阴道用微生态制剂治疗细菌性阴道病临床综合评价  

Clinical comprehensive evaluation of vaginal microecologicsfor the treatment of bacterial vaginosis

作　　者：赖丽婷 朱建红 霍晓潼[1] 张田甜 蒋杰[1] 伍俊妍[2] 李沙[1] LAI Li-ting;ZHU Jian-hong;HUO Xiao-tong;ZHANG Tian-tian;JIANG Jie;WU Jun-yan;LI Sha(School of Pharmacy,Jinan University,Guangzhou 510000,China;Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University,Guangzhou 510000,China)

机构地区：[1]暨南大学药学院,广州510000 [2]中山大学孙逸仙纪念医院,广州510000

出　　处：《中国新药杂志》2025年第2期217-224,共8页Chinese Journal of New Drugs

摘　　要：目的:比较阴道用乳杆菌活菌胶囊(定君生)和乳酸菌阴道胶囊(延华)2种阴道用微生态制剂治疗细菌性阴道病(bacterial vaginosis, BV)的药品临床综合价值,为临床用药和药品目录遴选决策提供依据。方法:根据《药品临床综合评价管理指南(2021年版试行)》相关要求,采用循证医学、比较研究、最小成本分析法等方法,对2种药品治疗BV的安全性、有效性、经济性、创新性、适宜性和可及性进行综合评估。结果:在安全性方面,定君生不包含潜在的条件致病菌肠球菌,在菌株安全性方面优于延华。在有效性方面,二者治疗BV的效果无显著差异。在经济性方面,基于文献研究的用法用量,延华的经济性优于定君生;而基于真实世界研究的用法用量结果相反,定君生更便宜。在创新性方面,定君生国内首创采用阴道原籍菌及更安全的菌株组成设计,较延华更具优势。在适宜性方面,定君生优于延华。在可及性方面,二者治疗BV的价格水平、可负担性均较好,定君生可获得性更优。结论:整体上,2种药品在临床使用中安全性和有效性相当。定君生作为国内首创采用阴道原籍菌乳杆菌的活菌制剂,在创新性和安全性方面具有一定优势。Objective:To conduct a comprehensive clinical evaluation of live lactobacillus capsule for vaginal use(Dingjunsheng)and lacidophilin vaginal capsules(Yanhua)in the treatment of bacterial vaginosis(BV)to provide evidence for decision of clinical usage and drug list selection.Methods:In accordance with the“Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs(Trial Version 2021)”,methods like evidence-based medicine research,comparative studies,and cost-minimization analysis were utilized to comprehensively evaluate the safety,efficacy,economy,innovation,suitability,and accessibility of the two drugs in the treatment of BV.Results:In terms of safety,Dingjunsheng does not include Enterococcus,thereby demonstrating superior strain safety compared to Yanhua.In terms of effectiveness,there is no significant difference between Dingjunsheng and Yanhua in the treatment of BV.In terms of economic performance,based on the usage and dosage reported in literature,Yanhua shows better economy than Dingjunsheng in general senario.However,the results are inverted when based on the usage and dosage of real-world study,i.e.,Dingjunsheng is cheaper than Yanhua.In terms of innovation,compared to Yanhua,Dingjunsheng has a safer and more creative strain composition.In terms of suitability,Dingjunsheng is superior to Yanhua.In terms of accessibility,the price level and affordability of both medicines in treating BV are good,with Dingjunsheng of higher availability than Yanhua.Conclusion:Overall,Dingjunsheng and Yanhua exhibit comparable safety and effectiveness in clinical use.As a microecological preparation initiatively employing vaginal indigenous Lactobacillus in domestic,Dingjunsheng demonstrates certain advantages in innovativeness and safety.

关 键 词：微生态制剂 细菌性阴道病 药品临床综合评价 定君生 延华 

分 类 号：R969.3[医药卫生—药理学]