Xu Xiang-Ru, Zhou Shuang, Jin Guo-Qiang, Wu Hong-Ze, Li Jin-Hua, Zhou Jing, Peng Wei, Zhang Wen, Sun Ding, Fang Bang-Jiang
Department of Emergency, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai, 200032, China.
Acupuncture and Massage College, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Chin J Integr Med. 2023 Oct;29(10):867-874. doi: 10.1007/s11655-023-3609-0. Epub 2023 Jul 31.
To assess the effect and safety of Reyanning Mixture (RYN) in treating asymptomatic or mild severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection in children and adolescents.
This is a prospective, open-label, randomized controlled trial. Patients aged 1-17 years and diagnosed with asymptomatic or mild coronavirus disease-2019 (COVID-19) were assigned to an intervention group (RYN plus standard care) and a control group (standard care) according to a randomization list. The primary outcomes were SARS-CoV-2 negative conversion time. Secondary outcomes included negative conversion rate on days 3 and 7, hospital length of stay, symptom relief rate, new-onset symptoms of asymptomatic infected patients, and progressive disease rate. The cycle threshold (Ct) values of ORF1ab or N genes were also tested.
A total of 214 patients in the intervention group and 217 in the control group were analyzed. The SARS-CoV-2 negative conversion time was significantly shortened in the intervention group [5 days (interquartile range (IQR): 5-6) vs. 7 days (IQR: 6-7), P<0.01]. By days 3 and 7, the negative conversion rates were significantly higher in the intervention group (day 3: 32.7% vs. 21.2%, P=0.007; day 7: 75.2% vs. 60.8%, P=0.001). Ct values significantly increase on day 2 [ORF1ab gene: 35.62 (IQR: 29.17-45.00) vs. 34.22 (IQR: 28.41-39.41), P=0.03; N gene: 34.97 (IQR: 28.50-45.00) vs. 33.51 (IQR: 27.70-38.25), P=0.024] and day 3 [ORF1ab gene: 38.00 (IQR: 32.72-45.00) vs. 35.81 (IQR: 29.96-45.00), P=0.003; N gene: 37.16 (IQR: 32.01-45.00) vs. 35.26 (IQR: 29.09-45.00), P=0.01]. No significant difference was found in hospital length of stay between the two groups (P>0.05). Symptoms of cough were significantly improved (82.2% vs. 70.0%, P=0.02) and wheezing was significantly reduced (0.7% vs. 12.9%, P<0.01) in the intervention group compared with the control group. During the trial, no disease progression or serious adverse events were reported.
Adding RYN to standard care may be a safe and effective treatment for children with asymptomatic and mild SARS-CoV-2 infection. (Registration No. ChiCTR2200060292).
评估热炎宁合剂治疗儿童及青少年无症状或轻度新型冠状病毒2（SARS-CoV-2）感染的疗效及安全性。
这是一项前瞻性、开放标签、随机对照试验。将年龄在1至17岁、诊断为无症状或轻度新型冠状病毒病2019（COVID-19）的患者根据随机列表分为干预组（热炎宁合剂加标准治疗）和对照组（标准治疗）。主要结局为SARS-CoV-2核酸转阴时间。次要结局包括第3天和第7天的核酸转阴率、住院时间、症状缓解率、无症状感染者的新发症状以及疾病进展率。还检测了开放阅读框1ab（ORF1ab）或N基因的循环阈值（Ct）值。
共分析了干预组的214例患者和对照组的217例患者。干预组的SARS-CoV-2核酸转阴时间显著缩短[5天（四分位数间距（IQR）：5至6） vs. 7天（IQR：6至7），P<0.01]。到第3天和第7天，干预组的核酸转阴率显著更高（第3天：32.7% vs. 21.2%，P = 0.007；第7天：75.2% vs. 60.8%，P = 0.001）。第2天[ORF1ab基因：35.62（IQR：29.17至45.00） vs. 34.22（IQR：28.41至39.41），P = 0.03；N基因：34.97（IQR：28.50至45.00） vs. 33.51（IQR：27.70至38.25），P = 0.024]和第3天[ORF1ab基因：38.00（IQR：32.72至45.00） vs. 35.81（IQR：29.96至45.00），P = 0.003；N基因：37.16（IQR：32.01至45.00） vs. 35.26（IQR：29.09至45.00），P = 0.01]时，Ct值显著升高。两组的住院时间无显著差异（P>0.05）。与对照组相比，干预组咳嗽症状显著改善（82.2% vs. 70.0%，P = 0.02），喘息显著减轻（0.7% vs. 12.9%，P<0.01）。试验期间，未报告疾病进展或严重不良事件。
在标准治疗基础上加用热炎宁合剂可能是治疗儿童无症状和轻度SARS-CoV-2感染的一种安全有效的方法。（注册号：ChiCTR2200060292）
