摘要
目的:对肠炎宁颗粒治疗腹泻等相关研究进行系统梳理整合,分析肠炎宁颗粒的疗效与特点,为临床合理用药、医院采购及药品供应提供全面、科学的参考依据。方法:本研究基于循证医学、流行病学、药物经济学、卫生技术评估(HTA)等方法学,采用定性与定量相结合的评价方法,通过问卷调查、官网数据信息、已发表文献和真实世界数据的二次评估等,对肠炎宁颗粒的安全性、有效性、创新性、经济性、适宜性、可及性及中医药特色,“6+1”维度建立评价体系。结果:(1)安全性:肠炎宁颗粒的安全性综合评价为A,即安全性证据充足,结果明确,安全性好。(2)有效性:相比单用益生菌治疗方案,使用肠炎宁颗粒联合益生菌治疗小儿腹泻效果更好,评价为B级,即有效性较好。(3)经济性:相比单用益生菌治疗方案,使用肠炎宁颗粒联合益生菌治疗小儿腹泻在缩短止泻时间方面,平均每缩短1 d治疗时间,需要多花费29.7元,经济性评价为B级,即经济性证据比较充分,结果明确,经济性较好。(4)创新性:肠炎宁颗粒不仅对过快肠道蠕动有保护性抑制作用,还可解除平滑肌痉挛、恢复肠道动力功能,双向调节,止泻不便秘。创新性评价为B级,创新性较好。(5)适宜性:肠炎宁颗粒用法较易,无需特殊时间给药,评价为B级,即适宜性证据比较充分,适宜性较好。(6)可及性:肠炎宁颗粒中标价格9.16元/包或9.67元/包。限定日费用占城镇居民可支配收入中位数的0.08%~0.09%,占农村居民可支配收入中位数的0.31%~0.32%,可负担性较好;销售范围涉及31个省、市、自治区,可获得性好,综合评价等级为A,可及性好。(7)中医药特色:肠炎宁颗粒来源于民间验方,方中清热利湿药与行气药共用;该药上市后开展人用经验临床研究,评价其中医药特色得3个+,为B级,中医药特色维度证据比较充分,结果明确,肠炎宁颗粒中医药特色较突出。(8)临床价值综合评价:综合以上“6+1”维度,并结合多准则决策分析(MCDA)模型及通过临床证据与价值评估软件(CSC v2.0)进行计算,结果显示,肠炎宁颗粒临床价值证据比较充分,结果明确。结论:经全面评估,肠炎宁颗粒在安全性、可及性、有效性、创新性、适宜性、经济性、中医药特色及临床价值证据充分,结果清晰,结论明确。建议在满足特定条件的情况下,将相关政策成果转化为基本临床用药管理的实践指导,更好地服务于临床治疗。
Objective:To conduct a comprehensive review and synthesis of research pertaining to the treatment of diarrhea using Changyanning granules,showcasing their effectiveness and unique attributes,and thereby offering guidance for clinical rational drug utilization,hospital procurement strategies,and drug supply management.Methods:Incorporating evidence-based medicine,epidemiology,pharmacoeconomics,and health technology assessment(HTA),along with other relevant methodologies,this study employed a combined qualitative and quantitative evaluation approach.Through questionnaires,official website data information,published literature and secondary evaluation of real-world data,a total of"6+1"dimensions were used to build an evaluation system for the safety,effectiveness,economy,innovation,suitability,accessibility and characteristics of traditional Chinese patent medicines and simple preparations.Results:①Safety:The comprehensive safety evaluation of Changyanning granules was A,indicating sufficient safety evidence,clear results,and good safety.②Effectiveness:Compared with the treatment plan of using probiotics alone,the combination of Changyanning granules and probiotics demonstrated superior efficacy in treating pediatric diarrhea,and was evaluated as Grade B,indicating good effectiveness.3 Economy:Compared to probiotic monotherapy,the use of Changyanning granules combined with probiotics to treat pediatric diarrhea could shorten the duration of diarrhea by an average of 1 day,this additional day of treatment incurred an extra cost of 29.7 Yuan.The economic evaluation was B-level,which meant that the economic evidence was relatively sufficient,the results were clear,and the economy was good.④Innovation:Changyanning granules not only had a protective inhibitory effect on excessive intestinal peristalsis,but also could relieve smooth muscle spasm,restore intestinal motility,regulate bidirectionally,and stop diarrhea without constipation.The innovation evaluation was B-level,with good innovation.⑤Suitability:Changyanning granules was easy to use,no special administration time was required,and it was evaluated as grade B,indicating sufficient evidence of suitability and good suitability.⑥Accessibility:The winning bid price for Changyanning granules was 9.16 Yuan/pack or 9.67 Yuan/pack.The limited daily expenses accounted for 0.08%-0.09%of the median disposable income of urban residents and 0.31%-0.32%of the median disposable income of rural residents,indicating good affordability.The sales scope covered 31 provinces,municipalities,and autonomous regions,with good accessibility and a comprehensive evaluation level of A.7 Traditional Chinese medicine(TCM)characteristics:Changyanning granules was derived from a traditional folk formula,which had the functions of clearing heat and removing dampness with promoting Qi.Post-marketing clinical studies evaluating TCM characteristics of this drug yielded 3+ratings,placing it in grade B.The evidence of TCM characteristic dimension was relatively sufficient,and the results were clear,indicating that Changyanning granules exhibited particularly prominent TCM characteristics.8 Comprehensive evaluation of clinical value:Based on the"6+1"dimensions mentioned above,combined with multi-criteria decision analysis(MCDA)model and calculations using CSC v2.0 software,the results showed that there was sufficient evidence for the clinical value of Changyanning granules,and the results were clear.Conclusion:After comprehensive evaluation,Changyanning granules demonstrates sufficient evidences of safety,effectiveness,economy,innovation,suitability,accessibility and TCM characteristics and clinical value,with clear results and definitive conclusions.It is recommended that,under specific conditions,relevant policy achievements be translated into practical guidance for basic clinical medication management to better serve clinical treatment.
作者
马雨彤
王晓燕
路振凯
谢雁鸣
MA Yutong;WANG Xiaoyan;LU Zhenkai;XIE Yanming(Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,Beijing 100700,China)
出处
《中国实验方剂学杂志》
北大核心
2025年第23期164-172,共9页
Chinese Journal of Experimental Traditional Medical Formulae
基金
国家中医药管理局岐黄学者支持项目(国中医药人教函[2022]6号)
全国名老中医药专家传承工作室建设项目(国中医药人教函[2022]175号)。
关键词
肠炎宁颗粒
腹泻
湿热证
临床综合评价
多准则决策分析
安全性
有效性
Changyanning granules
diarrhea
damp-heat syndrome
clinicalcomprehensive assessment
multicriteria decision analysis
safety
effectiveness
