中国中西医结合杂志2024，Vol.44Issue(9)：1044-1050,7.DOI:10.7661/j.cjim.20240710.050
散结通络颗粒治疗肺部纯磨玻璃小结节气虚痰瘀证随机双盲安慰剂对照研究
Sanjie Tongluo Granule for Pure Ground-Glass Lung Nodules with Qi Deficiency and Phlegm Stasis Syndrome:A Randomized Double-Blind and Placebo Controlled Trial
摘要
Abstract
Objective To evaluate the clinical efficacy and safety of Sanjie Tongluo Granule(SJTLG)in pure ground-glass lung nodules patients with qi deficiency and phlegm stasis syndrome.Methods Eighty-six patients were randomly assigned to the treatment group(43 cases)and the control(43 cases)groups.Patients in both groups received regular health education on lung nodules.Patients in the treatment group were given oral SJTLG,while patients in the control group were given placebo Chinese medicine(CM)Granule.All treatment lasted for 24 weeks.Primary outcome measures were long diameter of the largest pure ground-glass lung nodule and disease response rate,while secondary outcome measures were CM clinical symptom scores,density of the largest pure ground-glass lung nodules,malignant risk probability of the Brock model,and Self-Rating Depression Scale(SDS)score.Results Totally 81 patients completed the study,41 patients in the treatment group and 40 patients in the control group.Compared with the same group before treatment,the long diameter of the largest pure ground-glass lung nodule decreased,the total scores of CM clinical symptom and the malignancy risk probability in the Brock model decreased,with SDS score was improved in the treatment group(P＜0.05).There was change in the density of the largest nodule in the treatment group(P＞0.05).There was no statistically significant difference in the above indicators before and after treatment in the control group(P＞0.05).Compared with the control group during the same period,the treatment group showed better results in the reduction of the long diameter of the largest pure ground-glass lung nodules,disease response rate,total scores of CM clinical symptom,malignant risk probability in the Brock model,and SDS score(P＜0.05).There were no adverse reactions or serious adverse events in both groups.Conclusion SJTLG can reduce the long diameter of nodules,improve clinical symptoms,and decrease malignant risk probability in the Brock model and SDS score of pure ground-glass small lung nodules patients with qi deficiency and phlegm stasis syndrome,with no adverse reactions.关键词
散结通络颗粒/肺部纯磨玻璃结节/气虚痰秦/Brock模型恶性风险概率/中药复方/中西医结合Key words
Sanjie Tongluo Granule/pure ground-glass nodules/Qi deficiency and phlegm stasis/malignancy risk probability in the Brock model/Chinese herbal compound/integrative medicine引用本文复制引用
陈飞飞,张炜,史苗颜,张一乐,苏子舰..散结通络颗粒治疗肺部纯磨玻璃小结节气虚痰瘀证随机双盲安慰剂对照研究[J].中国中西医结合杂志,2024,44(9):1044-1050,7.基金项目
上海市科委上海中医临床重点实验室项目(No.14DZ2273200) （No.14DZ2273200）
上海市临床重点专科(中医肺病科)建设项目(No.shslczdzk05101) （中医肺病科）
