美国FDA磷酸奥司他韦治疗一岁以下儿童报道

FDA expands Tamiflu’s use to treat children younger than 1 year Parents, health care professionals must ensure proper dosing FDA批准扩大达菲的适应证用于1岁以下儿童流感的治疗。家长和医疗工作者须确保使用合适的剂量。 The U.S. Food and Drug Administration today expanded the approved use of Tamiflu (oseltamivir) to treat children as young as 2 weeks old who have shown symptoms of flu for no longer than two days. 2012年12月21日FDA批准扩大达菲的适应证用于2周以上的儿童表现流感感染症状不超过两天的治疗。 The drug is not approved to prevent flu infection in this population. In addition, the safety and efficacy of Tamiflu to treat flu infection has not been established in children younger than 2 weeks old. 达菲并未被批准用于1岁以下儿童流感的预防。此外，该药在治疗小于2周儿童流感患者中的有效性和安全性还未被证实。 Tamiflu was approved in 1999 to treat adults infected with flu who have shown symptoms for no longer than two days. It has since been approved to treat flu in children ages 1 year and older who have shown symptoms of flu for no longer than two days, and to prevent flu in adults and children ages 1 year and older. 达菲早在1999年就被获批用于成人表现流感感染症状不超过两天的治疗，后来又被批准用于1岁以上人群表现流感感染症状不超过两天的治疗，同时还可预防成人和1岁以上儿童流感的预防。 Although there is a fixed dosing regimen for patients 1 year and older according to weight categories, the dosing for children younger than 1 year must be calculated for each patient based on their exact weight. These children should receive 3 milligrams per kilogram twice daily for five days. These smaller doses will require a different dispenser than what is currently co-packaged with Tamiflu. 尽管1周岁以上患者有根据体重分类而制定的固定给药，但是小于1周岁的患者必须根据各自的准确体重来制定给药剂量。这些儿童人群应接受3 mg/kg的剂量，每天2次，连续用药5天。这些更小的剂量则需要不同于当前的药品包装。 “Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “Parents and pediatricians must make sure children receive only the amount of Tamiflu appropriate for their weight.” 药剂师必须在配药的时候准备适当的药品包装，以便家长能给自己的孩子使用恰当的剂量。家长和儿科医生必须确认儿童患者所接受的治疗剂量适用于他们的体重。 Tamiflu is the only product approved to treat flu infection in children younger than 1 year old, providing an important treatment option for a vulnerable population. According to the Centers for Disease Control and Prevention (CDC), children younger than 2 years are at higher risk for developing complications from the flu, with the highest rates of hospitalization in those less than 6 months of age. 达菲仅批准用于治疗1周岁以下儿童的流感治疗，作为这类弱势群体的重要治疗手段。按照疾病控制和预防中心的建议，2周岁以上儿童流感患者出现并发症的风险更高，而6个月以下儿童住院治疗的几率则最高。 The FDA expanded the approved use of Tamiflu in children younger than 1 year based on extrapolation of data from previous study results in adults and older children, and additional supporting safety and pharmacokinetic studies sponsored by both the National Institutes of Health and Roche Group, Tamiflu’s manufacturer. FDA扩大达菲适应证用于1岁以下儿童流感的治疗是基于之前成人和1岁以上儿童的研究数据通过外推法所获得。另外支持性的安全性和药代动力学研究由美国国立卫生研究院和罗氏共同完成。 Pediatric legislation permits efficacy to be extrapolated from previous study results in adults and older children if the illness being studied and the effects of the drug are sufficiently similar in adult and pediatric patients. Data on how the drug is metabolized in the body (pharmacokinetic data) indicated a dose of 3 mg/kg twice daily provided concentrations of Tamiflu similar to those observed in older children and adults, and is expected to provide similar efficacy in this very young age group. 如果现在的病情和药物效果和再成人和儿童患者足够相似的话，儿童法规便认可来自大龄儿童和成人之前相关研究结果的外推法。药代动力学数据显示3 mg/kg的剂量一天2次，在那些大龄的儿童和成人中观察到的达菲浓度类似，因此便有望在1周岁以下儿童患者中也能提供相似的有效性。 Almost all of the 135 pediatric patients enrolled in the two safety studies had confirmed flu. Results from these studies showed the safety profile in children younger than 1 year was consistent with the established safety profile of adults and older children. The most common side effects reported with Tamiflu use in this age group include vomiting and diarrhea. Although not seen in the new studies, rare cases of severe rash, skin reactions, hallucinations, delirium, and abnormal behavior have been reported. 几乎所有135例确诊的儿童流感患者参加了2项安全性研究。这些研究结果显示1周岁以下儿童的安全性特性与成人和大龄儿童的安全性特性一致。达菲在这个年龄组最常见的不良反应是呕吐和腹泻。目前还没有新的研究报道称发现极小概率出现的严重皮疹、皮肤反应、幻觉、精神错乱和异常行为等不良反应。 The FDA monitors drugs for side effects and believes reporting side effects is important. Health care professionals and patients should report any side effects associated with Tamiflu’s use to FDA’s MedWatch program. FDA监管药品的不良反应，并且认为报道不良反应是非常重要的，希望医疗工作者和病人能通过FDA的MedWatch报道任何与达菲相关的不良反应。 Tamiflu is not a substitute for early, annual flu vaccination, as recommended by the CDC’s Advisory Committee on Immunization Practices. CDC recommends all persons aged 6 months and older receive an annual flu vaccine. 美国疾病预防控制中心资询委员会建议：达菲并不能替代早期的流感接种疫苗。同时美国疾病预防控制中心还建议所有年龄超过6个月的人群均需接种流感疫苗。