Clinical study on Yiqi Yangyin Jiedu Decoction in treatment of patients with pulmonary nodules and Qi-Yin deficiency syndrome after early lung cancer surgery
Objective 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-β Horizontal.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=1 7.66),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＜0.01).The effective rate of TCM syndrome in treatment group was 81.08％(30/37),higher than 54.29％(19/35)in control group(Z=-2.00,P=0.040).After the treatment,the ECOG PS score stability rate in the treatment group was 89.19％(33/37),higher than 82.86％(29/35)in control group,without statistical significance(x2=0.19,P＞0.05).The increase and stable rate of body weight was 88.10％(32/37)in treatment group and 62.86％(22/35)in control group(x2=5.36,P＜0.05).After 2-year follow-up,the control rate of pulmonary nodules in the treatment group was 91.89％(34/37),while in the control group it was 65.71％(23/35).The difference between the two groups was statistically significant(x2=7.47,P＜0.01).After the treatment,the level of NSE[(12.54±2.52)ng/L vs.(13.85±2.71)ng/L,t=-2.12],TGF-β[(218.38±102.63)ng/L vs.(301.24±193.69)ng/L,t=-2.29]in treatment group were lower than those in the control group(P＜0.05),and the level of CD3+T cells[(70.60±7.90)％vs.(65.99±9.27)％,t=2.32]in treatment group was higher than that of the control group(P＜0.05).Conclusion Yiqi Yangyin Jiedu Decoction can delay the development of pulmonary nodules in patients after early lung cancer surgery,increasing the body weight of patients,relieving the TCM syndromes and improve the immune function of patients,with the potential to prevent and treat the occurrence and development of early lung cancer.
Lung neoplasmsPulmonary nodulesYiqi Yangyin Jiedu DecoctionTraditional Chinese Medicine therapy
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