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抗肿瘤蛋白A5注射液的I期临床研究。

Phase I clinical studies of antineoplaston A5 injections.

作者信息

Burzynski S R, Kubove E, Burzynski B

出版信息

Drugs Exp Clin Res. 1987;13 Suppl 1:37-43.

PMID:3569014
Abstract

Antineoplaston A5 is a mixture of small peptides and amino acid derivatives isolated from human urine which show a unique pattern of growth inhibition in the tissue culture of human neoplastic cells and no significant animal toxicity. Clinical trials described in this paper involved 15 patients diagnosed with advanced neoplastic diseases. The patients' diagnoses included: lung cancer, stage III (4 cases); breast, stages III and IV (3); colorectal, stage IV (2); bladder (2); and single cases of adenocarcinoma of the jejunum, stage IV; adenocarcinoma of the prostate, stage IV; adenocarcinoma of the ovary, stage IV and astrocytoma, grade IV. Antineoplaston A5 was administered daily in divided doses intravenously through a subclavian vein catheter. The formulation was given from 47 to 130 days. The highest dosage attained was 153 mg/kg/24 h. Adverse effects included febrile reaction in five patients, arthralgia in one patient and premature beats and pressure in the chest in one patient. The side-effects were very mild and usually experienced only once during the entire course of treatment. Desirable side-effects included increase of platelet count, increase of white blood cell count and hypertrophy of epidermis. Nine patients (60%) had objective response to the treatment. They were diagnosed with cancer of the lung (3 patients), breast (2), colorectal (2) and bladder (2). Four patients had increasing disease and two patients were classified as having stable disease without objective improvement.

摘要

抗瘤氨酸A5是从人尿中分离出的小肽和氨基酸衍生物的混合物,在人肿瘤细胞的组织培养中显示出独特的生长抑制模式,且无明显的动物毒性。本文所述的临床试验涉及15名被诊断患有晚期肿瘤疾病的患者。患者的诊断包括:III期肺癌(4例);III期和IV期乳腺癌(3例);IV期结直肠癌(2例);膀胱癌(2例);以及IV期空肠腺癌、IV期前列腺腺癌、IV期卵巢腺癌和IV级星形细胞瘤各1例。抗瘤氨酸A5通过锁骨下静脉导管每日分剂量静脉给药。给药持续47至130天。达到的最高剂量为153毫克/千克/24小时。不良反应包括5名患者出现发热反应,1名患者出现关节痛,1名患者出现早搏和胸部压迫感。副作用非常轻微,通常在整个治疗过程中仅出现一次。有益的副作用包括血小板计数增加、白细胞计数增加和表皮肥厚。9名患者(60%)对治疗有客观反应。他们被诊断患有肺癌(3例)、乳腺癌(2例)、结直肠癌(2例)和膀胱癌(2例)。4名患者病情进展,2名患者被归类为病情稳定但无客观改善。

相似文献

1
Phase I clinical studies of antineoplaston A5 injections.抗肿瘤蛋白A5注射液的I期临床研究。
Drugs Exp Clin Res. 1987;13 Suppl 1:37-43.
2
Initial clinical study with antineoplaston A2 injections in cancer patients with five years' follow-up.对癌症患者注射抗肿瘤药A2的初始临床研究及五年随访。
Drugs Exp Clin Res. 1987;13 Suppl 1:1-11.
3
Phase I clinical studies of antineoplaston A3 injections.抗肿瘤素A3注射液的一期临床研究。
Drugs Exp Clin Res. 1987;13 Suppl 1:17-29.
4
Toxicology studies on antineoplaston A10 injections in cancer patients.癌症患者使用抗癌灵A10注射液的毒理学研究。
Drugs Exp Clin Res. 1986;12 Suppl 1:47-55.
5
Toxicology studies on antineoplaston AS2-1 injections in cancer patients.癌症患者使用抗肿瘤药AS2-1注射剂的毒理学研究。
Drugs Exp Clin Res. 1986;12 Suppl 1:25-35.
6
Toxicology studies on antineoplaston AS2-5 injections in cancer patients.癌症患者使用抗肿瘤物质AS2-5注射液的毒理学研究。
Drugs Exp Clin Res. 1986;12 Suppl 1:17-24.
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[Effort to radically cure stage III and IV esophageal carcinoma with simultaneous radiotherapy and chemotherapy in standard clinical practice].[在标准临床实践中采用同步放疗和化疗根治Ⅲ期和Ⅳ期食管癌的努力]
Radiol Med. 2001 Jul-Aug;102(1-2):72-7.
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Tissue culture and animal toxicity studies of antineoplaston A5.抗瘤酮A5的组织培养及动物毒性研究。
Drugs Exp Clin Res. 1987;13 Suppl 1:31-5.

引用本文的文献

1
Potential of antineoplastons in diseases of old age.
Drugs Aging. 1995 Sep;7(3):157-67. doi: 10.2165/00002512-199507030-00001.