Carpenter Anna Lynne, McGuire Joseph Aaron, Nemergut Edward Charles, Bauer Kelsey Marie, Navalgund Yeshvant Ashok, Scalzo David Carmine, Vaglienti Richard Martin, Layne-Stuart Corinne Michel
Department of Anesthesiology, Division of Pain Medicine, West Virginia University School of Medicine, Morgantown, WV.
Department of Anesthesiology, West Virginia University School of Medicine, Morgantown, WV.
Pain Physician. 2025 Mar;28(2):147-154.
The optimal dosing and delivery strategies for intrathecal ziconotide are debated. Previous research suggests that high volume, low concentration dosing techniques may decrease side effects and enhance analgesic effect. Previous studies that have investigated the effects of diluting ziconotide have examined continuous infusions of the medication through an intrathecal pump.
This study investigates the trial phase to determine if diluting the bolus dose leads to improved outcomes. The hypothesis of the authors is that the dilution of ziconotide will improve the trial outcomes.
This single-center, retrospective, case-control study included 62 patients with chronic pain refractory to conservative therapy who received a one-time intrathecal bolus dose of ziconotide.
The study included 62 patients who received a single outpatient trial dose of ziconotide. The study was approved by an institutional review board. Data were collected from electronic medical records. Doses ranged from a total of 2.5 µg-5 µg in a volume of 0.5 mL-5 mL. The primary endpoints were the number of patients that achieved significant pain relief (>= 50%) and the presence or absence of side effects. Statistical analysis was performed using a c2 test to evaluate side effects and meaningful pain relief and an unpaired, 2-tailed t test to evaluate pain relief percentage.
There were no differences in side effects experienced by the patients in the Undiluted Group compared to the patients in the Diluted Group (21% vs 25%; P = 0.679). There were no differences in pain relief in the Undiluted Group compared to the Diluted Group (59% vs 61%; P = 0.880). The mean (SD) pain relief in the Undiluted Group was 46% (± 40%) compared to 51% (± 41%) in the Diluted Group (P = 0.645). A power analysis revealed a 68% power to detect a difference between the groups.
These results are limited by the accuracy of the chart review and sample size; therefore, additional investigation may be warranted.
This study demonstrates there is no substantial difference between diluted and undiluted bolus doses of intrathecal ziconotide in regard to analgesic effect or side effects.
鞘内注射齐考诺肽的最佳给药剂量和给药策略仍存在争议。先前的研究表明，大容量、低浓度给药技术可能会减少副作用并增强镇痛效果。以往研究齐考诺肽稀释效果时，均是通过鞘内泵持续输注该药物。
本研究旨在调查试验阶段，以确定稀释推注剂量是否能带来更好的结果。作者的假设是，齐考诺肽的稀释将改善试验结果。
这项单中心、回顾性、病例对照研究纳入了62例对保守治疗无效的慢性疼痛患者，他们接受了一次性鞘内推注齐考诺肽。
该研究纳入了62例接受单次门诊齐考诺肽试验剂量的患者。该研究经机构审查委员会批准。数据从电子病历中收集。剂量范围为总量2.5μg - 5μg，体积为0.5mL - 5mL。主要终点是实现显著疼痛缓解（≥50%）的患者数量以及是否存在副作用。使用卡方检验进行统计分析，以评估副作用和有意义的疼痛缓解情况，并使用不成对双尾t检验评估疼痛缓解百分比。
与稀释组患者相比，未稀释组患者经历的副作用无差异（21%对25%；P = 0.679）。与稀释组相比，未稀释组的疼痛缓解情况无差异（59%对61%；P = 0.880）。未稀释组的平均（标准差）疼痛缓解率为46%（±40%），而稀释组为51%（±41%）（P = 0.645）。功效分析显示检测两组间差异的功效为68%。
这些结果受图表审查准确性和样本量的限制；因此，可能需要进一步研究。
本研究表明，鞘内注射齐考诺肽时，稀释和未稀释的推注剂量在镇痛效果或副作用方面没有实质性差异。
