Miser J S, Smithson W A, Krivit W, Hughes C, Davis D, Krailo M, Hammond D
Department of Pediatrics, Mayo Clinic Foundation, Rochester, Minnesota.
Invest New Drugs. 1991 Nov;9(4):339-42. doi: 10.1007/BF00183576.
We used indicine N-oxide to treat 46 children with malignant solid tumors: 17 with osteosarcoma, 12 with neuroblastoma, 13 with a brain tumor, and 4 with other miscellaneous tumors. The efficacy and toxicity of the drug was assessed at the dose of 2000 mg/m2/day for five consecutive days. None of the 39 patients evaluable for response achieved a complete or partial response. Hepatotoxicity was experienced by 13 patients: 11 patients developed asymptomatic elevations of transaminases, 1 patient developed hyperbilirubinemia, and 1 developed ascites. Indicine N-oxide appears to be ineffective in the treatment of osteosarcoma, neuroblastoma, and pediatric brain tumors at this dose and schedule. Because higher doses are associated with an unacceptably high incidence of severe, irreversible hepatotoxicity, we do not recommend further study of this agent in pediatric solid tumors.
我们使用印度獐牙菜N-氧化物治疗46例儿童恶性实体瘤：17例骨肉瘤、12例神经母细胞瘤、13例脑肿瘤和4例其他杂类肿瘤。连续5天以2000 mg/m²/天的剂量评估该药物的疗效和毒性。39例可评估反应的患者中无一例实现完全或部分缓解。13例患者出现肝毒性：11例患者转氨酶无症状升高，1例患者出现高胆红素血症，1例出现腹水。在此剂量和给药方案下，印度獐牙菜N-氧化物似乎对骨肉瘤、神经母细胞瘤和小儿脑肿瘤的治疗无效。由于更高剂量与严重的、不可逆的肝毒性发生率高到无法接受相关，我们不建议在小儿实体瘤中对该药物进行进一步研究。
