Longo F, Lepore L, Agosti E, Panizon F
Istituto per l'Infanzia "Burlo Garofolo" - Trieste, Italia.
Pediatr Med Chir. 1988 Nov-Dec;10(6):603-7.
Numerous trials of prophylaxis of recurrent respiratory infections in children have been performed, even though the only controlled trials providing incontrovertible results were the ones carried out with levamisole and thymostimulin through intramuscular administration. We have experimented a calf-thymic extract administered by oral route (thymomodulin). During the summer we enrolled 40 children aged between 3.5, and 9 years who had suffered from RRI during the previous winter. The patients were randomly divided in two groups and respectively treated with thymomodulin or with placebo; 21 children were given the thymic extract and 19 the placebo. The trial was carried out according to a double-blind schedule for a period of four months, from the beginning of October '84. At the end of the trial we assessed the catharral bouts observed during the research period by the family doctors and the parents evaluation on the clinical state. The difference between the two groups is statistically highly significant both with reference to the reduction of the total number of catharral bouts and to the general clinical state according to the parents opinion. The research clearly demonstrates the protective effect of the thymomodulin, probably due to the "restorative" effect on some immunological functions, temporarily compromised during the infection bouts.
尽管唯一能提供确凿结果的对照试验是通过肌肉注射左旋咪唑和胸腺刺激素进行的,但针对儿童复发性呼吸道感染的预防已开展了大量试验。我们对口服的小牛胸腺提取物(胸腺调节素)进行了试验。在夏季,我们招募了40名年龄在3.5至9岁之间、上一个冬季曾患复发性呼吸道感染的儿童。将这些患者随机分为两组,分别用胸腺调节素或安慰剂进行治疗;21名儿童给予胸腺提取物,19名给予安慰剂。该试验从1984年10月初开始,按照双盲方案进行了四个月。试验结束时,我们评估了家庭医生在研究期间观察到的卡他性发作次数以及家长对临床状况的评价。根据家长的意见,两组在卡他性发作总数的减少以及总体临床状况方面的差异在统计学上具有高度显著性。该研究清楚地证明了胸腺调节素的保护作用,这可能归因于其对某些免疫功能的“恢复”作用,这些免疫功能在感染发作期间暂时受损。