XM-310型便携式心电图仪有效性与安全性的随机临床研究  

randomized clinical study on the efficacy and safety of XM-310 portable electrocardiograph

作　　者：周子杰[1] 韩智红[2] 李静[1] ZHOU Zijie;HAN Zhihong;LI Jing(Department of Drug Clinical Trial Institution Beijing Anzhen Hospital,Capital Medical University,Beijing Institute of Heart,Lung and Blood Vessel Diseases,Beijing 100029,China)

机构地区：[1]首都医科大学附属北京安贞医院-北京市心肺血管疾病研究所,药物临床试验机构办公室,100029 [2]首都医科大学附属北京安贞医院-北京市心肺血管疾病研究所心内科,100029

出　　处：《心肺血管病杂志》2023年第7期688-692,共5页Journal of Cardiovascular and Pulmonary Diseases

摘　　要：目的:验证XM-310型便携式心电图仪准确性与安全性。方法:这是一个验证XM-310型便携式心电图仪准确性与安全性的临床研究。总共入选120例患者,根据普通心电图诊断分别入选相应的心电图大致正常组、心律失常组、有ST段抬高或压低组。在各个组内,采用随机化配对设计方法,将患者进行自身对照研究。与日本福田心电图机比较,分析XM-310型便携式心电图仪所测得的各项心电图参数是否准确(包括心率、PR间期、QRS时程、QT间期、P波振幅、QRS高度、T波振幅、ST段与基线的距离等);XM-310型便携式心电图仪对于心律失常的诊断与ST段抬高或压低识别的准确性;XM-310型便携式心电图仪临床应用的安全性。结果:XM-310型便携式心电图仪与日本福田心电图机两组心电图测量参数比较,差异无统计学意义(P>0.05);对于心律失常的诊断与ST段抬高或压低识别的准确性达到100%;受试产品使用时无不良反应发生。结论:XM-310型便携式心电图仪临床使用的安全性和有效性及操作方便程度均与日本福田心电图机一致,临床使用安全、有效,且操作方便。Objective:To verify the accuracy and safety of XM-310 portable electrocardiograph.Methods:This was a clinical study to verify the accuracy and safety of XM-310 portable electrocardiograph.A total of 120 patients were selected into the normal ECG group,arrhythmia group,ST-segment elevation or depression group based on the general ECG diagnosis.Within each group,patients were enrolled in self-controlled studies using a randomized matching design.Compared with Fukuda electrocardiograph in Japan,the accuracy of various ECG parameters measured by XM-310 portable electrocardiograph was analyzed(including heart rate,PR interval,QRS time history,QT interval,P wave amplitude,QRS height,T wave amplitude,distance between ST-segment and baseline,etc.);At the same time,the accuracy of the XM310 portable electrocardiograph in the diagnosis of arrhythmia and the recognition of ST-segment elevation or depression and the safety of XM-310 portable electrocardiograph in clinical application were also analyzed.Results:There was no significant difference in ECG parameters between XM-310 portable electrocardiograph and Fukuda electrocardiograph(P>0.05).The diagnosis of arrhythmia and the recognition of ST-segment elevation or depression achieved 100%accuracy;No side effects occurred when the tested product was used.Conclusions:The XM-310 protable electrocardiograph is safe,effective and easy to operate,which is consistent with the Fukuda electrocardiograph.

关 键 词：心电图仪 心电图参数 准确性 

分 类 号：R54[医药卫生—心血管疾病]