国产心脏起搏器Qingming 2312S/M 与进口心脏起搏器临床效果研究

孟天宇  张勇  袁记行

[摘要] 目的 比较国产心脏起搏器Qingming 2312S/M型与百多力Axios S、圣犹达2402、美敦力RES01心脏起搏器的一般参数、起搏参数，分析国产心脏起搏器的临床疗效。 方法 随机选取我院2010年1月～2013年11月间安装心脏起搏器的患者100例作为观察对象，将其随机分为4组，每组25例，分别安置国产心脏起搏器Qinming 2312S/M、百多力Axios S、圣犹达2402、美敦力RES01起搏器，在患者术后即刻、术后3个月、6个月进行随访，记录起搏器的参数变化，比较各组起搏器的参数及功能。 结果 4组患者100%起搏理论寿命、50%起搏理论寿命差异无统计学意义（P＞0.05）；4组患者术后即刻、术后3个月、6个月起搏参数（阈值、阻抗、波幅）差异无统计学意义（P＞0.05）。 结论 国产心脏起搏器Qinming 2312S/M安全可靠，与进口心脏起搏器临床疗效无显著性差异。

[关键词] 心脏起搏器；临床疗效；起搏参数

[中图分类号] R318.11   [文献标识码] B   [文章编号] 2095-0616（2014）09-183-03

Study of clinical effects of domestic cardiac pacemaker Qinming 2312S/M and imported pacemakers

MENG Tianyu  ZHANG Yong  YUAN Jixing

Department of Cardiology, Zhumadian First People's Hospital, Zhumadian 463000,China

[Abstract] Objective To compare the general parameters and pacing parameters of the domestic pacemaker Qingming 2312S/M to those of Biotronik Axios S, St. Jude 2402 and Medtronic RES01 and analyze the clinical efficacy of the domestic pacemaker. Methods One hundred patients who installed cardiac pacemaker in our hospital from January 2010 to November 2013 were selected as the observation subjects and randomly divided into 4 groups, with 25 patients in each group. The 4 groups installed the domestic pacemaker Qingming 2312S/M, Biotronik Axios S, St. Jude 2402 and Medtronic RES01 respectively. The patients received follow-up visits immediately after the surgery, 3 months after the surgery and 6 months after the surgery and the parameter changes of the pacemakers were recorded. The parameters and function of the pacemaker of each group were compared. Results The 100% pacing theoretical lifetime and the 50% pacing theoretical lifetime of the 4 groups of patients did not have statistically significant differences(P＞0.05); The pacing parameters immediately after the surgery, 3 months after the surgery and 6 months after the surgery of the 4 groups of patients did not have statistically significant differences(P＞0.05). Conclusion The domestic pacemaker Qingming 2312S/M is safe and reliable and its clinical efficacy is not significantly different from that of the imported cardiac pacemakers.

[Key words] Pacemaker; Clinical efficacy; Pacing parameter

从1958年的第一例植入性起搏器问世至今，心脏起搏器已有50多年历史，随着人们对起搏血流动力学认识的不断深入，起搏器技术的进一步发展，起搏器不仅用于对症状性心动过缓的治疗，还扩大了对以血流动力学改变为基础的疾病的治疗，其适应证不断扩大[1-3]。近年来随着心血管疾病患者的不断增加，相当一部分患者因经济因素得不到有效的治疗，国产心脏起搏器Qinming 2312S/M是唯一一款具有自主知识产权的心脏起搏器，具有寿命长、体积小、重量轻、价格低等优点[4-7]，本研究选取我院2010年1月～2013年11月安装心脏起搏器的100例患者作为观察对象，对国产Qinming 2312S/M心脏起搏器与进口起搏器的起搏参数进行了比较，提示国产心脏起搏器Qinming 2312S/M临床疗效不亚于进口心脏起搏器，且价格实惠，值得临床借鉴。……