Nabulsi Mona M, Tamim Hala, Mahfoud Ziyad, Itani Mohammad, Sabra Ramzi, Chamseddine Fadi, Mikati Mohammad
Department of Pediatrics, American University of Beirut Medical Center, Beirut, Lebanon.
BMC Med. 2006 Mar 4;4:4. doi: 10.1186/1741-7015-4-4.
Alternating ibuprofen and acetaminophen for the treatment of febrile children is a prevalent practice among physicians and parents, despite the lack of evidence on effectiveness or safety. This randomized, double-blind and placebo-controlled clinical trial aims at comparing the antipyretic effectiveness and safety of a single administration of alternating ibuprofen and acetaminophen doses to that of ibuprofen mono-therapy in febrile children.
Seventy febrile children were randomly allocated to receive either a single oral dose of 10 mg/kg ibuprofen and 15 mg/kg oral acetaminophen after 4 hours, or a similar dose of ibuprofen and placebo at 4 hours. Rectal temperature was measured at baseline, 4, 5, 6, 7 and 8 hours later. Endpoints included proportions of afebrile children at 6, 7 and 8 hours, maximum decline in temperature, time to recurrence of fever, and change in temperature from baseline at each time point. Intent-to-treat analysis was planned with statistical significance set at P < 0.05.
A higher proportion of subjects in the intervention group (83.3%) became afebrile at 6 hours than in the control group (57.6%); P = 0.018. This difference was accentuated at 7 and 8 hours (P < 0.001) with a significantly longer time to recurrence of fever in the intervention group (mean +/- SD of 7.4 +/- 1.3 versus 5.7 +/- 2.2 hours), P < 0.001. Odds ratios (95%CI) for defervescence were 5.6 (1.3; 23.8), 19.5 (3.5; 108.9) and 15.3 (3.4; 68.3) at 6, 7 and 8 hours respectively. Two-way ANOVA with repeated measures over time revealed a significantly larger decline in temperature in the intervention group at times 7 (P = 0.026) and 8 (P = 0.002) hours.
A single dose of alternating ibuprofen and acetaminophen appears to be a superior antipyretic regimen than ibuprofen mono-therapy. Further studies are needed to confirm these findings.
尽管缺乏有效性或安全性方面的证据，但在医生和家长中，交替使用布洛芬和对乙酰氨基酚治疗发热儿童是一种普遍的做法。这项随机、双盲和安慰剂对照的临床试验旨在比较单剂量交替使用布洛芬和对乙酰氨基酚与布洛芬单一疗法在发热儿童中的退热效果和安全性。
70名发热儿童被随机分配，一组在4小时后接受单剂量口服10mg/kg布洛芬和15mg/kg口服对乙酰氨基酚，另一组在4小时后接受类似剂量的布洛芬和安慰剂。在基线、4、5、6、7和8小时测量直肠温度。终点指标包括6、7和8小时时体温正常儿童的比例、体温最大降幅、发热复发时间以及每个时间点相对于基线的体温变化。计划进行意向性分析，设定统计学显著性水平为P<0.05。
干预组在6小时时体温恢复正常的受试者比例（83.3%）高于对照组（57.6%）；P = 0.018。这种差异在7小时和8小时时更加明显（P<0.001），干预组发热复发时间明显更长（平均±标准差为7.4±1.3小时，而对照组为5.7±2.2小时），P<0.001。6、7和8小时时退热的优势比（95%置信区间）分别为5.6（1.3；23.8）、19.5（3.5；108.9）和15.3（3.4；68.3）。随时间重复测量的双向方差分析显示，干预组在7小时（P = 0.026）和8小时（P = 0.002）时体温下降幅度明显更大。
单剂量交替使用布洛芬和对乙酰氨基酚似乎是比布洛芬单一疗法更优的退热方案。需要进一步研究来证实这些发现。
