Pulmonary-Critical Care, Wake Forest University School of Medicine, Winston Salem, NC 27157, USA.
Crit Care. 2010;14(3):R125. doi: 10.1186/cc9089. Epub 2010 Jun 30.
Hospitalized patients are often unable to ingest or tolerate oral antipyretics and recently an aqueous formulation of intravenous (IV) ibuprofen was approved by the US-FDA for the reduction of fever in adults.
We evaluated IV ibuprofen to reduce fever exceeding 101.0 degrees F, measured as the percentage of subjects achieving a temperature <101.0 degrees F at four hours after a single dose of IV ibuprofen vs. placebo. Secondary evaluations included the effect on temperature at 24 hours. Nine sites randomized patients to receive either a placebo or IV ibuprofen (100, 200, or 400 mg), and patients were given four hours for six doses. Subjects were excluded for platelet count <30 k and/or creatinine >3.0 mg/dL.
At entry, there were no significant baseline differences between the IV ibuprofen group and placebo, n = 120. At four hours, the number (percentage) with T<101.0 degrees F was: Placebo n = 9/28 (32%); 100 mg IV ibuprofen n = 19/31 (61%), P = 0.0264; 200 mg IV ibuprofen n = 21/30 (70%) P = 0.0043; 400 mg IV ibuprofen n = 24/31 (77%) P = 0.0005. A total of 53/120 patients (44%) were prospectively defined as critically ill at baseline and similar temperature reductions were observed in this subgroup. There were no statistically significant differences between treatment groups or when compared to placebo in transfusion, bleeding, renal failure or mortality.
All doses of IV ibuprofen tested reduced fever at four hours and throughout the first 24 hours of dosing. The 400 mg dose was effective in lowering temperature to normal and maintaining this over the first 24 hours of dosing. IV ibuprofen was effective in reducing fevers in critically ill and non-critically ill groups. Following 24 hours of administration of IV ibuprofen, no clinically significant differences in any safety parameter including renal function or bleeding occurred through the 28-day follow-up period.
Clinicaltrials.gov registration number: NCT01131000.
住院患者通常无法口服或耐受解热药，最近美国食品药品监督管理局批准了一种静脉（IV）布洛芬的水制剂，用于降低成人发热。
我们评估了 IV 布洛芬在单次 IV 布洛芬给药后 4 小时内，与安慰剂相比，将体温降至 101.0 华氏度以下的疗效，以达到体温的受试者百分比作为衡量标准。次要评估包括 24 小时内的体温影响。9 个地点随机将患者分配至安慰剂或 IV 布洛芬（100、200 或 400mg）组，患者有 4 小时的时间服用 6 剂。排除血小板计数<30 k 和/或肌酐>3.0mg/dL 的患者。
入组时，IV 布洛芬组和安慰剂组之间无明显基线差异，n = 120。4 小时时，体温<101.0 华氏度的人数（百分比）为：安慰剂 n = 28/9（32%）；100mg IV 布洛芬 n = 31/19（61%），P = 0.0264；200mg IV 布洛芬 n = 30/21（70%），P = 0.0043；400mg IV 布洛芬 n = 31/24（77%），P = 0.0005。共有 120 名患者中的 53 名（44%）在基线时被前瞻性定义为危重症患者，在该亚组中观察到类似的体温降低。在输血、出血、肾功能衰竭或死亡率方面，各治疗组之间或与安慰剂相比均无统计学显著差异。
所有测试剂量的 IV 布洛芬在 4 小时内和整个第 1 天的首次 24 小时内均降低了发热。400mg 剂量可有效降低体温至正常，并在首次 24 小时的给药期间保持正常。IV 布洛芬在危重症和非危重症患者中均能有效降低发热。在 IV 布洛芬给药 24 小时后，在 28 天的随访期间，在任何安全性参数（包括肾功能或出血）方面均未出现临床意义上的差异。
Clinicaltrials.gov 注册号：NCT01131000。
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