1.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
2.Material basis of toad oil and its pharmacodynamic effect in a mouse model of atopic dermatitis.
Yu-Yang LIU ; Xin-Wei YAN ; Bao-Lin BIAN ; Yao-Hua DING ; Xiao-Lu WEI ; Meng-Yao TIAN ; Wei WANG ; Hai-Yu ZHAO ; Yan-Yan ZHOU ; Hong-Jie WANG ; Ying YANG ; Nan SI
China Journal of Chinese Materia Medica 2025;50(1):165-177
This study aims to comprehensively analyze the material basis of toad visceral oil(hereafter referred to as toad oil), and explore the pharmacological effect of toad oil on atopic dermatitis(AD). Ultra-high performance liquid chromatography-linear ion trap/orbitrap high-resolution mass spectrometry(UHPLC-LTQ-Orbitrap-MS) and gas chromatography-mass spectrometry(GC-MS) were employed to comprehensively identify the chemical components in toad oil. The animal model of AD was prepared by the hapten stimulation method. The modeled animals were respectively administrated with positive drug(0.1% hydrocortisone butyrate cream) and low-and high-doses(1%, 10%) of toad oil by gavage. The effect of toad oil on AD was evaluated with the AD score, ear swelling rate, spleen index, and pathological section results as indicators. A total of 99 components were identified by UHPLC-LTQ-Orbitrap-MS, including 14 bufadienolides, 7 fatty acids, 6 alkaloids, 10 ketones, 18 amides, and other compounds. After methylation of toad oil samples, a total of 20 compounds were identified by GC-MS. Compared with the model group, the low-and high-dose toad oil groups showed declined AD score, ear swelling rate, and spleen index, alleviated skin lesions, and reduced infiltrating mast cells. This study comprehensively analyzes the chemical composition and clarifies the material basis of toad oil. Meanwhile, this study proves that toad oil has a good therapeutic effect on AD and is a reserve resource of traditional Chinese medicine for external use in the treatment of AD.
Animals
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Dermatitis, Atopic/immunology*
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Disease Models, Animal
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Mice
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Male
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Gas Chromatography-Mass Spectrometry
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Humans
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Bufonidae
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Oils/administration & dosage*
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Chromatography, High Pressure Liquid
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Female
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Mice, Inbred BALB C
3.Current status and suggestions on regulation of traditional Chinese medicine raw materials and preparations under regulatory system of drugs.
Li-Ping QU ; Yong-Dan XU ; Wei-Jing HE ; Ding-Kun ZHANG ; Nan YANG ; Min-Xian SONG ; Zhi-Qiang MIN ; Ting-Mo ZHANG
China Journal of Chinese Materia Medica 2025;50(3):824-832
At present, the cause of traditional Chinese medicine(TCM) in China has entered a new period of high-quality development. How to strengthen the foundation for the TCM industry from the source is an important issue that deserves the attention of the authorities, industry, and academia. This study systematically analyzed the regulatory system of TCM raw materials and preparations. The study took the TCM industry chain and the product life cycle as a clue and focused on the dimensions of TCM resource protection and plant cultivation(farming), production and quality supervision of TCM raw materials and preparations, and their market access and distribution. It analyzed the current situation of the regulation of TCM raw materials and preparations under the regulatory system of drugs, discussed the main problems, and put forward corresponding suggestions. The results can provide an important reference value for the subsequent improvement of the regulatory system of drugs and the construction of a prominent regulatory system of drugs in accordance with TCM characteristics.
Drugs, Chinese Herbal/economics*
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Medicine, Chinese Traditional/standards*
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China
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Quality Control
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Humans
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Plants, Medicinal/chemistry*
4.Dimethyloxalylglycine improves functional recovery through inhibiting cell apoptosis and enhancing blood-spinal cord barrier repair after spinal cord injury.
