Nekrasov A A, Timoshchenko E S, Erofeeva S G, Karpukhina E V
Privolzhsky Research Medical University, Minin and Pozharsky square 10/1, Nizhny Novgorod 603950.
Municipal Clinical Hospital #5, Nesterova 34, Nizhny Novgorod 603005.
Kardiologiia. 2019 Apr 13;59(3S):43-51. doi: 10.18087/cardio.2536.
The aim of the study was to evaluate efficacy, safety and treatment compliance for different ASA forms (Aspirin Cardio, Cardiomagnyl and Trombo Ass) in a 6-month study.
A prospective 6-month open, comparative study originally included 600 patients with IHD and stable angina who received chronic therapy with different forms of aspirin. In the prospective part of the study, these patients were subdivided into four groups: group 1 consisted of 200 patients switched to Aspirin Cardio; group 2 - 200 pa - tients receiving chronic therapy with this drug; group 3 - 100 patients continuing on the Trombo Ass treatment; and group 4 - 100 pa - tients who had been treated with Cardiomagnyl for a long time. Efficacy, safety and compliance to the treatment were evaluated using standard tests and analogue scales; symptoms of dyspepsia were evaluated with a study-specific questionnaire. Switching to Aspirin Cardio (group 1) was on discretion of the physician in charge based on the history of gastrointestinal (GI) complications or significant manifestations of dyspepsia.
The efficacy in prevention of cardiovascular events was similar in all groups. No "major" or "minor, clinically significant" bleeding (ISTH) were observed. Proportions of patients with "minor" bleeding were similar in all groups with a tendency towards their decrease under the Aspirin Cardio treatment. After switching to Aspirin Cardio, positive changes in severity of GI symptoms by results of the questionnaire: a significant improvement of compliance by the treatment satisfaction index in group 1 and 2; and a 1.7 time decrease in the proportion of ASA-noncompliant patients were observed. According to the results of ROC analysis an average GI symptom score ≥3 predicted an improvement of compliance in case of switching to Aspirin Cardio with a diagnostic sensitivity of 72.3% and specificity of 51.1% (р=0.012) as well as alleviation of GI symptoms (sensitivity, 74.5%; specificity, 63.8%, р=0.001).
Different dosage forms of ASA are characterized with similar efficacy in prevention of cardiovascular events and effects on the risk of bleeding. Aspirin Cardio showed a better tolerability due to a less effect on GI symptoms. It provided a better compliance to chronic treatment. This study confirmed advisability of using the proposed questionnaire to evaluate GI symptoms for specification of prediction and modification of therapy.
本研究的目的是在一项为期6个月的研究中评估不同阿司匹林剂型(阿司匹林心脑健、心脉隆和曲克芦丁阿司匹林片)的疗效、安全性和治疗依从性。
一项为期6个月的前瞻性开放比较研究,最初纳入600例患有缺血性心脏病和稳定型心绞痛且接受不同剂型阿司匹林长期治疗的患者。在研究的前瞻性部分,这些患者被分为四组:第1组由200例换用阿司匹林心脑健的患者组成;第2组——200例接受该药物长期治疗的患者;第3组——100例继续使用曲克芦丁阿司匹林片治疗的患者;第4组——100例长期接受心脉隆治疗的患者。使用标准测试和类似量表评估疗效、安全性和治疗依从性;使用特定研究问卷评估消化不良症状。换用阿司匹林心脑健(第1组)由主管医生根据胃肠道(GI)并发症病史或消化不良的显著表现自行决定。
所有组在预防心血管事件方面的疗效相似。未观察到“严重出血”或“轻微、具有临床意义的出血”(国际血栓与止血学会标准)。所有组中“轻微出血”患者的比例相似,且在阿司匹林心脑健治疗下有下降趋势。换用阿司匹林心脑健后,根据问卷结果,胃肠道症状严重程度出现积极变化:第1组和第2组的治疗满意度指数显示依从性显著改善;阿司匹林不依从患者的比例下降了1.7倍。根据ROC分析结果,平均胃肠道症状评分≥3预测换用阿司匹林心脑健时依从性改善,诊断敏感性为72.3%,特异性为51.1%(p = 0.012),同时胃肠道症状缓解(敏感性74.5%;特异性63.8%,p = 0.001)。
不同剂型的阿司匹林在预防心血管事件方面疗效相似,对出血风险的影响也相似。阿司匹林心脑健对胃肠道症状的影响较小,耐受性更好。它为长期治疗提供了更好的依从性。本研究证实了使用所提出的问卷评估胃肠道症状以明确预测和调整治疗的可取性。