硫酸氯吡格雷各种药物替代品的成本最小化分析

A. Yahya, Ata ul Razzaq Khan, W. Naeem, S. Bashir, B. Murtaza, Aqeel Aslam
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引用次数: 0

摘要

心脏病很普遍,占美国所有死亡人数的四分之一。氯吡格雷广泛用于各种心脏疾病,但价格高昂。考虑到所有干预措施具有完全相同的健康效果,并且在健康益处和不利影响方面必须具有生物等效性,成本最小化分析(CMA)根据价格区分各种替代疗法。使用四种上市产品进行溶出研究,使用六阶段II型溶出仪进行。用紫外可见分光光度计在240nm处对样品进行分析。根据盐酸氯吡格雷RS构建的校准曲线计算30min后各样品的浓度值,并采用方差分析分析活性溶出量之间的显著差异。发现Plavix的释放率最高,为97%,而Ogrel的SEM最低,为3.9,释放率为95%。低洼地和Pidogrel的平均释放率均大于85%,但其SEM和林分偏差较大,单位含量差异较大。方差分析结果p>0.05,表明活性溶出物的均数差异无统计学意义,证明生物等效性。CMA得出结论,Ogrel可以代替更昂贵的Plavix。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
COST-MINIMIZATION ANALYSIS OF VARIOUS PHARMACEUTICAL ALTERNATIVES OF CLOPIDOGREL BISULFATE
Heart disease is widespread, and accounts for a quarter of all deaths in the US. Clopidogrel is used extensively for various cardiac conditions but has a high price. Cost-minimization analysis (CMA) differentiates alternative therapies based on price, given that all of the interventions have exactly the same health effects and must be bioequivalent when it comes to health benefits and adverse effects. Dissolution studies, using four marketed products, were conducted using a six stage, type II dissolution apparatus. Samples were analyzed at 240nm using a UV-VIS spectrophotometer. Concentration values of each sample, taken after 30 minutes were calculated from the calibration curve constructed with Clopidogrel Bisulfate RS. ANOVA was used to analyze any significant differences between the means of active dissolved. Plavix was found to have the highest percentage release of 97% but Ogrel had the least SEM of 3.9 with a percentage release of 95%. Lowplat and Pidogrel, although showed average percent releases of greater than 85%, their SEM and stand deviations were large showing widespread variations in unit contents. ANOVA gave a p>0.05, indicating a non-statistically significant difference between the means of active dissolved hence proving bioequivalence. CMA concluded that Ogrel may be used instead of the more expensive Plavix.
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