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目的探讨兰菌净疫苗对儿童呼吸道反复感染的预防效果。方法采用随机、双盲、对照的方法。收集深圳市上梅林社区6月龄～1 2周岁符合反复呼吸道感染诊断标准的儿童1 0 8例,随机分为疫苗组与对照组(每组54例),在双盲背景下给予兰菌净或安慰剂。随访观察1 2个月,滴服前后8周取空腹静脉血进行血常规、肾功能及血清IgA、T细胞亚群、免疫球蛋白测定。服疫苗前、后第1、2、3、6、9和1 2月留取唾液及血清进行sIgA测定。所有数据采用S P S S 20.0统计软件包进行统计学处理。结果与对照组相比,疫苗组患儿干预后呼吸道感染次数、发热天数、咳嗽天数和咽痛天数均显著减少,差异具有统计学意义(P<0.0 5或0.0 1)。干预第1、3、6个月后唾液sIgA与干预前比较均有显著升高,第6个月到达峰值,以后慢慢减少,到第1 2月时与干预前水平基本等同;干预3个月后血清IgA与干预前比较也有显著升高。与对照组比较也显示显著升高,对照组干预前后差异无统计学意义(P>0.0 5)。干预后,疫苗组CD 3、CD 4、IgG、IgA明显高于对照组(P<0.0 1)。结论兰菌净对儿童反复呼吸道感染的预防效果安全而明显,值得推广与应用。
Objective To investigate the preventive effect of lancaster net vaccine on recurrent respiratory infections in children. Methods A randomized, double-blind, controlled approach was used. A total of 108 children aged 6 months to 12 years who met the diagnostic criteria of recurrent respiratory tract infection were collected in Shangmeilin community of Shenzhen City and randomly divided into vaccine group and control group (54 cases in each group) Or placebo. All the patients were followed up for 12 months. Blood samples were collected for fasting, renal function, serum IgA, T lymphocyte subsets and immunoglobulin in 8 weeks before and 8 and 12 weeks after oral administration. Serum sIgA was measured by taking saliva and serum at the 1st, 2nd, 3rd, 6th, 9th and 12th months after taking the vaccine. All data were statistically processed using SPSS 20.0 statistical software package. Results Compared with the control group, the number of respiratory tract infections, days of fever, days of cough and days of sore throat in the vaccine group were significantly decreased after intervention (P <0.0 5 or 0.0 1). The salivary sIgA levels of saliva were significantly increased after the first, third and sixth months of intervention, reaching the peak at the 6th month and then decreasing gradually. The levels of sIgA in the 1st, Month after the serum IgA compared with the pre-intervention also significantly increased. Compared with the control group also showed a significant increase in the control group before and after intervention was no significant difference (P> 0.0 5). After intervention, the levels of CD 3, CD 4, IgG and IgA in the vaccine group were significantly higher than those in the control group (P <0.01). Conclusion Lan or net prevention of recurrent respiratory tract infections in children safe and obvious, it is worth promoting and application.