健脾补肾活血解毒方联合地西他滨治疗骨髓增生异常综合征的多中心随机对照研究  

A Multicenter Randomized Controlled Trial of Jianpi Bushen Huoxue Jiedu Recipe Combined with Demethylation for the Treatment of Myelodysplastic Syndrome

作　　者：任建业 陆嘉惠[1] 施艳[1] 曾庆[2] 陶雨晨 REN Jian-ye;LU Jia-hui;SHI Yan;ZENG Qing;TAO Yu-chen(Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China;Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China)

机构地区：[1]上海中医药大学附属市中医医院,上海200071 [2]上海中医药大学附属岳阳中西医结合医院,上海200437

出　　处：《中医肿瘤学杂志》2024年第2期17-23,共7页Journal of Oncology in Chinese Medicine

基　　金：上海申康医院发展中心三年行动计划(编号:16CR2040B);国家自然科学基金面上项目(编号:81873286);上海市优秀学术带头人计划(编号:20XD1403500);上海市科学技术委员会医学创新研究专项重大项目(编号:21Y31920400);上海申康医院发展中心临床科技创新项目(编号:SHDC12020128)。

摘　　要：目的观察健脾补肾活血解毒方联合地西他滨(Decitabine,DAC)治疗骨髓增生异常综合征的临床疗效及安全性。方法收集2017年1月至2019年9月在上海中医药大学附属市中医医院、上海中医药大学附属岳阳中西医结合医院、上海交通大学医学院附属瑞金医院北院、上海交通大学医学院附属第九人民医院诊断为骨髓增生异常综合征(myelodysplastic syndromes,MDS)患者120例,使用中心分层随机化方法,对满足DAC治疗要求的各危度MDS患者根据随机数字表进入西医组和中西医结合组,各60例。两组均给予相同的西医标准治疗,中西医结合组加以健脾补肾活血解毒方辨证加减治疗,比较两组患者西医、中西医结合的疗效及不良反应情况。结果本研究共收集120例,完成研究97例,其中西医组44例,中西医结合组53例。两组未出现完全缓解和部分缓解患者,西医疗效方面,西医组总有效率为25.0%,中西医结合组总有效率47.2%,中西医结合组总有效率高于西医组(P<0.05)。在中医证候评分情况方面,西医组总有效率为52.3%,中西医结合组总有效率为73.6%,中西医结合组总有效率高于西医组(P<0.05)。在生存质量方面,治疗后中西医结合组生活质量及卡氏评分改善优于西医组(P<0.05)。在安全性评价方面,两组不良反应率差异没有统计学意义(P>0.05)。结论健脾补肾活血解毒方联合DAC治疗方案在总有效率及生活质量等方面优于单纯应用DAC,且对于MDS患者中医症状改善更为明显。Objective To observe the clinical efficacy and safety of Jianpi Bushen Huoxue Jiedu Recipe combined with Decitabine(DAC)for the treatment of myelodysplastic syndrome(MDS).Methods 120 patients with MDS diagnosed in Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,North Hospital of Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine,and Ninth People’s Hospital Affiliated to Shanghai Jiaotong University School of Medicine from January 2017 to September 2019 were collected,and were randomized by central stratification.All MDS patients who met the requirements of DAC treatment were enrolled into the western medicine group and the integrated traditional Chinese and western medicine group according to the random number table,with 60 cases in each group.Both groups were given the same standard treatment of western medicine,and the integrated traditional Chinese and western medicine group was additionally treated with Jianpi Bushen Huoxue Jiedu Recipe according to syndrome differentiation.The curative effects and adverse reactions of the two groups were compared.Results A total of 120 cases were collected,and 97 cases completed the research,including 44 cases in the western medicine group and 53 cases in the integrated traditional Chinese and western medicine group.There was no complete response or partial response case in the two groups.The total effective rate was 25.0%in the western medicine group,and 47.2%in the integrated traditional Chinese and western medicine group.The total effective rate in the integrated traditional Chinese and western medicine group was higher than that in the western medicine group(P<0.05).In terms of traditional Chinese medicine syndrome score,the total effective rate was 52.3%in the western medicine group,and 73.6%in the integrated traditional Chinese and western medicine group w

关 键 词：骨髓增生异常综合征 健脾补肾活血解毒方 去甲基化 多中心 随机对照 

分 类 号：R273[医药卫生—中西医结合] R551.3[医药卫生—中医肿瘤科]