Oksenhendler E, Chevret S, Léger J M, Louboutin J P, Bussel A, Brouet J C
Department of Immunology and Hematology, Hôpital Saint-Louis, Paris, France.
J Neurol Neurosurg Psychiatry. 1995 Sep;59(3):243-7. doi: 10.1136/jnnp.59.3.243.
The study compared chlorambucil alone with chlorambucil in combination with plasma exchange in patients with polyneuropathy associated with monoclonal IgM. Forty four patients were prospectively randomly assigned, in a comparative open trial, to receive either 0.1 mg/kg/day chlorambucil orally, for 12 months or chlorambucil associated with 15 courses of plasma exchange, during the first four months of treatment. They were evaluated by a neuropathy disability score and nerve conduction studies. No difference was found between the two treatment groups. The average neuropathy disability score improved by 2.1 points from baseline (21.0 to 18.9) in the chlorambucil group and by 1.8 points (20.4 to 18.6) in the chlorambucil + plasma exchange group (P = 0.70). The mean motor nerve conduction velocity decreased from 20.0 to 18.2 m/s in the chlorambucil group and increased from 20.5 to 22.5 m/s in the chlorambucil + plasma exchange group (P = 0.51). A slight improvement of the sensory component of the neuropathy disability score (from 10.5 to 8.3) was noted in both groups (P = 0.01). At the end of the study and according to self evaluation, 15 patients--eight from the chlorambucil group and seven from the chlorambucil + plasma exchange group--reported clinical improvement, whereas 15--eight from the chlorambucil group and seven from the chlorambucil + plasma exchange group--reported clinical worsening. Neuropathy remained stable in the others. Thus plasma exchange seemed to confer no additional benefit in the treatment of polyneuropathy associated with monoclonal IgM.
该研究比较了苯丁酸氮芥单药治疗与苯丁酸氮芥联合血浆置换疗法对单克隆IgM相关性多发性神经病患者的疗效。在一项比较性开放试验中，44例患者被前瞻性随机分配，分别接受为期12个月、每日口服0.1mg/kg苯丁酸氮芥的治疗，或在治疗的前四个月接受苯丁酸氮芥联合15个疗程血浆置换的治疗。通过神经病残疾评分和神经传导研究对患者进行评估。结果发现，两个治疗组之间没有差异。苯丁酸氮芥组的平均神经病残疾评分从基线时的21.0分改善至18.9分，提高了2.1分；苯丁酸氮芥+血浆置换组的平均神经病残疾评分从20.4分改善至18.6分，提高了1.8分（P = 0.70）。苯丁酸氮芥组的运动神经传导速度从20.0m/s降至18.2m/s，而苯丁酸氮芥+血浆置换组的运动神经传导速度从20.5m/s增至22.5m/s（P = 0.51）。两组患者的神经病残疾评分中的感觉部分均有轻微改善（从10.5分降至8.3分）（P = 0.01）。在研究结束时，根据患者的自我评估，15例患者——苯丁酸氮芥组8例，苯丁酸氮芥+血浆置换组7例——报告临床症状改善，而另有15例患者——苯丁酸氮芥组8例，苯丁酸氮芥+血浆置换组7例——报告临床症状恶化。其余患者的神经病病情保持稳定。因此，血浆置换似乎并未给单克隆IgM相关性多发性神经病的治疗带来额外益处。
