【摘要】 目的:比较目前国内获批上市的金双歧、培菲康、贝飞达、聚克和适怡等5种三联微生态活菌制品预防和治疗儿童及成人腹泻的临床综合价值。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、文献研究、比较研究、最小成本分析法等方法，从安全性、有效性、经济性、创新性、适宜性和可及性6个维度进行综合评价。结果:在安全性方面，5种药品在相关信息的描述上各有侧重，其中金双歧不含条件致病菌肠球菌，因此在菌株安全性方面表现更佳。在有效性方面，5种药品之间疗效无显著差异。在经济性方面，贝飞达、培菲康和金双歧的治疗成本在同一水平，聚克和适怡的治疗成本显著高于这3种药品。在创新性方面，金双歧和培菲康都属于国家一类生物制品，其中金双歧在说明书中还列有使用抗生素治疗无效的腹泻适应证。在适宜性方面，金双歧和适怡表现较好，两者说明书对儿童用药都有详细描述，其中金双歧对不同年龄组别的儿童有明确剂量推荐。在可及性方面，金双歧、培菲康略优于贝飞达、聚克和适怡。结论:5种药品的疗效无显著性差异，在其他5个维度的优势排序各有先后，临床宜根据患者实际情况合理选用药品。更多还原

【Abstract】 Objective: To conduct an evaluation of the clinical comprehensive value of triple viable bacteria microecological preparations, including Golden Bifid, Perficon, Bifid, JuKe, and ShiYi, in preventing and treating pediatric and adult diarrhea. Methods: In accordance with the “Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs(Trial Version 2021)”, the evaluation was carried out using methods of evidence-based medicine literature research, comparative studies, and cost-minimization analysis in six dimensions of safety, effectiveness, economy, innovativeness, suitability, and accessibility. Results: In terms of safety, the package inserts of the five medicines have different emphasis on the items related to safety. Particularly, Golden Bifid stands out for its safer strain composition due to absence of Enterococcus. In terms of effectiveness, it shows no significant differences among the evaluated medicines. In terms of economic performance, the treatment costs of Bifid, Perficon, and Golden Bifid are at the same level, whereas the treatment costs of JuKe and ShiYi are significantly higher. In terms of innovativeness, both Golden Bifid and Perficon are classified as class I biological products, which outrun the other three medicines. Moreover, Golden Bifid particularly includes indication of diarrhea unresponsive to antibiotic therapy. In terms of suitability, Golden Bifid and ShiYi perform better, especially regarding the suitability for pediatric use, both providing detailed descriptions for children’s medication. Golden Bifid, in particular, offers clear dosage recommendations for pediatric patients of different age groups. In terms of accessibility, Golden Bifid and Perficon are slightly better than Bifid, JuKe, and ShiYi. Conclusion: The effectiveness of these five triple viable bacteria microecological preparations shows no significant difference. Regarding the remaining five dimensions, the prioritization of advantages of the five medicines varies. Therefore, reasonable selection of medicines for treatment should be based on the actual situation in clinical practice.更多还原