Wen HAN ; Chao-Chao DING ; Jie WEI ; Dan-Dan DAI ; Nan WANG ; Jian-Min REN ; Hai-Lin CHEN ; Ling XIE
Chinese Journal of Traumatology 2025;28(5):361-369
PURPOSE:
The secondary damage of spinal cord injury (SCI) starts from the collapse of the blood spinal cord barrier (BSCB) to chronic and devastating neurological deficits. Thereby, the retention of the integrity and permeability of BSCB is well-recognized as one of the major therapies to promote functional recovery after SCI. Previous studies have demonstrated that activation of hypoxia inducible factor-1α (HIF-1α) provides anti-apoptosis and neuroprotection in SCI. Endogenous HIF-1α, rapidly degraded by prolylhydroxylase, is insufficient for promoting functional recovery. Dimethyloxalylglycine (DMOG), a highly selective inhibitor of prolylhydroxylase, has been reported to have a positive effect on axon regeneration. However, the roles and underlying mechanisms of DMOG in BSCB restoration remain unclear. Herein, we aim to investigate pathological changes of BSCB restoration in rats with SCI treated by DOMG and evaluate the therapeutic effects of DMOG.
METHODS:
The work was performed from 2022 to 2023. In this study, Allen's impact model and human umbilical vein endothelial cells were employed to explore the mechanism of DMOG. In the phenotypic validation experiment, the rats were randomly divided into 3 groups: sham group, SCI group, and SCI + DMOG group (10 rats for each). Histological analysis via Nissl staining, Basso-Beattie-Bresnahan scale, and footprint analysis was used to evaluate the functional recovery after SCI. Western blotting, TUNEL assay, and immunofluorescence staining were employed to exhibit levels of tight junction and adhesion junction of BSCB, HIF-1α, cell apoptosis, and endoplasmic reticulum (ER) stress. The one-way ANOVA test was used for statistical analysis. The difference was considered statistically significant at p < 0.05.
RESULTS:
In this study, we observed the expression of HIF-1α reduced in the SCI model. DMOG treatment remarkably augmented HIF-1α level, alleviated endothelial cells apoptosis and disruption of BSCB, and enhanced functional recovery post-SCI. Besides, the administration of DMOG offset the activation of ER stress induced by SCI, but this phenomenon was blocked by tunicamycin (an ER stress activator). Finally, we disclosed that DMOG maintained the integrity and permeability of BSCB by inhibiting ER stress, and inhibition of HIF-1α erased the protection from DMOG.
CONCLUSIONS
Our findings illustrate that the administration of DMOG alleviates the devastation of BSCB and HIF-1α-induced inhibition of ER stress.
Spinal Cord Injuries/pathology*
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Animals
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Apoptosis/drug effects*
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Amino Acids, Dicarboxylic/therapeutic use*
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Recovery of Function/drug effects*
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Rats
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Rats, Sprague-Dawley
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Hypoxia-Inducible Factor 1, alpha Subunit/metabolism*
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Male
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Spinal Cord/blood supply*
5.Granulomatous primary central nervous system vasculitis in a child.
Ya-Nan ZHANG ; Chang-Hong DING ; Shu-Hong REN ; Wei-Hua ZHANG ; Fang LIU ; Nan ZHANG ; Yu-Juan ZHANG
Chinese Journal of Contemporary Pediatrics 2025;27(9):1140-1142
A 14-year-old boy was admitted to the hospital due to a single episode of afebrile seizure and four hours of impaired consciousness. Three months prior to admission, he had a history of bilateral uveitis. Cerebrospinal fluid analysis revealed a mild elevation in white blood cell count. Cranial magnetic resonance imaging and contrast-enhanced scans showed multiple abnormal signals in both cerebral hemispheres, with punctate and nodular enhancement. Susceptibility-weighted imaging revealed multiple punctate hemorrhages within lesions in the bilateral frontal and left parietal lobes, suggestive of vasculitis. Brain biopsy demonstrated inflammatory granulomatous lesions. No secondary causes were identified, and the final diagnosis was granulomatous primary central nervous system vasculitis. The patient's condition improved after treatment with methylprednisolone sodium succinate and mycophenolate mofetil. This report describes a rare case of granulomatous central nervous system vasculitis in a child and provides valuable insights for the diagnosis and treatment of this disease.
