A randomised controlled trial of warfarin anticoagulation after mechanical heart valve replacement via WeChat platform management
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摘要:
目的 通过前瞻性、随机、单中心研究比较微信平台管理与常规术后管理对于心脏机械瓣膜置换术后应用华法林抗凝治疗的疗效和并发症。 方法 根据入选标准将宁波市医疗中心李惠利医院心脏机械瓣膜置换术后患者按出院时间排序,奇数组设为观察组(微信平台管理组,153例),偶数组设为对照组(常规术后管理组,144例)。对照组进行常规术后护理指导,观察组应用微信平台实施延续性护理干预。通过定期门诊随访,调整患者华法林剂量并记录2组患者的一般情况和并发症发生情况。主要终点事件为INR达标率,次要终点事件包括任何原因导致的死亡、栓塞事件、出血事件、抗凝相关急诊就诊次数。 结果 共297例患者入组,2组患者在年龄、性别、手术方式等一般资料比较差异均无统计学意义。与对照组比较,观察组明显提高了国际标准化比值(INR)的达标率(75.48% vs. 59.38%, P < 0.001)。而2组在严重出血事件(1.31% vs. 2.78%, P=0.368)、血栓栓塞事件(1.31% vs. 0.69%, P=0.598)和任何原因导致的死亡事件(0.65% vs. 1.39%,P=0.527)方面比较差异无统计学意义;观察组轻度出血事件发生率(17.6% vs. 30.6%, P=0.023)和抗凝相关急诊就诊次数[0.86(0.00, 1.00)次vs. 1.36(1.00, 2.00)次,P=0.031]低于对照组。 结论 与常规术后管理相比,通过微信平台管理可明显提高华法林抗凝治疗的INR达标率,降低轻度出血事件的发生率,减少抗凝相关急诊就诊次数。 Abstract:Objective A prospective, randomised, single-centre study was conducted to compare the efficacy and complications of warfarin anticoagulation in patients undergoing mechanical heart valve replacement postoperative management of patients was performed via WeChat platform or conventional methods. Methods According to the inclusion criteria, the patients in our hospital after undergoing mechanical valve replacement were randomly assigned to an experimental group (WeChat platform management group) and a control group (traditional management group). The control group received routine postoperative nursing guidance, whereas the experimental group received continuous nursing intervention via WeChat platform. Through regular outpatient follow-up, warfarin dosage was adjusted, and the general situation and complications of the two groups were recorded. The primary end point was international normalised ratio (INR) compliance rate, whereas the secondary end point included death, thromboembolism, bleeding and the number of, and anticoagulation-related emergency department visits. Results A total of 297 patients were enrolled in this study. No significant difference was observed between the two groups in terms of baseline characteristics, including gender, age and type of surgery. Compared with the control group, the experimental group had significantly improved INR compliance rate (75.48% vs. 59.38%, respectively; P < 0.001). No significant difference was found between the two groups in terms of major bleeding events (1.31% vs. 2.78%, respectively; P=0.368), thromboembolism events (1.31% vs. 0.69%, respectively; P=0.598) and deaths from any cause (0.65% vs. 1.39%, respectively; P=0.527). However, the incidence of mild bleeding events (17.6% vs. 30.6%, respectively; P=0.023) and the number of anticoagulation-related emergency department visits [0.86(0.00, 1.00) vs. 1.36(1.00, 2.00), respectively; P=0.031] in the experimental group were lower than those in the control group. Conclusion Compared with routine postoperative management, the application of WeChat platform to manage anticoagulation treatment of the patients after mechanical heart valve replacement can improve the INR compliance rate, reduced the incidence of mild bleeding events and the number of, anticoagulation-related emergency department visits. -
Key words:
- WeChat /
- Mechanical heart valve replacement /
- Warfarin /
- Anticoagulation
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表 1 2组心脏机械瓣膜置换术患者术前一般资料比较(例)
组别 例数 年龄(x±s, 岁) 性别(男/女) 手术方式 同期行 合并症 MVR AVR DVR TVP 高血压 糖尿病 脑卒中史 消化道溃疡史 房颤 观察组 153 50.42±10.37 77/67 61 33 59 20 33 13 13 12 43 对照组 144 49.77±10.80 76/77 63 29 52 26 24 12 16 8 47 统计量 0.532a 0.429b 0.459b 1.408b 1.149b 0.003b 0.575b 0.618b 0.722b P值 0.606 0.513 0.795 0.235 0.284 0.960 0.448 0.432 0.395 注:a为t值,b为χ2值。MVR为二尖瓣置换术,AVR为主动脉瓣置换术,DVR为双瓣置换术,TVP为三尖瓣成形术。 表 2 2组心脏机械瓣膜置换术患者随访结果比较
