Department of Physical Medicine and Rehabilitation, University of Missouri, Columbia, MO, USA.
Neuromodulation. 2019 Oct;22(7):805-810. doi: 10.1111/ner.12934. Epub 2019 Mar 19.
The objective of this study was to evaluate the accuracy and precision of SynchroMed II programmable infusion pumps for delivery of intrathecal baclofen to treat severe spasticity.
Retrospective chart review study.
Urban academic rehabilitation clinic.
PATIENTS (OR PARTICIPANTS): Patients with spasticity treated with intrathecal baclofen.
METHODS OR INTERVENTIONS (OR ASSESSMENT OF RISK FACTORS): A retrospective chart review of 149 patients inclusive of 755 individual patient encounters more than a 2.5-year span for baclofen pump refills was performed.
Charts were reviewed to obtain data on the concentration and dose of intrathecal baclofen, aspirated and residual volumes, age of the pump, and reservoir volume of the pump. Flow rate (mL/day) was calculated for each chronological visit. Flow rates from clinical data were used to calculate the accuracy and precision based on the manufacturer's specifications for both the 20 mL and 40 mL pumps.
The infused volume accuracy and precision of both the 20 mL pumps and 40 mL pumps remained within manufacturer's specifications while delivering drug at a rate slightly lower than predicted. There were no cases of pump over-infusion. There is a statistically significant decrease in flow rate accuracy over the lifespan of the pump.
SynchroMed II pumps infuse at slightly less than their predicted rate while remaining within the manufacturer's specifications. No pump over-infusions were noted. Pump flow rate declines over time. Further study is warranted to assess the impact of this flow rate decrease on patient treatment and safety.
本研究旨在评估 SynchroMed II 可编程输注泵在鞘内输注巴氯芬以治疗严重痉挛方面的准确性和精密度。
回顾性图表研究。
城市学术康复诊所。
患者（或参与者）：接受鞘内巴氯芬治疗的痉挛患者。
方法或干预措施（或评估危险因素）：对 149 名患者的病历进行了回顾性分析，这些患者在超过 2.5 年的时间内接受了 755 次单独的鞘内泵补充治疗。
对图表进行了审查，以获取有关鞘内巴氯芬的浓度和剂量、抽吸和残留量、泵龄以及泵储液器容积的数据。对每个时间点的流速（mL/天）进行了计算。根据制造商对 20 mL 和 40 mL 泵的规格，使用临床数据中的流速来计算准确性和精密度。
在以略低于预期的速度输送药物时，20 mL 泵和 40 mL 泵的输注体积准确性和精密度均符合制造商的规格，没有出现泵过度输注的情况。随着泵的使用寿命的延长，流速的准确性呈现出统计学上显著下降的趋势。
SynchroMed II 泵的输注速度略低于其预测值，但仍在制造商的规格范围内。未观察到泵过度输注的情况。泵的流速随时间下降。需要进一步研究以评估这种流速下降对患者治疗和安全性的影响。
