Department of Neurology, Aarhus University Hospital, Aarhus C, Denmark.
Eur J Neurol. 2013 May;20(5):836-42. doi: 10.1111/ene.12080. Epub 2013 Jan 7.
We hypothesized that subcutaneous administration of immunoglobulins (SCIG) in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) is feasible, safe and superior to treatment with saline for the performance of muscle strength.
Thirty patients with motor involvement in maintenance therapy with intravenous immunoglobulin (IVIG) fulfilling the EFNS/PNS criteria for CIDP, aged 18-80 years, were randomized either to SCIG at a dose corresponding to their pre-study IVIG dose or to subcutaneous saline given twice or thrice weekly for 12 weeks at home. At the start and end of the trial as well as 2 weeks before (-2, 0, 10, 12 weeks), isokinetic strength performance of four predetermined and weakened muscle groups was measured. Also, an Overall Disability Sum Score (ODSS), 40-m-walking test (40-MWT), nine-hole-peg test, Neurological Impairment Score (NIS), Medical Research Council (MRC) score, grip strength, standardized electrophysiological recordings from three nerves, and plasma IgG levels were evaluated.
SCIG treatment was well tolerated in all 14 patients. Six patients complained of mild side-effects at the injection site. In the SCIG group there was an increase of isokinetic muscle strength of 5.5 ± 9.5% (P < 0.05) as compared with a decline of 14.4 ± 20.3% (P < 0.05) in the placebo group; the difference between the two groups being significant (P < 0.01). ODSS, NIS, MRC, grip strength and 40-MWT improved following SCIG versus saline.
SCIG treatment in CIDP is feasible, safe and effective, and seems an attractive alternative to IVIG.
我们假设在慢性炎症性脱髓鞘性多发性神经病（CIDP）中，皮下给予免疫球蛋白（SCIG）是可行的、安全的，并且在肌肉力量方面优于生理盐水治疗。
30 名患有运动障碍的患者在静脉免疫球蛋白（IVIG）维持治疗中符合 EFNS/PNS 制定的 CIDP 标准，年龄在 18-80 岁之间，随机分为 SCIG 组或生理盐水组，SCIG 组给予与研究前 IVIG 剂量相对应的剂量，生理盐水组在家中每周皮下给予 2 或 3 次，共 12 周。在试验开始和结束时，以及在试验前 2 周（-2、0、10、12 周），测量了四个预定的、减弱的肌肉群的等速肌力表现。此外，还评估了总体残疾总和评分（ODSS）、40 米步行测试（40-MWT）、九孔钉测试、神经损伤评分（NIS）、医学研究委员会（MRC）评分、握力、来自三根神经的标准化电生理记录以及血浆 IgG 水平。
14 名患者均能耐受 SCIG 治疗。6 名患者在注射部位出现轻微不良反应。与安慰剂组相比，SCIG 组的等速肌力增加了 5.5%±9.5%（P<0.05），而安慰剂组的等速肌力下降了 14.4%±20.3%（P<0.05）；两组之间的差异具有统计学意义（P<0.01）。与生理盐水相比，SCIG 治疗后 ODSS、NIS、MRC、握力和 40-MWT 均得到改善。
CIDP 中 SCIG 治疗是可行的、安全的和有效的，并且似乎是 IVIG 的一种有吸引力的替代方案。
