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阿克拉霉素A在日本的临床综述。

Clinical review of aclacinomycin A in Japan.

作者信息

Ota K

出版信息

Drugs Exp Clin Res. 1985;11(1):17-21.

PMID:3869800
Abstract

Single agent activity of aclacinomycin A or aclarubicin (ACR) for acute leukaemia in adults was as follows: complete remission was achieved in 8 of 21 (38%) with untreated patients and 7 of 41 (17%) with prior chemotherapy; thus the overall complete remission rate was 24%. The optimal dose schedule was 14 mg/m2/d daily i.v. administration, and a median total dose of 200 mg/m2 and 16 days were necessary for induction of complete remission. In combination, with behenoyl ara-C, ACR, 6-mercaptopurine and prednisolone, complete remission was achieved in 40 of 60 (67%) previously untreated patients, and 41 of 65 (63%) with prior chemotherapy; thus the overall rate was 65%. In a phase II study of ACR for solid tumours, response was achieved in carcinoma of oesophagus (1/3), stomach (12/84, 14%), gall bladder (1/4), pancreas (1/8), lung (4/30, 13%), breast (6/33, 18%), uterus (1/4), ovary (3/9, 33%), head and neck (1/5) and sarcoma (1/5). Side-effects of ACR most frequently observed were nausea and vomiting (around 30%) and a moderate grade marrow suppression was noted. An ECG change was observed in 7%, but there were no cases of chronic heart failure.

摘要

阿克拉霉素A或阿柔比星(ACR)对成人急性白血病的单药活性如下:未治疗患者中21例有8例(38%)达到完全缓解,接受过前期化疗的41例中有7例(17%)达到完全缓解;因此总体完全缓解率为24%。最佳剂量方案是每日静脉注射14mg/m²,诱导完全缓解需要的中位总剂量为200mg/m²,疗程为16天。与山嵛酰阿糖胞苷、ACR、6-巯基嘌呤和泼尼松龙联合使用时,60例先前未治疗的患者中有40例(67%)达到完全缓解,65例接受过前期化疗的患者中有41例(63%)达到完全缓解;因此总体缓解率为65%。在一项ACR用于实体瘤的II期研究中,食管癌(1/3)、胃癌(12/84,14%)、胆囊癌(1/4)、胰腺癌(1/8)、肺癌(4/30,13%)、乳腺癌(6/33,18%)、子宫癌(1/4)、卵巢癌(3/9,33%)、头颈癌(1/5)和肉瘤(1/5)出现缓解。最常观察到的ACR副作用是恶心和呕吐(约30%),并观察到中度骨髓抑制。7%的患者出现心电图改变,但无慢性心力衰竭病例。

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