Strom Claes C, Andreasen Hans B
Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark.
Int J Mol Sci. 2017 Jan 10;18(1):121. doi: 10.3390/ijms18010121.
All IV iron complexes carry a risk of potentially fatal allergic type hypersensitivity reactions. The mechanism(s) behind these reactions is unknown but the limited data available suggests that classic IgE mediated allergy is exceedingly rare, if ever occurring. Iron-carbohydrate molecules are complex nano-particles and trying to reduce the risk of serious hypersensitivity to antibody binding of an artificial antibody seems meaningless. A recently published analysis of safety data from randomized clinical trials confirms the method reported by Neiser to be useless to predict reaction risk. In conclusion, the study by Neiser et al. is biased, contains no new information, and has no clinical relevance. We are concerned that the association of the authors with a commercial entity has caused a conflict of interest that biases not only the results, but the entire experimental setup against competitors. (Comment on Neiser et al. . , , 1185, doi:10.3390/ijms17071185).
所有静脉注射铁络合物都有发生潜在致命性过敏型超敏反应的风险。这些反应背后的机制尚不清楚，但现有有限数据表明，经典的IgE介导的过敏极为罕见，即便曾经发生过。铁碳水化合物分子是复杂的纳米颗粒，试图降低对人工抗体抗体结合产生严重超敏反应的风险似乎毫无意义。最近发表的一项对随机临床试验安全数据的分析证实，Neiser报告的方法对于预测反应风险毫无用处。总之，Neiser等人的研究存在偏差，没有新信息，也没有临床相关性。我们担心作者与商业实体的关联导致了利益冲突，这不仅使结果产生偏差，还使整个实验设置对竞争对手不利。（对Neiser等人的评论，……，1185，doi:10.3390/ijms17071185）
