Whitehall-Robins Healthcare, 5 Giralda Farms, 07940-0871, Madison, NJ, USA.
Inflammopharmacology. 1999;7(3):219-25. doi: 10.1007/s10787-999-0005-0.
The Children's Analgesic Medicine Project (CAMP) was a multicenter, all-comers, openlabel, prospective study to compare the safety of ibuprofen suspension with acetaminophen suspension in children with fever and/or pain. Four hundred and twenty four (424) pediatricians enrolled 41 810 children (aged 1 month to 18 years old) at 69 US clinics. Safety data included information concerning medication use and adverse events (AEs) summarized by severity and analyzed by age groups (younger and older than 2 years). Among 30 144 children who took at least one dose of ibuprofen or acetaminophen, 14 281 were younger (< 2 yrs) and 15 863 were older ([Symbol: see text] 2 to < 12 yrs). Within both age groups, the incidence rates for specific AEs, including abdominal pain, insomnia, and hyperkinesia were rare and generally < 1% for both treatments. For younger children, fever, vomiting, diarrhea, rhinitis, rash and otitis media were the only AEs with an incidence rate > 1% (in either treatment group). For older children, the only AEs with an incidence rate > 1% in either group were rhinitis, pharyngitis and otitis media. AEs were generally mild to moderate for both treatments within the two age groups. There were no serious AEs, including anaphylaxis, Reye's syndrome, renal failure, GI bleeding/perforation or necrotizing fasciitis. There was a slightly higher overall incidence of side effects in the ibuprofen group (17.6% vs. 15.0%) for the younger children; and similar results were seen in the older children (11.9% vs. 10.7%). This may have been due to the preference of physicians to treat the sicker children with ibuprofen. There were four deaths, all unrelated to study medication, all occurring in children < 2 yrs (herpes encephalitis, sepsis due to 5. pneumoniae, medulloblastoma, and sudden infant death syndrome). The safety of ibuprofen suspension in children < 2 yrs was demonstrated in this study. The safety profile in children < 2 yrs is consistent with the excellent profile observed in children [Symbol: see text] 2 yrs. Overall, ibuprofen exhibited an AE profile similar to acetaminophen in both younger and older children.
儿童镇痛药项目（CAMP）是一项多中心、全入组、开放性、前瞻性研究，旨在比较布洛芬混悬液和对乙酰氨基酚混悬液在发热和/或疼痛儿童中的安全性。424 名儿科医生在 69 家美国诊所招募了 41810 名儿童（年龄 1 个月至 18 岁）。安全性数据包括药物使用和不良事件（AE）信息，按严重程度和年龄组（<2 岁和>2 岁）进行分析。在至少服用一次布洛芬或对乙酰氨基酚的 30144 名儿童中，14281 名年龄较小（<2 岁），15863 名年龄较大（[符号：见正文]2 至<12 岁）。在这两个年龄组中，特定 AE 的发生率均较低，包括腹痛、失眠和多动，对于两种治疗方法，一般均<1%。对于年龄较小的儿童，发热、呕吐、腹泻、鼻炎、皮疹和中耳炎是唯一发生率>1%（两种治疗组中）的 AE。对于年龄较大的儿童，两种治疗组中唯一发生率>1%的 AE 是鼻炎、咽炎和中耳炎。在这两个年龄组中，对于两种治疗方法，AE 通常为轻至中度。没有严重的 AE，包括过敏反应、瑞氏综合征、肾功能衰竭、胃肠道出血/穿孔或坏死性筋膜炎。布洛芬组的总体不良反应发生率略高（17.6%比 15.0%），年龄较小的儿童中观察到类似的结果；年龄较大的儿童中也观察到类似的结果（11.9%比 10.7%）。这可能是由于医生更倾向于使用布洛芬治疗病情较重的儿童。有 4 例死亡，均与研究药物无关，均发生在<2 岁的儿童中（疱疹性脑炎、肺炎链球菌引起的败血症、髓母细胞瘤和婴儿猝死综合征）。本研究证实了布洛芬混悬液在<2 岁儿童中的安全性。<2 岁儿童的安全性特征与观察到的 2 岁以上儿童的极佳特征一致。总体而言，布洛芬在年龄较小和较大的儿童中的不良反应特征与对乙酰氨基酚相似。
