培元抗癌汤联合NP化疗方案治疗晚期非小细胞肺癌的近期疗效及不良反应的临床观察

Clinical Observation on the Short-Term Effect and Adverse Reactions of Peiyuan Kangai Decoction Combined with Navelbine+Cisplatin Regimen in the treatment of Advanced Non-Small Cell Lung Cancer

目的 观察培元抗癌汤联合NP化疗方案(长春瑞滨加顺铂)治疗晚期非小细胞肺癌(Non-small cell lung cancer, NSCLC)的近期疗效及不良反应。方法 选取2020年1月—2021年6月期间陕西中医药大学附属医院收治的88例NSCLC患者作为研究对象,按随机数字表法分为对照组和联合组,每组各44例。对照组给予NP化疗方案进行治疗,联合组在对照组基础之上给予培元抗癌汤治疗。治疗3个疗程后,采用WHO实体瘤客观疗效评定标准对两组患者近期疗效进行评估;对两组患者中医症候改善情况进行评估;采用发光免疫分析仪对胞角蛋白19片段(Cvtokeratin 19 fragment, CY-FRA21-1)、癌胚抗原(Carcinoembryonic antigen, CEA)、神经元特异性烯醇化酶(Neuron-specific enolase, NSE)水平进行检测;通过流式细胞术对两组患者NK细胞、T淋巴细胞、B淋巴细胞水平进行检测;统计两组患者治疗期间不良反应总发生率。结果 治疗后联合组总缓解率68.18%与对照组54.55%比较,差异无统计学意义(P>0.05)。治疗后联合组中医证候总有效率为72.72%,明显高于对照组的52.27%,差异有统计学意义(P<0.05)。治疗后两组患者血清中CY-FRA21-1、CEA、NSE水平均较治疗前明显降低,差异有统计学意义(P<0.05);且联合组明显低于对照组,差异有统计学意义(P<0.05)。治疗后联合组NK细胞、T淋巴细胞明显高于对照组,差异有统计学意义(P<0.05);两组患者B淋巴细胞比较,差异无统计学意义(P>0.05)。治疗期间,联合组不良反应总发生率为36.36%,明显低于对照组的59.09%,差异有统计学意义(P<0.05)。结论 培元抗癌汤联合NP化疗方案(长春瑞滨加顺铂)治疗可以更好地改善中医症候,降低肿瘤标准物水平,提高免疫功能且降低不良反应发生率。

Objective To observe the short-term effect and adverse reactions of Peiyuan Kangai decoction com-bined with navelbine+cisplatin(NP)regimen in the treatment of advanced non-small cell lung cancer(NSCLC).Meth-ods A total of 88 patients with NSCLC admitted to the Affiliated Hospital of Shaanxi University of Traditional Chinese Medicine from January 2020 to June 2021 were taken as the research objects.According to the random number table meth-od,they were divided into a combination group and a control group,with 44 cases in each group.The control group was treated with NP chemotherapy,while the combination group was additionally treated with Peiyuan Kangai decoction.After three courses of treatment,the short-term curative effects in both groups were evaluated by WHO response evaluation cri-teria in solid tumor(RECIST).The improvement of traditional Chinese medicine(TCM)symptoms in both groups was eval-uated.The levels of cytokeratin 19 fragment(CY-FRA21-1),carcinoembryonic antigen(CEA),and neuron-specific enolase(NSE)were detected by a luminescence immunoassay analyzer.The levels of NK cells,T lymphocytes,and B lym-phocytes in both groups were detected by flow cytometry.The total incidence of adverse reactions in both groups during treatment was statistically analyzed.Results After treatment,there was no statistically significant difference(P>0.05)in the total remission rate between the combination group(68.18%)and the control group(54.55%).In addition,the total effective rate of TCM symptoms in the combination group(72.72%)was significantly higher than that in the control group(52.27%)(P<0.05).After treatment,the levels of CY-FRA21-1,CEA,and NSE in the serum of both groups were significantly decreased(P<0.05).In addition,the levels of the combination group were significantly lower than those of the control group(P<0.05).After treatment,the levels of NK cells and T lymphocytes in the combination group were sig-nificantly higher than those in the control group(P<0.05),but there was no significant difference in B lymphocytes be-tween the two groups(P>0.05).During treatment,the total incidence of adverse reactions in the combination group(36.36%)was significantly lower than that in the control group(59.09%)(P<0.05).Conclusion Peiyuan Kangai de-coction combined with NP regimen can better improve TCM symptoms,reduce levels of tumor markers,enhance immune function,and alleviate adverse reactions.