1.Progress in mechanistic research on traditional Chinese medicine interventions for irritable bowel syndrome with diarrhea based on omics technologies
Shanxue GAO ; Jiale MA ; Long PENG ; Jie CHEN
China Pharmacy 2026;37(3):401-406
Irritable bowel syndrome with diarrhea (IBS-D), as a prototypical disorder involving the microbiota-gut-brain axis, remains poorly understood in terms of its pathogenesis, posing ongoing challenges for clinical diagnosis. Omics technologies, leveraging their high-throughput detection and systematic analysis advantages, has emerged as a critical tool for deciphering the complex mechanisms underlying traditional Chinese medicine (TCM) treatment of IBS-D. This systematic review summarizes the research progress of transcriptomics, proteomics, metabolomics, microbiomics, and multi-omics integration techniques in TCM interventions for IBS-D. In single-omics studies, transcriptomics using techniques like RNA-seq, reveals the regulatory mechanisms of TCM on IBS-related signaling pathways. Proteomics, leveraging quantitative technologies such as 2D-difference gel electrophoresis and tandem mass tag, identifies differentially expressed proteins and elucidates the action targets of TCM in treating IBS-D. Metabolomics, employing methods like UPLC-Q-TOF-MS and LC-MS/MS, discovers metabolic pathways regulated by TCM to improve metabolic disturbances in IBS-D. Microbiomics, based on 16S rRNA sequencing, confirms that TCM can reshape the gut microbiota structure and restore the intestinal microecological balance, thereby improving IBS-D. Multi-omics integration further overcomes the limitations of single-omics approaches by synthesizing information from transcriptomics, proteomics, metabolomics, and microbiomics, enabling a more comprehensive and systematic elucidation of the complex mechanisms underlying TCM treatment for IBS-D. In the future, research related to IBS-D should be advanced from three aspects: stratified clinical research based on TCM syndrome types, multi-omics integration verification mechanisms, and emerging omics to explore new mechanisms, providing more innovative ideas for the precise diagnosis and treatment of this disease.
2.Polydatin Delays Progression of Colitis-associated Colorectal Cancer by Modulating IL-17A/Wnt/β-catenin Signaling Pathway
Jie LIU ; Mengmeng LYU ; Yanfei HONG ; Xinmei NAN ; Jialong SU ; Huachen LIU ; Qing WANG ; Guiying PENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):144-154
ObjectiveTo investigate the effects and underlying mechanisms of polydatin in delaying the progression of colitis-associated colorectal cancer (CAC) by constructing an azoxymethane (AOM)/dextran sulfate sodium (DSS)-induced CAC mouse model and conducting in vitro experiments. MethodsFifty-four male C57BL/6J mice were randomly divided into normal, model, and polydatin groups (0.045 g·kg-1). The CAC mouse model was established using AOM/DSS, and samples were collected at 4, 7, and 10 weeks. Body weight change rate, disease activity index (DAI), and tumor formation were assessed. Hematoxylin-eosin (HE) staining was used to observe pathological injury in intestinal tissues. Immunohistochemistry (IHC) was performed to detect zonula occludens-1 (ZO-1) expression in colonic tissues, and Western blot was used to detect the expression of E-cadherin, N-cadherin, and Vimentin in colonic epithelial cells. Real-time PCR was used to measure mRNA expression of interleukin-17A (IL-17A), Wnt3a, β-catenin, T cell factor 1 (Tcf1), E-cadherin, N-cadherin, and Vimentin in colonic tissues. Flow cytometry was used to analyze the proportion of CD8+T cells and the expression of exhaustion-related molecules in tumors. Human colon cancer DLD-1 cells were cultured in a polydatin-containing medium, and wound healing assays were performed to observe migration changes. Real-time PCR was used to detect mRNA expression of interleukin-17 receptor A (IL-17RA), Wnt3a, β-catenin, Tcf1, E-cadherin, N-cadherin, and Vimentin in DLD-1 cells. ResultsCompared with the normal group, the model group at all three time points showed significantly decreased body weight change rate (P<0.01), significantly shortened colon length (P<0.01), and markedly increased DAI scores (P<0.01). HE staining revealed significant inflammatory cell infiltration in the submucosa of the colon in the model group, accompanied by epithelial dysplasia. ZO-1 expression in colonic tissues was significantly reduced (P<0.01). The mRNA expression of the pro-inflammatory factor IL-17A and key molecules of the Wnt/β-catenin pathway (Wnt3a, β-catenin, Tcf1) was significantly elevated (P<0.05). The mRNA and protein expression of