益气解毒复方联合免疫治疗对初发型重症肌无力患者的治疗效果及机制  

Therapeutic effect of Yiqi Jiedu formula combined with immunotherapy on patients with newly diagnosed myasthenia gravis and its mechanism

作　　者：于明杰 李艳 刘霞 赵芝兰 刘思思 赵琼 况时祥 YU Mingjie;LI Yan;LIU Xia;ZHAO Zhilan;LIU Sisi;ZHAO Qiong;KUANG Shixiang(Faculty of Postgraduate Studies,Guizhou University of Traditional Chinese Medicine,Guiyang 550002,Guizhou,China;Department of Neurology,the Second Affiliated Hospital of Guizhou University of Traditional Chinese Medicine,Guiyang 550002,Guizhou,China)

机构地区：[1]贵州中医药大学研究生院,贵州贵阳550002 [2]贵州中医药大学第二附属医院神经内科,贵州贵阳550002

出　　处：《贵州医科大学学报》2025年第3期425-433,共9页Journal of Guizhou Medical University

基　　金：国家自然科学基金(82260884,81760815);贵州省中医药管理局课题(QZYY-2019-028)。

摘　　要：目的探讨益气解毒复方联合免疫治疗对初发型重症肌无力(myasthenia gravis,MG)患者治疗效果及可能机制。方法选取2020年9月—2023年2月在贵州中医药大学第二附属医院神经内科就诊的100例初发型MG患者,按照随机原则将患者分为对照组(n=30)和益气解毒复方联合治疗组(n=70);对照组给予免疫治疗(溴吡斯的明片联合糖皮质激素),益气解毒复方联合治疗组在免疫治疗基础上同时给予益气解毒复方,治疗周期为12个月;采用电子数据捕获系统记录患者的人口统计学资料、临床特征及中医证型;通过Kaplan-Meier法比较两组12个月随访期内达到最轻微临床(minimal manifestation status,MMS)或更好状态的达标率及首次达到时间;使用单因素和多因素Cox回归分析MMS或更好状态的影响因素,并于治疗12个月后结合定量MG(quantitative MG,QMG)评分评估益气解毒复方联合免疫治疗对初发型MG患者治疗效果;观察两组治疗前后CD3^(+)CD4^(+)T细胞、CD3^(+)CD8^(+)T细胞百分比及绝对计数的变化。结果与对照组比较,益气解毒复方联合治疗组达到MMS或更好状态的中位随访时间更早、且达标率更高(P<0.05);Cox回归分析显示,比较对照组,益气解毒复方联合治疗组达到MMS或更好状态的概率更高(HR=2.29,95%CI为1.11~4.74;P<0.05);两组治疗后QMG评分均较治疗前显著下降,且益气解毒复方联合治疗组较对照组评分下降更为显著(P<0.05);对照组及益气解毒复方联合治疗组治疗前后CD3^(+)CD4^(+)T细胞百分比及绝对计数变化差异无统计学意义(P>0.05),但与治疗前比较,益气解毒复方联合治疗组CD3^(+)CD8^(+)T细胞百分比及绝对计数显著下降(P<0.05)。结论益气解毒复方联合免疫治疗可改善初发型MG患者的临床疗效,有利于其更早达到MMS或更好治疗状态,其机制可能与降低CD3^(+)CD8^(+)T细胞有关。Objective To investigate the therapeutic effect of Yiqi Jiedu formula combined with immunotherapy on patients with newly diagnosed myasthenia gravis(MG)and potential mechanisms.Methods A total of 100 patients with newly diagnosed MG were enrolled at the department of Neurology at the Second Affiliated Hospital of Guiyang University of Traditional Chinese Medicine from September 2020 to February 2023.The patients were randomly assigned to control group(n=30)and Yiqi Jiedu formula combined treatment group(n=70).Control group received immunotherapy(pyridostigmine bromide combined with corticosteroids),while Yiqi Jiedu formula combined treatment group received both immunotherapy and Yiqi Jiedu compound.The treatment lasted for 12 months.An electronic data capture system was used to collect demographic data,clinical characteristics and syndrome types of traditional Chinese medicine(TCM).Kaplan Meier method was used to compare the achievement rate and the first arrival time of minimal manifestation status(MMS)or good status between two groups during 12-month follow-up period.Univariate and multivariate Cox regression analyses were used to analyze the influencing factors of MMS or good status.After 12 months of treatment,quantitative myasthenia gravis(QMG)score was used to evaluate therapeutic effect of Yiqi Jiedu formula combined with immunotherapy on the patients with initial onset of MG.The changes in the percentages and absolute counts of CD3^(+)CD4^(+)T cells and CD3^(+)CD8^(+)T cells were observed before and after treatment in two groups.Results The median follow-up time and achievement rate of MMS or good status were earlier and higher in Yiqi Jiedu formula combined treatment group than those in control group(P<0.05).Cox regression analysis showed that Yiqi Jiedu formula combined treatment group had a higher probability of achieving MMS or good status than those in control group(HR=2.29,95%CI was from 1.11 to 4.74;P<0.05).After treatment,both groups showed a significant reduction in QMG scores when compared to be

关 键 词：重症肌无力 益气解毒复方 免疫治疗 治疗达标 最轻微临床状态 

分 类 号：R285.6[医药卫生—中药学]