ObjectiveTo investigate the distribution of traditional Chinese medicine （TCM） syndromes in intrahepatic cholestasis of pregnancy （ICP） and its association with perinatal outcomes， and to provide a basis for precise treatment based on TCM syndrome differentiation. MethodsA cross-sectional study was conducted among 275 patients with ICP who were admitted to The Affiliated Hospital of Chengdu University of Traditional Chinese Medicine from April 2023 to April 2025. A hierarchical cluster analysis was used to summarize TCM syndromes. The Kruskal-Wallis H test was used for comparison of non-normally distributed continuous data between groups， and the chi-square test was used for comparison of categorical data between groups. A multivariate Logistic regression analysis was used to identify the clinical features significantly associated with TCM syndrome. ResultsThe cluster analysis identified three core TCM syndromes among the 275 patients with ICP， i.e.， liver-gallbladder damp-heat syndrome （45.8%）， syndrome of blood deficiency generating wind （30.9%）， and liver depression and spleen deficiency syndrome （23.3%）. There was a significant difference in the distribution of TCM syndromes between different groups stratified by maternal age at delivery， parity， history of ICP recurrence， gestational weeks at disease onset， total bile acid （TBA）， alanine aminotransferase （ALT）， and comorbidity with gestational diabetes mellitus （GDM） （all P<0.05）. The multivariate Logistic regression analysis showed that<34 gestational weeks at disease onset was significantly associated with all three syndromes （damp-heat： odds ratio ［OR］=3.769， P<0.001； blood deficiency： OR=4.031， P<0.001； liver stagnation： OR=3.552， P<0.001）. Liver-gallbladder damp-heat syndrome was associated with maternal age ≥35 years at disease onset （OR=2.048， P=0.014）， parity ≥2 times （OR=1.921， P=0.034）， history of ICP recurrence （OR=2.404， P=0.030）， ALT ≥200 U/L （OR=2.051， P=0.018）， comorbidity with GDM （OR=1.944， P=0.029）， and TBA ≥40 μmol/L （OR=2.542， P=0.024）. The syndrome of blood deficiency generating wind syndrome was associated with maternal age ≥35 years （OR=2.939， P=0.003）， parity ≥2 time （OR=3.222， P=0.003）， history of ICP recurrence （OR=3.809， P=0.010）， ALT ≥200 U/L （OR=2.889， P=0.006）， comorbidity with GDM （OR=3.711， P=0.001）， and comorbidity with hypertensive disorders of pregnancy （OR=4.472， P=0.011）. Liver depression and spleen deficiency syndrome was associated with TBA ≥40 μmol/L （OR=2.995， P=0.044）. The analysis of perinatal outcomes showed that there were significant differences in mode of delivery， gestational weeks at the time of delivery， postpartum blood loss， and neonatal birth weight between the three groups with different TCM syndromes （all P<0.05）. ConclusionLiver-gallbladder damp-heat syndrome， syndrome of blood deficiency generating wind， and liver depression and spleen deficiency syndrome are the main TCM syndrome types in ICP， and the distribution of TCM syndromes is closely associated with clinical factors and perinatal outcomes， which provides a basis for precise TCM syndrome differentiation and individualized treatment.

The Consolidated Standards of Reporting Trials (CONSORT) statement aims to enhance the quality of reporting for randomized controlled trial (RCT) by providing a minimum item checklist. It was first published in 1996, and updated in 2001 and 2010, respectively. The latest version was released in April 2025, continuously reflecting new evidence, methodological advancements, and user feedback. CONSORT 2025 includes 30 essential checklist items and a template for a participant flow diagram. The main changes to the checklist include the addition of 7 items, revision of 3 items, and deletion of 1 item, as well as the integration of multiple key extensions. This article provides a comprehensive interpretation of the statement, aiming to help clinical trial staff, journal editors, and reviewers fully understand the essence of CONSORT 2025, correctly apply it in writing RCT reports and evaluating RCT quality, and provide guidance for conducting high-level RCT research in China.

