Ohnuma T, Sridhar K S, Ratner L H, Holland J F
Cancer Treat Rep. 1982 Jul;66(7):1509-15.
Indicine N-oxide is a pyrrolizidine alkaloid isolated from Heliotropium indicum, one of the widely used herbs in Ayurvedic medicine. Thirty-seven patients with solid tumors received the drug: 15 men and 22 women (mean age, 53 years). All had had prior chemotherapy, and 25 had had prior radiotherapy. Eighty-four percent had a performance status of 0-3 (Cancer and Leukemia Group B criteria). The drug was given as a short infusion over 15 minutes and repeated with a median interval of 4 weeks. Doses were escalated from 1 to 9 g/m2. A total of 55 courses were evaluable. Dose-limiting toxic effects were leukopenia and thrombocytopenia, and the toxicity was cumulative with repeated doses. Other toxic effects included nausea and vomiting, anemia, and hepatic dysfunction. The hematologic toxicity tended to be more pronounced in patients with hepatic dysfunction, poor marrow reserve, and heavy prior chemotherapy and radiotherapy. There were no complete or partial responses. One patient with skin melanoma and another with ovarian carcinoma had improvement lasting 2 months. The maximally tolerated dose is 9 g/m2 in our population. A recommended dose for therapeutic study is 7 g/m2. High-risk patients should be started at a dose of 5 g/m2. The treatment may be repeated at 4-week intervals with close monitoring of wbc and platelet counts. Dose reductions may be necessary for repeated courses.
印度天芥菜碱氮氧化物是一种从印度天芥菜中分离出的吡咯里西啶生物碱，印度天芥菜是阿育吠陀医学中广泛使用的草药之一。37例实体瘤患者接受了该药物治疗：15名男性和22名女性（平均年龄53岁）。所有患者均接受过先前的化疗，25名患者接受过先前的放疗。84%的患者体力状况为0 - 3（癌症和白血病B组标准）。药物通过15分钟的短时间输注给药，中位间隔4周重复给药。剂量从1 g/m²逐步增加至9 g/m²。总共55个疗程可评估。剂量限制性毒性反应为白细胞减少和血小板减少，且毒性随着重复给药而累积。其他毒性反应包括恶心、呕吐、贫血和肝功能障碍。血液学毒性在肝功能障碍、骨髓储备差以及先前接受过大量化疗和放疗的患者中往往更为明显。没有完全缓解或部分缓解的病例。1例皮肤黑色素瘤患者和另1例卵巢癌患者病情改善持续了2个月。在我们的研究人群中，最大耐受剂量为9 g/m²。治疗性研究的推荐剂量为7 g/m²。高危患者应以5 g/m²的剂量开始治疗。治疗可每4周重复进行，密切监测白细胞和血小板计数。重复疗程可能需要减少剂量。
