益气健脾化积方对气虚血瘀型胃癌化疗患者的效果  

Study on effect of Yiqi Jianpi Huaji Formula for gastric cancer patients differentiated as qi deficiency and blood stasis syndrome undergoing chemotherapy

作　　者：徐婷婷[1] 严展鹏[1] 朱方石 霍介格[2] 李勇[3] 王中奇[4] 钱建业 潘迎英 曹蕊云 XU Tingting;YAN Zhanpeng;ZHU Fangshi;HUO Jiege;LI Yong;WANG Zhongqi;QIAN Jianye;PAN Yingying;CAO Ruiyun(Digestive Department,Hospital of Integrated Chinese and Western Medicine Affiliated to Nanjing University of Traditional Chinese Medicine,Academy of Traditional Chinese Medicine of Jiangsu Province,Nanjing,Jiangsu,210046;Oncology Department,Hospital of Integrated Chinese and Western Medicine Affiliated to Nanjing University of Traditional Chinese Medicine,Academy of Traditional Chinese Medicine of Jiangsu Province,Nanjing,Jiangsu,210046;Oncology Department,Gongli Hospital Affiliated to Second Military Medical University,Shanghai,200433;Oncology Department,Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai,201203;Oncology Department,Jiangyan Hospital of Traditional Chinese Medicine in Taizhou City in Jiangsu Province,Taizhou,Jiangsu,225500;Oncology Department,Zhangjiagang City Hospital of Traditional Chinese Medicine of Jiangsu Province,Suzhou,Jiangsu,215600;Digestive Department,Wujin Hospital of Traditional Chinese Medicine in Changzhou City of Jiangsu Province,Changzhou,Jiangsu,213100)

机构地区：[1]南京中医药大学附属中西医结合医院/江苏省中医药研究院消化内科,江苏南京210046 [2]南京中医药大学附属中西医结合医院/江苏省中医药研究院肿瘤科,江苏南京210046 [3]第二军医大学附属公利医院肿瘤科,上海200433 [4]上海中医药大学附属龙华医院肿瘤科,上海201203 [5]江苏省泰州市姜堰中医院肿瘤科,江苏泰州225500 [6]江苏省张家港市中医医院肿瘤科,江苏苏州215600 [7]江苏省常州市武进中医医院消化内科,江苏常州213100

出　　处：《实用临床医药杂志》2021年第9期52-56,共5页Journal of Clinical Medicine in Practice

基　　金：国家中医临床研究基地业务建设科研专项(JDZX2012089)。

摘　　要：目的评价益气健脾化积方对气虚血瘀型胃癌化疗患者外周血中免疫指标的调节作用。方法采取随机双盲、单模拟、安慰剂平行对照的多中心临床研究方案收集38例气虚血瘀型胃癌化疗患者的临床资料,并将其随机分为2组。治疗组(n=19)在采用多西他赛联合顺铂(DC)化疗方案的基础上口服益气健脾化积方免煎颗粒,对照组(n=19)在DC方案基础上口服益气健脾化积方免煎颗粒模拟剂,1剂/d,疗程为56 d。比较2组治疗前后外周血中CD4、CD8、自然杀伤(NK)细胞比率,TNF-α、IFN-γ水平变化及毒副反应情况。结果与治疗前比较,治疗组治疗后CD4及NK细胞比率升高,差异有统计学意义(P<0.05);治疗组治疗后CD8细胞比率低于治疗前,差异有统计学意义(P<0.01)。对照组治疗后CD4细胞比率低于治疗前,CD8细胞比率高于治疗前,差异有统计学意义(P<0.01);对照组治疗后NK细胞比率低于治疗前,差异有统计学意义(P<0.05)。与治疗前比较,治疗组治疗后TNF-α水平下降,IFN-γ水平升高,差异有统计学意义(P<0.01);对照组治疗后TNF-α水平高于治疗前,差异有统计学意义(P<0.01),IFN-γ水平治疗前后差异无统计学意义(P>0.05)。治疗后,2组CD4、CD8及NK细胞比率及外周血中TNF-α、IFN-γ水平比较,差异有统计学意义(P<0.01)。第2次化疗后,治疗组与对照组毒副反应评分比较,差异有统计学意义(P<0.05)。结论益气健脾化积方能调节DC方案化疗的气虚血瘀型胃癌患者外周血CD4、CD8、NK细胞比率及TNF-α、IFN-γ水平,并可减轻化疗后毒副反应,对于提高患者细胞免疫功能方面有显著优势。Objective To evaluate the effect of Yiqi Jianpi Huaji Formula on regulation of immunity indexes of peripheral blood in gastric cancer patients differentiated as qi deficiency and blood stasis syndrome undergoing chemotherapy.Methods A design of multi-centered,randomized,double-blind,single-dummy,paralleled,placebo-controlled was adopted to collect the data of 38 gastric cancer patients differentiated as qi deficiency and blood stasis syndrome undergoing chemotherapy,and they were divided into two groups.The treatment group(n=19)was orally administered Yiqi Jianpi Huaji Formula granules based on chemotherapy of docetaxel plus cisplatin(DC),while the control group(n=19)was given Yiqi Jianpi Huaji granules placebo based on DC chemotherapy.Both groups were given one dose daily for 56 days.The change of ratios of CD4,CD8,NK cell count,TNF-αand IFN-γin peripheral blood,toxic and side effects before and after treatment of two groups were compared.Results In the treatment group,the ratios of CD4 and NK cells increased significantly after intervention of Yiqi Jianpi Huaji Formula(P<0.05),and ratio of CD8 cells was lower than treatment before(P<0.01).In the control group,ratio of CD4 cells was significantly decreased,and ratio of CD8 cells was higher than treatment before(P<0.01),while ratio of NK cells was also decreased than treatment before(P<0.05).Compared with before treatment,the level of TNF-αdecreased and the level of IFN-γincreased in the treatment group after treatment(P<0.01).The level of TNF-αin the control group after treatment was significantly higher than that before treatment(P<0.01),while the level of IFN-γbefore and after treatment had no statistically significant difference(P>0.05).After treatment,the ratios of CD4,CD8 and NK cells and the levels of TNF-αand IFN-γin peripheral blood showed significant difference between the two groups(P<0.01).After the second round of chemotherapy,there was a statistically significant difference in the toxic and side effects scores between the treatment group and

关 键 词：益气健脾化积方 胃癌 气虚血瘀 免疫功能 临床研究 

分 类 号：R735.2[医药卫生—肿瘤] R242[医药卫生—临床医学]