侵袭性真菌感染治疗药品的临床综合评价指标体系建立探讨——以两性霉素B为例

Establishment of comprehensive clinical evaluation index system for the treatment of invasive fungal infection—A case study of amphotericin B

目的:探索建立侵袭性真菌感染治疗药品的临床综合评价指标体系,并展开实证研究,以期为医疗机构药品准入及临床合理用药提供评价方法学参考。方法:基于文献综述和相关指南,采用德尔菲法构建侵袭性真菌感染治疗药品的临床综合评价指标体系及各指标的相应权重,并以传统两性霉素B和两性霉素B胆固醇硫酸酯复合物为例展开实证研究。结果:经专家论证,最终确定了6个一级指标和13个二级指标及其相应权重,一级指标的重要性排序依次为有效性、安全性、经济性、创新性、可及性和适宜性,百分制权重分别为23.75%、39.58%、13.46%、8.1%、7.31%和7.81%。结论:实证研究表明,两性霉素B胆固醇硫酸酯复合物的临床综合价值得分较传统两性霉素B更高(79.68分vs.67.43分),该结果具有较高的科学性、可靠性和代表性。

OBJECTIVE To explore the content of clinical comprehensive evaluation of drugs for the treatment of invasive fungal diseases,and to carry out empirical research,so as to point out the evaluation suggestions for drug access and clinical rational use of drugs in medical institutions.METHODS Based on literature review and relevant guidelines,the clinical comprehensive evaluation index system and the corresponding weight of each index for the treatment of invasive fungal diseases were constructed by Delphi method,and the empirical study was carried out by taking conventional amphotericin B and amphotericin B cholesteryl sulfate complex as an example.RESULTS After the expert interview,6 first-level indicators and 13 second-level indicators and their corresponding weights were finally determined.The importance ranking of the first-level indicators were effectiveness,safety,economy,innovation,accessibility and suitability,and the weight of them were 23.75%,39.58%,13.46%,8.1%,7.31%and 7.81%,respectively.The results are scientific,reliable and representative.CONCLUSION Complex was higher than that of conventional amphotericin B(79.68 vs.67.43).Empirical studies showed that the clinical comprehensive value score of amphotericin B cholesteryl sulfate.