北京中医药大学学报2025，Vol.48Issue(11)：1519-1530,12.DOI:10.3969/j.issn.1006-2157.2025.11.006
益肺散结方治疗多发肺结节的随机对照临床研究
Randomized controlled clinical study of Yifei Sanjie Decoction in the treatment of multiple pulmonary nodules
摘要
Abstract
Objective To observe the efficacy and safety of Yifei Sanjie Decoction in the treatment of multiple pulmonary nodules.Methods A prospective randomized controlled clinical study was conducted to select 189 patients with multiple pulmonary nodules who saught medical attention at the Pulmonary Nodule Diagnosis and Treatment Center of Dongfang Hospital,Beijing University of Chinese Medicine and the Department of Thoracic Surgery of Beijing Shijitan Hospital Affiliated to Capital Medical University from January 2023 to March 2025.According to the random number table method,126 cases were randomly divided into the trial group and 63 cases in the blank control group at a ratio of 2∶1.The trial group was treated with modified Yifei Sanjie Decoction,and the blank control group was only followed up without intervention.The course of treatment was 3 months.The patients in the two groups were reexamined with lung CT after 3 months.The efficacy was evaluated by the area reduction rate of the major pulmonary nodules and the cumulative multiple pulmonary nodules in patients with multiple pulmonary nodules combined with the average diameter and malignant signs.According to the property of the major pulmonary nodules,we divided the patients into ground glass,solid,and mixed ground glass subgroups to evaluate the efficacy of different types of pulmonary nodules.We evaluated the change of malignant risk of pulmonary nodules according to the change of Mayo score.We evaluated the safety of the treatment medicine by blood routine,urine routine,and liver and kidney function.Results A total of 175 patients completed the study,117 in the trial group and 58 in the blank control group.The total effective rates of the major pulmonary nodules and the cumulative multiple pulmonary nodules in the trial group were 41.03%and 42.74%,respectively,the total effective rate of nodule number change was 29.91%which were significantly higher than those in the blank control group(P<0.05).In the trial group,the total effective rates of the major pulmonary nodules in the ground glass(72 cases),solid(28 cases),and mixed ground glass(17 cases)subgroups were 40.28%,32.14%,and 58.82%,respectively,the total effective rates of the cumulative multiple pulmonary nodules were 38.89%,42.86%,and 58.82%,respectively,which were significantly higher than those in corresponding subgroups of ground glass(37 cases),solid(14 cases),and mixed ground glass(7 cases)of the blank control(P<0.05).After treatment,the average diameter,area,and Mayo score of the major pulmonary nodules and the cumulative multiple pulmonary nodules in the trial group were significantly lower than those in the blank control group and before treatment(P<0.05),the average diameter,area,and Mayo score of the major pulmonary nodules and the cumulative multiple pulmonary nodules in the ground glass,solid,and mixed ground glass subgroups were lower than those in corresponding subgroups of the blank control group,and significantly lower than those before treatment(P<0.05).The number of nodules and malignant signs in the trial group were lower than before,while those in the blank control group were higher than before.There were no serious adverse events in the two groups during the study.Conclusion Yifei Sanjie Decoction can effectively treat the major pulmonary nodules and the cumulative multiple pulmonary nodules in patients with multiple pulmonary nodules,reduce the average diameter and area of nodules,reduce the Mayo score,and reduce the malignant signs and number of nodules.In the ground glass,solid,and mixed ground glass groups,the curative effect is well,and the safety is high,it can be used for the clinical treatment of multiple pulmonary nodules.关键词
益肺散结方/多发肺结节/随机对照/临床研究/疗效评价Key words
Yifei Sanjie Decoction/multiple pulmonary nodules/randomized control/clinical research/efficacy evaluation分类
医药卫生引用本文复制引用
李梦乾,张晓梅,李宝重,赖宇鑫,李燕妮,杨天舒,谭新蕾,孙云龙..益肺散结方治疗多发肺结节的随机对照临床研究[J].北京中医药大学学报,2025,48(11):1519-1530,12.基金项目
首都卫生发展科研专项(No.2020-2-4202) （No.2020-2-4202）
中央高水平中医医院临床科研项目(No.2024-DYZJ-006) （No.2024-DYZJ-006）
北京中医药大学2024年基本科研业务费"揭榜挂帅"项目(No.2024-JYB-JBZD-009) Capital Health Development Research Project(No.2020-2-4202) （No.2024-JYB-JBZD-009）
