镁铝匹林抑制血小板聚集的Ⅱ期临床研究

A phase II clinical trial for evaluating the efficacy and safety of dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin in inhibition of platelet aggregation

目的:评价镁铝匹林(阿司匹林、甘羟铝、重质碳酸镁复方制剂)对心血管患者血小板聚集功能的影响。方法:选择需要服用阿司匹林抗血小板治疗且ADP诱导的血小板聚集率增高的患者223例,随机分为两组,即镁铝匹林组(113例)和阿司匹林组(110例),试验组给予镁铝匹林2片(含阿司匹林162 mg),对照组给予阿斯匹林150 mg口服。于用药前及用药6周后分别测定血小板聚集率。结果:两组的血小板聚集率均显著降低,组内比较有极显著差异。组间比较无显著差异(P=0.51)。两组患者血小板聚集抑制率分别为-(20.28±22.45)%,-(21.57±23.67)%。镁铝匹林组药物不良反应较阿司匹林组少。结论:镁铝匹林与普通阿司匹林对患者血小板聚集功能的作用无明显差别。镁铝匹林比普通阿司匹林不良反应少。

Objective：To evaluate the efficacy and safety of dihydroxyaluminum aminoacetateheavy magnesium carbonate-aspirin in inhibition of platelet aggregation in Chinese cardiovascular pa- tients. Methods： We enrolled 223 cardiovascular patients with high platelet aggregation rate who needed the treatment of aspirin. The patients were randomly divided into 2 groups and treated with either oral doses of dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin tablets （contain 162 mg aspirin） or aspirin tablets （150 mg） daily for 6 weeks. Platelet aggregation and urine 11-dTXB2 concentration were measured before and 6 weeks after administration. Results： The platelet aggregation in both groups was significantly inhibited 6 weeks after administration. There was no significant difference in inhibition of platelet aggregation between two groups - （20.28 ± 22.45 ） % vs - （21.57± 23.67 ） %. The incidence of adverse effects of dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin tablet was lower than those of aspirin tablet. Conclusion ： The inhibitive effect of dihydroxyaluminum aminoacetate-heavy magnesium carbonate-aspirin tablet on platelet aggregation is similar to, but its adverse effect is lower than that of aspirin tablet.