摘要
目的运用药品临床综合评价方法,对比多糖铁复合物胶囊(红源达和力蜚能)与琥珀酸亚铁缓释片(速力菲)治疗妊娠期缺铁性贫血的临床综合价值。方法以《药品临床综合评价管理指南(2021年版试行)》为重要依据,采用查阅工具书和说明书、Meta分析、真实世界回顾性研究、调研问卷等方法,以红源达和力蜚能为研究药品,以速力菲为对照药品,从有效性、安全性、经济性、创新性、适宜性、可及性六个维度进行药品临床综合评价。结果在有效性方面,红源达和力蜚能升高血红蛋白和铁蛋白效果优于速力菲(P<0.05);在安全性和创新性方面,力蜚能不良反应发生率较低,产品专利较多;在可及性和经济性方面,红源达的医疗机构配备率较高,治疗成本较低;在适宜性方面,三种药品未见明显差异。结论汇集各维度证据发现,红源达和力蜚能在多个维度优于速力菲,红源达的可及性和经济性较为突出,力蜚能的安全性和创新性较突出。
AIM To compare the clinical value of polysaccharide iron complex capsule(Hongyuanda and NIFEREX)and ferrous succinate sustained-release tablet(Sulifei)in the treatment of iron deficiency anemia in pregnancy by using the conception of clinical comprehensive evaluation of drugs.METHODS Based on the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs(Trial Edition 2021),the methods of consulting reference books and instructions,meta-analysis,real-world retrospective study,and survey questionnaires were adopted to analyze the clinical comprehensive drug evaluation from six dimensions including effectiveness,safety,economy,innovation,suitability,and accessibility,with Hongyuanda and NIFEREX used as research drugs and Sulifei used as control drugs.RESULTS In terms of effectiveness,Hongyuanda and NIFEREX had better effect on increasing hemoglobin than Sulifei(P<0.05).In terms of safety and innovation,NIFEREX has a low incidence of adverse reactions and more product patents.In terms of accessibility and economy,Hongyuanda has a higher rate of availability rate in medical institutions and a lower cost of treatment.In terms of suitability,there was no significant difference between the three drugs.CONCLUSION A comprehensive synthesis of the evidence across dimensions shows that Hongyuanda and NIFEREX are superior to Sulifei in many dimensions.Hongyuanda has outstanding accessibility and economy,and NIFEREX has outstanding safety and innovation.
作者
陈伟
焦萍
李国辉
CHEN Wei;JIAO Ping;LI Guo-hui(Department of Pharmacy,Jinan Maternity and Child Care Hospital,Ji-nan SHANDONG 250000,China)
出处
《中国新药与临床杂志》
北大核心
2025年第12期953-960,共8页
Chinese Journal of New Drugs and Clinical Remedies
基金
山东省第二批药品临床综合评价项目(2022YZ016)
山东省医学会临床科研资金——齐鲁专项(YXH2022ZX02073)。
关键词
药品临床综合评价
妊娠期
缺铁性贫血
多糖铁复合物胶囊
琥珀酸亚铁缓释片
clinical comprehensive drug evaluation
duration of pregnancy
iron deficiency anemia
polysaccharide iron complex capsules
ferrous succinate sustained-release tablets
