植入药物洗脱支架后短期与长期双联抗血小板疗效比较的Meta分析
投稿时间:2019-07-29  修订日期:2019-12-25  点此下载全文
引用本文:费舒扬,赵力,孙琳,张蓉,李晶,葛长江.植入药物洗脱支架后短期与长期双联抗血小板疗效比较的Meta分析[J].药学实践杂志,2020,38(1):81~87
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作者单位E-mail
费舒扬 首都医科大学附属北京安贞医院, 北京 100048  
赵力 解放军总医院第六医学中心, 北京 100048  
孙琳 解放军总医院第六医学中心, 北京 100048  
张蓉 解放军总医院第六医学中心, 北京 100048  
李晶 解放军总医院第六医学中心, 北京 100048  
葛长江 首都医科大学附属北京安贞医院, 北京 100048 cjge1116@163.com 
中文摘要:目的 评价短期(3~6个月)与长期(12个月)双联抗血小板治疗对冠状动脉药物洗脱支架植入后的临床效果。方法 研究病例包括稳定性心绞痛、急性冠脉综合征、无症状心肌缺血,均为原位血管病变。临床观察终点为:全因死亡、心源性死亡、心肌梗死、卒中、支架内血栓形成、靶病变再血管化治疗、严重出血、净不良临床事件(net adverse clinical event)。通过检索Pubmed、中国生物医学文献等中、英文数据库及手工检索,对符合条件的随机对照研究经质量评估、数据提取,进行Meta分析。结果 共计纳入12项随机对照研究。Detsky评分均大于5分。共计25 949个病例,随访率97.9%。两组在全因死亡(OR=0.86,95%CI 0.71~1.05,P=0.14)、心源性死亡(OR=0.94,95% CI 0.70~1.25,P=0.67)、支架血栓形成(OR=1.36,95%CI 0.94~1.98,P=0.11)、卒中(OR=1.01,95%CI 0.71~1.42,P=0.98)、靶病变再血管化(OR=0.121,95%CI 0.94~1.55,P=0.14)及净不良临床事件(OR=0.98,95%CI 0.83~1.14,P=0.75)均无明显差别;短期组随访期间心肌梗死发生率高于长期组(OR=1.27,95%CI 1.02~1.59,P=0.04),长期组严重出血的比例明显增加(OR=0.69,95%CI 0.50~0.95,P=0.02)。亚洲人群研究结果:长期治疗组全因死亡高于短期组(OR=0.72,95%CI 0.53~0.97,P=0.03),两组严重出血无明显差别。结论 依据限定的临床观察终点,短期双联抗血小板疗效不劣于长期组;7项亚组人群研究,长期组全因死亡率高,不排除与样本量偏少产生的偏移及(或)人群的个体差异有关,结果还有待进一步验证。此结果可作为临床工作警示,依据患者出血风险及冠状动脉病变结果个体化调整双联抗血小板周期。
中文关键词:双联抗血小板治疗  药物洗脱支架  急性冠脉综合征  稳定性心绞痛  随机对照研究  Meta分析
 
Comparison of short-term and long-term dual antiplatelet therapy after implantation of drug-eluting stents—Meta analysis
Abstract:Objective To evaluate the clinical effects of short-term (3-6 months) and long-term (12 months) dual antiplatelet therapy (DAPT) after the implantation of coronary drug-eluting stents (DES).Methods The eligibilities of the patients included stable angina, acute coronary syndrome and silent ischemia. The lesions were in a native coronary vessel. The clinical observation endpoints were all-cause death, cardiogenic death, myocardial infarction, stroke, stent thrombosis, target lesion revascularization, severe bleeding, and true adverse clinical events. The clinical observation endpoints were all-cause death, cardiogenic death, myocardial infarction, stroke, stent thrombosis, target lesion revascularization, severe bleeding, and true adverse clinical events. By searching Pubmed, Chinese biomedical literature and other Chinese and English databases and manual search, qualified randomized controlled studies were evaluated and data were extracted for meta-analysis.Results A total of 12 randomized controlled studies were conducted. Detsky scores were all greater than 5 points. There were a total of 25949 patients in the study with a follow-up rate of 97.9%. There were no significantly different in all cause death (OR=0.86,95%CI 0.71-1.05,P=0.14), cardiac death (OR=0.94,95% CI 0.70-1.25,P=0.67), stent thrombosis (OR=1.36,95%CI 0.94-1.98,P=0.11), stroke (OR=1.01,95%CI 0.71-1.42,P=0.98), target lesion revascularization (OR=0.121,95%CI 0.94-1.55,P=0.14),and true adverse clinical events (OR=0.98,95%CI 0.83-1.14,P=0.75). The incident rate of myocardial infarction during the follow-up period was higher in the short-term group than in the long-term group (OR=1.27, 95% CI 1.02-1.59, P=0.04). The proportion of severe bleeding in the long-term group increased significantly (OR=0.69, 95% CI 0.50-0.95, P=0.02). Asian population studies showed that all-cause mortality was higher in the long-term treatment group than in the short-term group (OR=0.72, 95% CI 0.53-0.97, P=0.03), and there was no significant difference in severe bleeding between the two groups.Conclusion According to the defined clinical observation endpoints, the short-term dual antiplatelet effect is not inferior to the long-term group. Seven asian group studies have shown that the long-term group has high all-cause mortality. It can not rule out the deviation and/or population caused by the small sample size or individual variation. The results need to be further verified. This result can be used as a clinical warning to adjust the dual antiplatelet cycle based on the individualized risk of bleeding and coronary lesions.
keywords:dual antiplatelet therapy  drug eluting stents  acute coronary syndrome  stable angina  randomized controlled trial  Meta analysis
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