Objective:To systematically analyze the registration status of clinical trials related to inflammatory bowel disease (IBD) in China Clinical Trial Registry (ChiCTR); To focus on the characteristics and shortcomings of TCM research; To provide data support and theoretical basis for optimizing clinical trial design and improving the quality of TCM research.Methods:The IBD-related clinical trials registered by ChiCTR from the establishment of the database to September 18, 2024 were retrieved. SPSS 26.0 software was used to analyze the frequency of research objects, registration time, registration area and institution, source of funds, research type and design scheme, random method and blind method, trial staging and research center, sample size, intervention measures and outcome indicators.Results:There were 317 clinical trials of IBD. Shanghai, Jiangsu, Beijing, Guangdong and Zhejiang accounted for 72.87% of the total number of registrations. Most of the registered projects were intervention studies (51.42%), 48 studies used blind method, and randomized controlled study was the main research design type. In the 68 clinical trials related to TCM, the intervention measures were divided into 4 categories, of which Chinese materia medica was the most (42 items); the sample size was the most in the intervention study, with a total of 6 787 cases; the total frequency of outcome indicators was 1 866 times, and the quality of life and mental health were the most (147 items).Conclusions:The number of registered IBD clinical trials is generally increasing, but there may be problems such as uneven distribution of regions and institutions, poor design of sample size, blind method and other research, and non-standard filling of registration information. In the research of TCM treatment of IBD, it is suggested to further strengthen the depth and breadth, especially the characteristic therapy of TCM.

Objective:To evaluate the efficacy of Qinggan Huashi Huoxue Decoction combined with conventional Western medicine in the treatment of alcoholic cirrhosis with spleen deficiency and phlegm stasis syndrome.Methods:Randomized controlled trial. A total of 110 patients from Tangshan Fengrun District Hospital of Traditional Chinese Medicine from March 2020 to March 2022 were selected as observation objects and divided into 2 groups with 55 patients in each group by computer random drawing method. The control group was treated with conventional Western medicine, while the observation group was treated with Qinggan Huashi Huoxue Decoction on the basis of the control group treatment. Both groups were treated for 3 months. The traditional Chinese medicine syndrome score was performed before and after treatment, and the levels of proline peptidase (PLD), type Ⅳ collagen (Ⅳ-C) and type Ⅰ procollagen aminopeptidase (PINP) were detected by phthalaldehyde contrast colorimetry, and the levels of pentamylin 3 (PTX3), protein kinase B (Akt) and B cell activating factor receptor (BAFF-R) were determined by ELISA. Adverse events were recorded and clinical efficacy was evaluated.Results:The total effective rate in the observation group was 92.73% (51/55), while that in the control group was 76.36% (42/55), the difference between the two groups was statistically significant ( χ2=5.64, P=0.018). After treatment, the score and total score of costal pain and fullness, swelling and firmness, anorexia, white and greasy tongue coating in the observation group were significantly lower than those in the control group ( t values were 11.02, 7.36, 7.47, 6.38, 9.37, respectively, P<0.01). After treatment, the levels of serum PLD[(143.28±16.38)U/L vs. (160.69±18.35)U/L, t=5.25], Ⅳ-C[(71.93±8.33)μg/L vs. (83.12±9.91)μg/L, t=6.41], and PINP[(32.36±5.32)ng/L vs. (39.02±5.61)ng/L, t=6.39] in the observation group were significantly lower than those in the control group ( P<0.01); The levels of PTX3[(36.82±4.96)ng/L vs. (42.14±5.83)ng/L, t=5.15], Akt[(69.22±7.94)ng/L vs. (77.24±8.63)ng/L, t=5.07], and BAFF-R[(15.29±3.64)ng/L vs. (19.92±4.15)ng/L, t=6.22] in the observation group were significantly lower than those in the control group ( P<0.01). During the treatment period, the incidence of adverse reactions was 12.73% (7/55) in the observation group and 9.09% (5/55) in the control group, with no statistically significant difference between the two groups ( χ2=0.37, P=0.541). Conclusion:Qinggan Huashi Huoxue Decoction combined with conventional Western medicine therapy can improve the Traditional Chinese Medicine syndrome and the degree of liver fibrosis damage in patients with alcoholic cirrhosis with spleen deficiency and phlegm stasis syndrome, inhibit the expression of serum inflammatory factors, and improve clinical efficacy.

