Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, Beijing 100700, China.
National Resource Center for Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China.
Phytomedicine. 2021 Jan;81:153367. doi: 10.1016/j.phymed.2020.153367. Epub 2020 Oct 8.
Treatments for coronavirus disease 2019 (COVID-19) are limited by suboptimal efficacy.
From January 30, 2020 to March 23, 2020, we conducted a non-randomised controlled trial, in which all adult patients with laboratory-confirmed COVID-19 were assigned to three groups non-randomly and given supportive treatments: Group A, Lopinavir-Ritonavir; Group B, Huashi Baidu Formula (a Chinese medicineformula made by the China Academy of Chinese Medical Sciences to treat COVID-19, which is now in the clinical trial period) and Lopinavir-Ritonavir; and Group C, Huashi Baidu Formula. The use of antibiotics, antiviruses, and corticosteroids was permitted in Group A and B. Traditional Chinese medicine injections were permitted in Group C. The primary outcomes were clinical remission time (interval from admission to the first time the patient tested negatively for novel coronavirus or an obvious improvement was observed from chest CT) and clinical remission rate (number of patients whose clinical time was within 16 days/total number of patients).
A total of 60 adult patients with COVID-19 were enrolled at sites in Wuhan, China, and the sample size of each group was 20. In Groups A, B and C, the clinical remission rates were 95.0%%(19/20), 100.0%%(20/20) and 100.0%%(20/20), respectively. Compared with Groups A and B, the clinical remission time of Group C was significantly shorter (5.9 days vs. 10.8 days, p < 0.05; 5.9 days vs. 9.7 days, p < 0.05). There was no significant difference among Groups A, B, and C in terms of the time taken to be released from quarantine. The clinical biochemical indicators and safety indexes showed no significant differences among the three groups.
Our findings suggest that Lopinavir-Ritonavir has some efficacy in the treatment of COVID-19, and the Huashi Baidu Formula might enhance this effect to an extent. In addition, superiority was displayed in the treatment of COVID-19 through a combination of the Huashi Baidu Formula and traditional Chinese medicine injection. In future, well-designed prospective double-blinded randomised control trials are required to confirm our findings.
治疗 2019 年冠状病毒病（COVID-19）的方法有限，疗效不理想。
从 2020 年 1 月 30 日至 2020 年 3 月 23 日，我们进行了一项非随机对照试验，将所有实验室确诊的 COVID-19 成年患者非随机分为三组并给予支持性治疗：A 组，洛匹那韦/利托那韦；B 组，化湿败毒方（由中国中医科学院研制的治疗 COVID-19 的中药方剂，目前处于临床试验阶段）加洛匹那韦/利托那韦；C 组，化湿败毒方。A 组和 B 组允许使用抗生素、抗病毒药物和皮质类固醇。C 组允许使用中药注射液。主要结局是临床缓解时间（从入院到首次新型冠状病毒检测阴性或胸部 CT 明显改善的时间）和临床缓解率（临床缓解时间在 16 天内的患者数/总患者数）。
在中国武汉的多个地点共纳入 60 例成年 COVID-19 患者，每组样本量为 20 例。A、B 和 C 组的临床缓解率分别为 95.0%（19/20）、100.0%（20/20）和 100.0%（20/20）。与 A 组和 B 组相比，C 组的临床缓解时间明显缩短（5.9 天比 10.8 天，p<0.05；5.9 天比 9.7 天，p<0.05）。A、B 和 C 组解除隔离的时间无显著差异。三组的临床生化指标和安全性指标无显著差异。
我们的研究结果表明，洛匹那韦/利托那韦对 COVID-19 有一定疗效，化湿败毒方能在一定程度上增强这种疗效。此外，化湿败毒方联合中药注射液治疗 COVID-19 具有优势。未来需要进行精心设计的前瞻性双盲随机对照试验来证实我们的研究结果。
