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社交应用程序改善 MHVR 后中国患者华法林治疗:一项随机对照试验。

Social App to Improve Warfarin Therapy in Post-MHVR Chinese Patients: A Randomized Controlled Trial.

机构信息

Clinical Laboratory, Wuhan Asia General Hospital Affiliated to Wuhan University of Science and Technology, Wuhan, China 430056.

Anticoagulation Clinic, Wuhan Asia Heart Hospital, Wuhan, China 430022.

出版信息

Cardiovasc Ther. 2023 Jan 14;2023:2342111. doi: 10.1155/2023/2342111. eCollection 2023.

Abstract

BACKGROUND

Poor anticoagulation quality was a major problem among warfarin-treated patients, which called for innovative and effective methods to improve it.

OBJECTIVE

To investigate whether social app could be used to reduce warfarin-associated adverse events among post-MHVR Chinese patients.

METHOD

735 warfarin-treated patients (aged 50.8 ± 9.6 years, 59.9% female) were enrolled and randomized to a social app care group (warfarin therapy was guided by experienced clinicians via a social app) or a routine care group (warfarin therapy was managed through traditional in-office visits) at a 1 : 1 ratio. Ending points (bleeding and thrombotic events) were recorded during an 18-month follow-up period.

RESULTS

A total of 718 patients were included in analysis. 57 of them suffered warfarin-associated adverse events, including 30 major bleedings and 27 thrombotic events. The time in the therapeutic range (TTR, Rosendaal method) in the social app group was 71.5%, which was significantly better than 52.6% in the routine care group (difference: 18.8%, 95% CI: 16.8-20.8). Compared with the patients from the social app group, patients under routine care experienced more bleeding (hazard ratio (HR): 2.31, 95% CI: 1.13-4.72). The social app care group had lower variation (0.55 vs. 0.70) in the international normalized ratio (INR) values and fewer incidents of extremely high INR (e.g., INR > 5.0, 0.87% vs. 3.42%) than the routine care group.

CONCLUSIONS

Social app management could significantly improve warfarin control and was associated with a reduction in bleeding risk. This trial was registered with NCT03264937.

摘要

背景

华法林治疗患者的抗凝质量差是一个主要问题,需要创新和有效的方法来改善。

目的

研究社交应用程序是否可用于降低 MHVR 后中国患者的华法林相关不良事件。

方法

纳入 735 例华法林治疗患者(年龄 50.8±9.6 岁,59.9%为女性),按 1:1 比例随机分为社交应用程序护理组(经验丰富的临床医生通过社交应用程序对华法林治疗进行指导)或常规护理组(通过传统门诊就诊管理华法林治疗)。在 18 个月的随访期间记录终点事件(出血和血栓事件)。

结果

共有 718 例患者纳入分析。其中 57 例发生华法林相关不良事件,包括 30 例大出血和 27 例血栓事件。社交应用程序组的治疗范围内时间(TTR,Rosendaal 法)为 71.5%,明显优于常规护理组的 52.6%(差异:18.8%,95%CI:16.8-20.8)。与社交应用程序组患者相比,常规护理组患者出血更多(风险比(HR):2.31,95%CI:1.13-4.72)。社交应用程序护理组的国际标准化比值(INR)值变化较小(0.55 比 0.70),INR 极高的事件(如 INR>5.0,0.87%比 3.42%)较少。

结论

社交应用程序管理可显著改善华法林控制,降低出血风险。本试验在 NCT03264937 注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e765/9867580/de9d9f2ec73b/CDTP2023-2342111.001.jpg

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