ObjectiveThe development trend and knowledge structure of the research on human use experience （HUE） of traditional Chinese medicine （TCM） were systematically reviewed， and the core challenges and future directions were identified. This study aims to provide reference for the construction of a scientific and feasible research and development framework and evidence transformation system. MethodsLiterature related to "human use experience" published from January 1， 2019 to July 31， 2025 was retrieved from the China National Knowledge Infrastructure （CNKI）， Wanfang， China Science and Technology Journal Database （VIP）， and PubMed databases. Bibliometric visualization was conducted using Excel， VOSviewer， and CiteSpace， followed by in-depth reading and thematic summarization of core literature. ResultsA total of 181 papers were included for bibliometric analysis， with 45 articles used for in-depth thematic mining. The analysis showed that the number of publications on HUE research has increased in a stepwise manner over the past five years. Yang Zhongqi （24 times） was the core of the author network， the journal with the highest number of publications was China Journal of Chinese Materia Medica， the institutions publishing the most articles were mainly research institutions， regulatory agencies， hospitals， and universities， high-frequency keywords included "new TCM drugs"， "real-world studies"， and "clinical comprehensive evaluation"， keyword clustering analysis formed three major clusters： Policy orientation， application fields， and methodological approaches. Thematic analysis reveals that HUE-based evaluation should be integrated throughout the research and development process， encompassing three dimensions： TCM theory， clinical value， and pharmaceutical fundamentals， with toxic herbs and compatibility contraindications being key foci. Data collection primarily relies on empirical data， while real-world data constitute the primary source for clinical research， with efficacy and safety as the shared core. Data management emphasizes quality control and statistical analysis； however， the management of bias and confounding remains a critical bottleneck in evidence transformation. In practice， HUE-based approaches have successfully supported the registration and evaluation of multiple categories of new TCM drugs. ConclusionThe research on HUE of TCM has formed a policy-driven pattern characterized by， rapid development and close link with regulatory practice. A technical framework covering the whole chain of research and development has been constructed with clinical value as the core， which provides methodological basis and strategy reference for the scientific transformation of HUE of TCM from "experience" to "evidence".

ObjectiveTo explore the efficacy and mechanisms of Sini San in the treatment of depression and liver injury based on gut microbiota. MethodsThirty-two male Sprague-Dawley （SD） rats were randomly divided into a normal group， model group （M）， Sini San group （MS， 2.5 g·kg^-1）， and fluoxetine group （MF， 2 mg·kg^-1）. Except for the normal group， rats in the other three groups were subjected to chronic unpredictable mild stress （CUMS）. After 8 weeks， the open-field test and sucrose preference test were conducted. Enzyme-linked immunosorbent assay （ELISA） was used to detect serum corticosterone （CORT）， adrenocorticotropic hormone （ACTH）， corticotropin-releasing factor （CRF）， lipopolysaccharide （LPS）， Zonulin， interleukin-6 （IL-6）， tumor necrosis factor-α （TNF-α）， interleukin-1β （IL-1β）， γ-aminobutyric acid （GABA） levels in the hippocampus and prefrontal cortex， and brain-derived neurotrophic factor （BDNF） levels in the hippocampus. Real-time quantitative polymerase chain reaction （Real-time PCR） was used to detect hippocampal BDNF mRNA expression. Serum alanine aminotransferase （ALT） and aspartate aminotransferase （AST） levels were measured using the ultraviolet lactate dehydrogenase method. The ultrastructure of the intestinal epithelium was observed by electron microscopy， and gut microbiota in rat feces were analyzed using 16S rDNA high-throughput sequencing. ResultsCompared with the normal group， the sucrose preference of rats in the model group was significantly reduced （P0.01）， whereas it was significantly increased in the Sini San group compared with the model group （P0.05）. Compared with the normal group， hippocampal GABA protein levels and BDNF mRNA expression in the model group were significantly decreased （P0.05）， and compared with the model group， both were significantly increased in the Sini San group （P0.05， P0.01）. Compared with the normal group， serum LPS and Zonulin levels in the model group were significantly increased （P0.05， P0.01）， and compared with the model group， Zonulin levels in the Sini San group were significantly decreased （P0.05）. No obvious changes were observed in the ultrastructure of the jejunal mucosa among groups. Compared with the normal group， widened and blurred tight junctions， sparse and shortened microvilli， and mitochondrial swelling with cristae disruption in epithelial cells were observed in the ileal and colonic mucosa of the model group， which were markedly improved in the Sini San and fluoxetine groups. The results of 16S rDNA high-throughput sequencing showed that Sini San improved CUMS-induced dysbiosis of Bacteroidetes and Proteobacteria. Correlation analysis indicated that Bacteroidetes and Proteobacteria were significantly correlated with depression-related indicators， liver function， and intestinal mucosal permeability. ConclusionSini San exerts antidepressant and hepatoprotective effects by improving Bacteroidetes and Proteobacteria and inhibiting the increase in intestinal mucosal permeability in CUMS rats.

