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目的通过Meta分析和试验序贯分析(TSA)系统评价药物洗脱球囊(DEB)治疗冠状动脉支架内再狭窄(ISR)的疗效。方法计算机检索PubMed、EMbase、The Cochrane Library(2016年4期)、CNKI、CBM、VIP和WanFang Data数据库,搜集有关DEB治疗冠状动脉ISR的随机对照试验(RCT),检索时限均从建库至2016年4月。由2名评价员独立筛选文献、提取资料和评价纳入研究的偏倚风险后,采用Rev Man 5.3软件进行Meta分析,采用TSA v0.9软件进行TSA。结果最终纳入10个RCT,共1 909例患者,其中DEB vs.普通球囊血管成形术(POBA)747例,DEB vs.药物洗脱支架(DES)1 162例。Meta分析结果显示:与POBA组相比,DEB组患者死亡率明显降低[OR=0.36,95%CI(0.14,0.93),P=0.04],且TSA结果显示累积Z值跨过了传统界值,但未跨过TSA界值,提示Meta分析为假阳性结果。与POBA组相比,DEB组患者靶病变血管重建(TLR)率明显降低[OR=0.16,95%CI(0.07,0.38),P<0.01],且TSA结果显示累积Z值跨过了传统界值和TSA界值,进一步肯定了Meta分析的结果。DEB组和DES组患者死亡率[OR=0.84,95%CI(0.41,1.72),P=0.63]和TLR率[OR=1.55,95%CI(0.76,3.16),P=0.22]无明显差异,且TSA结果显示累积Z值既未穿过传统界值线也未穿过TSA界值线,样本量未达到期望信息量(RIS),提示该Meta分析结果尚有待更多研究予以证实。但在依维莫司洗脱支架(EES)的亚组分析中,DEB组患者较EES组TLR率明显增加[OR=3.37,95%CI(1.59,7.15),P<0.01],且TSA结果显示累积Z值跨过了传统界值和TSA界值,进一步肯定了Meta分析的结果。结论在降低冠状动脉ISR患者靶病变血管重建率方面,EES优于DEB,而DEB优于POBA;在降低冠状动脉ISR患者死亡率方面,尚需更多试验予以证明。
Objective To evaluate the efficacy of drug-eluting balloon (DEB) in the treatment of coronary stent restenosis (ISR) by Meta-analysis and Sequencing Analysis (TSA). Methods PubMed, EMbase, The Cochrane Library (2016 4), CNKI, CBM, VIP and WanFang Data were searched by computer. Randomized controlled trials (RCTs) on DEB for treatment of coronary artery coronary artery disease were collected. April. After two reviewers independently screened the literature, extracted data and assessed the risk of being included in the study, Meta-analysis was performed using Rev Man 5.3 software and TSA was performed using the TSA v0.9 software. Results A total of 1 909 patients were enrolled in 10 RCTs, including 747 cases of DEB vs. POBA and 1 162 cases of DEB vs. DES. The results of Meta-analysis showed that the mortality rate of DEB group was significantly lower than that of POBA group [OR = 0.36,95% CI (0.14,0.93), P = 0.04], and TSA showed that the cumulative Z value crossed the traditional threshold , But did not cross the TSA cutoff, suggesting a meta-analysis of false-positive results. Compared with POBA group, the target lesion revascularization (TLR) rate was significantly decreased in patients with DEB [OR = 0.16,95% CI (0.07,0.38), P <0.01], and the TSA results showed that the cumulative Z value crossed the traditional boundaries Values and TSA cutoffs, further confirming the results of Meta analysis. Mortality in the DEB and DES groups [OR = 0.84, 95% CI (0.41, 1.72), P = 0.63] and TLR rates [OR = 1.55,95% CI (0.76,3.16), P = 0.22] , And the TSA results showed that the cumulative Z value did not pass through the traditional cutoff line nor the TSA cutoff line, and the sample size did not reach the expected information amount (RIS), suggesting that the results of this Meta analysis have yet to be confirmed by more studies. However, in the subgroup analysis of everolimus-eluting stent (EES), the TLR rate was significantly increased in DEB group compared with EES group [OR = 3.37,95% CI (1.59, 7.15), P <0.01] It shows that the cumulative Z value crosses the traditional threshold and the TSA threshold, further confirming the result of Meta analysis. Conclusion EES is superior to DEB in reducing target vessel revascularization rate in coronary artery, and DEB is better than POBA. More trials are needed to reduce the mortality of ISR patients with coronary artery disease.