急性冠脉综合征患者置入药物洗脱支架后应用双联抗血小板治疗时间的Meta分析

发布时间：2018-01-11 03:01

本文关键词：急性冠脉综合征患者置入药物洗脱支架后应用双联抗血小板治疗时间的Meta分析　出处：《河北医科大学》2015年硕士论文　论文类型：学位论文

【摘要】：背景:双联抗血小板治疗(DAPT)和经皮冠状动脉介入治疗(PCI)均被证实为治疗急性冠脉综合征的有效临床手段。现阶段对置入药物洗脱支架(DES)后,DAPT的使用时间指南建议为12个月,以减少晚期或超晚期的支架内血栓的形成,对于ACS患者则建议延长DAPT使用时间。新一代的DES改良了血管愈合和再内皮化的特性,并越来越多投入临床使用,有试验表明其临床疗效优于早期DES。应用光学相干断层成像术(OCT)对二代和三代DES置入后血管进行观察研究,也发现87%支架术后3个月内新生内膜完全覆盖支架,提示不用延长DAPT应用时间的可能。这些发现进而引发了对DAPT使用时长的讨论。大量临床试验在探索短期(≤6个月)与长期(≥12个月)双联抗血小板治疗的安全性与有效性,以找出合理的应用时长。对于ACS患者,目前并没有直接的临床随机试验对该人群置入DES后应用DAPT的安全性与有效性进行研究,对其置入DES后DAPT的时间选择有待进一步探讨。目的:旨在通过对当前随机临床试验中ACS患者临床愈后的总结和Meta分析,评估ACS患者在置入DES后不同DAPT治疗时间的临床疗效,进而推测出更为安全有效的DAPT使用时间。方法:通过参考《医学科研方法》与Cochrane推荐的针对临床治疗的Meta分析方法制定了试验方法。对Pub Med,Cochrane Library,Clinical Trials.gov,万方和中国知网,自2002年1月至2015年2月的文章进行检索。并制定筛选标准,试验须为临床随机对照试验,研究主题为置入药物释放支架后使用双联血小板治疗的时长,并包含ACS患者的亚组数据,符合所有标准的试验纳入此Meta分析中。通过对纳入试验进行质量分析和数据整理,列出病人数量、试验类型、随访时长、试验分组等试验特征。并在进行异质性检验后,合并分析短时间DAPT组与长时间DAPT组缺血事件与出血事件的发生率,对DAPT使用时间的安全性与有效性进行分析。结果:共纳入6项试验共涉及病人14471名,其中ACS患者6199名,占患者人数的42.8%。7236名患者接受短期DAPT治疗(≤6个月),7235名患者接受长期DAPT治疗(≥12个月),其中ACS患者各占42.6%和43%。对试验进行异质性检验得到I2=0%和I2=30%,异质性较小,可采用固定效应模型计算合并后的综合效应。对ACS患者短期(≤6个月)与长期(≥12个月)DAPT不同使用时间组进行统计学分析,得出缺血事件发生率组间P=0.41,差异无统计学意义;出血事件发生率组间P=0.007,差异有统计学意义。即短期或长期使用DAPT对死亡、心肌梗死、支架内血栓形成等缺血事件的发生无影响,但对出血事件发生率有影响。延长DAPT使用时间,增加了出血风险。鉴于本试验采纳有限的试验信息,未来需要更多的临床试验来证明该结论。结论:对于ACS患者的DAPT使用,延长DAPT使用时间对缺血事件可以认为无影响,但增加了出血风险。从治疗安全性考虑,短期DAPT组对ACS患者优于长期使用DAPT。但鉴于当前有效的试验信息,需要更多临床随机试验进一步验证。
[Abstract]:Background: dual antiplatelet therapy (DAPT) and percutaneous coronary intervention (PCI) were identified as effective means of clinical treatment of acute coronary syndrome. At the present stage of drug eluting stents (DES), the use of DAPT time guidelines for 12 months, in order to reduce the formation of advanced or ultra late stent the thrombus, for patients with ACS is proposed to extend the service time of DAPT. A new generation of DES improved the vascular healing and re endothelialization characteristics, and more and more into clinical use, a test showed that the clinical curative effect of early application of DES. optical coherent tomography (OCT) were studied on the two generation and the three generation of DES after implantation of vascular stent, also found that 87% within 3 months after the stent neointimal coverage, suggesting that DAPT may not extend the application time. These findings led to a discussion on DAPT when using long. A large amount of clinical trials in the To explore the short-term (less than 6 months) and long-term (12 months) the effectiveness and safety of dual antiplatelet therapy, in order to find out the reasonable application time. For patients with ACS, there is no randomized clinical trials of direct application of DAPT in this population with DES's safety and effectiveness were studied. Further research is needed to the choice of DAPT time after DES implantation. Objective: to based on the current randomized clinical trials of ACS patients after healing up and Meta, to evaluate the clinical efficacy in patients with ACS after DES implantation in different DAPT treatment time, and thus make more safe and effective use of time. Methods: by DAPT with reference to Cochrane < medical research methods recommended for clinical treatment > Meta analysis method developed test method for Pub Med, Cochrane Library, Clinical Trials.gov, and China HowNet Wanfang, from January 2002 to February 2015 The retrieval. And to develop screening criteria, test required for clinical randomized controlled trials, using double antiplatelet therapy research theme for the placement of drug-eluting stents after long, and contains a subgroup of ACS patients included in the test data, to meet all standards. Based on the analysis of the Meta into the test quality analysis and data collection list, the number of patients, the types of test, follow-up duration, test group test features. And in heterogeneity test, combined with analysis of the incidence of short time and long time DAPT group DAPT group of ischemic events and bleeding events, the DAPT safety and efficacy were analyzed using time. Results: a total of 6 trials involving a total of 14471 patients, including 6199 patients with ACS, accounting for the number of patients with 42.8%.7236 patients receiving short-term DAPT treatment (within 6 months), 7235 patients receiving long-term DAPT treatment (12 months), which with ACS Each accounted for 42.6% and 43%. test for heterogeneity test of I2=0% and I2=30%, the heterogeneity is small, can calculate the combined effects of the fixed effect model. The ACS patients with short-term (less than 6 months) and long-term (12 months) DAPT different time group for statistical analysis, draw the ischemic events the incidence of P=0.41 between groups, the difference was not statistically significant; the occurrence rate of bleeding between groups P=0.007, the difference was statistically significant. The short-term or long-term use of DAPT of death, myocardial infarction, in stent thrombosis without affecting ischemic events, but the incidence of bleeding events affected. Prolong service time of DAPT, increased the risk of bleeding. In view of this experiment adopted test information limited, the future more clinical trials are needed to prove the conclusion. Conclusion: for ACS patients with the use of DAPT, prolong the service time of ischemic events can be considered without affecting DAPT, However, the risk of bleeding is increased. Considering the safety of treatment, the short-term DAPT group is superior to DAPT. in long-term ACS patients. However, considering the current effective test information, more clinical randomized trials are needed for further validation.

【学位授予单位】：河北医科大学
【学位级别】：硕士
【学位授予年份】：2015
【分类号】：R541.4

【参考文献】