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作 者:陈信步 李业涛[2] 龙娟[1] 张永春[2] Chen Xinbu;Li Yetao;Long Juan;Zhang Yongchun(Department of Hepatobiliary Surgery,Guizhou Provincial People′s Hospital,Guiyang 550002,China;Department of Cardiovascular Surgery,Guizhou Provincial People′s Hospital,Guiyang 550002,China)
机构地区:[1]贵州省人民医院肝胆外科,贵阳550002 [2]贵州省人民医院心外科,贵阳550002
出 处:《中华健康管理学杂志》2021年第4期368-372,共5页Chinese Journal of Health Management
基 金:国家自然科学基金(71563006)。
摘 要:目的:评价基于移动医疗技术及人工智能的抗凝管理模式的效果。方法:本研究为一项单中心、前瞻性、随机对照非劣性临床试验。2017年11月至2018年9月,贵州省人民医院心外科连续纳入机械瓣膜置换术后口服华法林抗凝治疗的67例患者,通过Excel软件简单随机分为试验组34例、对照组33例。试验组通过“抗凝助手”进行管理,对照组采用常规抗凝管理方式进行管理。患者纳入至少3个月后开始进行随访,于2019年9月30日结束。以治疗范围内时间(TTR)11.0%、国际标准化比率(INR)达标率10.0%为界值,非劣性单侧t检验试验组患者TTR及INR达标率是否非劣于对照组。结果:试验组、对照组TTR分别为(58.2±23.4)%、(54.8±23.6)%(差值3.4%,差值单侧95%CI下限:-6.4%;t=2.441,P=0.009)。试验组、对照组INR达标率分别为(55.4±21.9)%、(52.8±22.5)%(差值2.6%,差值单侧95%CI下限:-6.6%;t=2.309,P=0.012)。结论:基于移动医疗技术及人工智能的抗凝管理模式的结局指标不劣于传统抗凝管理模式。Objective To evaluate an anticoagulation management method based on mobile health technology and artificial intelligence.Methods The study was a single-center,prospective,randomized,controlled,non-inferiority clinical trial.From November 2017 to September 2018,67 patients who received warfarin therapy after mechanical valve replacement were consecutively enrolled and randomized into two groups:34 were randomized to intervention group and 33 to control group.The intervention group was managed via Anticlot Assistant and the control group was handled as routine care.Evaluations were performed at least 3 months after enrollment and ended on 30 September 2019.Non-inferiority was evaluated using one-sided tests with a non-inferiority margin set 11.0% for time in therapeutic range(TTR)and 10.0%for the percentage of international normalized ratio(INR)in the therapeutic range.Results The mean TTR was(58.2±23.4)% in the intervention group and(54.8±23.6)% in the control(the difference:3.4%;low limit of one-side 95% confidence interval for the difference:-6.4%;and P value for non-inferiority was 0.009).The percentage of INR in the therapeutic range was(55.4±21.9)% in the intervention group and(52.8±22.5)% in the control(the difference:2.6%,low limit of one-side 95% confidence interval for the difference:-6.6%;and P value for non-inferiority was 0.012).Conclusion The outcomes of patients managed via the anticoagulation management method base on mobile health technology and artificial intelligence are not inferior to those handled as routine care.
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