益气生髓方联合rhG-CSF治疗上皮性卵巢癌化疗所致中性粒细胞减少症的临床疗效观察  

Clinical effects of Yi QiShengSui formula formula combined with rhG-CSF on neutropenia of epithelial ovarian cancer patients caused by chemotherapy

作　　者：李晶 陈瑞芳 陈宏亮 胡建英 朱芝玲 曹琦 LI Jing;CHEN Rui-fang;CHEN Hong-liang;HU Jian-ying;ZHU Zhi-ling;CAO Qi(Department of Integrative Medicine,Obstetrics and Gynecology Hospital,Fudan University,Shanghai 200011,China;Department of Breast Surgery,Obstetrics and Gynecology Hospital,Fudan University,Shanghai 200011,China)

机构地区：[1]复旦大学附属妇产科医院中西医结合科,上海200011 [2]复旦大学附属妇产科医院乳腺外科,上海200011

出　　处：《复旦学报（医学版）》2022年第2期249-256,共8页Fudan University Journal of Medical Sciences

基　　金：上海市综合医院中西医结合专项(ZHYY-ZXYJHZX-2-23);上海市卫健委中医药科研项目(2020LP021)。

摘　　要：目的 评价益气生髓方治疗上皮性卵巢癌化疗所致中性粒细胞减少症的临床疗效和安全性。方法 采用前瞻性随机对照非盲临床研究方法,将复旦大学附属妇产科医院60例上皮性卵巢癌化疗后出现以白细胞减少为主的重度骨髓抑制患者随机分为研究组和对照组,每组各30例。在化疗间歇期对照组采用重组人粒细胞刺激因子注射液(recombinant human granulocyte stimulating factor injection,rhG-CSF)150μg皮下注射q6-24 h,直至血常规恢复正常;研究组在使用rhG-CSF的基础上加中药经验方“益气生髓方”口服。监测治疗后下次化疗时白细胞总数(white blood cells,WBC)和中性粒细胞计数(absolute neutrophil count,ANC)水平,比较两组患者化疗后第7天和第10天WBC和ANC水平,记录化疗间隔时间、升白治疗时间和rhG-CSF使用剂量,检测肝肾功能水平,采用癌症生活质量通用量表FACT-G(V4.0)中文版评估两组患者的生活质量。结果 化疗后第7天和第10天研究组患者的WBC和ANC均高于对照组,差异有统计学意义(P<0.05);进一步的多因素Logistic回归分析显示,“益气生髓方”是缓解第10天中性粒细胞中重度减少的显著相关因素。研究组和对照组的化疗间隔时间分别为(22.31±1.25)天和(25.79±4.76)天,升白治疗时间分别为(4.67±2.11)天和(6.86±2.35)天,组间差异均有统计学意义(P<0.05)。rhG-CSF使用量在研究组和对照组分别为(552.6±173.6)μg和(852.6±200.3)μg,差异有统计学意义(P<0.05)。两组患者肝肾功能损伤情况差异无统计学意义。研究组FACT的量表总分、生理状况评分、情感状况评分和功能状况评分方面均高于对照组(P<0.05)。结论 益气生髓方联合rhG-CSF治疗可以有效升高白细胞,缩短化疗间隔时间和升白治疗时间,减少rhG-CSF使用剂量,提高患者生活质量。采用益气生髓方治疗并未增加患者肝肾功能的损伤。Objective To study the efficacy and safety of Yi Qi Sheng Sui(YQSS) formula, a traditional Chinese medicine(TCM) herbal prescription,on neutropenia of epithelial ovarian cancer patients caused by chemotherapy. Methods This was a prospective randomized controlled non-blind clinical study. A total of 60 patients from Obstetrics and Gynecology Hospital of Fudan University were randomly assigned to the research group and the control group with a ratio of 1∶1.During the intermission of chemotherapy,the patients in the control group took recombinant human granulocyte stimulating factor injection(rh G-CSF),the dose of rh G-CSF was 150 μg i.h. q6-24 h,according to grade of neutropenia. The patients in the research group took YQSS formula for 21 days along with rh G-CSF in the same period.The changes of white blood cells(WBC),absolute neutrophil count(ANC)of the next chemotherapy,as well as the changes on the 7 thday and 10 thday after this chemotherapy,duration of chemotherapy interval,treatment time of leukocyte elevation and dosage of rh G-CSF,as well as the hepatic and renal function,and quality of life scale(FACT-G)were observed for safety and efficacy evaluation. Results The levels of WBC and ANC in the research group were higher than those in the control group on the 7 thand 10 thdays after chemotherapy, with statistical significance(P<0.05). Further Logistic multivariate regression analysis showed that YQSS was a significant correlation factor for alleviating moderate and severe ANC reduction on the 10 thday after this chemotherapy.The interval time of chemotherapy in the research group and the control group was(22.31±1.25) days and(25.79±4.76) days,respectively,and the treatment time of leukocyte elevation was(4.67±2.11) days and(6.86±2.35) days,respectively,the differences were statistically significant(P<0.05).The dosage of rh G-CSF in the research group and the control group was(552.6±173.6)μg and(852.6±200.3)μg,respectively,and the difference was statistically significant(P<0.05). There was no stat

关 键 词：益气生髓方 中性粒细胞减少症 卵巢癌 化疗不良反应 

分 类 号：R737.31[医药卫生—肿瘤]