Reefhuis Jennita, Honein Margaret A, Whitney Cynthia G, Chamany Shadi, Mann Eric A, Biernath Krista R, Broder Karen, Manning Susan, Avashia Swati, Victor Marcia, Costa Pamela, Devine Owen, Graham Ann, Boyle Coleen
National Center on Birth Defects and Developmental Disabilities, Centers for Disease Control and Prevention, Atlanta, GA 30333, USA.
N Engl J Med. 2003 Jul 31;349(5):435-45. doi: 10.1056/NEJMoa031101.
In June 2002, the Food and Drug Administration received reports of bacterial meningitis in patients with cochlear implants for treatment of hearing loss. Implants that included a positioner (a wedge inserted next to the implanted electrode to facilitate transmission of the electrical signal by pushing the electrode against the medial wall of the cochlea) were voluntarily recalled in the United States in July 2002.
We identified patients with meningitis and conducted a cohort study and a nested case-control investigation involving 4264 children who had received cochlear implants in the United States between January 1, 1997, and August 6, 2002, and who were less than six years of age when they received the implants. We calculated the incidence of meningitis in the cohort and assessed risk factors for meningitis among patients and among 199 controls, using data from interviews with parents and abstracted from medical records.
We identified 26 children with bacterial meningitis. The incidence of meningitis caused by Streptococcus pneumoniae was 138.2 cases per 100,000 person-years--more than 30 times the incidence in a cohort of the same age in the general U.S. population. Postimplantation bacterial meningitis was strongly associated with the use of an implant with a positioner (odds ratio, 4.5 [95 percent confidence interval, 1.3 to 17.9], with adjustment for medical, surgical, and environmental factors) and with the joint presence of radiographic evidence of a malformation of the inner ear and a cerebrospinal fluid leak (adjusted odds ratio, 9.3 [95 percent confidence interval, 1.2 to 94.5]). The incidence of meningitis among patients who had received an implant with a positioner remained higher than the incidence among those whose implants did not have a positioner for the duration of follow-up (24 months from the time of implantation).
Parents and health care providers should ensure that all children who receive cochlear implants are appropriately vaccinated and are then monitored and treated promptly for any bacterial infections after receiving the implant.
2002年6月，美国食品药品监督管理局收到关于接受人工耳蜗植入治疗听力损失的患者发生细菌性脑膜炎的报告。2002年7月，美国自愿召回了包含定位器（一种插入植入电极旁边的楔子，通过将电极推向耳蜗内侧壁来促进电信号传输）的植入物。
我们确定了患有脑膜炎的患者，并对1997年1月1日至2002年8月6日期间在美国接受人工耳蜗植入且植入时年龄小于6岁的4264名儿童进行了队列研究和巢式病例对照调查。我们计算了队列中脑膜炎的发病率，并使用来自家长访谈和病历摘要的数据评估了患者及199名对照中脑膜炎的危险因素。
我们确定了26名患有细菌性脑膜炎的儿童。肺炎链球菌引起的脑膜炎发病率为每10万人年138.2例——是美国同年龄普通人群队列发病率的30多倍。植入后细菌性脑膜炎与使用带有定位器的植入物密切相关（优势比为4.5 [95%置信区间为1.3至17.9]，对医疗、手术和环境因素进行调整后），也与内耳畸形和脑脊液漏的影像学证据同时存在密切相关（调整后的优势比为9.3 [95%置信区间为1.2至94.5]）。在随访期间（从植入时间起24个月），接受带有定位器植入物的患者中脑膜炎的发病率仍然高于植入物没有定位器的患者。
家长和医疗保健提供者应确保所有接受人工耳蜗植入的儿童都接种适当的疫苗，并在植入后对任何细菌感染进行及时监测和治疗。
