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免疫调节剂和血小板生成素受体激动剂在合并出血的埃及原发性免疫性血小板减少症患者中的疗效及药物不良反应模式

The Outcomes and Adverse Drug Patterns of Immunomodulators and Thrombopoietin Receptor Agonists in Primary Immune Thrombocytopenia Egyptian Patients with Hemorrhage Comorbidity.

作者信息

Hamed Eman Mostafa, Ibrahim Ahmed R N, Meabed Mohamed Hussein, Khalaf Ahmed M, El Demerdash Doaa Mohamed, Elgendy Marwa O, Saeed Haitham, Salem Heba F, Rabea Hoda

机构信息

Department of Clinical Pharmacy, Faculty of Pharmacy, Nahda University (NUB), Beni-Suef 62521, Egypt.

Department of Clinical Pharmacy, College of Pharmacy, King Khalid University, Abha 61421, Saudi Arabia.

出版信息

Pharmaceuticals (Basel). 2023 Jun 12;16(6):868. doi: 10.3390/ph16060868.

Abstract

Immune thrombocytopenia (ITP) treatment has evolved recently. However, none of the treatments have only benefits without drawbacks. This study aimed to compare the clinical outcomes and adverse drug patterns of Eltrombopag, Romiplostim, Prednisolone + Azathioprine, High Dose-dexamethasone (HD-DXM) (control group), and Rituximab in primary ITP Egyptian patients. All patients were initiated with corticosteroids, HD-DXM, as a first-line treatment for the first month immediately following diagnosis. Four hundred sixty-seven ITP patients were randomly assigned to five groups. The outcome measures were judged at baseline, at the end of treatment (6 months), and after an additional 6-month free treatment period. The follow-up period for which relapse is noted was 6 months after the end of treatment. Eltrombopag and Romiplostim resulted in a significantly higher incidence of sustained response than Rituximab, HD-DXM, and Prednisolone + Azathioprine (55.2% and 50.6% vs. 29.2%, 29.1%, and 18%, respectively; -value < 0.001). More patients on immunomodulators (Prednisolone+ Azathioprine, HD-DXM, and Rituximab) relapsed than those on Romiplostim and Eltrombopag (81.9%, 70.8%, and 70.7% vs. 49.3%, and 44.7%, respectively; -value < 0.01). We also describe 23 reports of pulmonary hypertension with Prednisolone+ Azathioprine and 13 reports with HD-DXM. The thrombotic events occurred in 16.6% and 13% of patients who received Eltrombopag and Romiplostim treatment, respectively. Most patients had at least one or two risk factors (92.8% of cases). Corticosteroids are effective first-line therapy in primary ITP patients. However, relapse is frequent. Eltrombopag and Romiplostim are safer and more effective than Prednisolone, HD-DXM, and Rituximab. They might be reasonable beneficial options after a one-month HD-DXM regimen.

摘要

免疫性血小板减少症(ITP)的治疗近年来有所发展。然而,没有一种治疗方法只有益处而没有缺点。本研究旨在比较艾曲泊帕、罗米司亭、泼尼松龙+硫唑嘌呤、大剂量地塞米松(HD-DXM)(对照组)和利妥昔单抗在埃及原发性ITP患者中的临床疗效和药物不良反应模式。所有患者在确诊后的第一个月立即开始使用皮质类固醇、HD-DXM作为一线治疗。467例ITP患者被随机分为五组。在基线、治疗结束时(6个月)以及额外6个月的无治疗期后评估疗效指标。记录复发情况的随访期为治疗结束后6个月。与利妥昔单抗、HD-DXM和泼尼松龙+硫唑嘌呤相比,艾曲泊帕和罗米司亭导致持续缓解的发生率显著更高(分别为55.2%和50.6%,而利妥昔单抗、HD-DXM和泼尼松龙+硫唑嘌呤分别为29.2%、29.1%和18%;P值<0.001)。与使用罗米司亭和艾曲泊帕的患者相比,使用免疫调节剂(泼尼松龙+硫唑嘌呤、HD-DXM和利妥昔单抗)的患者复发更多(分别为81.9%、70.8%和70.7%,而罗米司亭和艾曲泊帕分别为49.3%和44.7%;P值<0.01)。我们还描述了23例使用泼尼松龙+硫唑嘌呤和13例使用HD-DXM导致肺动脉高压的报告。接受艾曲泊帕和罗米司亭治疗的患者中,血栓形成事件分别发生在16.6%和13%的患者中。大多数患者至少有一两个风险因素(92.8%的病例)。皮质类固醇是原发性ITP患者有效的一线治疗方法。然而,复发很常见。艾曲泊帕和罗米司亭比泼尼松龙、HD-DXM和利妥昔单抗更安全、更有效。在一个月的HD-DXM治疗方案后,它们可能是合理的有益选择。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9ccd/10303883/e1cf2e7abba8/pharmaceuticals-16-00868-g001.jpg

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