 days.Concerning drug safety,88.37% of the experts believed that Wendan Decoction should not be used in patients with severe liver and kidney dysfunction,and 44.19% thought that drug safety concerns should be addressed when using the medicine for 15 to 30 days.Conclusion:Experts generally agreed that the primary therapeutic indication for Wendan Decoction was insomnia,with a TCM syndrome of phlegm-heat internal disturbance.The common symptoms included excessive phlegm,chest tightness,indigestion,bitter taste in the mouth,nausea,and belching.Additionally,long-term use should be avoided,and the drug was contraindicated in patients with severe liver and kidney dysfunction.

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吕文文,徐威,龚雪,温俊凯,王海彬,谭红胜.基于德尔菲法的温胆汤精准临床定位研究[J].世界中医药,2024,(21).

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  • 收稿日期:2024-05-15
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  • 在线发布日期: 2025-01-20
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