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OptiLink HF研究结果发布:远程医疗指导较标准临床评估并无明显优势

2015-09-08 李妍 整理 中国医学论坛报

2015欧洲心脏病学会年会(ESC2015)专题报道伦敦当地时间9月1日下午,OptiLink HF研究结果发布。该研究评估了全自动无线远程监控能否较标准临床评估减少全因死亡或因心血管疾病住院的发生。结果并未显示对心衰患者进行远程医疗指导较标准临床评估存在优势。研究纳入置入ICD或CRT-ICD患者1002例,置入ICD患者为存在慢性心力衰竭(HF)、NYHAⅡ-Ⅲ级、LVEF≤35%并接受优化药

2015欧洲心脏病学会年会(ESC2015)专题报道

伦敦当地时间9月1日下午,OptiLink HF研究结果发布。该研究评估了全自动无线远程监控能否较标准临床评估减少全因死亡或因心血管疾病住院的发生。结果并未显示对心衰患者进行远程医疗指导较标准临床评估存在优势。

研究纳入置入ICD或CRT-ICD患者1002例,置入ICD患者为存在慢性心力衰竭(HF)、NYHAⅡ-Ⅲ级、LVEF≤35%并接受优化药物治疗;置入CRT-ICD患者为慢性HF、NYHA Ⅲ级、LVEF≤35%、QRS≥120 msec、LVEDD≥55 mm并接受优化药物治疗。入选患者随机分入评估组(n=505)或对照组(n=497),评估组接受远程医疗指导,并对液体潴留发送无声警报;对照组接受标准临床评估,对液体潴留不发送警报。平均随访22.9±18.2个月。主要研究终点为全因死亡率和心血管(CV)住院的复合终点,次要研究终点包括全因死亡、CV住院、全因死亡和HF住院复合终点、HF住院、CV死亡率、随访期间全因住院。

结果为,评估组和对照组各有45%和48.1%的患者达到主要研究终点[危险比(HR)为0.87,P=0.13]。次要研究终点方面,评估组和对照组发生全因死亡或首次因HF住院比例分别为27.5%和31.2%(HR=0.81,P=0.09)。

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    2015-09-08 lovetcm

    这项研究结果对当前的移动医疗热可能是一个沉重的打击。远程监护类产品看起来很美,能不能真正经得起科学的检验,还需要更多的证据。因此,医疗级的产品,严格监管,还是有道理的。

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