中国临床药理学杂志2025，Vol.41Issue(13)：1811-1815,5.DOI:10.13699/j.cnki.1001-6821.2025.13.003
美泊利单抗治疗严重哮喘患者的临床研究
Clinical trial of mepolizumab in the treatment of patients with severe asthma
摘要
Abstract
Objective To observe the clinical efficacy and safety of mepolizumab injection in the treatment of patients with severe asthma.Methods Patients with severe asthma were divided into control group and treatment group by randon number table method.The control group received routine treatment.The treatment group was given mepolizumab 100 mg per time,once every 4 weeks and injected subcutaneously on the basis of the control group.Patients in both groups were treated for 24 weeks.The clinical efficacy,inflammatory markers,airway remodeling parameters,lung function indexes and safety were compared between the two groups.Results A total of 42 patients were enrolled in the treatment group and 43 patients in the control group.No patients dropped out in both groups.After treatment,the total effective rates of the treatment group and the control group were 92.86％(39 cases/42 cases)and 74.42％(32 cases/43 cases),respectively,and the difference was statistically significant(P＜0.05).After treatment,the eosinophil counts in treatment group and control group were(0.54±0.11)and(0.62±0.15)× 109·L-1,the interleukin-5 levels were(90.38±10.46)and(109.57±12.02)ng·L-1,the C-reactive protein levels were(3.05±0.73)and(4.60±0.92)mg·L-1,the tumor necrosis factor-α levels were(61.14±6.05)and(70.28±6.93)pg·mL-1,the lumen area parameters were(16.83±3.14)and(14.96±2.87)mm2,the wall area parameters were(56.33±6.02)％and(59.18±6.45)％,the forced expiratory volume in the first second were(3.10±0.76)and(2.28±0.64)L,forced vital capacities were(3.62±0.87)and(2.80±0.66)L,respectively;the above indexes in treatment group and control group were statistically different(all P＜0.05).The adverse drug reactions in the treatment group were headache,fatigue and asthma aggravation,while those in the control group were headache,respiratory infection and asthma aggravation.The total incidences of adverse drug reactions in treatment and control groups were 28.57％and 39.53％,and there was no statistical difference(P＞0.05).Conclusion Mabinotuzumab injection has a definitive clinical efficacy in the treatment of patients with severe asthma,which can reduce the inflammatory reaction and inhibit airway remodeling,improve their lung function and asthma control,and has high safety.关键词
美泊利单抗注射液/哮喘/炎性标志物/气道重塑/安全性评价Key words
mepolizumab injection/asthma/inflammatory marker/airway remodeling/safety evaluation分类
医药卫生引用本文复制引用
徐震,张海生,赵杰,许鑫铭..美泊利单抗治疗严重哮喘患者的临床研究[J].中国临床药理学杂志,2025,41(13):1811-1815,5.基金项目
河南省医学科技攻关计划基金资助项目(LHGJ20210898) （LHGJ20210898）
