Cantekin E I, Mandel E M, Bluestone C D, Rockette H E, Paradise J L, Stool S E, Fria T J, Rogers K D
N Engl J Med. 1983 Feb 10;308(6):297-301. doi: 10.1056/NEJM198302103080601.
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.
在一项针对553名患有中耳积液（“分泌性”中耳炎）的婴幼儿和儿童的双盲随机试验中，我们比较了为期四周的口服减充血剂-抗组胺药组合（盐酸伪麻黄碱，每日每千克体重4毫克，以及马来酸氯苯那敏，每日每千克体重0.35毫克）与安慰剂的疗效。在最初患有单侧疾病的患者中，四周时安慰剂治疗组中耳积液消退的比例为38%，药物治疗组为34%（P = 0.74）。在最初患有双侧疾病的患者中，相应比例分别为19%和21%（P = 0.67）。报告显示，药物治疗组出现副作用的频率高于安慰剂治疗组。减充血剂-抗组胺药组合似乎并不适用于治疗婴幼儿和儿童的中耳积液。
