摘要
目的：对芪明颗粒治疗糖尿病视网膜病变的临床疗效及安全性进行综述，并对其经济性进行初步评价。方法：在CNKI中检索芪明颗粒治疗糖尿病视网膜病变的临床研究文献，采用Meta分析对其临床有效性及安全性进行统计合并。在Meta分析的基础上，对芪明颗粒的经济性进行初步评价。结果：对检索到的7项研究进行Meta分析，结果发现芪明颗粒治疗糖尿病视网膜病变的视力、眼底或中医证候疗效均显著高于羟苯磺酸钙。文献中不良事件报告较少，总体上芪明颗粒不良事件发生率低于羟苯磺酸钙。通过3个月疗程药品价格的比较，进行粗略的模拟药物经济学评价，在芪明颗粒与羟苯磺酸钙组患者其他医疗成本相同的保守假设下，芪明颗粒相对于羟苯磺酸钙的ICER在372.7元~679.9元之间。结论：现有的临床研究文献显示芪明颗粒治疗糖尿病视网膜病变的疗效优于羟苯磺酸钙，不良事件发生率可能更低。在初步短期模拟评价中，芪明颗粒的经济性可能由于优于羟苯磺酸钙，但该结论需要更加严谨的研究设计进一步验证。
Objective：To review the clinical efficacy and safety of Qiming granule for diabetic retinophathy and to conduct an initial economic evaluation. Methods：Clinical studies of Qiming granule for diabetic retinophathy in CNKI were retrieved. Statistical analysis of clinical efficacy and safety data was performed in meta-analyses. Following meta-analysis, an initial cost-effectiveness analysis was conducted. Results：Seven studies were included in meta-analysis. The clinical response rates defined by eyesight, fundus examination and TCM syndromes were significantly higher in Qiming group than calcium dobesilate group. Adverse events were rarely reported in the literature. The reported adverse events were fewer in Qiming group. Based on the assumption that other costs were same for the two groups, we compared the drug costs in three months, and simulated an initial economic evaluation. The ICERs of Qiming granule compared with calcium dobesilate was between 372.7 to 679.9 RMB per patient achieving response. Conclusion：The results in published clinical studies showed that the clinical efficacy of Qiming granule was superior to calcium dobesilate and the safety performance may be better. In the short time simulated economic evaluation, Qiming granule was cost-effective in comparison with calcium dobesilate. However, this result needs to be confirmed in more scientifically designed studies in the future.
出处
《药品评价》
CAS
2014年第2期33-39,共7页
Drug Evaluation
关键词
糖尿病视网膜病变
芪明颗粒
羟苯磺酸钙
疗效
药物经济学
Diabetic Retinopathy
Qiming Granule
Calcium Dobesilate
Clinical Efficacy
Economic Evaluation