Humans
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Male
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Vasculitis, Central Nervous System/diagnosis*
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Adolescent
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Magnetic Resonance Imaging
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Granuloma/diagnosis*
6.Quercetin Confers Protection against Sepsis-Related Acute Respiratory Distress Syndrome by Suppressing ROS/p38 MAPK Pathway.
Wei-Chao DING ; Juan CHEN ; Quan LI ; Yi REN ; Meng-Meng WANG ; Wei ZHANG ; Xiao-Hang JI ; Xin-Yao WU ; Shi-Nan NIE ; Chang-Bao HUANG ; Zhao-Rui SUN
Chinese journal of integrative medicine 2025;31(11):1011-1020
OBJECTIVE:
To identify the underlying mechanism by which quercetin (Que) alleviates sepsis-related acute respiratory distress syndrome (ARDS).
METHODS:
In vivo, C57BL/6 mice were assigned to sham, cecal ligation and puncture (CLP), and CLP+Que (50 mg/kg) groups (n=15 per group) by using a random number table. The sepsisrelated ARDS mouse model was established using the CLP method. In vitro, the murine alveolar macrophages (MH-S) cells were classified into control, lipopolysaccharide (LPS), LPS+Que (10 μmol/L), and LPS+Que+acetylcysteine (NAC, 5 mmol/L) groups. The effect of Que on oxidative stress, inflammation, and apoptosis in mice lungs and MH-S cells was determined, and the mechanism with reactive oxygen species (ROS)/p38 mitogen-activated protein kinase (MAPK) pathway was also explored both in vivo and in vitro.
RESULTS:
Que alleviated lung injury in mice, as reflected by a reversal of pulmonary histopathologic changes as well as a reduction in lung wet/dry weight ratio and neutrophil infiltration (P<0.05 or P<0.01). Additionally, Que improved the survival rate and relieved gas exchange impairment in mice (P<0.01). Que treatment also remarkedly reduced malondialdehyde formation, superoxide dismutase and catalase depletion, and cell apoptosis both in vivo and in vitro (P<0.05 or P<0.01). Moreover, Que treatment diminished the release of inflammatory factors interleukin (IL)-1β, tumor necrosis factor-α, and IL-6 both in vivo and in vitro (P<0.05 or P<0.01). Mechanistic investigation clarifified that Que administration led to a decline in the phosphorylation of p38 MAPK in addition to the suppression of ROS expression (P<0.01). Furthermore, in LPS-induced MH-S cells, ROS inhibitor NAC further inhibited ROS/p38 MAPK pathway, as well as oxidative stress, inflammation, and cell apoptosis on the basis of Que treatment (P<0.05 or P<0.01).
CONCLUSION
Que was found to exert anti-oxidative, anti-inflammatory, and anti-apoptotic effects by suppressing the ROS/p38 MAPK pathway, thereby conferring protection for mice against sepsis-related ARDS.
Animals
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Sepsis/drug therapy*
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Quercetin/therapeutic use*
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Respiratory Distress Syndrome/enzymology*
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p38 Mitogen-Activated Protein Kinases/metabolism*
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Mice, Inbred C57BL
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Reactive Oxygen Species/metabolism*
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Apoptosis/drug effects*
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Male
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Oxidative Stress/drug effects*
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MAP Kinase Signaling System/drug effects*
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Lung/drug effects*
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Mice
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Lipopolysaccharides
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Macrophages, Alveolar/pathology*
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Inflammation/pathology*
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Protective Agents/therapeutic use*
7.Ionizing Radiation Alters Circadian Gene Per1 Expression Profiles and Intracellular Distribution in HT22 and BV2 Cells.