epithelial-mesenchymal transition (EMT) markers N-cadherin and Vimentin was significantly upregulated (P<0.05), while E-cadherin expression was significantly downregulated (P<0.05). The proportion of tumor-infiltrating CD8+T cells expressing immunosuppressive molecules (TIM-3, LAG-3, PD-1) was significantly increased (P<0.05). Compared with the model group, the polydatin group showed significant improvement in body weight and DAI score (P<0.01), as well as recovery of colon length and tissue injury. ZO-1 expression in colonic tissue was significantly increased (P<0.01), while IL-17A, Wnt3a, β-catenin, Tcf1, N-cadherin, and Vimentin expression levels were significantly decreased (P<0.05), and E-cadherin expression was significantly increased (P<0.01). Tumor-infiltrating CD8+ T cells expressing immunosuppressive molecules were significantly reduced (P<0.05). In vitro experiments showed that polydatin significantly inhibited migration of DLD-1 cells (P<0.01) and reversed the upregulation of IL-17RA, Wnt3a, β-catenin, N-cadherin, and Vimentin mRNA, as well as the downregulation of E-cadherin mRNA (P<0.05). ConclusionPolydatin inhibits IL-17A secretion and IL-17RA expression, improves the immune microenvironment, blocks activation of the Wnt/β-catenin signaling pathway, suppresses EMT markers (N-cadherin and Vimentin), and restores tight junction protein expression in intestinal epithelial cells, thereby delaying the progression from colitis to colorectal cancer in mice.
3.Mume Fructus Restores Intestinal Mucosal Epithelial Barrier Through MEK/ERK Signaling Pathway in Mouse Model of Inflammatory Bowel Disease
Huachen LIU ; Chonghao ZHANG ; Yalan LI ; Jie LIU ; Jialong SU ; Na LI ; Shaoshuai LIU ; Qing WANG ; Guiying PENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):76-85
ObjectiveTo clarify the repair effect of Mume Fructus on the intestinal mucosal epithelial barrier in the mouse model of inflammatory bowel disease (IBD) and explore the repair mechanism. MethodsThirty-six male C57BL/6 mice were randomly assigned into six groups: normal, model, low-, medium-, and high-dose (200, 400, and 800 mg·kg-1) Mume Fructus, and sulfasalazine (300 mg·kg-1). Except the normal group, the rest groups had free access to 2% dextran sulfate sodium (DSS) solution for seven days to establish the IBD model, followed by a seven-day drug intervention. The body weight change and disease activity index (DAI) were recorded. After the last administration, spleen and colon tissue samples were collected to analyze the differences in colon length and spleen index. Hematoxylin-eosin staining was used to observe the morphology of the colon tissue. The level of diamine oxidase (DAO) in the serum was measured by the DAO assay kit. Immunohistochemistry was employed to determine the expression of tight junction proteins such as Claudin-1, Occludin, and zonula occludens-1 (ZO-1) in the colon tissue. Real-time PCR was performed to measure the mRNA levels of tumor necrosis factor-α (TNF-α) and interleukin-1β (IL-1β) in the colon tissue. Finally, Western blot was employed to determine the protein levels of mitogen-activated protein kinase kinase (MEK), extracellular signal-regulated kinase (ERK), phosphorylated (p)-MEK, and phosphorylated ERK in the colon tissue. ResultsCompared with the normal group, the model group exhibited decreases in body weight and colon length (P<0.01), increases in DAI, spleen index, and serum DAO level (P<0.01), damaged colonic epithelium and goblet cells, and obvious infiltration of inflammatory cells. In addition, the model group exhibited higher positive expression of Claudin-1, Occludin, and ZO-1 (P<0.01), higher mRNA levels of TNF-α and IL-1β (P<0.01), and higher protein levels of p-MEK and p-ERK (P<0.05, P<0.01) than the normal group. However, sulfasalazine and three doses of Mume Fructus markedly decreased the body weight and DAI (P<0.05), recovered the colon length and spleen index, alleviated colon tissue damage, lowered the level of DAO in the serum (P<0.01), and down-regulated the mRNA levels of TNF-α and IL-1β (P<0.01) and the protein levels of p-MEK and p-ERK (P<0.05). Sulfasalazine and low- and medium-dose Mume Fructus increased the positive expression of Occludin, Claudin-1, and ZO-1 (P<0.05, P<0.01). Furthermore, high-dose Mume Fructus elevated the protein expression of Occludin (P<0.05). ConclusionMume Fructus can restore the expression of intestinal epithelial tight junction proteins by inhibiting the phosphorylation of proteins in the MEK/ERK signaling pathway and down-regulating the levels of TNF-α and IL-1β, thus repairing the intestinal mucosal barrier in the mouse model of IBD.
