Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, Beijing Institute of Traditional Chinese Medicine, Beijing, China.
Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
Ann Palliat Med. 2021 May;10(5):5146-5155. doi: 10.21037/apm-20-2121. Epub 2021 Apr 9.
Reduning injection is a traditional Chinese medicine (TCM) with known efficacy against a variety of viral infections, but there is no data about its efficacy against coronavirus disease 2019 (COVID-19).
To explore the efficacy and safety of Reduning injection in the treatment of COVID-19, a randomized, open-labeled, multicenter, controlled trial was conducted from 12 general hospitals between 2020.02.06 and 2020.03.23. Patients with COVID-19 who met the diagnostic criteria of the "Diagnosis and Treatment Program for Novel Coronavirus Infection Pneumonia (Trial Fifth Edition)". Patients were randomized to routine treatment with or without Reduning injection (20 mL/day for 14 days) (ChiCTR2000029589). The primary endpoint was the rate of achieving clinical symptom recovery on day 14 of treatment.
There were 77 and 80 participants in the Reduning and control groups. The symptom resolution rate at 14 days was higher in the Reduning injection than in controls [full-analysis set (FAS): 84.4% vs. 60.0%, P=0.0004]. Compared with controls, the Reduning group showed shorter median time to resolution of the clinical symptoms (143 vs. 313.5 h, P<0.001), shorter to nucleic acid test turning negative (146.5 vs. 255.5 h, P<0.001), shorter hospital stay (14.1 vs. 18.1 days, P<0.001), and shorter time to defervescence (29 vs. 71 h, P<0.001). There was no difference in AEs (3.9% vs. 8.8%, P=0.383).
This preliminary trial suggests that Reduning injection might be effective and safe in patients with symptomatic COVID-19.
热毒宁注射液是一种中药，已被证实对多种病毒感染有效，但尚无其治疗 2019 年冠状病毒病（COVID-19）的疗效数据。
为了探索热毒宁注射液治疗 COVID-19 的疗效和安全性，我们于 2020 年 2 月 6 日至 3 月 23 日在 12 家综合医院进行了一项随机、开放标签、多中心、对照试验。符合《新型冠状病毒感染的肺炎诊疗方案（试行第五版）》诊断标准的 COVID-19 患者，随机分为常规治疗加用或不加用热毒宁注射液（20 mL/天，疗程 14 天）（ChiCTR2000029589）。主要终点为治疗第 14 天临床症状恢复率。
热毒宁组和对照组各有 77 例和 80 例患者。热毒宁组在第 14 天的症状缓解率高于对照组[全分析集（FAS）：84.4% vs. 60.0%，P=0.0004]。与对照组相比，热毒宁组临床症状缓解的中位时间更短（143 小时 vs. 313.5 小时，P<0.001），核酸检测转阴的中位时间更短（146.5 小时 vs. 255.5 小时，P<0.001），住院时间更短（14.1 天 vs. 18.1 天，P<0.001），退热时间更短（29 小时 vs. 71 小时，P<0.001）。不良事件发生率无差异（3.9% vs. 8.8%，P=0.383）。
初步试验表明，热毒宁注射液对有症状的 COVID-19 患者可能有效且安全。
