Gupta Hema, Shah Dheeraj, Gupta Piyush, Sharma K K
Department of Pediatrics, University College of Medical Sciences and GTB Hospital, Dilshad Garden, Delhi 110 095, India.
Indian Pediatr. 2007 Dec;44(12):903-11.
To investigate whether paracetamol administration (i) increases the overall duration of fever; and (ii) is effective and safe, in symptomatic treatment of febrile children.
Randomized double blind placebo controlled trial.
The trial was conducted at a tertiary care setting. 210 febrile children (6 months - 6 years) with uncomplicated respiratory tract infection received oral paracetamol (15 mg/kg) or placebo, if axillary temperature was 37.6C. Outcome measures included fever clearance time, rate of fall of temperature, percent reduction of temperature, proportion of afebrile children, symptomatic improvement (based on categorical improvement in activity, alertness mood, comfort, appetite and fluid intake) and clinical and biochemical adverse effects.
Fever clearance time [median (SE, 95% CI)] was comparable between the two groups [paracetamol: 32 (2, 22-37) h; placebo: 36 (1, 33-39) h; P = 0.23]. Paracetamol resulted in significantly higher rate of fall of temperature (paracetamol: 0.33 +/-; 0.16 degrees C/h; placebo 0.07 +/- 0.13 degrees C/h: P <0.001), and percentage reduction of temperature (paracetamol: 85.4 +/- 22.4; placebo 45.5 +/- 34.1; mean difference 39.9; 95% CI 31.9-47.9; P<0.001) during first four hours after drug administration. Proportion of afebrile children after 4 hours (paracetamol: 46.6%; placebo: 12.1%; P <0.001) and symptomatic improvement at 6 hours were significantly higher (P<0.001) after administration of paracetamol as compared to placebo. No serious clinical or biochemical adverse drug effects were observed.
Paracetamol achieves effective antipyresis and provides early symptomatic improvement in children with febrile illness without prolongation of fever duration or excessive adverse effects.
探讨对发热儿童进行对症治疗时，给予对乙酰氨基酚是否（i）会增加发热的总时长；以及（ii）有效且安全。
随机双盲安慰剂对照试验。
该试验在一家三级医疗机构进行。210名患有单纯呼吸道感染的发热儿童（6个月至6岁），若腋温为37.6℃，则口服对乙酰氨基酚（15毫克/千克）或安慰剂。观察指标包括退热时间、体温下降速率、体温降低百分比、无热儿童比例、症状改善情况（基于活动、警觉性、情绪、舒适度、食欲和液体摄入量的分类改善）以及临床和生化不良反应。
两组的退热时间[中位数（标准误，95%置信区间）]相当[对乙酰氨基酚组：32（2，22 - 37）小时；安慰剂组：36（1，33 - 39）小时；P = 0.23]。对乙酰氨基酚使给药后前四小时的体温下降速率显著更高（对乙酰氨基酚组：0.33±0.16℃/小时；安慰剂组0.07±0.13℃/小时：P <0.001），体温降低百分比也显著更高（对乙酰氨基酚组：85.4±22.4；安慰剂组45.5±34.1；平均差值39.9；95%置信区间31.9 - 47.9；P <0.001）。给药后4小时无热儿童比例（对乙酰氨基酚组：46.6%；安慰剂组：12.1%；P <0.001）以及6小时时的症状改善情况，对乙酰氨基酚组均显著高于安慰剂组（P <0.001）。未观察到严重的临床或生化药物不良反应。
对乙酰氨基酚可有效退热，并能使发热疾病儿童的症状得到早期改善，且不会延长发热时长或产生过多不良反应。
