摘要
目的通过对中成药渴络欣胶囊治疗糖尿病肾病进行临床综合评价,为糖尿病肾病的合理用药及卫生决策提供参考。方法采用系统性文献综述等方法,从安全性、有效性、经济性、创新性、适宜性和可及性6个维度对渴络欣胶囊治疗糖尿病肾病进行临床综合评价。结果渴络欣胶囊引起的不良反应发生率较低,轻度不良反应通过适当调整可有效缓解或消除,无严重不良事件发生;可有效降低24 h蛋白尿、血肌酐、尿素氮、空腹血糖及糖化血红蛋白水平(P<0.05);在最小成本分析中,渴络欣胶囊日均用药价格与其他益肾类药物中位值相比处于较低水平;该药物是我国首个取得治疗糖尿病肾病适应证的中成药,全方基于传统中医药理论并结合现代药理学研究,具有一定的创新性;贮藏便捷,服用方便,符合中成药治疗糖尿病肾病指南推荐,具有技术适宜性及临床使用适宜性;渴络欣胶囊产能充足,具有良好的可及性,治疗周期内药品总费用超过北京市最低日薪标准,价格可负担性有待提高。结论渴络欣胶囊用于治疗糖尿病肾病在6个维度的综合评价中均有良好的表现,具有较好的临床价值。
Objective To conduct a comprehensive clinical evaluation of keluoxin capsules in the treatment of diabetic kidney disease,aiming to provide a reference for the rational use of medication and health decision-making in clinical diabetic kidney disease.Methods A systematic literature review was employed,using a combination of qualitative and quantitative approaches to evaluate keluoxin capsules in the treatment of diabetic kidney disease from six dimensions:safety,efficacy,economy,innovation,appropriateness,and accessibility.Results The incidence of adverse reactions associated with keluoxin capsules was relatively low;mild adverse reactions could be effectively alleviated or eliminated through appropriate adjustments,with no serious adverse events reported.keluoxin capsules effectively reduced 24-hour proteinuria,serum creatinine,blood urea nitrogen,fasting blood glucose,and glycated hemoglobin levels(P<0.05).In a cost-minimization analysis,the average daily cost of keluoxin capsules was lower compared to the median prices of other medications.It was the first traditional Chinese medicine in China to obtain an indication for"treatment of diabetic kidney disease"based on traditional Chinese medicine theories combined with modern pharmacological research,demonstrating a certain degree of innovation.The product information is complete,appropriate for use without special monitoring,and aligns with guidelines for treating diabetic kidney disease with traditional Chinese medicine,indicating technical and clinical appropriateness.Keluoxin capsules have sufficient production capacity and good accessibility;however,the total cost of the medication during the treatment period exceeds the minimum daily wage standard in Beijing,indicating that affordability needs improvement.Conclusion Keluoxin capsules are characterized by safety,efficacy,economy,convenience of use,and wide coverage for treating diabetic kidney disease,demonstrating significant clinical value.
作者
孙格
方振威
韩嘉伦
曹景琳
赵翊如
张梦迪
石秀锦
林阳
SUN Ge;FANG Zhenwei;HAN Jialun;CAO Jinglin;ZHAO Yiru;ZHANG Mengdi;SHI Xiujin;LIN Yang(Department of Pharmacy,Beijing Anzhen Hospital,Capital Medical University,Beijing 100029,China;Department of Clinical Pharmacy,School of Pharmaceutical Sciences,Capital Medical University,Beijing 100069,China)
出处
《临床药物治疗杂志》
2024年第12期28-35,共8页
Clinical Medication Journal
关键词
渴络欣胶囊
糖尿病肾病
药品临床综合评价
keluoxin capsules
diabetic kidney disease
comprehensive clinical evaluation
