【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。更多还原

【Abstract】 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.更多还原