首页|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

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

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  • 国家科技期刊平台
  • NETL
  • NSTL
  • 万方数据
目的 评价散结通络颗粒治疗肺部纯磨玻璃小结节气虚痰瘀证患者的临床有效性和安全性。方法 86例患者随机分为治疗组(43例)和对照组(43例)。两组均定期进行肺部结节健康宣教，治疗组口服散结通络颗粒，对照组口服安慰剂中药颗粒，疗程均为24周。主要结局指标为最大肺纯磨玻璃结节长径和疾病有效率，次要结局指标为中医临床症状积分、最大肺部纯磨玻璃结节密度、Brock模型恶性风险概率评分和抑郁自评量表(SDS)评分。结果 最终81例患者完成研究，其中治疗组41例，对照组40例。与本组治疗前比较，治疗组最大肺磨玻璃结节长径缩小，中医临床症状总积分降低，Brock模型恶性风险概率降低，SDS评分改善(P＜0。05)，最大结节密度差异无统计学意义(P＞0。05)。对照组治疗前后上述指标差异均无统计学意义(P＞0。05)。治疗组最大肺部纯磨玻璃结节长径缩小量、疾病总有效率、中医临床症状总积分、Brock模型恶性风险概率评分和SDS评分均优于对照组(P＜0。05)。两组均未发生不良反应及严重不良事件。结论 散结通络颗粒治疗气虚痰瘀型肺部纯磨玻璃小结节患者能够缩小结节长径，改善临床症状，降低Brock模型恶性风险概率评分和SDS评分，且无明显不良反应。
Sanjie Tongluo Granule for Pure Ground-Glass Lung Nodules with Qi Deficiency and Phlegm Stasis Syndrome:A Randomized Double-Blind and Placebo Controlled Trial
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.

Sanjie Tongluo Granulepure ground-glass nodulesQi deficiency and phlegm stasismalignancy risk probability in the Brock modelChinese herbal compoundintegrative medicine

陈飞飞、张炜、史苗颜、张一乐、苏子舰

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上海市嘉定区中医医院肺病科(上海 201800)

上海中医药大学附属曙光医院肺病科(上海 201203)

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

上海市科委上海中医临床重点实验室项目上海市临床重点专科(中医肺病科)建设项目

14DZ2273200shslczdzk05101

2024

10.7661/j.cjim.20240710.050

中国中西医结合杂志
中国中西医结合学会 中国中医科学院

中国中西医结合杂志

CSTPCD北大核心
影响因子：2.149
ISSN：1003-5370
年,卷(期)：2024.44(9)