Dargahi-Malamir Mehrdad, Hosseinzadeh Mofid, Khedri Reza, Hosseininejad Hooshmand, Behmanesh Babak, Hatami Ali, Oskouei Seyed Yashar, Mehraban Zahra, Kouti Wesam, Pouladzadeh Mandana
Department of Pulmonology, Air Pollution and Respiratory Diseases Research Center, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Emergency Medicine Department, School of Medicine, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Maedica (Bucur). 2024 Jun;19(2):322-329. doi: 10.26574/maedica.2024.19.2.322.
This placebo-controlled and randomized pilot study aimed to assess the feasibility and impact of tofacitinib/remdesivir combination therapy compared to remdesivir alone on clinical and laboratory findings of severely ill COVID-19 patients for future large-scale studies.
Fifty patients were included in this study. They were randomly allocated into two groups of 25 subjects each. Patients in the treatment group received a five-day course of tofacitinib (10 mg twice daily) in addition to a five-day course of remdesivir, whereas the control group received a 10-day course of remdesivir with a placebo.
There was no significant difference in rates of need for intubation (oxygen saturation level), intensive care unit (ICU) admission, death and length of hospitalization between the two groups (P>0.05). Nevertheless, the PRIEST severity score was significantly reduced in the treatment group compared to the control group (P=0.03, effect size [95% CI]: -0.616 [0.0233-1.1723]). Moreover, the mean level of C-reactive protein after 10 days was significantly decreased in the treatment group but increased in the control group (P=0.006).
Tofacitinib adopted in this pilot study modulate the inflammation and reduce the PRIEST score in severe COVID-19 patients. So, it is feasible and could be applied in future larger-scale trials to precisely determine its effects on coronavirus infections.
这项安慰剂对照随机试点研究旨在评估与单独使用瑞德西韦相比，托法替布/瑞德西韦联合疗法对重症COVID-19患者临床和实验室检查结果的可行性及影响，为未来大规模研究提供依据。
本研究纳入50例患者，随机分为两组，每组25例。治疗组患者在接受为期5天的瑞德西韦治疗的基础上，加用为期5天的托法替布（每日两次，每次10mg），而对照组接受为期10天的瑞德西韦加安慰剂治疗。
两组在插管需求率（血氧饱和度水平）、重症监护病房（ICU）入住率、死亡率和住院时间方面无显著差异（P>0.05）。然而，与对照组相比，治疗组的PRIEST严重程度评分显著降低（P=0.03，效应量[95%CI]：-0.616[0.0233-1.1723]）。此外，治疗组10天后C反应蛋白平均水平显著降低，而对照组升高（P=0.006）。
本试点研究中采用的托法替布可调节重症COVID-19患者的炎症反应并降低PRIEST评分。因此，该联合疗法是可行的，可应用于未来更大规模的试验，以精确确定其对冠状病毒感染的影响。
