Objective To evaluate the efficacy and safety of six kinds of commonly used traditional Chi-nese medicine combined with mesalazine in the treatment of ulcerative colitis(UC)based on frequency statis-tical network meta-analysis.Methods Randomized controlled trials(RCT)of oral Chinese medicine for the treatment of UC were searched from the establishment of the database to June 2024 of PubMed,CNKI,Wan-fang,VIP,Sinomed and other databases.The quality of the included literatures was evaluated by Cochrane bias risk assessment tool,and the data were statistically analyzed by Stata MP17.0 software.Results A total of 24 RCTs involving 1 939 patients were included,involving 6 kinds of traditional Chinese medicine and Chinese pa-tent medicine,including 4 macro and micro outcome indicators.In terms of improving the total clinical effec-tive rate,Shaoyao decoction,Gancao Xiexin decoction,Huangqin decoction granule,Baitouweng decoction,Kangfuxin liquid,Shenlingbaizhu powder+mesalazine were all superior to using mesalazine alone,and Kang-fuxin liquid+mesalazine had the best effect(P<0.05).In terms of down-regulation of interleukin(IL)-6 expression in colonic mucosa,Shaoyao decoction,Gancao Xiexin Decoction,Huangqin Decoction granules,Pul-satilla decoction,Kangfuxin Liquid+mesalazine were better than using mesalazine alone,and Pulsatilla De-coction+mesalazine had the best effect on reducing IL-6(P<0.05).In terms of down-regulation of colonic mucosal tumor necrosis factor(TNF)-α expression,Shaoyao decoction,Gancao Xiexin decoction,Huangqin decoction granule,Baitouweng decoction,Shenlingbaizhu decoction+mesalazine was better than using me-salazine alone,and Gancao Xiexin decoction+mesalazine had the best effect(P<0.05).In terms of down-regulation of IL-10 expression in colonic mucosa,Pulsatilla decoction+mesalazine was better than mesalazine alone(P<0.05).Conclusion Traditional Chinese medicine combined with mesalazine could alleviate the clin-ical symptoms of UC patients,improve inflammatory factor indicators,eliminate inflammation,and show a better treatment effect for UC than mesalazine used alone.

Objective To explore the feasibility and corresponding implementation methods of constructing a sample resource bank based on individual-level data of completed clinical trials and using it to construct external controls for drug/device clinical trials.Methods Taking the pre-marketing clinical trial of transcatheter active valve replacement(TAVR)for the treatment of aortic valve stenosis as an example,the individual-level databases of multiple trials were standardized to form a sample bank.The original data of any trial in the sample bank were selected as the experimental group,and the remaining samples were selected as the control group.The potential confounding was handled by using the propensity score matching and stratification methods to clarify the process of constructing external controls based on the sample bank of individual-level data of clinical trials.Results This study included individual-level data of single-group trials of 4 TAVR devices,with a total of 569 subjects(59.2%male).The number of subjects in Trials 1 to 4 was 120,120,163,and 166,respectively.Propensity score matching enabled the matching of 113,117,125,and 147 subjects with comparable or similar characteristics from individual-level data from other trials,respectively,demonstrating a high matching success rate.The PS score distribution plot after stratification showed that the proportions of subjects in the experimental and control groups in strata 1 to 5 in scheme 1 were 4/103,11/103,22/92,32/87,and 51/64,respectively.For all constructed external controlled trials,a certain number of control samples with similar baseline characteristics to the experimental groups were distributed within each propensity score stratum.The results of the simulation test also reflected the potential differences between different devices in the 12-month all-cause mortality rate.Conclusions The sample bank constructed with individual-level data from clinical trials,as a high-quality data source,can serve as a source of external control for single-arm trials in the same field,and as a useful supplement to the external control scenario of real-world evidence to support drug and device development.At the same time,targeted research on research methods and bias control measures in related fields is also needed.

