艾迪注射液对直肠癌术后辅助化疗增效减毒作用的临床研究

Clinical Study of Addie Injection on the Efficacy and Toxicity of Adjuvant Chemotherapy for Rectal Cancer

目的:探讨艾迪注射液对直肠癌术后辅助化疗增效减毒作用的临床效果。方法:选取120例直肠癌患者,所有患者均采用保肛根治术治疗,按照随机数表法分为治疗组与对照组,各60例。对照组术后给予FOLFOX-4化疗方案进行治疗,治疗组于首个化疗周期同时给予艾迪注射液静脉滴注治疗。治疗12周后比较两组临床疗效、治疗前后免疫功能指标(总T、Th、Ts、Th/Ts、NK细胞)、生活质量评分(FACT-L评分)的变化情况,并统计两组不良反应发生情况。结果:治疗组治疗后临床有效率为30.0%,对照组为11.7%,两组比较,差异有统计学意义(P<0.05);两组治疗前免疫功能指标比较,差异无统计学意义(P>0.05),治疗组治疗后总T、Th、Th/Ts及NK细胞均明显高于治疗前(P<0.05),Ts明显低于治疗前(P<0.05),对照组治疗后总T、Th、Th/Ts及NK细胞均明显低于治疗前(P<0.05),Ts明显高于治疗前(P<0.05)。两组治疗后比较,差异有统计学意义(P<0.05);两组治疗前FACT-L评分比较,差异无统计学意义(P>0.05),治疗后,治疗组FACT-L各项评分均显著高于对照组,差异有统计学意义(P<0.05);治疗组治疗后不良反应发生情况显著优于对照组(P<0.05)。结论:直肠癌术后辅助化疗期间给予艾迪注射液静滴治疗,可有效增强机体细胞免疫功能,提高近期疗效,减少不良反应发生,促进生活质量改善,具有明显的增效减毒作用。

Objective： To investigate the efficacy of addie injection in the treatment of rectal cancer after adjuvant chemotherapy. Methods： A total of 120 patients with rectal cancer were randomly divided into observa- tion group and control group, with 60 cases in each group. The control group was given FOLFOX-4 chemother- apy regimen after operation, and the observation group was received addie injection at the first chemotherapy cycle. After 12 weeks of treatment, the clinical efficacy, the immune function indexes （Th, Ts, T, Th, /Ts, NK cells） and life quality score （FACT-L score） changes of the two groups before and after treatment were com- pared, and the incidence of adverse reactions of the two groups before and after treatment were also computed. Results： The effective rate of the observation group was 30.0%, and the effective rate of the control group was 11.7%, which had significant difference between two groups （P〈O.05）; There was no significant difference in im- mune function index between the two groups before treatment （P〉0.05）. After treatment, the content of Th, Th/Ts T and NK cell of the observation group were significantly higher than before treatment （P〈0.05）, and Ts was sig- nificantly lower than that before treatment （P〈0.05）; The content of Th, Th/Ts T and NK cells of the control group after treatment were significantly lower than before treatment （P〈0.05）, and the Ts was significantly higher than before treatment （P〈0.05）. The FACT-L score had no significant difference between the two groups before treatment （P〉0.05）. After treatment, the FACT-L scores of the observation group were significantly higher than the control group, and the difference was statistically significant （P〈0.05）; The incidence of adverse reactions in the observation group was significantly better than that in the control group （P〈0.05）. Conclusion： The application of addie injection in patients with rectal cancer after postoperative adjuvant chemotherapy can effectively en- hance immune function, improve curative effect, reduce the incidence of adverse reactions, and promote the im- provement of the quality of life, which has obvious synergistic attenuation.