中医药荆银固表方治疗可提高轻症 COVID-19 患者的 SARS-CoV-2 转阴率。
Traditional Chinese Medicine JingYinGuBiao Formula Therapy Improves the Negative Conversion Rate of SARS-CoV2 in Patients with Mild COVID-19.
机构信息
Department of Hepatopathy, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
Medical Department, Shuguang Hospital, Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, China.
出版信息
Int J Biol Sci. 2022 Sep 1;18(15):5641-5652. doi: 10.7150/ijbs.76699. eCollection 2022.
Traditional Chinese Medicine (TCM) JingYinGuBiao formula (JYGB) was recommended by the Expert consensus on Traditional Chinese Medicine diagnosis and treatment of COVID-19 infection in Shanghai. We evaluated the safety and efficacy of JYGB in treating mild COVID-19 patients. Methods: A prospective, double-blind, randomized, controlled trial was conducted (ClinicalTrial.gov registration number: ChiCTR2200058695). A total of 885 patients were randomized into the treatment group (administration of JYGB,n=508) or the control group (administration of TCM placebo, n=377) with 7-day treatment. The primary outcomes were the negative conversion rate and negative conversion time of SARS-CoV2 RNA. Secondary outcomes included the hospitalized days and symptom improvement. A total of 490 and 368 patients in the treatment and control groups completed the study. The cumulative negative conversion rates at 2 days, 3 days, 4 days, and 6 days post randomization in the treatment group were all markedly higher than those in the control group (13.88% vs. 9.24%, =0.04; 32.24% vs. 16.58%, <0.001; 51.43% vs. 36.14%, <0.001; 77.76% vs. 69.84%, =0.008). Compared with the control group, after JYGB treatment, the median negative conversion time (4.0 [3.0-6.0] vs. 5.0 [4.0-7.0] days, <0.001) and hospitalized days (6.0 [4.0-8.0] vs. 7.0 [5.0-9.0] days, <0.001) were reduced. While the symptoms were improved, there were no significant differences in symptom disappearance rates between both groups. In addition, further sub-group analysis showed that for patients with interval time ≤4 days or patients≤ 60 years, the clinical effects of JYGB were more remarkable with an increase in cumulative negative conversion rates, a decrease in negative conversion time and hospitalized days. JYGB was well tolerated without any severe side effects. JYGB, a TCM prescription, improves the negative conversion rate of SARS-CoV2 in mild COVID-19 patients.
中药荆银固表方（JYGB）是上海中医药治疗 COVID-19 感染专家共识推荐的。我们评估了 JYGB 治疗轻症 COVID-19 患者的安全性和疗效。方法：前瞻性、双盲、随机、对照临床试验（ClinicalTrials.gov 注册号：ChiCTR2200058695）。共纳入 885 例患者，随机分为治疗组（JYGB 组，n=508）或对照组（TCM 安慰剂组，n=377），疗程 7 天。主要结局是 SARS-CoV2 RNA 的阴转率和阴转时间。次要结局包括住院天数和症状改善。治疗组和对照组分别有 490 例和 368 例患者完成研究。治疗组在随机后第 2、3、4、6 天的累积阴转率均明显高于对照组（13.88% vs. 9.24%，=0.04；32.24% vs. 16.58%，<0.001；51.43% vs. 36.14%，<0.001；77.76% vs. 69.84%，=0.008）。与对照组相比，JYGB 治疗后，中位阴转时间（4.0[3.0-6.0] vs. 5.0[4.0-7.0]天，<0.001）和住院天数（6.0[4.0-8.0] vs. 7.0[5.0-9.0]天，<0.001）缩短。症状改善方面，两组症状消失率无统计学差异。此外，进一步的亚组分析显示，对于间隔时间≤4 天或年龄≤60 岁的患者，JYGB 的累积阴转率增加，阴转时间和住院天数减少，临床效果更为显著。JYGB 耐受性良好，无严重不良反应。中药处方 JYGB 可提高轻症 COVID-19 患者 SARS-CoV2 的阴转率。
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