OBJECTIVETo explore the feasibility and clinical significance of the detection of serum neutrophil gelatinase-associated lipocalin (NGAL) in human colorectal cancer.

METHODSLevels of NGAL in serum samples from 133 healthy people, 125 colorectal polyps patients and 100 colorectal cancer patients respectively were determined by sandwich ELISA assay. Relationship of NGAL level with clinicopathological features of colorectal cancer patients was analyzed. The optimal cut-off value of serum NGAL for diagnosing colorectal cancer was determined by ROC curve and compared with CEA and CA19-9. Univariate and multivariate analyses were performed to examine the relationship of NGAL level with the prognosis of patients with colorectal cancer.

RESULTSThe median serum NGAL protein level in 100 colorectal cancer cases was 67.96 (53.30-79.86) μg/L, significantly higher than that in healthy people and colorectal polyps patients. The differences were statistically significant (all P<0.01). Serum NGAL protein level was significantly associated with tumor diameter, TNM stage, lymph node metastasis and vascular involvement (P<0.05). The optimal cut-off point of serum NGAL protein level for diagnosing colorectal cancer was 49.78 μg/L, and the sensitivity and specificity were 88% and 81% respectively. As for colorectal cancer patients with stage I, the sensitivity of serum NGAL (78.9%) was significantly higher as compared to CA19-9 (31.6%) and CEA (36.8%); as for those with stage II, the sensitivity of serum NGAL(88.0%) was also significantly higher compared to CA19-9 (48.0%) and CEA (52.0%). Kaplan-Meier analysis showed that patients with positive NGAL (≥49.78 μg/L) had worse survival than those with negative NGAL (P=0.002). Multivariate analysis showed that NGAL was an independent prognostic factor (HR=2.060, 95%CI:1.023-4.150, P=0.043).

CONCLUSIONSNGAL can be served as the novel malignant biological phenotype marker for human colorectal cancer and can be used for the risk stratification. NGAL may be an independent prognostic factor in colorectal cancer.

Acute-Phase Proteins ; Adult ; Aged ; Aged, 80 and over ; Biomarkers, Tumor ; blood ; Case-Control Studies ; Colorectal Neoplasms ; blood ; diagnosis ; Early Detection of Cancer ; Female ; Humans ; Lipocalin-2 ; Lipocalins ; blood ; Male ; Middle Aged ; Prognosis ; Proto-Oncogene Proteins ; blood

Objective To explore the feasibility and clinical significance of the detection of serum neutrophil gelatinase-associated lipocalin (NGAL) in human colorectal cancer. Methods Levels of NGAL in serum samples from 133 healthy people, 125 colorectal polyps patients and 100 colorectal cancer patients respectively were determined by sandwich ELISA assay. Relationship of NGAL level with clinicopathological features of colorectal cancer patients was analyzed. The optimal cut-off value of serum NGAL for diagnosing colorectal cancer was determined by ROC curve and compared with CEA and CA19-9. Univariate and multivariate analyses were performed to examine the relationship of NGAL level with the prognosis of patients with colorectal cancer. Results The median serum NGAL protein level in 100 colorectal cancer cases was 67 . 96 ( 53 . 30-79 . 86 ) μg/L , significantly higher than that in healthy people and colorectal polyps patients. The differences were statistically significant (all P<0.01). Serum NGAL protein level was significantly associated with tumor diameter, TNM stage, lymph node metastasis and vascular involvement (P<0.05). The optimal cut-off point of serum NGAL protein level for diagnosing colorectal cancer was 49.78 μg/L, and the sensitivity and specificity were 88%and 81%respectively. As for colorectal cancer patients with stage Ⅰ, the sensitivity of serum NGAL (78.9%) was significantly higher as compared to CA19-9 (31.6%) and CEA (36.8%);as for those with stage Ⅱ, the sensitivity of serum NGAL (88.0%) was also significantly higher compared to CA19-9 (48.0%) and CEA (52.0%). Kaplan-Meier analysis showed that patients with positive NGAL (≥49.78 μg/L) had worse survival than those with negative NGAL (P=0.002). Multivariate analysis showed that NGAL was an independent prognostic factor (HR=2.060, 95%CI:1.023-4.150, P=0.043). Conclusions NGAL can be served as the novel malignant biological phenotype marker for human colorectal cancer and can be used for the risk stratification. NGAL may be an independent prognostic factor in colorectal cancer.

