阴道用乳杆菌活菌胶囊治疗细菌性阴道病临床综合评价

Comprehensive clinical evaluation of live lactobacillus capsule for vaginal use in the treatment of bacterial vaginosis

目的:根据药品临床综合评价的要求和方法,比较治疗细菌性阴道病的微生态制剂(阴道用乳杆菌活菌胶囊和乳酸菌阴道胶囊)的临床综合价值,为我国《国家基本药物目录》遴选药物提供科学参考依据。方法:首先,根据《药品临床综合评价管理指南(试行)》2021年版,通过文献综述和专家调研构建细菌性阴道病微生态治疗药品的临床综合评价指标体系。其次,采用循证医学研究(文献系统评价等)、真实世界数据研究(医疗机构数据回顾性调查)的方法,根据指标体系对阴道用乳杆菌活菌胶囊和乳酸菌阴道胶囊各指标进行分析。结果:各维度综合评价结果显示,在安全性方面,阴道用乳杆菌活菌胶囊主要活性成分菌株安全性优于乳酸菌阴道胶囊;在有效性方面,阴道用乳杆菌活菌胶囊临床疗效与乳酸菌阴道胶囊无显著性差异;在经济性方面,阴道用乳杆菌活菌胶囊治疗细菌性阴道病相对乳酸菌阴道胶囊人均成本更低,更具经济性;在适宜性方面,阴道用乳杆菌活菌胶囊在适应证及治疗亚型人群的适宜性方面优于乳酸菌阴道胶囊;在可及性方面,二者的可负担性均较好,而阴道用乳杆菌活菌胶囊的可获得性(26.97%)高于乳酸菌阴道胶囊(16.36%)。在创新性方面,阴道用乳杆菌活菌胶囊在药品技术和安全性方面上的创新价值均优于乳酸菌阴道胶囊。结论:阴道用乳杆菌活菌胶囊在6个维度上总体具有较好的表现,其临床综合价值高于乳酸菌阴道胶囊。

Objective:According to the requirements and methods of comprehensive clinical evaluation of drugs,the clinical comprehensive value of microecological preparations(live lactobacillus capsule for vaginal use and lacidophilin vaginal capsules)for treating bacterial vaginosis is compared,providing scientific reference for the selection of drugs in the“National Essinal Drug List in China”.Methods:Firstly,the clinical comprehensive evaluation index system of microecological preparations for the treatment of bacterial vaginosis was constructed through literature review and expert research according to the“Guidelines for the management of comprehensive clinical evaluation of pharmaceuticals(2021 version Pilot)”.Secondly,each index of live lactobacillus capsule for vaginal use and lacidophilin vaginal capsules were analyzed according to the index system by using the methods of evidence-based medical research(systematic evaluation of literature,etc.)and real-world data research(retrospective survey of medical institution data).Results:In terms of safety,live lactobacillus capsule for vaginal use was safer than lacidophilin vaginal capsules in the main active ingredient strains.In terms of efficacy,there was no significant difference in clinical efficacy between live lactobacillus capsule for vaginal use and lacidophilin vaginal capsules.In terms of economy,live lactobacillus capsule for vaginal use was more economical than lacidophilin vaginal capsules,the per capital cost for the treatment of bacterial vaginosis was lower.In terms of suitability,live lactobacillus capsule for vaginal use was more suitable than lacidophilin vaginal capsules in the indications and therapeutic subpopulations.In terms of accessibility,both were more affordable,while the accessibility of live lactobacillus capsule for vaginal use(26.97%)was higher than that of lacidophilin vaginal capsules(16.36%).In terms of innovation,live lactobacillus capsule for vaginal use had better innovation value than lacidophilin vaginal capsules in technology and safety.Conclusion:Live lactobacillus capsule for vaginal use had better performance in all 6 dimensions and its overall clinical value higher than the lacidophilin vaginal capsules.