4.Regulatory Effect of Modified Wumeiwan on Th17/Treg Balance and Intestinal Microbiota in Ulcerative Colitis with Dampness-heat Obstruction Syndrome in Human Flora-associated Model
Chonghao ZHANG ; Peiguang MA ; Huachen LIU ; Jialong SU ; Jie LIU ; Yalan LI ; Guichuan XU ; Na LI ; Guiying PENG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):86-93
ObjectiveTo investigate the modulating effect of modified Wumeiwan (MWMW) on the ulcerative colitis (UC)-associated intestinal helper T cell 17 (Th17)/regulatory T cell (Treg) balance and intestinal flora by using a human flora-associated model of UC patients with dampness-heat obstruction syndrome, thus providing a new idea for the UC-related research and therapeutic strategies. MethodsThe 24 male C57BL/6J mice were randomized into normal control, model, and MWMW groups (n=8). Model and MWMW groups were first treated with an antibiotic cocktail (vancomycin, 0.1 g·kg-1; neomycin sulfate, 0.2 g·kg-1; ampicillin, 0.2 g·kg-1; metronidazole, 0.2 g·kg-1) for 21 days. At the end of antibiotic treatment, the gavage of fecal microbiota suspension from UC patients with dampness-heat obstruction syndrome was started at a dose of 0.2 mL·d-1 for 19 consecutive days, by which a human flora-associated model of UC was obtained. The MWMW group was administrated daily with MWMW liquid (12.5 g·kg-1), while the normal control and model groups were administrated by gavage with an equal amount of sterile water for 7 consecutive days. The symptoms of dampness-heat obstruction were observed. The colon length and spleen index were measured and calculated, and the proportions of Th17 and Treg cells were detected by flow assay. The intestinal flora was analyzed by 16S rRNA high-throughput sequencing. ResultsCompared with the normal control group, the model group showed shortened colon (P<0.05) and increased spleen index (P<0.01). Compared with the model group, the MWMW group showed prolonged colon (P<0.01) and decreased spleen index (P<0.05). After the intervention of MWMW, the Th17 proportion and Th17/Treg ratio in the colon decreased (P<0.01), and the proportion of Treg cells increased (P<0.05). The number of species and alpha and beta diversity of intestinal flora in mice were regulated by MWMW (P<0.05). In terms of intestinal flora composition, MWMW increased the relative abundance of several phyla (Firmicutes, Proteobacteria, Fusobacteriota, Actinobacteriota, and Gemmatimonadota), the genus Bacteroides, and two species (Bacteroides thetaiotaomicron and B. fragilis) in model mice. Moreover, Spearman's correlation analysis showed that the relative abundance of B. thetaiotaomicron and B. fragilis were negatively correlated with the Th17 level (P<0.05). In addition, the above changes in intestinal flora caused the changes in microbial genes involved in 14 pathways, such as glycolysis, amino acid degradation, inorganic nutrient metabolism, biosynthesis of pyrimidine deoxyribonucleotides, antibiotic resistance, and degradation of polysaccharides. ConclusionsThe human flora-associated model successfully simulated the changes (marked by a decrease in the abundance of Bacteroides) of intestinal flora in UC patients with dampness-heat obstruction syndrome. MWMW can enrich the abundance of beneficial bacteria such as B. thetaiotaomicron and B. fragilis and promote the synergistic intestinal immune modulation with the metabolic functions centered on glycolysis, amino acid metabolism, and nucleotide synthesis through bacterial polysaccharide utilization sites to reduce the Th17/Treg ratio, thereby exerting a protective effect on UC.