ObjectiveTo explore the efficacy and mechanisms of Sini San in the treatment of depression and liver injury based on gut microbiota. MethodsThirty-two male Sprague-Dawley （SD） rats were randomly divided into a normal group， model group （M）， Sini San group （MS， 2.5 g·kg^-1）， and fluoxetine group （MF， 2 mg·kg^-1）. Except for the normal group， rats in the other three groups were subjected to chronic unpredictable mild stress （CUMS）. After 8 weeks， the open-field test and sucrose preference test were conducted. Enzyme-linked immunosorbent assay （ELISA） was used to detect serum corticosterone （CORT）， adrenocorticotropic hormone （ACTH）， corticotropin-releasing factor （CRF）， lipopolysaccharide （LPS）， Zonulin， interleukin-6 （IL-6）， tumor necrosis factor-α （TNF-α）， interleukin-1β （IL-1β）， γ-aminobutyric acid （GABA） levels in the hippocampus and prefrontal cortex， and brain-derived neurotrophic factor （BDNF） levels in the hippocampus. Real-time quantitative polymerase chain reaction （Real-time PCR） was used to detect hippocampal BDNF mRNA expression. Serum alanine aminotransferase （ALT） and aspartate aminotransferase （AST） levels were measured using the ultraviolet lactate dehydrogenase method. The ultrastructure of the intestinal epithelium was observed by electron microscopy， and gut microbiota in rat feces were analyzed using 16S rDNA high-throughput sequencing. ResultsCompared with the normal group， the sucrose preference of rats in the model group was significantly reduced （P<0.01）， whereas it was significantly increased in the Sini San group compared with the model group （P<0.05）. Compared with the normal group， hippocampal GABA protein levels and BDNF mRNA expression in the model group were significantly decreased （P<0.05）， and compared with the model group， both were significantly increased in the Sini San group （P<0.05， P<0.01）. Compared with the normal group， serum LPS and Zonulin levels in the model group were significantly increased （P<0.05， P<0.01）， and compared with the model group， Zonulin levels in the Sini San group were significantly decreased （P<0.05）. No obvious changes were observed in the ultrastructure of the jejunal mucosa among groups. Compared with the normal group， widened and blurred tight junctions， sparse and shortened microvilli， and mitochondrial swelling with cristae disruption in epithelial cells were observed in the ileal and colonic mucosa of the model group， which were markedly improved in the Sini San and fluoxetine groups. The results of 16S rDNA high-throughput sequencing showed that Sini San improved CUMS-induced dysbiosis of Bacteroidetes and Proteobacteria. Correlation analysis indicated that Bacteroidetes and Proteobacteria were significantly correlated with depression-related indicators， liver function， and intestinal mucosal permeability. ConclusionSini San exerts antidepressant and hepatoprotective effects by improving Bacteroidetes and Proteobacteria and inhibiting the increase in intestinal mucosal permeability in CUMS rats.

