单硝酸异山梨酯缓释胶囊治疗冠心病、心绞痛临床综合评价

Clinical comprehensive evaluation of isosorbide mononitrate sustained⁃release capsule in the treatment of coronary heart disease and angina pectoris

目的评价单硝酸异山梨酯缓释胶囊治疗冠心病、心绞痛的临床综合价值,以期为临床合理用药和政府决策提供参考。方法根据《药品临床综合评价管理指南(2021版试行)》和《心血管病药品临床综合评价技术指南(2022年版试行)》相关要求,主要运用文献研究法和专家咨询法对单硝酸异山梨酯缓释胶囊的安全性、有效性、经济性、适宜性、创新性和可及性6个维度进行综合评估。结果安全性方面,相关文献和说明书均表明头痛为缓释胶囊最主要的不良反应,且缓释胶囊和缓释片之间的安全性无统计学差异。有效性方面,使用单硝酸异山梨酯缓释胶囊对冠心病、心绞痛进行干预有显著效果,且与单硝酸异山梨酯缓释片有效性相当。经济性方面,无论是进行最小成本分析和成本⁃效果分析,研究品均具有一定的经济性。创新性方面,缓释胶囊在维持血药浓度和保证产品质量稳定方面有创新。适宜性方面,缓释胶囊与缓释片均具有良好的技术特点适宜性和使用适宜性。可及性方面,患者使用缓释胶囊的经济负担较低,且相关中选企业能有效保障缓释胶囊的供应和价格的稳定。结论单硝酸异山梨酯缓释胶囊在六个维度均具有良好的表现,其临床综合价值与单硝酸异山梨酯缓释片相当。

Objective To evaluate the clinical comprehensive value of isosorbide mononitrate sustained⁃release capsules in the treatment of coronary heart disease and angina pectoris,and to provide reference for clinical rational drug use and government decision⁃making.Methods According to the relevant requirements of the"Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(Trial Version 2021)"and the"Technical Guidelines for the Clinical Comprehensive Evaluation of Cardiovascular Disease Drugs(Trial Version 2022)",the safety,effectiveness,economy,suitability,innovation and accessibility of isosorbide mononitrate sustained⁃release capsules were evaluated by secondary literature research and expert consultation methods.Results In terms of safety,the relevant literature and instructions showed that headache was the worst adverse reaction of sustained⁃release capsules,and there was no significant difference in safety between sustained⁃release capsules and sustained⁃release tablets.In terms of effectiveness,the use of isosorbide mononitrate sustained⁃release capsules had a significant effect on coronary heart disease and angina pectoris,and the effectiveness was equivalent to isosorbide mononitrate sustained⁃release tablets.In terms of economy,the research products were economical regardless of the cost⁃minimization analysis and cost⁃effectiveness analysis.In terms of innovation,sustained⁃release capsules were innovative in maintaining blood drug concentration and ensuring the stability of product quality.In terms of suitability,both sustained⁃release capsules and sustained⁃release tablets had good technical characteristics and suitability for use.In terms of accessibility,the economic burden of patients using sustained release capsules was low,and the relevant selected enterprises could effectively guarantee the supply and price stability of sustained release capsules.Conclusion Isosorbide mononitrate sustained⁃release capsules have good performance in all six dimensions,and its clinical comprehensive value is equivalent to that of isosorbide mononitrate sustained⁃release tablets.