中药方剂辅助神经胶质瘤术后化疗的临床疗效及安全性评价

摘要

目的:评价中药方剂辅助神经胶质瘤术后化疗的临床疗效及安全性.方法:按照随机数字法将2014年至2016年在我院进行手术治疗的106例神经胶质瘤患者分为研究组(n=55)与对照组(n=51).对照组患者在术后服用替莫唑胺化疗,研究组患者在对照组化疗的基础上加用中药方剂,28天为1个周期,均治疗4个周期.比较两组的近期与远期疗效、Karnofsky评分、免疫功能指标(CD3+、CD4+、CD4+/CD8+、NK细胞)及不良反应发生情况.结果:观察组的ORR、DCR分别为72.7％(40/55)、90.9％(50/55),对照组的ORR、DCR分别为54.9％(28/51)、70.6％(36/51),观察组的ORR、DCR均显著高于对照组(P＜0.05);研究组与对照组的1年生存率分别为87.3％(48/55)、80.4％(41/51),差异无统计学意义(P＞0.05);治疗后,两组的CD3+、CD4+、CD4+/CD8+、NK细胞水平均显著增高(P＜0.05),研究组显著高于对照组(P＜0.05),两组的Karnofsky评分均显著提高(P＜0.05),研究组显著高于对照组(P＜0.05);两组的不良反应发生情况比较差异无统计学意义(P＞0.05).结论:中药方剂辅助神经胶质瘤术后化疗是一种有效的治疗方法,能够改善患者的免疫功能及生活质量,且不增加化疗不良反应.%Objective:To evaluate of the clinical efficacy and safety about traditional Chinese medicine(TCM)subsidiary postoperative chemotherapy in neuroglioma.Methods:106 cases of neuroglioma patients were randomly di-vided into research group(n=55)and control group(n=51)in our hospital from 2014 to 2016.The patients were given oral Temozolomide after surgery in control group and the patients were added Chinese medicinal formulae.Each cycle including 28 days and all the patients were treated for 4 cycles.The short－term effects,long－term effects,im-mune function index(CD3+、CD4+、CD4+/CD8+、NK cell),Karnofsky scores and adverse reaction were compared between two groups.Results:The ORR and DCR of research group was 72.7％(40/55),90.9％(50/55),the ORR and DCR of control group was 54.9％(28/51),70.6％(36/51),respectively,the ORR and DCR of research group was significantly higher than that of control group(P＜0.05).The one year survival rate was 87.3％(48/55),80.4％(41/51)in research group and control group,respectively,there was no statistically significant difference between two groups(P＞0.05).After treatment,the CD3+,CD4+,CD4+/CD8+,NK cell level was significantly in-creased in two groups,but the research group was significantly higher than control group(P＜0.05).The Karnofsky scores were significantly increased in two groups,but the research group was significantly higher than control group(P＜0.05).There was no statistically significant difference of adverse reaction between two groups(P＞0.05).Con-clusion:It was an effective adjuvant therapeutic method of TCM for neuroglioma afterv surgery.This method could im-prove the immune function and living quality of patients but did not increase the toxicity of chemotherapy medicine.