沙利度胺治疗新型冠状病毒肺炎：一项随机对照临床试验。

Thalidomide for the Treatment of COVID-19 Pneumonia: A Randomized Controlled Clinical Trial.

作者信息

Amra Babak, Ashrafi Farzaneh, Torki Mehdi, Hashemi Marzieh, Shirzadi Mohamad, Soltaninejad Forogh, Sadeghi Somayeh, Salmasi Mehrzad, Sami Ramin, Darakhshandeh Ali, Nasirian Maryam, Pourajam Samaneh

机构信息

Bamdad Respiratory and Sleep Research Center, Department of Internal Medicine, Pulmonary and Sleep Ward, Isfahan University of Medical Sciences, Isfahan, Iran.

Department of Hematology Oncology, Isfahan University of Medical Sciences, Isfahan, Iran.

出版信息

Adv Biomed Res. 2023 Jan 27;12:14. doi: 10.4103/abr.abr_248_21. eCollection 2023.

DOI:10.4103/abr.abr_248_21

PMID:36926422

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10012021/

Abstract

BACKGROUND

Coronavirus disease 2019 has become a public health concern with a high number of fatalities. Thalidomide can target inflammatory mediators and decrease inflammation in SARS-CoV-2.

MATERIALS AND METHODS

An open-label, randomized controlled trial was conducted on patients with compatible lung high-resolution computed tomography scan for COVID-19 pneumonia and moderate involvement. Childbearing-age women were excluded. A total of 20 patients in the control group receiving usual treatment were compared with 26 patients in the case group who in addition to the same regimen also received thalidomide. The primary outcome was time for clinical recovery (TTCR) and intensive-care unit (ICU) admission.

RESULTS

From April 25 to August 8, 2020, based on the inclusion criteria, 47 patients were assigned to the study. Patients receiving thalidomide had a mean TTCR of days 5.5 (95% confidence interval [CI], 0.7-10.3), as compared with days 5.3 (95% CI, 1.7-8.9) with control (odds ratio 0.01; 95% CI, -1.58-1.59, = 0.807). The incidence of ICU admission was 27% in the thalidomide group compared with 20% in the control group (odds ratio 3.89; 95% CI, 0.55-27.4, = 0.425). The mean length of stay in hospital in both groups was 10 days. Progressive improvement in respiratory rate, fever, and O saturation during the study was seen in both groups without a significant difference between the thalidomide and control group ( > 0.05).

CONCLUSION

This study investigated the effects of thalidomide to treat moderate COVID-19 clinical outcomes. The results established that this drug regimen did not add more effect to usual treatment for moderate COVID-19 pneumonia.

摘要

背景

2019年冠状病毒病已成为一个引起公众健康关注且导致大量死亡的问题。沙利度胺可作用于炎症介质并减轻严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染引发的炎症。

材料与方法

对符合新型冠状病毒肺炎（COVID-19）且肺部高分辨率计算机断层扫描显示中度受累的患者进行了一项开放标签、随机对照试验。排除育龄期女性。将20例接受常规治疗的对照组患者与26例除相同治疗方案外还接受沙利度胺治疗的病例组患者进行比较。主要结局指标为临床恢复时间（TTCR）和入住重症监护病房（ICU）情况。

结果

2020年4月25日至8月8日，根据纳入标准，47例患者被纳入研究。接受沙利度胺治疗的患者的平均临床恢复时间为5.5天（95%置信区间[CI]，0.7 - 10.3），而对照组为5.3天（95%CI，1.7 - 8.9）（比值比0.01；95%CI， - 1.58 - 1.59，P = 0.807）。沙利度胺组入住ICU的发生率为27%，而对照组为20%（比值比3.89；95%CI，0.55 - 27.4，P = 0.425）。两组的平均住院时间均为10天。研究期间两组患者的呼吸频率、发热及血氧饱和度均有逐渐改善，沙利度胺组与对照组之间无显著差异（P>0.05）。