细菌溶解产物防治儿童反复呼吸道感染临床疗效评估

Efficacy of bacterial lysates in the adjuvant therapy for children with recurrent respiratory tract infections

目的评估口服细菌溶解产物防治小儿反复呼吸道感染的有效性和安全性。方法 2010年7月至2012年6月连续两年,采用前瞻、随机、单盲、安慰剂对照方法,将上海市静安区中心医院门诊80例反复呼吸道感染的患儿分别入选治疗组(40例)和对照组(40例),两组均给予常规抗感染及对症治疗,在此基础上,治疗组给予口服细菌溶解产物,对照组则给予口服安慰剂。观察两组患儿治疗前及治疗后第3、6、12个月末的临床疗效及不良事件发生情况,并检测相应窗口期唾液分泌型Ig A水平变化。结果观察期间治疗组呼吸道感染的症状有明显缓解或减轻、累计发病率呈下降、发热及抗生素使用的频率减少,未见明显不良反应。治疗组唾液分泌型Ig A较对照组有显著升高,治疗后第3个月末水平最高,停药后则有所降低,但仍高于基础水平。结论细菌溶解产物可以提高唾液分泌型Ig A的水平,可能因此增强机体免疫能力,并有效地防治小儿反复呼吸道感染。

ObjectiveTo evaluate Efficacy and safety of bacterial lysates in adjuvant therapy of children with recurrentrespiratory tract infections.MethodsA total of 80 children with recurrent respiratory tract infections were randomly dividedinto treatment group（n=40）with bacterial lysates（Broncho-Vaxom,BV）and control group（n=40）with bifico（placeto）.The clinical efficacy was observed and secretory immunoglobuli A（sIgA）in the saliva samples was detected at the indicatedtime point after treatment of 0,3,6 and 12 months.ResultsThey were more efficient to alleviate the clinical symptom andreduce the incidence of infection in treatment group than those in control group. The level of s Ig A was obviously increasedin the saliva samples of treatment group at the 3-month time point,and kept higher level than that from the saliva samplesof control group.ConclusionBacterial lysates can be an effective adjuvant therapy for Children with recurrent respiratorytract infections by increasing the level of sIgA,promoting the immunity,and reducing respiratory tract symptom.