Chen Bowu, Xue Yan, Jing Hua, Wang Xiaodong, Zhu Peimin, Hao Weiwei, Li Man, Gao Yueqiu
Department of Hepatology, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Laboratory of Cellular Immunity, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Integr Med Res. 2023 Jun;12(2):100950. doi: 10.1016/j.imr.2023.100950. Epub 2023 Apr 21.
The effectiveness and safety of Huashibaidu granule (HSBD) in treating mild Corona Virus Disease 2019 (COVID-19) patients infected with SARS-CoV-2 remain to be identified. We aimed to evaluate the effectiveness of HSBD in mild COVID-19 patients.
A prospective, non-randomized, controlled study in mild COVID-19 patients was conducted in Shanghai, from April 8 to May 6, 2022. The enrolled patients were diagnosed as mild COVID-19. Finally, 360 patients received HSBD, and 368 patients received TCM placebo (administered orally 20 g twice daily for 7 days). The primary endpoints were the negative conversion rate of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and the negative conversion time. Secondary endpoints included the hospitalized days and the improvement in the clinical condition.
The negative conversion rate of SARS-CoV-2 at 7 days posttreatment in the HSBD group was higher than that in the control group (95.28% vs. 82.61%, < 0.001). The median negative conversion time in the HSBD group was markedly decreased by 2 days compared with the control group (3 [3-6] vs. 5 [4-7], < 0.001). In addition, the median hospitalized day was shortened in the HSBD group by 1 day compared with the control group (6 [4-7] vs. 7 [5-9], < 0.001). The clinical improvement rate (275/360 [76.39%]) in the HSBD group within 7 days was significantly higher than that (203/368 [55.16%]) in the control group ( < 0.001). The improvement of symptom scores in the HSBD group was higher than that in the control group (2 [1-4] vs. 1 [1-2], < 0.001). No severe adverse events occurred.
Our study suggested that HSBD effectively increased the negative conversion rate of SARS-CoV-2 and shortened the negative conversion time and hospitalized days in mild COVID-19 patients.
Chinese Clinical Trial Registry, ChiCTR2200058668.
化湿败毒颗粒（HSBD）治疗新型冠状病毒2019（COVID-19）轻症患者的有效性和安全性尚待明确。我们旨在评估HSBD对COVID-19轻症患者的有效性。
于2022年4月8日至5月6日在上海对COVID-19轻症患者进行了一项前瞻性、非随机对照研究。纳入患者被诊断为COVID-19轻症。最终，360例患者接受HSBD治疗，368例患者接受中药安慰剂治疗（口服，20 g，每日2次，共7天）。主要终点为严重急性呼吸综合征冠状病毒2（SARS-CoV-2）转阴率和转阴时间。次要终点包括住院天数和临床状况改善情况。
HSBD组治疗7天后SARS-CoV-2转阴率高于对照组（95.28% 对82.61%，<0.001）。HSBD组的中位转阴时间较对照组明显缩短2天（3[3 - 6]对5[4 - 7]，<0.001）。此外，HSBD组的中位住院天数较对照组缩短1天（6[4 - 7]对7[5 - 9]，<0.001）。HSBD组7天内的临床改善率（275/360[76.39%]）显著高于对照组（203/368[55.16%]）（<0.001）。HSBD组症状评分的改善高于对照组（2[1 - 4]对1[1 - 2]，<0.001）。未发生严重不良事件。
我们的研究表明，HSBD可有效提高COVID-19轻症患者的SARS-CoV-2转阴率，缩短转阴时间和住院天数。
中国临床试验注册中心，ChiCTR2200058668
