壮药扶正复方辅助治疗晚期表皮生长因子受体敏感型突变非小细胞肺癌临床研究

Clinical study on Zhuang medicine Fuzheng compound in the treatment of advanced epidermal growth factor receptor sensitive mutant non-small cell lung cancer

目的评价壮药扶正复方辅助治疗晚期表皮生长因子受体(epidermal growth factor receptor,EGFR)敏感型突变非小细胞肺癌(non small cell lung cancer,NSCLC)的疗效。方法将符合入选标准的2019年6月-2020年5月广西国际壮医医院120例晚期NSCLC患者,按随机数字表法分为2组,每组60例。对照组以酪氨酸激酶抑制剂(tyrosine kinase inhibitor,TKIs)治疗,观察组以壮药扶正复方辅助表皮生长因子受体-酪氨酸激酶抑制剂(EGFR-TKIs)治疗。2组均治疗至疾病进展或出现不可耐受的毒副作用时为治疗终点。分别于治疗前后进行中医证候评分,采用生活质量量表(QLQ-C30)评估生活质量;采用放射免疫分析法检测血清癌胚抗原(CEA)、鳞状细胞癌抗原(SCC-Ag)、糖类抗原50(CA50)水平;采用流式细胞仪检测CD3^(+)、CD4^(+)、CD8^(+)水平,计算CD4^(+)/CD8^(+)比值;观察并记录治疗期间的毒副作用,评价疗效。结果观察组客观缓解率为66.7%(40/60)、疾病控制率为81.7%(49/60),对照组分别为48.3%(29/60)、63.3%(38/60),2组客观缓解率、疾病控制率比较,差异有统计学意义(χ^(2)值分别为4.13、5.06,P值分别为0.042、0.025)。观察组治疗后胸闷气促、痰中带血、神疲乏力评分低于对照组(t值分别为8.72、5.02、5.47,P值均<0.001);QLQ-C30评分高于对照组(t=5.21,P<0.01)。治疗后,观察组CEA[(31.45±4.56)mU/L比(38.98±5.71)mU/L,t=7.98]、SCC-Ag[(4.87±0.93)μg/L比(7.29±1.25)μg/L,t=12.03]、CA50[(58.27±7.14)U/L比(66.48±7.94)U/L,t=5.96]水平低于对照组(P<0.01);CD3^(+)[(52.43±5.01)%比(48.56±4.87)%,t=4.29]、CD4^(+)[(54.89±5.03)%比(51.09±5.22)%,t=4.06]、CD4^(+)/CD8^(+)比值[(1.95±0.28)比(1.65±0.27),t=5.97]高于对照组(P<0.01),CD8^(+)[(28.12±2.70)%比(31.23±2.64)%,t=6.38]低于对照组(P<0.01)。治疗期间,观察组毒副作用发生率为13.3%(8/60)、对照组为8.3%(5/60),2组比较差异无统计学意义(χ^(2)=0.78,P=0.378)。结论壮药扶正复方辅助EGFR-TKIs可降低晚期EGFR敏感型突变NSCLC患者肿瘤标志物水平,改善患者中医证候、生活质量,增强患者免疫力,提高疗效。

Objective To evaluate Zhuang medicine Fuzheng compound combined with epidermal growth factor receptor-tyrosine kinase inhibitors(EGFR-TKIs)in the treatment of advanced epidermal growth factor receptor(EGFR)sensitive mutant non-small cell lung cancer(NSCLC).Methods A total of 120 patients with advanced NSCLC who met the inclusion criteria from June 2019 to May 2020 in Guangxi International Zhuang Medical Hospital were divided into 2 groups according to the random number table method,with 60 in each group.The control group was treated with TKIs,and the observation group was treated with Zhuang medicine Fuzheng compound combined with EGFR-TKIs.TCM syndrome scores were compared,and the quality of life of the patients was assessed by the Quality of Life Scale(QLQ-C30).The serum levels of carcinoembryonic antigen(CEA),squamous cell carcinoma associated antigen(SCC-Ag)and carbohydrate antigen 50(CA50)were detected by radioimmunoassay,and the levels of CD3^(+),CD4^(+),and CD8^(+)were detected by flow cytometry,and the CD4^(+)/CD8^(+)ratio was calculated.The adverse reactions during the treatment were observed and recorded.Results The objective remission rate in the observation group was 66.7%(40/60)and the disease control rate was 81.7%(49/60),while in the control group were 48.3%(29/60)and 63.3%(38/60),respectively.The differences were statistically significant(χ^(2) values were 4.13 and 5.06,P values were 0.042 and 0.025,respectively).After treatment,the scores of chest tightness,shortness of breath,blood in sputum,mental fatigue in the observation group were significantly lower than those in the control group(t values were 8.72,5.02,5.47,all Ps<0.001),After treatment,QLQ-C30 score in the observation group was significantly higher than that of the control group(t=5.21,P<0.01).After treatment,CEA[(31.45±4.56)mU/L vs.(38.98±5.71)mU/L,t=7.98],SCC-Ag[(4.87±0.93)μg/L vs.(7.29±1.25)μg/L,t=12.03],CA50[(58.27±7.14)U/L vs.(66.48±7.94)U/L,t=5.96]levels were significantly lower than those in the control group(P<0.01);CD3^(+)[(52.43±5.01)%vs.(48.56±4.87)%,t=4.29],CD4^(+)[(54.89±5.03)%vs.(51.09±5.22)%,t=4.06],CD4^(+)/CD8^(+)[(1.95±0.28)vs.(1.65±0.27),t=5.97]significantly higher than those in the control group(P<0.01),CD8^(+)[(28.12±2.70)%vs.(31.23±2.64)%,t=6.38]significantly lower than that of the control group(P<0.01).During the treatment period,the incidence of adverse reactions in the observation group was 13.3%(8/60)and that in the control group was 8.3%(5/60),with a statistically significant difference between two groups(χ^(2)=0.78,P=0.378).Conclusion The Zhuang medicine Fuzheng compound combined with EGFR-TKIs can reduce the level of tumor markers in patients with advanced EGFR-sensitive mutant NSCLC,improve patients'TCM syndromes,quality of life,enhance patient immunity,and improve efficacy.