Sajgure Atul, Kulkarni Ajit, Joshi Atul, Sajgure Vasanti, Pathak Vaishali, Melinkeri Rashida, Pathak Shilpa, Agrawal Sumit, Naik Manoj, Rajurkar Milind, Sajgure Ameya, Date Girish
Sahyadri Speciality Hospital, Pune, Maharashtra, India.
BJ Medical College, Pune, Maharashtra, India.
Lancet Reg Health Southeast Asia. 2023 Apr;11:100154. doi: 10.1016/j.lansea.2023.100154. Epub 2023 Jan 25.
Antivirals and immunosuppressive agents are used with variable success in the treatment of COVID-19. Mycophenolate, an inhibitor of enzyme inosine monophosphate dehydrogenase, is an immunosuppressant used to prevent allograft rejection and other autoimmune diseases. Few laboratory studies have also reported antiviral properties of mycophenolate. The current study tried to assess the safety and efficacy of mycophenolate in patients hospitalised with COVID-19.
This was a prospective non-randomised open label study with the objective to assess the effect of addition of mycophenolate to the standard of care on mortality due to COVID-19 and duration of hospital stay. The target study population was comprised of patients requiring inpatient treatment for COVID-19 during the period from Jan 15-April 15, 2021. The study was registered with Clinical Trial Registry of India (CTRI/2021/01/030477, registered on date-14/01/2021). Adult patients (n = 106) requiring hospitalisation for COVID-19 received mycophenolate, 360 mg, one tablet daily for one month. Mycophenolate was initiated within 48 h of the diagnosis of SARS-CoV-2 infection by RT‒PCR. While patients who did not consent for mycophenolate (n = 106), received only standard of care, and were considered as control group. The relevant clinical data including NEWS2 scores and high-resolution computed tomography of the thorax were collected and analysed.
The mortality and hospital stay were significantly lower in the study group compared to the control group. Mycophenolate significantly reduced mortality after adjustment for other predictors (adjusted odds ratio: 0.082 with 95% CI: 0.012-0.567). Mycophenolate was an independent predictor of survival in patients hospitalised due to COVID-19. There was also no evidence of secondary bacterial infections and post-COVID complications.
Mycophenolate administration is safe in COVID-19. Mycophenolate reduces mortality and duration of hospital stay in patients with COVID-19.
Shri Janai Research Foundation, India.
抗病毒药物和免疫抑制剂在治疗2019冠状病毒病（COVID-19）方面的疗效各不相同。霉酚酸酯是肌苷单磷酸脱氢酶的抑制剂，是一种免疫抑制剂，用于预防同种异体移植排斥反应和其他自身免疫性疾病。也有少数实验室研究报道了霉酚酸酯的抗病毒特性。本研究旨在评估霉酚酸酯对COVID-19住院患者的安全性和疗效。
这是一项前瞻性非随机开放标签研究，目的是评估在标准治疗基础上加用霉酚酸酯对COVID-19所致死亡率和住院时间的影响。目标研究人群包括2021年1月15日至4月15日期间需要住院治疗COVID-19的患者。该研究已在印度临床试验注册中心注册（CTRI/2021/01/030477，注册日期为2021年1月14日）。因COVID-19需要住院的成年患者（n = 106）接受霉酚酸酯，360毫克，每日一片，共服用一个月。在通过逆转录-聚合酶链反应（RT‒PCR）诊断出严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染后的48小时内开始使用霉酚酸酯。而不同意使用霉酚酸酯的患者（n = 106）仅接受标准治疗，被视为对照组。收集并分析了包括国家早期预警评分2（NEWS2）和胸部高分辨率计算机断层扫描在内的相关临床数据。
与对照组相比，研究组的死亡率和住院时间显著降低。在对其他预测因素进行调整后，霉酚酸酯显著降低了死亡率（调整后的比值比：0.082，95%置信区间：0.012 - 0.567）。霉酚酸酯是COVID-19住院患者生存的独立预测因素。也没有证据表明存在继发性细菌感染和COVID-19后并发症。
在COVID-19患者中使用霉酚酸酯是安全的。霉酚酸酯可降低COVID-19患者的死亡率和住院时间。
印度什里贾奈研究基金会。
