氯醋甲胆碱与乙酰甲胆碱在支气管激发试验临床应用中的对比分析  

Comparison of methacholine chloride and methacholine bronchial provocation tests in clinical practice

作　　者：刘舒怡 谢燕清[1] 李允 王柱锋 叶培韬 谭论芳 高怡[1] 郑劲平[1] Liu Shuyi;Xie Yanqing;Li Yun;Wang Zhufeng;Ye Peitao;Tan Lunfang;Gao Yi;Zheng Jinping(The First Affiliated Hospital of Guangzhou Medical University,National Center for Respiratory Medicine,National Clinical Research Center for Respiratory Disease,State Key Laboratory of Respiratory Disease,Guangzhou Institute of Respiratory Health,Guangzhou 510120,China)

机构地区：[1]广州医科大学附属第一医院、国家呼吸医学中心、国家呼吸系统疾病临床医学研究中心、呼吸疾病全国重点实验室、广州呼吸健康研究院,广州510120

出　　处：《国际呼吸杂志》2023年第8期937-943,共7页International Journal of Respiration

基　　金：国家重点研发计划(2018YFC1311900);国家科技支撑计划(2015BAI12B10);广东省医学科学技术研究基金(C2021073);广东省钟南山医学基金项目(ZNSA-2020013);广东省卫生健康适宜技术推广项目(202107051451251384)。

摘　　要：目的:比较我国首个经国家药监局绿色通道批准优先上市的支气管激发试验(BPT)激发剂氯醋甲胆碱与传统激发剂乙酰甲胆碱在临床诊断应用效果与安全性方面的差异。方法:本研究为单中心横断面研究,收集广州医科大学附属第一医院肺功能室2022年9月至11月的氯醋甲胆碱BPT报告以及2017年3月至2022年4月的乙酰甲胆碱BPT报告,纳入成人(≥18岁)例数:氯醋甲胆碱组2196例,乙酰甲胆碱组23729例;儿童(4~17岁)例数:氯醋甲胆碱组365例,乙酰甲胆碱组5330例。将成年和儿童分别用倾向性匹配法按照氯醋甲胆碱∶乙酰甲胆碱为1∶2匹配,匹配后成人分别为2196例、4392例,儿童分别为365例、730例。比较匹配后2组的阳性率、气道高反应性分级、阳性后舒张用药及恢复时间,以及匹配前的不良反应等情况。结果:匹配后的氯醋甲胆碱组和乙酰甲胆碱组在成人的阳性率分别为25.77%(566/2196)、27.62%(1213/4391);儿童的阳性率分别为81.64%(298/365)、80.82%(590/730)。2组激发试剂间在成人及儿童的阳性率差异均无统计学意义(均P>0.05)。成人2组间的气道高反应性分级差异无统计学意义(P=0.341),儿童2组间的阳性后舒张用药及舒张后恢复时间差异均无统计学意义(均P>0.05)。匹配前氯醋甲胆碱组中有6例出现极轻、轻度不良反应;乙酰甲胆碱组中有57例极轻、轻度和1例中度不良反应。结论:与乙酰甲胆碱对比,临床诊断试剂氯醋甲胆碱BPT阳性率、激发后恢复时间没有明显差异,且安全性良好,可在临床推广应用。Objective To compare the differences in diagnostic efficacy and safety in bronchial provocation test(BPT)between traditional activator methacholine and methacholine chloride,the first methacholine activator approved by the Green Channel of the State Food and Drug Administration for priority marketing for bronchial provocation test(BPT).Methods In this single-centered cross-sectional study,the methacholine chloride BPT reports from September to November 2022 and the methacholine BPT reports from March 2017 to April 2022 were derived from the First Affiliated Hospital of Guangzhou Medical University.For adults(aged≥18 years old),2196 reports in methacholine chloride group and 23729 reports in methacholine group were enrolled in the analysis.For children(aged 4-17 years old),365 reports in the methacholine chloride group and 5330 reports in methacholine group were enrolled in the analysis.A 1∶2 Propensity Score Match analysis was performed for both adult and child patients.Consequently,2196 reports in methacholine chloride group and 4392 reports in methacholine group were enrolled in the analysis for adults,and 365 reports in the methacholine chloride group and 730 reports in methacholine group were enrolled in the analysis for children.The positive rate of BPT,airway hyperresponsiveness grades,diastolic drugs,and recovery time for positive patients and adverse reactions were compared between the methacholine group and methacholine chloride group.Results After matching,the positive rate of BPT in methacholine chloride group and methacholine group were 25.77%(566/2196)and 27.62%(1213/4391)respectively for adults,and 81.64%(298/365)and 80.82%(590/730)respectively for children.No significant difference was found in the positive rate of activator between the two groups in both adults and children(both P>0.05).No significant difference was found in airway hyperresponsiveness grades between the two groups in adults(P=0.341).No significant difference was observed in the diastolic drugs and recovery time for positive pa

关 键 词：哮喘 支气管激发试验 氯醋甲胆碱 乙酰甲胆碱 倾向性匹配 

分 类 号：R562.25[医药卫生—呼吸系统]