摘要
目的 观察孟鲁司特钠咀嚼片联合布地奈德混悬液治疗急性期支气管哮喘患儿的临床疗效及安全性。方法 将急性期支气管哮喘患儿随机分为对照组和试验组。2组患儿均给予常规对症处理。在此基础上,对照组给予吸入用布地奈德混悬液0.5 mg,bid,雾化吸入;试验组在对照组治疗的基础上,给予孟鲁司特钠咀嚼片5 mg,qd,睡前口服。2组患儿均治疗10 d。比较2组患儿的临床疗效、肺通气功能、血嗜酸性粒细胞直接计数(EOS),以及药物不良反应的发生情况。结果 试验组和对照组分别入组50和53例,试验过程中共脱落9例,最终试验组和对照组各纳入47例进行统计分析。治疗后,试验组和对照组的总有效率分别为93.62%(44例/47例)和76.60%(36例/47例),差异有统计学意义(P<0.05)。治疗后,试验组和对照组的1秒率分别为(79.52±7.11)%和(69.26±6.62)%,最大呼气中段流量分别为(229.56±15.27)和(219.45±25.14)L·min^(-1),EOS分别为(0.07±0.01)×10^(9)和(0.12±0.02)×10^(9)·L^(-1),差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应有皮疹、皮肤潮红和声音嘶哑,对照组发生的药物不良反应有皮疹、恶心和声音嘶哑。试验组和对照组的总药物不良反应发生率分别为8.51%和10.64%,差异无统计学意义(P>0.05)。结论 孟鲁司特钠咀嚼片联合布地奈德混悬液治疗急性期支气管哮喘患儿的临床疗效显著,其能有效地改善患儿的肺通气功能,且不增加药物不良反应的发生率。
Objective To observe the clinical efficacy and safety of montelukast sodium chewable tablets combined with budesonide suspension in the treatment of children with acute asthma. Methods A total of 103 children with acute asthma were randomly divided into control group(n=50 cases)and treatment group(n=53 cases). The 2 groups were given conventional symptomatic treatment. The control group was given budesonide suspension for inhalation 0.5 mg, bid, atomized inhalation;on the basis of the control group, the treatment group was given montelukast sodium chewable tablets 5 mg, qd, orally before sleep. Two groups of children were both treated for 10 d. The clinical efficacy, pulmonary ventilation function indexes, eosinophil direct count(EOS), and adverse drug reactions were compared between 2 groups.Results There were 50 patients in the treatment group and 53 cases in the control group. There were 9 cases ofshedding during the trial. Finally, 47 cases in each group were included in the treatment group and control group forstatistical analysis. The total effective rates of treatment and control groups after treatment were 93. 62%(44 cases/47cases) and 76. 60%(36 cases/47 cases) with significant difference(P< 0. 05). After treatment, the 1 second rates oftreatment and control groups were(79. 52 ± 7. 11)% and(69. 26 ± 6. 62)%, maximum mid-expiratory flow were(229. 56 ± 15. 27) and(219. 45 ± 25. 14) L·min^(-1), EOS were(0. 07 ± 0. 01) × 10^(9)and(0. 12 ± 0. 02) × 10^(9)·L^(-1), the differences were statistically significant(allP< 0. 05). The adverse drug reactions of treatment group wereskin rash, skin flushing and hoarseness, while those in the control group mainly included skin rash, nausea andhoarseness. The total incidences of adverse drug reactions in the treatment and control groups were 8. 51% and10. 64% without significant difference(P> 0. 05).Conclusion Montelukast sodium chewable tablets combined withbudesonide suspension have a definitive clinical efficacy in the treatment of children with acute asthma, which canimprove the pulmonary ventilation function, without increasing the incidence of adverse drug reactions.
作者
范新凤
李艳玲
孙晓宝
薛明
FAN Xin-feng;LI Yan-ling;SUN Xiao-bao;XUE Ming(Department of Pediatrics,Huainan First People’s Hospital,Huainan 232007,Anhui Province,China)
出处
《中国临床药理学杂志》
CAS
CSCD
北大核心
2023年第3期320-323,共4页
The Chinese Journal of Clinical Pharmacology
