文摘
摘要目的:确定神经传导研究(nc)保持稳定患者的慢性炎性脱髓鞘多神经病(CIDP)在研究药物管理局与低或高剂量皮下免疫球蛋白(SCIG)或安慰剂。
背景:nc形式必不可少的一部分CIDP的诊断标准和客观措施周围神经功能的独立的混杂因素会干扰临床分数。
设计/方法:这是一个随机、双盲试验调查0.2(低)和0.4克/公斤(高)每周剂量的维护SCIG IgPro20 (CSL贝林)与172例安慰剂。测试依赖Ig治疗后,病人被随机分为SCIG或安慰剂,nc进行研究药物管理局开始和结束的时期在25周或提前终止。从每个病人平均电生理数据给平均近端延迟,传导速度,传导阻滞(30、40和50%)、复合肌肉动作电位振幅,意味着平均参数变化的运动神经从基线完成访问。
结果:大多数的nc参数没有变化;然而,在安慰剂组平均近端延迟增加(+ 1.1 ms)但仍稳定在IgPro20组(低剂量:+ 0.1女士;高剂量:−0.1毫秒)。的平均运动神经传导速度(MNCV)安慰剂组下降(−1.6 m / s),但增加在IgPro20组(低剂量:+ 0.2米/秒;高剂量:+ 1.0 m / s)。这些变化将是进一步的临床相关探索。
结论:大多数nc参数没有改变在SCIG治疗阶段路径的研究除了那些反映传导速度(平均延迟和MNCV近端),以一种积极的方向去SCIG患者治疗与安慰剂比较的病人。
研究支持:CSL贝林
披露:成Bril博士已经收到个人赔偿咨询、担任科学顾问委员会说,与Octapharma或其他活动,Grifols, CSL,药。Van Schaik博士已经收到了个人在一篇社论中补偿能力Cochrane神经肌肉疾病组。Van Schaik博士已经收到了来自中超贝林研究支持;巴克斯特。范博士Geloven已经收到了来自中超贝林研究支持。哈博士已经收到个人赔偿咨询、担任科学顾问委员会说,或其他活动Idec, GeNeuro,赛诺菲安万特Genzyme,默克公司,诺华制药、Octapharma, Opexa疗法,梯瓦制药、落实的拜耳医疗、医药,和罗氏。刘易斯博士已经收到个人赔偿咨询、担任科学顾问委员会说,与中超贝林或其他活动;Axelacare;Pharnext;生物监测; Kedrion; Nufactor; Optioncare; Grifols. Dr. Lewis has received research support from Neutralis; Cytokinetics. Dr. Sobue has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Mitsubishi Tanabe Pharma Co; Shionogi Co Ltd; Bristol Myers Squibb; Sumitomo Dainippon Pharma Co Ltd; Novartis Pharma KK; Bayer Yakuhin Ltd; Pfizer Japan Inc; Boehringer Ingelheim Japan Inc; Kissei Pharmaceutical Co Ltd; Janssen Pharmaceutical KK; Teijin. Dr. Lawo has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with CSL Behring GmbH. Dr. Mielke has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with CSL Behring GmbH. Dr. Durn has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with CSL Behring. Dr. Cornblath has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Acetylon Pharmaceuticals Inc; Alcobra Pharma; Alnylam Pharmaceuticals; Annexon Biosciences; Akros Pharma; Biotest; Boehringer Ingelheim; Cigna Health Management Inc; CSL Behring; DP Clinical Inc; GLAXOSMITHKLINE Plc; Grifols S.A.; Hansa Medical Inc; Karos. Dr. Cornblath has received royalty, license fees, or contractual rights payments from Acetylon Pharmaceuticals Inc; AstraZeneca Pharmaceuticals LP; Calithera Biosciences; Genentech Inc; Neurocrine Biosciences; Merrimack Pharmaceuticals Inc; Seattle Genetics, Inc; Shire Development, LLC. Dr. Merkies has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Talecris. Dr. Merkies has received personal compensation in an editorial capacity for Journal of Peripheral Nervous System.
