The First Affiliated Hospital of Wenzhou Medical University, Zhejiang, 325000, PR China.
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Henan, 450099, PR China.
J Ethnopharmacol. 2023 Jun 12;309:116207. doi: 10.1016/j.jep.2023.116207. Epub 2023 Feb 2.
Children's Zibei Xuanfei syrup is an herbal preparation from a lifetime professor, famous old Chinese doctor, and postgraduate supervisor of medical doctor of Shandong University of Traditional Chinese Medicine. This herbal preparation promotes lung health, relieves cough, reduces phlegm, and benefits pharynx.
To verify the clinical efficacy and safety of Zibei Xuanfei syrup for children in treatment of acute trachea bronchitis with wind-heat invading lung syndrome.
This was an age-stratified, block randomized, double-blind, extremely low dose parallel control, multi-center clinical trial. A total of 453 pediatric patients diagnosed with acute tracheal bronchitis in Western medicine and cough due to exogenous factors with wind-heat invading lung syndrome in Chinese medicine were enrolled. They were divided into three subgroups based on age 1∼3, 4-7, and 8-14 years old, and randomly assigned to children's Zibei Xuanfei syrup and extremely low doses of children's Zibei Xuanfei syrup (control) in a 3:1 ratio. The primary outcome was the decreased values of cough Visual Analogue Scale (VAS) score after 7 days of administration. Secondary outcomes included a decrease in cough VAS score after 3 and 5 days of the administration, and the total score of Traditional Chinese Medicine(TCM) syndrome after 3, 5, and 7 days of treatment. The chest X-ray and blood C-reactive protein were examined during screening. The safety assessment included blood urine, and stool routine, liver and kidney function of laboratory tests, and an electrocardiogram at the screening and the last visit.
The subjects of two groups had high administration adherence (completion over 80%) (299/323, 92.6% in children's Zibei Xuanfei syrup group vs 103/107, 96.3% in the control group; p > 0.05). The children's Zibei Xuanfei syrup group was significantly better than the control group in the decreased values of cough VAS score after 7 days of administration(6.35 ± 3.45 vs 3.73 ± 3.98, p < 0.001). The subgroup analysis of the decreased value of cough VAS scores aged 1-3 years old were 5.80 ± 3.43 vs 3.75 ± 4.38 (P = 0.003), 4-7 years old was 6.30 ± 3.69 vs 2.73 ± 3.65 (P < 0.001), and 8-14 years old were 6.91 ± 3.12 vs 4.69 ± 3.75(P = 0.001)respectively. The secondary outcomes decrease values of cough VAS score of children's Zibei Xuanfei syrup group vs control group after 5 days of administration were 5.88 ± 2.90 vs 3.55 ± 3.41(P < 0.001), after 3 days of administration were 3.61 ± 2.53 vs 2.43 ± 2.56 (P < 0.001). The effective rate of the TCM symptom total score of children's Zibei Xuanfei syrup group vs control group was 91.38% vs 54.95%after 7 days of the administration, 86.93% vs 50.94% after 5 days of the administration, and 64.78% vs 40.19% after 3 days administration(each p < 0.001). There was no significant difference in Adverse Event between the two groups (59/331, 17.82% vs 15/111, 13.51%, P > 0.05). The children's Zibei Xuanfei syrup group had 5 Serious Adverse Events (incidence rate 1.21%), all of which were unrelated to the trial drug.
Children's Zibei Xuanfei syrup appears to be extremely effective and safe in the treatment of acute trachea bronchitis with wind-heat invading lung syndrome. Future studies with large sample sizes will need to collect more safety data use for children.
儿童止咳平喘口服液是由山东中医药大学终身教授、著名老中医、医学博士研究生导师研制的一种草药制剂。该草药制剂有益于肺部健康,可止咳、化痰、利咽。
验证儿童止咳平喘口服液治疗风热犯肺型小儿急性气管-支气管炎的临床疗效和安全性。
这是一项分层、分组随机、双盲、极低剂量平行对照、多中心临床试验。共纳入 453 例西医诊断为急性气管-支气管炎、中医辨证为咳嗽外感风邪热犯肺证的儿科患者。根据年龄 13 岁、47 岁和 8~14 岁分为三组,按 3∶1 的比例随机分为儿童止咳平喘口服液组和极低剂量儿童止咳平喘口服液(对照组)。主要结局指标为 7 天治疗后咳嗽视觉模拟量表(VAS)评分的降低值。次要结局指标包括治疗后 3 天和 5 天咳嗽 VAS 评分的降低值,以及治疗后 3 天、5 天和 7 天的中医证候总评分。在筛选期间检查了胸部 X 线和血 C-反应蛋白。安全性评估包括血、尿、便常规、肝肾功能实验室检查以及筛选和最后一次就诊时的心电图。
两组受试者的服药依从性均较高(完成率超过 80%)(儿童止咳平喘口服液组 299/323,92.6%;对照组 103/107,96.3%;p>0.05)。儿童止咳平喘口服液组在 7 天治疗后咳嗽 VAS 评分降低值方面明显优于对照组(6.35±3.45 比 3.73±3.98,p<0.001)。年龄 13 岁组咳嗽 VAS 评分降低值的亚组分析分别为 5.80±3.43 比 3.75±4.38(P=0.003),47 岁组为 6.30±3.69 比 2.73±3.65(P<0.001),8~14 岁组为 6.91±3.12 比 4.69±3.75(P=0.001)。儿童止咳平喘口服液组在 5 天和 3 天治疗后咳嗽 VAS 评分降低值的次要结局均明显优于对照组(5 天治疗后分别为 5.88±2.90 比 3.55±3.41,p<0.001;3 天治疗后分别为 3.61±2.53 比 2.43±2.56,p<0.001)。儿童止咳平喘口服液组治疗后第 7 天的中医证候总评分有效率为 91.38%比 54.95%,第 5 天为 86.93%比 50.94%,第 3 天为 64.78%比 40.19%(均 p<0.001)。两组间不良反应发生率无显著差异(59/331,17.82%比 15/111,13.51%,p>0.05)。儿童止咳平喘口服液组有 5 例严重不良事件(发生率 1.21%),均与试验药物无关。
儿童止咳平喘口服液治疗风热犯肺型小儿急性气管-支气管炎疗效显著,安全性良好。未来需要更大样本量的研究来收集更多关于儿童用药的安全性数据。