三伏贴防治小儿反复呼吸道感染的随机对照研究

Randomized Controlled Study on Mid-summer Patches Preventing Repetitive Respiratory Infection in Children

目的观察基于冬病夏治理论的三伏贴对小儿反复呼吸道感染的干预作用。方法在对北京市东城区、朝阳区44所幼儿园的8201名3~6岁儿童进行流行病学调查的基础上,筛查出反复呼吸道感染患儿885例为研究对象,随机分为干预组427例,对照组428例,干预组给予温肺化痰穴位贴敷,对照组给予穴位贴敷模拟贴,两组均贴敷大椎、膻中、肺俞（双侧）、膏肓（双侧）。从每伏第1日起,隔2日贴敷1次,每次4 h,每伏贴3次,共贴三伏。连续3年观察三伏贴对小儿反复呼吸道感染的干预作用,并随访3年。每年贴敷后分别于6月及12月各进行1次随访,观察三伏贴预防小儿反复呼吸道感染的有效率及患儿呼吸道感染的发病次数、发病天数。结果按意向性治疗和符合方案集分析,贴敷第2年干预组总有效率分别为52.0%、50.5%,对照组为44.9%、49.3%,两组总有效率比较差异无统计学意义（P〉0.05）,而贴敷第3年干预组总有效率为70.3%、78.1%,对照组为61.4%、68.0%,干预组明显高于对照组（P〈0.05）。三伏贴对减少反复呼吸道感染小儿发病次数方面具有明显作用（P〈0.05）。结论基于冬病夏治理论的三伏贴对防治小儿反复呼吸道感染疗效确切,干预疗程以3年为宜。

Objective To observe the intervention effect of mid-summer patches on child repetitive respiratory infection based on the theory of treating winter disease in summer. Methods On the basis of epidemiological investigation of 8201 3-6 years old children from 44 kindergartens in Dongcheng District and Chaoyang District in Beijing,855 children with repetitive respiratory infection were selected to be study subjects. Enrolled children were randomly divided into intervention group（ n = 427） and control group（ n = 428）. Application with warming lung and reducing phlegm herbal medicine patches at Points Da Zhui（ DU14）,Danzhong（ RN17）,Feishu（ BL13）（ bilateral） and Gaohuang（ BL43）（ bilateral） was given to the intervention group,and application with placebo patches at the same acupoints was given to control group. Treatment course was from the first day of each dog-day,one application was given for 4 hours every three days,3 times each dog-day,for 3 dog-days in total. One treatment course was given each year for three consecutive years,and the intervention effect of mid-summer patches on child repetitive respiratory infection was observed and followed up for 3 years. Patients were followed up in every June and December for three years to observe the effective rate,onset frequency,and days of repetitive respiratory infection after point application treatment.Results According to intention to treat and per-protocol population set analysis,up to the second year of application,total effective rate was 52. 0% and 50. 5% respectively,in intervention group,and 44. 9% and 49. 3% respectively,in control group,with no significant difference between the two groups（P 0. 05）. But in the third year,total effective rate was 70. 3% and 78. 1% respectively,in intervention group,and 61. 4% and 68. 0% respectively,in control group.The intervention group was obviously superior to the control group（ P 0. 05）. Mid-summer patches had remarkable effects on decreasing onset frequency（ P 0. 05）. Conclusion Mid-summer patches had definite therapeutic effect on preventing child repetitive respiratory infection. The suitable appropriate intervention course was 3 years.