益气养阴解毒方治疗早期肺癌术后伴肺结节气阴两虚证的临床研究  

Clinical study on Yiqi Yangyin Jiedu Decoction in treatment of patients with pulmonary nodules and Qi-Yin deficiency syndrome after early lung cancer surgery

作　　者：阮广欣[1] 沈丽萍[1] 毕向雁 周蕾[1] Ruan Guangxin;Shen Liping;Bi Xiangyan;Zhou Lei(Oncology Department of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai200032,China)

机构地区：[1]上海中医药大学附属龙华医院肿瘤科,上海200032

出　　处：《国际中医中药杂志》2024年第8期986-992,共7页International Journal of Traditional Chinese Medicine

基　　金：上海市2022年度“科技创新行动计划”医学创新研究专项(22Y11921400)。

摘　　要：目的评价益气养阴方治疗早期肺癌术后伴肺结节气阴两虚证的疗效。方法随机对照试验研究。选择2020年3-9月上海中医药大学附属龙华医院肿瘤科76例早期肺癌术后伴肺结节气阴两虚证患者作为观察对象, 采用随机数字表法分为2组, 每组38例。对照组予以西医常规对症治疗, 治疗组自入组后第1天起服用益气养阴解毒方。2组均治疗6个月, 随访2年。分别于治疗前后进行中医证候评分, 采用美国东部肿瘤协作组活动状态(ECOG PS)评分评估患者的活动状态;采用电化学发光法检测癌胚抗原(CEA)、神经元特异性烯醇化酶(NSE), 流式细胞仪检测T淋巴细胞亚群CD3+、CD4+百分比, ELISA法检测TGF-β水平。记录患者体重, 观察治疗后体重变化。观察记录治疗期间的不良反应, 评价中医证候疗效及肺结节控制率。结果观察期间, 治疗组失访1例、对照组失访3例, 最终治疗组37例、对照组35例完成本研究。治疗组治疗后气短[(0.27±0.07)分比(0.68±0.12)分, t=17.66]、自汗盗汗[(0.16±0.16)分比(0.79±0.16)分, t=16.55]评分低于对照组(P<0.01);对照组治疗后失眠[(0.15±0.08)分比(0.54±0.13)分, t=15.52]评分低于治疗组(P<0.01)。治疗后, 治疗组证候疗效总有效率为81.08%(30/37)、对照组为54.29%(19/35), 2组比较差异有统计学意义(Z=-2.00, P=0.040);ECOG PS评分稳定率为89.19%(33/37)、对照组为82.86%(29/35), 2组比较差异无统计学意义(χ^(2)=0.19, P>0.05);治疗组体重增加及稳定率为88.10%(32/37)、对照组为62.86%(22/35), 2组比较差异有统计学意义(χ^(2)=5.36, P<0.05)。随访2年, 治疗组肺结节控制率为91.89%(34/37)、对照组为65.71%(23/35), 2组比较差异有统计学意义(χ^(2)=7.47, P<0.01)。治疗组治疗后NSE[(12.54±2.52)ng/L比(13.85±2.71)ng/L, t=-2.12]、TGF-β[(218.38±102.63)ng/L比(301.24±193.69)ng/L, t=-2.29]水平低于对照组(P<0.05), CD3+ T淋巴细胞[(70.60±7.90)%比(65.99±9.27)%, t=2.32Objective:To evaluate the efficacy of Yiqi Yangyin Jiedu Decoction in the treatment of patients with pulmonary nodules and qi-yin deficiency syndrome after early lung cancer surgery.Methods:Randomized controlled trial was conducted.A total of 76 patients with lung nodules and qi-yin deficiency syndrome after early lung cancer surgery at the Oncology Department of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from March to September 2020 were selected and randomly divided into two groups using a random number table method,with 38 cases in each group.The control group received symptomatic treatment,while the treatment group took Yiqi Yangyin Jiedu Decoction from the first day after enrollment.Both groups were treated for 6 months and followed up for 2 years.TCM syndrome scores before and after treatment were evaluated;the patients'activity status was evaluated using the Eastern Oncology Collaborative Group Activity Status(ECOG PS)score in the United States,and electrochemiluminescence was used to detect carcinoembryonic antigen(CEA)and neuron specific enolase(NSE).Flow cytometry was used to detect the percentage of T lymphocyte subsets CD3+and CD4+,and ELISA was used to detect TGF-βHorizontal.The patients'weight was recorded and their weight changes after treatment were observed.Adverse reactions during treatment were observed and recorded,the efficacy of TCM syndromes and pulmonary nodules was evaluated.Results:During the observation period,one case was lost to follow-up in the treatment group and three cases were lost to follow-up in the control group.Finally,37 cases in the treatment group and 35 cases in the control group completed the observation.After the treatment,the panting(0.27±0.07 vs.0.68±0.12,t=17.66),spontaneous sweating and night sweating(0.16±0.16 vs.0.79±0.16,t=16.55)score of the treatment group were lower than those in the control group(P<0.01);insomnia(0.15±0.08 vs.0.54±0.13,t=15.52)score of the control group was lower than that of the treatment group(P

关 键 词：肺肿瘤 肺结节 益气养阴解毒方 中医药疗法 

分 类 号：R273[医药卫生—中西医结合]