Objective:To compare the clinical characteristics of monogenic and non-monogenic early-onset inflammatory bowel disease (EO-IBD) in children and to explore the necessity of genetic analysis in EO-IBD research.Methods:A retrospective analysis of clinical data was conducted on 73 children diagnosed with EO-IBD at the Children's Hospital affiliated with Capital Institute of Pediatrics between January 2017 and December 2023. Genetic analysis was performed utilizing next-generation sequencing technology, with patients stratified into monogenic and non-monogenic groups based on the presence or absence of pathogenic mutations. Subsequently, a comparative analysis of clinical characteristics was conducted between these two cohorts of EO-IBD patients.Results:Among the 73 EO-IBD cases, 27 (37%) were diagnosed as monogenic IBD, and 46 (63%) as non-monogenic IBD. Compared to the non-monogenic group, the monogenic group had an earlier age of onset [1 (0.2, 3.0) months vs. 15 (4.1, 51.3) months, P < 0.001], with a higher incidence within the first month of life (70.4% vs. 13.0%, P < 0.001). Monogenic IBD cases were more likely to present with Crohn's disease (CD) phenotypes (88.9% vs. 52.2%, P = 0.003) and colonic involvement (L2) (91.7% vs. 62.5%, P < 0.001), but were less likely to present with non-penetrating, non-stricturing (B1) disease (87.5% vs. 95.8%, P = 0.019). Children in the monogenic group were more prone to severe malnutrition (74.1% vs. 21.3%, P < 0.001), perianal abscesses (40.7% vs. 8.7%, P < 0.001), perianal tags (22.2% vs. 0%, P = 0.004), fever (74.1% vs. 23.9%, P < 0.001), oral ulcers (44.4% vs. 6.5%, P < 0.001), and skin lesions (33.3% vs. 2.2%, P < 0.001). Regarding treatment, the monogenic group had higher usage of thalidomide (88.9% vs. 54.3%, P = 0.002) and hematopoietic stem cell transplantation (HSCT) (37.0% vs. 0, P < 0.001) and a higher mortality rate (22.2% vs. 2.2%, P = 0.017) . Conclusions:For children with IBD presenting at an early age, especially within the first month of life, and showing symptoms like fever, oral ulcers, skin lesions, severe malnutrition, and perianal disease, monogenic IBD should be considered. Genetic testing results can aid in guiding treatment decisions.

Objective:To investigate the antibiotic resistance of Helicobacter pylori (Hp) and to evaluate the eradication efficacy of individualized treatment for Hp in children. Methods:A retrospective cohort study was conducted on 227 children who visited the Department of Gastroenterology, Capital Center for Children′s Health, Capital Medical University from June 2022 to December 2023 due to gastrointestinal symptoms. All patients underwent gastroscopy and tested positive on 13C-urea breath testing. They were grouqed according to the Hp culture and drug susceptibility test. Children with positive Hp culture received personalized treatment based on the results of their drug sensitivity tests, while the other children who didn′t undergo Hp culture received empirical treatment. The effects of different treatment groups was compared by chi-square test or Fisher exact probability test. Results:A total of 227 children with Hp infection (121 males and 106 females) were included, with the age of 11.7 (8.9, 13.6) years. Among the 131 samples submitted for testing, 105 cases (80.1%) had positive results. Only 9.5% (10/105) of patients were sensitive to 6 antibiotics. The resistance rates to clarithromycin, metronidazole and levofloxacin were 90.5% (95/105), 86.7% (91/105) and 22.9% (24/105) respectively. The resistance rate to both clarithromycin and metronidazole was 77.1% (81/105). The resistance rate to both levofloxacin and metronidazole was 19.0% (20/105). The resistance rate to both levofloxacin and clarithromycin was 21.9% (23/105). The resistance rate to these three antibiotics was 16.2% (17/105). No strains resistant to furazolidone, amoxicillin or tetracycline hydrochloride were found. Eighty-nine cases were treated with bismuth quadruple therapy based on the drug sensitivity results, and the overall eradication rate was 88.8% (79/89), including 42 treatment-naive cases with a 100% eradication rate (42/42) and 47 retreatment cases with a 78.7% eradication rate (37/47). The eradication rate of empirical treatment was 75.7% (56/74). Among them, 65 patients received amoxicillin, clarithromycin and omeprazole because of negative penicillin skin tests, with a 75.4% (49/65) eradication rate; 9 patients received clarithromycin, metronidazole, omeprazole and bismuth with positive penicillin skin tests, achieving 7/9 eradication rate. The comparison of eradication rates between two treatment groups suggested a statistically significant difference ( P<0.05). No statistically significant difference was found in drug reactions such as nausea, vomiting, and rash between the two groups ( P>0.05). Conclusions:Hp strains had a relatively high dual resistance to clarithromycin and metronidazole, especially clarithromycin. For areas with a high resistance rate to clarithromycin, the bismuth quadruplet of clarithromycin removal combined with bismuth agent can be chosen as empirical treatment. In medical institutions where drug susceptibility test can be conducted, personalized treatment plans are recommended as the first-line treatment.

