贴片式心电仪临床应用的有效性和安全性研究  

Effectiveness and Safety of Patch Electrocardiograph in Monitoring Heart Rate and Arrhythmia: Clinical Application in 274 Patients

作　　者：李瑶 蒋捷[2] 张海涛[3] 石亚君[4] 陈尔冬[2] 王学良[3] 张海澄[1] LI Yao;JIANG Jie;ZHANG Haitao;SHI Yajun;CHEN Erdong;WANG Xueliang;ZHANG Haicheng(Department of Cardiology,Peking University People's Hospital,Beijing(100044),China)

机构地区：[1]北京大学人民医院心内科,北京市100044 [2]北京大学第一医院 [3]中国人民解放军空军总医院 [4]中国人民解放军总医院

出　　处：《中国循环杂志》2019年第12期1196-1200,共5页Chinese Circulation Journal

基　　金：浙江省科技计划项目“2018年度重点研发计划项目”（2018C01037）

摘　　要：目的:评估贴片式心电仪监测心率、心律失常方面的有效性和安全性。方法:研究纳入北京大学人民医院、北京大学第一医院、中国人民解放军空军总医院的18周岁以上住院患者(有或无心律失常)共274例,采用自身对照配对实验设计,对同一受试者同时应用贴片式心电仪和迈瑞心电监护仪采集其心电指标(包括心率、心动过缓、心房颤动等各种心律失常)并进行对比。结果:有效性评价主要评价指标中,两者心律失常诊断总符合率在全分析集中为0.995,在符合方案集中为1.000,分别对等效性界值下限(0.80)和上限(1.25)进行检验,P值均<0.001。次要评价指标中,各类型心律失常检出率基本一致,卡方检验P>0.05;心率监测方面,总误差(ATE)/最大误差限(LER)区域图中,两者测量的心率均落在ATE区域中,其中ATE区域落入率的95%单侧可信区间的下限为99.01%(>92%),LER区域落入率的95%单侧可信区间的上限为0.99%(<1%),心率监测两者基本一致。对于安全性评价,使用试验产品及对照产品在整个临床试验期间均未出现不良事件和其他安全性事件。结论:贴片式心电仪在心律失常、心率监测方面具有较高的有效性和安全性,可用于心血管疾病患者长期自我监测及心脏病前期的筛查、诊断及长期随访。Objectives: To evaluate the effectiveness and safety of patch electrocardiograph(CH-E1) in monitoring heart rate and arrhythmia. Methods: A total of 274 adult(over 18 years old) patients(with or without arrhythmia) hospitalized in Peking University People’s Hospital, Peking University First Hospital and Air Force General Hospital, PLA between April to September 2018 were enrolled. Self-matched experimental design was used. Patch electrocardiograph(CHERO, Jiaxing, China, CH-E1) and traditional electrocardiogram(Mindray, Shenzhen, China, iPM12) were used simultaneously for the same subjects. The electrocardiogram(ECG) parameters(heart rate, bradycardia, atrial fibrillation and other arrhythmias) were collected and compared between the two instruments. Results: The total coincidence rate of diagnosis of arrhythmia was 0.995 in full analysis set and 1.000 in per-protocol set. For the primary evaluation index, the lower limit(0.80) and the upper limit(1.25) of equivalence tests were performed, with a consequence of P<0.001 respectively. For the secondary evaluation index, the detection rate of all types of arrhythmias was basically the same(Chi-square test P>0.05). Besides, the heart rate measured by both instruments fell in the ATE region in ATE/LER regional chart. Among which, the lower limit of 95% unilateral confidence interval of ATE regional fall rate was99.01%(> 92%), while the upper limit of 95% unilateral confidence interval of LER regional fall rate was 0.99%(<1%). Therefore, heart rate monitoring was basically the same. For safety evaluation, there were no adverse events and other safety incidents related to test products and control products during the whole clinical trial period. Conclusion: The patch electrocardiograph(CH-E1) is effective and safe in monitoring arrhythmia and heart rate. It could be used for screening, diagnosis and long-term monitoring of heart rate and arrhythmias in patients with cardiovascular and non-cardiovascular diseases.

关 键 词：贴片式心电仪 心率 心律失常 有效 安全 

分 类 号：R54[医药卫生—心血管疾病]