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一种用于系统性红斑狼疮相关难治性免疫性血小板减少症患者的低剂量利妥昔单抗改良治疗方案。

A modified regimen of low-dose rituximab therapy for patients with refractory immune thrombocytopenia associated with systemic lupus erythematosus.

作者信息

Zhang Shuo, Jiang Nan, Wang Li, Zhang Li, Chen Hua, Li Mengtao, Zeng Xiaofeng

机构信息

Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, Beijing, China.

Department of Rheumatology and Clinical Immunology, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Sciences, No. 1 Shuaifuyuan, Dongcheng District, Beijing 100730, China.

出版信息

Ther Adv Chronic Dis. 2021 Oct 10;12:20406223211048643. doi: 10.1177/20406223211048643. eCollection 2021.

Abstract

BACKGROUND

Severe and refractory immune thrombocytopenia (ITP) affects the life expectancy of patients with systemic lupus erythematosus (SLE) and poses a challenge in their clinical management. This intervention study employed a small sample size to evaluate the efficacy and safety of a modified low-dose rituximab (RTX) regimen in patients with SLE-associated refractory ITP.

METHODS

Eight patients with severe SLE-associated refractory ITP were enrolled in this intervention study. They received an infusion of intravenous RTX (200 mg) on days 1 and 15. The dose of corticosteroids (prescribed previously) was gradually tapered, and immunosuppressants were withdrawn. Patients were followed up at 1, 3, 6, and 12 months; platelet counts, other laboratory indicators, and side effects were recorded. We used intention-to-treat analysis to calculate the response rate.

RESULTS

Seven participants (87.5%) completed the study. At 1 month, two patients (25.0%) achieved partial response (PR); the PR rate increased to 87.5% at 3 months. At 6 months, three patients (37.5%) achieved complete response (CR). However, the CR rate dropped to 25.0% at 12 months. The overall responses (ORs) were 25.0% (2/8), 87.5% (7/8), 75.0%(6/8), and 75.0%(6/8) at 1, 3, 6, and 12 months, respectively. Two patients developed a mild infusion reaction and one discontinued the study due to herpes zoster virus infection and an allergic reaction 2 weeks after the first dose of RTX.

CONCLUSION

Modified low-dose RTX therapy (two infusions of 200 mg every 2 weeks) could be a promising new option for patients with SLE-associated refractory ITP with a satisfactory response rate.

摘要

背景

严重且难治性免疫性血小板减少症(ITP)影响系统性红斑狼疮(SLE)患者的预期寿命,并给其临床管理带来挑战。本干预性研究采用小样本量评估改良低剂量利妥昔单抗(RTX)方案对SLE相关难治性ITP患者的疗效和安全性。

方法

8例严重SLE相关难治性ITP患者纳入本干预性研究。他们在第1天和第15天接受静脉输注RTX(200mg)。逐渐减少先前开具的皮质类固醇剂量,并停用免疫抑制剂。在1、3、6和12个月对患者进行随访;记录血小板计数、其他实验室指标和副作用。我们采用意向性分析计算缓解率。

结果

7名参与者(87.5%)完成了研究。1个月时,2例患者(25.0%)达到部分缓解(PR);3个月时PR率增至87.5%。6个月时,3例患者(37.5%)达到完全缓解(CR)。然而,12个月时CR率降至25.0%。1、3、6和12个月时的总体缓解率分别为25.0%(2/8)、87.5%(7/8)、75.0%(6/8)和75.0%(6/8)。2例患者出现轻度输注反应,1例在首次输注RTX后2周因带状疱疹病毒感染和过敏反应而退出研究。

结论

改良低剂量RTX疗法(每2周输注2次200mg)可能是SLE相关难治性ITP患者的一种有前景的新选择,缓解率令人满意。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5cb8/8512260/e5398dc6cf82/10.1177_20406223211048643-fig1.jpg

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