苗药芪胶升白胶囊防治化疗相关白细胞减少的临床研究  

Clinical Study of Miao Nationality Medicine Qijiao Shengbai Capsule on Prevention and Treatment of Chemotherapy Related Leukopenia

作　　者：赵同德 田劭丹[1] 侯丽[1] 张玲 葛楠[3] 夏小军[4] 段赟[4] 陈莲[5] 许亚梅[1] ZHAO Tong-de;TIAN Shao-dan;HOU Li;ZHANG Ling;GE Nan;XIA Xiao-jun;DUAN Yun;CHEN Lian;XU Ya-mei(Department of Hematology and Oncology,Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700;Yunnan University of Traditional Chinese Medicine,Kunming Yunnan 650000;Beijing Hospital of TCM,Capital Medical University,Beijing 100010;Gansu Provincial Cancer Hospital,Lanzhou Gansu 730000;The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine,Nanning Guangxi 530000)

机构地区：[1]北京中医药大学东直门医院,北京100010 [2]云南中医药大学,云南昆明650000 [3]首都医科大学附属北京中医医院,北京100010 [4]甘肃省肿瘤医院,甘肃兰州730000 [5]广西中医药大学第一附属医院,广西南宁530000

出　　处：《世界中西医结合杂志》2020年第8期1547-1552,共6页World Journal of Integrated Traditional and Western Medicine

基　　金：国家科技重大专项项目重大新药创制(2014ZX09301308007)。

摘　　要：目的评价苗药芪胶升白胶囊对恶性肿瘤气血两虚证患者化疗后白细胞减少的干预作用。方法采用随机、双盲、双模拟、阳性药平行对照、多中心临床试验设计,拟纳入8个中心260例化疗患者,按脱落率不超过20%计算,拟纳入312例,包括肺癌和乳腺癌。采用中央随机法,受试者按2∶1随机进入治疗组或对照组。治疗组口服芪胶升白胶囊,对照组口服安多霖胶囊,两组患者均口服包装编盲药物每次4粒,每日3次,两组疗程均为1个化疗周期(20d)。化疗后4级和3/4级中性粒细胞下降发生率作为主要疗效指标,以不同时期白细胞及中性粒细胞计数与下降分级、白细胞及中性粒细胞最低值、粒细胞集落刺激因子(G-CSF)使用率作为次要疗效指标,并进行安全性评价。结果纳入309例肺癌及乳腺癌患者,共收集全数据集(FAS)287例(治疗组192例、对照组95例),符合方案集(PPS)共252例(治疗组175例、对照组77例)。主要疗效指标分别使用FAS、PPS进行统计,次要疗效指标使用PPS进行统计。两组4级和3/4级中性粒细胞下降发生率、各访视点白细胞及中性粒细胞计数与下降分级、白细胞及中性粒细胞最低值、G-CSF使用率组间比较,差异无统计学意义(P>0.05),两组疗效相当。对于化疗前基线白细胞(WBC)3.5×10^9/L^4.0×10^9/L的患者,治疗组第(10±1)天中性粒细胞计数明显高于对照组(P=0.037)。两组均未发生严重不良反应。结论芪胶升白胶囊能够防治化疗相关白细胞减少症。Objective To evaluate the intervention effect of Qijiao Shengbai Capsule,Miao Nationality Medicine on leukopenia after chemotherapy in patients with malignant tumor of deficiency of both qi and blood. Methods A randomized,double-blind,double-dummy,positive drug parallel controlled,multi-center clinical trial design was employed. 260 chemotherapy patients were planned to be recruited in 8 centers,and 312 patients were planned to be involved according to the dropout rate of not more than 20%,including lung cancer and breast cancer. Using central randomization,subjects were randomly divided into treatment group or control group in a 2∶ 1 ratio. The treatment group orally taken Qijiao Shengbai Capsules,while the control group taken Anduolin Capsules. The patients in both groups were orally taken 4 capsules of blinding coded drug each time,t. i. d. The course of treatment in both groups was 20 days( 1 chemotherapy cycle).The incidence of grade 4 and grade 3/4 neutropenia after chemotherapy was used as the primary efficacy endpoints,and the white blood cell and neutrophil count and decline grade at different periods,WBC and neutrophil nadir,and granulocyte colony-stimulating factor( G-CSF) use rate were used as the secondary efficacy endpoints,and safety was evaluated. The study protocol was approved by the Ethics Committee of Dongzhimen Hospital,Beijing University of Chinese Medicine. Results A total of 309 patients with lung cancer and breast cancer were included,of which 287 patients( 192 in the treatment group and 95 in the control group) in the Full Analysis Set( FAS) and 252 patients( 175 in the treatment group and 77 in the control group) in the Per Protocol Set( PPS). The primary efficacy endpoint was analyzed using FAS and PPS,and the secondary efficacy endpoint was analyzed using PPS. There was no significant difference between the two groups in the incidence of grade 4 and grade 3/4 neutropenia,WBC and neutrophil counts at each visit point and grade of decline,WBC and neutrophil nadir,and G-CSF use rate( P

关 键 词：芪胶升白胶囊 气血两虚 白细胞减少症 化疗 多中心研究 

分 类 号：R285[医药卫生—中药学] R244[医药卫生—中医学]