加味扶正抑瘤汤联合XELOX方案辅助化疗治疗结肠癌随机对照研究  

Effect of Modified Fuzheng Yiliu Formula Combined with XELOX Regimen Adjuvant Chemotherapy on Colon Cancer : A Randomized Controlled Trial

作　　者：黄采炀 熊文俊 吴舒婷 陈妍 郑燕生 罗立杰 蔡炳勤 王伟[2] HUANG Cai-yang;XIONG Wen-jun;WU Shu-ting;CHEN Yan;ZHENG Yan-sheng;LUO Li-jie;CAI Bing-qin;WANG Wei(Second Clinical College of Guangzhou University of Chinese Medicine,Guangzhou,510000;Department of Gastrointestinal Surgery,Second Hospital Affiliated to Guangzhou University of Chinese Medicine,Guangzhou,510000)

机构地区：[1]广州中医药大学第二临床医学院,广州510000 [2]广州中医药大学第二附属医院胃肠外科,广州510000

出　　处：《中国中西医结合杂志》2022年第7期827-833,共7页Chinese Journal of Integrated Traditional and Western Medicine

基　　金：广东省中医院中医药科学技术研究专项(No.YN2016ZD02);全国名老中医药专家传承工作室建设项目(No.12BMGG02)。

摘　　要：目的 探讨加味扶正抑瘤汤治疗结肠癌术后辅助化疗患者的临床疗效。方法 本研究方案在中国临床试验中心注册(No.ChiCTR2100045384)。采用随机对照研究方法,纳入2017年10月—2020年6月于广东省中医院胃肠外科行结肠癌根治术并接受XELOX方案辅助化疗的Ⅱ期高危、Ⅲ期肠癌气阴两虚型患者126例,采用随机数字表法将患者分为中药组和对照组各63例。两组均给予XELOX方案化疗,中药组在XELOX方案化疗的基础上口服加味扶正抑瘤汤。分析两组化疗完成率、不良反应情况、生活质量情况和无疾病生存率。结果 共14例脱落,脱落率11.1%。中药组63例,其中化疗周期为3个月的患者53例,化疗周期为6个月的患者10例;对照组63例,化疗周期为3个月和6个月的患者分别为51例和10例。126例患者平均随访18.7个月。中药组总化疗完成率较对照组高(90.5%vs. 87.3%,P>0.05);规范化疗完成率中药组显著高于对照组(81.0%vs. 46.0%,P<0.05)。两组白细胞减少、中性粒细胞减少、血小板减少、恶心、疲劳、体质量减轻等不良反应比较差异无统计学意义(P>0.05);中药组腹泻(P=0.012)、呕吐(P=0.017)、疼痛(P=0.048)和手足综合征(P=0.017)不良反应分级低于对照组。化疗前两组生活质量评分差异无统计意义(P>0.05);化疗后及末次随访时,中药组生活质量评分显著高于对照组(P<0.05)。随访期内,中药组无疾病生存率较对照组高(P>0.05)。结论 加味扶正抑瘤汤可提高Ⅱ期高危、Ⅲ期肠癌术后患者化疗完成率,减轻不良反应,提高患者生活质量、增加无疾病生存率。Objective To explore the clinical efficacy of Modified Fuzheng Yiliu Formula combined with XELOX chemotherapy on colon cancer. Methods A randomized controlled trial registered in the Chinese Clinical Trial Registry(No.ChiCTR2100045384)was conducted. A total of 126 patients with high-risk stage Ⅱ or Ⅲ colon cancer and Qi and Yin deficiency clinical efficacy who underwent gastrointestinal surgery and received adjuvant chemotherapy with XELOX regimen at the Department of Gastrointestinal Surgery of Guangdong Hospital of Traditional Chinese Medicine were recruited from October 2017 to June 2020. They were assigned randomly to the Chinese medicine(CM) group and control group according to random digit table,63 in each group. All patients received XELOX chemotherapy,and patients in the CM group took modified Fuzheng Yiliu Formula additionally.The chemotherapy completion rate,adverse events,quality of life,and disease-free survival rate were analyzed.Results A total of 14 cases(11%) dropped out during the treatment. There were 63 cases in the CM group,including 53 patients with a 3-month chemotherapy cycle and 10 patients with a 6-month chemotherapy cycle,and 63 cases in the control group,with 51 and 10 patients with a 3-month and 6-month chemotherapy cycle,respectively. All patients were followed up for an average of 18.7 months. The overall chemotherapy completion rate in the CM group was higher than that in the control group,and there was a statistically significant difference(90.5% vs. 87.3%,P>0.05). Moreover,the completion rate of standardized chemotherapy in the CM group was significantly higher than that in the control group(81.0% vs. 46.0%,P<0.05). There was no statistically significant difference between the two groups in the comparison of adverse reactions such as leukopenia,neutropenia,thrombocytopenia,nausea,fatigue,and weight lose(P>0.05). However,diarrhea(P=0.012), vomiting(P=0.017), pain(P=0.048), and hand-foot syndrome(P=0.017) in the CM group were milder than those in the control group. Before chemot

关 键 词：结肠癌术后 加味扶正抑瘤汤 中药 中西医结合 XELOX方案 不良反应 生活质量 随机对照试验 

分 类 号：R735.35[医药卫生—肿瘤]