The theory of constitution in traditional Chinese medicine （TCM） has emerged as a new discipline in recent years. Constitution plays a vital role in the onset，progression，transformation，and prognosis of diseases. At present，some clinical scholars have adopted a novel diagnostic and treatment model of "constitution differentiation-disease identification-syndrome differentiation"，in which constitution is regarded as a core element throughout the diagnostic and therapeutic process. Constitution is closely associated with etiology，onset，pathogenesis，syndrome differentiation，and treatment. Against this background，the construction of animal models based on constitution holds far-reaching significance for advancing clinical research. This paper focuses on the construction and evaluation of rodent models with Qi-deficiency constitution，aiming to explore how to further induce Qi-deficiency syndromes and related disease states on the basis of Qi-deficiency constitution models，thereby developing an integrated animal model that embodies the trinity of "constitution-disease-syndrome". The establishment of this model not only provides a solid experimental foundation for the development of new therapies and drugs in TCM targeting specific constitutions，diseases，and syndromes，but also greatly promotes the modernization and scientific advancement of TCM theory. By comprehensively applying multidisciplinary technologies and methods，the study evaluates the model's validity，reliability，and practicality，with the aim of opening new avenues for future research in TCM and promoting the development of the field.

The theory of constitution in traditional Chinese medicine （TCM） has emerged as a new discipline in recent years. Constitution plays a vital role in the onset，progression，transformation，and prognosis of diseases. At present，some clinical scholars have adopted a novel diagnostic and treatment model of "constitution differentiation-disease identification-syndrome differentiation"，in which constitution is regarded as a core element throughout the diagnostic and therapeutic process. Constitution is closely associated with etiology，onset，pathogenesis，syndrome differentiation，and treatment. Against this background，the construction of animal models based on constitution holds far-reaching significance for advancing clinical research. This paper focuses on the construction and evaluation of rodent models with Qi-deficiency constitution，aiming to explore how to further induce Qi-deficiency syndromes and related disease states on the basis of Qi-deficiency constitution models，thereby developing an integrated animal model that embodies the trinity of "constitution-disease-syndrome". The establishment of this model not only provides a solid experimental foundation for the development of new therapies and drugs in TCM targeting specific constitutions，diseases，and syndromes，but also greatly promotes the modernization and scientific advancement of TCM theory. By comprehensively applying multidisciplinary technologies and methods，the study evaluates the model's validity，reliability，and practicality，with the aim of opening new avenues for future research in TCM and promoting the development of the field.

OBJECTIVE To evaluate the cost-utility of disitamab vedotin （DV） combined with toripalimab versus platinum-containing chemotherapy as first-line therapy for locally advanced or metastatic urothelial carcinoma（UC） with human epidermal growth factor receptor 2 （HER2） expression from the perspective of China’s health-care system.METHODS A cost-utility analysis was performed. A three-state partitioned survival model was constructed based on the RC48-C016 trial with a 1-week cycle length. The long-term health benefits [quality-adjusted life years（QALYs）] and costs of disitamab vedotin combined with toripalimab versus platinum-containing chemotherapy as first-line therapy for locally advanced or metastatic UC with HER2 expression were simulated. The simulation time horizon was set to 15 years， and the discount rate was 4.5%. The willingness-to-pay （WTP） threshold was defined as twice China’s per capita gross domestic product（GDP） in 2025 （199 330 yuan/QALY）. The incremental cost-effectiveness ratio （ICER） between the two groups was compared， and one-way sensitivity analysis and probabilistic sensitivity analysis were conducted.RESULTS Compared with platinum-containing chemotherapy regimen， the DV plus toripalimab regimen yielded an additional 1.01 QALYs with an incremental cost of 183 224.45 yuan， and the ICER was 181 728.15 yuan/QALY， which was below the WTP threshold. At the current threshold， the probability that the DV combination regimen had a cost-utility advantage was 79.9%.CONCLUSIONS Taking twice China’s per capita GDP in 2025 as the WTP threshold， DV combined with toripalimab exhibits a cost-utility advantage over platinum-containing chemotherapy as first-line treatment for HER2-expressing locally advanced or metastatic urothelial carcinoma.

