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背景有关口服抗凝剂的自我监测和自我管理的意见依然有所不同,尽管对他们的有效性有良好的证据。为了澄清口服抗凝药自我监测的价值,我们对涉及证据的几个重要缺陷个体病人数据做了荟萃分析,含死亡、首次大出血及血栓栓塞时间影响的评估。方法我们对医学文摘资料库数据库(1980—2009)和联机医学文献分析与检索系统(1966—2009)Ovid版进行检索。我们联系了所含试验的所有作者,索要了个体病人的数据:主要结果为死亡、首次大出血和首次发生血栓事件的时间。根据年龄、对照组照顾类型(抗凝制剂-临床照顾对初级保健);仅做自我检测对自我管理及性别做了预设亚组分析。对心脏机械瓣或房颤分别做分析。我们采用了随机效应模式方法计算混合危害比,且做了交互作用和异质性检测,及计算了与时间相关需要治疗的数目。发现1 357篇摘要,我们的研究含11项试验数据,6 417例参试者,做12 800人年跟踪。我们报告,自我监测组血栓事件明显减少〔HR=0.51,95%CI(0.31,0.85)〕,但不含大出血事件〔HR=0.88,95%CI(0.74,1.06)〕或死亡〔HR=0.82,95%CI(0.62,1.09)〕。<55岁参试者血栓事件明显减少〔HR=0.33,95%CI(0.17,0.66)〕、有心脏机械瓣病人也显示了同样的效果〔HR=0.52,(0.35,0.77)〕。而对≥85岁老年人(n=99)的主要结果分析表明,所有结果未见明显的干预负性作用。解释我们的分析表明,口服抗凝剂的自我监测和自我管理为所有年龄段病人的安全选择。应向病人提供相关保健支持项目,就他们的疾病帮助病人做好自我管理。
Background Opinions on the self-monitoring and self-management of oral anticoagulants are still different, despite good evidence of their effectiveness. To clarify the value of oral anticoagulant self-monitoring, we performed a meta-analysis of individual patient data on several important deficiencies of evidence, including the assessment of the effects of death, first major bleeding, and time to thromboembolism. Methods We searched the Medical Abstracts Database (1980-2009) and Ovid Edition of the Online Medical Document Analysis and Retrieval System (1966-2009). We contacted all authors of the included trials and asked for individual patient data: the primary outcome was death, first major haemorrhage, and first episode of thrombosis. Control group type of care based on age (anticoagulant - clinical care for primary care); self-administered only for self-management and gendered pre-set subgroup analysis. Mechanical heart valve or atrial fibrillation were analyzed. We used a random effects model approach to calculate the ratio of mixed hazard, and did an interaction and heterogeneity test, and calculated the number of time-related treatments needed. A total of 1 357 abstracts were found, including 11 trials in our study and 6 417 participants, tracking 12 800 people. We report significant reductions in thrombotic events in the self-monitoring group (HR 0.51, 95% CI 0.31, 0.85) but not major bleeding (HR 0.88, 95% CI 0.74, 1.06) or death [HR 0.82 , 95% CI (0.62, 1.09)]. Thrombotic events were significantly reduced in patients <55 years of age (HR = 0.33, 95% CI, 0.17, 0.66). Patients with mechanical heart valves also showed similar results (HR = 0.52, 0.35, 0.77). Analysis of the primary results for ≥85 years of age (n = 99) showed no significant negative effect of all interventions on interventions. Interpretation Our analysis shows that the self-monitoring and self-management of oral anticoagulants is a safe choice for patients of all ages. Patients should be provided with relevant health support programs to help patients self-regulate their illness.