Mandel E M, Casselbrant M L, Rockette H E, Bluestone C D, Kurs-Lasky M
Department of Otolaryngology, Children's Hospital of Pittsburgh, PA 15213-2583, USA.
Pediatr Infect Dis J. 1996 Dec;15(12):1074-82. doi: 10.1097/00006454-199612000-00004.
This trial compared the efficacy of amoxicillin prophylaxis with that of placebo for the management of recurrent middle ear effusion (MEE) in children.
Children between 7 months and 12 years of age who were effusion-free at entry but had histories of chronic or recurrent MEE were randomly assigned to receive either amoxicillin (20 mg/kg once daily) or placebo for 1 year. They were examined monthly and when there were symptoms of ear, nose or throat disease. Acute otitis media (AOM) and new episodes of otitis media with effusion (OME) were treated with amoxicillin-clavulanate; tympanocentesis was performed when possible for episodes of AOM. Throat cultures were obtained at entry; 4, 8 and 12 months after entry; and with new episodes of AOM and OME. Tympanometry was performed at each visit and audiometry was performed at entry and 4, 8 and 12 months after entry.
One hundred eleven children were entered in this study. The rates per person year of new episodes of disease in the amoxicillin and placebo groups, respectively, were: MEE, 1.81 vs. 3.18 (P < 0.001); AOM, 0.28 vs. 1.04 (P < 0.001); and OME, 1.53 vs. 2.15 (P = 0.016). Subjects in the amoxicillin group had less time with MEE than the placebo group (19.7 and 33.2%, respectively; P = 0.002). Middle ear and throat cultures did not reveal any increase in beta-lactamase-producing organisms or in Streptococcus pneumoniae attributable to daily use of amoxicillin.
Amoxicillin prophylaxis lowered the rates of occurrence of MEE, AOM and OME and decreased the percentage of time with MEE. However, because of present day concerns regarding antibiotic resistance, management should be individualized.
本试验比较了阿莫西林预防用药与安慰剂对儿童复发性中耳积液（MEE）的治疗效果。
年龄在7个月至12岁之间、入组时无积液但有慢性或复发性MEE病史的儿童被随机分配接受阿莫西林（20mg/kg，每日一次）或安慰剂治疗1年。每月进行检查，出现耳、鼻或咽喉疾病症状时也进行检查。急性中耳炎（AOM）和新发性中耳积液（OME）发作时使用阿莫西林 - 克拉维酸进行治疗；对于AOM发作，尽可能进行鼓膜穿刺术。入组时、入组后4、8和12个月以及出现新的AOM和OME发作时进行咽喉培养。每次就诊时进行鼓室图检查，入组时以及入组后4、8和12个月进行听力测定。
111名儿童参与了本研究。阿莫西林组和安慰剂组每人每年新发病例的发生率分别为：MEE，1.81对3.18（P < 0.001）；AOM，0.28对1.04（P < 0.001）；OME，1.53对2.15（P = 0.016）。阿莫西林组的受试者患MEE的时间比安慰剂组少（分别为19.7%和33.2%；P = 0.002）。中耳和咽喉培养未显示因每日使用阿莫西林导致产β - 内酰胺酶的生物体或肺炎链球菌增加。
阿莫西林预防用药降低了MEE、AOM和OME的发生率，并减少了患MEE的时间百分比。然而，由于当今对抗生素耐药性的关注，治疗应个体化。
