复肺解毒方联合西医标准方案治疗气阴两虚型Ⅲa~Ⅳ期驱动基因阴性非小细胞肺癌的临床观察OA
Clinical Observation of Fufei Jiedu Formula Combined with Standard Western Therapy for Stage Ⅲa~Ⅳ Driver Gene-Negative Non-Small Cell Lung Cancer Patients with Qi and Yin Deficiency Syndrome
目的 评估复肺解毒方联合西医标准方案治疗气阴两虚型Ⅲa~Ⅳ期驱动基因阴性非小细胞肺癌(non-small cell lung cancer,NSCLC)的临床疗效.方法 选择2024年2月~2025年2月陕西中医药大学附属医院肿瘤医院收治的61例气阴两虚型Ⅲa~Ⅳ期驱动基因阴性NSCLC患者,随机分为对照组30例和治疗组31例.对照组予以西医标准方案治疗;治疗组在对照组基础上联合口服中药汤剂复肺解毒方治疗,每21天为1个周期,共治疗3个周期.比较两组患者治疗前及治疗后的实体瘤近期疗效[客观缓解率(objective response rate,ORR)、疾病控制率(disease control rate,DCR)]、远期疗效[无进展生存期(progression-free survival,PFS)]、生活质量(quality of life questionnaire lung cancer module 30,QLQ-C30)评分、中医证候积分及疗效、体力状态、肿瘤标志物[癌胚抗原(carcinoembryonic antigen,CEA)、鳞癌特异性抗原(squamous cell carcinoma antigen,SCC)、细胞角蛋白19片段(cytokeratin 19 fragment,CYFRA21-1)、胃泌素释放肽前体(pro-gastrin-releasing peptide,ProGRP)、神经元特异性烯醇化酶(neuron-specific enolase,NSE)]和安全性.结果 在实体瘤近期疗效方面,两组ORR与DCR对比差异不具有统计学意义,两组患者PFS对比差异不具有统计学意义.治疗组美国东部肿瘤协作组体能状态(Eastern Cooperative Oncology Group Performance Status,ECOG)评分、生活质量评分、中医证候积分及疗效、CEA、SCC、CYFRA21-1明显低于治疗前(P<0.05),对照组生活质量评分中恶心呕吐较治疗前加重(P<0.05),治疗组上述指标均明显低于对照组(P<0.05).治疗组白细胞减少、血红蛋白减少、中性粒细胞减少、恶心呕吐及呼吸困难发生率明显低于对照组(P<0.05).结论 复肺解毒方在一定程度上具有抑制肿瘤进展趋势、显著提高晚期驱动基因阴性NSCLC患者的生活质量、缓解症状、改善患者体力状态、降低患者肿瘤标志物水平、降低治疗相关的不良反应的作用.
Objective To explore the clinical efficacy of Fufei Jiedu Formula combined with standard Western therapy in the treatment of stage Ⅲa~Ⅳ driver gene-negative non-small cell lung cancer(NSCLC)with qi and yin deficiency syndrome.Methods From February 2024 to February 2025,61 patients with stage Ⅲa~Ⅳ negative driver-genes NSCLC of qi and yin deficiency syndrome admitted to Tumor Hospital,Affiliated Hospital of Shaanxi University of Chinese Medicine were selected and randomly divided into a control group of 30 cases and a treatment group of 31 cases.The control group was treated with standard Western therapy.The treatment group was treated with Fufei Jiedu Formula on the basis of the control group.Each 21-day cycle was considered as one cycle,and a total of three cycles were administered.The short-term efficacy[objective response rate(ORR),disease control rate(DCR)],long-term efficacy[progression-free survival(PFS)],quality of life[quality of life questionnaire lung cancer module 30(QLQ-C30)score],traditional Chinese medicine(TCM)syndrome score and efficacy,physical status efficacy,tumor markers[carcinoembryonic antigen(CEA),squamous cell carcinoma specific antigen(SCC),cytokeratin 19 fragment(CYFRA21-1),gastrin-releasing peptide precursor(ProGRP),and neuron-specific enolase(NSE)],and safety of the two groups of patients before treatment and after 3 chemotherapy cycles were compared.Results In terms of short-term efficacy in solid tumors,the differences in ORR and DCR between the two groups were not statistically significant.There was no statistically significant difference in PFS between the two groups of patients.After treatment,the Eastern Cooperative Oncology Group Performance Status(ECOG)score,quality of life score,TCM syndrome score and efficacy,CEA,SCC,and CYFRA21-1 in the treatment group were significantly lower than those before treatment(P<0.05).In the quality of life score of the control group,nausea and vomiting were more severe than those before treatment(P<0.05).All the above indicators in the treatment group were significantly lower than those in the control group(P<0.05).The incidences of leukopenia,hemoglobin reduction,neutropenia reduction,nausea,vomiting,and dyspnea in the treatment group were significantly lower than those in the control group(P<0.05).Conclusion To a certain extent,Fufei Jiedu Formula can inhibit the trend of tumor progression,significantly improve the quality of life of patients with advanced driver gene-negative NSCLC,relieve symptoms,improve the physical status,reduce the levels of tumor markers,and lower treatment-related adverse reactions.
王毓贤;王院春;陈雅丽;王希胜;千维娜;李洁洁
陕西中医药大学第一临床医学院,陕西 咸阳 712000陕西中医药大学附属医院肿瘤医院三病区,陕西 咸阳 712000陕西中医药大学第一临床医学院,陕西 咸阳 712000陕西中医药大学附属医院肿瘤医院三病区,陕西 咸阳 712000陕西中医药大学附属医院肿瘤医院三病区,陕西 咸阳 712000陕西中医药大学第一临床医学院,陕西 咸阳 712000
医药卫生
复肺解毒方非小细胞肺癌驱动基因阴性气阴两虚
Fufei Jiedu Formulanon-small cell lung cancerdriver gene-negativeqi and yin deficiency
《中医肿瘤学杂志》 2026 (1)
20-28,9
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