3种含有双歧杆菌的三联活菌剂治疗腹泻的临床综合评价  

Comprehensive clinical evaluation of three kinds of triple viable agents containing bifidobacteria in the treatment of diarrhea

作　　者：史桂泽 林腾飞 张田甜 蒋杰 SHI Gui-ze;LIN Teng-fei;ZHANG Tian-tian;JIANG Jie(Department of Pharmacy,School of Pharmacy,Jinan University,Guangzhou 511436,China;Shenzhen Institute of Advanced Technology,Chinese Academy of Sciences,Shenzhen 518000,China;Guangzhou Huabo Institute of Biophamaceuticals,Guangzhou 510520,China;Dongguan Research Institute,Jinan University,Dongguan 523000,China)

机构地区：[1]暨南大学药学院药学系,广州511436 [2]中国科学院深圳先进技术研究院,深圳518000 [3]广州华博生物制药研究所,广州510520 [4]暨南大学东莞研究院,东莞523000

出　　处：《中国新药杂志》2022年第4期397-408,共12页Chinese Journal of New Drugs

摘　　要：目的:比较3种含有双歧杆菌的三联活菌制剂:双歧杆菌乳杆菌三联活菌片(商品名:金双歧)、双歧三联活菌肠溶胶囊(商品名:贝飞达)和双歧杆菌三联活菌胶囊(商品名:培菲康)治疗儿童腹泻、成人腹泻的临床综合价值,以期为临床合理用药和政府决策提供参考。方法:根据《药品临床综合评价管理指南(试行)》2021年版相关要求,主要运用循证医学研究(文献系统评价等)、上市前临床试验研究、专家咨询等方法对金双歧、贝飞达和培菲康的安全性、有效性、经济性、适宜性、创新性和可及性这6个维度进行综合评估。结果:在安全性方面,金双歧治疗腹泻具有较好的安全性,尤其是金双歧因活性成分菌株中不含粪肠球菌,其安全性优于培菲康与贝飞达。在有效性方面,金双歧治疗腹泻有效性优于常规腹泻治疗方案,且非劣于贝飞达与培菲康。在经济性方面,在保证临床疗效的前提下,按照金双歧最低剂量使用,则金双歧治疗腹泻经济性优于培菲康和贝飞达。在创新性方面,金双歧在几个创新性维度上略优于贝飞达、培菲康。在适宜性方面,在适应证及治疗亚型人群、药品临床使用方法方式、儿童用药适宜性方面优于培菲康和贝飞达,不存在"用药靠掰、剂量靠猜"现象。在可及性方面,金双歧与培菲康可及性略优于贝飞达。结论:金双歧具有显著的安全性、临床必需性以及儿童适宜性,在6个维度上总体具有较好的表现,其临床综合价值高于贝飞达和培菲康。Objective:To compare the clinical comprehensive value of three triple viable preparations containing bifidobacteria:live combined bifidobacterium and lactobacillus tablets(trade name:Jin Shuangqi),bifid triple viable capsules dissolving at intestines(trade name:Bei Feida),and live combined bifidobacterium(trade name:Pei Feikang)in the treatment of diarrhea in children and adults,in order to provide references for clinical rational use of drugs and government decision-making.Methods:According to the relevant requirements of the“Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs(Trial Version 2021)”,using the evidence-based medicine research(document system evaluation,etc.),pre-market clinical trial research,expert consultation and other methods,The safety,effectiveness,economy,suitability,innovation and accessibility of live combined bifidobacterium,bifid triple viable capsules dissolving at intestines and live combined bifidobacteriumwill be comprehensively evaluated.Results:In terms of safety,live combined bifidobacterium has good safety in the treatment of diarrhea.In particular,the active ingredient strain of live combined bifidobacterium does not contain coccus faecalis,and its safety is better than that of live combined bifidobacterium and bifid triple viable capsules dissolving at intestines.In terms of effectiveness,live combined bifidobacterium is more effective in treating diarrhea than conventional diarrhea treatment programs,and is not inferior to bifid triple viable capsules dissolving at intestines and live combined bifidobacterium.In terms of economy,under the premise of ensuring clinical efficacy,using live combined bifidobacterium at the lowest dose,the economic efficiency of live combined bifidobacterium in treating diarrhea is better than that of live combined bifidobacterium and bifid triple viable capsules dissolving at intestines.In terms of innovation,live combined bifidobacterium is slightly better than bifid triple viable capsules dissolving at intestines and l

关 键 词：微生态制剂 腹泻 双歧杆菌乳杆菌三联活菌片 双歧三联活菌肠溶胶囊 双歧杆菌三联活菌胶囊 药品临床综合评价 

分 类 号：R956[医药卫生—药学] R975.3