Objective:To investigate the influencing factors for safe abdominal wall recons-truction in giant ventral hernia based on imaging and clinical features.Methods:The retrospective case-control study was conducted. The imaging and clinical data of 369 patients with giant ventral hernia who were admitted to Beijing Chaoyang Hospital of Capital Medical University from January 2017 to December 2023 were collected. There were 182 males and 187 females, aged (63±14)years. Among 369 patients, 311 cases underwent safe abdominal wall reconstruction and 58 underwent high-risk abdominal wall reconstruction. Observation indicators: (1) clinical and imaging characteris-tics; (2) analysis of influencing factors for safe abdominal wall reconstruction in giant ventral hernia. Comparison of measurement data with normal distribution between groups was conducted using the t test. Comparison of measurement data with skewed distribution between groups was conducted using the Mann-Whitney U test. Comparison of count data between groups was conducted using the chi-square test. Comparison of ordinal data between groups was conducted using the nonparametic rank sum test. Logistic regression, Lasso regression, and random forest analyses were used for influencing factors analysis. Results:(1) Clinical and imaging characteristics. There were significant differences between patients with safe and high-risk abdominal wall reconstruction in presence of a definite secondary abdominal cavity, maximum axial diameter of the defect, maximum transverse diameter of the defect, abdominal wall defect area, component separation index (CSI), abdominal wall opening angle, ratio of CSI, muscle grayscale at the defect, hernia sac volume, hernia sac-abdominal cavity volume ratio, and defect long-axis-to-abdominal cavity ratio ( P<0.05). (2) Analysis of influencing factors for safe abdominal wall reconstruction in giant ventral hernia. Results of Logistic regression analysis showed that presence of a definite secondary abdominal cavity, maximum axial diameter of the defect, maximum transverse diameter of the defect, abdominal wall defect area, CSI, abdominal wall opening angle, ratio of CSI, muscle grayscale at the defect (inner-superior or right), hernia sac volume, hernia sac-abdominal cavity volume ratio, and defect long-axis-to-abdominal cavity ratio were factors associated with safe abdominal wall reconstruction in giant ventral hernia [ odds ratio ( OR)=3.955, 1.189, 1.395, 1.127, 2.006, 1.042, 1.095, 0.881, 1.102, 1.109, 1.601, 95% confidence interval ( CI) as 2.179-7.178, 1.113-1.271, 1.267-1.537, 1.090-1.166, 1.651-2.437, 1.014-1.071, 1.066-1.125, 0.798-0.972, 1.057-1.148, 1.067-1.153, 1.343-1.909]. The top 3 factors for discriminative performance were abdominal wall CSI, ratio of CSI, maximum transverse diameter of the defect and the abdominal wall defect area, with area under the curve of 0.794, 0.777, 0.772, and 0.772, respectively. Results of Lasso regression analysis showed that body mass index, smoking, chronic obstructive pulmonary disease, American Society of Anesthesiologists classification, presence of a definite secondary abdominal cavity, abdominal wall defect area, abdominal wall opening angle, abdominal wall CSI, muscle grayscale at the defect (inner-superior or right), and hernia sac-to-abdominal cavity volume ratio were associated factors with safe abdominal wall reconstruction in giant ventral hernia (coefficients as -0.002, 0.003, 0.007, 0.014, 0.021, 0.077, 0.023, 0.059, -0.010, 0.037). Results of random forest analysis showed the abdominal wall CSI, maximum transverse diameter of the defect, abdominal wall defect area, ratio of defectr opening angle, maximum axial long diameter of the defect, hernia sac-to-abdominal cavity volume ratio, abdominal wall opening angle, defect long-axis-to-abdominal cavity ratio, muscle grayscale at the defect (inner-superior or right), and body mass index as associated factors with safe abdominal wall reconstruction in giant ventral hernia (importance score=0.092, 0.089, 0.079, 0.056, 0.051, 0.047, 0.045, 0.039, 0.038, 0.035). Conclusion:Abdominal wall CSI, abdominal wall defect area, abdominal wall opening angle, muscle grayscale at the defect (inner-superior or right), and hernia sac-to-abdominal cavity volume ratio are factors associated with safe abdominal wall reconstruction in giant ventral hernia.