ObjectiveTo investigate the optimal termination time for acupuncture in treating patients with acute peripheral facial paralysis and its cost-effectiveness. MethodsA total of 120 eligible patients with acute-stage peri-pheral facial paralysis were randomly assigned to either the mild dysfunction termination group and the complete recovery termination group， with 60 patients in each group. Both groups received the standard acupuncture treatment protocol. Treatment in the mild dysfunction termination group was terminated when the Sunnybrook facial grade scale （SFGS） score first reached or exceeded 83 points， while that in the complete recovery termination group was terminated when the SFGS score first reached or exceeded 95 points. Assessments were conducted before treatment， 6 and 12 months after onset. SFGS， facial disability index （FDI） including physical function （FDIp） and social function （FDIs）， self-rating anxiety scale （SAS）， and self-rating depression scale （SDS） scores were assessed before treatment， and 6 and 12 months after onset. Any acupuncture-related adverse events during treatment were recorded for safety evaluation. Treatment sessions and medical costs including direct costs， indirect costs， insurance coverage， total societal costs， and patient out-of-pocket expenses were also recorded， and an economic evaluation was conducted including cost-effectiveness ratio （CER） and incremental cost-effectiveness ratio （ICER）. ResultsUltimately， 56 patients in the mild dysfunction termination group and 55 in the complete recovery termination group completed the follow-up. At 6 and 12 months after onset， SFGS and FDIp scores in both groups improved significantly while FDIs， SAS and SDS scores decreased （P＜0.05）. Comparison of scores between groups 6 months and 12 months after onset showed no statistically significant differences （P＞0.05）. During the trial， the incidence of adverse events was 13.3% （8/60） in the mild dysfunction termination group and 18.3% （11/60） in the complete recovery termination group， with no statistically significant difference （P＞0.05）. The number of treatment sessions， total social costs， and out-of-pocket expenses in the mild dysfunction termination group were significantly lower than those in the complete recovery termination group （P＜0.05）. The CER of the mild dysfunction termination group in SFGS， FDIp， FDIs， SAS， and SDS scores was lower than that of the complete recovery termination group. The ICER analysis showed that continuing treatment until full recovery incurred an additional cost of 573.30 CNY/point in SFGS improvement， whereas 1-point improvement in FDIp， FDIs， SAS， and SDS required 21,355.25 CNY， 1779.60 CNY， 3713.96 CNY， and 2755.52 CNY， respectively. ConclusionFor acupuncture in treating acute peripheral facial palsy， terminating treatment when mild dysfunction is achieved yields long-term efficacy comparable to that of continuing treatment until complete recovery， while significantly reducing medical costs and socioeconomic burden.

OBJECTIVE To establish the HPLC fingerprint of Xintong granules and the quantitative analysis of multi-components by single-marker method(QAMS)to determine the contents of 7 components,so as to provide a scientific basis for their quality control.METHODS HPLC method was used to establish the fingerprints for 10 batches of Xintong granules(No.S1-S10),and similarity evaluation,cluster analysis(CA)and partial least squares-discriminant analysis(PLS-DA)were performed.At the same time,the contents of seven components,including puerarin,daidzin,calycosin-7-O-β-D-glucoside,stilbene glycoside,naringin,icariin and tanshinone ⅡA,were determined by QAMS method,and were compared with the results of external standard method.RESULTS A total of 18 common peaks were marked and 7 peaks were identified in the HPLC fingerprints for 10 batches of Xintong granules,namely puerarin(peak 4),daidzin(peak 7),calycosin-7-O-β-D-glucoside(peak 9),stilbene glycoside(peak 10),naringin(peak 12),icariin(peak 17),and tanshinone ⅡA(peak 18);the similarities among them were more than 0.990,and CA and PLS-DA results showed that S4-S5,S8-S10,S1-S3 and S6-S7 were clustered into three categories,respectively.Using naringin as the internal standard,the contents of puerarin,daidzin,calycosin-7-O-β-D-glucoside,stilbene glycoside,icariin and tanshinone ⅡA were determined to be 7.868 1-10.181 2,1.709 2-2.374 1,0.285 2-0.326 3,1.024 1-1.523 9,0.140 2-0.290 4,and 0.077 1-0.219 4 mg/g,respectively,by the QAMS.These results showed no significant differences compared to those obtained by the external standard method.CONCLUSIONS Established HPLC fingerprint and QAMS method are convenient,stable and accurate,which can provide a basis for the quality evaluation of Xintong granules.

