Masaoka T, Ogawa M, Yamada K, Kimura K
5th Dept. of Internal Medicine, Center for Adult Disease, Osaka.
Gan To Kagaku Ryoho. 1993 Oct;20(13):2007-14.
A late phase II study of idarubicin hydrochloride combined with vincristine and prednisolone was conducted in adult patients with acute lymphocytic leukemia (ALL) in the first relapse as a multi-center joint research project. The dosages used were idarubicin 12 mg/m2/day i.v. for 3 consecutive days (day 1-3), vincristine 1.4 mg/m2 i.v. (day 1) and prednisolone 60 mg/m2/day po for 5 consecutive days (day 1-5). The number of evaluable patients was 20. The patients showed responses including 3 complete remissions (CR) and 10 partial remissions (PR), with an efficacy rate (CR + PR) of 65.0%. Adverse reactions occurred in 19 of 20 patients. The main symptoms were gastrointestinal symptoms including anorexia, nausea/vomiting, and stomatitis and fever, infection, and alopecia. Abnormal laboratory data were observed in 6 of 20 patients with 13 events. Although one case of an increase in GPT with WHO grade 3 was observed, the other cases were not of significance. From the above study, idarubicin hydrochloride was considered to be effective in relapsed ALL patients in combination therapy with vincristine and prednisolone.
作为一项多中心联合研究项目，对盐酸伊达比星联合长春新碱和泼尼松龙用于首次复发的成年急性淋巴细胞白血病（ALL）患者进行了一项II期晚期研究。使用的剂量为：盐酸伊达比星12mg/m²/天，静脉注射，连续3天（第1 - 3天）；长春新碱1.4mg/m²，静脉注射（第1天）；泼尼松龙60mg/m²/天，口服，连续5天（第1 - 5天）。可评估患者数量为20例。患者出现的反应包括3例完全缓解（CR）和10例部分缓解（PR），有效率（CR + PR）为65.0%。20例患者中有19例出现不良反应。主要症状为胃肠道症状，包括厌食、恶心/呕吐、口腔炎以及发热、感染和脱发。20例患者中有6例出现13次实验室数据异常。虽然观察到1例谷丙转氨酶升高达WHO 3级，但其他病例无显著意义。从上述研究来看，盐酸伊达比星在与长春新碱和泼尼松龙联合治疗复发ALL患者时被认为是有效的。
