冠心病稳定期抗血小板治疗消化道不良反应的前瞻性队列研究
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“重大新药创制”科技重大专项(编号:2009ZX09502-031);国家自然科学基金(编号:81030063,81303150);国家中医药管理局中医药行业科研专项(编号:200707001,201007001)


Prospective Cohort Study on Gastrointestinal Adverse Reactions Induced by Antiplatelet Therapy in Coronary Heart Disease Patients in Stable Phase
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    摘要:

    目的:评价稳定性冠心病患者服用阿司匹林和/或氯吡格雷的消化道不良反应。方法:采用前瞻性队列研究设计,制定消化道不良反应调查表,经预调查并完善调查表后,观察符合稳定性冠心病入选标准(既往有心肌梗死病史或冠状动脉造影检查至少有一支冠状动脉狭窄≥50%,且近3个月内无明显心绞痛症状)患者的消化道不良反应。根据患者是否服用阿司匹林和/或氯吡格雷分为单抗组(仅阿司匹林或氯吡格雷)和双抗组两个队列。采用门诊和电话随访的方式每3个月随访1次,随访1年,观察并记录终点指标(非致死性心肌梗死、脑卒中、经皮冠状动脉介入术和/或冠状动脉旁路移植术的需求、心源性死亡以及总死亡)、消化道不良反应的表现及程度。采用卡方检验分析单抗和双抗的消化道不良反应发生率及消化道不良反应程度。结果:共计入选1 099例稳定性冠心病患者,其中单抗组401例,双抗组698例;两组在性别、年龄、冠心病病程、合并病、合并用药、阿司匹林服药史、氯吡格雷服药史、入选时消化道症状等方面无统计学意义(P>0.05)。两组同期比较,恶心或呕吐、胃痛、脘痞、腹胀或腹痛的发生率无统计学意义,然而在6个月、12个月随访时,双抗组出现反酸烧心的发生率要显著高于单抗组(P<0.05,P<0.01)。两组同期比较,6个月、12个月随访时,双抗组消化道不良反应总体发生率明显高于单抗组(P<0.05,P<0.01)。两组同期比较,6个月、12个月随访时,双抗组消化道不良反应积分也明显高于单抗组(P<0.05,P<0.01),两组终点指标发生率无统计学意义(P>0.05)。结论:长期服用阿司匹林和氯吡格雷双联抗血小板药物,消化道不良反应发生率高于单独服用阿司匹林或氯吡格雷。

    Abstract:

    To evaluate the gastrointestinal adverse reactions induced by aspirin and/or clopidogrel in patients with stable coronary heart disease (CHD). Methods:A prospective cohort study was designed using gastrointestinal adverse reaction questionnaire. After a preliminary investigation and consummating the questionnaire,the gastrointestinal adverse reactions of stable coronary heart disease (CHD) patients conforming to the criteria (having a history of myocardial infarction or coronary angiography examination showing at least a coronary artery stenosis 50% or higher and no obvious symptoms of angina pectoris nearly three months) were observed. The patients were divided into single-antiplatet group (aspirin or clopidogrel only) and dual-antiplatet group according to whether patients used aspirin and/or clopidogrel. We had one follow-up every 3 months for 1 year,using the outpatient service and telephone follow-up. We Observed and recorded the endpoint and gastrointestinal adverse reaction. The incidence and degree of gastrointestinal adverse reactions using chi-square were analyzed. Results:A total number of 1099 cases of patients met the inclusion criteria,including 401 cases of single-antiplatet group and 698 cases of dual-antiplatet group. There was no significant difference between both groups on sex,age,CHD history,complicating disease,aspirin medication history,clopidogrel medication history and digestive tract symptoms. There was no significant difference between single-antiplatelet group and dual-antiplatelet group in the incidence of nausea or vomiting,stomachache or gastric stuffiness,abdominal distension heartburn or abdominal pain at the same time(P>0.05). At the sixth and twelfth month of follow-up,compared with the single-antiplatet group,the incidence rate of pantothenic acid heartburn of dual- antiplatet was significantly higher(P<0.05,P<0.01. At the sixth and twelfth month of follow-up,compared with the single-antiplatet group,the overall incidence rate of gastrointestinal adverse reactions and gastrointestinal adverse reactions credits of dual- antiplatet group was significantly higher too(P<0.05,P<0.01). There was no statistical difference between two groups of the end index (P> 0.05).Conclusion:Long-term usage of antiplatelet drugs aspirin and clopidogrel can cause gastrointestinal adverse reactions higher than application of aspirin or clopidogrel only.

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张庆翔 高铸烨 史大卓 刘剑刚 徐 浩.冠心病稳定期抗血小板治疗消化道不良反应的前瞻性队列研究[J].世界中医药,2013,8(12).

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  • 收稿日期:2013-11-07
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  • 在线发布日期: 2013-12-30
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