Objective To analyze the respective abnormal brain regions and commonly altered brain regions of spontaneous brain ac-tivity in post-stroke aphasia(PSA)and post-stroke depression(PSD),and to explore the potential pathological mechanisms underlying single disease and comorbidity.Methods Literatures were retrieved from PubMed,Embase,Web of Science,Cochrane Library,CNKI,Wanfang data,VIP and SinoMed,from establishment to April 19th,2025.Resting-state functional magnetic resonance imaging(fMRI)studies were included if they focused on patients with PSA or PSD,with healthy controls(HC)serving as control group,and amplitude of low-frequency fluctuation(ALFF),fractional amplitude of low-frequency fluctu-ation(fALFF)and regional homogeneity(ReHo)were adopted as outcome indicator.Data regarding differential brain regions were extracted from the original studies,and a neuroimaging meta-analysis was conducted using SDM-PSI V6.23 beta.Results A total of 17 articles on PSA(339 patients and 351 HC)and five articles on PSD(102 patients and 149 HC)were included.The spontaneous brain activity in the left cerebellar area 9,right middle temporal gyrus and right insula was significantly higher in PSA patients than in HC(P<0.05),while activity in the right cerebellar area 6,left medial superior frontal gyrus(SFGmed),left middle frontal gyrus and right anterior cingulate/paracingulate gyrus was lower(P<0.05).For PSD,spontaneous brain activity was elevated in the right cuneus gyrus and right superior occipital gyrus compared to HC(P<0.05),while it was reduced in the left SFGmed and left inferior pa-rietal lobe(P<0.05).Additionally,spontaneous brain activity in the left medial superior frontal gyrus was lower in both diseases compared to HC(P<0.05).Conclusion The pathological mechanism of PSA may involve a pattern of right-sided compensatory hyperfunction and left-sided inhibitory damage within the language-related network,accompanied by cross-hemispheric synergistic activity of the cerebellum.The occurrence of PSD may be attributed to hyperactivity of the right occipital net-work,and functional inhibition involving the left inferior parietal lobe.The inhibition observed in the left SFG-med(MNI coordinates x=0,y=26,z=44)likely represents the language-emotion integration hub,mediating the co-occurrence of PSA and PSD.

Objective:To analyze the feasibility and safety of breast-conserving surgery for young women with breast cancer whose tumor is close to nipple areola complex after neoadjuvant therapy.Methods:Young female breast cancer patients treated at Maoming People’s Hospital from Jan. 2016 to Jan. 2022 were selected. The inclusion criteria were primary solitary tumors located within ≤2 cm from the areola margin (excluding carcinoma in situ, nipple discharge, and Paget’s disease), tumor diameter ranging from 1 to 3 cm, and no abnormal adhesion between the tumor and the areola, breast skin, or chest wall. A total of 87 patients were enrolled, including 44 who underwent NAC-sparing breast-conserving surgery (NAC-preservation group) and 43 who underwent breast-conserving surgery without NAC preservation (non-NAC-preservation group). All patients received postoperative radiotherapy and continued systemic therapy. Local recurrence and distant metastasis were compared between the two groups.Results:No statistically significant differences were observed between the two groups in pre-neoadjuvant therapy tumor stage, tumor location, tumor diameter, lymph node metastasis, or molecular subtype ( χ2=0.22, 0.67, 0.80, 1.25, 1.76, respectively; P>0.05). At the 2-year postoperative follow-up, no local recurrence was detected in either group. Distant metastasis occurred in one case in the NAC-preservation group and three cases in the non-NAC-preservation group, with no statistically significant difference (2.27% vs. 6.98%, χ2=1.097, P=0.295) . Conclusions:This study, to some extent, validates the feasibility of both patient groups undergoing breast-conserving surgery with or without NAC preservation after neoadjuvant therapy, in young breast cancer patients with tumors located near the nipple areola complex. Routine NAC excision does not improve therapeutic outcomes.

