联合化疗方案治疗中、高危骨髓增生异常综合征及急性髓系白血病的疗效分析

Treatment in Middle and High Risk Myelodysplastic Syndrome and Acute Myeloid Leukemia

目的探讨阿糖胞苷（AraC）、去甲氧柔红霉素（IDA）和粒细胞集落刺激因子（G-CSF）联合方案（CIG方案），治疗中、高危骨髓增生异常综合征（MDs）和难治、复发、老年初治以及继发于MDS的急性髓系白血病（AML）的临床疗效及不良反应。方法选择2004年4月至2010年3月，在本院住院的AML和MDS患者中，符合本研究纳入标准和排除标准的34例患者为研究对象。将其随机分为治疗组（n=16）和对照组（n=18）（本研究遵循的程序符合本院人体试验委员会所制定的伦理学标准，得到该伦理会批准，分组征得受试对象本人的知情同意，并与之签订临床研究知情同意书）。治疗组共16例采用CIG方案治疗，其中包括3例MDS和13例AML患者；对照组共18例采用米托蒽醌（mitoxantrone）联合AraC方案（MA方案），其中包括2例MDS转化为AML和16例AML患者。完成1个疗程后评估疗效，治疗失败患者则退出观察，有效患者再接受1个疗程治疗。随访分析患者总体生存期（OS），评判CIG方案的疗效。结果治疗组16例患者中，完全缓解（CR）为9例（56．25％），部分缓解（PR）为4例（25％），未缓解（NR）为2例（12．5％），死亡为1例（6．25％），总有效率达81．25％。其中，第1个疗程达CR患者为6例，第2个疗程达CR为3例。治疗组中位0S为26个月。对照组18例患者中CR为8例（44．44％），PR为4例（22．22％），NR为3例（16．67％），死亡为3例（16．67％），总有效率为66．67％。其中，第1个疗程达CR为4例，第2个疗程达CR为2例。中位0S为20个月。结论在高危MDS和难治、复发、老年AMI。患者治疗中，CIG方案较MA方案更为有效，且不良反应发生率较低，长期疗效较好。

Objective To investigate the clinical efficacy and adverse reactions of the CIG regimen, which composed of cytosine arabinoside （AraC）, idarubicin （IDA） and granulocyte colony-stimulating factor （G-CSF）, in middle and high risk myelodysplastic syndrome （MDS）, previously untreated elderly acute myeloid leukemia （AML）, refractory AML/relapsed AML and secondary AML from MDS patients. Methods From April 2004 to March 2010, 40 patients who were in line with the study inclusion criteria and exclusion criteria were included into this study. By the method of randomized controlled trial, they were randomly divided into research group （n=16） and control group （n=18）. The study protocol was approved by the Ethical Review Board of Investigation in Human Being of the Tenth People＇s Hospital, Tongji University. The CIG regimen was used to treat 3 cases of MDS and 13 cases of AML patients in research group. The mitoxantrone and AraC （MA regimen） were used to treat 2 cases of AML from MDA and 16 cases of AML patients. The outcomes of each group were evaluated after 1 course of treatment. The patients with treatment failure were exited from the trial and the responders continued to receive another course of treatment. All patients were followed up, and overall survival （OS） were analyzed. Results In treatment group, 9 cases achieved complete remission（CR）, 4 cases achieved partial remission（PR）. The total responsive rate was 81.25%. 6 cases were CR after the first course, 3 cases were PR after the second course. The median OS was 26 months. In control group,8 cases achieved CR,and 4 cases achieved PR. The total responsive rate was 66.67~. 4 cases were CR after the first course, and 2 cases were PR after thesecond course. The median OS was 20 months. Conclusions Treatment for middle and high risk MDS and unfavourable prognosis AML with CIG regiment is safe and effective. Long-term outcome need to be observed further.