Department of Family Medicine, Pain and Palliative Care Unit, Siaal Family Medicine and Primary Care Research Center, Ben-Gurion University of the Negev, Beer-Sheva 84105, Israel.
Support Care Cancer. 2010 Sep;18(9):1165-70. doi: 10.1007/s00520-009-0736-x. Epub 2009 Sep 30.
The purpose of this study was to evaluate safety, feasibility, and efficacy of continuous drug delivery by the subcutaneous route through a solution bag connected to an infusion set compared with an infusion pump in a home palliative care setting.
Patients in need of continuous subcutaneous medication delivery for pain control, nausea, and/or vomiting were recruited. The study was designed as a double-blind, crossover study. The patient was connected to two parallel subcutaneous lines running simultaneously, connected together to a line entering the subcutaneous tissue. One line is connected to an infusion set and the other to a pump. The infusion set included a 500-cc solution bag connected to a 1.5-m plastic tube containing a drip chamber controlled by a roller clamp that is gravity driven without hyaluronidase. Active medications were randomly assigned to start in either administration method and switched after 24 h. An independent research assistant evaluated symptom control and side effects at baseline and every 24 h for 2 days using a structured questionnaire. Another independent research assistant connected the lines after adding medications and evaluated technical and clinical failures.
Twenty-seven patients were recruited, and of them, 18 completed the study. Incidents in fluid administration were more common through the infusion set (18 times) compared to the pump (only twice). On the other hand, no clinical significant change was noted in the average symptom levels and side effects when medications were given through the infusion set versus the pump. No local edema or irritation was observed in either way of administration.
In a home palliative care setting with a medical staff on call for 24 h, using medications for symptom control can be considered to be infused to a fluid solution bag through an infusion set instead of using a syringe driver or a pump when there is a responsible caregiver to follow up on the fluid. Subcutaneous constant drug delivery through a pump is more accurate.
本研究旨在评估在家庭姑息治疗环境中，通过与输注套件相连的溶液袋进行皮下持续药物输送与输注泵相比的安全性、可行性和疗效。
招募需要连续皮下给药以控制疼痛、恶心和/或呕吐的患者。该研究设计为双盲、交叉研究。患者连接到两条同时运行的并行皮下线，连接到进入皮下组织的一条线。一条线连接到输注套件，另一条线连接到泵。输注套件包括连接到 500 毫升溶液袋的 1.5 米塑料管，其中包含一个由滚轮夹控制的滴注室，该滴注室由重力驱动，不使用透明质酸酶。活性药物随机分配开始于任一种给药方法，并在 24 小时后切换。一名独立的研究助理在基线和每 24 小时使用结构化问卷评估症状控制和副作用，共评估两天。另一名独立的研究助理在添加药物后连接线路，并评估技术和临床失败。
共招募了 27 名患者，其中 18 名完成了研究。通过输注套件给药时发生的液体给药事件更常见（18 次），而通过泵给药时仅发生两次。另一方面，当通过输注套件与泵给药时，药物给予时平均症状水平和副作用没有明显变化。两种给药方式均未观察到局部水肿或刺激。
在有医疗人员 24 小时随叫随到的家庭姑息治疗环境中，当有负责的护理人员跟进液体时，可以考虑使用输注套件将药物输注到溶液袋中，而不是使用注射器驱动器或泵来控制症状。通过泵进行皮下持续药物输送更准确。