5.Thoughts on Development Path of Traditional Chinese Medicine Processing Technology from Perspective of Traditional Medicine and Techniques
Ying LIU ; Yun WANG ; Zhe JIA ; Peng ZHANG ; Jie ZOU ; Cun ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):233-240
As an important part of Chinese traditional culture, the processing technology of traditional Chinese medicine(TCM) carries the wisdom of TCM for thousands of years, and its process is complex and rigorous. With the popularization of modern production technology, traditional processing techiques are facing the dual pressures from technological innovation and production standardization under the perspective of intangible cultural heritage. The modernization of TCM processing technology is an inevitable trend for industrial upgrading, but it cannot be separated from the foundation of traditional skills and ignore the core concepts and cultural values it embodies. Therefore, by analyzing the core characteristics of TCM processing technology and its differences with modern production, this paper discusses the establishment of a synergistic innovation mechanism between traditional techniques and modern technologies, the promotion of joint research and development between scientific research institutes and the industry, the strengthening of standardization of processing techniques, and the enhancement of social education and industry training to improve the recognition and inheritance of processing techniques in order to achieve the goal of innovation and protection of TCM processing technologies in the context of modernization, and to promote the high-quality development of the TCM processing industry.
6.Study on component analysis,fingerprint establishment and anti-inflammatory spectrum-effect relationship of Yao ethnic medicine Pittosporum pauciflorum
Dan QIN ; Peng FU ; Jiajie CAO ; Qingchen TANG ; Jie GAO
China Pharmacy 2025;36(18):2244-2249
OBJECTIVE To analyze chemical components of Yao ethnic medicine Pittosporum pauciflorum, establish its fingerprint and investigate the spectrum-effect relationship of its anti-inflammatory effect. METHODS UHPLC-Q-Orbitrap-MS technology was used to analyze the chemical components of P. pauciflorum (batch S6). The fingerprints for 10 batches of P. pauciflorum from different producing areas in Guangxi Province (batches S1-S10) were established by HPLC, and similarity assessment and chemometric pattern recognition analysis were conducted. RAW264.7 inflammatory cell model was induced by lipopolysaccharide, and the anti-inflammatory activity of P. pauciflorum was investigated. Using inhibition rates of nitric oxide (NO), tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6) and IL-1β as efficacy indicators, grey relational analysis and partial least squares regression analysis were adopted to evaluate the spectrum-effect relationship of the anti-inflammatory effect of P. pauciflorum. RESULTS There were 60 chemical components, including flavonoids, phenolic acids, lipids, etc., identified in P. pauciflorum. The fingerprints for 10 batches of P. pauciflorum showed 14 common peaks,with similarity values ranging from 0.883 to 0.991. Three common peaks were assigned neochlorogenic acid (peak 5), chlorogenic acid (peak 7), and syringaldehyde (peak 10). The classification results of the systematic clustering analysis and the principal component analysis were basically consistent. Batches S1 to S10 of P. pauciflorum significantly reduced the levels of NO, TNF-α, IL-6 (except for batch S5) and IL-1β in the cell supernatant (P<0.05 or P<0.01). Inhibition rates of above inflammatory indexes were 10.26%-39.96%, 14.96%-31.36%, 1.38%-21.27%, 18.54%-28.00%, respectively. The contents of neochlorogenic acid, syringaldehyde, as well as the components corresponding to peaks 1, 3, 9, 12 and 14,exhibited a strong correlation with the anti-inflammatory effects of P. pauciflorum. CONCLUSIONS The present study has analyzed the chemical components of P. pauciflorum and established HPLC fingerprints for 10 batches of P. pauciflorum. Each batch of medicinal herbs demonstrates certain anti- inflammatory activities, among which neochlorogenic acid, syringaldehyde, and the components corresponding to peaks 1, 3, 9, 12 and 14 are likely to be the active anti-inflammatory components.
