中医肿瘤学杂志2024，Vol.6Issue(2)：17-23,7.DOI:10.19811/j.cnki.ISSN2096-6628.2024.03.003
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
摘要
Abstract
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 which was higher than that in the western medicine group(P＜0.05).In terms of quality of life,the integrated traditional Chinese and western medicine group showed better improvement in the quality of life and KPS scores after treatment than those in the western medicine group(P＜0.05).In terms of safety evaluation,there was no statistical difference in adverse reaction rate between the two groups(P＞0.05).Conclusion The combination of Jianpi Bushen Huoxue Jiedu Recipe with DAC was superior to DAC alone in total effective rate and quality of life,and the improvement of traditional Chinese medicine symptoms of MDS patients was more obvious.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Key words
myelodysplastic syndrome/Jianpi Bushen Huoxue Jiedu Recipe/multicenter/randomized controlled分类
医药卫生引用本文复制引用
任建业,陆嘉惠,施艳,曾庆,陶雨晨..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[J].中医肿瘤学杂志,2024,6(2):17-23,7.基金项目
上海申康医院发展中心三年行动计划(编号:16CR2040B) （编号:16CR2040B）
国家自然科学基金面上项目(编号:81873286) （编号:81873286）
上海市优秀学术带头人计划(编号:20XD1403500) （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) （编号:21Y31920400）
上海申康医院发展中心临床科技创新项目(编号:SHDC12020128). （编号:SHDC12020128）
