Masaoka T, Ogawa M, Yamada K, Kimura K, Ohhashi Y
5th Dept. of Internal Medicine, Center for Adult Disease, Osaka.
Gan To Kagaku Ryoho. 1993 Oct;20(13):1995-2005.
In adult patients with acute non-lymphocytic leukemia (ANLL), idarubicin (IDA) and daunorubicin (DNR) were compared for efficacy and safety in combination with cytarabine (Ara-C). IDA 12 mg/m2/day and DNR 40 mg/m2/day were administered iv bolus for 3 consecutive days (day 1-3), respectively, in combination with Ara-C 80 mg/m2 given by 2-hour intravenous infusion, every 12 hours for 7 consecutive days. The number of evaluable patients was 32 for each group previously untreated. The rates of complete remission (CR) were 59.4% (19/32) in the IDA group and 40.6% (13/32) in the DNR group. The clinical equivalence test with delta = 10% demonstrated that the IDA group is equal or superior in remission rates (p = 0.010) compared to the DNR group. In addition, the Cochran-Mantel-Haenszel test for response means with scores of 3 (CR), 2 (PR) and 1 (NR) showed the significant superiority (p = 0.044) of the IDA group to the DNR group. The duration needed to attain less than 5% leukemic cells in bone marrow tended to be shorter in the IDA group (p = 0.072), and in the CR patients the number of days needed to reach the nadir value in leukemic cells were significantly fewer in the IDA group (p = 0.037). The nadir value of WBC was significantly lower in the IDA group (p = 0.022). As for adverse reactions, high incidences of diarrhea and stomatitis were observed in the IDA group, while the incidences of other adverse reactions were similar between the two groups. When effects of the drug on the ECG were examined, significant changes in ECG parameters were observed in the DNR group after treatment but not in the IDA group. From the above, remission induction in adult AN LL, IDA + Ara-C therapy showed better efficacy than DNR + Ara-C therapy, and IDA was considered to be a drug of first choice in the treatment of ANLL patients.
在成年急性非淋巴细胞白血病（ANLL）患者中，比较了伊达比星（IDA）和柔红霉素（DNR）与阿糖胞苷（Ara-C）联合使用时的疗效和安全性。IDA 12 mg/m²/天和DNR 40 mg/m²/天分别静脉推注连续3天（第1 - 3天），同时联合Ara-C 80 mg/m²，每12小时静脉输注2小时，连续7天。每组之前未接受过治疗的可评估患者均为32例。IDA组的完全缓解（CR）率为59.4%（19/32），DNR组为40.6%（13/32）。δ = 10%的临床等效性检验表明，IDA组在缓解率方面等于或优于DNR组（p = 0.010）。此外，对缓解均值进行Cochran-Mantel-Haenszel检验，缓解评分为3（CR）、2（PR）和1（NR），结果显示IDA组显著优于DNR组（p = 0.044）。IDA组骨髓中白血病细胞低于5%所需的时间趋于更短（p = 0.072），在CR患者中，IDA组达到白血病细胞最低点值所需的天数显著更少（p = 0.037）。IDA组白细胞最低点值显著更低（p = 0.022）。至于不良反应，IDA组腹泻和口腔炎的发生率较高，而两组其他不良反应的发生率相似。在检查药物对心电图的影响时，DNR组治疗后心电图参数有显著变化，而IDA组未观察到。综上所述，在成年ANLL患者的缓解诱导治疗中，IDA + Ara-C疗法比DNR + Ara-C疗法疗效更好，IDA被认为是治疗ANLL患者的首选药物。
