van der Veen Erwin L, Rovers Maroeska M, Albers Frans W J, Sanders Elisabeth A M, Schilder Anne G M
Department of Otorhinolaryngology, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, Netherlands.
Pediatrics. 2007 May;119(5):897-904. doi: 10.1542/peds.2006-2787.
The goal was to determine the clinical effectiveness of prolonged outpatient treatment with trimethoprim/sulfamethoxazole for children with chronic active otitis media.
We performed a randomized, placebo-controlled trial with 101 children (1-12 years of age) with chronic active otitis media (defined as otorrhea for > or =12 weeks). In addition to a short course of steroid and antibiotic eardrops, children were assigned randomly to receive 6 to 12 weeks of orally administered trimethoprim/sulfamethoxazole (18 mg/kg, 2 times per day) or placebo and were monitored for 1 year.
At 6 weeks, 28% of children in the trimethoprim/sulfamethoxazole group and 53% of children in the placebo group had otomicroscopic signs of otorrhea. At 12 weeks, these values were 32% and 47%, respectively. At 1 year, the numbers of children with otorrhea were similar in the 2 groups (25% and 20%, respectively). One child in the trimethoprim/sulfamethoxazole group developed a skin rash. Vomiting or diarrhea was reported for 9% of the trimethoprim/sulfamethoxazole group and 2% of the placebo group. Pure-tone hearing levels and health-related quality of life improved during the study but did not differ between the trimethoprim/sulfamethoxazole group and the placebo group. Pseudomonas aeruginosa was the most frequently isolated bacteria in the otorrhea samples from both groups.
A 6- to 12-week course of high-dose, orally administered trimethoprim/sulfamethoxazole therapy is beneficial for children with chronic active otitis media. The treatment effect is most pronounced with the shorter course and disappears if administration of the medication is discontinued.
本研究旨在确定长期门诊使用甲氧苄啶/磺胺甲恶唑治疗慢性活动性中耳炎患儿的临床疗效。
我们对101名1至12岁的慢性活动性中耳炎患儿（定义为耳漏持续≥12周）进行了一项随机、安慰剂对照试验。除了短期使用类固醇和抗生素耳滴剂外，患儿被随机分配接受6至12周的口服甲氧苄啶/磺胺甲恶唑（18mg/kg，每日2次）或安慰剂治疗，并进行1年的监测。
在6周时，甲氧苄啶/磺胺甲恶唑组28%的患儿和安慰剂组53%的患儿有耳漏的耳镜检查体征。在12周时，这些数值分别为32%和47%。在1年时，两组中耳漏患儿的数量相似（分别为25%和20%）。甲氧苄啶/磺胺甲恶唑组有1名患儿出现皮疹。甲氧苄啶/磺胺甲恶唑组9%的患儿和安慰剂组2%的患儿报告有呕吐或腹泻。在研究期间，纯音听力水平和与健康相关的生活质量有所改善，但甲氧苄啶/磺胺甲恶唑组和安慰剂组之间没有差异。铜绿假单胞菌是两组耳漏样本中最常分离出的细菌。
6至12周的高剂量口服甲氧苄啶/磺胺甲恶唑治疗对慢性活动性中耳炎患儿有益。疗程较短时治疗效果最明显，如果停药则治疗效果消失。