OBJECTIVE To analyze the trends of potentially inappropriate medication （PIM） among elderly cancer patients in the context of the diagnosis-related groups（DRG）-based medical insurance payment reform.METHODS Relevant data were extracted for elderly inpatients with cancer at a Grade-A Level-Ⅲ hospital from January 2018 to March 2025. Prescribed medications were screened for PIM using the 2024 Chinese Criteria for Identifying PIM in the Elderly and the US 2023 Beers Criteria， and consistency was evaluated. An interrupted time-series （ITS） model was established， with the period from January 2018 to December 2020 designated as the pre-implementation group， and January 2021 to March 2025 as the post-implementation group. The study analyzed the impact of the medical insurance DRG payment reform on per capita hospitalization costs， per capita length of stay， average number of medication specifications per patient， overall PIM incidence， and PIM incidences for target medications among elderly cancer inpatients. To eliminate the influence of baseline characteristics （age， sex）， propensity score matching（PSM） was further applied， followed by an ITS model analysis to assess the impact of the DRG payment reform on the overall PIM incidence among elderly cancer inpatients.RESULTS A total of 16 910 elderly cancer inpatients were included （6 552 in the pre-implementation group， and 10 358 in the post-implementation group）； PIMs occurred in 9 138 patients， with an incidence of 54.04%. PIMs involved 198 types of medications， among which six target medications （including Diclofenac sodium enteric capsules and Oxycodone hydrochloride sustained-release tablets）， exhibited a higher average PIM incidence or a significant trend change； the Kappa value for the consistency evaluation of the assessments by two pharmacists was 0.931 （ P ＜0.001） . After the implementation of DRG， the per capita hospitalization costs showed a downward trend of 103.501 yuan per month （ P ＜0.001）； the per capita length of stay showed a slight upward trend （increasing by 0.052 days per month， P ＝0.017）， but the actual slope （－0.036） was less than 0； there was no significant change in the average number of medication specifications per patient （ P ＝0.193）. The DRG payment reform under medical insurance can produce statistically significant instantaneous impact effects on the PIM incidences among users of Diclofenac sodium enteric capsules， Doxofylline injection， and Cimetidine injection （ P values of 0.041， 0.001， and 0.036， respectively）， a statistically significant long-term trend effect on the PIM incidences among users of Oxycodone hydrochloride sustained-release tablets （ P ＝0.008）， and statistically significant instantaneous shock and long-term trend effects on the PIM incidences among users of Spironolactone tablets （ P values of 0.035 and 0.031） and Aminophylline injection （ P values of 0.009 and 0.031）. Regardless of whether PSM was applied， the overall PIM incidence among patients showed a slight upward trend [an increase of 0.228% per month， P ＝0.001 （without PSM）， or an increase of 0.239% per month， P ＜0.001 （after PSM）].CONCLUSIONS Following the implementation of the DRG payment reform for medical insurance， the per capita hospitalization cost for elderly inpatients with cancer decreases significantly， while the decline in the per capita length of stay slows. The overall PIM incidence shows a slight upward trend， and the trends in PIM incidence vary across different drug formulations.

BACKGROUND: Endoscopic sphincterotomy (EST) is widely used to treat common bile duct stones (CBDS); however, long-term studies have revealed the increasing incidence of recurrent CBDS after EST. Loss of sphincter of Oddi function after EST was the main cause of recurrent CBDS. Reparation of the sphincter of Oddi is therefore crucial. This study aims to investigate the effectiveness and safety of endoclip papilloplasty (ECPP) for repairing the sphincter of Oddi and elucidate its mechanism. METHODS: Eight healthy Bama minipigs were randomly divided into the EST group and the ECPP group at a 1:1 ratio, and bile samples were collected before endoscopy and 6 months later. All minipigs underwent transabdominal biliary ultrasonography for the diagnosis of cholelithiasis 6 months after endoscopy. The biliary microbiota composition and alpha and beta diversity were analyzed by 16S ribosomal RNA gene sequencing. Differential metabolites were analyzed by bile acid metabolomics to explore the predictive indicators of cholelithiasis. RESULTS: Three minipigs were diagnosed with cholelithiasis in the EST group, while none in the ECPP group showed cholelithiasis. The biliary Firmicutes/Bacteroidota (F/B) ratio was increased after EST and decreased after ECPP. The Chao1 and observed species index significantly decreased 6 months after EST ( P  = 0.017 and 0.018, respectively); however, the biliary α-diversity was similar before and 6 months after ECPP. The β-diversity significantly differed in the EST group before and 6 months after EST, as well as in the ECPP group before and 6 months after ECPP (analysis of similarities [ANOSIM]: R  = 0.917, P  = 0.040; R  = 0.740, P  = 0.035; respectively). Glycolithocholic acid (GLCA) and taurolithocholic acid (TLCA) accumulated in bile 6 months after EST. CONCLUSIONS ECPP has less impact on the biliary microenvironment than EST and prevents duodenobiliary reflux by repairing the sphincter of Oddi. The bile levels of GLCA and TLCA may be used to predict the risk of cholelithiasis.
Animals ; Swine, Miniature ; Swine ; Cholelithiasis/prevention & control* ; Sphincterotomy, Endoscopic/methods* ; Sphincter of Oddi/surgery* ; Female ; Male

