Zhou S, Sheng X Y, Xiang Q, Wang Z N, Zhou Y, Cui Y M
Department of Pharmacy, Peking University First Hospital, Beijing, China.
J Clin Pharm Ther. 2016 Dec;41(6):602-611. doi: 10.1111/jcpt.12438. Epub 2016 Sep 28.
Anticoagulation management services are well known to improve the quality of patient care and to reduce the rates of hospitalization and emergency department visits following adverse events related to anticoagulation therapy. The complexity of managing warfarin has led to the development of a variety of specialized models managed by pharmacists, physicians, nurses, and self-managed care. The aim of the study is to compare the effectiveness of pharmacist-managed anticoagulation control of warfarin with other models.
We performed a systematic literature search of the PubMed, Medline@Web of Knowledge, EMBASE, Cochrane Library and Cumulative Index to Nursing and Allied Health Literature to identify randomized controlled trials (RCTs) from database inception up to July 2015. The search terms used for the study were 'warfarin', 'pharmacists', 'Vitamin K antagonist', 'anticoagulation' and 'management model.' We used the Cochrane Collaboration's tool from the Cochrane Handbook to assess the risk of bias of RCTs. We performed statistical analyses using RevMan 5.3 and used the Grading of Recommendations, Assessment, Development, and Evaluations profiler to rate the quality of evidence of the outcomes. The anticoagulation control outcomes were the percentage of time within the standard and expanded therapeutic range and thrombosis events; the safety outcomes were bleeding events and mortality, and patients' satisfaction of anticoagulation service.
Eight RCTs from 981 potentially relevant publications with a total of 1493 patients were included. Meta-analysis of the RCTs showed that a significant difference existed between pharmacist-managed care and other models for satisfaction (mean difference (MD) = 0·41, 95% CI, 0·01-0·81, P = 0·04, low-quality evidence) with heterogeneity, and the percentage of time within the standard therapeutic range (MD = 3·66, 95% CI 2·20-5·11, P < 0·00001, high-quality evidence) without heterogeneity. However, the pharmacist-managed group demonstrated no significant improvement on the percentage of time within the expanded therapeutic range (MD = 2·85, 95% CI -0·56 to 6·26, P = 0·10, moderate-quality evidence) with heterogeneity, mortality [odds ratio (OR) = 0·97, 95% CI, 0·44-2·11, P = 0·09, high-quality evidence] without heterogeneity, the prevention of bleeding events (OR = 0·89, 95% CI, 0·56-1·44, P = 0·64, high-quality evidence) without heterogeneity, and thrombosis events (OR = 0·81, 95% CI, 0·34-1·92, P = 0·64, high-quality evidence) without heterogeneity.
The advantage of pharmacist-managed warfarin anticoagulation therapy in terms of anticoagulation control, safety and mortality are unclear, but resulted in significantly better patient satisfaction. Compared with other models, the superiority of pharmacist-managed warfarin anticoagulation needs to be further evaluated and validated in future research.
抗凝管理服务有助于提高患者护理质量,并降低抗凝治疗相关不良事件后的住院率和急诊就诊率,这是广为人知的。华法林管理的复杂性促使了由药剂师、医生、护士和自我管理护理所管理的多种专业模式的发展。本研究的目的是比较药剂师管理的华法林抗凝控制与其他模式的有效性。
我们对PubMed、Web of Knowledge中的Medline@、EMBASE、Cochrane图书馆以及护理与健康相关文献累积索引进行了系统的文献检索,以识别从数据库建立到2015年7月的随机对照试验(RCT)。本研究使用的检索词为“华法林”“药剂师”“维生素K拮抗剂”“抗凝”和“管理模式”。我们使用Cochrane手册中的Cochrane协作工具来评估RCT的偏倚风险。我们使用RevMan 5.3进行统计分析,并使用推荐分级、评估、制定与评价工具来对结果的证据质量进行评级。抗凝控制结果为处于标准和扩展治疗范围内的时间百分比以及血栓形成事件;安全结果为出血事件和死亡率,以及患者对抗凝服务的满意度。
从981篇潜在相关出版物中纳入了8项RCT,共1493例患者。RCT的荟萃分析表明,药剂师管理的护理与其他模式在满意度方面存在显著差异(平均差(MD)=0.41,95%置信区间,0.01 - 0.81,P = 0.04,低质量证据),存在异质性,且在标准治疗范围内的时间百分比方面(MD = 3.66,95%置信区间2.20 - 5.11,P < 0.00001,高质量证据)不存在异质性。然而,药剂师管理组在扩展治疗范围内的时间百分比(MD = 2.85,95%置信区间 - 0.56至6.26,P = 0.10,中等质量证据)方面存在异质性,死亡率[比值比(OR)= 0.97,95%置信区间,0.44 - 2.11,P = 0.09,高质量证据]不存在异质性,预防出血事件(OR = 0.89,95%置信区间,0.56 - 1.44,P = 0.64,高质量证据)不存在异质性,以及血栓形成事件(OR = 0.81,95%置信区间,0.34 - 1.92,P = 0.64,高质量证据)不存在异质性方面均未显示出显著改善。
药剂师管理的华法林抗凝治疗在抗凝控制、安全性和死亡率方面的优势尚不清楚,但患者满意度显著更高。与其他模式相比,药剂师管理的华法林抗凝的优越性需要在未来研究中进一步评估和验证。