The Efficacy and Safety of Different Dosages of Rituximab for Adults with Immune Thrombocytopenia: A Systematic Review and Meta-Analysis.
The Efficacy and Safety of Different Dosages of Rituximab for Adults with Immune Thrombocytopenia: A Systematic Review and Meta-Analysis.
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DOI：
10.1155/2021/9992086
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发表时间：
2021
影响因子：
--
通讯作者：
Hu M
中科院分区：
文献类型：
--
作者：
Dong Y;Yue M;Hu M
利妥昔单抗经常被用作免疫性血小板减少症（ITP）患者的二线治疗。利妥昔单抗的最佳剂量和疗程尚不确定。对报告使用低剂量（100 mg）或标准剂量（375 mg/m2）利妥昔单抗治疗ITP的随机对照试验进行了全面检索。对CRR（完全缓解率）、ORR（总缓解率）、PRR（部分缓解率）、SRR（持续缓解率）、感染率、SB（显著出血）率和SAE（严重不良事件）率进行meta分析。共纳入12项研究，包括869例患者。与对照组相比，利妥昔单抗治疗组在第6个月和第12个月的CRR （P < 0.00001）、ORR （P < 0.0001）和SRR （P = 0.0007、P = 0.0003）明显升高，但未增加感染率（P = 0.12）和SAE率（P = 0.11）。低剂量和标准剂量亚组的CRR （RR 1.61 vs. 1.42, P = 0.45）、ORR （RR 1.26 vs. 1.49, P = 0.28）、PRR （RR 1.25 vs. 1.00, P = 0.11）、第12个月SRR （RR 2.00 vs. RR 1.64, P = 0.54）、感染率（RR 0.85 vs. 1.46, P = 0.36）、SB率（RR 0.14 vs. 1.19, P = 0.17）差异无统计学意义。利妥昔单抗对成人ITP患者安全有效。低剂量利妥昔单抗方案可能是ITP标准剂量方案的有效替代方案，因为它在第12个月显示出相似的CRR， ORR和SRR，并且相对更安全，成本更低。
Rituximab has been frequently used as a second-line treatment for patients with immune thrombocytopenia (ITP). The optimal dose and course of rituximab are uncertain. A comprehensive search for randomized controlled trials reporting the use of low-dose (100 mg) or standard-dose (375 mg/m2) rituximab in ITP treatment was conducted. Meta-analyses were performed on CRR (complete response rate), ORR (overall response rate), PRR (partial response rate), SRR (sustained response rate), infection rate, SB (significant bleeding) rate, and SAE (serious adverse event) rate. A total of 12 studies were included, comprising 869 patients. Compared to the control group, rituximab treatment resulted in an obvious increase in CRR (P < 0.00001), ORR (P < 0.0001), and SRR at month 6 and 12 (P = 0.0007, P = 0.0003), without increasing the infection rate (P = 0.12) and SAE rate (P = 0.11). No significant differences in CRR (RR 1.61 vs. 1.42, P = 0.45), ORR (RR 1.26 vs. 1.49, P = 0.28), PRR (RR 1.25 vs. 1.00, P = 0.11), SRR at month 12 (RR 2.00 vs. RR 1.64, P = 0.54), infection rate (RR 0.85 vs. 1.46, P = 0.36), and SB rate (RR 0.14 vs. 1.19, P = 0.17) were found in subgroups of low dose and standard dose. Rituximab was effective and safe for adult patients with ITP. A low-dose rituximab regimen might be an effective alternative to the standard-dose regimen in ITP, as it showed similar CRR, ORR, and SRR at month 12 and was relatively safer with a lower cost.
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