Ceschi Alessandro, Gregoriano Claudia, Rauber-Lüthy Christine, Kupferschmidt Hugo, Banner Nicholas R, Krähenbühl Stephan, Taegtmeyer Anne B
Swiss Toxicological Information Centre, Associated Institute of the University of Zurich , Freiestrasse 16, CH-8032 Zurich , Switzerland +41 44 634 1034 ; +41 44 252 8833 ;
Expert Opin Drug Saf. 2014 May;13(5):525-34. doi: 10.1517/14740338.2014.903032. Epub 2014 Mar 21.
Literature regarding acute human toxicity of mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS) is limited.
Our objectives were to describe all cases of overdose with MMF or EC-MPS reported to the Swiss Toxicological Information Centre (STIC) or in the literature between 1995 and 2013. Therefore, we performed an observational case-series and systematic literature search to determine circumstances, magnitude, management and outcome of overdose with MMF or EC-MPS.
Of 152,762 reports to STIC, 15 (7 pediatric) involved overdose with MMF (n = 13) or EC-MPS (n = 2). Three cases from other centers were identified from a systematic literature search. The magnitude of overdose ranged from 1.2 to 16.7 (median 2.9) times usual dose. Six (33%) MMF overdoses had attributable symptoms, which included abdominal pain, vomiting, headache and dizziness. The majority of findings were minor, although a 9-fold MMF overdose caused hypotension 8 h after ingestion and a 12.5-fold overdose caused leukopenia after 5 days. Symptoms did not occur in patients who took 2.5 times or less of their usual MMF dose. Gastrointestinal decontamination measures with activated charcoal were undertaken in one-third of cases.
Acute MMF and EC-MPS overdoses had a favorable outcome in all cases reported to STIC and in the literature.
关于霉酚酸酯(MMF)和肠溶型霉酚酸钠(EC-MPS)急性人体毒性的文献有限。
我们的目的是描述1995年至2013年间向瑞士毒理学信息中心(STIC)报告的或文献中报道的所有MMF或EC-MPS过量服用病例。因此,我们进行了一项观察性病例系列研究和系统的文献检索,以确定MMF或EC-MPS过量服用的情况、程度、处理方法及结果。
在向STIC报告的152,762份报告中,15例(7例为儿童)涉及MMF(n = 13)或EC-MPS(n = 2)过量服用。通过系统的文献检索,又确定了其他中心的3例病例。过量服用的程度为通常剂量的1.2至16.7倍(中位数为2.9倍)。6例(33%)MMF过量服用有相关症状,包括腹痛、呕吐、头痛和头晕。尽管1例过量9倍的MMF服用者在摄入后8小时出现低血压,1例过量12.5倍的服用者在5天后出现白细胞减少,但大多数发现的症状较轻。服用MMF剂量为其通常剂量2.5倍及以下的患者未出现症状。三分之一的病例采取了用活性炭进行胃肠道去污的措施。
向STIC报告的及文献中报道的所有急性MMF和EC-MPS过量服用病例均有良好结局。