Kusche Werner, Paxinos Rafaela, Haselmann Jutta, Schwantes Ulrich, Breddin Hans Klaus
A. CRO Clinical Research Services GmbH, Wiesbaden, Germany.
Adv Ther. 2003 Sep-Oct;20(5):237-45. doi: 10.1007/BF02849852.
To determine the tolerability of a glycine (Gly)-containing acetylsalicylic acid (ASA) preparation (Gly-ASA), investigators selected 1135 patients already receiving longterm antiplatelet therapy for a noninterventional trial of Gly-ASA 50 to 300 mg daily. After an average treatment period of 42.6 days, tolerability rating scores and the frequency of 5 gastrointestinal (GI) complaints were compared with those reported for any previous treatment, including plain ASA. After treatment with Gly-ASA, the mean percentage of patients without GI complaints increased more than 2-fold, from 28.2% to 60.6%. Furthermore, the mean percentage of patients reporting any GI symptoms as "always" present decreased from 8.5% to 0.5%. Gly-ASA tolerability was rated "excellent" or "good" by 98% of the patients. In 10 patients (0.9%), Gly-ASA treatment was terminated prematurely due to GI intolerance (n=4) and nonmedication-related causes (n=6). With respect to long-term treatment compliance, the improved tolerability profile observed with this Gly-ASA preparation indicates an important advantage over nonglycine-containing ASA alternatives.
为确定含甘氨酸（Gly）的阿司匹林（ASA）制剂（甘氨酸 - ASA）的耐受性，研究人员选择了1135名已接受长期抗血小板治疗的患者，进行每日50至300毫克甘氨酸 - ASA的非干预性试验。在平均42.6天的治疗期后，将耐受性评分以及5种胃肠道（GI）不适症状的发生频率与之前包括普通ASA在内的任何治疗报告的情况进行比较。接受甘氨酸 - ASA治疗后，无胃肠道不适症状的患者平均百分比增加了两倍多，从28.2%增至60.6%。此外，报告任何胃肠道症状“总是”出现的患者平均百分比从8.5%降至0.5%。98%的患者对甘氨酸 - ASA耐受性的评价为“优秀”或“良好”。10名患者（0.9%）因胃肠道不耐受（n = 4）和非药物相关原因（n = 6）提前终止了甘氨酸 - ASA治疗。关于长期治疗依从性，这种甘氨酸 - ASA制剂观察到的耐受性改善表明其相对于不含甘氨酸的ASA替代品具有重要优势。