AIM:This study aimed to investigate whether Xiang-Sha-Liujunzi decoction(XSLJZD)prevents ethanol-induced gastric ulcer(GU)in rats by inhibiting nucleotide-binding oligomerization domain-like receptor protein 3(NLRP3)inflammasome activation-mediated pyroptosis.METHODS:A total of 60 rats were randomly divided into 5 groups:normal control group,model group,positive control(0.33 mg/kg rabeprazole)group,low-dose(3.40 g/kg)XSLJZD group and high-dose(6.80 g/kg)XSLJZD group,with 12 rats per group.Prior to the induction of GU,all rats received their respective treatments via intragastric gavage for 3 d.The GU model was established in all groups except the normal control group using the anhydrous ethanol method.The ulcer index and ulcer inhibition rate were measured.Hematoxylin-eosin staining was performed to observe pathological changes of gastric tissues,and periodic acid-Schiff staining was used to evaluate the mucus content.Scanning electron microscopy and transmission electron microscopy were employed to inves-tigate ultrastructural changes of gastric tissues.Enzyme-linked immunosorbent assay was conducted to measure the levels of interleukin-4(IL-4),IL-10,IL-1β,IL-18,prostaglandin E2(PGE2)and nitric oxide(NO).Additionally,visible spectrophotometric assay was used to determine the levels of malondialdehyde(MDA),glutathione(GSH)and superoxide dismutase(SOD).The protein levels of NLRP3,apoptosis-associated speck-like protein containing a caspase recruitment domain(ASC),caspase-1,gasdermin D(GSDMD),phosphorylated nuclear factor-κB(p-NF-κB)and phosphorylated NF-κB inhibitor β(p-IκBβ)were assessed using immunofluorescence staining.RESULTS:Compared with model group,XSLJZD significantly alleviated gastric tissue injury,reduced the ulcer index,and enhanced the ulcer inhibition rate in GU rats.Treatment with XSLJZD markedly increased the levels of SOD,GSH,IL-4,IL-10,PGE2 and NO in gas-tric tissue,but significantly decreased the levels of MDA,IL-1β and IL-18.At the molecular level,XSLJZD significantly down-regulated the protein levels of NLRP3,ASC,caspase-1,GSDMD,p-NF-κB and p-IκBβ in gastric tissues.CON-CLUSION:Treatment with XSLJZD demonstrates a significant preventive effect against ethanol-induced GU in rats.Its mechanisms may involve the inhibition of NLRP3 inflammasome activation,reduction of the inflammatory response,pre-vention of pyroptosis in gastric mucosal epithelial cells,and enhancement of antioxidant levels.

