Arnold Donald M, Dentali Francesco, Crowther Mark A, Meyer Ralph M, Cook Richard J, Sigouin Christopher, Fraser Graeme A, Lim Wendy, Kelton John G
McMaster University and Juravinski Cancer Centre, Hamilton, Ontario, Canada.
Ann Intern Med. 2007 Jan 2;146(1):25-33. doi: 10.7326/0003-4819-146-1-200701020-00006.
Rituximab, a monoclonal anti-CD20 antibody, is increasingly used to treat idiopathic thrombocytopenic purpura (ITP).
To systematically review the literature on the efficacy and safety of rituximab for the treatment of adults with ITP.
MEDLINE, EMBASE, the Cochrane Library, abstracts from the American Societies of Hematology and Clinical Oncology annual meetings, and bibliographies of relevant articles and reviews were searched in duplicate until April 2006.
Descriptive and comparative studies in any language that met predefined inclusion criteria were eligible. Efficacy analysis was restricted to studies enrolling 5 or more patients.
Platelet count response, toxicities, dose, previous treatments, baseline platelet count, duration of ITP, study design, and sources of funding were extracted in duplicate.
We identified 19 eligible reports on efficacy (313 patients) and 29 on safety (306 patients). Weighted means for complete response (platelet count > 150 x 10(9) cells/L) and overall response (platelet count > 50 x 10(9) cells/L) with rituximab were 43.6% (95% CI, 29.5% to 57.7%) and 62.5% (CI, 52.6% to 72.5%), respectively. Responses lasted from 2 to 48 months. Nearly all patients had received corticosteroids, and 53.8% had undergone splenectomy. Nine patients (2.9%) died.
There were no controlled studies, and no studies met all criteria for study quality. Reported deaths could not necessarily be attributed to rituximab. Overall, the number of rituximab-treated patients with ITP reported in the literature is small.
Rituximab resulted in an overall platelet count response in 62.5% of adults with ITP. However, this finding derives from uncontrolled studies that also reported significant toxicities, including death in 2.9% of cases. These data suggest that providers should avoid indiscriminate use of rituximab and that randomized, controlled trials of rituximab for ITP are urgently needed.
利妥昔单抗是一种单克隆抗CD20抗体，越来越多地用于治疗特发性血小板减少性紫癜（ITP）。
系统评价利妥昔单抗治疗成人ITP的疗效和安全性的文献。
检索MEDLINE、EMBASE、Cochrane图书馆、美国血液学会和临床肿瘤学会年会摘要以及相关文章和综述的参考文献，重复检索至2006年4月。
符合预定义纳入标准的任何语言的描述性和比较性研究均符合条件。疗效分析仅限于纳入5名或更多患者的研究。
血小板计数反应、毒性、剂量、既往治疗、基线血小板计数、ITP病程、研究设计和资金来源均重复提取。
我们确定了19篇关于疗效的合格报告（313例患者）和29篇关于安全性的合格报告（306例患者）。利妥昔单抗治疗完全缓解（血小板计数>150×10⁹/L）和总体缓解（血小板计数>50×10⁹/L）的加权平均值分别为43.6%（95%CI，29.5%至57.7%）和62.5%（CI，52.6%至72.5%）。缓解持续2至48个月。几乎所有患者都接受过皮质类固醇治疗，53.8%的患者接受过脾切除术。9例患者（2.9%）死亡。
没有对照研究，也没有研究符合所有研究质量标准。报告的死亡不一定归因于利妥昔单抗。总体而言，文献中报道的接受利妥昔单抗治疗的ITP患者数量较少。
利妥昔单抗使62.5%的成人ITP患者血小板计数总体得到缓解。然而，这一发现来自非对照研究，这些研究也报告了显著的毒性，包括2.9%的病例死亡。这些数据表明，医疗人员应避免滥用利妥昔单抗，迫切需要对利妥昔单抗治疗ITP进行随机对照试验。
