Safety profile of the oral iron chelator deferiprone: a multicentre study
Safety profile of the oral iron chelator deferiprone: a multicentre study
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口服铁螯合剂去铁酮的安全性：一项多中心研究
DOI：
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发表时间：
2000
影响因子：
6.5
通讯作者：
F. Tricta
中科院分区：
文献类型：
--
作者：
A. Cohen;R. Galanello;A. Piga;A. Dipalma;C. Vullo;F. Tricta
在以前的试验中，口服活性铁螯合剂去铁酮（L1）与散发性粒细胞缺乏症、轻度中性粒细胞减少症和其他副作用有关。为了确定这些事件的发生率，我们对螯合剂进行了多中心前瞻性研究。每周进行一次血细胞计数，确认中性粒细胞减少症后，要求停止治疗。在187例重型地中海贫血患者中，粒细胞缺乏症（中性粒细胞<0.5 × 109/l）的发生率为0.6/100患者-年，轻度中性粒细胞减少症（中性粒细胞0.5-1.5 × 109/l）的发生率为5.4/100患者-年。 所有中性粒细胞减少症病例均在中断治疗后消退。中性粒细胞减少主要发生在非脾切除患者中。恶心和/或呕吐发生在治疗早期，通常是短暂的，并导致3例患者停用去铁酮。轻度至中度关节疼痛和/或肿胀不需要永久停用去铁酮，并且在铁蛋白水平较高的患者中更常见。治疗期间平均丙氨酸转氨酶（ALT）水平升高。ALT水平升高通常是一过性的，在丙型肝炎患者中更常见。免疫学研究中的持续性变化并不常见，但经常发生散发性异常。治疗期间平均锌水平降低。铁蛋白水平在整个组中没有变化，但在基线水平> 2500 μg/l的患者中有所下降。 本研究描述了去铁酮的安全性特征，并在特定的监测条件下，证明粒细胞缺乏症比以前预测的要少见。
In previous trials, the orally active iron chelator deferiprone (L1) has been associated with sporadic agranulocytosis, milder forms of neutropenia and other side‐effects. To determine the incidence of these events, we performed a multicentre prospective study of the chelator. Blood counts were performed weekly, and confirmed neutropenia mandated discontinuation of therapy. Among 187 patients with thalassaemia major, the incidence of agranulocytosis (neutrophils < 0.5 × 109/l) was 0.6/100 patient–years, and the incidence of milder forms of neutropenia (neutrophils 0.5–1.5 × 109/l) was 5.4/100 patient–years. All cases of neutropenia resolved after interruption of therapy. Neutropenia occurred predominantly in non‐splenectomized patients. Nausea and/or vomiting occurred early in therapy, was usually transient and caused discontinuation of deferiprone in three patients. Mild to moderate joint pain and/or swelling did not require permanent cessation of deferiprone and occurred more commonly in patients with higher ferritin levels. Mean alanine transaminase (ALT) levels rose during therapy. Increased ALT levels were generally transient and occurred more commonly in patients with hepatitis C. Persistent changes in immunological studies were infrequent, although sporadic abnormalities occurred commonly. Mean zinc levels decreased during therapy. Ferritin levels did not change in the overall group but decreased in those patients with baseline levels > 2500 μg/l. This study characterized the safety profile of deferiprone, and, under the specific conditions of monitoring, demonstrated that agranulocytosis is less common than previously predicted.
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影响因子：
158.5
作者：
Olivieri, NF;Brittenham, GM;Fleming, KA
通讯作者：
Fleming, KA
影响因子：
158.5
作者：
OLIVIERI, NF;BRITTENHAM, GM;KOREN, G
通讯作者：
KOREN, G
3-羟基吡啶-4-一铁螯合剂对超载和非超载小鼠的亚急性毒性和功效比较。
影响因子：
20.3
作者：
Porter,JB;Hoyes,KP;Abeysinghe,RD;Brooks,PN;Huehns,ER;Hider,RC
通讯作者：
Hider,RC
影响因子：
158.5
作者：
BRITTENHAM, GM;GRIFFITH, PM;HARRIS, JW
通讯作者：
HARRIS, JW