Department of Respiratory, Anhui Provincial Children's Hospital, Hefei City, Anhui Province, China.
Department of Respiratory, Anhui Provincial Children's Hospital, Hefei City, Anhui Province, China;
Allergol Immunopathol (Madr). 2023 Jul 1;51(4):182-188. doi: 10.15586/aei.v51i4.926. eCollection 2023.
To evaluate the clinical efficacy and safety of combining omalizumab with budesonide formoterol to treat children with moderate and severe allergic asthma, and investigate the effect of this combination therapy on pulmonary and immune functions.
The data of 88 children with moderate and severe allergic asthma, who were admitted to our hospital between July 2021 and July 2022, were included in the study. The patients were randomly assigned either to control group (n = 44; received budesonide formoterol inhalation therapy) or experimental group (n = 44; received omalizumab subcutaneous injection + budesonide formoterol inhalation therapy) using computer-generated randomization. The clinical efficacy, asthma control (measured using childhood Asthma-Control Test [C-ACT] score), pulmonary function (forced expiratory volume in 1 s, forced vital capacity, and peak expiratory flow), immune function (cluster of differentiation 3 cells [CD3 cells], cluster of differentiation 4 cells [CD4 cells], immunoglobulin G, immunoglobulin A, and immunoglobulin E), and adverse reactions were observed and compared between both groups.
After treatment, the experimental group had improved levels of pulmonary function and immune function indexes, higher C-ACT scores, and a higher overall response rate than the control group (P < 0.05). In addition, the incidence of adverse reactions was not significantly different between both groups (P > 0.05).
The combination of omalizumab with budesonide formoterol for treating moderate and severe allergic asthma in children demonstrated promising clinical efficacy and improved their pulmonary and immune functions, leading to more rational asthma control. The combined regimen demonstrated satisfactory clinical safety and deserved clinical promotion.
评估奥马珠单抗联合布地奈德福莫特罗治疗中重度过敏性哮喘患儿的临床疗效和安全性，并探讨该联合疗法对肺功能和免疫功能的影响。
选取 2021 年 7 月至 2022 年 7 月我院收治的 88 例中重度过敏性哮喘患儿为研究对象，采用计算机随机分组法将其分为对照组（n=44，给予布地奈德福莫特罗吸入治疗）和实验组（n=44，给予奥马珠单抗皮下注射+布地奈德福莫特罗吸入治疗）。观察并比较两组患儿的临床疗效、哮喘控制情况（采用儿童哮喘控制测试评分[C-ACT]评估）、肺功能[第 1 秒用力呼气容积（FEV1）、用力肺活量（FVC）、呼气峰流速（PEF）]、免疫功能[CD3 细胞、CD4 细胞、免疫球蛋白 G（IgG）、免疫球蛋白 A（IgA）、免疫球蛋白 E（IgE）]和不良反应发生情况。
治疗后，实验组患儿的肺功能和免疫功能指标改善水平、C-ACT 评分均高于对照组，总有效率高于对照组（P<0.05）。两组患儿不良反应发生率比较，差异无统计学意义（P>0.05）。
奥马珠单抗联合布地奈德福莫特罗治疗儿童中重度过敏性哮喘的临床疗效确切，可改善患儿的肺功能和免疫功能，有助于更合理地控制哮喘，且联合方案具有较好的临床安全性，值得临床推广。
