Multi-center, randomized controlled, open evaluation of efficacy and safety of Arbidol hydrochloride tablets in the treatment of influenza-like cases

Abstract

Abstract Objective To study the efficacy and safety of Arbidol hydrochloride tablets in the treatment of influenza-like cases. Methods A multicenter, randomized controlled, open study was conducted. 412 influenza-like cases were collected from 14 hospitals in 7 regions of Hebei Province from September 2021 to March 2022. They were randomly divided into 2 groups. 207 patients in the control group were given oseltamivir phosphate capsules for 5 days. 205 patients in the experimental group were given Arbidol hydrochloride tablets for 5 days. The primary endpoint was the time to normal body temperature, and the secondary endpoint included the time to remission of influenza symptoms, the incidence of influenza-like complications, and the incidence of adverse reactions. Results 1) Before treatment, there was no significant difference between the two groups in general conditions, blood routine, body temperature and symptom severity.2) After treatment, there was no significant difference between the experimental group and the control group in the mean remission time of fever (59.24 ± 25.21) H vs. (61.05 ± 29.47) H and the mean remission time of influenza symptoms (57.31 ± 30.19) H vs. (62.02 ± 32.08) H. Survival analysis Logrank and Wilcoxon bilateral test showed that there was no significant difference in fever relief time and influenza symptom relief time between the two groups.3) Incidence of complications and adverse events: there was only 1 case of tracheitis in the control group. In the control group, nausea occurred in 1 case, vomiting in 1 case and dizziness in 1 case. In experimental group, nausea occurred in 1 case, vomiting in 1 case and drowsiness in 1 case. In addition, 1 patient in control group was hospitalized for urinary calculi. Conclusion There is no significant difference between Arbidol hydrochloride tablets and Oseltamivir phosphate capsules in the treatment of influenza like cases, and Arbidol hydrochloride tablets have less adverse reactions and are safe to use.