Update on the Incidence of Metamizole Sodium-induced Blood Dyscrasias in Poland
Update on the Incidence of Metamizole Sodium-induced Blood Dyscrasias in Poland
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DOI：
10.1177/147323001003800419
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发表时间：
2010-07-01
影响因子：
1.6
通讯作者：
Wiktor-Jedrzejczak, W.
中科院分区：
文献类型：
--
作者：
Basak, G. W.;Drozd-Sokolowska, J.;Wiktor-Jedrzejczak, W.
安乃近钠（安乃近）是一种受欢迎的非阿片类镇痛药，也是波兰常见的非处方药。关于与其使用相关的粒细胞缺乏症或再生障碍性贫血的风险水平存在争议。之前在波兰进行的两项药物警戒研究发现风险较低。为波兰3000万成年人提供专科护理的25个血液学中心中的24个参加了这项为期12个月的前瞻性研究。报告粒细胞缺乏症21例，再生障碍性贫血48例，中性粒细胞减少症15例，全血细胞减少症11例。在这些病例中，3例（2例粒细胞缺乏症; 1例再生障碍性贫血）被判定为可能与安乃近有关。与安乃近相关的粒细胞缺乏症和再生障碍性贫血的粗估计率分别为0.16和0.08例/百万人-日使用。波兰正在进行的国家安全性监测表明，尽管安乃近可能引起药物性血液恶液质，但风险非常低。
Metamizole sodium (metamizole) is a popular non-opioid analgesic and a common non-prescription product in Poland. Controversy exists regarding the level of risk of agranulocytosis or aplastic anaemia associated with its use. Two previous pharmacovigilance studies conducted in Poland found the risk was low. Twenty-four of the 25 haematology centres that provide specialist care for the 30 million adults in Poland participated in this prospective 12-month study. Twenty-one cases of agranulocytosis, 48 of aplastic anaemia, 15 of neutropenia and 11 of pancytopenia were reported. Of these cases, three (two agranulocytosis; one aplastic anaemia) were judged as being possibly related to metamizole. Crude estimates of the rate of agranulocytosis and aplastic anaemia associated with metamizole were 0.16 and 0.08 cases/million person-days of use, respectively. Ongoing national safety surveillance in Poland shows that, despite the possibility of drug-induced blood dyscrasias with metamizole, the risk is very low.