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首页> 外文期刊>Archives of neurology. >Timing and course of clinical response to intravenous immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy.
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Timing and course of clinical response to intravenous immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy.

机译:时间和课程的临床反应静脉注射免疫球蛋白在慢性炎症性脱髓鞘多神经根神经病。

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OBJECTIVE: To investigate the timing, course, and clinical characteristics of the response to intravenous immunoglobulin in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). DESIGN: Data were extracted from the ICE trial, a randomized, double-blind, placebo-controlled trial of immune globulin intravenous, 10% caprylate/chromatography purified (IGIV-C). SETTING: Multiple international centers. PARTICIPANTS: One hundred seventeen individuals with CIDP. Intervention Treatment with IGIV-C (Gamunex, n = 59) or placebo (n = 58), with IGIV-C administered as a 2-g/kg loading dose followed by a 1-g/kg maintenance dose every 3 weeks, for up to 24 weeks. MAIN OUTCOME MEASURES: The primary efficacy parameter was an improvement of 1 or more points in adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score. Participants treated with IGIV-C were divided into subgroups based on meeting responder vs nonresponder definitions and by time to first improvement. RESULTS: Among 30 responders to IGIV-C, 14 (47%) patients had improved adjusted INCAT scores by week 3, and 16 (53%) patients improved at week 6 after a second infusion. Participants who improved by week 3 were more severely disabled at baseline than those who improved at 6 weeks. In patients who improved, the number of individuals reaching maximal improvement continued to increase during maintenance therapy for up to 24 weeks. For patients with first improvement by week 3, the change in dominant-hand grip strength over time tended to parallel the INCAT score. In patients with first improvement by week 6, however, the improvement in dominant-hand grip strength preceded initial improvement in INCAT score. CONCLUSIONS: Data suggest that treatment with 2 courses of IGIV-C administered 3 weeks apart may be required for initial improvement, and continued maintenance therapy may be necessary to achieve a maximal therapeutic response. Trial Registration clinicaltrials.gov Identifier: NCT00220740.
机译:摘要目的:探讨时机,和反应的临床特征静脉注射免疫球蛋白在慢性炎性脱髓鞘多神经根神经病(CIDP)。试验,随机、双盲、免疫球蛋白的安慰剂对照试验静脉注射,10%辛酸盐/色谱法净化(IGIV-C)。国际中心。十七CIDP患者。治疗IGIV-C (Gamunex, n = 59)或安慰剂组(n = 58),与IGIV-C管理2 g /公斤负荷剂量1克/公斤维持剂量每3周,24周。疗效参数是1或有所改善更多的点调整的炎性病变原因和治疗(INCAT)残疾得分。参与者接受IGIV-C分裂根据会议响应者和成子组nonresponder定义和时间先改进。IGIV-C, 14名(47%)患者有改善调整INCAT分数,星期3,16例(53%)患者改善在第6周后第二个输液。参与者3更提高了一周在基线比那些严重残疾改善在6周。个体的数量达到最大改善持续增加中维持治疗24周。患者首先改善周3,随着时间的推移变化优势手握力倾向于并行INCAT分数。首先改进第6周,然而,提高优势手握力之前初步改善INCAT得分。结论:数据显示,治疗2每隔3周IGIV-C可能的课程需要初步改善,继续维持疗法可能是必要的实现最大的治疗反应。登记clinicaltrials.gov标识符:NCT00220740。

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