7.Characteristics of ocular biometric parameters and distribution of corneal astigmatism before cataract surgery in cataract patients with high myopia
Yehui TAN ; Yi SHAO ; Zhonggang PEI ; Tao ZHANG ; Jie RAO ; Mengying PENG ; Chun LIU ; Lijuan ZHANG
International Eye Science 2025;25(12):1919-1925
AIM:To evaluate the characteristics of ocular biometric parameters and the distribution of corneal astigmatism(CA)in patients with high myopia before cataract surgery.METHODS:A prospective cross-sectional study was conducted, and 695 cataract patients(695 eyes)with high myopia [defined as an axial length(AL)≥26.00 mm] scheduled to undergo cataract surgery at our hospital from January 2022 to December 2024 were consecutively enrolled, another 695 cataract patients(695 eyes)with normal ALs(22.00 mm ≤AL≤25.00 mm)who underwent cataract surgery at our hospital during the same period were included in the control group. For patients with both eyes eligible, the right eye was used for analysis. Before cataract surgery, IOL Master 700 was used to measure the ocular biometric parameters of both eyes for each patient in the two groups. The medical records and ocular biometric data in the two groups were recorded and collected.RESULTS:There were no statistically significant differences between the two groups in genger, age, corneal diameter, and central corneal thickness(all P>0.05). In the high myopia group, the mean AL was 29.20±2.61 mm, and 252 eyes(34.1%)had AL ≥30.00 mm(extremely high myopia). The mean anterior chamber depth(ACD), lens thickness, vitreous chamber depth(VCD), CA, AL/corneal radius of curvature and VCD/AL in the high myopia group were 3.45±0.40, 4.41±0.47, 21.34±2.60 mm, 1.18±0.78 D, 3.79±0.38, and 0.73±0.03, respectively, which were all greater than those in the control group(all P<0.01). In the high myopia group, 350 eyes(50.4%)had CA ≥1.00 D, 192 eyes(27.6%)had CA ≥1.50 D, and 94 eyes(13.5%)had CA ≥2.00 D, which were all higher than those in the control group(32.8%, 15.1%, and 6.6%, respectively; all P<0.001). In the high myopia group, 87 eyes(12.5%)had flat corneas, 424 eyes(61.0%)had moderate CA, and 40 eyes(5.8%)had high CA. These proportions were all higher than those in the control group(6.0%, 46.9%, and 2.9%, respectively; all P<0.001). In the high myopia group, ACD and ACD/AL were negatively correlated with AL(r=-0.162 and -0.661, respectively; all P<0.001), while both ACD and ACD/AL in the control group were positively correlated with AL(r=0.338 and 0.105, respectively; both P<0.01). In the high myopia group, CA increased with age when the patient's age was ≥50 years(r=0.197, P<0.001), which was consistent with the control group.CONCLUSION: The standardized ocular biometric data of cataract patients with high myopia before cataract surgery are helpful for ophthalmologists to accurately calculate the intraocular lens(IOLs)power and select the appropriate IOL type. The majority of high myopia patients need simultaneous correction of CA during cataract surgery.
8.Association of COVID-19 'circuit breaker' with higher rates of elderly trauma admissions.
Yee Har LIEW ; Zhenghong LIU ; Mian Jie LIM ; Pei Leng CHONG ; Norhayati Bte Mohamed JAINODIN ; Teng Teng PEH ; Jing Jing CHAN ; Sachin MATHUR ; Jeremy Choon Peng WEE
Singapore medical journal 2025;66(2):91-96
INTRODUCTION:
In December 2019, the severe acute respiratory syndrome coronavirus 2 (SARS-COV-2) virus emerged and caused a worldwide pandemic, leading to measures being imposed by many countries to reduce its transmission. Singapore implemented the 'circuit breaker', which restricted all movements except for access to necessities and healthcare services. We aimed to investigate the impact of lockdown measures on the pattern of trauma and its effects.
