晚期结直肠癌诱导治疗后复方苦参注射液维持治疗101例的临床研究

Clinical Research of Compound Kushen Injection Maintaining Therapy for Treatment of Advanced Colorectal Cancer After Induction Therapy:An Observation of 101 Cases

目的:评价复方苦参注射液对晚期结直肠癌维持治疗的疗效,并分析其与患者中医体质类型的相关性。方法:选取2015年6月至2018年5月广州市中西医结合医院收治的晚期结直肠癌患者101例,经含5-Fu两药标准化疗后随机分为对照组和观察组,对照组41例,观察组60例,两组基础治疗均按国家中医药管理局医政司的'结直肠癌中医诊疗方案'口服中药及中成药,观察组在基础治疗上加用复方苦参注射液25 ml维持治疗,观察两组的生存质量及不良反应,并进行生存分析。再根据中华中医药学会(2009年)发布《中医体质分类及判定》标准,将两组患者进行中医体质分组,观察两组ECOG评分受益率、不良反应并进行生存分析。结果:观察组在生存质量、中位无进展生存期(PFS)方面优于对照组,有统计学差异(P <0.05),亚组分析两组患者中中医体质均以痰湿质为主,观察组痰湿质患者的ECOG评分受益率和PFS高于对照组,有统计学差异(P <0.05)。结论:复方苦参注射液对于改善大肠癌患者生存质量具有一定效果,可能对痰湿体质患者效果更佳,且用药安全。

Objective:To evaluate the therapeutic effect of Compound Kushen Injection maintaining therapy for the treatment of advanced colorectal cancer and to explore the correlation of effect with the constitution of traditional Chinese medicine(TCM).Methods:One hundred and one advanced colorectal cancer patients admitted in Guangzhou Hospital of Integrated Traditional Chinese and Western Medicine from June of 2015 to May of 2018 were treated with 5-fluorouracil(5-Fu)standard chemotherapy,and then were randomly assigned into control group(41 cases)and observation group(60 cases).Both groups received basic treatment with oral use of Chinese medicine and patent medicine following Traditional Chinese Medicine Project for Diagnosis and Treatment of Colorectal Cancer issued by State Administration of Traditional Chinese Medicine.And additionally,the observation group was given intravenous dripping of 25 mL of Compound Kushen Injection for maintaining treatment.Quality of life and adverse effects in the two groups were observed and survival analysis was also conducted.The TCM constitution types of the patients in both groups were differentiated following the criteria of Classification and Determination of Constitution in Traditional Chinese Medicine issued by China Association of Chinese Medicine in 2009,and then the improvement rate of astern Cooperative Oncology Group Performance Status(ECOG-PS)scores and adverse reaction in the patients with various types of TCM constitution were examined for the survival analysis.Results:The improvement of the quality of life and the median progressionfree survival(PFS)in the observation group is superior to that in the control group,the difference being significant(P<0.05).The subgroup analysis results showed that phlegm-dampness constitution was the dominated TCM constitution type in the two groups,and the improvement rate of ECOG-PS scores and PFS scores in the observation group was superior to those in the control group,the difference being significant(P<0.05).Conclusion:The Compound Kushen Injection is effective on improving the quality of life of advanced colorectal cancer patients in particular on the patients with phlegm-dampness constitution,and it is safe during the treatment.