Zhi Ang SHAO ; Yuan WANG ; Pei QU ; Zhou Hang ZHENG ; Yi Xuan LI ; Wei WANG ; Qing Feng WU ; Dan XU ; Ju Fang WANG ; Nan DING
Biomedical and Environmental Sciences 2025;38(11):1451-1457
8.Hepatitis C virus infection:surveillance report from China Healthcare-as-sociated Infection Surveillance System in 2020
Xi-Mao WEN ; Nan REN ; Fu-Qin LI ; Rong ZHAN ; Xu FANG ; Qing-Lan MENG ; Huai YANG ; Wei-Guang LI ; Ding LIU ; Feng-Ling GUO ; Shu-Ming XIANYU ; Xiao-Quan LAI ; Chong-Jie PANG ; Xun HUANG ; An-Hua WU
Chinese Journal of Infection Control 2024;23(1):1-8
Objective To investigate the infection status and changing trend of hepatitis C virus(HCV)infection in hospitalized patients in medical institutions,and provide reference for formulating HCV infection prevention and control strategies.Methods HCV infection surveillance results from cross-sectional survey data reported to China Healthcare-associated Infection(HAI)Surveillance System in 2020 were summarized and analyzed,HCV positive was serum anti-HCV positive or HCV RNA positive,survey result was compared with the survey results from 2003.Results In 2020,1 071 368 inpatients in 1 573 hospitals were surveyed,738 535 of whom underwent HCV test,4 014 patients were infected with HCV,with a detection rate of 68.93%and a HCV positive rate of 0.54%.The positive rate of HCV in male and female patients were 0.60%and 0.48%,respectively,with a statistically sig-nificant difference(x2=47.18,P<0.001).The HCV positive rate in the 50-<60 age group was the highest(0.76%),followed by the 40-<50 age group(0.71%).Difference among all age groups was statistically signifi-cant(x2=696.74,P<0.001).In 2003,91 113 inpatients were surveyed.35 145 of whom underwent HCV test,resulting in a detection rate of 38.57%;775 patients were infected with HCV,with a positive rate of 2.21%.In 2020,HCV positive rates in hospitals of different scales were 0.46%-0.63%,with the highest in hospital with bed numbers ranging 600-899.Patients'HCV positive rates in hospitals of different scales was statistically signifi-cant(X2=35.34,P<0.001).In 2020,12 provinces/municipalities had over 10 000 patients underwent HCV-rela-ted test,and HCV positive rates ranged 0.19%-0.81%,with the highest rate from Hainan Province.HCV posi-tive rates in different departments were 0.06%-0.82%,with the lowest positive rate in the department of pedia-trics and the highest in the department of internal medicine.In 2003 and 2020,HCV positive rates in the depart-ment of infectious diseases were the highest,being 7.95%and 3.48%,respectively.Followed by departments of orthopedics(7.72%),gastroenterology(3.77%),nephrology(3.57%)and general intensive care unit(ICU,3.10%)in 2003,as well as departments of gastroenterology(1.35%),nephrology(1.18%),endocrinology(0.91%),and general intensive care unit(ICU,0.79%)in 2020.Conclusion Compared with 2003,HCV positive rate decreased significantly in 2020.HCV infected patients were mainly from the department of infectious diseases,followed by departments of gastroenterology,nephrology and general ICU.HCV infection positive rate varies with gender,age,and region.
9.Effects of Shenxiao Jiedu Tongluo Recipe on AIM2-mediated pyroptosis of renal cells in a golden hamster model of diabetic nephropathy
Yu-Peng XIAO ; Ying-Jun DING ; Bao-Zhu DING ; Shu-Jie HOU ; Si-Yang LIU ; Zi-Wei ZHANG ; Xiao-Xia LI ; Wen-Jie LIANG ; Nan ZHANG
Chinese Traditional Patent Medicine 2024;46(11):3603-3612
