Ramot Yuval, Kannan Kamala, Reddy Sathish, Krishnappa H, Dillberger John E, Nyska Abraham
1 Hadassah-Hebrew University Medical Center, Jerusalem, Israel.
2 Eurofins Advinus Ltd., Bengaluru, Karnataka, India.
Toxicol Pathol. 2019 Jan;47(1):93-96. doi: 10.1177/0192623318808989. Epub 2018 Nov 8.
It is important to detect injection site reactions during the nonclinical phases of drug development. However, differentiating between normal changes following needle trauma and changes due to the toxicity of injected drugs can be challenging. Therefore, we used the Sprague-Dawley rat model to evaluate the pathological findings expected following a single subcutaneous injection of normal saline. Rats were subcutaneously administered with normal saline, and the injection sites were examined microscopically. Inflammation was evident in most of the injection sites, mostly in minimal severity. Parakeratosis/epithelial crust was also seen in several sites, and necrosis was observed in a minority of the cases. These findings indicate that needle puncture trauma can present with some degree of inflammation and necrosis. Although limited to a specific time point and strain, this study shows that inflammation following subcutaneous injection can be attributed in part to the needle trauma and not necessarily to the drug itself.
在药物研发的非临床阶段检测注射部位反应很重要。然而，区分针刺创伤后的正常变化和注射药物毒性导致的变化可能具有挑战性。因此，我们使用Sprague-Dawley大鼠模型来评估单次皮下注射生理盐水后预期的病理结果。给大鼠皮下注射生理盐水，并对注射部位进行显微镜检查。大多数注射部位出现炎症，大多程度轻微。在几个部位还可见角化不全/上皮结痂，少数病例观察到坏死。这些发现表明针刺创伤可出现一定程度的炎症和坏死。尽管该研究限于特定时间点和品系，但表明皮下注射后的炎症部分可归因于针刺创伤，而不一定归因于药物本身。