Objective To explore the feasibility and clinical significance of the detection of serum neutrophil gelatinase-associated lipocalin (NGAL) in human colorectal cancer. Methods Levels of NGAL in serum samples from 133 healthy people, 125 colorectal polyps patients and 100 colorectal cancer patients respectively were determined by sandwich ELISA assay. Relationship of NGAL level with clinicopathological features of colorectal cancer patients was analyzed. The optimal cut-off value of serum NGAL for diagnosing colorectal cancer was determined by ROC curve and compared with CEA and CA19-9. Univariate and multivariate analyses were performed to examine the relationship of NGAL level with the prognosis of patients with colorectal cancer. Results The median serum NGAL protein level in 100 colorectal cancer cases was 67 . 96 ( 53 . 30-79 . 86 ) μg/L , significantly higher than that in healthy people and colorectal polyps patients. The differences were statistically significant (all P<0.01). Serum NGAL protein level was significantly associated with tumor diameter, TNM stage, lymph node metastasis and vascular involvement (P<0.05). The optimal cut-off point of serum NGAL protein level for diagnosing colorectal cancer was 49.78 μg/L, and the sensitivity and specificity were 88%and 81%respectively. As for colorectal cancer patients with stage Ⅰ, the sensitivity of serum NGAL (78.9%) was significantly higher as compared to CA19-9 (31.6%) and CEA (36.8%);as for those with stage Ⅱ, the sensitivity of serum NGAL (88.0%) was also significantly higher compared to CA19-9 (48.0%) and CEA (52.0%). Kaplan-Meier analysis showed that patients with positive NGAL (≥49.78 μg/L) had worse survival than those with negative NGAL (P=0.002). Multivariate analysis showed that NGAL was an independent prognostic factor (HR=2.060, 95%CI:1.023-4.150, P=0.043). Conclusions NGAL can be served as the novel malignant biological phenotype marker for human colorectal cancer and can be used for the risk stratification. NGAL may be an independent prognostic factor in colorectal cancer.

The fungus Trichophyton schoenleinii (T. schoenleinii) is the causative agent of Trichophytosis and Tinea favosa of the scalp in certain regions of Eurasia and Africa. Human innate immune system plays an important role in combating with various pathogens including fungi. The inflammasome is one of the most critical arms of host innate immunity, which is a protein complex controlling maturation of IL-1β. To clarify whether T. schoenleinii is able to activate the inflammasome, we analyzed human monocytic cell line THP-1 for IL-1β production upon infection with T. schoenleinii strain isolated from Tinea favosa patients, and rapid IL-1β secretion from THP-1 cells was observed. Moreover, applying competitive inhibitors and gene specific silencing with shRNA, we found that T. schoenleinii induced IL-1β secretion, ASC pyroptosome formation as well as caspase-1 activation were all dependent on NLRP3. Cathepsin B activity, ROS production and K⁺ efflux were required for the inflammasome activation by T. schoenleinii. Our data thus reveal that the NLRP3 inflammasome plays an important role in host defense against T. schoenleinii, and suggest that manipulating NLRP3 signaling can be a novel approach for control of diseases caused by T. schoenleinii infection.
Animals ; Bone Marrow Cells ; cytology ; Carrier Proteins ; metabolism ; Caspase 1 ; metabolism ; Cell Line ; Dendritic Cells ; cytology ; metabolism ; microbiology ; Enzyme Activation ; Hot Temperature ; Humans ; Inflammasomes ; metabolism ; Interleukin-1beta ; biosynthesis ; metabolism ; Lysosomes ; metabolism ; Mice ; Monocytes ; cytology ; metabolism ; microbiology ; NLR Family, Pyrin Domain-Containing 3 Protein ; Potassium ; metabolism ; Reactive Oxygen Species ; metabolism ; Signal Transduction ; Trichophyton ; physiology