AIM:This study aimed to investigate whether Xiang-Sha-Liujunzi decoction(XSLJZD)prevents ethanol-induced gastric ulcer(GU)in rats by inhibiting nucleotide-binding oligomerization domain-like receptor protein 3(NLRP3)inflammasome activation-mediated pyroptosis.METHODS:A total of 60 rats were randomly divided into 5 groups:normal control group,model group,positive control(0.33 mg/kg rabeprazole)group,low-dose(3.40 g/kg)XSLJZD group and high-dose(6.80 g/kg)XSLJZD group,with 12 rats per group.Prior to the induction of GU,all rats received their respective treatments via intragastric gavage for 3 d.The GU model was established in all groups except the normal control group using the anhydrous ethanol method.The ulcer index and ulcer inhibition rate were measured.Hematoxylin-eosin staining was performed to observe pathological changes of gastric tissues,and periodic acid-Schiff staining was used to evaluate the mucus content.Scanning electron microscopy and transmission electron microscopy were employed to inves-tigate ultrastructural changes of gastric tissues.Enzyme-linked immunosorbent assay was conducted to measure the levels of interleukin-4(IL-4),IL-10,IL-1β,IL-18,prostaglandin E2(PGE2)and nitric oxide(NO).Additionally,visible spectrophotometric assay was used to determine the levels of malondialdehyde(MDA),glutathione(GSH)and superoxide dismutase(SOD).The protein levels of NLRP3,apoptosis-associated speck-like protein containing a caspase recruitment domain(ASC),caspase-1,gasdermin D(GSDMD),phosphorylated nuclear factor-κB(p-NF-κB)and phosphorylated NF-κB inhibitor β(p-IκBβ)were assessed using immunofluorescence staining.RESULTS:Compared with model group,XSLJZD significantly alleviated gastric tissue injury,reduced the ulcer index,and enhanced the ulcer inhibition rate in GU rats.Treatment with XSLJZD markedly increased the levels of SOD,GSH,IL-4,IL-10,PGE2 and NO in gas-tric tissue,but significantly decreased the levels of MDA,IL-1β and IL-18.At the molecular level,XSLJZD significantly down-regulated the protein levels of NLRP3,ASC,caspase-1,GSDMD,p-NF-κB and p-IκBβ in gastric tissues.CON-CLUSION:Treatment with XSLJZD demonstrates a significant preventive effect against ethanol-induced GU in rats.Its mechanisms may involve the inhibition of NLRP3 inflammasome activation,reduction of the inflammatory response,pre-vention of pyroptosis in gastric mucosal epithelial cells,and enhancement of antioxidant levels.

Objective To explore the feasibility and corresponding implementation methods of constructing a sample resource bank based on individual-level data of completed clinical trials and using it to construct external controls for drug/device clinical trials.Methods Taking the pre-marketing clinical trial of transcatheter active valve replacement(TAVR)for the treatment of aortic valve stenosis as an example,the individual-level databases of multiple trials were standardized to form a sample bank.The original data of any trial in the sample bank were selected as the experimental group,and the remaining samples were selected as the control group.The potential confounding was handled by using the propensity score matching and stratification methods to clarify the process of constructing external controls based on the sample bank of individual-level data of clinical trials.Results This study included individual-level data of single-group trials of 4 TAVR devices,with a total of 569 subjects(59.2%male).The number of subjects in Trials 1 to 4 was 120,120,163,and 166,respectively.Propensity score matching enabled the matching of 113,117,125,and 147 subjects with comparable or similar characteristics from individual-level data from other trials,respectively,demonstrating a high matching success rate.The PS score distribution plot after stratification showed that the proportions of subjects in the experimental and control groups in strata 1 to 5 in scheme 1 were 4/103,11/103,22/92,32/87,and 51/64,respectively.For all constructed external controlled trials,a certain number of control samples with similar baseline characteristics to the experimental groups were distributed within each propensity score stratum.The results of the simulation test also reflected the potential differences between different devices in the 12-month all-cause mortality rate.Conclusions The sample bank constructed with individual-level data from clinical trials,as a high-quality data source,can serve as a source of external control for single-arm trials in the same field,and as a useful supplement to the external control scenario of real-world evidence to support drug and device development.At the same time,targeted research on research methods and bias control measures in related fields is also needed.

