【作者】 林静；

【导师】 高卫真；

【作者基本信息】 天津医科大学 ， 药理学， 2014， 硕士

【摘要】 目的：应用Meta分析方法对比伐卢定与肝素单药治疗用于经皮冠状动脉介入治疗的安全性(主要心脏不良事件发生率、死亡率、心肌梗死发生率、大出血发生率和输血发生率等5方面)进行比较分析,为临床用药提供参考。方法：检索PubMed、EMbase、Cochrane Library、CBM、CNKI、维普和万方数据库(起始时间1990年1月,截止于2013年5月),获取相关临床对照试验资料,应用RevMan5.2软件进行统计分析。采用改良的Jadad量表和NOS量表分别对随机对照试验和观察性研究进行质量评价,比值比作为主要的合并效应量,各效应量均采用95%置信区间表示。采用Q和JI2检验方法定量分析进行异质性检验,当P>0.1(I2≤50%)时,表明纳入研究无异质性,使用固定效应模型。当P<0.1(I2>50%)时,表明纳入研究存在异质性,使用随机效应模型。采用Χ2检验进行统计学检验,当P_<0.05时,认为纳入研究合并统计量有统计学意义,最后对分析结果进行敏感性分析和对纳入研究进行发表偏倚评估分析。结果：共筛选出关于比伐卢定与肝素单药治疗用于经皮冠状动脉介入治疗文献14篇,患者29226例,其中观察试验研究9篇,患者21712例,随机对照试验研究5篇,患者7514例。纳入研究中患者平均年龄67岁,69%的患者为男性,37%的患者伴有糖尿病,21%的患者伴有慢性肾衰竭。分析结果表明,比伐卢定用于经皮冠状动脉介入治疗在死亡率与大出血发生率方面低于肝素。比伐卢定组与肝素组相比死亡率相对降低55.2%,[0.17%VS0.39％,OR合并=0.38,95％CI=[0.25,0.59],p<0.0001],比伐卢定组与肝素组相比大出血发生率相对降低24.2％,[2.01％VS2.65％,OR合并=0.67,95％CI=[0.55,0.80],P=0.0001]。比伐卢定用于经皮冠状动脉介入治疗在心肌梗死发生率方面与肝素相比未见明显减少。比伐卢定组与肝素组相比心肌梗死发生率相对降低8.4%,[4.43%VS4.84％,OR合并=0.97,95％CI=[0.77,1.23],P=0.83].比伐卢定用于经皮冠状动脉介入治疗在主要不良心脏事件发生率和输血发生率方面与肝素相比无显著差异。比伐卢定组与肝素组相比主要不良心脏事件发生率相对降低13.5％,[4.96％VS5.73％,OR合并=0.95,95％CI=[0.78,1.16],P=0.59],比伐卢定组与肝素组相比输血发生率相对降低7.9%,[2.90%VS3.15%,OR合并=0.91,95%CI=[0.76,1.08],P=0.28]。结论：比伐卢定用于经皮冠状动脉介入治疗在死亡率和大出血发生率方面低于肝素,在心肌梗死发生率方面未见减少,两药基本一样,在主要心脏不良事件和输血发生率方面与肝素治疗相比无显著差异,有待扩大样本量进一步进行系统分析。更多还原

【Abstract】 Objective:Using a systematic review and meta-analysis to compare outcomes bivalirudin versus heparin monotherapy on safety (incidence of MACEs, death, MI, major bleeding and transfusion) on percutaneous coronary intervention. This method can provide reference for clinical.Method:Articles were selected from PubMed, EMbase, Cochrane Library, CBM, CNKI, VIP and Wan-Fang database (all searches are starting in Jan1990and ending in May2013) for relevant information on controlled clinical trials. The RevMan5.2software was used for statistical analysis. The Modified Jadad scale and NOS scale were used for evaluate the quality for randomized controlled trials and observational studies, respectively. Outcomes were reported as Odds Ratio (OR) and the95%confidence interval (95%CI) for all studies. We examined heterogeneity across studies with the Q and I2test statistic methods. When P>0.1and I2<50%were considered to indicate homogeneity and then use the fixed effect model. When P<0.1and I2>50%were considered to indicate heterogeneity and then use the random effects model. Statistical test was used x2test method. When P≤0.05was considered the combined statistics values of included studies have statistically significant. Finally, we used the sensitivity and publication bias assessment method for further analysis results.Result:We retained14studies (29226paitents) about the comparing biavlirudin versus heparin monotherapy on safety in PCI, among which9studies (21712paitents) are observational studies and5studies (7514paitents) are RCT. In the all studies, most patients mean age were similar (67years old),69%of the patients were male,37%of patients with diabetes and21%of patients with chronic renal failure.The analysis shows that bivalirudin lower than heparin in mortality and the incidence of major bleeding in PCI. The bivalirudin group relative reduction55.2%in the mortality compared to heparin group,[0.17%VS0.39%, ORcom=0.38,95%CI=[0.25,0.59], P<0.0001], the bivalirudin group relative reduction24.2%in the incidence of major bleeding compared to heparin group,[2.01%VS2.65%, ORcom=0.67,95%CI=[0.55,0.80],P=0.0001].The bivalirudin had no obviously decrease compared with heparin in the incidence of MI in PCI. The bivalirudin group relative reduction8.4%in the incidence of MI compared to heparin group,[4.43%VS4.84%, ORcom=0.97,95%CI=[0.77,1.23],P=0.83].The bivalirudin had no significant difference compared with heparin in the incidence of MACEs and transfusion in PCI. The bivalirudin group relative reduction13.5%in the incidence of MACEs compared to heparin group,[4.96%VS5.73%, ORcom=0.95,95%CI=[0.78,1.16],P=0.59],The bivalirudin group relative reduction7.9%in the incidence of transfusion compared to heparin group,[2.90%VS3.15%, ORcom=0.91,95%CI=[0.76,1.08], P=0.28].Conclusion:The bivalirudin is superior to heparin in mortality and the incidence of major bleeding in PCI. The bivalirudin had no obviously decrease compare with heparin in the incidence of MI in PCI, and these two drugs basically similar. The bivalirudin had no significant difference in the incidence of MACEs and transfusion in PCI and pending further system analysis based on expand the sample size.更多还原