目的 开展馥感啉口服液（Fuganlin Oral Liquid，FGL）治疗小儿急性上呼吸道感染（气虚风热证）的临床综合评价，为临床合理用药和医疗卫生决策提供参考。方法 基于文献资料、相关数据平台、临床调查等信息，采用定性与定量相结合的方法，围绕安全性、有效性、经济性、适宜性、创新性、可及性6个维度，对FGL进行临床综合评价。结果 ①安全性方面，FGL在处方、非临床安全性、质量监管方面均未提示安全性风险；临床安全性方面，一般不良反应发生率较低，程度轻且短暂，总体安全性良好且可控。②有效性方面，上市前随机对照试验（randomized controlled trial，RCT）研究、基于上市后RCT的Meta分析结果均提示，在临床总有效率方面，FGL治疗小儿急性上呼吸道感染优于对照组（西医常规治疗或其他中成药）；真实世界研究结果也提示，FGL治疗小儿急性上呼吸道感染具有较高的临床痊愈率和较低的并发症发生率。③经济性方面，基于RCT的药物经济学评价研究结果提示，FGL治疗小儿急性上呼吸道感染更具有经济学优势。④适宜性方面，临床调研结果提示，FGL在药品信息和药品使用方面均具有较好的适宜性。⑤创新性方面，FGL为唯一治疗小儿气虚风热感冒的儿童专用中成药，获得多项国家专利，并获批增加新适应证（咳嗽变异性哮喘）的临床申请。⑥可及性方面，FGL疗程药品费用占居民可支配收入的比例较低，销售范围广、药材资源可持续，具有较好的可及性。结论 综合6个维度证据，采用儿童中成药临床综合评价工具计算，FGL的临床价值评分为77.36分。说明其治疗小儿急性上呼吸道感染（气虚风热证）临床价值较好，其评价结果可为临床合理用药与医疗卫生决策提供参考，建议按程序有条件转化为基本临床用药管理相关政策结果。

Objective To comprehensively evaluate the clinical application value of Fuganlin Oral Liquid (馥感啉口服液, FGL) in the treatment of acute upper respiratory tract infection in children(qi deficiency wind heat syndrome), so as to provide evidence for clinical rational use and regulatory decision-making. Method Based on literature, relevant data platform, clinical investigation and other information, the clinical comprehensive evaluation of FGL was conducted by combining qualitative and quantitative methods around six dimensions of safety, effectiveness, economy, suitability，innovation and accessibility. Result ①Safety: FGL does not reflect safety risks in terms of prescription, non-clinical safety and quality supervision. In terms of clinical safety, the incidence of adverse reactions is generally low, the degree is mild and short, and the overall safety is good and controllable. ②Effectiveness: The results of pre-marketing RCT studies and meta-analysis based on post-marketing RCT showed that FGL was superior to the control group (conventional Western medicine or proprietary Chinese medicine) in the treatment of acute upper respiratory tract infection in children in terms of total clinical response rate. Real-world results also suggest that FGL in the treatment of pediatric acute upper respiratory tract infections has a higher clinical recovery rate and a lower complication rate. ③Economy: The results of pharmacoeconomic evaluation based on RCT suggest that FGL has more economic advantages in the treatment of acute upper respiratory tract infection in children. ④Suitability: The results of clinical investigation suggested that FGL has good suitability in drug information and drug use. ⑤Innovation: FGL is the only Chinese patent medicine for the treatment of children with qi deficiency wind heat and cold, has obtained a number of national patents, and has been approved to add a new indication (cough variant asthma) clinical application. ⑥Accessibility: The ratio of FGL treatment drug cost to residents' disposable income is low, the sales range is wide, the medicinal materials resources are sustainable, and it has good accessibility. Conclusion Based on six dimensions of evidence, the clinical value score of FGL was 77.36 points by using the clinical comprehensive evaluation tool of children's proprietary Chinese medicine. It is indicated that it has good clinical value in the treatment of acute upper respiratory tract infection in children(qi deficiency wind heat syndrome), and the evaluation results can provide evidence-based reference for clinical rational drug use and drug decision-making,it is suggested that the results of basic clinical drug management policies should be translated according to procedures.

R285.64

中华中医药学会求实项目(儿科专项) "儿童中成药临床综合评价技术及示范案例研究" (2020ZX09201-008)