芬太尼离子电渗透皮系统(ITS)[IONSYS®,药品公司,Parsippany,NJ,美国]是无针的,病人控制,术后阿片类药物疼痛管理治疗。它适用于在医院需要阿片类药物镇痛的成年人的急性术后疼痛的短期管理。芬太尼ITS用于急性术后疼痛管理的安全性和有效性已在7项3期试验(3项安慰剂对照试验和4项主动比较试验)的一系列手术和患者类型中得到证明。3期试验中的大多数患者都经历了腹部/骨盆,骨科,或者是胸外科手术.与处方信息一致,临床实践中的医师可以在任何类型的手术后使用该系统治疗患者,包括可能未包括在3期试验中的手术.本案例系列的目的是说明芬太尼ITS如何在各种手术后的现实临床实践中以及在自完成第3阶段计划以来可能已经发展的当前疼痛管理方案中用于术后疼痛管理。在这个病例系列中描述了来自三个临床中心的七个病例,每个人都根据处方信息使用芬太尼ITS。包括的手术类型是减肥(N=3),前列腺(N=2),结直肠(N=1),直肠周围脓肿引流(N=1)。由管理每个患者的临床医生通过标准化的回顾性评估对每个患者图表进行系统审查。此外,对每位医疗保健专业人员进行了采访,了解他们使用芬太尼ITS的总体经验和关键经验.总的来说,在当前临床实践环境中,这些病例报告中芬太尼ITS有效且耐受性良好.这些案例研究提供了有关产品批准后不久使用芬太尼ITS的信息,并为其他临床研究奠定了基础。
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.