Abstract:

Objective　To investigate the clinical efficacy and safety of inhaled compound ipratropium bromide combined with Lycium Barbarum L. granules in treating pediatric cough-variant asthma (CVA). Methods　This study was a randomized controlled trial. A total of 106 children with CVA admitted to Sun Simiao Hospital, Beijing University of Chinese Medicine from January 2022 to December 2023 were enrolled and were divided into two groups using the random number table method. In group B, 27 boys and 26 girls, aged (9.64±2.89) years, with a duration of disease of (3.72±1.03) months, were given inhaled compound ipratropium bromide at 0.5 mg/time, 15 min/time, twice a day, on the basis of conventional treatment. In group A, 28 boys and 25 girls, aged (9.37±2.93) years, with a duration of disease of (3.84±1.12) months, were in combination with Lycium Barbarum L. granules taken orally on the basis of group B, 10 g/time, twice a day. Both groups were treated for 2 weeks. The efficacy and the changes of Cough Evaluation Test (CET) score, Leicester Cough Questionnaire (LCQ) score, indicators of immune function [CD3⁺, CD4⁺, CD8⁺, immunoglobulin A (IgA), ad IgM], and pulmonary function test results [forced expiratory volume in 1 second (FEV₁), forced vital capacity (FVC), and FEV₁/FVC], and inflammatory factors [interleukin-6 (IL-6), IL-8, and substance P (SP)] before and after treatment were compared between the two groups, and the adverse reactions were recorded. Statistical analysis was performed using t test and χ² test. Results　After 2 weeks of treatment, the total effective rate of group A was 96.23% (51/53), which was higher than that of group B [77.36% (41/53)], with a statistically significant difference (χ²=8.230, P=0.004); the CET scores in both groups were decreased, and that in group A was lower than that in group B [(2.97±0.47) points vs. (4.62±0.91) points] (t=11.728, P<0.001); the LCQ scores in both groups were improved, and that in group A was higher than that in group B [(18.00±1.60) points vs. (16.35±2.80) points] (t=3.725, P<0.001); the levels of CD8⁺ were decreased in both groups, and that in group A was lower than that in group B (all P<0.05); the levels of CD3⁺, CD4⁺, IgA, and IgM were increased in both groups, and those in group A were higher than those in group B (all P<0.05); the FEV₁, FVC, and FEV₁/FVC in both groups were increased, and those in group A were higher than those in group B [(1.70±0.22) L vs. (1.45±0.19) L, (2.53±0.37) L vs. (2.26±0.68) L, (67.19±6.23)% vs. (64.16±5.44)%] (all P<0.05); serum levels of IL-6, IL-8, and SP were decreased in both groups, and those in group A were lower than those in group B [(0.72±0.43) µg/L vs. (1.50±1.08) µg/L, (1.89±0.21) ng/L vs. (3.74±0.48) ng/L, (2.15±1.65) nmol/L vs. (3.70±2.35) nmol/L] (all P<0.05). There was no statistically significant difference in the incidence of mild adverse reactions between the two groups [5.66% (3/53) vs. 7.55% (4/53)] (χ²=0.153, P=0.696), and no serious adverse reactions were reported. Conclusion　In the treatment of pediatric CVA, inhaled compound ipratropium bromide combined with Lycium Barbarum L. granules can significantly improve the cough symptoms, quality of life, immune function, and lung function, reduce the inflammation level, and has good safety.

Key words:

Cough variant asthma, Ipratropium bromide, Lycium Barbarum L. granules, Immune function, Lung function, Children

摘要：

目的　探讨吸入用异丙托溴铵联合槐杞黄颗粒治疗小儿咳嗽变异性哮喘（CVA）的临床疗效及安全性。方法　本研究为随机对照试验。纳入北京中医药大学孙思邈医院2022年1月至2023年12月期间收治的106例CVA患儿，使用随机数字表法分为两组。B组53例中男27例、女26例，年龄（9.64±2.89）岁，病程（3.72±1.03）个月，在常规治疗基础上给予吸入用异丙托溴铵溶液雾化吸入，0.5 mg/次，15 min/次，2次/d。A组53例中男28例、女25例，年龄（9.37±2.93）岁，病程（3.84±1.12）个月，在B组基础上联合槐杞黄颗粒口服，10 g/次，每天2次。两组均持续用药2周。比较两组临床疗效，治疗前后的简易咳嗽程度评分表（CET）、莱塞斯特咳嗽生命质量问卷（LCQ）、免疫功能指标［CD3⁺、CD4⁺、CD8⁺、免疫球蛋白A（IgA）、IgM］、肺功能测试结果［第１秒用力呼气容积（FEV₁）、用力肺活量（FVC）、FEV₁/FVC］及炎症因子［白介素-6（IL-6）、IL-8、P物质（SP）］的变化，并记录不良反应。采用χ²检验、t检验进行统计分析。结果　治疗2周后，A组总有效率为96.23%（51/53），高于B组的77.36%（41/53），差异有统计学意义（χ²=8.230，P=0.004）；两组CET评分均较治疗前降低、LCQ评分均较治疗前提高，A组CET评分、LCQ评分分别为（2.97±0.47）分、（18.00±1.60）分，B组分别为（4.62±0.91）分、（16.35±2.80）分，差异均有统计学意义（t=11.728、3.725，均P<0.001）；两组CD8⁺均较治疗前降低，CD3⁺、CD4⁺、IgA、IgM均较治疗前提高，A组CD8⁺低于B组和CD3⁺、CD4⁺、IgA、IgM均高于B组（均P<0.05）；两组FEV₁、FVC、FEV₁/FVC均较治疗前提高，A组均高于B组［（1.70±0.22）L比（1.45±0.19）L、（2.53±0.37）L比（2.26±0.68）L、（67.19±6.23）%比（64.16±5.44）%］（均P<0.05）；两组血清IL-6、IL-8、SP均较治疗前降低，且A组均低于B组［（0.72±0.43）µg/L比（1.50±1.08）µg/L、（1.89±0.21）ng/L比（3.74±0.48）ng/L、（2.15±1.65）nmol/L比（3.70±2.35）nmol/L］（均P<0.05）。A、B组患儿不良反应比较［5.66%（3/53）比7.55%（4/53）］，差异无统计学意义（χ²=0.153，P=0.696），均未发现严重不良反应。结论　吸入用异丙托溴铵联合槐杞黄颗粒治疗小儿CVA，能显著改善患儿的咳嗽症状和生活质量，提高免疫功能，改善肺功能，减轻炎症水平，且安全性好。

关键词:

咳嗽变异性哮喘, 异丙托溴铵, 槐杞黄颗粒, 免疫功能, 肺功能, 儿童