国产安吖啶治疗急性白血病 Ⅲ 期临床试验

Phase Ⅲ clinical trial on domastic amsacrine in patients with acute leukemias

目的：进一步观察国产安吖啶的疗效及不良反应。方法：用国产安吖啶联合化疗方案治疗急性白血病初、复治病例２９１例。结果和结论：总完全缓解（ＣＲ）率４７．１％，急性淋巴细胞白血病（ＡＬＬ）为４３．３％，急性非淋巴细胞白血病（ＡＮＬＬ）为４９．０％。一线治疗无效和复发病例的ＣＲ率在ＡＬＬ和ＡＮＬＬ为２８．９％和３４．４％。国产安吖啶联合方案的不良反应与其它化疗方案相似。安吖啶的药代参数Ｃ１２ｈ／Ｃ６ｈ、Ｋ２１与疗效相关。

Objective:To further evaluate the efficacy and side effects of domastic amsacrine. Methods:Two handred and ninty one patients with acute leukemias,including initial,relapsed and refractory cases,were treated with regimens combining the amsacrine with other antileukemic drugs.Results and Conclusion:The total CR rate was 43.3% in ALL and 49.0% in ANLL.The CR rates of relapsed/refractory ALL and ANLL was 28.9% and 34.4%,respectively.The side effects and toxicity of the amsacrine based regimen were similar to that of other antileukemia regimens.The pharmacokinetic parameters of the domastic amsacrine,C12h/C6h ,K21 were correlated with therapeutic effectiveness.