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米托蒽醌的II期研究

[Phase II study of mitoxantrone].

作者信息

Tada A, Ogawa M, Usui N, Inagaki J, Horikoshi N, Inoue K, Ikeda K, Adachi K, Nakada H, Okada Y

出版信息

Gan To Kagaku Ryoho. 1984 Aug;11(8):1649-54.

PMID:6476838
Abstract

A phase II clinical trial of an anthraquinone, mitoxantrone was performed in a total of 31 patients with various advanced solid tumors and 2 patients with malignant lymphomas refractory to extensive prior chemotherapies. Mitoxantrone was administered at dosages of 2 to 4 mg/m2 with a 5-day schedule or 6 to 12 mg/m2 with a one day schedule, repeating at 4-week intervals. Of 18 evaluable patients with breast cancer, one out of 2 patients who had not been exposed to regimens containing adriamycin achieved partial response lasting 3.6 months, while the remaining 16 patients exposed to adriamycin did not respond. Leukopenia less than 4 X 10(3)/cm3 and thrombocytopenia less than 100 X 10(3)/cm3 were observed in 100% and 55% of cases, respectively. Nausea and vomiting were observed in 36% of cases. Diarrhea, pyrexia, liver damage, mucositis and palpitation were observed in one case each. No ECG abnormality was recorded.

摘要

对蒽醌类药物米托蒽醌进行了一项II期临床试验,共有31例各种晚期实体瘤患者和2例对广泛的前期化疗难治的恶性淋巴瘤患者参与。米托蒽醌的给药剂量为2至4mg/m²,每5天给药一次,或6至12mg/m²,每日给药一次,每4周重复一次。在18例可评估的乳腺癌患者中,2例未接受过含阿霉素方案治疗的患者中有1例获得了持续3.6个月的部分缓解,而其余16例接受过阿霉素治疗的患者无反应。分别有100%和55%的病例观察到白细胞减少低于4×10³/cm³和血小板减少低于100×10³/cm³。36%的病例观察到恶心和呕吐。分别有1例观察到腹泻、发热、肝损伤、粘膜炎和心悸。未记录到心电图异常。

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