Lieker Ina, Slowinski Torsten, Harms Lutz, Hahn Katrin, Klehmet Juliane
Department of Nephrology, Charité University Medicine, Berlin, Germany.
Department of Neurology, Charité University Medicine, Berlin, Germany.
J Clin Apher. 2017 Dec;32(6):486-493. doi: 10.1002/jca.21546. Epub 2017 May 9.
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare paralyzing inflammatory neuropathy with probably autoimmune origin. While plasma exchange (PE) constitutes a first-line treatment option for CIDP, there is only little known about the efficacy and safety of immunoadsorption (IA), a more selective apheresis procedure with assumed better tolerability.
In this prospective-randomized pilot trial, patients were randomly assigned to receive 6 sessions of PE (n = 10) or IA (n = 10) treating equal plasma volumes. To evaluate efficacy, we calculated the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score and the Medical Research Council (MRC) sum score at baseline (V1), after completion of 6 sessions (V2) as well as 4 weeks after completion (V3) in 9 patients per group (1 patient in each group did not complete follow-up). We additionally assessed safety and tolerability of treatments by monitoring adverse event and blood parameters.
With IA, 6 out of 9 (66.7%) patients improved clinically, whereas with PE, 4 out of 9 (44.4%) patients improved, most of them immediately with completion of the apheresis treatment series. There was one adverse event (AE) out of 52 treatment sessions for the 9 patients in the IA group. In the PE group of 9 patients, there was 1 AE out of 51 sessions and a trend of greater fibrinogen reduction. No severe AE occurred in either group.
The results of this pilot study suggest that IA is at least equally effective and safe compared to PE in CIDP patients.
慢性炎症性脱髓鞘性多发性神经病(CIDP)是一种罕见的麻痹性炎性神经病,可能起源于自身免疫。虽然血浆置换(PE)是CIDP的一线治疗选择,但对于免疫吸附(IA)这种更具选择性且耐受性可能更好的单采程序的疗效和安全性却知之甚少。
在这项前瞻性随机试点试验中,患者被随机分配接受6次PE治疗(n = 10)或IA治疗(n = 10),置换等量血浆。为评估疗效,我们计算了每组9例患者(每组各有1例患者未完成随访)在基线时(V1)、6次治疗完成后(V2)以及完成治疗4周后(V3)的校正炎症性神经病病因与治疗(INCAT)残疾评分和医学研究委员会(MRC)总分。我们还通过监测不良事件和血液参数评估了治疗的安全性和耐受性。
IA治疗组的9例患者中有6例(66.7%)临床症状改善,而PE治疗组的9例患者中有4例(44.4%)改善,其中大多数在完成单采治疗系列后立即改善。IA组9例患者的52次治疗中有1次不良事件(AE)。PE组9例患者的51次治疗中有1次AE,且有纤维蛋白原降低幅度更大的趋势。两组均未发生严重AE。
这项试点研究的结果表明,在CIDP患者中,IA与PE相比至少同样有效且安全。