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

作　　者：黄岩[1] 樊朝美[1] 胡大一[2] 杨新春[3] 贾三庆[4] 高炜[5] 黄一玲[1] 边文彦[1] 刘文玲[2] 丁枭伟[3] 郑平渝[4] 韩江莉[5] 李一石[1] 

机构地区：[1]中国医学科学院中国协和医学院阜外心血管病医院卫生部心血管药物临床研究重点实验室,北京100037 [2]北京大学人民医院,北京100044 [3]北京朝阳医院,北京100020 [4]北京友谊医院,北京100050 [5]北京大学第三医院,北京100083

出　　处：《中国新药杂志》2007年第24期2066-2068,2082,共4页Chinese Journal of New Drugs

摘　　要：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.

关 键 词：镁铝匹林 阿司匹林 血小板聚集 药效学 安全性 

分 类 号：R971.1[医药卫生—药品]