Virginia Commonwealth University Spine Center, Richmond, VA 23235, USA.
Pain Med. 2012 Oct;13(10):1304-13. doi: 10.1111/j.1526-4637.2012.01451.x. Epub 2012 Jul 30.
Long-term follow-up with the use of low-dose opioids in intrathecal (IT) drug delivery system (DDS) for the treatment of intractable, severe chronic nonmalignant pain.
This is a prospective, cohort long-term outcome study. Intervention. The intervention was the implantation of DDS.
A total of 61 consecutive patients (60% females, 40% males) with a mean age of 59.2 years and a mean duration of symptoms prior to implant of 6.2 years were referred for implant of DDS for severe intractable noncancer pain. After adequate patient evaluation, each underwent a trial with IT opioids. Three patients failed the trial and 58 patients were implanted. Follow-up was 36 months, with intervals at 6, 12, 18, 24, and 36 months. The Brief Pain Inventory was used for follow-up assessment criteria at baseline prior to implant as well as throughout the duration of the study.
Outcome measures included self-reported pain scores (worst and average), functional improvement, and IT dose, and oral opioid consumption.
We observed a statistically significant reduction in both worst and average pain from baseline (8.91 and 7.47 at baseline) throughout the duration of the study (4.02 and 3.41, respectively, at 36 months) (P = 0.012 and P < 0.001, respectively). We also documented a statistically significant improvement in physical and behavioral function. All subjects showed a significant reduction in the oral opioid consumption. The dose of IT opioids remained low and virtually unchanged for 36 months of follow-up: 1.4 morphine equivalent/day at 6 months and 1.48 at 36 months. Oral opioid averaged 128.9 mg of morphine equivalent/patient/day at baseline to 3.8 at 3 month and remained at the same level throughout the study.
Low-dose IT opioid can provide sustained significant improvement in pain and function for long-term follow-up in chronic noncancer pain.
长期使用鞘内（IT）药物输送系统（DDS）中的低剂量阿片类药物治疗难治性严重慢性非恶性疼痛。
这是一项前瞻性队列长期结果研究。干预措施是 DDS 的植入。
共有 61 例连续患者（女性占 60%，男性占 40%），平均年龄 59.2 岁，植入前症状平均持续 6.2 年，因严重难治性非癌性疼痛而接受 DDS 植入。在对患者进行充分评估后，每位患者都进行了 IT 阿片类药物试验。有 3 名患者试验失败，58 名患者接受了植入。随访时间为 36 个月，间隔为 6、12、18、24 和 36 个月。在植入前的基线以及整个研究期间，使用简短疼痛量表（BPI）作为随访评估标准。
我们观察到，从基线（植入前分别为 8.91 和 7.47）到研究期间（36 个月时分别为 4.02 和 3.41），最差和平均疼痛均有统计学显著下降（P = 0.012 和 P < 0.001）。我们还记录到身体和行为功能的统计学显著改善。所有患者的口服阿片类药物消耗量均显著降低。IT 阿片类药物的剂量在 36 个月的随访期间保持低且几乎不变：6 个月时为 1.4 吗啡当量/天，36 个月时为 1.48。口服阿片类药物的平均吗啡当量为 128.9mg/患者/天，基线时为 3.8 个月，整个研究期间保持不变。
低剂量 IT 阿片类药物可为慢性非癌性疼痛的长期随访提供持续显著的疼痛和功能改善。
