凝结芽孢杆菌活菌片预防小儿反复呼吸道感染前瞻性研究

Prospective Study on the Effect of Live Bacillus Coagulans Tablets on the Prevention of Recurrent Respiratory Tract Infections in Infant

目的评价凝结芽孢杆菌活菌片对3岁以下婴幼儿反复呼吸道感染的预防效果.方法采用前瞻性随机对照临床试验方法,选取213例6个月~3岁的反复呼吸道感染患儿,随机分为观察组、对照组、空白组,每组各71例,观察组和对照组研究期间各失访2例.观察组患儿口服凝结芽孢杆菌活菌片2个月,对照组患儿口服匹多莫德2个月,空白组患儿不给予任何干预,停药后随访观察4个月,记录每个月3组患儿呼吸道感染次数、发热、咳嗽、喘息时间、抗生素使用时间、不良反应.结果第4个月起,观察组患儿发热、咳嗽、喘息的发生率明显低于空白组;第5个月起,对照组患儿发热、咳嗽、喘息的发生率明显低于空白组;研究期间观察组患儿累计呼吸道感染、发热、咳嗽、喘息的发生率明显低于对照组和空白组,差异具有统计学意义（P〈0.05）.观察组患儿发热、咳嗽持续时间从第3个月起明显短于空白组,差异具有统计学意义（P〈0.05）;对照组患儿从第5个月起发热、咳嗽、喘息持续时间明显短于空白组,差异具有统计学意义（P〈0.05）.观察组累计抗生素使用率明显低于空白组累计使用率,差异具有统计学意义（P〈0.05）;观察组与对照组累计抗生素使用率之间差异无统计学意义（P〉0.05）.研究及观察期间均未发生药物相关不良反应.结论凝结芽孢杆菌活菌片可有效降低婴幼儿反复呼吸道感染的次数,缩短发热、咳嗽、喘息时间,抗生素的使用量减少.

Objective To evaluate the preventive effect of live bacillus tablets on recurrent respiratory tract infection in infants under 3 years old.M ethod P rospective randomized controlled clinical trial method was used in this study.A total of 2 1 3 cases from 6 months to 3 years old with recurrent respiratory infection were randomly divided into observation group,control group and blank control group with 7 1cases in each group.Both the observation group and the control study group lost 2 cases during the followup.The observation group was administrated live bacillus coagulans orally for 2 months,the control group was treated with pidotimod for 2 months,and the blank group did not accepted any intervention.The follow-up lasted for 4 months after drug withdrawal.The respiratory infection times,fever,cough,wheezing,use of antibiotics and adverse reactions of the children in 3 groups were recorded every month.Results The incidences of fever,cough and wheezing in the observation group were significantly lower than those in the blank control group at the 4th month.The incidences of fever,cough and wheezing in the control group were significantly lower than those in theblank control group at the fifth month.The incidences of respiratory tract infection,fever,cough and wheezing in the observation group were significantly lower than those in the control group and the blank group,during the period of study（P〈0.0 5）.The durations of fever,coughing and wheezing of the control group were obviously shorter than those of the blank group from the 5th month（P〈0.05）.The usage of total antibiotic in the observation group was remarkably lower than that in the blank group（P〈0.05）,and no significant difference was found between the observation group and the control group（P〈0.05）.During the study period,no drug related adverse reaction was observed.Conclusion The live bacillus coagulans tablets can effectively reduce the times of recurrent respiratory tract infections in infants,shorten the durations of fever,cough and wheezing,and reduce the usage of antibiotics.