小儿肺热咳喘口服液治疗小儿急性支气管炎(风热犯肺证)的临床综合评价  

Clinical comprehensive evaluation of Xiaoer Feire Kechuan Oral Liquid in treatment of acute bronchitis in children(syndrome of wind-heat invading lung)

作　　者：李梅芳[1] 胡思源[1] 牛丽青 曾静 杨金玉 许玥 LI Meifang;HU Siyuan;NIU Liqing;ZENG Jing;YANG Jinyu;XU Yue(First Teaching Hospital of Tianjin University of Traditional Chinese Medicine,National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion,Tianjin 300381,China)

机构地区：[1]天津中医药大学第一附属医院/国家中医针灸临床医学研究中心,天津300381

出　　处：《药物评价研究》2024年第6期1326-1336,共11页Drug Evaluation Research

基　　金：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)。

摘　　要：目的开展小儿肺热咳喘口服液(FRKC)治疗小儿急性支气管炎(风热犯肺证)的临床综合评价,为临床合理用药和药事决策提供参考依据。方法基于文献资料、相关数据平台、临床调查等信息,采用循证医学、药物经济学、临床调研等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,依据基于多准则决策分析构建的儿童中成药临床综合评价技术体系对FRKC进行临床综合评价。结果(1)安全性:FRKC在处方、非临床安全性、质量监管等方面均未体现安全性风险,临床安全性方面,尚未发现严重不良反应,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:Meta分析显示,FRKC联合西医常规治疗对于小儿急性支气管炎的总有效率优于单用西医常规治疗;同类品种的网状Meta分析显示,FRKC在咳嗽消失时间、退热时间、啰音消失时间方面,均排名第1位。临床调研结果显示,医生和患者对FRKC治疗小儿急性支气管炎的疗效认可度较高。(3)经济性:药物经济学研究显示,与西医常规治疗相比,FRKC联合常规治疗更具有成本-效果优势。(4)适宜性:FRKC说明书内容完整、更新及时,患儿对剂型和口味可接受程度较高,运输和存储方便,可满足各年龄段整包装服药,在药物信息和药品使用方面都具有较好的适宜性。(5)创新性:FRKC为中药第四类新药,临床研究和指南、共识推荐其用于治疗流感、毛细支气管炎、病毒性肺炎、支气管肺炎、支原体肺炎、慢性咳嗽、荨麻疹等,外溢效应较好。(6)可及性:FRKC销售范围广,市场占有率高;疗程费用占家庭可支配收入比例较低,不含濒危、贵细药材,可及性和可负担性方面均较好。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,FRKC的临床价值评分为75.578分,说明其治疗小儿支气管炎(风热Objective To comprehensively evaluate the clinical application value of Xiaoer Feire Kechuan Oral Liquid(FRKC)in the treatment of acute bronchitis(syndrome of wind-heat invading lung),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,evidence-based medicine,pharmacoeconomics,clinical investigation and other qualitative and quantitative methods were adopted to focus on the six dimensions of safety,effectiveness,economy,suitability,innovation,and accessibility.According to the clinical comprehensive evaluation technology system of children's proprietary Chinese medicine based on multi-criteria decision analysis,the clinical comprehensive evaluation of FRKC was carried out.Result(1)Safety:FRKC does not reflect safety risks in terms of prescription,non-clinical safety,quality supervision,etc.In terms of clinical safety,no serious adverse reactions have been found,and the incidence of adverse reactions is generally low,the degree is mild and short.Overall safety is good and controllable.(2)Effectiveness:Meta-analysis showed that the total effective rate of FRKC combined with conventional western medicine was better than that of conventional Western medicine alone in treating acute bronchitis in children.Network meta-analysis of similar varieties showed that this product ranked first in terms of cough disappearance time,fever reduction time and rales disappearance time.The results of clinical investigation showed that doctors and patients recognized the efficacy of this product in the treatment of acute bronchitis in children.(3)Economy:Pharmacoeconomic studies showed that FRKC combined with conventional treatment has more cost-effectiveness advantages.(4)Suitability:The contents of the FRKC manual are complete and updated in a timely manner,the dosage form and taste are acceptable to children,and the transportation and storage are convenient,which can meet the whole packaging of medicine for

关 键 词：小儿肺热咳喘口服液 小儿急性支气管炎 风热犯肺证 临床综合评价 多准则决策分析 

分 类 号：R974[医药卫生—药品]