Objective:To investigate the influencing factors for safe abdominal wall recons-truction in giant ventral hernia based on imaging and clinical features.Methods:The retrospective case-control study was conducted. The imaging and clinical data of 369 patients with giant ventral hernia who were admitted to Beijing Chaoyang Hospital of Capital Medical University from January 2017 to December 2023 were collected. There were 182 males and 187 females, aged (63±14)years. Among 369 patients, 311 cases underwent safe abdominal wall reconstruction and 58 underwent high-risk abdominal wall reconstruction. Observation indicators: (1) clinical and imaging characteris-tics; (2) analysis of influencing factors for safe abdominal wall reconstruction in giant ventral hernia. Comparison of measurement data with normal distribution between groups was conducted using the t test. Comparison of measurement data with skewed distribution between groups was conducted using the Mann-Whitney U test. Comparison of count data between groups was conducted using the chi-square test. Comparison of ordinal data between groups was conducted using the nonparametic rank sum test. Logistic regression, Lasso regression, and random forest analyses were used for influencing factors analysis. Results:(1) Clinical and imaging characteristics. There were significant differences between patients with safe and high-risk abdominal wall reconstruction in presence of a definite secondary abdominal cavity, maximum axial diameter of the defect, maximum transverse diameter of the defect, abdominal wall defect area, component separation index (CSI), abdominal wall opening angle, ratio of CSI, muscle grayscale at the defect, hernia sac volume, hernia sac-abdominal cavity volume ratio, and defect long-axis-to-abdominal cavity ratio ( P<0.05). (2) Analysis of influencing factors for safe abdominal wall reconstruction in giant ventral hernia. Results of Logistic regression analysis showed that presence of a definite secondary abdominal cavity, maximum axial diameter of the defect, maximum transverse diameter of the defect, abdominal wall defect area, CSI, abdominal wall opening angle, ratio of CSI, muscle grayscale at the defect (inner-superior or right), hernia sac volume, hernia sac-abdominal cavity volume ratio, and defect long-axis-to-abdominal cavity ratio were factors associated with safe abdominal wall reconstruction in giant ventral hernia [ odds ratio ( OR)=3.955, 1.189, 1.395, 1.127, 2.006, 1.042, 1.095, 0.881, 1.102, 1.109, 1.601, 95% confidence interval ( CI) as 2.179-7.178, 1.113-1.271, 1.267-1.537, 1.090-1.166, 1.651-2.437, 1.014-1.071, 1.066-1.125, 0.798-0.972, 1.057-1.148, 1.067-1.153, 1.343-1.909]. The top 3 factors for discriminative performance were abdominal wall CSI, ratio of CSI, maximum transverse diameter of the defect and the abdominal wall defect area, with area under the curve of 0.794, 0.777, 0.772, and 0.772, respectively. Results of Lasso regression analysis showed that body mass index, smoking, chronic obstructive pulmonary disease, American Society of Anesthesiologists classification, presence of a definite secondary abdominal cavity, abdominal wall defect area, abdominal wall opening angle, abdominal wall CSI, muscle grayscale at the defect (inner-superior or right), and hernia sac-to-abdominal cavity volume ratio were associated factors with safe abdominal wall reconstruction in giant ventral hernia (coefficients as -0.002, 0.003, 0.007, 0.014, 0.021, 0.077, 0.023, 0.059, -0.010, 0.037). Results of random forest analysis showed the abdominal wall CSI, maximum transverse diameter of the defect, abdominal wall defect area, ratio of defectr opening angle, maximum axial long diameter of the defect, hernia sac-to-abdominal cavity volume ratio, abdominal wall opening angle, defect long-axis-to-abdominal cavity ratio, muscle grayscale at the defect (inner-superior or right), and body mass index as associated factors with safe abdominal wall reconstruction in giant ventral hernia (importance score=0.092, 0.089, 0.079, 0.056, 0.051, 0.047, 0.045, 0.039, 0.038, 0.035). Conclusion:Abdominal wall CSI, abdominal wall defect area, abdominal wall opening angle, muscle grayscale at the defect (inner-superior or right), and hernia sac-to-abdominal cavity volume ratio are factors associated with safe abdominal wall reconstruction in giant ventral hernia.

