Deglurkar Revati, Mathew Joseph L, Singh Meenu
Department of Pediatrics, Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research, Chandigarh.
Department of Pediatrics, Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research, Chandigarh. Correspondence to: Prof Joseph L Mathew, Advanced Pediatrics Centre, Postgraduate Institute of Medical Education and Research, Chandigarh.
Indian Pediatr. 2022 Mar 15;59(3):201-205. Epub 2022 Jan 9.
To study whether addition of pidotimod to inhaled corticosteroid (ICS) therapy enhances control in children with persistent asthma, as compared to ICS therapy alone.
Triple-blinded, randomized controlled trial.
Allergy and Asthma Clinic, Department of Pediatrics, at a tertiary care hospital between May, 2018 and June, 2019.
79 children (5-12 years) with newly diagnosed persistent asthma as per Global Initiative for Asthma guidelines.
Children received 7 mL twice-a-day for 15 day, followed by 7 mL once-a-day for 45 days of either pidotimod (n=39) or placebo (n=40). In addition, both groups received inhaled budesonide via metered dose inhaler and spacer, throughout the study. Children were followed up every 4 weeks for a total of 12 weeks. At each follow-up visit, peak expiratory flow (PEF) and asthma symptom score and medicine adverse effects were recorded.
Change in PEF at 12 weeks compared to baseline. Secondary outcomes were PEF at each follow-up visit, asthma symptom score at each visit, change in asthma symptom score at 12 weeks, and adverse event profile.
The median (IQR) change in PEF (from baseline to 12 weeks) was 13.0% (0.8%, 28.3%) in pidotimod group (n=35) vs 17.7% (4.3%, 35.2%) in placebo group (n=35) (P=0.69). All the secondary outcomes were also comparable between the two groups. There were no significant adverse effects observed.
Addition of pidotimod for 8 weeks to standard ICS therapy did not enhance asthma control compared to placebo.
研究与单独使用吸入性糖皮质激素（ICS）治疗相比，在ICS治疗基础上加用匹多莫德是否能增强持续性哮喘儿童的病情控制。
三盲随机对照试验。
2018年5月至2019年6月期间，一家三级护理医院的儿科过敏与哮喘诊所。
79名年龄在5至12岁之间、根据全球哮喘防治创议指南新诊断为持续性哮喘的儿童。
儿童接受为期15天、每日两次、每次7毫升的治疗，之后45天每日一次、每次7毫升的匹多莫德（n = 39）或安慰剂（n = 40）治疗。此外，在整个研究过程中，两组均通过定量气雾剂和储物罐吸入布地奈德。儿童每4周随访一次，共随访12周。每次随访时，记录呼气峰值流速（PEF）、哮喘症状评分及药物不良反应。
与基线相比，12周时PEF的变化。次要观察指标为每次随访时的PEF、每次随访时的哮喘症状评分、12周时哮喘症状评分的变化以及不良事件情况。
匹多莫德组（n = 35）从基线到12周时PEF的中位数（IQR）变化为13.0%（0.8%，28.3%），安慰剂组（n = 35）为17.7%（4.3%，35.2%）（P = 0.69）。两组所有次要观察指标也具有可比性。未观察到明显不良反应。
与安慰剂相比，在标准ICS治疗基础上加用8周匹多莫德并未增强哮喘控制。
