环孢素为基础的方案治疗原发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 cyclosporine-based regimens for primary immune thrombocytopenia: a systematic review and meta-analysis.
机构信息
The Hematological Dept., Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, China.
The Hematological Dept., Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai, China.
出版信息
J Int Med Res. 2023 Jan;51(1):3000605221149870. doi: 10.1177/03000605221149870.
OBJECTIVE
To conduct a meta-analysis assessing the efficacy and safety of cyclosporine-based combinations for primary immune thrombocytopenia (ITP).
METHODS
Randomized controlled clinical trials were collected by systematically searching databases (PubMed®, MEDLINE®, EMBASE, The Cochrane Library, China National Knowledge Infrastructure) from inception to June 2022. All studies included patients with ITP who received cyclosporine-based regimens. We performed comprehensive analyses of the overall response rate (ORR), complete response (CR) rate, partial response (PR) rate, relapse rate, platelet count, and adverse drug reaction (ADR) rate.
RESULTS
Seven studies (n = 418) were ultimately included. According to a fixed-effects model, cyclosporine-based combinations improved the ORR and CR rate and reduced the relapse rate. The ADR rate was not increased in the cyclosporine-based combination group. Cyclosporine-based regimens effectively increased the platelet count. Subgroup analysis illustrated that cyclosporine-based combinations were linked to higher ORRs in both children (odds ratio [OR] = 5.74, 95% confidence interval [CI] = 1.79-18.41) and adults (OR = 5.46, 95% CI = 2.48-12.02) and a higher CR rate in adults (OR = 2.97, 95% CI = 1.56-5.63).
CONCLUSION
Cyclosporine exhibited efficacy in the treatment of ITP without increasing the risk of ADRs.
目的
系统评价环孢素为基础的联合治疗方案治疗原发免疫性血小板减少症（ITP）的疗效和安全性。
方法
通过系统检索数据库（PubMed®、MEDLINE®、EMBASE、The Cochrane Library、中国知网），收集从建库至 2022 年 6 月的随机对照临床试验。所有研究均纳入接受环孢素为基础的方案治疗的 ITP 患者。我们对总缓解率（ORR）、完全缓解率（CR 率）、部分缓解率（PR 率）、复发率、血小板计数和药物不良反应（ADR）率进行综合分析。
结果
最终纳入 7 项研究（n=418）。根据固定效应模型，环孢素为基础的联合治疗方案可提高 ORR 和 CR 率，降低复发率。环孢素为基础的联合治疗方案并未增加 ADR 发生率。环孢素为基础的方案可有效提高血小板计数。亚组分析表明，环孢素为基础的联合治疗方案在儿童（比值比 [OR] = 5.74，95%置信区间 [CI] = 1.79-18.41）和成人（OR = 5.46，95% CI = 2.48-12.02）中均与更高的 ORR 相关，在成人中与更高的 CR 率相关（OR = 2.97，95% CI = 1.56-5.63）。
结论
环孢素治疗 ITP 有效，且不增加 ADR 风险。
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