肿瘤诊治新光敏剂(PSD-007)对狗的亚急性毒性

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。

SUBACUTE TOXICITY OF A NEW PHOTOSENSITIZER PSD-007 IN DOGS

In this paper the subacute toxicity of the new photosensitizer FSD-007 in dogs is reported. The manifestations of its subacute toxicity such as salivation, nausea, vomi-tus and other early syndromes were similar to those of porphyrinemia. The laboratory findings showed that the red cell system was depressed markedly, and hepatic and renal functions were impaired to some extent. These lesions were reversible and coincident with what was observed in its acute toxicity. The experimental results have further provided the evidence that these may be used clinically fer guard against its toxic effects.The results of phase I of clinical pharmacological study of FSD-007 have shown that there were no toxic effects observed after 2.5-5.0mg/kg iv on condition that the patient were kept away from direct sunlight for a month. And its subacute toxieity test has demonstrated that all its toxic changes arc dose-related,reversible and predictable. This preparation, therefore, may be safely tested in phase II with same dosage, but no duplicate administration is permitted within two weeks.