盐酸阿比多尔在成人新型冠状病毒肺炎患者中的一项试验。

A trial of arbidol hydrochloride in adults with COVID-19.

作者信息

Zhao Jingya, Zhang Jinnong, Jin Yang, Tang Zhouping, Hu Ke, Sun Hui, Shi Mengmeng, Yang Qingyuan, Gu Peiyu, Guo Hongrong, Li Qi, Zhang Haiying, Li Chenghong, Yang Ming, Xiong Nian, Dong Xuan, Xu Juanjuan, Lin Fan, Wang Tao, Yang Chao, Huang Bo, Zhang Jingyi, Chen Shi, He Qiong, Zhou Min, Qu Jieming

机构信息

Department of Pulmonary and Critical Care Medicine, Ruijin Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China.

institute of Respiratory Diseases, School of Medicine, Shanghai Jiao Tong University, Shanghai 200025, China.

出版信息

Chin Med J (Engl). 2022 Jul 14;135(13):1531-8. doi: 10.1097/CM9.0000000000002104.

DOI:10.1097/CM9.0000000000002104

PMID:35830201

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9532042/

Abstract

BACKGROUND

To date, there is no effective medicine to treat coronavirus disease 2019 (COVID-19), and the antiviral efficacy of arbidol in the treatment for COVID-19 remained equivocal and controversial. The purpose of this study was to evaluate the efficacy and safety of arbidol tablets in the treatment of COVID-19.

METHODS

This was a prospective, open-label, controlled and multicenter investigator-initiated trial involving adult patients with confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Patients were stratified 1:2 to either standard-of-care (SOC) or SOC plus arbidol tablets (oral administration of 200 mg per time, three times a day for 14 days). The primary endpoint was negative conversion of SARS-CoV-2 within the first week. The rates and 95% confidential intervals were calculated for each variable.

RESULTS

A total of 99 patients with laboratory-confirmed SARS-CoV-2 infection were enrolled; 66 were assigned to the SOC plus arbidol tablets group, and 33 to the SOC group. The negative conversion rate of SARS-CoV-2 within the first week in patients receiving arbidol tablets was significantly higher than that of the SOC group (70.3% [45/64] vs. 42.4% [14/33]; difference of conversion rate 27.9%; 95% confidence interval [CI], 7.7%-48.1%; P = 0.008). Compared to those in the SOC group, patients receiving arbidol tablets had a shorter duration of clinical recovery (median 7.0 days vs. 12.0 days; hazard ratio [HR]: 1.877, 95% CI: 1.151-3.060, P = 0.006), symptom of fever (median 3.0 days vs. 12.0 days; HR: 18.990, 95% CI: 5.350-67.410, P < 0.001), as well as hospitalization (median 12.5 days vs. 20.0 days; P < 0.001). Moreover, the addition of arbidol tablets to SOC led to more rapid normalization of declined blood lymphocytes (median 10.0 days vs. 14.5 days; P > 0.05). The most common adverse event in the arbidol tablets group was the elevation of transaminase (5/200, 2.5%), and no one withdrew from the study due to adverse events or disease progression.

CONCLUSIONS

SOC plus arbidol tablets significantly increase the negative conversion rate of SARS-CoV-2 within the first week anas, accelerate the recovery of COVID-19 patients. During the treatment with arbidol tablets, we find no significant serious adverse events.

TRIAL REGISTRATION

Chinese Clinical Trial Registry, NCT04260594, www.clinicaltrials.gov/ct2/show/NCT04260594?term=NCT04260594&draw=2&rank=1.

摘要

背景

迄今为止，尚无治疗新型冠状病毒肺炎（COVID-19）的有效药物，阿比多尔治疗COVID-19的抗病毒疗效仍存在争议。本研究旨在评估阿比多尔片治疗COVID-19的疗效和安全性。

方法

这是一项前瞻性、开放标签、对照、多中心研究者发起的试验，纳入确诊感染严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的成年患者。患者按1:2分层，分别接受标准治疗（SOC）或SOC加阿比多尔片（每次口服200mg，每日3次，共14天）。主要终点为第1周内SARS-CoV-2转阴。计算每个变量的发生率和95%置信区间。

结果

共纳入99例实验室确诊的SARS-CoV-2感染患者；66例被分配到SOC加阿比多尔片组，33例被分配到SOC组。接受阿比多尔片治疗的患者第1周内SARS-CoV-2转阴率显著高于SOC组（70.3%[45/64]对42.4%[14/33]；转阴率差异27.9%；95%置信区间[CI]，7.7%-48.1%；P = 0.008）。与SOC组相比，接受阿比多尔片治疗的患者临床恢复时间更短（中位时间7.0天对12.0天；风险比[HR]：1.877，95%CI：1.151-3.060，P = 0.006），发热症状持续时间更短（中位时间3.0天对12.0天；HR：18.990，95%CI：5.350-67.410，P < 0.001），住院时间更短（中位时间12.5天对20.0天；P < 0.001）。此外，SOC加用阿比多尔片可使下降的血液淋巴细胞更快恢复正常（中位时间10.0天对14.5天；P > 0.05）。阿比多尔片组最常见的不良事件是转氨酶升高（5/200，2.5%），没有患者因不良事件或疾病进展退出研究。