Fraticelli Paolo, Martino Giuseppe Pio, Murri Marta, Mattioli Massimo, Gabrielli Armando
Clinica Medica, Department of Internal Medicine, Ospedali Riuniti, Università Politecnica delle Marche, Ancona, Italy.
Clinica Medica, Department of Internal Medicine, Ospedali Riuniti University Hospital, Ancona; and Department of Clinical and Molecular Sciences, Section of Clinical Medicine, Università Politecnica delle Marche, School of Medicine, Ancona, Italy.
Clin Exp Rheumatol. 2017 Sep-Oct;35 Suppl 106(4):173-178. Epub 2017 Aug 31.
The objective of the study is to evaluate the feasibility, safety and efficacy of home infusion of iloprost with the new portable syringe pump Infonde®, for the treatment of scleroderma-related Raynaud's phenomenon and digital ulcers.
12 scleroderma patients were treated with iloprost at home, using the pump, with infusion cycles of 2 days per month (24 hours a day), for 6 months.
The home treatment proved feasible since ten patients (83%) completed the entire infusion cycle, thus satisfying the feasibility target imposed by the protocol (75%). Side effects related to the device or venous access occurred in 3 out of 65 total 48-hour infusions (4.6%). They mostly consisted in phlebitis. No adverse events related to the device management were reported. Among the ten patients who completed the infusions, three showed a reduction in the number of ulcers, three maintained the same number, and four had no ulcers throughout the observation period. Patient's perception of their quality of life and wellness during home infusions, expressed with the Visual Analogue Scale (VAS) improved from 79/100 at the first infusion to 91/100 at the end of the study. All patients expressed a positive global judgment regarding this innovative method of iloprost infusion.
The infusion of iloprost at home with Infonde® is feasible, safe and effective. Moreover, this approach presents potential advantages from the economic and organisational point of view. Because of the pilot design of our study, these results need to be confirmed in larger randomised trials.
本研究的目的是评估使用新型便携式注射泵Infonde®在家中输注伊洛前列素治疗硬皮病相关雷诺现象和指端溃疡的可行性、安全性和有效性。
12例硬皮病患者在家中使用该泵接受伊洛前列素治疗，每月进行2天（每天24小时）的输注周期，持续6个月。
家庭治疗被证明是可行的，因为10名患者（83%）完成了整个输注周期，从而达到了方案规定的可行性目标（75%）。在总共65次48小时的输注中，有3次（4.6%）出现了与设备或静脉通路相关的副作用。主要为静脉炎。未报告与设备管理相关的不良事件。在完成输注的10名患者中，3名患者的溃疡数量减少，3名患者的溃疡数量维持不变，4名患者在整个观察期内没有溃疡。患者在家庭输注期间对生活质量和健康状况的感知，用视觉模拟量表（VAS）表示，从第一次输注时的79/100提高到研究结束时的91/100。所有患者对这种伊洛前列素输注的创新方法都给予了积极的总体评价。
使用Infonde®在家中输注伊洛前列素是可行、安全且有效的。此外，从经济和组织角度来看，这种方法具有潜在优势。由于我们研究的试点设计，这些结果需要在更大规模的随机试验中得到证实。
