Clinical trial of pidotimod combined with budesonide suspension for inhalation in the treatment of recurrent respiratory tract infections in children
Objective To observe the clinical efficacy and safety of pidomoide oral solution combined with budesonide suspension for inhalation in the treatment of recurrent respiratory tract infections(RRTIs)in children.Methods Children with recurrent respiratory tract infection were divided into control and treatment groups according to cohort methods.Control group was given the initial dose of pidotimod oral solution 400 mg bid,adjusted to 400 mg each time after 10 days of continuous treatment,qd;treatment group was given budesonide suspension for inhalation 0.5 mg atomized inhalation therapy on the basis of control group,bid;both groups were treated for 8 weeks.The disappearance time of clinical symptoms,humoral immunity[immunoglobulin G(IgG),immunoglobulin M(IgM),immunoglobulin A(IgA)],cytokine[human insulin-like growth factor-1(IGF-1),monocyte chemotactic protein-1(MCP-1),and cyclooxygenase-2(COX-2)]levels in the 2 groups were compared.The clinical efficacy of the children was evaluated and the incidence of adverse drug reactions was counted.Results A total of 47 cases were enrolled in the control group and 53 cases in the treatment group.The total clinical effective rate of treatment group and control group was 92.45％and 76.60％,respectively,and the difference was statistically significant(P＜0.05).After treatment,the difference of clinical symptom disappearance time between treatment group and control group was statistically significant(P＜0.05).After treatment,IgG levels in treatment group and control group were(11.26±0.85)and(10.92±0.69)g·L-1;IgM levels were(1.58±0.35)and(1.23±0.32)g·L-1;IgA levels were(1.57±0.24)and(1.36±0.30)g.L-1;IGF-1 levels were(149.67±25.81)and(130.24±24.73)μg·mL-1;MCP-1 levels were(71.35±11.89)and(99.36±12.27)pg·mL-1;COX-2 levels were(16.87±4.59)and(20.53±4.83)U·L-1.Compared with the control group,the above indexes in treatment group were statistically significant(all P＜0.05).There was no significant difference in the incidence of adverse drug reactions between treatment group and control group(11.32％vs 6.38％,P＞0.05).Conclusion Pidotimod oral solution combined with budesonide suspension for inhalation can significantly relieve the clinical symptoms of children with RRTIs,improve humoral immunity,improve clinical efficacy,and have high safety.
pidotimod oral solutionbudesonide suspension for inhalationchildren with recurrent respiratory tract infectionstherapeutic effectsafety
国家科技期刊平台
NSTL
万方数据
维普
