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首页> 外文期刊>Prescrire international >Dexrazoxane: new indication. Anthracycline extravasation: continue using dimethyl sulfoxide.
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Dexrazoxane: new indication. Anthracycline extravasation: continue using dimethyl sulfoxide.

机译：右雷佐生：新适应症。蒽环类药物外渗：继续使用二甲基亚砜。

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1) Anthracycline extravasation can provoke extensive tissue necrosis, sometimes with serious consequences. Topical dimethylsulfoxide (DMSO) is the main antidote known to prevent this necrosis. It is used off-licence in France, based on the results of non-comparative trials. Among nearly 150 patients treated with dimethylsulfoxide, only one required surgery and about 10% of patients had sequelae; 2) A product based on dexrazoxane, an iron chelator, also approved to prevent anthracycline cardiotoxicity, has now been authorized for intravenous treatment of anthracycline extravasation; 3) Clinical evaluation of dexrazoxane in this setting does not include any trials versus dimethylsulfoxide. The combination of dexrazoxane plus dimethylsulfoxide is contraindicated, based on the results of animal studies; 4) Clinical evaluation of dexrazoxane only includes one case of anthracycline extravasation from a central venous line; 5) In two non-comparative trials in a total of 54 patients, only one patient required surgery for tissue necrosis. About one-third of patients had local complications (sensory disorders, pain, cutaneous atrophy, or restricted movement); 6) The only known adverse effect of topical dimethylsulfoxide is local irritation. In contrast, 10% of patients who received intravenous dexrazoxane had an infection that the investigators considered possibly linked to dexrazoxane. In addition to the known haematological effects of dexrazoxane (leukopenia and thrombocytopenia), other serious adverse events observed in the two trials included a major increase in hepatic transaminase activity, elevated creatinine levels, and hyper- or hypokalaemia; 7) Based on an evaluation that is neither sufficiently thorough nor rigorous, the risk-benefit balance of intravenous dexrazoxane appears to be less favourable than that of local dimethylsulfoxide, which should therefore continue to be used in this setting. In the meantime, preventive measures should be strictly followed in order to prevent extravasation from occurring. The assessment of dexrazoxane in anthracycline extravasation from a central line also remains inadequate.
机译：1）蒽环类药物的外渗可引起广泛的组织坏死，有时会造成严重后果。局部使用二甲基亚砜（DMSO）是已知的预防这种坏死的主要解毒剂。根据非比较性试验的结果，它在法国被许可使用。在将近150名接受二甲亚砜治疗的患者中，只有一名需要手术治疗，约10％的患者患有后遗症。 2）基于右雷佐生（一种铁螯合剂）的产品也被批准用于预防蒽环类药物的心脏毒性，现已被批准用于蒽环类药物外渗的静脉内治疗; 3）在这种情况下右雷佐生的临床评估不包括对二甲亚砜的任何试验。根据动物研究的结果，禁忌使用右雷佐生与二甲亚砜的混合物。 4）右雷佐生的临床评估仅包括一例蒽环类药物从中心静脉线渗出的病例; 5）在总共54例患者的两项非对照试验中，只有一名患者需要手术治疗组织坏死。约三分之一的患者有局部并发症（感觉障碍，疼痛，皮肤萎缩或活动受限）; 6）局部使用二甲亚砜的唯一已知不良反应是局部刺激。相反，接受静脉注射右雷佐生的患者中有10％的感染被研究者认为可能与右雷佐生有关。除了已知的右雷佐生的血液学作用（白细胞减少症和血小板减少症）外，在两项试验中观察到的其他严重不良事件还包括肝转氨酶活性大幅增加，肌酐水平升高以及高钾血症或低钾血症。 7）根据既不充分也不严格的评估，静脉右雷佐生的风险收益平衡似乎不如局部二甲基亚砜的风险收益平衡，因此在这种情况下应继续使用。同时，应严格遵守预防措施，以防止外溢的发生。从中心线的蒽环类药物渗出中右雷佐生的评估也仍然不足。

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    《Prescrire international》 |2009年第99期|共3页
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