Lack of efficacy of a decongestant-antihistamine combination for otitis media with effusion ("secretory" otitis media) in children. Results of a double-blind, randomized trial.
Lack of efficacy of a decongestant-antihistamine combination for otitis media with effusion ("secretory" otitis media) in children. Results of a double-blind, randomized trial.
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减充血剂-抗组胺药组合对儿童渗出性中耳炎（“分泌性”中耳炎）缺乏疗效。
DOI：
10.1056/nejm198302103080601
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发表时间：
1983
期刊：
影响因子：
--
通讯作者：
Rogers,KD
中科院分区：
文献类型：
--
作者：
Cantekin,EI;Mandel,EM;Bluestone,CD;Rockette,HE;Paradise,JL;Stool,SE;Fria,TJ;Rogers,KD
在一项对553名患有渗出性中耳炎（“分泌性”中耳炎）的婴儿和儿童进行的双盲、随机试验中，我们比较了口服减充血剂-抗组胺药复方制剂（盐酸伪麻黄碱，每天每公斤体重4 mg，马来酸氯苯那敏，每天每公斤体重0.35 mg）与安慰剂的疗效。在最初单侧疾病的患者中，38%的安慰剂治疗组和34%的药物治疗组的中耳积液在四周后消退（P = 0.74）。在最初双侧病变的患者中，相应的比例分别为19%和21%（P = 0.67）。药物治疗组比安慰剂治疗组更常报告副作用。减充血剂-抗组胺药组合似乎不适用于治疗婴儿和儿童的渗出性中耳炎。（《新英格兰医学杂志》1983年; 308：297-301）
In a double-blind, randomized trial of 553 infants and children who had otitis media with effusion ("secretory" otitis media), we compared the efficacy of a four-week course of an oral decongestant-antihistamine combination (pseudoephedrine hydrochloride, 4 mg per kilogram of body weight per day, and chlorpheniramine maleate, 0.35 mg per kilogram per day) with that of placebo. Among patients with initially unilateral disease, resolution of middle-ear effusion occurred at four weeks in 38 per cent of those treated with placebo and 34 per cent of those treated with drug (P = 0.74). Among patients with initially bilateral disease the corresponding proportions were 19 and 21 per cent, respectively (P = 0.67). Side effects were reported more often among drug-treated than placebo-treated patients. Decongestant-antihistamine combinations do not appear to be indicated for the treatment of otitis media with effusion in infants and children. (N Engl J Med. 1983; 308:297–301.)