Kocoshis S, Gryboski J D
JAMA. 1979 Sep 14;242(11):1169-73.
A double-blind clinical trial was undertaken to evaluate the efficacy of orally given cromolyn sodium vs that of pacebo in the management of food allergy. Fourteen children, aged 2 to 15 years, with milk allergy and concomitant allergies to one or more foods were given cromolyn or placebo. Eleven had positive intradermal skin reactions or coproantibodies to offending antigens. Treatment was begun while the children were receiving elimination diets; they were challenged with specific antigen only after 48 hours of drug administration. Crossover took place if the initial agent was ineffective. Cromolyn afforded protection in 11 of 13 trials, whereas placebo was effective in only three of nine trials. By chi 2 analysis, the drug's effect was statistically significant.
进行了一项双盲临床试验,以评估口服色甘酸钠与安慰剂在治疗食物过敏方面的疗效。14名年龄在2至15岁之间、对牛奶过敏且对一种或多种食物伴有过敏反应的儿童,被给予色甘酸钠或安慰剂。其中11名儿童对致病抗原的皮内皮肤反应或粪抗体呈阳性。在儿童接受排除饮食时开始治疗;仅在给药48小时后才用特定抗原来激发。如果初始药物无效,则进行交叉治疗。在13次试验中,色甘酸钠在11次试验中提供了保护作用,而安慰剂仅在9次试验中的3次有效。通过卡方分析,该药物的效果具有统计学意义。