Objective To evaluate the clinical efficacy of Zhuanggu Kangsong Soft Extract combined with percutaneous vertebroplasty(PVP)in the treatment of osteoporotic vertebral compression fractures(OVCF).Methods A total of 90 eligible OVCF patients admitted to Guangzhou Integrated Chinese and Western Medicine Hospital between January 2023 and May 2024 were enrolled and randomly divided into an observation group(n=45)and a control group(n=45)using a random number table.Both groups underwent PVP.After treatment,the control group received conventional western medication orally(calcium carbonate D3 tablets+calcitriol soft capsules),while the observation group received additional Zhuanggu Kangsong Soft Extract treatment orally.Western medication was administered for 6 months,and herbal treatment lasted 3 months.Changes in Visual Analogue Scale(VAS)scores for pain,Oswestry Disability Index(ODI)scores for low back function,bone mineral density(BMD)T-values,and serum bone metabolism markers were observed before and after treatment.Results(1)At postoperative day 3,3 months,and 6 months,both groups showed significant improvements in VAS and ODI scores compared to those before treatment(P＜0.05).The observation group demonstrated superior improvements in VAS and ODI scores at 3 and 6 months compared to the control group(P＜0.05).(2)At 3,6,and 12 months postoperatively,BMD T-values were improved in both groups(P＜0.05),with the observation group exhibiting greater improvements at 6 and 12 months(P＜0.05).(3)Serum N-terminal osteocalcin and 25-hydroxyvitamin D3[25(OH)D3]levels increased in both groups at 1,3,and 6 months(P＜0.05).The observation group showed more pronounced elevations in these markers at 3 and 6 months(P＜0.05).Conclusion The combination of Zhuanggu Kangsong Soft Extract and PVP demonstrates significant therapeutic benefits for OVCF by effectively alleviating pain,enhancing BMD,and improving activities of daily living,which highlights its high clinical value.

N6 methyladenosine(m6A)methylation modification is a common form of mRNA modification,which is involved in the regulation of mRNA output,splicing,translation,localization and degradation,and plays an important role in the regulation of gene expression,body growth and development,and the development of tumors.The expression levels of many m6A methylation-related molecules in bladder cancer are altered to varying degrees,thus affecting the clinical treatment and prognosis of bladder cancer.The m6A methylation modification is closely related to the occurrence and development of bladder cancer,and a deeper understanding of the relevant regulatory mechanisms is beneficial to provide more reference for the clinical application of m6A methyla-tion in bladder cancer.

Objective To evaluate the value of modified percutaneous endoscopic gastrostomy(PEG)for patients with amyotrophic lateral sclerosis(ALS)and dysphagia.Methods From January 2018 to December 2023,47 patients with ALS were treated with modified PEG in our hospital.The surgery was performed under local anesthesia.The patients were placed in a semi-seated position,and the surgeon performed surgery with an ultra-fine endoscope through oral entrance to the stomach.Results The modified PEG were successfully completed in all the 47 cases.The operation time was5-20 min[mean,(10.3±1.7)min].The postoperative hospitalization lasted for2-8 d(mean,2.8 d).Postoperative complications occurred in6 cases(12.8%),including aspiration pneumonia in4 cases(8.5%)and incision infection in2 cases(4.3%).The body mass index was17.06±0.89 before PEG and 18.15±0.81 at 3 months after PEG,with significant difference(t=-10.373,P=0.000).Conclusion For ALS patients with dysphagia,modified PEG is feasible,which significantly improves nutritional status of patients.

