Burzynski S R, Kubove E
Drugs Exp Clin Res. 1987;13 Suppl 1:1-11.
This paper describes Phase I clinical studies of Antineoplaston A2 injections. The studies involved 15 patients diagnosed with advanced neoplastic diseases including cancers of the breast, bladder, lung, kidney, oesophagus, colon and liver, mesothelioma and glioma. Antineoplaston A2 was administered in divided doses daily intravenously through a subclavian vein catheter. The treatment was given from 53 to 358 days. The highest dosage administered was 147 mg/kg/24 h. Only minimal adverse effects were noticed sometime during the treatment, including fever, chills and myalgia. Desirable side-effects included increase of platelet and white blood cell counts, hypertrophy of epidermis and decrease of cholesterol and triglyceride levels. Nine patients showed objective response to the treatment. Cases of complete remission included adenocarcinoma of the lung, mesothelioma, metastatic liver and bladder cancers. In an additional case of breast cancer, the patient obtained complete remission of liver metastasis and stabilization of bone metastases. Partial remission was accomplished in cancers of the breast and oesophagus. Three patients, including cases of adenocarcinoma of the lung, mesothelioma and bladder cancer, were in complete remission for over five years.
本文描述了抗肿瘤素A2注射剂的I期临床研究。该研究涉及15名被诊断患有晚期肿瘤疾病的患者，包括乳腺癌、膀胱癌、肺癌、肾癌、食管癌、结肠癌和肝癌、间皮瘤和神经胶质瘤。抗肿瘤素A2通过锁骨下静脉导管每日分剂量静脉给药。治疗持续53至358天。给药的最高剂量为147毫克/千克/24小时。在治疗期间的某些时候仅观察到轻微的不良反应，包括发热、寒战和肌痛。理想的副作用包括血小板和白细胞计数增加、表皮肥大以及胆固醇和甘油三酯水平降低。9名患者对治疗有客观反应。完全缓解的病例包括肺癌腺癌、间皮瘤、转移性肝癌和膀胱癌。在另一例乳腺癌中，患者肝转移完全缓解，骨转移稳定。乳腺癌和食管癌实现了部分缓解。3名患者，包括肺癌腺癌、间皮瘤和膀胱癌患者，完全缓解超过五年。
