Hartrick Craig T, Knapke Donald M, Ding Li, Danesi Hassan, Jones James B
Professor, Anesthesiology, Beaumont Health System, Troy, Michigan.
Troy Orthopedic Associates, Troy, Michigan.
J Opioid Manag. 2016 Jan-Feb;12(1):37-45. doi: 10.5055/jom.2016.0310.
To compare the efficacy and safety of patient-controlled pain management following orthopedic surgery using either fentanyl iontophoretic transdermal system (ITS) or morphine intravenous (i.v.) patient-controlled analgesia (PCA).
Acute Care Hospital.
Three-open-label, multicenter, randomized, active-controlled, parallel-group phase 3B studies (N = 2095) were conducted that compared fentanyl ITS with morphine i.v. PCA for postoperative pain in hospitalized postoperative patients. A subgroup of orthopedic surgery patients (N = 1,216) was pooled for this analysis; of which 819 completed treatment.
A total of 590 patients received fentanyl ITS (40 µg/dose) and 626 patients received morphine i.v. PCA (1 mg/dose) for up to 72 hours.
Efficacy measures included the patient global assessment (PGA) and the investigator global assessment (IGA) of the method of pain control.
Patients had a mean age of about 60 years, were predominantly Caucasian (90.5 percent), and the majority underwent hip replacement (80.3 percent). There were more patients treated with fentanyl ITS who rated their pain control method as "excellent" compared to morphine i.v. PCA at 24 hours postsurgery (44.8 percent vs 33.0 percent, respectively; p < 0.001), 48 hours (37.5 percent vs 25.3 percent, respectively; p < 0.001), and at the last assessment (54.3 percent vs 39.6 percent, respectively; p < 0.001). There were more investigators who rated treatment with fentanyl ITS as "excellent" compared to morphine i.v. PCA at the last assessment (57.4 percent vs 36.9 percent, respectively; p < 0.001).
Following orthopedic surgery, patients and investigators more frequently reported global assessment of pain control as "excellent" on the PGA and IGA assessments with fentanyl ITS than with morphine i.v. PCA.
比较骨科手术后使用芬太尼离子导入透皮系统（ITS）或吗啡静脉自控镇痛（PCA）进行患者自控疼痛管理的疗效和安全性。
急性护理医院。
进行了三项开放标签、多中心、随机、活性对照、平行组3B期研究（N = 2095），比较芬太尼ITS与吗啡静脉PCA用于住院术后患者的术后疼痛。将一组骨科手术患者（N = 1216）汇总进行此分析；其中819例完成治疗。
总共590例患者接受芬太尼ITS（40μg/剂量），626例患者接受吗啡静脉PCA（1mg/剂量），持续72小时。
疗效指标包括患者对疼痛控制方法的总体评估（PGA）和研究者总体评估（IGA）。
患者平均年龄约60岁，主要为白种人（90.5%），大多数接受髋关节置换术（80.3%）。与吗啡静脉PCA相比，更多接受芬太尼ITS治疗的患者在术后24小时（分别为44.8%和33.0%；p < 0.001）、48小时（分别为37.5%和25.3%；p < 0.001）以及最后一次评估时（分别为54.3%和39.6%；p < 0.001）将其疼痛控制方法评为“优秀”。与吗啡静脉PCA相比，更多研究者在最后一次评估时将芬太尼ITS治疗评为“优秀”（分别为57.4%和36.9%；p < 0.001）。
骨科手术后，与吗啡静脉PCA相比，患者和研究者在PGA和IGA评估中更频繁地将芬太尼ITS的疼痛控制总体评估报告为“优秀”。
