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从状态论治中危肺实性结节的随机对照临床研究 被引量:8

Randomized controlled clinical study on the treatment of mediate-risk solid pulmonary nodules based on the state theory
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摘要 目的 观察从患者状态论治中危肺实性结节的临床疗效。方法 采用前瞻随机对照临床研究方法,选择2020年9月—2022年7月就诊于北京中医药大学东方医院及首都医科大学附属北京世纪坛医院的中危肺实性结节患者共128例,按照随机数字表法,以2∶1的比例随机分为试验组(85例)和空白对照组(43例)。将患者辨为单一的气虚、阴虚、阳虚、气郁、湿热状态,或兼夹态,如均不符合则为一般态。试验组患者根据就诊时的状态口服散结基础方(法半夏、胆南星、桔梗、茯苓、生牡蛎、三七)加味治疗,空白对照组不予治疗。每个疗程3个月,1或2个疗程。2组患者分别于3、6个月后进行肺部CT复查,以肺结节最大径面面积减小率结合密度、形态变化为指标进行疗效评价。结果 共115例患者完成研究,其中试验组77例、空白对照组38例。试验组3、6个月的临床总有效率分别为51.95%和49.02%,高于空白对照组的7.89%及8.57%(P<0.01)。试验组最大肺结节直径较基线值减小,而空白对照组增加。结论 在传统辨证论治受限的条件下,针对肺结节患者整体病机状态论治中危肺实性结节具有临床疗效。 Objective To observe the clinical efficacy of treating mediate-risk solid pulmonary nodules from the state theory.Methods A prospective randomized controlled study was conducted to select patients with mediate-risk solid pulmonary nodules who were admitted to Dongfang Hospital of Beijing University of Chinese Medicine and Shijitan Hospital affiliated to Capital Medical University from September 2020 to July 2022,128 cases in total.According to the random number table method,the patients were randomly divided into the experimental group 85 cases and blank control group 43 cases by 2:1 ratio.We identified patients as a single qi deficiency,yin deficiency,yang deficiency,qi stagnation,damp-thermal state,or combined state,or general state if they did not meet.The experimental group were treated with additional Sanjie Basic Prescription(Processed pinellia,Arisaema with bile,Balloon flower,Tuckahoe,Raw oyster,Radix notoginseng)according to the state at the time of consultation,while the blank control group without any treatment.Each course of 3 months,1 to 2 courses.The two groups of patients were rechecked Lung CT after 3 and 6 months,according to the reduction rate of the maximum diameter area of pulmonary nodules combined with the density and morphological changes to evaluate the efficacy.Results 115 cases finished the study,77 cases in the experimental group and 38 cases in blank control group.The total clinical effective rates of the experimental group at 3 and 6 months were 51.95%and 49.02%,respectively,which were higher than 7.89%and 8.57%of the blank control group(P<0.001).The maximum diameter of pulmonary nodules in the experimental group decreased compared with the baseline value,while the blank control group increased.Conclusion Under the condition of limited traditional syndrome differentiation and treatment,the treatment of mediate-risk solid pulmonary nodules based on the overall pathogenesis state of patients with pulmonary nodules has certain clinical efficacy.
作者 李梦乾 张晓梅 李宝重 车丽坤 胡家蕊 李瑞 于小林 许秋雯 金颖 赖宇鑫 姜良铎 LI Mengqian;ZHANG Xiaomei;LI Baozhong;CHE Likun;HU Jiarui;LI Rui;YU Xiaolin;XU Qiuwen;JIN Ying;LAI Yuxin;JIANG Liangduo(Beijing University of Chinese Medicine,Beijing 100029,China;Dongfang Hospital of Beijing University of Chinese Medicine,Beijing 100078,China;Beijing Shijitan Hospital Affiliated to Capital Medical University,Beijing 100038,China;Dongzhimen Hospital of Beijing University of Chinese Medicine,Beijing 100700,China)
出处 《北京中医药大学学报》 CAS CSCD 北大核心 2023年第4期551-556,共6页 Journal of Beijing University of Traditional Chinese Medicine
基金 国家自然科学基金项目(No.81273696) 首都卫生发展科研专项(No.2020-2-4202)。
关键词 从状态论治 中危肺结节 肺实性结节 随机对照临床研究 treatment based on the state theory mediate-risk pulmonary nodules pulmonary solid nodules randomized controlled clinical study
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