匹多莫德联合吸入用布地奈德混悬液治疗反复性呼吸道感染患儿的临床研究

Clinical trial of pidotimod combined with budesonide suspension for inhalation in the treatment of recurrent respiratory tract infections in children

目的 观察匹多莫德口服溶液联合吸入用布地奈德混悬液治疗反复性呼吸道感染(RRTIs)患儿的临床疗效及安全性。方法 将RRTIs患儿按队列法分为对照组和试验组。对照组给予匹多莫德口服溶液初始剂量400 mg,bid,连续治疗10 d后调整为每次400 mg,qd;试验组在对照组治疗的基础上,给予吸入用布地奈德混悬液0.5 mg,雾化吸入治疗,bid。2组患儿均连续治疗8周。比较2组患儿的临床症状消失时间、体液免疫[免疫球蛋白G(IgG)、IgM、IgA]、细胞因子[人胰岛素样生长因子-1(IGF-1)、单核细胞趋化蛋白-1(MCP-1)、环氧化酶-2(COX-2)]水平变化,评估2组患儿的临床疗效,统计药物不良反应发生情况。结果 对照组入组47例、试验组入组53例。治疗后,试验组和对照组的总有效率分别为92.45%和76.60%,在统计学上差异有统计学意义(P<0.05)。治疗后,试验组和对照组的临床症状消失时间比较,在统计学上差异均有统计学意义(均P<0.05)。治疗后,试验组和对照组的IgG水平分别为(11.26±0.85)和(10.92±0.69)g·L^(-1),IgM水平分别为(1.58±0.35)和(1.23±0.32)g·L^(-1),IgA水平分别为(1.57±0.24)和(1.36±0.30)g·L^(-1),IGF-1水平分别为(149.67±25.81)和(130.24±24.73)μg·mL^(-1),MCP-1水平分别为(71.35±11.89)和(99.36±12.27)pg·mL^(-1),COX-2水平分别为(16.87±4.59)和(20.53±4.83)U·L^(-1),在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组的总药物不良反应发生率分别为11.32%和6.38%,在统计学上差异无统计学意义(P>0.05)。结论 匹多莫德口服溶液联合吸入用布地奈德混悬液治疗可明显缓解RRTIs患儿的临床症状,改善体液免疫,提高临床疗效,安全性较高。

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·m L^(-1);MCP-1 levels were (71.35±11.89) and (99.36±12.27) pg·m L^(-1);COX-2levels 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.