Emergency Department, Second Hospital of Hebei Medical University, No. 215 Heping West Road, Xinhua District, Shijiazhuang, 050051, Hebei, China.
Hebei Chest Hospital, Shijiazhuang, Hebei, China.
BMC Infect Dis. 2023 Sep 6;23(1):585. doi: 10.1186/s12879-023-08570-9.
To study the efficacy and safety of arbidol hydrochloride tablets as a treatment for influenza-like diseases.
In this multicenter, randomized, controlled, open label study, a total of 412 influenza-like cases were collected from 14 hospitals in seven regions of Hebei Province from September 2021 to March 2022. Patients were randomly divided into two groups. The control group (n = 207) were administered oseltamivir phosphate capsules for five days and the experimental group (n = 205) were administered arbidol hydrochloride tablets for five days. The primary endpoint was the time to normal body temperature, and the secondary endpoints included the time to remission of influenza symptoms, incidence of influenza-like complications, and incidence of adverse reactions.
Before treatment, there was no significant difference between the two groups in general conditions, blood routine, body temperature, or symptom severity. After treatment, there was no significant difference between the groups in the mean time to fever remission (59.24 h ± 25.21 vs. 61.05 h ± 29.47) or the mean time to remission of influenza symptoms (57.31 h ± 30.19 vs. 62.02 h ± 32.08). Survival analyses using Log-rank and Wilcoxon bilateral tests showed that there was no significant difference in fever relief time or influenza symptom relief time between the two groups. Regarding the incidence of complications and adverse events, there was only one case of tracheitis, one case of nausea, one case of vomiting, and one case of dizziness in the control group. In the experimental group, there was one case of nausea, one case of vomiting, and one case of drowsiness. In addition, one patient in the control group was hospitalized for urinary calculi.
There was no significant difference between the patients with influenza-like cases treated with arbidol hydrochloride tablets and those treated with oseltamivir phosphate capsules. Further, the patients treated with arbidol hydrochloride tablets had fewer adverse reactions, and thus, the tablets were safe to use.
研究盐酸阿比多尔片治疗流感样疾病的疗效和安全性。
本多中心、随机、对照、开放标签研究共纳入 2021 年 9 月至 2022 年 3 月河北省 7 个地区 14 家医院的 412 例流感样病例。患者随机分为两组，对照组（n=207）给予磷酸奥司他韦胶囊治疗 5 天，试验组（n=205）给予盐酸阿比多尔片治疗 5 天。主要终点为体温恢复正常时间，次要终点包括流感症状缓解时间、流感样并发症发生率和不良反应发生率。
治疗前两组一般情况、血常规、体温及症状严重程度比较，差异均无统计学意义（P>0.05）。治疗后两组体温恢复正常时间的平均时间（59.24±25.21比 61.05±29.47）和流感症状缓解时间的平均时间（57.31±30.19比 62.02±32.08）比较，差异均无统计学意义（P>0.05）。Log-rank 检验和 Wilcoxon 双侧检验生存分析结果显示，两组患者体温缓解时间和流感症状缓解时间比较，差异均无统计学意义（P>0.05）。并发症和不良反应发生率方面，对照组仅 1 例出现气管炎，1 例出现恶心，1 例出现呕吐，1 例出现头晕；试验组 1 例出现恶心，1 例出现呕吐，1 例出现嗜睡。此外，对照组 1 例患者因尿路结石住院。
盐酸阿比多尔片治疗流感样病例与磷酸奥司他韦胶囊治疗的患者相比，差异无统计学意义。且盐酸阿比多尔片治疗的患者不良反应更少，使用安全。
