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手动推注技术,慢性炎症性脱髓鞘性多发性神经病皮下免疫球蛋白给药的另一种途径:一项概念验证研究。

Manual push technique, an alternative route of subcutaneous immunoglobulin administration in chronic inflammatory demyelinating polyradiculoneuropathy: A proof-of-concept study.

机构信息

Divisione di Riabilitazione Neuromotoria, Istituti Clinici Scientifici Maugeri, Presidio Sanitario Major, Via Santa Giulia, 60, 10124, Torino, Italy.

Dipartimento di Neuroscienze - Università di Torino, A.O.U. Città della Salute e della Scienza di Torino, Corso Bramante, 88, 10126, Torino, Italy.

出版信息

Clin Neurol Neurosurg. 2020 Nov;198:106240. doi: 10.1016/j.clineuro.2020.106240. Epub 2020 Sep 16.

DOI:10.1016/j.clineuro.2020.106240
PMID:32971302
Abstract

OBJECTIVE

Subcutaneous immunoglobulin (SCIg) administered through infusion pump has been reported as effective in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) patients. In this study we evaluate an alternative technique of SCIg administration, based on the delivery of lower volumes administered daily using manual push technique (MPT) in 10 CIDP patients.

METHODS

In this randomized, controlled, two-arm, crossover clinical trial, CIDP patients were randomly assigned 1:1 to receive SCIg either by MPT or pumps for 4 consecutive months with crossover to the other. The primary objective was to assess whether MPT had the same effectiveness as pumps. The secondary objectives were to assess whether MPT resulted in greater plasma IgG levels and improved quality of life (QoL).

RESULTS

Ten patients (mean age = 48.3) were enrolled. No significant changes were observed in the efficacy parameters (INCAT, MRC, R-ODS, and GS scales). A positive mean variation of 5.4 % in plasma IgG levels in the group treated with MPT was observed at the end of MPT periods. Treatment interference, which is one of the dimensions of the Life Quality Index, showed a significant improvement in the MPT periods.

CONCLUSION

In CIDP patients, the MPT technique was as effective as pump infusion, allowed comparable, slightly increases plasma IgG levels, and also improved the QoL.

摘要

目的

通过输注泵给予皮下免疫球蛋白(SCIg)已被报道可有效治疗慢性炎症性脱髓鞘性多发性神经病(CIDP)患者。在这项研究中,我们评估了一种替代的 SCIg 给药技术,即通过手动推注技术(MPT)每天给予较低体积的药物,共 10 例 CIDP 患者接受了该技术。

方法

在这项随机、对照、双臂、交叉临床试验中,将 CIDP 患者随机 1:1 分配接受 MPT 或泵治疗,连续 4 个月,然后交叉至另一种治疗。主要目的是评估 MPT 是否与泵治疗具有相同的疗效。次要目的是评估 MPT 是否导致更高的血浆 IgG 水平和改善生活质量(QoL)。

结果

共纳入 10 例患者(平均年龄为 48.3 岁)。在疗效参数(INCAT、MRC、R-ODS 和 GS 量表)方面未观察到显著变化。接受 MPT 治疗的患者在 MPT 期间观察到血浆 IgG 水平的平均变化为 5.4%。生活质量指数的一个维度,即治疗干扰,在 MPT 期间显著改善。

结论

在 CIDP 患者中,MPT 技术与泵输注一样有效,可产生相当的效果,略微增加血浆 IgG 水平,并且还改善了生活质量。

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