苗药芪胶升白胶囊防治乳腺癌化疗相关白细胞减少症的临床研究  

Clinical study of Miao medicine Qijiao Shengbai Capsule in the prevention and treatment of chemotherapy-induced leukopenia in breast cancer

作　　者：楚立园 韩丹阳 田劭丹[1] 张玲 段赟[4] 曾清[5] 吕丽媛 陈信义[1] 兰梦好 CHU Liyuan;HAN Danyang;TIAN Shaodan;ZHANG Ling;DUAN Yun;ZENG Qing;LYU Liyuan;CHEN Xinyi;LAN Menghao(Department of Hematology and Oncology,Dongzhimen Hospital of Beijing University of Chinese Medicine,Beijing 100700,China;Beijing Gulou Hospital of Chinese Medicine,Beijing 100009,China;Yunnan University of Chinese Medicine,Kunming,Yunnan 650500,China;Gansu Provincial Cancer Hospital,Lanzhou,Gansu 730050,China;The First Affiliated Hospital of Guangxi University of Chinese Medicine,Nanning,Guangxi 530023,China)

机构地区：[1]北京中医药大学东直门医院血液肿瘤科,北京100700 [2]北京市鼓楼中医医院,北京100009 [3]云南中医药大学,云南昆明650500 [4]甘肃省肿瘤医院,甘肃兰州730050 [5]广西中医药大学第一附属医院,广西南宁530023

出　　处：《湖南中医药大学学报》2024年第12期2210-2215,共6页Journal of Hunan University of Chinese Medicine

基　　金：北京中医药大学揭榜挂帅重点项目(2024-JYB-JBZD-007);国家科技重大专项项目-重大新药创制专项(2014ZX09301308007);国家中医药管理局高水平中医药重点学科建设项目中医血液病学(zyyzdxk-2023268);北京中医药大学东直门医院(国家中医药管理局下拨)-临床研究和成果转化能力提升试点项目(DZMG-ZJXY-23014)。

摘　　要：目的观察芪胶升白胶囊防治乳腺癌化疗相关白细胞减少症的临床疗效。方法采用多中心随机、阳性药对照的临床试验设计,纳入4个中心119例气血两虚型乳腺癌化疗患者,按2∶1比例随机分为芪胶升白胶囊治疗组(n=79)和安多霖胶囊对照组(n=40),疗程为20 d。比较两组患者治疗前后白细胞和中性粒细胞计数及减少分级、中医证候与症状积分、后续化疗按时进行率和用药安全性。结果治疗后,两组中医证候与症状积分均较治疗前降低(P<0.05),两组患者白细胞、中性粒细胞计数与减少程度分级和后续化疗按时进行率比较,差异无统计学意义(P>0.05)。治疗组有1例患者出现轻度腹泻,但停药后好转。结论芪胶升白胶囊防治乳腺癌化疗相关白细胞减少症具有一定优势,可有效改善气血两虚证,保障后续化疗按时进行,临床安全性良好。Objective To observe the clinical efficacy of Qijiao Shengbai Capsule in the prevention and treatment of chemotherapy-induced leukopenia in breast cancer.Methods A multi-center,randomized,and positive drug-controlled clinical trial design was used,enrolling 119 patients with breast cancer undergoing chemotherapy who presented with qi and blood deficiency pattern from four centers.They were randomly assigned to the Qijiao Shengbai Capsule treatment group(n=79)and the Anduolin Capsule control group(n=40)in a ratio of 2∶1.The treatment course lasted for 20 days.White blood cell count(WBC),absolute neutrophil count(ANC),and their respective reduction grades,as well as the Chinese medicine(CM)pattern and symptom scores,were compared between the two groups before and after treatment.Additionally,the rates of timely follow-up chemotherapy and medication safety were compared between the two groups.Results After treatment,the CM pattern and symptom scores in both groups decreased compared to those before treatment(P<0.05).There were no statistically significant differences in WBC,ANC,their respective reduction grades,or the rates of timely follow-up chemotherapy between the two groups(P>0.05).One patient in the treatment group experienced mild diarrhea,which improved after discontinuing the medication.Conclusion Qijiao Shengbai Capsule has certain advantages in preventing and treating chemotherapy-induced leukopenia in breast cancer patients.It can effectively alleviate the symptoms of qi and blood deficiency and ensure the timely continuation of chemotherapy,with good clinical safety.

关 键 词：乳腺癌 化疗 芪胶升白胶囊 白细胞减少症 临床研究 

分 类 号：R273[医药卫生—中西医结合]