【摘要】 目的：研制火热炽盛证（实热火毒）评价标准，为证候中药疗效评价提供依据。方法：检索火热炽盛证相关古籍和现代文献数据库，包括中国知网（CNKI）、万方数据知识服务平台（Wanfang）、维普数据库（VIP）、中国生物医学文献服务系统（SinoMed）以及《中华医典》数据库，获取文献指标；在此基础上，开展临床调查，完善补充修订相关条目，构建评价条目池。建立《德尔菲专家咨询问卷》，通过两轮德尔菲专家调查，筛选出重要条目和关键条目；对其结果举办专家共识论证会，确定评价核心条目；通过层次分析法定权重，量化评价指标。最后，通过临床调查方式，进行量表测评。结果：文献研究获取火热炽盛证症状、舌脉指标60个，经临床调查补充修订保留相关条目50个。第一轮德尔菲调查保留条目39个，第二轮保留条目17个。专家共识论证会确定评价核心条目11个。层次分析法计算核心条目权重，以量表形式建立火热炽盛证评价标准。最后，通过临床调查方式，对评价量表进行测评，结果显示，量表的可接受性、可行性、信度、效度较好。结论：通过定性和定量相结合的研究方法，研制了火热炽盛证（实热火毒）评价标准，为临床试验的开展提供支持，也为相应证候临床疗效评价提供可测评的指标。更多还原

【Abstract】 Objective: Developing evaluation criteria for syndrome of intense fire and heat(Shi Re Huo Du) to provide the basis of efficacy evaluation for new drugs for syndromes of traditional Chinese medicine. Methods: Literature indicators were obtained by searching CNKI, Wanfang, VIP, SinoMed and Chinese Medical Classics databases. Clinical investigation was carried out to revise entries and constructing entry pool. The Delphi Expert Consultation Questionnaire was established for consultation,screening out important entries and key entries. The expert consensus meeting was held on the screening results, determining core evaluated indicators, and quantizing the indicators through analytic hierarchy process. Finally, the scale was evaluated through clinical investigation. Results: A total of 60 entries were obtained after literature research and 50 entries were retained by the clinical investigation. A total of 39 entries retained in the first round of Delphi expert survey, and 17 entries retained in the second round. A total of 11 core entries were identified in the expert consensus meeting and were quantized through analytic hierarchy process to established evaluation scale for syndrome of intense fire and heat. Finally, the scale was evaluated by clinical investigation, and the results showed that the scale was acceptable, feasible, reliable and valid. Conclusion: Evaluation criteria for syndrome of intense fire and heat(Shi Re Huo Du) is developed by combining research methods of qualitative and quantitative,applying to clinical trials, and providing measurable indicators for the evaluation of clinical efficacy of syndromes.更多还原