益气养荣组方对脾肾两虚型小细胞肺癌患者化疗后免疫功能干预效果随机对照研究

A randomized controlled study on the effects of Yiqi Yangrong Formula on immune function after chemotherapy in patients with spleen and kidney deficiency syndrome small cell lung cancer

关键词:  益气养荣组方  脾肾两虚  小细胞肺癌  化疗  骨髓抑制  免疫功能

Key words:  Yiqi Yangrong Formula  spleen and kidney deficiency syndrome  small cell lung cancer  chemotherapy  myelosuppression  immune function

摘要:

[目的] 观察益气养荣组方对脾肾两虚型小细胞肺癌化疗患者免疫功能的影响。[方法] 随机选择2018年1月—2019年6月行小细胞肺癌化疗治疗患者120例进行本次研究。使用随机数字法将患者分为观察组和对照组各60例，所有患者均给予EC方案进行化疗，对照组患者给予EC化疗方案配合常规止呕、护肝、护胃治疗，观察组在对照组治疗方案基础上给予中药汤剂益气养荣组方进行治疗，观察组和对照组连续干预2个化疗周期。比较两组患者干预前后血常规、骨髓抑制情况、免疫功能变化情况。[结果] 两组患者干预前白细胞（WBC）、血小板（PLT）、中性粒细胞（NEUT）、血红蛋白（Hb）水平无明显差异（P>0.05），化疗1个疗程后14 d、化疗2个疗程后14 d两组患者上述血常规指标与干预前相比均有升高（P<0.05），但观察组各时间点各项指标均高于对照组，且差异具有统计学意义（P<0.05）；两组患者两次化疗发生骨髓抑制分度情况均有统计学差异（P<0.05），均为0度患者对照组低于观察组，Ⅲ、Ⅳ度骨髓抑制患者对照组高于观察组。观察组两次化疗患者骨髓抑制发生率均低于对照组，且具有统计学意义（P<0.05）；两组患者化疗前CD3⁺T、CD4⁺T、CD8⁺T、CD4⁺/CD8⁺、自然杀伤细胞（NK）水平均无明显差异（P>0.05），化疗2个疗程后CD3⁺T、CD4⁺T、CD4⁺/CD8⁺、NK水平与化疗前相比均有所降低（P<0.05），CD8⁺T水平无明显改变（P>0.05），观察组化疗后CD3⁺T、CD4⁺T、CD8⁺T、CD4⁺/CD8⁺、NK水平均高于对照组（P<0.05），CD8⁺T水平无组间差异（P>0.05）。[结论] 益气养荣组方对脾肾两虚型小细胞肺癌化疗患者的骨髓抑制具有很好的治疗效果，降低骨髓抑制的发生率，同时能够提高患者的免疫功能，应于临床推广应用。

Abstract:

[Objective] To observe the effect of Yiqi Yangrong Formula on immune function of small cell lung cancer patients with spleen and kidney deficiency syndrome. [Methods] From January 2018 to June 2019,120 patients with small cell lung cancer were randomly selected for this study. The patients were divided into observation group and control group,60 cases in each group. All patients were given EC scheme for chemotherapy. The patients in control group were given routine antiemetic,liver and stomach protection treatment. The patients in observation group were given Yiqi Yangrong Formula on the basis of the treatment scheme. The observation group and control group were continuously intervened in two chemotherapy cycles. The changes of blood routine,bone marrow suppression and immune function were compared between two groups before and after intervention. [Results] There was no significant difference in WBC,PLT, neut and Hb levels between two groups before the intervention (P>0.05). The above blood routine indexes of the two groups increased 14 days after one course of chemotherapy and 14 days after two courses of chemotherapy compared with that before the intervention (P<0.05),but the indexes of the observation group at each time point were higher than those of the control group,and there was statistical difference (P<0.05). Myelosuppression occurrence in the two groups after two times of chemotherapy had statistical difference in the degree of differentiation (P<0.05), the control group of patients with 0 degree bone marrow depression was lower than the observation group, and the control group of patients with Ⅲ and Ⅳ degree bone marrow depression was higher than the observation group. The incidence of myelosuppression in the observation group was lower than that in the control group (P<0.05),and there was no significant difference in CD3⁺ T,CD4⁺ T,CD8⁺ T,CD4⁺/CD8⁺,NK levels before chemotherapy between two groups (P>0.05). The levels of CD3⁺ T, CD4⁺ T,CD4⁺/CD8⁺,NK after two courses of chemotherapy were lower than those before chemotherapy (P<0.05),and there was no significant change in the level of CD8⁺ T (P>0.05). After chemotherapy,the level of CD4⁺ T in the observation group was lower than that before chemotherapy The level of CD4⁺/CD8⁺ was higher than that of the control group (P<0.05). There was no difference in the level of CD8⁺ T between two groups (P>0.05). [Conclusion] Yiqi Yangrong formula has a good therapeutic effect on the myelosuppression of patients with small cell lung cancer of spleen and kidney deficiency syndrome. It can reduce the incidence of myelosuppression and improve the immune function of patients. It should be widely used in clinical.