Objective:To compare the clinical characteristics of monogenic and non-monogenic early-onset inflammatory bowel disease (EO-IBD) in children and to explore the necessity of genetic analysis in EO-IBD research.Methods:A retrospective analysis of clinical data was conducted on 73 children diagnosed with EO-IBD at the Children's Hospital affiliated with Capital Institute of Pediatrics between January 2017 and December 2023. Genetic analysis was performed utilizing next-generation sequencing technology, with patients stratified into monogenic and non-monogenic groups based on the presence or absence of pathogenic mutations. Subsequently, a comparative analysis of clinical characteristics was conducted between these two cohorts of EO-IBD patients.Results:Among the 73 EO-IBD cases, 27 (37%) were diagnosed as monogenic IBD, and 46 (63%) as non-monogenic IBD. Compared to the non-monogenic group, the monogenic group had an earlier age of onset [1 (0.2, 3.0) months vs. 15 (4.1, 51.3) months, P < 0.001], with a higher incidence within the first month of life (70.4% vs. 13.0%, P < 0.001). Monogenic IBD cases were more likely to present with Crohn's disease (CD) phenotypes (88.9% vs. 52.2%, P = 0.003) and colonic involvement (L2) (91.7% vs. 62.5%, P < 0.001), but were less likely to present with non-penetrating, non-stricturing (B1) disease (87.5% vs. 95.8%, P = 0.019). Children in the monogenic group were more prone to severe malnutrition (74.1% vs. 21.3%, P < 0.001), perianal abscesses (40.7% vs. 8.7%, P < 0.001), perianal tags (22.2% vs. 0%, P = 0.004), fever (74.1% vs. 23.9%, P < 0.001), oral ulcers (44.4% vs. 6.5%, P < 0.001), and skin lesions (33.3% vs. 2.2%, P < 0.001). Regarding treatment, the monogenic group had higher usage of thalidomide (88.9% vs. 54.3%, P = 0.002) and hematopoietic stem cell transplantation (HSCT) (37.0% vs. 0, P < 0.001) and a higher mortality rate (22.2% vs. 2.2%, P = 0.017) . Conclusions:For children with IBD presenting at an early age, especially within the first month of life, and showing symptoms like fever, oral ulcers, skin lesions, severe malnutrition, and perianal disease, monogenic IBD should be considered. Genetic testing results can aid in guiding treatment decisions.

Objective:To investigate the antibiotic resistance of Helicobacter pylori (Hp) and to evaluate the eradication efficacy of individualized treatment for Hp in children. Methods:A retrospective cohort study was conducted on 227 children who visited the Department of Gastroenterology, Capital Center for Children′s Health, Capital Medical University from June 2022 to December 2023 due to gastrointestinal symptoms. All patients underwent gastroscopy and tested positive on 13C-urea breath testing. They were grouqed according to the Hp culture and drug susceptibility test. Children with positive Hp culture received personalized treatment based on the results of their drug sensitivity tests, while the other children who didn′t undergo Hp culture received empirical treatment. The effects of different treatment groups was compared by chi-square test or Fisher exact probability test. Results:A total of 227 children with Hp infection (121 males and 106 females) were included, with the age of 11.7 (8.9, 13.6) years. Among the 131 samples submitted for testing, 105 cases (80.1%) had positive results. Only 9.5% (10/105) of patients were sensitive to 6 antibiotics. The resistance rates to clarithromycin, metronidazole and levofloxacin were 90.5% (95/105), 86.7% (91/105) and 22.9% (24/105) respectively. The resistance rate to both clarithromycin and metronidazole was 77.1% (81/105). The resistance rate to both levofloxacin and metronidazole was 19.0% (20/105). The resistance rate to both levofloxacin and clarithromycin was 21.9% (23/105). The resistance rate to these three antibiotics was 16.2% (17/105). No strains resistant to furazolidone, amoxicillin or tetracycline hydrochloride were found. Eighty-nine cases were treated with bismuth quadruple therapy based on the drug sensitivity results, and the overall eradication rate was 88.8% (79/89), including 42 treatment-naive cases with a 100% eradication rate (42/42) and 47 retreatment cases with a 78.7% eradication rate (37/47). The eradication rate of empirical treatment was 75.7% (56/74). Among them, 65 patients received amoxicillin, clarithromycin and omeprazole because of negative penicillin skin tests, with a 75.4% (49/65) eradication rate; 9 patients received clarithromycin, metronidazole, omeprazole and bismuth with positive penicillin skin tests, achieving 7/9 eradication rate. The comparison of eradication rates between two treatment groups suggested a statistically significant difference ( P<0.05). No statistically significant difference was found in drug reactions such as nausea, vomiting, and rash between the two groups ( P>0.05). Conclusions:Hp strains had a relatively high dual resistance to clarithromycin and metronidazole, especially clarithromycin. For areas with a high resistance rate to clarithromycin, the bismuth quadruplet of clarithromycin removal combined with bismuth agent can be chosen as empirical treatment. In medical institutions where drug susceptibility test can be conducted, personalized treatment plans are recommended as the first-line treatment.