Clinical comprehensive evaluation of vaginal microecologics for the treatment of bacterial vaginosis

LAI Li-ting; ZHU Jian-hong; HUO Xiao-tong; ZHANG Tian-tian; JIANG Jie; WU Jun-yan; LI Sha

doi:10.20251/j.cnki.1003-3734.2025.02.016

Abstract：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.