气血方、养阴方、健脾方联合化疗预防高危Ⅱ期及Ⅲ期结直肠癌术后复发转移多中心随机对照研究  

Effects of Qixue Formula, Yangyin Formula and Jianpi Formula combined with chemotherapy on preventing colorectal cancer with high-risk phase Ⅱ and phase Ⅲ after operation: A multicenter randomized controlled trial

作　　者：柴可群[1] 陈淼[1] 余志红 应栩华[1] 陈嘉斌[1] 林建江[2] 盛勤松[2] 李德川[3] 柴瑞[4] 陈会林[5] CHAI Ke-qun;CHEN Miao;YU Zhi-hong;YING Xu-hua;CHEN Jia-bin;LIN Jian-jiang;SHENG Qin-song;LI De-chuan;CHAI Rui;CHEN Hui-lin(Department of Oncology,Tongde Hospital of Zhejiang Province,Hangzhou 310000,China;Department of Anorectal Surgery,The First Affiliated Hospital of Zhejiang University School of Medicine,Hangzhou 310003,China;Department of Anorectal Surgery,Zhejiang Cancer Hospital,Hangzhou 310014,China;Department of Anorectal Surgery,Zhejiang People's Hospital,Hangzhou 310000,China;Department of Anorectal Surgery,Jiaxing Hospital of Traditional Chinese Medicine,Jiaxing 314000,China)

机构地区：[1]浙江省立同德医院肿瘤科,杭州310000 [2]浙江大学医学院附属第一医院肛肠科,杭州310003 [3]浙江省肿瘤医院结直肠外科,杭州310014 [4]浙江省人民医院肛肠科,杭州310000 [5]嘉兴市中医医院肛肠科,嘉兴314000

出　　处：《中华中医药杂志》2022年第2期1158-1163,共6页China Journal of Traditional Chinese Medicine and Pharmacy

基　　金：浙江省中医药防治重大疾病攻关计划(No.2012ZGG003);浙江省名老中医专家传承工作室建设项目(No.GZS2017001);浙江省中医药科技计划(No.2018ZA025)。

摘　　要：目的:观察气血方、养阴方、健脾方对高危Ⅱ期及Ⅲ期结直肠癌术后患者复发转移的影响。方法:采用多中心随机对照方法,选择高危Ⅱ期及Ⅲ期结直肠癌术后患者303例按照2∶1的比例随机分为试验组202例及对照组101例,两组均接受4~9个周期奥沙利铂联合卡培他滨(CapeOx)方案辅助化疗,试验组根据证型加用气血方、养阴方、健脾方,观察两组1、2、5年无病生存率(DFS)、卡氏评分(KPS)、中医证候积分和不良反应。结果:最终纳入281例患者,随机分配至试验组190例,对照组91例。经过48个月的中位随访时间,试验组中74例(38.9%)出现复发,对照组中40例(44.0%)出现了复发,试验组1、2、5年DFS分别为94.2%(179/190)、84.2%(160/190)、61.1%(116/190),优于对照组的91.2%(83/91)、81.3%(74/91)、56.0%(51/91)。亚组分析中,试验组阴虚证患者干预后5年DFS差异有统计学意义(P=0.037)。两组不良反应总发生率差异无统计学意义,试验组的恶心/呕吐等消化道不良反应发生率显著低于对照组(P=0.014)。结论:气血方、养阴方、健脾方联合化疗可降低高危Ⅱ期及Ⅲ期结直肠癌术后患者复发转移风险,阴虚证患者是应用中医药抗结直肠癌术后复发转移的潜在优势人群。Objective: To evaluate the effects of Chinese herbal Qixue Formula(QXF), Yangyin Formula(YYF), and Jianpi Formula(JPF) on postoperative colorectal cancer with high-risk phase Ⅱ and phase Ⅲ. Methods: Prospective inclusion of patients with high risk phase Ⅱ and phase Ⅲ of colorectal cancer who met the criteria(303 patients) was randomly assigned to TCM groups(202 patients) and control group(101 patients) according to 2∶1, and both groups received 4~9 cycles oxaliplatin combined with Cape regimen adjuvant chemotherapy, meanwhile, according to different TCM syndromes, the experimental group took Chinese herbal internally to observe and follow up the incidence of 1 years, 2 years, 5 years disease-free survival rate(DFS),Karnofsky Performance Status(KPS), clinical syndromes of TCM and adverse reactions. Results: In 281 patients, 190 cases were randomly assigned to the TCM group and 91 cases in the control group. After 48 months of median follow-up, there were 74 cases(38.9%) of recurrence in the TCM group, 40 cases(44.0%) of control groups, 1 years 2 years, 5 years DFS were 94.2%(179/190),84.2%(160/190), 61.1%(116/190), better than the control group 91.2%(83/91), 81.3%(74/91), 56%(51/91). In the subgroup analysis, there was a significant difference in 5 years DFS before and after intervention between patients with yin deficiency in the test group(P=0.037). The total incidence of adverse recations between the two groups is not statistically significant, the nausea/vomiting adverse reactions of TCM group were lower than the control group(P=0.014). Conclusion: QXF, YYF and JPF combined with chemotherapy can reduce the risk of recurrence and metastasis after colorectal cancer operation of the patients with high risk Ⅱ and stage Ⅲ colorectal cancer, and yin deficiency syndrome may be suitable for the use of Chinese medicine.

关 键 词：结直肠肿瘤 气血方 养阴方 健脾方 无病生存率 多中心随机对照研究 

分 类 号：R273[医药卫生—中西医结合]