Safety and efficacy of Yupingfeng granules in children with recurrent respiratory tract infection: A randomized clinical trial
ABSTRACT 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. Yu...
| Main Authors: | , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2022-06-01
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| Series: | Pediatric Investigation |
| Subjects: | |
| Online Access: | https://doi.org/10.1002/ped4.12326 |
| _version_ | 1818547540956545024 |
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| author | Baoping Xu Xinmin Li Siyuan Hu Yixiao Bao Fengmei Chen Zhimin Chen Yonggang Du Enmei Liu Yufeng Liu Qinghui Mou Baoling Su Bo Wang Jianwen Xu Guiping Xu Qiaozhi Yang Liwei Gao Xiaohui Liu Lei Li Rong Ma Kunling Shen |
| author_facet | Baoping Xu Xinmin Li Siyuan Hu Yixiao Bao Fengmei Chen Zhimin Chen Yonggang Du Enmei Liu Yufeng Liu Qinghui Mou Baoling Su Bo Wang Jianwen Xu Guiping Xu Qiaozhi Yang Liwei Gao Xiaohui Liu Lei Li Rong Ma Kunling Shen |
| author_sort | Baoping Xu |
| collection | DOAJ |
| description | ABSTRACT 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 (www.chictr.org.cn) 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. |
| first_indexed | 2024-12-12T08:08:07Z |
| format | Article |
| id | doaj.art-5ec97852c4eb45f59bdeae5a382537d3 |
| institution | Directory Open Access Journal |
| issn | 2574-2272 |
| language | English |
| last_indexed | 2024-12-12T08:08:07Z |
| publishDate | 2022-06-01 |
| publisher | Wiley |
| record_format | Article |
| series | Pediatric Investigation |
| spelling | doaj.art-5ec97852c4eb45f59bdeae5a382537d32022-12-22T00:31:53ZengWileyPediatric Investigation2574-22722022-06-0162758410.1002/ped4.12326Safety and efficacy of Yupingfeng granules in children with recurrent respiratory tract infection: A randomized clinical trialBaoping Xu0Xinmin Li1Siyuan Hu2Yixiao Bao3Fengmei Chen4Zhimin Chen5Yonggang Du6Enmei Liu7Yufeng Liu8Qinghui Mou9Baoling Su10Bo Wang11Jianwen Xu12Guiping Xu13Qiaozhi Yang14Liwei Gao15Xiaohui Liu16Lei Li17Rong Ma18Kunling Shen19China National Clinical Research Center of Respiratory Diseases Beijing Children's Hospital Capital Medical University National Center for Children's Health Beijing ChinaThe First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin ChinaThe First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin ChinaXinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai ChinaGuangdong Women and Children Hospital and Health Institute Guangzhou Guangdong ChinaChildren's Hospital of Zhejiang University School of Medicine Zhejiang ChinaChangzhi People's Hospital Changzhi Shanxi ChinaChildren's Hospital of Chongqing Medical University Chongqing ChinaThe Fourth Affiliated Hospital of Liaoning University of Traditional Chinese Medicine Shenyang Liaoning ChinaQilu Children's Hospital of Shandong University Jinan Shandong ChinaHeji Hospital Affiliated to Changzhi Medical College Changzhi Shanxi ChinaGuangdong Women and Children Hospital and Health Institute Guangzhou Guangdong ChinaThe Third Affiliated Hospital of Xinxiang Medical College Xinxiang Henan ChinaHuizhou Traditional Chinese Medicine Hospital Guangdong ChinaLiaocheng People's Hospital Shandong ChinaChina National Clinical Research Center of Respiratory Diseases Beijing Children's Hospital Capital Medical University National Center for Children's Health Beijing ChinaBeijing Children's Hospital, Capital Medical University National Center for Children's Health Beijing ChinaDrug Research and Evaluation Technology Center Chinese Association of Traditional Chinese Medicine Beijing ChinaThe First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Tianjin ChinaChina National Clinical Research Center of Respiratory Diseases Beijing Children's Hospital Capital Medical University National Center for Children's Health Beijing ChinaABSTRACT 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 (www.chictr.org.cn) 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.https://doi.org/10.1002/ped4.12326PidotimodRecurrent childhood respiratory tract infectionTraditional Chinese medicineYupingfeng |
| spellingShingle | Baoping Xu Xinmin Li Siyuan Hu Yixiao Bao Fengmei Chen Zhimin Chen Yonggang Du Enmei Liu Yufeng Liu Qinghui Mou Baoling Su Bo Wang Jianwen Xu Guiping Xu Qiaozhi Yang Liwei Gao Xiaohui Liu Lei Li Rong Ma Kunling Shen Safety and efficacy of Yupingfeng granules in children with recurrent respiratory tract infection: A randomized clinical trial Pediatric Investigation Pidotimod Recurrent childhood respiratory tract infection Traditional Chinese medicine Yupingfeng |
| title | Safety and efficacy of Yupingfeng granules in children with recurrent respiratory tract infection: A randomized clinical trial |
| title_full | Safety and efficacy of Yupingfeng granules in children with recurrent respiratory tract infection: A randomized clinical trial |
| title_fullStr | Safety and efficacy of Yupingfeng granules in children with recurrent respiratory tract infection: A randomized clinical trial |
| title_full_unstemmed | Safety and efficacy of Yupingfeng granules in children with recurrent respiratory tract infection: A randomized clinical trial |
| title_short | Safety and efficacy of Yupingfeng granules in children with recurrent respiratory tract infection: A randomized clinical trial |
| title_sort | safety and efficacy of yupingfeng granules in children with recurrent respiratory tract infection a randomized clinical trial |
| topic | Pidotimod Recurrent childhood respiratory tract infection Traditional Chinese medicine Yupingfeng |
| url | https://doi.org/10.1002/ped4.12326 |
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