地榆升白片治疗白细胞减少症的临床综合评价OA
Clinical comprehensive evaluation of Diyu Shengbai Tablets in the treatment of leukopenia
目的 多维度探讨地榆升白片治疗白细胞减少症的临床综合价值,明确其临床优势,推进临床合理用药.方法 该研究以《药品临床综合评价管理指南(2021年版试行)》为依据,应用临床医学、流行病学、循证医学、药物经济学等方法学,采用文献研究和问卷调查的方式,利用多准则决策分析模型(MCDA)对地榆升白片的6+1维度进行综合评价,揭示地榆升白片的临床价值.结果 安全性方面:基于毒理学研究、国家不良反应监测中心数据、不良反应文献报道、药物警戒与风险管理等内容发现,地榆升白片安全性较高.有效性方面:系统评价与Meta分析结果显示,与利可君、鲨肝醇、维生素B4、苦参素等药物比较,地榆升白片在肿瘤放化疗、血液疾病、感染性疾病、精神疾病、内分泌疾病及儿童疾病治疗方面,改善白细胞计数,降低白细胞减少症、Ⅲ～Ⅳ度白细胞减少症发生率及升白细胞有效率效果均优于对照组.经济性方面:地榆升白片为国家医保乙类药物,与聚乙二醇化重组人粒细胞刺激因子(PEG-rhG-CSF)、重组人粒细胞集落刺激因子(rhG-CSF)、利可君联合鲨肝醇比较,更具经济效益.创新性方面:地榆升白片在适应证、用法、产业及生产工艺方面均有创新.适宜性方面,问卷调查结果提示,地榆升白片的医护及患者适宜性均高.可及性方面:地榆升白片价格低于同类医保及基本药物目录品种,经济负担小;医院覆盖率高,互联网医疗平台覆盖广泛;原药材资源丰富,产地分布广泛,药材可持续性好,总产能充足,可获得性高.中医药特色评价方面:地榆升白片药用历史悠久,应用广泛,为常用中药,且历代古籍也记载地榆具有促进造血的功效,中医药特色明显.结论 地榆升白片治疗白细胞减少症临床价值高.
Objective To explore the multi-dimensional clinical value of Diyu Shengbai Tablets in the treatment of leukopenia,clarify their clinical advantages,and promote rational drug use in clinical practice.Methods This study was conducted based on the Guidelines for the Management of Drug Clinical Comprehensive Evaluation(Trial Version 2021),applying methodologies from clinical medicine,epidemiology,evidence-based medicine,and pharmacoeconomics.Using literature research and questionnaire surveys,a multi-criteria decision analysis(MCDA)model was employed to comprehensively evaluate the"6+1"dimensions of Diyu Shengbai Tablets and reveal their clinical value.Results Safety:Based on toxicological studies,data from the National Adverse Reaction Monitoring Center,literature reports of adverse reactions,pharmacovigilance,and risk management,Diyu Shengbai Tablets were concluded to have high safety.Effectiveness:Systematic review and meta-analysis results showed that,compared with drugs such as Leucogen,Batilol,Vitamin B4,and oxymatrine,Diyu Shengbai Tablets were superior in improving white blood cell counts,reducing the incidence of leukopenia and grade III-IV leukopenia,and increasing the effective rate of white blood cell recovery in tumor radiotherapy and chemotherapy,blood disorders,infectious diseases,mental disorders,endocrine diseases,and pediatric diseases.Cost-effectiveness:Diyu Shengbai Tablets are Class B drugs in the national medical insurance catalog and are more economical than PEG-rhG-CSF,rhG-CSF,or the combination of Leucogen and Batilol.Innovation:Innovations were observed in indications,usage,industrial application,and production processes.Suitability:Questionnaire surveys indicated high suitability for both medical staff and patients.Accessibility:Diyu Shengbai Tablets are priced lower than similar drugs listed in the medical insurance and essential drug catalogs,imposing a small economic burden.They have high hospital coverage,extensive online medical platform availability,sufficient total production capacity,abundant and widely distributed raw medicinal material resources,and good sustainability.Traditional Chinese medicine characteristics:Diyu Shengbai Tablets have a long history of medicinal use and wide application as a commonly used TCM.Ancient texts also record that Sanguisorbae Radix promotes hematopoiesis,highlighting clear TCM characteristics.Conclusion Diyu Shengbai Tablets have high clinical value in the treatment of leukopenia.
彭博文;吴洁;陈信义;侯丽;陈晓涵;苌安;田英洁;焦倩
中国中医科学院广安门医院血液科,北京 100053中国中医科学院广安门医院血液科,北京 100053北京中医药大学东直门医院血液肿瘤科,北京 100700北京中医药大学东直门医院血液肿瘤科,北京 100700中国中医科学院广安门医院血液科,北京 100053中国中医科学院广安门医院血液科,北京 100053中国中医科学院广安门医院血液科,北京 100053中国中医科学院广安门医院血液科,北京 100053
地榆升白片白细胞减少症临床综合评价中成药
Diyu Shengbai Tabletsleukopeniaclinical comprehensive evaluationChinese patent medicine
《北京中医药》 2026 (1)
30-41,12
国家自然科学基金面上项目(82174200)中国中医科学院科技创新工程重大攻关项目(CI2021A01703)
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