健脾复方联合卡培他滨治疗Ⅲ期结直肠癌临床观察  

Clinical Observation of Jianpi Compound(健脾复方)Combined with Capecitabine in Treatment of Stage III Colorectal Cancer

作　　者：刘湘君 任建琳[1] 袁晨越 陆鑫熠 刘怡[1] 黄人可 储金砚 吴杏黎 LIU Xiangjun;REN Jianlin;YUAN Chenyue;LU Xinyi;LIU Yi;HUANG Renke;CHU Jinyan;WU Xingli(Shanghai Municipal Hospital of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200071,China)

机构地区：[1]上海中医药大学附属市中医医院,上海200071

出　　处：《辽宁中医杂志》2024年第1期82-86,I0004,共6页Liaoning Journal of Traditional Chinese Medicine

基　　金：国家自然科学基金项目(82174452,81873279);上海市科学技术委员会科研计划项目(19401935200);上海市科技创新行动计划生物医药科技支撑专项(22S21901000);上海申康医院临床三年行动计划项目(SHDC2020CR2047B)。

摘　　要：目的观察健脾复方联合卡培他滨治疗Ⅲ期结直肠癌(colorectal cancer,CRC)的临床疗效及安全性。方法将2018年10月—2021年6月上海市中医医院肿瘤科82例Ⅲ期术后接受卡培他滨维持化疗CRC患者,采用随机数字表分为治疗组41例和对照组41例,治疗组给予健脾复方联合卡培他滨,对照组给予单药卡培他滨,经过8个疗程(6个月)治疗,记录两组患者治疗前后的终点指标、中医证候疗效、肿瘤指标(CEA、CA199)、生活质量评分、化疗不良反应等指标,分析评价中西医结合的疗效及中医治疗的优势。结果①治疗后,两组无进展生存期(PFS)差异无统计学意义(P=0.23),但治疗组总体生存率高于对照组。②治疗后,治疗组患者的中医证候疗效有效率为97.56%(40/41),对照组为26.83%(11/41),治疗组中医证候总体有效率优于对照组(P<0.001)。③治疗后,治疗组在生活质量症状领域:排尿问题、化疗不良反应、胃肠道功能、排便问题、造瘘相关问题、体质量下降方面疗效高于对照组(P<0.05);功能领域:在性功能、性快感方面差异无统计学意义(P>0.05),其余各方面疗效优于对照组,差异有统计学意义(P<0.05)。④治疗后,两组患者的CEA、CA199水平较治疗前均显著降低(P<0.05),且治疗组患者的CEA、CA199水平明显低于对照组(P<0.01)。⑤治疗后,治疗组Ⅱ-Ⅳ级各不良反应发生率低于对照组(P<0.05)。结论相较于单药卡培他滨疗法,健脾复方联合卡培他滨可更好改善Ⅲ期术后CRC患者临床症状,减轻化疗不良反应,降低肿瘤指标水平,提高生存率。Objective To observe the clinical efficacy and safety of Jianpi Compound(健脾复方)combined with capecitabine in the treatment of stageⅢcolorectal cancer(CRC).Methods From October 2018 to June 2021,82 patients with CRC who received capecitabine maintenance chemotherapy after stage III surgery in the Department of Oncology,Shanghai Municipal Traditional Chinese Medicine Hospital were randomly divided into a treatment group(41 cases)and a control group(41 cases).The Jianpi Compound combined with capecitabine was given,and the control group was given single-agent capecitabine.After 8 courses of treatment(6 months),the endpoints,the efficacy of TCM syndromes and tumor markers(CEA,CA199),the quality of life score,chemotherapy toxicity and other indicators were recorded in the two groups before and after treatment to analyze and evaluate the efficacy of integrated traditional Chinese and Western medicine and the advantages of traditional Chinese medicine treatment.Results①After treatment,there was no significant difference in progression-free survival(PFS)between the two groups(P=0.23),but the overall survival rate of the treatment group was higher than that of the control group.②After treatment,the effective rate of TCM syndromes in the treatment group was 97.56%(40/41)and that in the control group was 26.83%(11/41).The overall effective rate of TCM syndromes of the treatment group was better than that of the control group(P<0.001).③After treatment,the treatment group had higher efficacy than the control group in the areas of quality of life symptoms:urination problems,chemotherapy side effects,gastrointestinal function,defecation problems,ostomy-related problems and weight loss(P<0.05).Functional areas:There was no significant difference in function and sexual pleasure(P>0.05),and the efficacy in other aspects was better than that of the control group,and the difference was statistically significant(P<0.05).④After treatment,the levels of CEA and CA199 in the two groups were significantly lower than those

关 键 词：结直肠癌 健脾复方 维持化疗 卡培他滨 疗效评价 

分 类 号：R273[医药卫生—中西医结合]