基于真实世界的注射用头孢吡肟治疗儿童社区获得性肺炎的临床综合评价

Clinical Comprehensive Evaluation of Cefepime for Injection in The Treatment of Community-Acquired Pneumonia With Children Based on Real-World

关键词:  真实世界研究  头孢吡肟  社区获得性肺炎  临床综合评价  德尔菲法  层次分析法

Key words:  real-world research  cefepime  community-acquired pneumonia  clinical comprehensive evaluation  delphi method  analytic hierarchy process

摘要:

目的：对头孢吡肟治疗儿童社区获得性肺炎（Community-Acquired Pneumonia, CAP）进行临床综合评价。方法：从安全性、有效性、经济性、适宜性、可及性、创新性6个维度，采用专家咨询法和文献调研法初步建立临床综合评价指标体系，使用德尔菲法结合层次分析法进行评价维度筛选与权重确定。通过真实世界研究法、文献调研法、问卷调查法、药品说明书、专家指南/共识等构建各个维度证据集合体，研究人员根据各维度临床综合评价证据集合体对头孢吡肟进行评分，并根据权重计算临床综合评价总得分。结果：该研究构建的头孢吡肟治疗儿童CAP临床综合评价指标体系包括评价维度6个一级指标，16个二级指标，35个三级指标，其中安全性（33.80%）、有效性（24.80%）及适宜性（18.40%）维度权重占比居前三位，创新性维度（11.49%）显著低于其他维度。最终，头孢吡肟综合评价总分为83.03。结论：基于吉林省单中心真实世界研究数据，头孢吡肟（1.0g，齐鲁安替）治疗儿童CAP在安全性、有效性及经济性方面表现良好（综合得分83.03），且在本研究背景下可及性较高。但创新性维度（11.49%）提示其缺乏儿童专用剂型等优化设计。结果可为区域性儿童CAP用药决策提供参考依据。

Abstract:

OBJECTIVE: A comprehensive clinical evaluation of cefepime for the treatment of community-acquired pneumonia (CAP) in children was conducted. METHODS: A comprehensive clinical evaluation index system was initially established using the expert consultation method and the literature research method in terms of six dimensions, namely, safety, efficacy, economy, appropriateness, accessibility, and innovativeness, and the Delphi method combined with hierarchical analysis was used for the screening of the evaluation dimensions and the determination of the weights. The real-world research method, literature research method, questionnaire survey method, drug inserts, expert guidelines/consensus, etc. were used to construct the evidence aggregates of each dimension, and the researchers scored cefepime according to the evidence aggregates of the comprehensive clinical evaluation of each dimension, and calculated the total score of the comprehensive clinical evaluation based on the weights. RESULTS: The comprehensive clinical evaluation index system of cefepime for the treatment of CAP in children constructed in this study included 6 primary indicators, 16 secondary indicators, and 35 tertiary indicators, among which the weights of safety (33.80%), efficacy (24.80%), and appropriateness (18.40%) were in the top three, and the innovativeness (11.49%) was significantly lower than the other dimensions. Finally, the total score of the comprehensive evaluation of cefepime was 83.03.CONCLUSION: Based on data from a single-centre real-world study in Jilin province, cefepime (1.0 g, Qilu Anti) performed well in terms of safety, efficacy and cost-effectiveness for the treatment of CAP in children (composite score of 83.03) and was highly accessible in the context of this study. However, the innovativeness dimension (11.49%) suggests that it lacks optimised design such as child-specific dosage forms. The results may provide a reference basis for regional decision-making on paediatric CAP medication use.