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药物性贫血:向意大利药物警戒数据库报告情况的十年回顾

Drug-induced anaemia: a decade review of reporting to the Italian Pharmacovigilance data-base.

作者信息

Carnovale Carla, Brusadelli Tatiana, Casini Maria Luisa, Renda Francesca, Ruggieri Sara, Pimpinella Giuseppe, Radice Sonia, Clementi Emilio

机构信息

Unit of Clinical Pharmacology, Department of Biomedical and Clinical Sciences, University Hospital "Luigi Sacco", Università di Milano, Via G. B. Grassi, 74, 20157, Milan, Italy.

出版信息

Int J Clin Pharm. 2015 Feb;37(1):23-6. doi: 10.1007/s11096-014-0054-3. Epub 2014 Dec 17.

DOI:10.1007/s11096-014-0054-3
PMID:25515616
Abstract

BACKGROUND

Studies investigating drug-induced anaemia are relatively scarce and mostly related to specific drugs or patients with specific pathologies.

OBJECTIVE

To analyse all reports of suspected drug-induced anaemias recorded in the National Pharmacovigilance Database of the Italian Medicines Agency.

METHOD

The cases of suspected drug-induced anaemias analysed were those retrieved from the Italian National Pharmacovigilance Database from January 2001 to December 2013.

RESULTS

The active substances involved were 375 in 3,305 reports of drug-induced anaemia; of these, 72 % were reported as serious. In 35 % of the reports patients were in polytherapy. In 24.3 % of the cases relevant DDIs were identified. We found a PRR value of 57.29 for peginterferon alfa-2a, of 12.57 for ribavirin, of 13 for flu vaccine for the occurrence of autoimmune haemolytic anaemia. The drugs mostly involved in the cases where the Naranjo causality was probable or possible were acetylsalicylic acid, warfarin, ribavirin, peginterferon alfa-2a, carboplatin and acenocoumarol.

CONCLUSIONS

A possible signal was detected for peginterferon alfa-2a, ribavirin and flu vaccine in the occurrence of autoimmune haemolytic anaemia. A great involvement of clopidogrel, enoxaparin, warfarin, ticlopidine and acetylsalicylic acid in preventable DDI-induced anaemia was detected, highlighting a poor awareness among healthcare providers on this issue.

摘要

背景

关于药物性贫血的研究相对较少,且大多与特定药物或患有特定疾病的患者有关。

目的

分析意大利药品管理局国家药物警戒数据库中记录的所有疑似药物性贫血报告。

方法

分析的疑似药物性贫血病例是从2001年1月至2013年12月的意大利国家药物警戒数据库中检索到的。

结果

在3305份药物性贫血报告中涉及的活性物质有375种;其中,72%的报告为严重病例。35%的报告中患者接受联合治疗。在24.3%的病例中发现了相关的药物相互作用。我们发现聚乙二醇干扰素α-2a导致自身免疫性溶血性贫血的PRR值为57.29,利巴韦林为12.57,流感疫苗为13。在Naranjo因果关系可能或很可能存在的病例中,最常涉及的药物是乙酰水杨酸、华法林、利巴韦林、聚乙二醇干扰素α-2a、卡铂和醋硝香豆素。

结论

在自身免疫性溶血性贫血的发生中,检测到聚乙二醇干扰素α-2a、利巴韦林和流感疫苗可能存在信号。检测到氯吡格雷、依诺肝素、华法林、噻氯匹定和乙酰水杨酸在可预防的药物相互作用引起的贫血中大量涉及,突出了医疗保健人员对该问题的认识不足。

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