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利妥昔单抗治疗儿童免疫性血小板减少症的疗效和安全性:系统评价和荟萃分析。

Efficacy and safety of rituximab for minors with immune thrombocytopenia: a systematic review and meta-analysis.

机构信息

The Second Clinical College, Kunming Medical University, Kunming, Yunnan, China.

Department of Hematology, the Second Affiliated Hospital of Kunming Medical University, Kunming, Yunnan, China.

出版信息

J Int Med Res. 2020 Oct;48(10):300060520962348. doi: 10.1177/0300060520962348.

Abstract

OBJECTIVE

We reviewed relevant research on rituximab (RTX) treatment for pediatric immune thrombocytopenia (ITP) to elucidate the efficacy and safety of RTX.

METHODS

Prospective clinical trials of RTX for the treatment of pediatric ITP were collected by searching the PubMed, Cochrane Library, Web of Science, and OVID: EMBASE databases and ClinicalTrials.gov. We examined rates of overall response (OR), complete response (CR), partial response (PR), sustained response (SR), relapse (R), and adverse drug reaction (ADR). The Methodological Index for Nonrandomized Studies scale was used, and sensitivity analyses were performed.

RESULTS

For five studies, including 100 patients, the pooled OR, CR, PR, SR, R, and ADR rates were 52% (95% CI: 0.36-0.77,  = 78%), 52% (95% CI: 0.41-0.67,  = 45%), 18% (95% CI: 0.10-0.33,  = 33%), 43% (95% CI: 0.29-0.63,  = 0%), 25% (95% CI: 0.06-0.96,  = 52%), and 30% (95% CI: 0.15-0.58,  = 64%), respectively.

CONCLUSION

There is evidence, albeit low quality, that RTX may be a better second-line therapy than splenectomy for children with ITP; however, its efficacy and safety need to be validated by further high-quality clinical trials, such as randomized controlled trials.

摘要

目的

我们回顾了关于利妥昔单抗(RTX)治疗儿科免疫性血小板减少症(ITP)的相关研究,以阐明 RTX 的疗效和安全性。

方法

通过检索 PubMed、Cochrane 图书馆、Web of Science、OVID:EMBASE 数据库和 ClinicalTrials.gov,收集了 RTX 治疗儿科 ITP 的前瞻性临床试验。我们检查了总反应率(OR)、完全反应率(CR)、部分反应率(PR)、持续反应率(SR)、复发率(R)和药物不良反应率(ADR)。使用非随机研究方法学指数进行了敏感性分析。

结果

对于 5 项研究,包括 100 名患者,汇总的 OR、CR、PR、SR、R 和 ADR 率分别为 52%(95% CI:0.36-0.77,=78%)、52%(95% CI:0.41-0.67,=45%)、18%(95% CI:0.10-0.33,=33%)、43%(95% CI:0.29-0.63,=0%)、25%(95% CI:0.06-0.96,=52%)和 30%(95% CI:0.15-0.58,=64%)。

结论

虽然证据质量较低,但有证据表明,RTX 可能是 ITP 儿童二线治疗优于脾切除术的治疗方法;然而,其疗效和安全性需要通过进一步的高质量临床试验(如随机对照试验)来验证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f4fa/7645434/d28b610569ee/10.1177_0300060520962348-fig1.jpg

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