Poplawski Steven, Johnson Matthew, Philips Philip, Eberhart Leopold H J, Koch Tilo, Itri Loretta M
Forest Health Medical Center, Ypsilanti, MI, USA.
Indispensable Healthcare, Grass Lake, MI, USA.
Pain Ther. 2016 Dec;5(2):237-248. doi: 10.1007/s40122-016-0061-2. Epub 2016 Nov 5.
Fentanyl iontophoretic transdermal system (ITS) [IONSYS, The Medicines Company, Parsippany, NJ, USA] is a needle-free, patient-controlled, postoperative opioid pain management treatment. It is indicated for the short-term management of acute postoperative pain in adults requiring opioid analgesia in the hospital. The safety and effectiveness of fentanyl ITS for acute postoperative pain management has been demonstrated in a range of surgery and patient types studied in seven phase 3 trials (three placebo-controlled trials and four active-comparator trials). The majority of the patients in the phase 3 trials had undergone either abdominal/pelvic, orthopedic, or thoracic surgery. Consistent with the prescribing information, physicians in clinical practice may treat patients with this system following any type of surgery including those that may not have been included in the phase 3 trials. The purpose of this case series is to illustrate how fentanyl ITS is being utilized for postoperative pain management in real-world clinical practice following a variety of surgeries and in current pain management protocols that may have evolved since the completion of the phase 3 program. There are seven cases from three clinical centers described within this case series, each using fentanyl ITS according to the prescribing information. The surgery types included are bariatric (N = 3), prostate (N = 2), colorectal (N = 1), and perirectal abscess drainage (N = 1). A systematic review of each patient chart was conducted via a standardized retrospective assessment by the clinicians who managed each patient. Additionally, each healthcare professional was interviewed regarding their overall experience and key learnings using fentanyl ITS. Overall, fentanyl ITS was effective and well tolerated in these case reports in current-day clinical practice settings. These case studies are informative about fentanyl ITS use shortly after product approval and set the stage for additional clinical research.
芬太尼离子导入透皮系统（ITS）[IONSYS，美国默克公司，新泽西州帕西帕尼]是一种无需针头、患者自控的术后阿片类疼痛管理治疗方法。它适用于在医院需要阿片类镇痛的成人急性术后疼痛的短期管理。在七项3期试验（三项安慰剂对照试验和四项活性对照试验）中研究的一系列手术和患者类型中，已证明芬太尼ITS用于急性术后疼痛管理的安全性和有效性。3期试验中的大多数患者接受了腹部/盆腔、骨科或胸科手术。与处方信息一致，临床实践中的医生可以使用该系统治疗任何类型手术的患者，包括那些可能未纳入3期试验的手术。本病例系列的目的是说明在各种手术之后的现实临床实践中以及自3期项目完成以来可能已经演变的当前疼痛管理方案中，芬太尼ITS如何用于术后疼痛管理。本病例系列描述了来自三个临床中心的七个病例，每个病例均根据处方信息使用芬太尼ITS。所包括的手术类型有减肥手术（N = 3）、前列腺手术（N = 2）、结直肠手术（N = 1）和直肠周围脓肿引流术（N = 1）。负责每位患者的临床医生通过标准化的回顾性评估对每位患者的病历进行了系统审查。此外，还就他们使用芬太尼ITS的总体经验和主要收获对每位医护人员进行了访谈。总体而言，在当今临床实践环境中的这些病例报告中，芬太尼ITS有效且耐受性良好。这些案例研究为产品批准后不久芬太尼ITS的使用提供了信息，并为进一步的临床研究奠定了基础。
