Mechanical versus Electronic Infusion Systems in Subcutaneous Immunoglobulin Therapy: A Structured Literature Review of Infusion-Site Reactions and Device Performance.

IF 1.5 Q4 ENGINEERING, BIOMEDICAL
Medical Devices-Evidence and Research Pub Date : 2026-07-27 eCollection Date: 2026-01-01 DOI:10.2147/MDER.S620773
Anna Majapuro-Hirvonen, Brent Rutland, Jasmin Bosshard
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引用次数: 0

Abstract

Objective: Objective was to compare spring-driven mechanical and electronic infusion systems used for subcutaneous immunoglobulin (SCIg) therapy in patients with primary or secondary immunodeficiency (PID, SID) and chronic inflammatory demyelinating polyneuropathy (CIDP), with a focus on local infusion-site reactions and reliable dose delivery.

Methods: A structured literature review was conducted (PubMed, Cochrane Library, Google Scholar; January 26, 2026). Eligible studies reported safety outcomes. As direct measures of dose delivery were not consistently reported, infusion system performance was evaluated using pharmacodynamic response, with immunoglobulin G (IgG) levels at the end of the study period considered an indicator of successful dose delivery. Data were extracted and descriptively aggregated across studies. Risk of bias was appraised using validated tools appropriate to study design.

Results: Fourteen studies met the inclusion criteria (4 mechanical, 10 electronic). Mechanical infusion systems were associated with lower reported proportions of local infusion-site reactions, including swelling (23.1% vs 61.4%), redness (28.6% vs 44.0%), and soreness (22.9% vs 50.0%) compared with electronic infusion systems. Variability across studies was substantial, likely reflecting differences in patient populations, immunoglobulin formulations, infusion protocols, publication era, and outcome reporting methods. Across studies, both mechanical and electronic infusion systems achieved IgG levels consistent with therapeutic targets, supporting effective SCIg delivery.

Conclusion: Mechanical infusion systems were associated with consistently lower reported rates of local infusion-site reactions compared with electronic infusion systems in this descriptive synthesis, while both system types effectively achieved IgG levels consistent with adequate dose delivery. Although variability across studies warrants cautious interpretation, the overall pattern suggests a favorable tolerability profile for mechanical systems. Device selection should remain individualized, and further comparative research is warranted.

皮下免疫球蛋白治疗中的机械与电子输注系统:输注现场反应和设备性能的结构化文献综述。
目的:比较弹簧驱动的机械和电子输注系统用于皮下免疫球蛋白(SCIg)治疗原发性或继发性免疫缺陷(PID, SID)和慢性炎症性脱髓鞘多神经病变(CIDP)患者,重点是局部输注现场反应和可靠的剂量递送。方法:进行结构化文献综述(PubMed, Cochrane Library,谷歌Scholar; 2026年1月26日)。符合条件的研究报告了安全性结果。由于剂量递送的直接测量方法没有一致的报道,因此使用药效学反应来评估输注系统的性能,研究期结束时的免疫球蛋白G (IgG)水平被认为是剂量递送成功的指标。从研究中提取数据并描述性地汇总。使用适合研究设计的有效工具评估偏倚风险。结果:14项研究符合纳入标准(机械4项,电子10项)。与电子输液系统相比,机械输液系统报告的局部输液反应比例较低,包括肿胀(23.1%对61.4%)、发红(28.6%对44.0%)和疼痛(22.9%对50.0%)。研究之间的差异很大,可能反映了患者群体、免疫球蛋白配方、输注方案、发表时间和结果报告方法的差异。在所有研究中,机械和电子输注系统都达到了与治疗目标一致的IgG水平,支持有效的SCIg输送。结论:在这一描述性合成中,机械输注系统与电子输注系统相比,报告的局部输注现场反应率始终较低,而两种系统类型都有效地达到了与适当剂量递送一致的IgG水平。尽管研究中的可变性需要谨慎的解释,但总体模式表明机械系统具有良好的耐受性。器械选择应保持个体化,进一步的比较研究是必要的。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Medical Devices-Evidence and Research
Medical Devices-Evidence and Research ENGINEERING, BIOMEDICAL-
CiteScore
2.80
自引率
0.00%
发文量
41
审稿时长
16 weeks
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