复方黄黛片联合全反式维甲酸治疗急性早幼粒细胞白血病的临床观察  

Clinical efficacy of compound Huangdai tablets combined with all-trans retinoic acid in the treatment of acute promyelocytic leukemi

作　　者：杨宇佳 张慧琪[1] Yang Yujia;Zhang Huiqi(Department of Hematology,the First People's Hospital of Huzhou,Huzhou 313000,Zhejiang Province,China)

机构地区：[1]湖州市第一人民医院血液内科,浙江省313000

出　　处：《中国基层医药》2021年第11期1683-1687,共5页Chinese Journal of Primary Medicine and Pharmacy

基　　金：浙江省湖州市科技局第二批科技计划项目(2017GYB04)。

摘　　要：目的观察复方黄黛片联合全反式维甲酸用于治疗急性早幼粒细胞白血病的临床疗效。方法选择2013年2月至2015年2月于湖州市第一人民医院治疗的急性早幼粒细胞白血病患者120例为研究对象,按照随机数字表法分为研究组(60例)和对照组(60例)。对照组患者予以全反式维甲酸、巯嘌呤联合甲氨蝶呤治疗,研究组患者予以全反式维甲酸联合复方黄黛片治疗,记录患者血红蛋白(Hb)开始回升时间、血小板(PLT)开始回升时间和首次完全缓解时间;统计随访5年内患者病情复发及死亡情况,观察患者治疗期间药物不良反应发生情况。结果研究组患者Hb开始回升时间、PLT开始回升时间和首次完全缓解时间[(19.56±2.61)d、(20.42±2.73)d、(1.74±0.45)个月]均显著短于对照组[(28.42±3.85)d、(30.63±4.02)d、(3.31±0.69)个月](t=10.328、9.746、8.521,均P<0.001);研究组患者随访1年内和5年内复发率(11.37%和21.67%)显著低于对照组(28.33%和41.67%)(χ^(2)=5.208、5.546,P=0.022、0.019),且研究组患者随访5年内病死率(8.33%)显著低于对照组(25.00%)(χ^(2)=6.000,P=0.014);研究组患者各类药物不良反应总发生率(28.33%)与对照组(26.67%)差异无统计学意义(χ^(2)=0.042,P=0.838)。结论复方黄黛片联合全反式维甲酸可有效缩短急性早幼粒细胞白血病病情缓解周期,降低患者复发率和病死率,且安全性较高。Objective To investigate the clinical efficacy of compound Huangdai tablets combined with all-trans retinoic acid in the treatment of acute promyelocytic leukemia.Methods A total of 120 patients with acute promyelocytic leukemia who received treatment in the First People's Hospital of Huzhou,China between February 2013 and February 2015 were included in this study.They were randomly assigned to receive either all-trans retinoic acid,mercaptopurine and methotrexate in combination(control group,n=60)or all-trans retinoic acid combined with compound Huangdai tablets(study group,n=60).The time to hemoglobin rebounding,the time to platelet count rebounding,and the time to first complete remission were recorded.The recurrence and death of patients during 5 years of follow up were recorded.Adverse drug reactions during the treatment period were recorded.Results The time to hemoglobin rebounding,the time to platelet count rebounding,and the time to first complete remission in the study group were(19.56±2.61)days,(20.42±2.73)days,(1.74±0.45)months,respectively,which were significantly shorter than those in the control group[(28.42±3.85)days,(30.63±4.02)days,(3.31±0.69)months,t=10.328,9.746,8.521,P<0.001].The 1-year and 5-year recurrence rate in the study group were 11.37%and 21.67%respectively,which were significantly lower than those in the control group[28.33%,41.67%,χ^(2)=5.208,5.546,P=0.022,0.019].5-year mortality rate in the study group was significantly lower than that in the control group[8.33%vs.25.00%,χ^(2)=6.000,P=0.014].There was no significant difference in adverse drug reaction between study and control group[28.33%vs.26.67%,χ^(2)=0.042,P=0.838].Conclusion Compound Huangdai tablets combined with all-trans retinoic acid can effectively shorten the remission time of acute promyelocytic leukemia,reduces the disease recurrence rate and mortality rate,and is highly safe.

关 键 词：白血病 早幼粒细胞 急性 复方黄黛片 全反式维甲酸 完全缓解 复发率 病死率 不良反应 临床疗效 

分 类 号：R733.71[医药卫生—肿瘤]