成人静脉注射布洛芬(凯扶兰(®))的综合安全性分析。

An integrated safety analysis of intravenous ibuprofen (Caldolor(®)) in adults.

作者信息

Southworth Stephen R, Woodward Emily J, Peng Alex, Rock Amy D

机构信息

North Mississippi Sports Medicine and Orthopaedic Clinic, PLLC, Tupelo, MS, USA.

Department of Research and Development, Cumberland Pharmaceuticals Inc., Nashville, TN, USA.

出版信息

J Pain Res. 2015 Oct 23;8:753-65. doi: 10.2147/JPR.S93547. eCollection 2015.

Abstract

Intravenous (IV) nonsteroidal anti-inflammatory drugs such as IV ibuprofen are increasingly used as a component of multimodal pain management in the inpatient and outpatient settings. The safety of IV ibuprofen as assessed in ten sponsored clinical studies is presented in this analysis. Overall, 1,752 adult patients have been included in safety and efficacy trials over 11 years; 1,220 of these patients have received IV ibuprofen and 532 received either placebo or comparator medication. The incidence of adverse events (AEs), serious AEs, and changes in vital signs and clinically significant laboratory parameters have been summarized and compared to patients receiving placebo or active comparator drug. Overall, IV ibuprofen has been well tolerated by hospitalized and outpatient patients when administered both prior to surgery and postoperatively as well as for nonsurgical pain or fever. The overall incidence of AEs is lower in patients receiving IV ibuprofen as compared to those receiving placebo in this integrated analysis. Specific analysis of hematological and renal effects showed no increased risk for patients receiving IV ibuprofen. A subset analysis of elderly patients suggests that no dose adjustment is needed in this higher risk population. This integrated safety analysis demonstrates that IV ibuprofen can be safely administered prior to surgery and continued in the postoperative period as a component of multimodal pain management.

摘要

静脉注射(IV)非甾体抗炎药,如静脉注射布洛芬,在住院和门诊环境中越来越多地被用作多模式疼痛管理的一部分。本分析介绍了在十项赞助的临床研究中评估的静脉注射布洛芬的安全性。总体而言,在11年的时间里,1752名成年患者被纳入了安全性和有效性试验;其中1220名患者接受了静脉注射布洛芬,532名患者接受了安慰剂或对照药物。不良事件(AE)、严重不良事件以及生命体征和具有临床意义的实验室参数变化的发生率已被总结,并与接受安慰剂或活性对照药物的患者进行了比较。总体而言,静脉注射布洛芬在手术前、手术后以及用于非手术疼痛或发热时,住院患者和门诊患者的耐受性良好。在这项综合分析中,接受静脉注射布洛芬的患者的AE总体发生率低于接受安慰剂的患者。血液学和肾脏影响的具体分析表明,接受静脉注射布洛芬的患者没有增加风险。老年患者的亚组分析表明,在这个高风险人群中不需要调整剂量。这项综合安全性分析表明,静脉注射布洛芬可以在手术前安全给药,并在术后继续作为多模式疼痛管理的一部分使用。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7fa0/4631431/e5f0c015f021/jpr-8-753Fig1.jpg

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