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  • 阮一鸣,胡方圆,贺佳*.生物可吸收支架与药物洗脱支架治疗心血管疾病的比较:临床试验meta分析[J].第二军医大学学报,2019,40(2):169-177    [点击复制]
  • RUAN Yi-ming,HU Fang-yuan,HE Jia*.Comparison of bioabsorbable stents and drug-eluting stents for cardiovascular disease: meta-analysis of clinical trial[J].Acad J Sec Mil Med Univ,2019,40(2):169-177   [点击复制]
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生物可吸收支架与药物洗脱支架治疗心血管疾病的比较:临床试验meta分析
阮一鸣,胡方圆,贺佳*
0
(海军军医大学(第二军医大学)卫生勤务学系卫生统计学教研室, 上海 200433
*通信作者)
摘要:
目的 比较生物可吸收支架与药物洗脱支架治疗心血管疾病的安全性和有效性。方法 计算机检索中国生物医学文献服务系统(SinoMed)、万方、中国知网(CNKI)、维普(VIP)、PubMed、Medline、Embase数据库,检索年限为1980年1月至2018年10月,筛选出符合纳入标准的临床试验研究文献,采用R 3.5.1软件计算评价指标比值比(OR)及95%置信区间(CI),评估生物可吸收支架与药物洗脱支架治疗心血管疾病的安全性和有效性。结果 最终纳入22项研究,包含33 570名研究对象。在合并的心脏冠状动脉疾病的临床试验随访结果中,生物可吸收支架相对于药物洗脱支架,主要的安全性指标、有效性指标差异均无统计学意义(P均>0.05),其中心源性死亡率合并OR(95% CI)为1.01(0.88,1.16)、总体死亡率合并OR(95% CI)为0.97(0.88,1.08)、心肌梗死发生率合并OR(95% CI)为0.98(0.87,1.10)、靶病变血运重建率合并OR(95% CI)为0.99(0.89,1.09)、靶血管血运重建率合并OR(95% CI)为1.03(0.95,1.13)。针对生物可吸收支架的应用目的对各时期支架内血栓发生率的合并分析中,临床确诊或疑似支架内血栓发生率合并OR(95% CI)为0.80(0.65,0.99),差异有统计学意义(P=0.042);早期支架内血栓发生率合并OR(95% CI)为0.97(0.69,1.37),差异无统计学意义(P=0.906);晚期支架内血栓发生率合并OR(95% CI)为0.61(0.43,0.86),差异有统计学意义(P=0.004)。结论 在冠心病的治疗中,不能认为生物可吸收支架与药物洗脱支架存在安全性或有效性的差异,但生物可吸收支架可降低支架内血栓尤其是晚期血栓的发生风险。
关键词:  生物可吸收支架  药物洗脱支架  血栓形成  临床试验  meta分析
DOI:10.16781/j.0258-879x.2019.02.0169
投稿时间:2018-12-27修订日期:2019-01-20
基金项目:上海市公共卫生三年行动计划重点学科建设项目循证公共卫生与卫生经济学(15GWZK0901).
Comparison of bioabsorbable stents and drug-eluting stents for cardiovascular disease: meta-analysis of clinical trial
RUAN Yi-ming,HU Fang-yuan,HE Jia*
(Department of Health Statistics, Faculty of Health Services, Naval Medical University(Second Military Medical University), Shanghai 200433, China
*Corresponding author)
Abstract:
Objective To compare the safety and effectiveness of bioabsorbable stents and drug-eluting stents for cardiovascular disease. Methods We searched SinoMed, Wanfang data, Chinese National Knowledge Infrastructure (CNKI), VIP, PubMed, Medline and Embase databases to obtain the clinical trial studies published between Jan. 1980 and Oct. 2018 according to inclusion criteria. The odds ratio (OR) and 95% confidence interval (95% CI) were calculated by the R 3.5.1 software to evaluate the safety and efficacy of bioabsorbable stents and drug-eluting stents in treatment of cardiovascular disease. Results A total of 22 studies with 33 570 subjects were included. Comparing the bioabsorbable stents with the drug-eluting stents, we found that OR (95% CI) for the main safety and effectiveness indicators were as follow:cardiac death (1.01[0.88, 1.16], P>0.05), all-caused death (0.97[0.88, 1.08], P>0.05), myocardial infarction (0.98[0.87, 1.10], P>0.05), target lesion revascularization (0.99[0.89, 1.09], P>0.05), and target vessel revascularization (1.03[0.95, 1.13], P>0.05). The OR (95% CI) was (0.80[0.65, 0.99], P=0.042) for the detection of confirmed or suspected stent thrombosis, (0.97[0.69, 1.37], P=0.906) for early stent thrombus, and (0.61[0.43, 0.86], P=0.004) for late stent thrombus. Conclusion In the treatment of coronary heart disease, the results of this meta-analysis indicate that there are no differences in safety or efficacy between bioabsorbable stents and drug-eluting stents. However, bioabsorbable stents can decrease the risk of stent thrombus, especially for the late stent thrombus.
Key words:  bioabsorbable stents  drug-eluting stents  thrombosis  clinical trial  meta-analysis