地榆升白片同步化疗对胃癌患者增效减毒效果及免疫机制调节作用的研究

Efficiency-enhancing and Toxicity-reducing Action of Diyu Shengbai Tablets Combined with Simultaneous Chemotherapy on Gastric Cancer Patients and Its Immuno-regulation Mechanism

【目的】探究地榆升白片同步化疗对胃癌患者的增效减毒效果及免疫机制的调节作用。【方法】将101例TNM分期为Ⅱ、Ⅲ期的胃癌脾虚瘀结证患者随机分为观察组51例和对照组50例。对照组给予EOF方案(表柔比星+奥沙利铂+氟尿嘧啶)治疗,观察组在对照组的基础上给予地榆升白片治疗,21 d为1个疗程,连续治疗2个疗程。观察2组患者治疗前后骨髓抑制、免疫功能和生活质量指标的变化情况,评价2组患者治疗2个疗程后的临床疗效,比较2组患者治疗期间消化道毒性和神经毒性的发生情况。【结果】(1)治疗2个疗程后,观察组的总有效率为78.4%(40/51),对照组为52.0%(26/50);组间比较,观察组的总体疗效和总有效率均明显优于对照组(P<0.01)。(2)治疗后,观察组的血小板(PLT)、白细胞(WBC)和血红蛋白(Hb)等血常规指标均无明显变化(P>0.05),而对照组的各项血常规指标均较治疗前明显下降(P<0.05);组间比较,对照组的各项血常规指标均明显低于观察组(P<0.01)。(3)治疗后,对照组的CD4^(+)T细胞和CD4^(+)/CD8^(+)比值明显降低而CD8^(+)T细胞明显升高(P<0.05),观察组的CD4^(+)T细胞和CD4^(+)/CD8^(+)比值明显升高而CD8^(+)T细胞明显降低(P<0.05);组间比较,观察组的CD4^(+)T细胞和CD4^(+)/CD8^(+)比值明显高于对照组(P<0.01),CD8^(+)T细胞明显低于对照组(P<0.01)。(4)治疗后,2组患者生活质量综合评定量表(GQOL-74)的社会功能、心理功能、躯体功能和物质生活等各项评分均较治疗前明显升高(P<0.05),且观察组的各项评分均明显高于对照组(P<0.01)。(5)治疗期间,观察组出现腹胀腹泻、食欲减退、恶心呕吐等消化道毒性反应的发生率及出现上消化道麻痹、上呼吸道麻痹及口周麻痹等神经毒性反应的发生率均明显低于对照组(P<0.05)。【结论】地榆升白片同步放疗对胃癌脾虚瘀结证患者疗效确切,可明显减少消化道和神经毒性及骨髓抑制等不良反应情况的发生,有效增强患者免疫功能和提高患者生活质量。

Objective To observe the efficiency-enhancing and toxicity-reducing action of Diyu Shengbai Tablets combined with simultaneous chemotherapy in the treatment of patients with gastric cancer,and to explore its immuno-regulation mechanism.Methods A total of 101 gastric cancer patients with TNM stageⅡandⅢand differentiated as spleen deficiency and blood-stasis stagnation syndrome were randomly divided into observation group(51 cases)and control group(50 cases).The control group was given EOF chemotherapy regimen(epirubicin+oxaliplatin+fluorouracil),and the observation group was given Diyu Shengbai Tablets on the basis of treatment for the control group.Twenty-one days constituted a course of treatment,and the treatment lasted for 2 continuous courses.The bone marrow suppression,immune function and quality of life in the two groups were observed before and after treatment.After 2 courses of treatment,the clinical efficacy of the two groups was evaluated,and the incidence of digestive tract toxicity and neurotoxicity was compared.Results(1)After 2 courses of treatment,the total effective rate in the observation group was 78.4%(40/51)and that in the control group was 52.0%(26/50).The intergroup comparison showed that the overall efficacy and total effective rate of the observation group were significantly superior to those of the control group(P<0.01).(2)After treatment,the levels of blood routine indexes of platelet(PLT),white blood cell(WBC),and hemoglobin(Hb)in the observation group showed no significant changes(P>0.05),while the levels of the blood routine indexes in the control group were significantly decreased compared with those before treatment(P<0.05).The intergroup comparison showed that the levels of blood routine indexes in the control group were significantly lower than those in the observation group(P<0.01).(3)After treatment,CD4^(+)T cell count and the ratio of CD4^(+)/CD8^(+)in the control group were significantly decreased while CD8^(+)T cell count was significantly increased(P<0.05).In the observation group,CD4^(+)T cell count and the ratio of CD4^(+)/CD8^(+)were significantly increased while CD8^(+)T cell count was significantly decreased(P<0.05).The intergroup comparison showed that the CD4^(+)T cell count and CD4^(+)/CD8^(+)ratio in the observation group were significantly higher and CD8^(+)T cell count was significantly lower than those in the control group(P<0.01).(4)After treatment,the scores of social function,psychological function,physical function and material life of Generic Quality of Life Inventory-74(GQOL-74)in the two groups were significantly increased compared with those before treatment(P<0.05),and the scores of observation group were significantly higher than those of control group(P<0.01).(5)During the treatment,the incidence of gastrointestinal toxicity such as abdominal distention and diarrhea,loss of appetite,nausea and vomiting,and the incidence of neurotoxicity such as upper gastrointestinal tract paralysis,upper respiratory tract paralysis and oral paralysis in the observation group were significantly lower than those in the control group(P<0.05).Conclusion Diyu Shengbai Tablets combined with simultaneous chemotherapy exert certain effect on gastric cancer patients with spleen deficiency and blood-stasis stagnation syndrome,which can significantly reduce the occurrence of adverse reaction such as digestive tract reaction,neurotoxicity and bone marrow suppression,and effectively improve the immune function and quality of life of the patients.