Chen Jiande, Tang Qiuyu, Zhang Baoqin, Yuan Shuhua, Chen Jia, Shen Shiyu, Wang Dong, Lin Jilei, Dong Hongliang, Yin Yong, Gao Jian
Department of Respiratory Medicine, Shanghai Children's Medical Center, School of Medicine, Shanghai Jiao Tong University, Shanghai, China.
Department of Respiration, Fujian Branch of Shanghai Children's Medical Centre Affiliated to Shanghai Jiao Tong University School of Medicine (Fujian Children's Hospital, Fujian Maternity and Child Health Hospital, College of Clinical Medicine for Obstetrics and Gynecology and Pediatrics, Fujian Medical University), Fuzhou, Fujian, China.
Front Pharmacol. 2023 Jan 19;14:1092748. doi: 10.3389/fphar.2023.1092748. eCollection 2023.
Since late February 2022, a wave of coronavirus disease 2019 (COVID-19) mainly caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron variant rapidly appeared in Shanghai, China. Traditional Chinese medicine treatment is recommended for pediatric patients; however, the safety and efficacy remain to be confirmed. We conducted a single-center, open-label, parallel-group randomized controlled trial to assess the efficacy and safety of a Chinese herb compound, Huashi Baidu granule (HSBDG) in pediatric patients with laboratory-confirmed mild COVID-19. 108 recruited children (aged 3-18 years) with laboratory-confirmed mild COVID-19 were randomly allocated 2:1 to receive oral HSBDG for five consecutive days (intervention group) and to receive compound pholcodine oral solution for five consecutive days (control group). The negative conversion time of SARS-CoV-2 nucleic acid and symptom scores were recorded. The median negative conversion time of SARS-CoV-2 nucleic acid was significantly shorter in the intervention group than in the control group (median days [interquartile range (IQR)]: 3 [3-5] vs. 5 [3-6]; = 0.047). The median total symptom score on day 3 was significantly lower in the intervention group than in the control group (median total symptom score [IQR]: 1 [0-2] vs. 2 [0-3]; = 0.036). There was no significant differences in the frequency of antibiotic use and side effects between the two groups. HSBDG is a safe, effective oral Chinese herbal compound granule, which shows a good performance within the Omicron wave among pediatric patients.
自2022年2月下旬起，由严重急性呼吸综合征冠状病毒2（SARS-CoV-2）奥密克戎变异株引发的新型冠状病毒肺炎（COVID-19）疫情在中国上海迅速蔓延。推荐对儿童患者采用中医药治疗；然而，其安全性和有效性仍有待证实。我们开展了一项单中心、开放标签、平行组随机对照试验，以评估中药复方化湿败毒颗粒（HSBDG）对实验室确诊的轻度COVID-19儿童患者的疗效和安全性。108名招募的实验室确诊为轻度COVID-19的儿童（年龄3至18岁）按2:1随机分配，连续5天口服HSBDG（干预组）或连续5天口服复方福尔可定口服溶液（对照组）。记录SARS-CoV-2核酸转阴时间和症状评分。干预组SARS-CoV-2核酸转阴时间的中位数显著短于对照组（中位数天数[四分位间距（IQR）]：3[3至5]天对5[3至6]天；P = 0.047）。干预组第3天的总症状评分中位数显著低于对照组（总症状评分中位数[IQR]：1[0至2]分对2[0至3]分；P = 0.036）。两组间抗生素使用频率和副作用无显著差异。HSBDG是一种安全、有效的口服中药复方颗粒剂，在奥密克戎疫情期间对儿童患者表现出良好疗效。