METHODS:
An observational, retrospective, single-centre descriptive study was conducted using the trauma registry in Singapore General Hospital. It included patients above 18 years old who presented to the emergency department with trauma and were subsequently admitted. Patients admitted from 1 February 2020 to 31 July 2020 and those admitted during the same timeframe in 2019 were studied. Subgroup analyses were performed for patients aged ≥65 years and those <65 years.
RESULTS:
A total of 1,037 patients were included for analysis. A 17.6% increase in trauma presentations was seen from 2019 to 2020. Patients aged ≥65 years accounted for the rise in admissions. The predominant mechanism of injury was falls at home for older patients and vehicular accidents in patients <65 years. There were no significant differences in injury severity score, intensive care/high-dependency unit admission rates, length of stay, mortality rate, and subsequent need for inpatient rehabilitation.
CONCLUSION
Our study provided information on differences in trauma presentations before and during the COVID-19 pandemic. Further studies are required to better inform on additional precautionary measures needed to reduce trauma and improve safety during future lockdowns and pandemics.
Humans
;
COVID-19/prevention & control*
;
Aged
;
Retrospective Studies
;
Singapore/epidemiology*
;
Male
;
Female
;
Wounds and Injuries/epidemiology*
;
Aged, 80 and over
;
Middle Aged
;
SARS-CoV-2
;
Hospitalization/statistics & numerical data*
;
Adult
;
Emergency Service, Hospital/statistics & numerical data*
;
Registries
;
Accidental Falls/statistics & numerical data*
;
Pandemics
;
Patient Admission/statistics & numerical data*
;
Length of Stay
;
Accidents, Traffic/statistics & numerical data*
9.Olaparib and niraparib as maintenance therapy in patients with newly diagnosed and platinum-sensitive recurrent ovarian cancer: A single-center study in China.
Dengfeng WANG ; Xunwei SHI ; Jiao PEI ; Can ZHANG ; Liping PENG ; Jie ZHANG ; Jing ZHENG ; Chunrong PENG ; Xiaoqiao HUANG ; Xiaoshi LIU ; Hong LIU ; Guonan ZHANG
Chinese Medical Journal 2025;138(10):1194-1201
BACKGROUND:
Poly adenosine-diphosphate-ribose polymerase (PARP) inhibitors (PARPi) have been approved to act as first-line maintenance (FL-M) therapy and as platinum-sensitive recurrent maintenance (PSR-M) therapy for ovarian cancer in China for >5 years. Herein, we have analyzed the clinical-application characteristics of olaparib and niraparib in ovarian cancer-maintenance therapy in a real-world setting to strengthen our understanding and promote their rational usage.
METHODS:
A retrospective chart review identified patients with newly diagnosed or platinum-sensitive recurrent ovarian cancer, who received olaparib or niraparib as maintenance therapy at Sichuan Cancer Hospital between August 1, 2018, and December 31, 2021. Patient medical records were reviewed. We grouped and analyzed patients based on the type of PARPi they used (the olaparib group and the niraparib group) and the line of PARPi maintenance therapy (the FL-M setting and the PSR-M setting). The primary endpoint was the 24-month progression-free survival (PFS) rate.
RESULTS:
In total, 131 patients (olaparib: n = 67, 51.1%; niraparib: n = 64, 48.9%) were enrolled. Breast cancer susceptibility genes ( BRCA ) mutations ( BRCA m) were significantly less common in the niraparib group than in the olaparib group [9.4% (6/64) vs . 62.7% (42/67), P <0.001], especially in the FL-M setting [10.4% (5/48) vs . 91.4% (32/35), P <0.001]. The 24-month progression-free survival (PFS) rates in the FL-M and PSR-M settings were 60.4% and 45.7%, respectively. In patients with BRCA m, the 24-month PFS rates in the FL-M and PSR-M settings were 62.2% and 72.7%, respectively.
