Guo Shengxuan, Li Xinmin, Zheng Yuejie, Zhong Chengliang, Xiong Lei, Ming Xi, Ding Ying, Yan Yongbin, Zhang Baoqing, Zhou Peng, Fu Zhou, Wang Jun, Wang Xuefeng, Wang Junhong, Yang Jinghua, Liu Yanxia, Cai Jianxin, Ning Lihua, Liu Xiaohong, Zhu Hang, Gai Linlin, Liu Pingding, Sun Dahong, Wang Taizhong, Li Xiaojiao, Tian Xinhua, Zhang Junguang, Guan Wenda, Li Yupin, Li Xueming, Liu Junfeng, Kuang Nanyue, Lu Ling, Gao Tongxun, Liang Haodong, Shen Kunling, Ma Rong
Department of Clinical Trial Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China.
Department of Pediatrics, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China.
Front Pharmacol. 2025 May 22;16:1584003. doi: 10.3389/fphar.2025.1584003. eCollection 2025.
Xiao'er Fengre Qing Oral Liquid (XFQOL) is developed based on the classical traditional Chinese medicinal formula . Compared to the original formulation, XFQOL exhibits enhanced heat-clearing, detoxification, and fever reduction, which can effectively address the common complications associated with influenza in children and is well-suited for pediatric use. However, there is currently a lack of high-quality evidence from clinical trials to support its efficacy and safety in clinical applications.
This study aimed to investigate the efficacy and safety of XFQOL compared with Oseltamivir in pediatric influenza.
A multicenter, block-randomized, double-blind, double-dummy, positive-drug-controlled, non-Inferiority clinical trial design was conducted. The study plans to enroll 420 pediatric participants, with 210 in each group. The experimental group will receive XFQOL with an Oseltamivir granules placebo, and the control group will receive Oseltamivir granules with a XFQOL placebo for 5 days, followed by a 2-day post-treatment observation. The primary endpoint was clinical recovery time, while secondary endpoints included complete fever resolution time, the area under the curve (AUC) of Canadian Acute Respiratory Illness and Flu Scale (CARIFS) symptom dimension Score over time, Traditional Chinese Medicine (TCM) syndrome efficacy, disappearance rates for individual symptoms, incidences of complications and severe and critical influenza, the usage of acetaminophen, and viral negative conversion rate. Safety evaluation focused on adverse events (AE) and adverse drug reactions (ADR).
A total of 418 participants were included in the Full Analysis Set, with 208 in the experimental group and 210 in the control group. Baseline characteristics were comparable between the groups. The median time to clinical recovery was 3 days for both groups, with a hazard ratio and its 95% confidence interval (experimental group/control group) of 1.115 (95% CI: 0.912-1.363). Non-inferiority testing demonstrated that the experimental group was not inferior to the control group. Subgroup analyses (positive for RT-PCR influenza, positive for RT-PCR influenza A, positive for RT-PCR influenza B) yielded results consistent with the primary endpoint. The median time to complete fever resolution was 32 h in both groups, with no statistically significant difference ( = 0.407). There were no statistically significant differences in the AUC of CARIFS symptom scores over time between the groups ( = 0.211). No significant differences were observed between the groups in the efficacy rates of TCM syndromes of Wind-Heat Invading the Defense Syndrome ( = 0.076) and Fright-complicated Syndrome ( = 0.168); however, significant differences were found in Phlegm-complicated Syndrome ( = 0.008) and Food-stagnation-complicated Syndrome ( = 0.024). The disappearance rates for individual symptoms, such as red and swollen pharynx, cough, copious sputum or audible phlegm sounds in the throat, and lack of appetite, showed statistically significant differences between the groups ( < 0.05), while no significant differences were observed for other symptoms. No statistically significant differences were observed between the experimental and control groups in the incidence of complications and severe and critical influenza, the usage of acetaminophen, and viral negative conversion rate ( > 0.05). The incidence rates of AE ( = 0.885) and ADR ( = 0.685) were comparable between the two groups, with no statistically significant differences observed.
The efficacy of XFQOL in treating pediatric influenza (Wind-Heat Invading the Defense Syndrome) is non-inferior to Oseltamivir with respect to clinical recovery time. Additionally, its effectiveness in terms of fever reduction, symptom alleviation, incidences of complications and severe and critical influenza, the usage of acetaminophen, and viral negative conversion rate is comparable to that of Oseltamivir. Furthermore, it demonstrates good safety, suggesting its potential for clinical application.
clinicaltrials.gov, identifier ChiCTR2300076191.
小儿风热清口服液（XFQOL）是在经典中药方剂基础上研制而成。与原配方相比，XFQOL清热、解毒、退热作用增强，能有效应对儿童流感常见并发症，非常适合儿科使用。然而，目前缺乏高质量的临床试验证据支持其在临床应用中的疗效和安全性。
本研究旨在探讨XFQOL与奥司他韦相比治疗儿童流感的疗效和安全性。
采用多中心、区组随机、双盲、双模拟、阳性药物对照、非劣效性临床试验设计。本研究计划招募420名儿科参与者，每组210名。试验组接受XFQOL加奥司他韦颗粒安慰剂，对照组接受奥司他韦颗粒加XFQOL安慰剂，疗程5天，治疗后观察2天。主要终点为临床恢复时间，次要终点包括完全退热时间、加拿大急性呼吸道疾病和流感量表（CARIFS）症状维度评分随时间的曲线下面积（AUC）、中医证候疗效、各症状消失率、并发症及重症和危重症流感发生率、对乙酰氨基酚使用情况及病毒转阴率。安全性评价重点关注不良事件（AE）和药物不良反应（ADR）。
全分析集共纳入418名参与者，试验组208名，对照组210名。两组基线特征具有可比性。两组临床恢复的中位时间均为3天，风险比及其95%置信区间（试验组/对照组）为1.115（95%CI：0.912 - 1.363）。非劣效性检验表明试验组不劣于对照组。亚组分析（RT-PCR流感阳性、RT-PCR甲型流感阳性、RT-PCR乙型流感阳性）结果与主要终点一致。两组完全退热的中位时间均为32小时，差异无统计学意义（ = 0.407）。两组CARIFS症状评分随时间的AUC差异无统计学意义（ = 0.211）。两组风热犯卫证（ = 0.076）和惊惕证（ = 0.168）的中医证候疗效差异无统计学意义；但痰热证（ = 0.008）和食滞证（ = 0.024）差异有统计学意义。两组如咽红、咳嗽、痰多或喉中痰鸣、食欲不振等个别症状的消失率差异有统计学意义（ < 0.05），其他症状差异无统计学意义。试验组与对照组在并发症及重症和危重症流感发生率、对乙酰氨基酚使用情况及病毒转阴率方面差异无统计学意义（ > 0.05）。两组AE发生率（ = 0.885）和ADR发生率（ = 0.685）相当差异无统计学意义。
XFQOL治疗儿童流感（风热犯卫证）在临床恢复时间方面疗效不劣于奥司他韦。此外，其在退热、症状缓解、并发症及重症和危重症流感发生率、对乙酰氨基酚使用情况及病毒转阴率方面的效果与奥司他韦相当。而且，它显示出良好的安全性表明其具有临床应用潜力。
clinicaltrials.gov，标识符ChiCTR2300076191。
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