组别 例数 INR达标率(%) 抗凝相关并发症[例(%)] 抗凝相关急诊就诊次数[M(P25, P75),次] 严重出血事件 轻度出血事件 血栓栓塞事件 任何原因导致的死亡 观察组 153 75.48 2(1.31) 27(17.6) 2(1.31) 1(0.65) 0.86(0.00, 1.00) 对照组 144 59.38 4(2.78) 44(30.6) 1(0.69) 2(1.39) 1.36(1.00,2.00) 统计量 14.580a 0.810a 7.582a 0.279a 0.401a -1.612b P值 < 0.001 0.368 0.023 0.598 0.527 < 0.001 注:a为χ2值,b为Z值。 -
[1] 薛源, 李海红, 刘婷, 等. 基于多中心的非瓣膜性心房颤动患者抗凝治疗现状及影响因素分析[J]. 中国临床医学, 2018, 25(5): 728-732. https://www.cnki.com.cn/Article/CJFDTOTAL-LCYX201805010.htm [2] 章小花. 国际标准化比值监测评估非瓣膜心房颤动患者华法林抗凝出血风险的研究[J]. 中华全科医学, 2015, 13(8): 1330-1331, 1384. https://www.cnki.com.cn/Article/CJFDTOTAL-SYQY201508044.htm [3] PATEL R, CHANG T, GREYSEN S R, et al. Social media use in chronic disease: a systematic review and novel taxonomy[J]. Am J Med, 2015, 128(12): 1335-1350. doi: 10.1016/j.amjmed.2015.06.015 [4] 朱治辉, 张海波, 焦玉清, 等. "互联网+"背景下心脏机械瓣膜置换术后患者华法林抗凝治疗的研究进展[J]. 中国医药, 2018, 13(12): 1902-1905. doi: 10.3760/j.issn.1673-4777.2018.12.034 [5] CHOW C K, REDFERN J, HILLIS G S, et al. Effect of Lifestyle-Focused Text messaging on risk factor modification in patients with coronary heart disease[J]. JAMA, 2015, 314(12): 1255-1263. doi: 10.1001/jama.2015.10945 [6] WIDMER R J, ALLISON T G, LERMAN L O, et al. Digital health intervention as an adjunct to cardiac rehabilitation reduces cardiovascular risk factors and rehospitalizations[J]. J Cardiovasc Transl Res, 2015, 8(5): 283-292. doi: 10.1007/s12265-015-9629-1 [7] 张如新, 董真真, 马波, 等. 基于微信平台的同伴教育对肝癌患者介入术后心理、自我护理能力和生活质量的影响[J]. 中华全科医学, 2019, 17(11): 1951-1953. https://www.cnki.com.cn/Article/CJFDTOTAL-SYQY201911044.htm [8] 陈旭娥, 李季, 马婷, 等. 应用微信平台开展STD门诊艾滋病知识与行为健康教育的效果观察[J]. 浙江临床医学, 2018, 20(9): 1613-1614. [9] ROSENDAAL F R, CANNEGIETER S C, VAN DER MEER F J, et al. A method to determine the optimal intensity of oralanticoagulant therapy[J]. Thromb Haemost, 1993, 69(3): 236-239. doi: 10.1055/s-0038-1651587 [10] 王金凤, 邢莱丽, 魏小丽, 等. 临床药师指导下非瓣膜病房颤患者应用华法林抗凝治疗的疗效分析[J]. 河北医学, 2018, 24(8): 1404-1408. doi: 10.3969/j.issn.1006-6233.2018.08.047 [11] 李莲静, 刘健, 蒋卫民. 105例非瓣膜性心房颤动患者门诊抗凝治疗调查[J]. 中华全科医学, 2015, 13(12): 2014-2017. https://www.cnki.com.cn/Article/CJFDTOTAL-SYQY201512041.htm [12] 刘锐, 张魁, 董然. 华法林剂量预测模型与个体化治疗研究进展[J]. 中华实用诊断与治疗杂志, 2015, 29(8): 729-730. https://www.cnki.com.cn/Article/CJFDTOTAL-HNZD201508001.htm [13] 许蔡艳, 曹莺, 严佳栋, 等. 临床药师用药指导下华法林的抗凝效果与安全性研究[J]. 安徽医药, 2018, 22(12): 2475-2478. doi: 10.3969/j.issn.1009-6469.2018.12.054 [14] FENG S, LIANG Z, ZHANG R, et al. Effects of mobile phone WeChat services improve adherence to corticosteroid nasal spray treatment for chronic rhinosinusitis after functional endoscopic sinus surgery: a 3-month follow-up study[J]. Eur Arch Otorhinolaryngol, 2017, 274(3): 1477-1485. doi: 10.1007/s00405-016-4371-0 [15] CAO Y, LIN S H, ZHU D, et al. WeChat public account use improves clinical control of cough-variant asthma: a randomized controlled trial[J]. Med Sci Monit, 2018, 24: 1524-1532. doi: 10.12659/MSM.907284 [16] 谭莲, 周蓓. 患者自我管理与专业机构管理在非瓣膜型心房颤动患者康复治疗中的应用效果比较[J]. 现代医药卫生, 2019, 35(16): 2520-2522. doi: 10.3969/j.issn.1009-5519.2019.16.030 [17] SØLVIK U Ø, LØKKEBØ E, KRISTOFFERSEN A H, et al. Quality of warfarin therapy and quality of life are improved by self-management for two years[J]. Thromb Haemost, 2019, 19(10): 1632-1641. http://www.ncbi.nlm.nih.gov/pubmed/31370074 [18] GRZYMALA-LUBANSKI B, SVENSSON P J, RENLUND H, et al. Warfarin treatment quality and prognosis in patients with mechanical heart valve prosthesis[J]. Heart, 2017, 103(3): 198-203. doi: 10.1136/heartjnl-2016-309585 [19] DURÀES A R, BITAR Y D S L, FILHO J A L, et al. Rivaroxaban versus warfarin in patients with mechanical heart valve: rationale and design of the RIWA study[J]. Drugs R D, 2018, 18(4): 303-308. doi: 10.1007/s40268-018-0249-5 [20] LOMBARDI N, CRESCIOLI G, BETTIOL A, et al. Italian emergency department visits and hospitalizations for outpatients' adverse drug events: 12-year active pharmacovigilance surveillance(the MEREAFaPS study)[J]. Front Pharmacol, 2020, 11: 412. doi: 10.3389/fphar.2020.00412