Objective To analyze the respective abnormal brain regions and commonly altered brain regions of spontaneous brain ac-tivity in post-stroke aphasia(PSA)and post-stroke depression(PSD),and to explore the potential pathological mechanisms underlying single disease and comorbidity.Methods Literatures were retrieved from PubMed,Embase,Web of Science,Cochrane Library,CNKI,Wanfang data,VIP and SinoMed,from establishment to April 19th,2025.Resting-state functional magnetic resonance imaging(fMRI)studies were included if they focused on patients with PSA or PSD,with healthy controls(HC)serving as control group,and amplitude of low-frequency fluctuation(ALFF),fractional amplitude of low-frequency fluctu-ation(fALFF)and regional homogeneity(ReHo)were adopted as outcome indicator.Data regarding differential brain regions were extracted from the original studies,and a neuroimaging meta-analysis was conducted using SDM-PSI V6.23 beta.Results A total of 17 articles on PSA(339 patients and 351 HC)and five articles on PSD(102 patients and 149 HC)were included.The spontaneous brain activity in the left cerebellar area 9,right middle temporal gyrus and right insula was significantly higher in PSA patients than in HC(P<0.05),while activity in the right cerebellar area 6,left medial superior frontal gyrus(SFGmed),left middle frontal gyrus and right anterior cingulate/paracingulate gyrus was lower(P<0.05).For PSD,spontaneous brain activity was elevated in the right cuneus gyrus and right superior occipital gyrus compared to HC(P<0.05),while it was reduced in the left SFGmed and left inferior pa-rietal lobe(P<0.05).Additionally,spontaneous brain activity in the left medial superior frontal gyrus was lower in both diseases compared to HC(P<0.05).Conclusion The pathological mechanism of PSA may involve a pattern of right-sided compensatory hyperfunction and left-sided inhibitory damage within the language-related network,accompanied by cross-hemispheric synergistic activity of the cerebellum.The occurrence of PSD may be attributed to hyperactivity of the right occipital net-work,and functional inhibition involving the left inferior parietal lobe.The inhibition observed in the left SFG-med(MNI coordinates x=0,y=26,z=44)likely represents the language-emotion integration hub,mediating the co-occurrence of PSA and PSD.

Objective:To explore the impact of air pollution on hospital visits for mental and behavioral disorders among residents in an industrial area in Henan Province from 2016 to 2021.Methods:Daily outpatient visits data for mental and behavioral disorders were collected from Angang General Hospital in Angang Industrial Area at Anyang City between January 2016 and December 2021. And air pollutants and meteorological data during the same period were also collected. A generalized additive model was used for time-series analysis to examine the relationship between daily average concentrations of nitrogen dioxide (NO 2), sulfur dioxide (SO 2), fine particulate matter (PM 2.5), inhalable particulate matter (PM 10), carbon monoxide (CO), and ozone (O 3) with a lag of 0 to 7 days on the number of visits for mental and behavioral disorders among residents. The single-day lag effect (lag0-lag7 d) and cumulative lag effect (lag01-lag07 d) were analyzed. The smooth cubic spline function was used to fit the exposure-response relationship, and subgroup analysis was performed according to different genders, seasons and ages. Results:A total of 26 268 hospital visits for mental and behavioral disorders were collected from the industrial area between 2016 and 2021. The daily average concentrations of SO 2, NO 2, PM 2.5, PM 10, and CO were (27.50±27.33), (43.11±18.33), (73.87±60.30), (134.01±83.81) μg/m 3, and (1.72±1.03) mg/m 3, respectively. The daily maximum 8-hour average concentration of O 3 was (82.18±53.70) μg/m 3. After controlling for long-term trends, temperature, relative humidity, day of the week effects, and holiday effects, the generalized additive model analysis