论文部分内容阅读
本文报道肿瘤诊治新光敏剂PSD-007对狗的亚急性毒性。亚急性毒性的表现举如流涎、恶心、呕吐及其他早期症群与血卟啉病相似,实验室检查可见血液红系统的抑制,以及肝、肾功能的一定程度的损害,均属可逆反应,并与急性毒性相一致,进一步证实这些可作为PSD-007临床试用中的监护指标。 鉴于PSD-007第一期临床试验的结果表明,一次静注2.5～5.0mg/kg后在避免日光直接照射一个月的情况下,未出现包括光毒在内的任何毒副反应;而亚急性毒性试验又证实其毒性是可逆的,并与剂量平行,且可预测,故本制剂以相同剂量在不短于两周内重复给药可安全地开展第二期临床试验。
This article reports the subacute toxicity of the new photosensitizer PSD-007 to dogs treated by tumor. Subacute toxicity of performance such as salivation, nausea, vomiting and other early symptoms group and hematoporphyrin disease similar to the laboratory tests showed inhibition of the blood red system, as well as liver and kidney function to a certain extent, are reversible reaction, And consistent with acute toxicity, further confirmed that these can be used as PSD-007 clinical trial monitoring indicators. In view of the results of Phase I clinical trial of PSD-007, there was no any toxic or side effect including phototoxicity after a single intravenous injection of 2.5-5.0 mg / kg to avoid direct sunlight for one month. Subacute Toxicity test confirmed that its toxicity is reversible and dose parallel and predictable, so the preparation of the same dose repeated in less than two weeks safe to carry out the second phase of clinical trials.