基于Meta分析的基因检测指导对个体化抗血小板治疗有效性和安全性研究  

Efficacy and Safety of Genotype-guided Individualized Antiplatelet Therapy:A Meta-analysis

作　　者：潘忙忙[1] 张弛[1] 李星霞[2] 李峥[3] 顾智淳 Pan Mangmang;Zhang Chi;Li Xingxia;Li Zheng;Gu Zhichun(Department of Pharmacy,Ren Ji Hospital,Shanghai Jiao Tong University School of Medicine,Shanghai 200127,China;Department of Pharmacy,Shanghai Jiao Tong University Affiliated Sixth People’s Hospital;Department of Cardiology,Ren Ji Hospital,Shanghai Jiao Tong University School of Medicine)

机构地区：[1]上海交通大学医学院附属仁济医院药剂科,上海200127 [2]上海交通大学附属第六人民医院药剂科 [3]上海交通大学医学院附属仁济医院心内科

出　　处：《药物流行病学杂志》2022年第5期314-320,352,共8页Chinese Journal of Pharmacoepidemiology

基　　金：上海市卫生健康委员会卫生行业临床研究专项(编号:20184Y0022);上海市临床药学重点专科建设项目(编号:2016-40044-002);上海市卫生计生系统重要薄弱学科建设项目(编号:2016ZB0304)。

摘　　要：目的:系统评价基因检测指导的个体化抗血小板治疗与常规治疗比较在急性冠状动脉综合征(ACS)或接受经皮冠状动脉介入治疗(PCI)患者中的有效性和安全性。方法:计算机检索PubMed、Cochrane Library、Embase、Web of Science、CNKI、WanFang Data、SinoMed数据库及中国临床试验注册中心(ChiCTR),搜集有关ACS或行PCI术的患者基因检测指导的个体化抗血小板治疗与常规抗血小板治疗比较的随机对照试验(RCT),检索时限均为从建库至2021年5月10日。由两位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用RevMan 5.3软件进行Meta分析。结果:共纳入5个RCT,累计6329例患者。Meta分析结果显示,与常规抗血小板治疗相比,基因检测指导的个体化抗血小板治疗可降低心肌梗死发生率[RR=0.57,95%CI(0.42,0.78),P<0.01]和支架内血栓形成发生率[RR=0.45,95%CI(0.25,0.80),P<0.01],两组的主要不良心血管事件(MACE)发生率[RR=0.73,95%CI(0.50,1.07),P=0.11]、全因死亡发生率[RR=0.82,95%CI(0.41,1.63),P=0.57]、任意出血发生率[RR=0.84,95%CI(0.58,1.23),P=0.37]、心血管死亡率[RR=0.78,95%CI(0.54,1.13),P=0.19]和卒中发生率[RR=0.70,95%CI(0.38,1.27),P=0.23]差异均无统计学意义;在安全性方面,两组大出血发生率差异无统计学意义[RR=0.88,95%CI(0.64,1.23),P=0.46],但基因指导治疗组可降低小出血发生率[RR=0.74,95%CI(0.59,0.94),P=0.01]。结论:基因检测指导的个体化抗血小板治疗相比于常规治疗虽未明显降低患者MACE、全因死亡、心血管死亡、卒中和任意出血、大出血等风险,但在降低患者心肌梗死、支架内血栓、小出血风险方面更有优势。基因检测指导的个体化抗血小板治疗方案可能更适合高危冠心病患者。Objective:To systematically review determine the efficacy and safety of individualized antiplatelet therapy guided by gene detection and conventional therapy in patients with acute coronary syndrome(ACS)or percutaneous coronary intervention(PCI).Methods:PubMed,Cochrane Library,Embase,Web of Science,CNKI,WanFang Data,SinoMed and ChiCTR were electronically searched to collect randomized clinical trials(RCTs)in which genotype-guided versus conventional therapy in patients with ACS or those undergoing PCI from inception to May 10th,2021.Two evaluators independently screened the literature,extracted the data and evaluated the bias risk included in the study.Then meta-analysis was performed by using RevMan 5.3 software.Results:A total of 5 RCTs involving 6329 patients were included.The results of meta-analysis showed that compared with the conventional treatment group,the genotype-guided group had a significantly lower incidence of myocardial infarction(RR=0.57,95%CI 0.42 to 0.78,P<0.01),incidence of stent thrombosis(RR=0.45,95%CI 0.25 to 0.80,P<0.01)and incidence of minor bleeding events(RR=0.74,95%CI 0.59 to 0.94,P=0.01).No significant difference was found between two groups for the risk of MACE(RR=0.73,95%CI 0.50 to 1.07,P=0.11),all-cause death(RR=0.82,95%CI 0.41 to 1.63,P=0.57),any bleeding events(RR=0.84,95%CI 0.58 to 1.23,P=0.37),cardiovascular death(RR=0.78,95%CI 0.54 to 1.13,P=0.19)and stroke(RR=0.70,95%CI 0.38 to 1.27,P=0.23).Conclusion:Compared with traditional therapy,genotype-guided antiplatelet treatment did not significantly reduce the risk of MACE,all-cause death,cardiovascular death,stroke,any bleeding and severe bleeding,but it had more advantages in reducing the risk of myocardial infarction,stent thrombosis and small hemorrhage.Individualized antiplatelet therapy guided by gene detection may be more suitable for patients with highrisk coronary heart disease.

关 键 词：抗血小板治疗 急性冠状动脉综合征 经皮冠状动脉介入治疗 基因检测指导 P2Y_(12)受体抑制药 META分析 

分 类 号：R973.2[医药卫生—药品]