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大剂量与标准剂量甲基泼尼松龙治疗特发性血栓性血小板减少性紫癜急性期:一项随机研究。

High versus standard dose methylprednisolone in the acute phase of idiopathic thrombotic thrombocytopenic purpura: a randomized study.

机构信息

Internal Medicine, IRCCS Policlinico San Matteo Foundation, University of Pavia, Pavia, Italy.

出版信息

Ann Hematol. 2010 Jun;89(6):591-6. doi: 10.1007/s00277-009-0877-5. Epub 2009 Dec 23.

DOI:10.1007/s00277-009-0877-5
PMID:20033409
Abstract

Therapeutic plasma exchange (PE) is the accepted therapy for thrombotic thrombocytopenic purpura (TTP). Because not all patients achieve remission, other treatment modalities have been used in addition to PE, but no randomized clinical trial evaluated their efficacy. The aim of this multicentric study was to compare the effectiveness of standard- versus high-dose methylprednisolone as an adjunctive treatment to PE in the acute phase of TTP. Sixty patients with idiopathic TTP were randomized to receive methylprednisolone 1 mg/kg/die intravenous or 10 mg/kg/die for 3 days, thereafter, 2.5 mg/kg/die in addition to PE. Both dosages of steroids were well tolerated. At the end of induction therapy (day 23), the percentage of patients failing to achieve complete remission was significantly higher in the standard dose (16 of 30) than in the high-dose group (seven of 30). Also, the number of cases without a good response at day 9 and the number of deaths were higher in the standard-dose arm, but the differences did not reach the statistical significance. Results of present study indicate that the association of PE with high-dose instead of standard-dose steroids reduces the percentage of TTP patients that fail to achieve complete remission.

摘要

治疗性血浆置换(PE)是治疗血栓性血小板减少性紫癜(TTP)的公认疗法。由于并非所有患者都能缓解,因此除了 PE 之外,还使用了其他治疗方式,但没有随机临床试验评估它们的疗效。本多中心研究的目的是比较标准剂量与高剂量甲基强的松龙作为 TTP 急性期 PE 辅助治疗的有效性。60 例特发性 TTP 患者随机接受甲基强的松龙 1mg/kg/d 静脉注射或 10mg/kg/d 连续 3 天,然后在 PE 基础上加用 2.5mg/kg/d。两种剂量的类固醇均耐受良好。在诱导治疗结束时(第 23 天),标准剂量组(30 例中有 16 例)未能完全缓解的患者比例明显高于高剂量组(30 例中有 7 例)。此外,标准剂量组第 9 天无良好反应的病例数和死亡人数较高,但差异无统计学意义。本研究结果表明,PE 联合高剂量而非标准剂量类固醇可降低 TTP 患者未能完全缓解的比例。

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