加味扶正抑瘤汤联合XELOX方案治疗进展期胃癌术后气阴两虚型患者的随机对照研究

Modified Fuzheng Yiliu Decoction Combined with XELOX Regimen for the Treatment of Postoperative Patients with Advanced Gastric Cancer of Qi and Yin Deficiency Type:A Randomized Controlled Study

【目的】探究加味扶正抑瘤汤(由生黄芪、党参、女贞子、白花蛇舌草、牡丹皮、槲寄生等中药组成)联合XELOX方案(奥沙利铂联合卡培他滨)辅助化疗治疗进展期胃癌术后气阴两虚型患者的临床疗效。【方法】将80例进展期胃癌术后气阴两虚型患者随机分为中药组和对照组,每组各40例。2组患者均接受XELOX方案化疗,中药组同时给予服用加味扶正抑瘤汤治疗,每3周为1个疗程,每个疗程服用中药汤剂两周或两周以上,共完成8个疗程。观察2组患者化疗期间不良反应发生情况及治疗前后血清肿瘤标志物[血清癌胚抗原(CEA)、糖类抗原199(CA199)和甲胎蛋白(AFP)]的变化情况,同时,通过Karnofsky功能状态(KPS)评分和世界卫生组织生活质量测定量表(WHOQOL-100)评分评估患者的生活质量,并对患者进行远期随访,观察其总生存期及术后1、2年总生存率等预后指标的差异。【结果】(1)2组患者均获得随访,中位随访时间为27.0个月(95%CI:23.59~27.86)。(2)治疗后,中药组的血清CEA、AFP水平均较治疗前明显降低(P<0.05或P<0.01),而血清CA199较治疗前有降低趋势,但差异无统计学意义(P>0.05);对照组治疗后的血清CEA、CA199、AFP水平均无显著性降低(P>0.05)。组间比较,中药组对血清CEA、CA199、AFP水平的降低程度均明显优于对照组(P<0.05或P<0.01)。(3)2组患者化疗期间出现的不良反应主要涉及骨髓抑制、胃肠道反应和肝功能异常等,中药组的各项不良反应发生率均有低于对照组趋势,但差异均无统计学意义(P>0.05)。(4)治疗后,2组患者的KPS评分均较治疗前改善(P<0.01),且中药组的改善程度明显优于对照组(P<0.01)。(5)治疗后,中药组WHOQOL-100量表的健康状态、行动能力、生活感受、其他日常活动等4个维度的生活质量评分均较治疗前明显改善(P<0.05),而对照组均无明显改善(P>0.05);组间比较,中药组对WHOQOL-100量表各个维度的生活质量评分的改善程度均明显优于对照组(P<0.05或P<0.01)。(6)中药组中位生存期为29.0个月(95%CI:25.95~31.70),对照组为22.0个月(95%CI:19.67~25.58),中药组的中位生存期明显高于对照组(P<0.01)。中药组术后1、2年生存率分别为97.5%、77.5%,对照组分别为92.5%、47.5%;组间比较,中药组术后1、2年生存率均高于对照组(P<0.01)。【结论】加味扶正抑瘤汤可有效缓解进展期胃癌术后气阴两虚型患者辅助化疗期间的不良反应,提高患者的生活质量,延长患者的生存时间。

Objective To investigate the clinical efficacy of modified Fuzheng Yiliu Decoction(composed of Astragali Radix,Codonopsis Radix,Ligustri Lucidi Fructus,Hedyotis Diffusae Herba,Moutan Cortex,Visci Herba,etc.)combined with XELOX regimen(Oxaliplatin plus Capecitabine)for the treatment of postoperative patients with advanced gastric cancer of qi and yin deficiency type.Methods A total of 80 postoperative patients with advanced gastric cancer of qi and yin deficiency type were randomly divided into the Chinese medicine group and the control group,with 40 cases in each group.Both groups received chemotherapy with XELOX regimen,while the Chinese medicine group was given modified Fuzheng Yiliu Decoction.Three weeks constituted a course of treatment,the medication of Chinese medicine decoction lasted for two weeks or more in each course of treatment,and a total of 8 courses of treatment were performed.The incidence of adverse reactions during chemotherapy was monitored and changes in serum tumor markers of serum carcinoembryonic antigen(CEA),carbohydrate antigen 199(CA199)and alpha-fetoprotein(AFP)were observed in the two groups before and after treatment.Moreover,the patients’quality of life was assessed by the scores of Karnofsky’s Performance Status(KPS)and World Health Organization Quality of Life Measurement Scale(WHOQOL-100).Long-term follow-up was carried out for the evaluation of the prognostic indicators such as overall survival and one-year and 2-year overall survival rates.Results(1)Patients in the two groups were all followed up,and the median follow-up time was 27 months(95%CI:23.59-27.86).(2)After treatment,the levels of serum CEA and AFP in the Chinese medicine group were significantly lower than those before treatment(P<0.05 or P<0.01),while serum CA199 tended to decrease compared with those before treatment,but the difference was not statistically significant(P>0.05);in the control group,the levels of serum CEA,CA199,and AFP were not significantly decreased after treatment(P>0.05).The intergroup comparison showed that the decrease of serum CEA,CA199 and AFP levels in the Chinese medicine group was significantly superior to that in the control group(P<0.05 or P<0.01).(3)The adverse reactions during chemotherapy in the two groups mainly involved bone marrow suppression,gastrointestinal reactions and liver function abnormalities,etc.The incidences of all adverse reactions in the Chinese medicine group tended to be lower than those in the control group,but the differences were not statistically significant(P>0.05).(4)After treatment,the KPS scores of patients in both groups were improved compared with those before treatment(P<0.01),and the improvement in the Chinese medicine group was significantly superior to that in the control group(P<0.01).(5)After treatment,the scores of the four dimensions of WHOQOL-100 such as health status,mobility,life feelings,and other activities of daily life in the Chinese medicine group were significantly improved compared with the pre-treatment(P<0.05),whereas there was no significant improvement in the control group(P>0.05).The intergroup comparison showed that the improvement of the scores of each dimension of the WHOQOL-100 in the Chinese medicine group was significantly superior to that in the control group(P<0.05 or P<0.01).(6)The median survival in the Chinese medicine group was 29.0 months(95%CI:25.95-31.70)and that in the control group was 22.0 months(95%CI:19.67-25.58),indicating that the median survival was significantly prolonged in Chinese medicine group(P<0.01).The one-year and 2-year postoperative survival rates were 97.5%and 77.5%in the Chinese medicine group and 92.5%and 47.5%in the control group,respectively.The intergroup comparison showed that the one-year and 2-year postoperative survival rates in the Chinese medicine group were higher than those in the control group(P<0.01).Conclusion Modified Fuzheng Yiliu Decoction can effectively alleviate the adverse reactions during adjuvant chemotherapy for postoperative patients with advanced gastric cancer of qi and yin deficiency type,improve the quality of life of patients,and prolong the survival time of patients.