AIM: To understand the publication status, research trends, and cutting-edge and hot topics in this field by conducting a bibliometrics analysis of relevant literatures on the pathogenesis of primary open angle glaucoma(POAG)in the past 30 a.METHODS:A total of 986 relevant literatures on the pathogenesis of POAG published on the core databases of China National Knowledge Infrastructure(CNKI)and Web of Science(WOS)from 1 September 1993 to 1 September 2023 were retrieved. CiteSpace(6.2.R.4)and VOSviewer(1.6.18)software were used to conduct knowledge graph analysis on the retrieved literature, including publication volume, author, research institution, country/region, and keywords.RESULTS:The United States(243 articles)has the highest number of publications, followed by China(121 articles). The foreign institution with the highest number of publications is Harvard University(37 articles), while domestic institutions such as Zhongshan Ophthalmic Center, Sun Yat-sen University, ophthalmology department of Xuanwu Hospital of Capital Medical University, and Peking University First Hospital tied for the highest number of publications. Louis R. Pasquale(21 articles)is the most prolific English author. Wang Ningli is the most active Chinese researcher in this field. Keywords include trabecular meshwork, intraocular pressure, aqueous humor, glucocorticoid, hemorheology, etc.CONCLUSION: The research on the pathogenesis of POAG is in a period of vigorous development. The United States has the largest number of publications in this field, and Harvard University is a leading institution in this field. The research focus in the field of POAG has shifted from the structural aspect to the genetic level, and gene research and traditional Chinese medicine treatment have broad application prospects in this field.

Literature related to robot-assisted gait training(RAGT)for stroke patients was summarized,and the results of the systematic search were analyzed using the method of scoping review.The positive effects of robot-assisted gait training(RAGT)on the recovery of walking function in stroke patients were described,and recommendations such as developing RAGT-based exoskeleton equipment and implementing a diversified gait rehabilitation training program were proposed to promote the application and development of RAGT and the recovery of walking function in stroke patients.[Chinese Medical Equipment Journal,2024,45(7):105-111]

Aim To explore the protective effects of Xiyanping injection against lipopolysaccharide(LPS)-induced acute lung injury(ALI)in mice,and investi-gate the underlying mechanism.Methods In the LPS-induced ALI mouse model,the protective effect of Xiyanping injection against ALI was evaluated by ob-serving the pathological indicators of lung tissue.Net-work pharmacology and molecular docking were used to explore its mechanism.Western blot method was used to validate the predicted target proteins.Results Xiy-anping injection significantly improved the pathological injury and alleviated inflammatory reactions in lungs of ALI mice.Four active ingredients were identified in Xiyanping injection,namely,14-deoxy-11-oxo-an-drographolide,14-deoxyandrographolide,14-deoxy-12-methoxyandrographolide,and andrographolide-19-β-D-glucoside.A total of 288 corresponding drug targets and 4 960 ALI-related targets were obtained,with 192 genes overlapping.The ten core targets associated with Xiyanping injection were identified as STAT3,EGFR,PIK3R1,MAPK1,PIK3CA,NFKB1,ESR1,MAPK8,JAK2,and FYN.GO enrichment analysis re-vealed 310 biological processes(BP),65 cellular components(CC),and 80 molecular functions(MF)associated with the overlapping genes.KEGG pathway enrichment analysis identified 141 pathways related to ALI,with the top 20 pathways including MAPK,TNF-α,VEGF,cAMP,mTOR,AMPK,NOD,JAK-STAT,IL-17,and NF-κB.Molecular docking results demonstrated strong binding affinity between core tar-gets(MAPK1,MAPK8,NFKB1)and active ingredi-ents(14-deoxy-12-methoxyandrographolide and 14-de-oxyandrographolide).Western blotting showed that medium and high doses of Xiyanping injection signifi-cantly downregulated p38,JNK,ERKl/2,NF-κB p65 protein expression in lung tissue of ALI mice(P＜0.01).Conclusions Xiyanping injection has a cer-tain protective effect against ALI,and the mechanism is related to regulating MAPK and NF-κB signaling pathways.