摘要
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 systematically evaluate the outcomes of drug-eluting balloon （DEB） in treating coronary artery in-stent restenosis （ISR） by using meta-analysis and trial sequential analysis （TSA）. Methods We searched PubMed, EMbase, The Cochrane Library （Issue 4, 2016）, CNKI, CBM, VIP and WanFang Data to collect randomized controlled trials （RCTs） regarding the treatment of ISR by DEB from inception to April 2016. After two reviewers independently screened citations, extracted data and assessed the bias risk of included studies, we carried out meta- analysis and TSA analysis by using RevMan 5.3 version and TSA v0.9 respectively. Results A total of 10 RCTs involving 1 909 patients were included. Seven-hundred and forty-seven patients were included with regard to the comparison between DEB and POBA, 1 162 patients were recruited to compare DEB and drug-eluting stents （DES）. The results of meta-analysis revealed that DEB was associated with decreased mortality （OR=0.36, 95%CI 0.14 to 0.93, P=0.04）, compared with that of plain old balloon angioplasty （POBA）. And TSA showed that cumulative Z-curve strode the conventional threshold value but not the TSA threshold value which suggested a false positive result of meta-analysis. In comparison with that of POBA, DEB had a lower incidence of target lesion revascularization （TLR） （OR=0.16, 95%CI 0.07 to 0.38, P〈0.0I）. And the result of TSA displayed that the cumulative Z-curve strode both the conventional and TSA threshold value which validated the result of meta-analysis. Besides, the results of meta-analysis showed that there were no significant differences in mortality （OR=0.84, 95%CI 0.41 to 1.72, P=0.63） and TLR （OR=1.55, 95%CI 0.76 to 3.16, P=0.22） between DEB and DES. However, the result of TSA revealed that the cumulative Z-curve did not strode both the conventional and TSA threshold value, and the included sample size less was than required information size which suggested that the reliability of the meta-analysis neede
出处
《中国循证医学杂志》
CSCD
2016年第5期523-531,共9页
Chinese Journal of Evidence-based Medicine
基金
国家自然科学基金项目(编号:81400267)
