Clinical comprehensive evaluation of isosorbide mononitrate sustained-release capsule in the treatment of coronary heart disease and angina pectoris
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.
万方数据
维普
