摘要
目的:评价阳和汤对乳腺癌新辅助化疗(NAC)患者的临床疗效及对患者炎症因子水平的影响。方法:选择62例经穿刺病理明确为乳腺癌、拟行术前NAC的初治乳腺癌女性患者,随机分为研究组和对照组,每组各31例。研究组患者在常规NAC基础上加用阳和汤口服,对照组患者在常规NAC基础上加用安慰剂口服,中药服用周期跟随NAC周期,治疗时间覆盖患者治疗全周期。评价两组患者的临床疗效及病理化疗反应疗效[包括Miller-Payne(MP)分级和残余肿瘤负荷系统(RCB)等级];于NAC前、中期及NAC后,检测患者的血清炎症因子水平,包括白介素(IL)-2R、IL-6、IL-8及肿瘤坏死因子-α(TNF-α);记录NAC期间患者发生的安全性事件及化疗常见不良反应,评价阳和汤应用于NAC的安全性。结果:①研究组患者的客观缓解率(ORR)为90.3%,对照组患者的ORR为87.1%,组间比较差异无统计学意义(P>0.05);在治疗应答时间(TTR)方面,在NAC前4周期临床疗效达到完全缓解或部分缓解的患者比例研究组为67.7%、对照组为41.9%,组间比较差异有统计学意义(P<0.05)。②治疗后,研究组中MP等级达到G4、G5级者21例(占67.7%),对照组中达到G4、G5级者13例(占41.9%),组间比较差异有统计学意义(P<0.05)。③NAC中及NAC后,研究组患者的IL-6、IL-8水平低于对照组(P<0.05);NAC后,研究组患者的TNF-α水平低于对照组(P<0.05)。④NAC期间,两组患者均未出现严重安全性事件,两组患者的安全性事件发生率比较,差异无统计学意义(P>0.05);在不良反应发生情况方面,研究组患者的乏力发生率显著低于对照组(P<0.05)。结论:阳和汤可提高乳腺癌患者NAC期间的肿瘤退缩速度,改善病理化疗反应疗效,降低患者的血清炎症因子水平,改善NAC期间的不良反应,且用药安全。
Objective:To evaluate the clinical efficacy of Yanghe Decoction in patients with breast cancer receiving neo-adjuvant chemotherapy(NAC)and its impact on inflammatory factors of the patients.Methods:Sixty-two female patients with breast cancer,confirmed by biopsy,who were scheduled to undergo preoperative NAC for the first time were selected and randomly divided into the study group and control group,31 cases in each group.The patients in the study group were treated with Yanghe Decoction orally based on routine NAC,and the patients in the control group were treated with placebo orally based on routine NAC.The administration of Chinese medicine followed the NAC cycles,and the treatment duration covered the entire NAC period of the patients.The clinical efficacy and pathological chemotherapy response [including Miller-Payne(MP)grade and residual cancer burden(RCB)grade)of the two groups were evaluated.Before and after NAC and in the middle of NAC,the levels of serum inflammatory factors including interleukin(IL)-2R,IL-6,IL-8 and tumor necrosis factor-α(TNF-α)were detected.Meanwhile,safety events and common adverse reactions during NAC were recorded in order to evaluate the safety of Yanghe Decoction applied in NAC.Results:①The objective response rate(ORR)was 90.3%in the study group and 87.1%in the control group,with no statistically significant difference between the two groups(P>0.05).In the aspect of time to response(TTR),the proportion of patients who achieved complete or partial response in the first 4 cycles of NAC was 67.7%in the study group and was 41.9%in the control group,with statistically significant difference between the two groups(P<0.05).②After treatment,21 patients(67.7%)in the study group reached MP grade 4 or grade 5,and 13 patients(41.9%)in the control group reached MP grade 4 or grade 5,with statistically significant difference between the two groups(P<0.05).③In the middle of NAC and after NAC,the levels of IL-6 and IL-8 in the study group were lower than those in the control group(P<0.0
作者
胡旻昊
毛若瑜
张馨月
李思雨
沙珊焱
高超
王洁琼
杨雨涵
林天依
季亚婕
薛晓红
HU Minhao;MAO Ruoyu;ZHANG Xinyue;LI Siyu;SHA Shanyan;GAO Chao;WANG Jieqiong;YANG Yuhan;LIN Tianyi;JI Yajie;XUE Xiaohong(Department of Breast Disease,Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China)
出处
《上海中医药大学学报》
CAS
2023年第4期1-8,共8页
Academic Journal of Shanghai University of Traditional Chinese Medicine
基金
国家自然科学基金资助项目(82004446)
上海市“科技创新行动计划”医学创新研究专项项目(22Y11923000,20Y21901100)
上海市促进市级医院临床技能与临床创新能力三年行动计划项目(SHDC2020CR4057)
上海中医药大学附属岳阳中西医结合医院薛晓红名医工作室建设项目。
关键词
乳腺癌
阳和汤
新辅助化疗
炎症因子
临床疗效
安全性
不良反应
breast cancer
Yanghe Decoction
neo-adjuvant chemotherapy
inflammatory factors
clinical efficacy
safety
adverse reactions