showed that NO 2 had a statistically significant impact on the hospital visits for mental and behavioral disorders at lag0 d, lag2 d and lag01-lag05 d and CO had a statistically significant impact at lag0-lag3 d and lag01-lag06 d (all P<0.05). NO 2 at lag02-lag04 d and CO at lag0-lag2 d and lag01-lag04 d had statistically significant effects on the visits for neurasthenia (both P<0.05). The impacts of NO 2 at lag03-lag04 d, PM 2.5 at lag3 d and lag03-lag04 d, PM 10 at lag3 d and lag03 d, and CO at lag3 d and lag01-lag05 d on visits for generalized anxiety disorder were also statistically significant (all P<0.05). After false discovery rate (FDR) correction, it was shown that for every 10 μg/m 3 increase in NO 2 and every 0.1 mg/m 3 increase in CO, the percentage increase in visits for mental and behavioral disorders and its 95% confidence interval (95% CI) were 3.38% (0.95%-5.87%) and 0.78% (0.38%-1.17%), respectively. For every 0.1 mg/m 3 increase in CO, the visits for neurasthenia increased by 0.78% (0.27%-1.29%). For every 10 μg/m 3 increase in PM 2.5 and every 0.1 mg/m 3 increase in CO, the visits for generalized anxiety disorder increased by 1.07% (0.46%-1.68%) and 1.17% (0.37%-1.97%), respectively (adjusted P<0.05). There was a linear exposure-response relationship between NO 2 and CO and the hospital visits for mental and behavioral disorders, CO and the hospital visits for neurasthenia, and CO and PM 2.5 and the hospital visits for generalized anxiety disorder ( P<0.05 for the overall association test and P>0.05 for the non-linearity test). Stratified analysis showed that air pollutants had an impact on male patients with neurasthenia, female patients with generalized anxiety disorder, individuals aged <45 years with mental and behavioral disorders, and individuals aged ≥65 years with generalized anxiety disorder. The impact of air pollutants was greater during the cold season or winter. Conclusion:Exposure to air pollution can increase hospital visits for mental and behavioral disorders among residents in industrial areas, with a higher risk among those aged<45 years old and during the cold season.

Objective:To analyze the feasibility and safety of breast-conserving surgery for young women with breast cancer whose tumor is close to nipple areola complex after neoadjuvant therapy.Methods:Young female breast cancer patients treated at Maoming People’s Hospital from Jan. 2016 to Jan. 2022 were selected. The inclusion criteria were primary solitary tumors located within ≤2 cm from the areola margin (excluding carcinoma in situ, nipple discharge, and Paget’s disease), tumor diameter ranging from 1 to 3 cm, and no abnormal adhesion between the tumor and the areola, breast skin, or chest wall. A total of 87 patients were enrolled, including 44 who underwent NAC-sparing breast-conserving surgery (NAC-preservation group) and 43 who underwent breast-conserving surgery without NAC preservation (non-NAC-preservation group). All patients received postoperative radiotherapy and continued systemic therapy. Local recurrence and distant metastasis were compared between the two groups.Results:No statistically significant differences were observed between the two groups in pre-neoadjuvant therapy tumor stage, tumor location, tumor diameter, lymph node metastasis, or molecular subtype ( χ2=0.22, 0.67, 0.80, 1.25, 1.76, respectively; P>0.05). At the 2-year postoperative follow-up, no local recurrence was detected in either group. Distant metastasis occurred in one case in the NAC-preservation group and three cases in the non-NAC-preservation group, with no statistically significant difference (2.27% vs. 6.98%, χ2=1.097, P=0.295) . Conclusions:This study, to some extent, validates the feasibility of both patient groups undergoing breast-conserving surgery with or without NAC preservation after neoadjuvant therapy, in young breast cancer patients with tumors located near the nipple areola complex. Routine NAC excision does not improve therapeutic outcomes.