与替卡格雷(创新药)相比,评估非专利药替卡格雷 90 毫克(ticaspan®)单独使用和与阿司匹林 75 毫克联合使用的抗血小板作用:体外研究。

Journal of postgraduate medicine Pub Date : 2024-07-01 Epub Date: 2023-12-07 DOI:10.4103/jpgm.jpgm_346_23
S Kamat, S Jalgaonkar, P Marathe, S Karekar, D Uchil, S Revankar
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引用次数: 0

摘要

目的方法:招募 18 名志愿者,使用乳酸脱氢酶(LDH)测定法检测 18 名志愿者中 6 名志愿者的血小板活力。在 12 名志愿者中,使用血小板聚集仪对六个研究组的血小板聚集最大值(MPA)和血小板聚集抑制百分比(PI)进行了评估:结果:与二甲基亚砜组相比,当血小板与创新药或仿制药单独或与阿司匹林联合培养时,LDH 水平没有明显增加。与二甲基亚砜组相比,所有五个研究组的 MPA 值均显著降低(P < 0.01)。非专利药与创新药的 MPA 下降幅度无明显差异(P = 0.325)。同样,两组联合用药观察到的 MPA 也没有差异(P = 1.000),但与阿司匹林观察到的 MPA 有显著差异(P = 0.039,各组)。与阿司匹林组相比,四个研究组[单独使用普通药物组;单独使用创新药物组;普通药物+阿司匹林组;创新药物+阿司匹林组]的血小板聚集PI明显更高(P<0.01):结论:非专利药替卡格雷及其与阿司匹林联用的抗血小板效果与创新药及其与阿司匹林联用的效果相当。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Evaluation of the antiplatelet effect of generic ticagrelor 90 mg (ticaspan ® ) alone and in combination with aspirin 75 mg as compared to ticagrelor (innovator): An in vitro study.

Objective: To evaluate an in vitro antiplatelet effect of generic ticagrelor 90 mg (ticaspan) alone and in combination with aspirin 75 mg as compared to the innovator formulation of ticagrelor alone and in combination with aspirin among healthy Indian volunteers.

Methods: 18 volunteers were enrolled and platelet viability was tested using lactate dehydrogenase (LDH) assay in six of 18 volunteers. In 12 volunteers, maximum platelet aggregation (MPA) and percentage inhibition of platelet aggregation (PI) were assessed using a platelet aggregometer in six study groups.

Results: There was no significant increase in LDH levels when platelets were incubated with an innovator or generic drug alone and in combination with aspirin as compared to the dimethyl sulfoxide [DMSO] group. All five study groups showed a significant reduction in the MPA values compared to the DMSO group ( P < 0.01). The extent of decrease in MPA observed with the generic drug was not significantly different from the innovator drug ( P = 0.325). Similarly, the MPA observed with the two combination groups did not differ from each other ( P = 1.000), but it was significantly different from the MPA observed with aspirin ( P = 0.039, each). The PI of platelet aggregation was significantly more in four study groups [generic drug alone; innovator alone; generic drug + aspirin; and innovator drug + aspirin] ( P < 0.01) as compared to the aspirin group.

Conclusion: The generic ticagrelor and its combination with aspirin demonstrated an antiplatelet effect equivalent to the innovator drug and its combination with aspirin.

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