肺结节中医药临床疗效评价体系探讨  

Discussion on the systematic assessment for the clinical efficacy of pulmonary nodules in traditional Chinese medicine

作　　者：李梦乾 姜良铎 张晓梅 李宝重 赖宇鑫 许秋雯 金颖 LI Mengqian;JIANG Liangduo;ZHANG Xiaomei;LI Baozhong;LAI Yuxin;XU Qiuwen;JIN Ying(Beijing University of Chinese Medicine,Beijing 100029,China;Dongzhimen Hospital,Beijing University of Chinese Medicine,Beijing 100700,China;Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China;Beijing Shijitan Hospital,Capital Medical University,Beijing 100038,China)

机构地区：[1]北京中医药大学,北京100029 [2]北京中医药大学东直门医院 [3]北京中医药大学东方医院 [4]首都医科大学附属北京世纪坛医院

出　　处：《北京中医药大学学报》2023年第10期1333-1337,共5页Journal of Beijing University of Traditional Chinese Medicine

基　　金：首都卫生发展科研专项(No.2020-2-4202)。

摘　　要：肺结节是肺部影像学的表现,患者缺少典型的呼吸系统症状,如咳嗽、咳痰、气喘等,在评价中医药治疗肺结节疗效时,无法使用以症状为主的中医证候评分评价体系,因此建立肺结节中医药临床疗效评价体系具有必要性和紧迫性。本文遵循国内外权威肺结节诊疗指南,在开展的大量临床研究实践基础上,总结提出了肺结节中医药临床疗效评价方法。本评价方法以总有效率为主要疗效指标,即综合考虑肺结节横截面积变化率和(或)直径变化、恶性征象变化,将疗效分为治愈、显效、有效、稳定、进展5个等级,总有效率(%)=(治愈例数+显效例数+有效例数)/总例数×100%;次要疗效指标包括平均直径变化、平均横截面积变化、危险度转化率、Mayo模型计算的恶性概率变化;以3、6个月为评价周期。建立以结节直径或横截面积变化为主的多维度疗效评价体系,有利于为中医药治疗肺结节的临床研究提供规范化、系统化及高循证级别的证据。Pulmonary nodules are lung imaging manifestations that lack typical respiratory symptoms,such as cough,expectoration,asthma,et al.In the evaluation of the efficacy of traditional Chinese medicine(TCM)in the treatment of pulmonary nodules,it is difficult to use the symptom⁃based TCM pattern score evaluation system.It is necessary and urgent to establish a TCM clinical efficacy evaluation system for pulmonary nodules.Following the authoritative guidelines for the diagnosis and treatment of pulmonary nodules in China and abroad,this paper summarizes and puts forward an evaluation of the clinical efficacy of TCM for pulmonary nodules on the basis of a large number of clinical research practices.This evaluation method takes the total effective rate as the main efficacy index,that is,comprehensively considering the change rate of cross⁃sectional area and(or)diameter change,and malignant sign change,the efficacy is divided into five levels:cured,significantly efficacious,effective,stable,and deteriorating,and the total effective rate(%)=(cured cases+significantly efficacious cases+effective cases)/total cases×100%.Secondary efficacy indexes include average diameter change,average cross⁃sectional area change,risk conversion rate,malignant probability change calculated by Mayo model.The evaluation period is 3 and 6 months.In short,the establishment of a multi⁃dimensional efficacy evaluation system based on changes in nodule diameter or cross⁃sectional area is conducive to providing standardized,systematic and high⁃level evidence for clinical research on the treatment of pulmonary nodules with TCM.

关 键 词：肺结节 疗效评价 直径 横截面积 危险度 Mayo模型 恶性征象 

分 类 号：R256.1[医药卫生—中医内科学]