慢性心衰患者的远程疾病管理计划有效性评价:一项非劣效性随机对照试验  

Effectiveness of telemonitoring-based disease management program in patients with chronic heart failure:A non-inferiority randomized controlled trial

作　　者：段永杰 钟琴 饶宠佑 李宗任 付立强 汪驰 朱頔 王瑞青 董蔚[2] 何昆仑[3] DUAN Yongjie;ZHONG Qin;RAO Chongyou;LI Zongren;FU Liqiang;WANG Chi;ZHU Di;WANG Ruiqing;DONG Wei;HE Kunlun(Chinese PLA Medical School,Beijing 100853,China;Department of Cardiology,Chinese PLA General Hospital,Beijing 100853,China;Medical Innovation Research Division,Chinese PLA General Hospital,Beijing 100853,China)

机构地区：[1]解放军医学院,北京100853 [2]解放军总医院第六医学中心心血管病医学部,北京100853 [3]解放军总医院医学创新研究部,北京100853

出　　处：《解放军医学院学报》2024年第3期213-222,238,共11页Academic Journal of Chinese PLA Medical School

基　　金：北京市自然科学基金项目(L22006);军队课题(2022SYSZZKY11)。

摘　　要：背景新冠肺炎疫情中,心力衰竭患者门诊复查受阻,而针对心衰患者运用体外远程监护设备进行疾病管理的有效性尚无定论。目的探究远程监护疾病管理计划是否非劣效于传统门诊复查。方法本研究为随机对照研究,采取非劣效性设计,招募2021年3月—2023年3月在解放军总医院第一医学中心住院治疗的心衰患者,随机分配至远程监护组或门诊随访组。干预持续6个月,在第3个月和第6个月进行随访收集患者数据。门诊随诊组接受常规门诊复查干预,远程监护组在降低门诊复查频率的同时接受远程监护管理。本研究主要结局指标为因心血管意外住院或全因死亡损失天数百分比,次要结局指标为患者的N末端脑利钠肽前体(N-terminal pro-B-type natriuretic peptide,NT-proBNP)、生活质量(MLHFQ评分)和依从性。结果招募113例患者(远程监护组57例,门诊随访组56例),97例完成随访。干预后3个月、6个月,远程监护组与门诊随访组受试者因心血管意外住院或全因死亡损失天数百分比在非劣性检验中有统计学差异(非劣效性检验P<0.05)。两组MLHFQ评分均较基线期下降,且远程监护组评分显著低于门诊随访组(P<0.05)。两组平均NT-proBNP均较基线期显著下降(P<0.05),远程监护组下降幅度显著高于门诊随访组(P=0.022)。在远程监护组中,远程监护系统使用率为76.92%;门诊随访组中,48例患者(85.71%)按要求完成了门诊复查。结论本研究中对心衰患者实施的远程监护疾病管理计划在减少因心血管意外住院或全因死亡损失天数百分比的效果上不劣于传统门诊复查;同时明显改善了患者的NT-proBNP和生活质量水平。Background Outpatient review of patients with heart failure(HF)is impeded in contexts of the COVID-19 pandemic,and the effectiveness of using telemonitoring devices for disease management in patients with HF is inconclusive.Objective To investigate whether a telemonitoring-based disease management program is noninferior to traditional outpatient review.Methods Adopting a non-inferiority design,this study recruited patients with HF at the First Medical Center of Chinese PLA General Hospital from March 2021 to March 2023 and randomly assigned them to the telemonitoring management group(TMG)and outpatient review group(ORG).The trial intervention lasted for six months,with follow-up visits in the third and sixth months to collect patients’data.The ORG received the routine outpatient review intervention.The TMG received telemonitoring management while reducing the frequency of outpatient reviews.The primary outcome in this study was the percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death.Secondary outcomes were patients’NT-proBNP,quality of life,and patient adherence.Results Totally 113 patients were recruited(57 in the TMG and 56 in the ORG),with 97 cases had completed the six-month follow-up.The percentage of days lost due to unplanned cardiovascular hospital admission or all-cause death was significantly different between subjects in the TMG and ORG review groups at 3-and 6-month post-intervention in the non-inferiority test(P<0.05 for non-inferiority test).MLHFQ scores decreased from the baseline period in both test groups,and a comparison between the two groups found that scores in the TMG were significantly lower than those in the ORG(P<0.05).The mean NT-proBNP level decreased significantly in both groups compared to the baseline period(P<0.05),and the decrease in the TMG was significantly higher than that in the ORG(P=0.022).In the TMG,the utilization rate of the telemonitoring system was 76.92%.In the ORG,48(85.71%)subjects completed the outpatient review as requi

关 键 词：心力衰竭 疾病管理 远程监护 随机对照试验 非劣效性 

分 类 号：R473.5[医药卫生—护理学]