Pediatric Emergency Medicine, Sutter Medical Center Sacramento, Sacramento, CA, United States of America.
Instituto Nacional de Salud Pública, Centro de Investigación en Salud Poblacional, Cuernavaca, Morelos, Mexico.
PLoS One. 2018 Jun 28;13(6):e0199493. doi: 10.1371/journal.pone.0199493. eCollection 2018.
We hypothesized (1) that gastrointestinal (GI) and renal adverse events (AE) would occur more often in infants first prescribed ibuprofen before rather than after six months of age and (2) that ibuprofen would be associated with more adverse effects than acetaminophen in infants younger than six months.
We created two partly overlapping retrospective cohorts of infants aged less than six months when California Medicaid first paid for ibuprofen or acetaminophen between 2004 and 2010. In the first cohort we compared the incidence rate ratio (RR) of GI and renal AE between those infants first prescribed ibuprofen before six months of age with those first prescribed ibuprofen after six months of age. In the second cohort we compared the RR of GI and renal AE between infants younger than six months prescribed ibuprofen (+/-acetaminophen) with those prescribed only acetaminophen.
We identified 41,669 prescriptions for ibuprofen and 176,991 prescriptions for acetaminophen in 180,333 eligible infants (median age 2.1 months). We did not observe higher RR of any AE in infants first prescribed ibuprofen before rather than after six months of age. Most infants prescribed ibuprofen were also prescribed acetaminophen. Any GI (adjusted (a)RR 1.25, 95% CI 1.13-1.38) and moderate or severe GI AE (aRR 1.24, 95% CI 1.09-1.40) were more common in infants younger than six months who were prescribed ibuprofen versus acetaminophen alone. Severe GI (aRR 0.63, 95% CI 0.27-1.45) and renal AE (aRR 1.84 95% CI 0.66-5.19) were not different between the ibuprofen (+/-acetaminophen) and acetaminophen-only groups.
GI and renal AEs were not higher in infants younger than six months who were prescribed ibuprofen compared with those aged six to 12 months. AEs were increased in infants younger than six months who were prescribed ibuprofen compared with infants who were prescribed acetaminophen alone.
我们假设（1）与 6 个月以后开始服用布洛芬的婴儿相比，6 个月之前开始服用布洛芬的婴儿会出现更多胃肠道（GI）和肾脏不良事件（AE）；（2）与仅服用对乙酰氨基酚的婴儿相比，6 个月以下婴儿服用布洛芬会出现更多不良影响。
我们创建了两个部分重叠的回顾性队列，队列纳入了 2004 年至 2010 年间加利福尼亚州医疗补助计划首次支付布洛芬或对乙酰氨基酚的 6 个月以下婴儿。在第一个队列中，我们比较了 6 个月之前开始服用布洛芬的婴儿与 6 个月后开始服用布洛芬的婴儿 GI 和肾脏 AE 的发病率比值（RR）。在第二个队列中，我们比较了 6 个月以下同时服用布洛芬（±对乙酰氨基酚）和仅服用对乙酰氨基酚的婴儿 GI 和肾脏 AE 的 RR。
我们在 180333 名符合条件的婴儿中确定了 41669 例布洛芬处方和 176991 例对乙酰氨基酚处方（中位数年龄为 2.1 个月）。我们没有观察到 6 个月之前开始服用布洛芬的婴儿发生任何 AE 的 RR 更高。大多数服用布洛芬的婴儿也同时服用了对乙酰氨基酚。与单独服用对乙酰氨基酚的婴儿相比，6 个月以下同时服用布洛芬的婴儿更常见任何 GI（校正（a）RR1.25，95%置信区间 1.13-1.38）和中度或重度 GI AE（aRR1.24，95%置信区间 1.09-1.40）。严重 GI（aRR0.63，95%置信区间 0.27-1.45）和肾脏 AE（aRR1.84，95%置信区间 0.66-5.19）在布洛芬（±对乙酰氨基酚）和仅对乙酰氨基酚组之间无差异。
与 6 至 12 个月大的婴儿相比，6 个月以下服用布洛芬的婴儿的 GI 和肾脏 AE 并未增加。与单独服用对乙酰氨基酚的婴儿相比，6 个月以下服用布洛芬的婴儿出现 AE 的风险增加。