AIM To investigate the effects and mechanism of Shenxiao Jiedu Tongluo Recipe on renal AIM 2-mediated pyroptosis of a golden hamster model of diabetic nephropathy(DN).METHODS Fifty male golden hamsters of SPF grade were randomly divided into the control group and the model group.The golden hamsters of the model group successfully developed into DN models by feeding of high glucose and high fat diet and intraperitoneal injection of STZ were further randomly assigned into the model group,the enagliflozin group(10 mg/kg),and the low-dose and the high-dose Shenxiao Jiedu Tongluo Recipe groups(12.8,25.6 g/kg)for 8 weeks gavage of the corresponding administration.The golden hamsters had their levels of fasting blood glucose,24 h-UTP,serum TC,LDL-C,Scr,and Sur detected by automatic biochemical analyzer;their serum SOD activity and MDA level detected by biochemical method;their serum levels of IL-1β,IL-18,and TNF-α detected by ELISA method;their pathomorphological changes of kidney tissue observed by HE and PAS staining;their protein expressions of ROS and γH2AX detected by immunofluorescence or immunohistochemistry;and their renal protein expressions of AIM 2,caspase-1 and GSDMD detected by Western blot and immunohistochemistry.RESULTS Compared with the control group,the model group showed atrophic glomeruli;enlarged glomerular capsule cavity;mesangial expansion;edema and necrosis in the dilated renal tubules;increased levels of fasting blood glucose,24 h-UTP,serum TC,LDL-C,Scr,Sur,IL-1β,IL-18,TNF-α,MDA and renal protein expressions of ROS,γH2AX,AIM2,caspase-1,GSDMD(P<0.01);and decreased serum SOD activity(P<0.01).Compared with the model group,the high-dose Shenxiao Jiedu Tongluo Recipe group and the enagliflozin group displayed improved renal histopathology,decreased levels of 24 h-UTP,serum TC,LDL-C,Scr,Sur,IL-1β,IL-18,TNF-α,MDA and renal protein expressions of ROS,γH2AX,AIM2,caspase-1,GSDMD(P<0.05,P<0.01);and increased serum SOD activity(P<0.01).CONCLUSION Shenxiao Jiedu Tongluo Recipe can inhibit AIM 2-mediated cell death and alleviate renal inflammatory damage in golden hamsters by inhibiting their expression of ROS-dsDNA-AIM 2 signal pathway to attain reduction of their renal ROS level,DNA damage of renal intrinsic cells,and synthesis of AIM 2 inflammatory corpuscles as well.
10.Comparison of Jinzhen oral liquid and ambroxol hydrochloride and clenbuterol hydrochloride oral solution in the treatment of acute bronchitis in children: A multicenter, non-inferiority, prospective, randomized controlled trial.
Qinhua FAN ; Chongming WU ; Yawei DU ; Boyang WANG ; Yanming XIE ; Zeling ZHANG ; Wenquan SU ; Zizhuo WANG ; Changchang XU ; Xueke LI ; Ying DING ; Xinjiang AN ; Jing CHEN ; Yunying XIAO ; Rong YU ; Nan LI ; Juan WANG ; Yiqun TENG ; Hongfen LV ; Nian YANG ; Yuling WEN ; Xiaoli HUANG ; Wei PAN ; Yufeng LIU ; Xueqin XI ; Qianye ZHAO ; Changshan LIU ; Jian XU ; Haitao ZHANG ; Lie ZHUO ; Qiangquan RONG ; Yu XIA ; Qin SHEN ; Shao LI ; Junhong WANG ; Shengxian WU
Acta Pharmaceutica Sinica B 2024;14(12):5186-5200
The comparison between traditional Chinese medicine Jinzhen oral liquid (JZOL) and Western medicine in treating children with acute bronchitis (AB) showed encouraging outcomes. This trial evaluated the efficacy and safety of the JZOL for improving cough and expectoration in children with AB. 480 children were randomly assigned to take JZOL or ambroxol hydrochloride and clenbuterol hydrochloride oral solution for 7 days. The primary outcome was time-to-cough resolution. The median time-to-cough resolution in both groups was 5.0 days and the antitussive onset median time was only 1 day. This randomized controlled trial showed that JZOL was not inferior to cough suppressant and phlegm resolving western medicine in treating cough and sputum and could comprehensively treat respiratory and systemic discomfort symptoms. Combined with clinical trials, the mechanism of JZOL against AB was uncovered by network target analysis, it was found that the pathways in TRP channels like IL-1β/IL1R/TRPV1/TRPA1, NGF/TrkA/TRPV1/TRPA1, and PGE2/EP/PKA/TRPV1/TRPA1 might play important roles. Animal experiments further confirmed that inflammation and the immune regulatory effect of JZOL in the treatment of AB were of vital importance and TRP channels were the key mechanism of action.


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