四君子汤加减辅助治疗晚期直肠癌临床研究

Clinical Study on Modified Sijunzi Tang in Adjuvant Treatment for Advanced Rectal Cancer

目的:观察四君子汤加减方辅助治疗晚期直肠癌的临床疗效。方法:选取106例晚期直肠癌患者,按照随机数字表法分为观察组52例和对照组54例。对照组采用mFOLFOX6方案化疗,观察组在对照组治疗基础上给予四君子汤加减治疗。对比2组临床疗效,观察2组中医证候、体力状况和生存质量的改善情况,记录不良反应发生情况。结果:观察组客观缓解率(ORR)为50.00%,对照组ORR为44.44%,2组比较,差异无统计学意义(P>0.05)。观察组中医证候疗效总有效率90.38%,对照组中医证候疗效总有效率66.67%,2组比较,差异有统计学意义(P<0.05)。治疗后,2组主症积分均较治疗前降低,Karnofsky功能状态评分(KPS评分)及QLQ-C30评分均较治疗前升高,差异均有统计学意义(P<0.05);观察组主症积分低于对照组,KPS及QLQ-C30评分均高于对照组,差异均有统计学意义(P <0.05)。观察组骨髓抑制、肝肾损伤、皮疹、恶心呕吐及神经毒性发生率均低于对照组,差异均有统计学意义(P <0.05)。结论:四君子汤加减辅助治疗晚期直肠癌,能改善患者的生活质量,提高中医证候疗效,减少不良反应发生。

Objective:To observe the clinical effect of modified Sijunzi tang in adjuvant treatment for advanced rectal cancer.Methods:Selected 106 cases of patients with advanced rectal cancer,and divided them into two groups randomly,52 cases in the observation group and 54 cases in the control group.The control group received mF OLFOX6 chemotherapy regimen,while the observation group additionally received modified Sijunzi tang.Compared the clinical effect in both groups,observed the improvements of Chinese medicine syndrome,physical strength and quality of life in both groups,and recorded the occurrence of adverse reactions.Results:The objective remission rate(ORR)was 50.00%in the observation group and 44.44%in the control group,difference being insignificant(P>0.05).The total effective rate of Chinese medicine syndrome was 90.38%in the observation group and 66.67%in the control group,difference being significant(P<0.05).After treatment,the main symptom scores in both groups were lower than those before treatment,and scores of Karnofsky performance status(KPS)and QLQ-C30 were higher than those before treatment,differences being significant(P<0.05);the main symptom scores in the observation group were lower than those in the control group,and scores of KPS and QLQ-C30 were higher than those in the control group,differences being significant(P<0.05).The incidences of such adverse reactions as myelosuppression,hepatorenal damage,rash,nausea,vomiting and neurotoxicity in the observation group were respectively lower than those in the control group,differences being significant(P<0.05).Conclusion:Modified Sijunzi tang in adjuvant treatment for advanced rectal cancer can improve the quality of life of patients,promote the clinical effect for Chinese medicine syndrome and decrease adverse reactions.