ten Berg Maarten J, van den Bemt Patricia M L A, Huisman Albert, Schobben Alfred F A M, Egberts Toine C G, van Solinge Wouter W
Department of Pharmacoepidemiology and Pharmacotherapy, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Netherlands.
Ann Pharmacother. 2009 Sep;43(9):1405-12. doi: 10.1345/aph.1L646. Epub 2009 Aug 18.
Summaries of product characteristics (SPCs) and clinical guideline recommendations are available for monitoring the platelet count for heparin-induced thrombocytopenia (HIT) in patients receiving low-molecular-weight heparin (LMWH). Testing for the presence of heparin-platelet factor 4 antibodies (HPF4-Ab) and starting alternative anticoagulation is recommended when HIT is suspected.
To investigate the frequency of compliance with recommendations for platelet count monitoring and management of possible HIT in hospitalized patients receiving prophylaxis and treatment dosing of LMWH for at least 5 consecutive days.
A retrospective cohort study within the Utrecht Patient Oriented Database (UPOD) was conducted. For all inpatients, all episodes of exposure to dalteparin or nadroparin for at least 5 consecutive days in 2004-2005 were selected. In 4 different nonexclusive groups of patients (all pts. receiving dalteparin, all pts. receiving nadroparin, surgical pts. with a prophylactic dose of either dalteparin or nadroparin, and pts. exposed to unfractionated heparin [UFH] within 100 days before receiving either dalteparin or nadroparin), compliance with recommendations for platelet count monitoring from SPCs and a clinical guideline was studied. The frequency of compliance with these recommendations was determined. In addition, it was determined whether patient and treatment characteristics were associated with regular platelet count monitoring. Finally, the frequency of testing for HPF4-Ab and the initiation of danaparoid treatment in patients with a drop of at least 50% in platelet count were investigated.
A total of 6804 patients, with 7770 episodes of LMWH treatment, were included in the analysis. The frequency of compliance with platelet count monitoring recommendations was 26.3% for all patients receiving dalteparin, 35.6% for all patients receiving nadroparin, 23.0% for surgical patients receiving prophylactic dosing of either dalteparin or nadroparin, and 41.5% for patients exposed to UFH within 100 days before the start of either dalteparin or nadroparin treatment. Regular platelet count monitoring was strongly positively associated with medical patients (relative risk [RR] 2.33), surgical patients (RR 2.03), critically ill patients (RR 2.80), and those with recent exposure to UFH (RR 2.19). The frequency of testing for HPF4-Ab was 5.4% and the initiation of alternative anticoagulation with danaparoid in patients with a 50% drop in platelet count was 0%.
The results suggest that compliance with recommendations for platelet count monitoring and management of possible HIT is low at our institution. Policies and tools to improve compliance with recommended laboratory monitoring should be developed to secure the safe use of LMWH and other medications.
产品特性摘要(SPCs)和临床指南建议可用于监测接受低分子量肝素(LMWH)治疗的患者是否发生肝素诱导的血小板减少症(HIT)。当怀疑发生HIT时,建议检测肝素 - 血小板因子4抗体(HPF4 - Ab)并开始使用替代抗凝药物。
调查在接受LMWH预防和治疗剂量至少连续5天的住院患者中,遵循血小板计数监测建议以及对可能的HIT进行管理的频率。
在乌得勒支患者导向数据库(UPOD)中进行了一项回顾性队列研究。对于所有住院患者,选取了2004 - 2005年期间所有连续至少5天使用达肝素或那屈肝素的病例。在4个不同的非排他性患者组(所有接受达肝素的患者、所有接受那屈肝素的患者、接受达肝素或那屈肝素预防剂量的外科患者以及在开始使用达肝素或那屈肝素前100天内接触过普通肝素[UFH]的患者)中,研究了遵循SPCs和临床指南中血小板计数监测建议的情况。确定了遵循这些建议的频率。此外,还确定了患者和治疗特征是否与定期血小板计数监测相关。最后,调查了血小板计数至少下降50%的患者中检测HPF4 - Ab的频率以及开始使用达那肝素进行替代抗凝治疗的频率。
分析共纳入6804例患者,7770次LMWH治疗病例。所有接受达肝素的患者遵循血小板计数监测建议的频率为26.3%,所有接受那屈肝素的患者为35.6%,接受达肝素或那屈肝素预防剂量的外科患者为23.0%,在开始使用达肝素或那屈肝素前100天内接触过UFH的患者为41.5%。定期血小板计数监测与内科患者(相对风险[RR] 2.33)、外科患者(RR 2.03)、重症患者(RR 2.80)以及近期接触过UFH的患者(RR 2.19)呈强正相关。检测HPF4 - Ab的频率为5.4%,血小板计数下降50%的患者中开始使用达那肝素进行替代抗凝治疗的频率为0%。
结果表明,在我们机构中,遵循血小板计数监测建议以及对可能的HIT进行管理的情况较差。应制定政策和工具以提高对推荐实验室监测的遵循程度,以确保LMWH和其他药物的安全使用。