基于临床综合评价维度的地衣芽孢杆菌活菌胶囊价值分析  

Value of the live Bacillus licheniformis capsules:an analysis based on the clinical comprehensive evaluation dimensions

作　　者：门鹏[1,2] 韩晟 朱贺[3,4] 赵荣生 MEN Peng;HAN Sheng;ZHU He;ZHAO Rong-sheng(Department of Pharmacy,Peking University Third Hospital,Beijing 100191,China;Institute for Drug Evaluation,Peking University Health Science Center,Beijing 100191,China;School of Pharmaceutical Sciences,Peking University,Beijing 100191,China;International Research Center of Medicinal Administration,Peking University,Beijing 100191,China)

机构地区：[1]北京大学第三医院药剂科,北京100191 [2]北京大学医学部药物评价中心,北京100191 [3]北京大学药学院,北京100191 [4]北京大学医药管理国际研究中心,北京100191

出　　处：《中国医院药学杂志》2023年第7期788-794,共7页Chinese Journal of Hospital Pharmacy

基　　金：北京健康促进会科研项目(编号:Z2022021056010)。

摘　　要：目的:对地衣芽孢杆菌活菌(0.5 g规格)胶囊进行价值分析,为药品供应保障决策和临床合理用药提供一定的信息支持。方法:遵循《药品临床综合评价管理指南(2021年版试行)》推荐的6个评价维度,收集临床诊疗指南(含专家共识)、循证医学研究、药品说明书,以及真实世界药品价格、采购、销售数据,采用定性和定量分析方法进行比较。结果:在腹泻相关疾病、消化性溃疡和便秘等疾病的治疗中,地衣芽孢杆菌活菌(0.5 g规格)胶囊安全性良好,与双歧杆菌三联活菌和枯草杆菌二联活菌相比有一定的有效性优势,其月均药物治疗成本与地衣芽孢杆菌活菌其他剂型、规格品种相比基本一致或偏低,与相关口服益生菌制剂基本处于较低水平;在药品有效期和储存/运输条件、最小制剂单位活菌含量、给药便利性以及菌种适宜性等方面具有良好的临床适宜性,可负担性和可获得性较好;此外,该药作为我国自主研发的微生态活菌制剂具有一定的创新性。结论:地衣芽孢杆菌活菌(0.5 g规格)胶囊具有较好的临床价值,建议进一步丰富该品种在中国真实世界临床使用数据/证据。OBJECTIVE To provide support for drug supply guarantee decision-making and clinical rational drug use through analyzing the value of the live Bacillus licheniformis capsules(0.5 g per capsule).METHODS The clinical value was analyzed based on the six dimensions,according to the management guideline for clinical comprehensive evaluation of drugs(trial version in 2021).Based on clinical diagnosis and treatment guidelines(including expert consensus),various evidence-based medical studies,drug instructions,and prices,purchase and sales data,qualitative and quantitative analysis methods were used for comparison.RESULTS The live Bacillus licheniformis capsules(0.5 g per capsule)had good efficacy and safety in the treatment of diarrhea-related diseases,peptic ulcer and constipation,with certain advantages over the live Bifidobacterium triple bacteria formulation and the live Bacillus subtilis double bacteria formulation;its drug treatment cost was equivalent to or lower than other dosage forms and varieties with the same general name,and at a lower level compared to related oral probiotics;it also had good clinical suitability in terms of expiry date and storage/transportation conditions,the content of live bacteria in the minimum preparation unit,administration convenience and strain suitability,and the affordability and accessibility were better as well.CONCLUSION The live Bacillus licheniformis capsules(0.5 g per capsule)has good clinical value.It is suggested to further enrich the data/evidence of the real-world clinical use of the variety in China.

关 键 词：地衣芽孢杆菌 活菌制剂 综合评价 临床价值 

分 类 号：R917[医药卫生—药物分析学]