细菌溶解产物预防支气管哮喘儿童并发呼吸道感染的临床疗效观察

Therapeutic efficacy of bacterial lysates prevents in children with asthma complicated with respiratory tract infection

目的观察细菌溶解产物对于支气管哮喘儿童并发急性呼吸道感染的临床疗效和安全性。方法采用前瞻性研究,选取2016年1月至2018年12月上海交通大学医学院附属新华医院收治的120例支气管哮喘缓解期患儿,采用随机方法将患儿平均分为两组:对照组和治疗组,每组各60例。对照组患儿仅采用常规吸入性糖皮质激素治疗,治疗组患儿在常规吸入性糖皮质激素治疗的基础上,给予细菌溶解产物治疗(3.5 mg/d,每月10 d,连续3个月),连续随访1年,比较两组患儿治疗9个月、12个月时急性呼吸道感染发生次数、哮喘累计发作次数、喘息累计发作天数及鼻塞发作次数,记录两组患儿血液淋巴细胞亚群及用药后不良反应发生情况。结果治疗组患儿的急性呼吸道感染发生次数(2.89±1.07、4.30±1.06)低于对照组(3.50±1.282、5.00±1.262),差异具有统计学意义(P<0.01);治疗组患儿哮喘发作次数(0.36±0.65、0.44±0.71)低于对照组(0.68±1.12、1.00±1.62),差异具有统计学意义(P<0.01);治疗组鼻塞发作次数(0.36±0.65、0.45±0.78)低于对照组(0.36±0.65、0.76±0.98),差异具有统计学意义(P<0.01)。治疗组患儿3个月随访患儿血清CD3^+%、CD4^+%、CD4^+/CD8^+水平高于对照组CD3^+%、CD4^+%、CD4^+/CD8^+,差异具有统计学意义(P<0.01),但两组患儿的CD8^+%水平比较,差异无统计学意义(P>0.05)。细菌溶解产物治疗期间共报道5例不良事件,均轻微短暂,未导致受试药品停用。结论应用细菌溶解产物可以预防支气管哮喘儿童并发呼吸道感染,可显著减少患儿呼吸道感染发生次数、喘息发作次数、鼻塞发作次数和喘息累计发作天数,增强细胞免疫机能,且安全性较高。

Objective To observe the clinical efficacy and safety of bacteria lysate for bronchial asthma children complicated with acute respiratory tract infection.Methods 120 cases of children with asthma complicated with respiratory tract infection were prospectively selected from January 2016 to December 2018,Xinhua hospital affiliated to Shanghai Jiaotong University and were randomly divided into two groups,including control group and treatment group,60 cases in each group.Children in the control group were only given conventional inhaled glucocorticoid treatment,and treatment group were given bacteria lysate treatment(3.5 mg/d,taking 10 day each month,for three months)on the basis of routine inhaled glucocorticoid treatment.The incidence of acute respiratory infection,the cumulative number of asthma attacks,the cumulative number of wheezing attacks and the number of nasal congestion attacks were compared between the two groups of children at 9 and 12 months after treatment,and the occurrence of blood lymphocyte subgroups and adverse reactions after treatment were recorded.Results The number of acute respiratory infection(2.89±1.07,4.30±1.06)in treatment group was lower than the control group(3.50±1.282,5.00±1.262),with statistically significant difference(P<0.01).The asthma attack frequency(0.36±0.65,0.44±0.71)in treatment group was lower than that in the control group(0.68±1.12,1.00±1.62),with statistically significant difference(P<0.01).The attack frequency of nasal congestion(0.36±0.65,0.45±0.78)in treatment group was lower than that of the control group(0.36±0.65,0.76±0.98),with statistically significant difference(P<0.01).The blood lymphocyte subgroup and drug adverse reactions before and after the situation were recorded.After one year follow-up,serum levels of CD3^+%,CD4^+%,CD4^+/CD8^+levels in treatment group at 3 month were higher than those of the control group with statistically significant difference(P<0.01),but CD8^+level of two groups had no statistically significant difference(P>0.05).Conclusion Application of bacteria lysate can can prevent children with bronchial asthma from developing respiratory tract infection,significantly reduce the frequency of respiratory tract infection,the frequency of wheezing attack,the frequency of nasal obstruction attack and the cumulative number of days of wheezing attack in children,enhance the cellular immune function,and it is safe.