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目的 对细小病毒H1用于临床的安全性作初步评估。方法 本文用Ames试验、哺乳动物细胞染色体畸变试验、小鼠骨髓细胞微核试验、过敏试验和热原试验对H1用于肿瘤治疗的临床安全性进行了检测。结果 上述所有试验都呈阴性。同时,小鼠对H1的最大耐受量大于5×1011空斑形成单位kg体重,相当于假定的人的临床剂量的2500倍。对H1的宿主NB324K细胞,进行了软琼脂集落试验和裸小鼠体内成瘤试验,其结果也呈阴性。结论 细小病毒H1对肿瘤治疗是安全的。
Objective To make a preliminary assessment of the safety of parvovirus H1 for clinical use. Methods Ames test, mammalian chromosome aberration test, mouse bone marrow micronucleus test, allergy test and pyrogen test were used to determine the clinical safety of H1 for tumor therapy. Results All the above tests were negative. At the same time, the maximum tolerated dose of H1 in mice was greater than 5 × 1011 plaque forming units of kg body weight, equivalent to 2500 times the putative human clinical dose. The host NB324K cells of H1 were subjected to soft agar colony assay and nude mice in vivo tumorigenicity test, and the results were also negative. Conclusions Parvovirus H1 is safe for cancer treatment.