清肺化痰汤治疗痰热郁肺证老年晚期非小细胞肺癌患者的临床疗效及对其生活质量、血清癌胚抗原、神经元特异性烯醇化酶、细胞角质素片段抗原水平的影响

Clinical Efficacy of Qingfei Huatan Decoction in Treating Elderly Patients with Advanced Non-small Cell Lung Cancer with Phlegm-Heat Stagnation Lung Syndrome and Its Impact on Quality of Life and Serum Levels of Carcinoembryonic Antigen,Neuron-Specific Enolase,and Cytokeratin 19 Fragment Antigen

目的探讨清肺化痰汤治疗痰热郁肺证老年晚期非小细胞肺癌患者的临床疗效及对其生活质量、血清癌胚抗原(Carcinoembryonic antigen,CEA)、神经元特异性烯醇化酶(Neuron specific enolase,NSE)、细胞角质素片段抗原(Cytokeratin 19 fragment antigen21-1,CYRAF21-1)水平的影响。方法选取2019年7月—2020年10月期间在东南大学医学院附属南京同仁医院接受治疗的非小细胞肺癌患者80例,采用随机数字表法分为对照组和观察组,每组各40例。对照组采用DP化疗方案治疗,观察组在对照组基础上联合清肺化痰汤治疗,每个疗程为21 d,连续治疗4个疗程。观察比较两组患者临床疗效、不良反应情况,治疗前后痰热郁肺证证候积分(咳嗽,咳痰、咯痰黄稠,气喘或气急,喉中痰鸣,发热,口渴)、血清肿瘤标记物(CEA、NSE、CYRAF21-1)、生命质量量表(QOL-38)评分改善情况。结果治疗后观察组总缓解率62.5%(25/40)、临床获益率85.0%(34/40)均明显高于对照组总缓解率40.0%(16/40)、临床获益率65.0%(26/40),差异有统计学意义(P<0.05)。治疗后两组患者咳嗽、咳痰、咯痰黄稠、气喘或气急、喉中痰鸣、发热、口渴评分均较治疗前降低,差异有统计学意义(P<0.01);且观察组痰热郁肺证证候积分明显低于对照组,差异有统计学意义(P<0.05)。治疗后两组患者血清CEA、NSE及CYRAF21-1水平均较治疗前明显降低,差异有统计学意义(P<0.01);且观察组血清CEA、NSE及CYRAF21-1水平均明显低于对照组,差异有统计学意义(P<0.05)。治疗后两组患者身体状况、情绪状况、功能状况、肺癌相关症状、社会/家庭状况评分均较治疗前明显降低,总体健康状况评分较治疗前明显升高,差异有统计学意义(P<0.01);且观察组QOL-38评分改善情况明显优于对照组,差异有统计学意义(P<0.05)。治疗期间,观察组不良反应发生率明显低于对照组,差异有统计学意义(P<0.05)。结论清肺化痰汤治疗痰热郁肺证老年晚期非小细胞肺癌疗效显著,能够有效降低血清CEA、NSE及CYRAF21-1水平,缓解临床症状,减轻化疗药物不良反应,提高患者生活质量。

Objective To explore the clinical efficacy of Qingfei Huatan decoction as an adjunct treatment for elderly patients with advanced non-small cell lung cancer(NSCLC)who exhibit phlegm-heat stagnation lung syndrome,and to evaluate its effects on their quality of life and serum levels of carcinoembryonic antigen(CEA),neuron-specific enolase(NSE),and cytokeratin 19 fragment antigen 21-1(CYRAF 21-1).Methods 80 patients with NSCLC treated at Nanjing Tongren Hospital affiliated with the School of Medicine,Southeast University,between July 2019 and October 2020,were selected as the research subjects and divided into a control group and an observation group according to the random number table method,with 40 patients in each group.The control group received DP chemotherapy,while the observation group received Qingfei Huatan decoction in combination with DP chemotherapy.Each treatment cycle last 21 days,with a total of four cycles administered.Clinical efficacy,adverse reactions,syndrome scores for phlegm-heat stagnation lung syndrome(cough,expectoration,yellow viscous phlegm,wheezing or shortness of breath,throat phlegm,fever,and thirst),serum tumor markers(CEA,NSE,CYRAF 21-1),and improvements in quality of life,measured by the QOL-38 scale,were compared between two groups before and after treatment.Results After treatment,the total remission rate(62.5%,25/40)and clinical benefit rate(85.0%,34/40)in the observation group were significantly higher than those in the control group[total remission rate of 40.0%(16/40);clinical benefit rate of 65.0%(26/40)],with statistically significant differences(P<0.05).Scores for cough,expectoration,yellow viscous phlegm,wheezing or shortness of breath,throat phlegm,fever,and thirst decreased significantly in both groups compared to before treatment,with statistically significant differences(P<0.01);the syndrome scores for phlegm-heat stagnation lung syndrome were significantly lower in the observation group than in the control group,with statistically significant differences(P<0.05).Serum levels of CEA,NSE,and CYRAF21-1 decreased significantly in both groups compared to pre-treatment levels,with statistically significant differences(P<0.01);the levels in the observation group were significantly lower than those in the control group,with statistically significant differences(P<0.05).Quality of life scores,including physical status,emotional status,functional status,lung cancer-related symptoms,and social/family status,improved significantly in both groups after treatment,with the overall health status score significantly higher,with statistically significant differences(P<0.01).The improvement in QOL-38 scores was significantly better in the observation group compared to the control group,with a statistically significant difference(P<0.05).During the treatment period,the incidence of adverse reactions in the observation group was significantly lower than that in the control group,with statistically significant differences(P<0.05).Conclusion Qingfei Huatan decoction is highly effective in treating elderly patients with advanced NSCLC exhibiting phlegm-heat stagnation lung syndrome.It significantly reduces serum levels of CEA,NSE,and CYRAF21-1,alleviates clinical symptoms,reduces chemotherapy-induced adverse reactions,and improves patients'quality of life.