Thu Le Thi Anh, Hoang Phong, Nguyen Tuan, Hoang Nguyen Phan, Thanh Ngan La Thi, Hai Thanh Nguyen Thi, Van Hiep Nguyen, Tuan Thanh Pham, Tuyet Lan Tran Thi, My Nuong Nguyen Thi, Thu Truc Lai Thi, Van Toan Vi, Thi Phuong Nguyen, Thien Minh Nguyen
Hoan My Academy, Ho Chi Minh City, Vietnam.
Hoan My Thu Duc Hospital, Ho Chi Minh City, Vietnam.
GMS Hyg Infect Control. 2025 Jul 9;20:Doc38. doi: 10.3205/dgkh000567. eCollection 2025.
To assess the efficacy and safety of methylprednisolone combined with rivaroxaban versus rivaroxaban monotherapy in mild cases of COVID-19.
This quasi-experimental study was conducted at three hospitals in Ho Chi Minh City, Vietnam, from September 2021 to March 2022. Patients received either rivaroxaban 10 mg/day (Regimen 1) or methylprednisolone 16 mg/day plus rivaroxaban 10 mg/day (Regimen 2) for 7 days. Outcomes included progression to severe disease, adverse events, and changes in clinical and laboratory parameters. Statistical analysis employed Fisher's exact test and Generalized Estimating Equations (GEE).
Among 108 patients, no progression to severe disease or deaths occurred. Regimen 2 significantly improved laboratory markers, including white blood cell counts (+0.290; p<0.001), platelet counts (+0.102; p=0.032), aspartate aminotransferase (+0.335; p=0.013), alanine aminotransferase (+0.397; p=0.006) and CD4 cells (+0.458; p<0.001), and reduced activated partial thromboplastin time (-0.083; p=0.003) compared to Regimen 1. No significant differences in clinical symptoms were observed. Adverse events were rare, with one non-serious event reported in Regimen 1.
Combination therapy with methylprednisolone and rivaroxaban enhanced immune and coagulation parameters without increasing adverse events. These findings suggest potential benefits of early intervention in mild COVID-19, warranting further research.
评估甲泼尼龙联合利伐沙班与利伐沙班单药治疗轻度新型冠状病毒肺炎（COVID-19）的疗效和安全性。
本准实验研究于2021年9月至2022年3月在越南胡志明市的三家医院进行。患者接受利伐沙班10毫克/天（方案1）或甲泼尼龙16毫克/天加利伐沙班10毫克/天（方案2）治疗7天。观察指标包括进展为重症疾病、不良事件以及临床和实验室参数的变化。统计分析采用Fisher精确检验和广义估计方程（GEE）。
108例患者中，无进展为重症疾病或死亡病例。与方案1相比，方案2显著改善了实验室指标，包括白细胞计数（增加0.290；p<0.001）、血小板计数（增加0.102；p=0.032）、天冬氨酸转氨酶（增加0.335；p=0.013）、丙氨酸转氨酶（增加0.397；p=0.006）和CD4细胞（增加0.458；p<0.001），并缩短了活化部分凝血活酶时间（缩短0.083；p=0.003）。临床症状方面未观察到显著差异。不良事件罕见，方案1报告了1例非严重事件。
甲泼尼龙和利伐沙班联合治疗可增强免疫和凝血参数，且不增加不良事件。这些发现提示了对轻度COVID-19进行早期干预的潜在益处，值得进一步研究。