CONCLUSIONS
Olaparib and niraparib were effective in patients with ovarian cancer without any new safety signals except for skin pigmentation. In patients with BRCA m, the 24-month PFS of the PARPi used in the PSR-M setting was even higher than that used in the FL-M setting.
Humans
;
Female
;
Ovarian Neoplasms/drug therapy*
;
Piperazines/therapeutic use*
;
Middle Aged
;
Retrospective Studies
;
Phthalazines/therapeutic use*
;
Piperidines/therapeutic use*
;
Indazoles/therapeutic use*
;
Poly(ADP-ribose) Polymerase Inhibitors/therapeutic use*
;
Adult
;
Aged
;
China
;
Neoplasm Recurrence, Local/drug therapy*
;
Progression-Free Survival
10.Safety and efficacy of Angong Niuhuang Pills in patients with moderate-to-severe acute ischemic stroke (ANGONG TRIAL): A randomized double-blind placebo-controlled pilot clinical trial.
Shengde LI ; Anxin WANG ; Lin SHI ; Qin LIU ; Xiaoling GUO ; Kun LIU ; Xiaoli WANG ; Jie LI ; Jianming ZHU ; Qiuyi WU ; Qingcheng YANG ; Xianbo ZHUANG ; Hui YOU ; Feng FENG ; Yishan LUO ; Huiling LI ; Jun NI ; Bin PENG
Chinese Medical Journal 2025;138(5):579-588
BACKGROUND:
Preclinical studies have indicated that Angong Niuhuang Pills (ANP) reduce cerebral infarct and edema volumes. This study aimed to investigate whether ANP safely reduces cerebral infarct and edema volumes in patients with moderate to severe acute ischemic stroke.
METHODS:
This randomized, double-blind, placebo-controlled pilot trial included patients with acute ischemic stroke with National Institutes of Health Stroke Scale (NIHSS) scores ranging from 10 to 20 in 17 centers in China between April 2021 and July 2022. Patients were allocated within 36 h after onset via block randomization to receive ANP or placebo (3 g/day for 5 days). The primary outcomes were changes in cerebral infarct and edema volumes after 14 days of treatment. The primary safety outcome was severe adverse events (SAEs) for 90 days.
RESULTS:
There were 57 and 60 patients finally included in the ANP and placebo groups, respectively for modified intention-to-treat analysis. The median age was 66.0 years, and the median NIHSS score at baseline was 12.0. The changes in cerebral infarct volume at day 14 were 0.3 mL and 0.4 mL in the ANP and placebo groups, respectively (median difference: -7.1 mL; interquartile range [IQR]: -18.3 to 2.3 mL, P = 0.30). The changes in cerebral edema volume of the ANP and placebo groups on day 14 were 11.4 mL and 4.0 mL, respectively ( median difference: 3.0 mL, IQR: -1.3 to 9.9 mL, P = 0.15). The rates of SAE within 90 days were similar in the ANP (3/57, 5%) and placebo (7/60, 12%) groups ( P = 0.36). Changes in serum mercury and arsenic concentrations were comparable. In patients with large artery atherosclerosis, ANP reduced the cerebral infarct volume at 14 days (median difference: -12.3 mL; IQR: -27.7 to -0.3 mL, P = 0.03).
CONCLUSIONS:
ANP showed a similar safety profile to placebo and non-significant tendency to reduce cerebral infarct volume in patients with moderate-to-severe stroke. Further studies are warranted to assess the efficacy of ANP in reducing cerebral infarcts and improving clinical prognosis.
TRAIL REGISTRATION
Clinicaltrials.gov , No. NCT04475328.
Aged
;
Female
;
Humans
;
Male
;
Middle Aged
;
Double-Blind Method
;
Drugs, Chinese Herbal/adverse effects*
;
Ischemic Stroke/drug therapy*
;
Pilot Projects
;
Stroke/drug therapy*
;
Treatment Outcome

Result Analysis
Print
Save
E-mail