發(fā)布時間：2018-01-11 03:01

  本文關鍵詞：急性冠脈綜合征患者置入藥物洗脫支架后應用雙聯(lián)抗血小板治療時間的Meta分析　出處：《河北醫(yī)科大學》2015年碩士論文　論文類型：學位論文

  更多相關文章： 雙聯(lián)抗血小板治療 藥物洗脫支架 急性冠脈綜合征 Meta分析 經(jīng)皮冠狀動脈介入治療

【摘要】：背景:雙聯(lián)抗血小板治療(DAPT)和經(jīng)皮冠狀動脈介入治療(PCI)均被證實為治療急性冠脈綜合征的有效臨床手段�，F(xiàn)階段對置入藥物洗脫支架(DES)后,DAPT的使用時間指南建議為12個月,以減少晚期或超晚期的支架內血栓的形成,對于ACS患者則建議延長DAPT使用時間。新一代的DES改良了血管愈合和再內皮化的特性,并越來越多投入臨床使用,有試驗表明其臨床療效優(yōu)于早期DES。應用光學相干斷層成像術(OCT)對二代和三代DES置入后血管進行觀察研究,也發(fā)現(xiàn)87%支架術后3個月內新生內膜完全覆蓋支架,提示不用延長DAPT應用時間的可能。這些發(fā)現(xiàn)進而引發(fā)了對DAPT使用時長的討論。大量臨床試驗在探索短期(≤6個月)與長期(≥12個月)雙聯(lián)抗血小板治療的安全性與有效性,以找出合理的應用時長。對于ACS患者,目前并沒有直接的臨床隨機試驗對該人群置入DES后應用DAPT的安全性與有效性進行研究,對其置入DES后DAPT的時間選擇有待進一步探討。目的:旨在通過對當前隨機臨床試驗中ACS患者臨床愈后的總結和Meta分析,評估ACS患者在置入DES后不同DAPT治療時間的臨床療效,進而推測出更為安全有效的DAPT使用時間。方法:通過參考《醫(yī)學科研方法》與Cochrane推薦的針對臨床治療的Meta分析方法制定了試驗方法。對Pub Med,Cochrane Library,Clinical Trials.gov,萬方和中國知網(wǎng),自2002年1月至2015年2月的文章進行檢索。并制定篩選標準,試驗須為臨床隨機對照試驗,研究主題為置入藥物釋放支架后使用雙聯(lián)血小板治療的時長,并包含ACS患者的亞組數(shù)據(jù),符合所有標準的試驗納入此Meta分析中。通過對納入試驗進行質量分析和數(shù)據(jù)整理,列出病人數(shù)量、試驗類型、隨訪時長、試驗分組等試驗特征。并在進行異質性檢驗后,合并分析短時間DAPT組與長時間DAPT組缺血事件與出血事件的發(fā)生率,對DAPT使用時間的安全性與有效性進行分析。結果:共納入6項試驗共涉及病人14471名,其中ACS患者6199名,占患者人數(shù)的42.8%。7236名患者接受短期DAPT治療(≤6個月),7235名患者接受長期DAPT治療(≥12個月),其中ACS患者各占42.6%和43%。對試驗進行異質性檢驗得到I2=0%和I2=30%,異質性較小,可采用固定效應模型計算合并后的綜合效應。對ACS患者短期(≤6個月)與長期(≥12個月)DAPT不同使用時間組進行統(tǒng)計學分析,得出缺血事件發(fā)生率組間P=0.41,差異無統(tǒng)計學意義;出血事件發(fā)生率組間P=0.007,差異有統(tǒng)計學意義。即短期或長期使用DAPT對死亡、心肌梗死、支架內血栓形成等缺血事件的發(fā)生無影響,但對出血事件發(fā)生率有影響。延長DAPT使用時間,增加了出血風險。鑒于本試驗采納有限的試驗信息,未來需要更多的臨床試驗來證明該結論。結論:對于ACS患者的DAPT使用,延長DAPT使用時間對缺血事件可以認為無影響,但增加了出血風險。從治療安全性考慮,短期DAPT組對ACS患者優(yōu)于長期使用DAPT。但鑒于當前有效的試驗信息,需要更多臨床隨機試驗進一步驗證。
[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.

【學位授予單位】：河北醫(yī)科大學
【學位級別】：碩士
【學位授予年份】：2015
【分類號】：R541.4

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本文編號：1407821