To systematically review randomized controlled trials （RCTs） of traditional Chinese medicine （TCM） intervention in ulcerative colitis （UC）， and analyze the characteristics of these studies and their outcome indicators， thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure （CNKI）， Wanfang Data， VIP， SinoMed， PubMed， Cochrane Library， EMbase， and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed， and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included， with a sample size of 44 853 participants. The largest sample size was 218 cases， and the smallest was 28 cases， with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types， the top three were large intestine dampness-heat syndrome （31.05%）， spleen and kidney yang deficiency syndrome （12.47%）， and spleen deficiency with dampness syndrome （9.17%）. The interventions， ranked by frequency of use， included internal Chinese medicine compounds/preparations （64.5%）， Chinese medicine compounds/preparations with retained enema （18.2%）， internal Chinese medicine compounds/preparations + external TCM treatment （5.95%）， and external TCM treatment alone （4.86%）. The treatment duration was mainly 4-8 weeks （64.86%）， with 61 studies （10.99%） reporting follow-up time. A total of 157 outcome indicators were used， with a frequency of 3 460 occurrences， classified into six domains： TCM syndromes and symptoms （346 occurrences， 10%）， symptoms/signs （541 occurrences， 15.64%）， physical and chemical examinations （2 119 occurrences， 61.24%）， quality of life （107 occurrences， 3.09%）， long-term prognosis （61 occurrences， 1.76%）， and safety events （284 occurrences， 8.21%）. The analysis reveals several limitations in the outcome indicators of TCM intervention in UC， including the lack of a basis for sample size calculation， non-standardized TCM syndrome classification， absence of trial design and registration， inadequate blinding and allocation concealment， adherence issues with interventions， imbalanced selection of surrogate and endpoint indicators， inconsistency in the timing of outcome measurements， design issues that require standardization， and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification， clear efficacy evaluation indicators， key endpoint indicators， and reasonable measurement time points. Long-term prognostic impacts， comprehensive assessments of patients' quality of life， and consideration of economic benefits should be emphasized， providing a basis for the clinical practice of TCM in the treatment of UC.

To systematically review randomized controlled trials （RCTs） of traditional Chinese medicine （TCM） intervention in ulcerative colitis （UC）， and analyze the characteristics of these studies and their outcome indicators， thereby providing references for the design of future RCTs of TCM intervention in UC and offering evidence supporting the clinical application of TCM in UC. A computerized search was conducted in the China National Knowledge Infrastructure （CNKI）， Wanfang Data， VIP， SinoMed， PubMed， Cochrane Library， EMbase， and Web of Science databases for RCTs of TCM intervention in UC published from January 2021 to August 2024. The risk of bias was assessed， and outcome indicators were qualitatively analyzed. A total of 555 RCTs were included， with a sample size of 44 853 participants. The largest sample size was 218 cases， and the smallest was 28 cases， with most studies focusing on 60-100 participants. Of the 386 RCTs that explicitly reported TCM syndrome types， the top three were large intestine dampness-heat syndrome （31.05%）， spleen and kidney yang deficiency syndrome （12.47%）， and spleen deficiency with dampness syndrome （9.17%）. The interventions， ranked by frequency of use， included internal Chinese medicine compounds/preparations （64.5%）， Chinese medicine compounds/preparations with retained enema （18.2%）， internal Chinese medicine compounds/preparations + external TCM treatment （5.95%）， and external TCM treatment alone （4.86%）. The treatment duration was mainly 4-8 weeks （64.86%）， with 61 studies （10.99%） reporting follow-up time. A total of 157 outcome indicators were used， with a frequency of 3 460 occurrences， classified into six domains： TCM syndromes and symptoms （346 occurrences， 10%）， symptoms/signs （541 occurrences， 15.64%）， physical and chemical examinations （2 119 occurrences， 61.24%）， quality of life （107 occurrences， 3.09%）， long-term prognosis （61 occurrences， 1.76%）， and safety events （284 occurrences， 8.21%）. The analysis reveals several limitations in the outcome indicators of TCM intervention in UC， including the lack of a basis for sample size calculation， non-standardized TCM syndrome classification， absence of trial design and registration， inadequate blinding and allocation concealment， adherence issues with interventions， imbalanced selection of surrogate and endpoint indicators， inconsistency in the timing of outcome measurements， design issues that require standardization， and ethical and safety concerns. It is recommended that future studies actively construct a set of core indicators for UC that include standardized TCM syndrome classification， clear efficacy evaluation indicators， key endpoint indicators， and reasonable measurement time points. Long-term prognostic impacts， comprehensive assessments of patients' quality of life， and consideration of economic benefits should be emphasized， providing a basis for the clinical practice of TCM in the treatment of UC.