Nura Pain Clinic, Minneapolis, MN, USA.
Department of Anesthesiology, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
Neuromodulation. 2021 Oct;24(7):1167-1175. doi: 10.1111/ner.13353. Epub 2021 Jan 15.
To assist in assessment of therapy risks and benefits of targeted drug delivery (TDD) for chronic nonmalignant pain using registry data on product performance, adverse events, and elective device replacement.
The Product Surveillance Registry (PSR) (NCT01524276) is an ongoing prospective, long-term, multicenter registry enrolling consented patients implanted with an intrathecal drug delivery system. Patients are followed prospectively with participating investigators providing pump and catheter performance data for events related to the device, procedure, and therapy. Event descriptions include patient symptoms and outcomes.
Registry data from the 4646 patients (59.7% female) treated with TDD for chronic, nonmalignant pain at 59 registry sites between August 2003 and October 2019, with over 17,000 patient-years (4646 patients with 44 months average follow-up), were analyzed. Registry discontinuation was largely (46.2% of discontinued patients) due to study site closure and patient death; exit due to an adverse or device event was limited to 10.2%.
Treating chronic pain with escalating doses of strong systemic opioids often leads to inconsistent pain control, impaired function, untenable side effects, and reduced quality of life and this practice has contributed to the current opioid crisis in the United States. TDD has been an available therapy for these patients for greater than 30 years, and data from this real-world registry offer supporting evidence to the long-term safety of this therapy as an alternative to systemic opioids, as well as insights into patient acceptance and satisfaction.
利用产品性能、不良事件和选择性设备更换的注册数据，协助评估靶向药物输送（TDD）治疗慢性非恶性疼痛的治疗风险和获益。
正在进行的前瞻性、长期、多中心登记研究——产品监测登记（PSR）（NCT01524276），纳入了同意植入鞘内药物输送系统的患者。前瞻性随访患者，由参与的研究者提供与设备、手术和治疗相关的泵和导管性能数据。事件描述包括患者症状和结局。
2003 年 8 月至 2019 年 10 月期间，在 59 个登记地点，对 4646 例（59.7%为女性）慢性非恶性疼痛患者使用 TDD 进行治疗，共收集了超过 17000 患者年（4646 例患者的平均随访时间为 44 个月）的数据。登记的退出主要是由于研究地点关闭和患者死亡（46.2%的退出患者）；由于不良事件或设备事件而退出的患者仅占 10.2%。
用递增剂量的强阿片类药物治疗慢性疼痛往往导致疼痛控制不一致、功能受损、不可耐受的副作用以及生活质量下降，这种做法促成了美国目前的阿片类药物危机。TDD 已经成为这些患者的一种可行治疗方法，已有超过 30 年的历史，来自这个真实世界登记研究的数据为这种治疗方法作为替代全身阿片类药物的长期安全性提供了支持证据，同时也深入了解了患者的接受度和满意度。
