Safety and efficacy of Yupingfeng granules in children with recurrent respiratory tract infection: A randomized clinical trial

作者全名："Xu, Baoping; Li, Xinmin; Hu, Siyuan; Bao, Yixiao; Chen, Fengmei; Chen, Zhimin; Du, Yonggang; Liu, Enmei; Liu, Yufeng; Mou, Qinghui; Su, Baoling; Wang, Bo; Xu, Jianwen; Xu, Guiping; Yang, Qiaozhi; Gao, Liwei; Liu, Xiaohui; Li, Lei; Ma, Rong; Shen, Kunling"

作者地址："[Xu, Baoping; Li, Lei; Shen, Kunling] Capital Med Univ, Beijing Childrens Hosp, Natl Ctr Childrens Hlth, China Natl Clin Res Ctr Resp Dis, Beijing, Peoples R China; [Li, Xinmin; Hu, Siyuan; Ma, Rong] Tianjin Univ Tradit Chinese Med, Teaching Hosp 1, Tianjin, Peoples R China; [Bao, Yixiao] Shanghai Jiao Tong Univ, Xinhua Hosp, Sch Med, Shanghai, Peoples R China; [Chen, Fengmei; Wang, Bo] Guangdong Women & Children Hosp & Hlth Inst, Guangzhou, Peoples R China; [Chen, Zhimin] Zhejiang Univ, Childrens Hosp, Sch Med, Hangzhou, Zhejiang, Peoples R China; [Du, Yonggang] Changzhi Peoples Hosp, Changzhi, Shanxi, Peoples R China; [Liu, Enmei] Chongqing Med Univ, Childrens Hosp, Chongqing, Peoples R China; [Liu, Yufeng] Liaoning Univ Tradit Chinese Med, Affiliated Hosp 4, Shenyang, Liaoning, Peoples R China; [Mou, Qinghui] Shandong Univ, Qilu Childrens Hosp, Jinan, Shandong, Peoples R China; [Su, Baoling] Changzhi Med Coll, Heji Hosp, Changzhi, Shanxi, Peoples R China; [Xu, Jianwen] Xinxiang Med Coll, Affiliated Hosp 3, Xinxiang, Henan, Peoples R China; [Xu, Guiping] Huizhou Tradit Chinese Med Hosp, Huizhou, Guangdong, Peoples R China; [Yang, Qiaozhi] Liaocheng Peoples Hosp, Liaocheng, Shandong, Peoples R China; [Liu, Xiaohui] Capital Med Univ, Beijing Childrens Hosp, Natl Ctr Childrens Hlth, Beijing, Peoples R China; [Li, Lei] Chinese Assoc Traditional Chinese Med, Drug Res & Evaluat Technol Ctr, Beijing, Peoples R China"

通信作者："Shen, KL (通讯作者)，Capital Med Univ, Beijing Childrens Hosp, Natl Ctr Childrens Hlth, China Natl Clin Res Ctr Resp Dis, Beijing, Peoples R China.; Ma, R (通讯作者)，Tianjin Univ Tradit Chinese Med, Teaching Hosp 1, Tianjin, Peoples R China."

来源：PEDIATRIC INVESTIGATION

ESI学科分类：　

WOS号：WOS:000804597100001

JCR分区：Q3

影响因子：2.2

年份：2022

卷号：　

期号：　

开始页：　

结束页：　

文献类型：Article; Early Access

关键词：Pidotimod; Recurrent childhood respiratory tract infection; Traditional Chinese medicine; Yupingfeng

摘要："Importance Recurrent respiratory tract infection (RRTI) is common in children. Inappropriate RRTI treatment will lead to asthma and other diseases, thereby seriously affecting the growth and physical health of children. Immune function modulation can prevent and alleviate childhood RRTI. Yupingfeng (YPF), a patented traditional Chinese medicine (TCM), has immunomodulatory effects and is widely used in China to treat children with RRTI. Objective To evaluate the safety and efficacy of YPF monotherapy in treating children with RRTI. Methods This multicenter, randomized, double-blind, double-simulation, noninferiority clinical trial was conducted from January 2015 to August 2017, with an 8-week treatment period and 52-week follow-up after the drug withdrawal. Children aged 2-6 years with RRTI meeting the inclusion and exclusion criteria were enrolled in 13 hospitals in China and divided randomly into three groups (2:2:1 ratio) to receive YPF, pidotimod, or placebo. The primary outcome was the proportion of RRTI returning to normal standard level during the follow-up. The secondary outcomes were reduction in the number of RRTI recurrences, effect on clinical symptoms (in accord with TCM practice), effect per symptom, and safety. The trial was registered at the Chinese Clinical Trials Registry () under the unique identifier ChiCTR-IPR-15006847. Results Three hundred and fifty-one children were enrolled and randomly assigned to 3 groups; 124, 125, and 61 children in the YPF, pidotimod, and placebo groups, respectively, had completed the trial. During the follow-up, the proportion of RRTI returning to normal standard level was 73.13%, 67.15%, and 38.81% with YPF, pidotimod, and placebo, respectively (P < 0.0001). The proportion of cases who returned to normal standard level in the YPF group was 34.32% higher than that in the placebo group. The safety profile did not significantly differ among the groups. Interpretation YPF granules were noninferior to the active control drug pidotimod oral solution for the treatment of RRTI in children, and were superior to placebo, with a high safety profile."

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