a Department of Hematology , The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University , Huai'an , China.
b Key Laboratory of Hematology of Nanjing Medical University , Nanjing , China.
Platelets. 2019;30(6):690-697. doi: 10.1080/09537104.2019.1624706. Epub 2019 Jun 3.
Rituximab has been frequently used as a second-line treatment for patients with immune thrombocytopenia (ITP). Recently, several studies have proposed low-dose (100 mg or 100mg/m per week for 4 weeks) rituximab instead of the standard dose of 375mg/m per week for 4 weeks to treat ITP patients. The aim of this review was to systematically evaluate the efficacy and safety of low-dose rituximab for patients with ITP. Pubmed, Web of Science, Cochrane Library and Embase were searched to identify the clinical studies published in full text or abstract that met the predefined inclusion criteria. Efficacy analysis was restricted to the studies enrolling five or more patients. While safety analysis was evaluated based on all the studies reported adverse events. Nine studies (329 patients) were included for effect assessment of low-dose rituximab treatment on the patients with ITP. The pooled overall response rate was 63% (95% CI, 0.54-0.71) while the pooled complete response was 44% (95% CI, 0.33-0.55). Thirty-one patients were reported to experience adverse effects associated with rituximab, among them 30 cases suffered mild to moderate side-effects (grade1-2). Only one patient developed into interstitial pneumonia (grade3). No death was reported. Low-dose rituximab exhibited a satisfactory efficacy and safety profile, indicating that this regimen is a promising therapy for ITP, and should be further investigated through randomized clinical trials with standard-dose rituximab.
利妥昔单抗已被广泛用于治疗免疫性血小板减少症（ITP）患者的二线治疗。最近，几项研究提出使用低剂量（每周 100mg 或 100mg/m，连续 4 周）利妥昔单抗替代标准剂量（每周 375mg/m，连续 4 周）来治疗 ITP 患者。本综述的目的是系统评价低剂量利妥昔单抗治疗 ITP 患者的疗效和安全性。通过检索 Pubmed、Web of Science、Cochrane Library 和 Embase，以识别符合预定纳入标准的全文或摘要发表的临床研究。疗效分析仅限于纳入 5 例或以上患者的研究。而安全性分析则基于所有报告不良事件的研究进行评估。纳入了 9 项研究（329 例患者）来评估低剂量利妥昔单抗治疗 ITP 患者的效果。总体反应率的合并值为 63%（95%CI，0.54-0.71），完全反应率的合并值为 44%（95%CI，0.33-0.55）。有 31 例患者报告与利妥昔单抗相关的不良反应，其中 30 例为轻度至中度副作用（1-2 级）。仅有 1 例患者发展为间质性肺炎（3 级）。无死亡报告。低剂量利妥昔单抗显示出令人满意的疗效和安全性，表明该方案是 ITP 的一种有前途的治疗方法，应通过与标准剂量利妥昔单抗的随机临床试验进一步研究。
