摘要
目的:观察贞芪扶正颗粒联合达沙替尼治疗BCR-ABL阳性白血病的疗效和安全性。方法:40例BCR-ABL阳性慢性粒细胞白血病(CML)或PH阳性急性淋巴细胞白血病患者随机分为对照组(20例)和观察组(20例)。对照组患者给予达沙替尼片(CML慢性期患者起始剂量100 mg,CML加速期、CML急变期患者起始剂量140 mg),每日1次,口服,早晚均可,整片吞服,不得切割或压碎。观察组患者在对照组治疗的基础上给予贞芪扶正颗粒15 g,每日2次。两组疗程均为24个月。观察两组患者的血液学效应、细胞遗传学效应、分子生物学效应,随访两组患者的病死率、平均随访时间及不良反应发生情况。结果:观察组患者完全缓解例数显著高于对照组,平均随访时间长于对照组,完全缓解中位时间显著短于对照组,不良反应发生率、病死率均显著低于对照组,差异均有统计学意义(P<0.05)。两组患者细胞遗传学效应、分子生物学效应比较,差异均无统计学意义(P>0.05)。结论:贞芪扶正颗粒联合达沙替尼治疗BCR-ABL阳性白血病在提高血液学效应和安全性方面优于单用达沙替尼,在细胞遗传学效应和分子生物学效应方面与单用达沙替尼相当。
OBJECTIVE：To observe the efficacy and safety of Zhenqi fuzheng granule combined with dasatinib in the treat-ment of BCR/ABL positive leukemia. METHODS：40 patients with BCR-ABL positive chronic myeloid leukemia or PH-positive acute lymphoblastic leukemia were randomly divided into control group（20 cases）and observation group（20 cases）. Control group received Dasatinib tablet,CML patients in chronic period received 100 mg,once a day,orally,morning or evening;CML patients in acceleration period and blastic period received 140 mg,once a day,orally,morning or evening,swallow whole,no cut or crushed. Observation group additionally received 15 g of Zhenqi fuzheng granule,twice a day. The treatment course for both groups was 24 months. Hematologic response,cytogenetic response and molecular biological response in 2 groups were observed, fatality rate,mean follow-up time and the incidence of adverse reactions were followed-up. RESULTS：CCR in observation group was significantly higher than control group,mean follow-up time was longer than control group,CCR median time was significant-ly shorter than control group,the incidence of adverse reactions and fatality rate were significantly lower than control group,the differences were statistically significant（P〈0.05）. There were no significant differences in the cytogenetic response and molecular biological response in 2 groups（P〉0.05）. CONCLUSIONS：Zhenqi fuzheng granule combined with dasatinib is superior to dasat-inib alone in proving hematologic response and safety in the treatment of BCR-ABL positive leukemia,and similar in cytogenetic response and molecular biological response.
出处
《中国药房》
CAS
北大核心
2016年第18期2482-2484,共3页
China Pharmacy
基金
贵阳市白云区科技计划项目(No.白科合同〔2014年〕6号)
