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一项关于口服抗凝治疗有效性所报告结局指标的系统评价。

A systematic review of outcome measures reported for the therapeutic effectiveness of oral anticoagulation.

作者信息

Fitzmaurice D A, Kesteven P, Gee K M, Murray E T, McManus R

机构信息

Department of Primary Care and General Practice, The Medical School, University of Birmingham B15 2TT, UK.

出版信息

J Clin Pathol. 2003 Jan;56(1):48-51. doi: 10.1136/jcp.56.1.48.

DOI:10.1136/jcp.56.1.48
PMID:12499433
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC1769863/
Abstract

AIMS

To evaluate the evidence of therapeutic international normalised ratio (INR) control reporting and to provide recommendations for future reporting, particularly for research and audit purposes.

METHODS

A systematic review of literature published over a five year period describing therapeutic INR control. Papers were identified from the Medline electronic database, and those that met the quality criteria were reviewed independently by an academic general practitioner and a consultant haematologist.

RESULTS

Fifteen papers were identified that met the quality criteria for review. The sample size of studies ranged from 53 to 2545 (mean, 483.9) patients. Follow up ranged from three months to 13 years. Twelve studies reported results from secondary care only, one from primary care only, and two from both primary and secondary care. Seven of the 15 papers reported percentage time in range, five of 15 papers reported mean INR, six of 15 papers reported the proportion of tests in range, and five of 15 papers reported mean warfarin dose. Additional methods of presenting INR results were: dose changes each month, distribution of INR results, deviation of INR value from mean, percentage dose changes, time between visits, and median INR value. Six papers reported only one outcome measure, six reported two outcomes, two papers reported three outcomes, and one paper reported five outcomes.

CONCLUSIONS

It is recommended that at least two outcome measures should be reported and measures should be selected so that both the INR determinations and dosing advice are monitored.

摘要

目的

评估治疗性国际标准化比值(INR)控制报告的证据,并为未来报告提供建议,特别是用于研究和审计目的。

方法

对五年期间发表的描述治疗性INR控制的文献进行系统综述。从Medline电子数据库中识别论文,符合质量标准的论文由一名学术全科医生和一名血液学顾问独立评审。

结果

识别出15篇符合评审质量标准的论文。研究样本量从53至2545名患者不等(平均483.9名)。随访时间从3个月至13年不等。12项研究仅报告了二级护理的结果,1项仅报告了初级护理的结果,2项报告了初级和二级护理的结果。15篇论文中有7篇报告了处于目标范围的时间百分比,15篇中有5篇报告了平均INR,15篇中有6篇报告了处于目标范围的检测比例,15篇中有5篇报告了华法林平均剂量。呈现INR结果的其他方法包括:每月剂量变化、INR结果分布、INR值与平均值的偏差、剂量变化百分比、就诊间隔时间和INR中位数。6篇论文仅报告了一项结果指标,6篇报告了两项结果,2篇论文报告了三项结果,1篇论文报告了五项结果。

结论

建议报告至少两项结果指标,并应选择相应指标以便同时监测INR测定和给药建议。

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本文引用的文献

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Analysis of warfarin therapy in pediatric patients: A prospective cohort study of 319 patients.小儿患者华法林治疗分析:一项针对319例患者的前瞻性队列研究。
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Racial background is a determinant of average warfarin dose required to maintain the INR between 2.0 and 3.0.种族背景是维持国际标准化比值(INR)在2.0至3.0之间所需华法林平均剂量的一个决定因素。
Br J Haematol. 1999 Oct;107(1):207-9. doi: 10.1046/j.1365-2141.1999.01672.x.
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The effect of self-monitoring the INR on quality of anticoagulation and quality of life.自我监测国际标准化比值(INR)对抗凝质量和生活质量的影响。
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