附桂消结汤治疗阳虚寒凝肺结节的临床研究

Clinical Study on the Treatment of Yang Deficiency and Cold Condensing Pulmonary Nodules with Fugui Xiaojie Decoction

目的:探讨附桂消结汤治疗阳虚寒凝型肺结节的疗效。方法:纳入2021年1月—2023年6月河南省中医院检出的80例阳虚寒凝型良性肺结节(0.5 cm≤直径≤1.0 cm)患者为研究对象,采用随机数字表法将患者分为观察组、空白对照组,各40例。两组均实施常规随访观察,期间空白对照组不应用中药及西药治疗,观察组应用附桂消结汤治疗,持续服用并观察6个月。于患者就诊时、随访3个月、6个月时进行胸部CT检查,并以上述时间为观察时点,比较两组各时点中医证候积分、肺结节大小变化情况及肿瘤标志物指标[癌胚抗原(CEA)、细胞角蛋白19片段(CYFRA21-1)]水平。并记录观察组用药安全性情况。结果:两组随访3个月、6个月时中医证候积分均较就诊时降低,且观察组低于空白对照组(P<0.05)。观察组随访3个月时肺结节消减率略高于空白对照组,但两组肺结节消减率、整体肺结节大小变化情况无差异(P>0.05)。观察组随访6个月时肺结节消减率高于空白对照组,肺结节消失缩小占比高于空白对照组(P<0.05)。两组随访3个月、6个月时血清CEA、CYFRA21-1水平均较就诊时降低,且观察组低于对照组(P<0.05)。观察组患者治疗过程中未见不良反应发生。结论:附桂消结汤能有效改善阳虚寒凝型肺结节患者中医证候积分,提高肺结节消减率,降低患者肿瘤标志物水平,安全性尚可。

Objective:To explore the curative effect of Fugui Xiaojie Decoction in the treatment of pulmonary nodules of yang deficiency and cold coagulation type.Methods:From January 2021 to June 2023,80 patients with benign pulmonary nodules(0.5 cm≤diameter≤1.0 cm)of yang deficiency and cold coagulation type detected in Henan Provincial Hospital of Traditional Chinese Medicine were included in the study.The patients were divided into observation group and blank control group by random number table method,with 40 patients in each group.Both groups were given routine follow-up observation.During the period,the blank control group was not treated with traditional Chinese medicine and western medicine,and the observation group was treated with Fugui Xiaojie Decoction,which was continuously taken and observed for 6 months.Chest CT examination was performed at the time of patient's visit,3 months and 6 months of follow-up,and the above time was taken as the observation time point.The TCM syndrome scores,changes in the size of pulmonary nodules and the levels of tumor markers[carcinoembryonic antigen(CEA),cytokeratin 19 fragment(CYFRA21-1)]were compared between the two groups at each time point.The safety of medication in the observation group was recorded.Results:The TCM syndrome score of the two groups at 3 and 6 months of follow-up was lower than that at the time of treatment,and that of the observation group was lower than that of the blank control group(P<0.05).The reduction rate of pulmonary nodules in the observation group was slightly higher than that in the blank control group at 3 months of follow-up,but there was no difference in the reduction rate of pulmonary nodules and the change of overall pulmonary nodule size between the two groups(P>0.05).At 6 months of follow-up,the reduction rate of pulmonary nodules in the observation group was higher than that in the blank control group,and the proportion of disappearance and reduction of pulmonary nodules was higher than that in the blank control group(P<0.05).The levels of serum CEA and CYFRA21-1 in the two groups at 3 months and 6 months of follow-up were lower than those at the time of treatment,and those in the observation group were lower than those in the control group(P<0.05).No adverse reactions occurred in the observation group during the treatment.Conclusion:Fugui Xiaojie Decoction can effectively improve the TCM syndrome score of patients with pulmonary nodules of yang deficiency and cold coagulation type,improve the reduction rate of pulmonary nodules,and reduce the level of tumor markers in patients,with acceptable safety.