Objective To compare the effects of 20 mg qd and 10 mg bidadministration of iprrazole enteric-coated tablets on the control of gastric acid in healthy subjects.Methods A randomized,single-center,parallel controlled trial was designed to include 8 healthy subjects.Randomly divided into 2 groups,20 mg qd administration group:20 mg enteric-coated tablets of iprrazole in the morning;10 mg bid administration group:10 mg enteric-coated tablets of iprrazole in the morning and 10 mg in the evening.The pH values in the stomach of the subjects before and 24 h after administration were monitored by pH meter.The plasma concentration of iprazole after administration was determined by HPLC-MS/MS.The main pharmacokinetic parameters were calculated by Phoenix WinNonlin(V8.0)software.Results The PK parameters of iprrazole enteric-coated tablets and reference preparations in fasting group were as follows:The Cmax of 20 mg qd group and 10 mg bid group were(595.75±131.15)and(283.50±96.98)ng·mL-1;AUC0-t were(5 531.94±784.35)and(4 686.67±898.23)h·ng·mL-1;AUC0-∞ were(6 003.19±538.59)and(7 361.48±1 816.77)h·ng·mL-1,respectively.The mean time percentage of gastric pH＞3 after 20 mg qd and 10 mg bid were 82.64％and 61.92％,and the median gastric pH within 24 h were 6.25±1.49 and 3.53±2.05,respectively.The mean gastric pH values within 24 h were 5.71±1.36 and 4.23±1.45,respectively.The correlation analysis of pharmacokinetic/pharmacodynamics showed that there was no significant correlation between the peak concentration of drug in plasma and the inhibitory effect of acid.Conclusion Compared with the 20 mg qd group and the 10 mg bid group,the acid inhibition effect is better,the administration times are less,and the safety of the two administration regimes is good.

OBJECTIVE To establish the project approval evaluation system for traditional Chinese medicine （TCM） preparations in medical institutions guided by new drug conversion， to improve the success rate of approval for TCM preparations in medical institutions and lay the foundation for the later drug conversion. METHODS Research and development team used the literature research method and brainstorming method to list and organize relevant elements of project evaluation and determine the initial indicator system. Experts were consulted using the Delphi method to confirm the evaluation index. The weights were calculated based on the proportion of importance scores for each indicator and assigned specific scores to each item. The indicator system was used to evaluate 31 TCM preparations applied for filing by various departments of our hospital from April to July 2023. RESULTS After two rounds of 17 experts’ consultation， the final TCM preparation system included five primary indicators， i.e. theoretical basis， clinical research foundation， pharmaceutical foundation， prescription， and clinical value， as well as 17 secondary indicators including prescription source， traditional Chinese medicine theory， clinical positioning and so on. Human experience was considered as the item which would be rejected as one vote. Based on the above indicator system， our hospital further improved the filing and project approval process for TCM preparations in medical institutions. Among the 31 TCM preparations applied for filing by various departments from April to July 2023， 8 TCM preparations with a score ≥65 were selected for development. CONCLUSIONS The evaluation system is objective， comprehensive， and highly operable. It is suitable for the selection of TCM preparations in medical institutions before research and development.

Objective:To investigate the value of a novel technique called visual transient elastography (ViTE) and liver steatosis analysis (LiSA) in assessing liver function injury in hepatitis B virus-related hepatocellular carcinoma (HBV-related HCC) patients after ablation therapy.Methods:A total of 129 HBV-related HCC patients in Harbin Medical University Cancer Hospital from January 2022 to August 2023 were retrospectively analyzed.ViTE and LiSA examinations were applied to record the liver stiffness E value and LiSA value before ablation. An albumin-bilirubin (ALBI) score was constructed using laboratory indicators. Spearman correlation analysis was used to assess the correlation between E value, LiSA value and ALBI score, body mass index (BMI). According to the change of ALBI grade in perioperative period, the patients could be divided into two groups: liver function unchanged group and liver function injury group. Univariate and multivariate statistical methods were used to analyze related factors affecting changes in liver function after ablation, followed by establishing a predictive model.Results:Spearman analysis showed a strong positive correlation between E value and ALBI score ( rs=0.686, P<0.001), and LiSA value was weakly positively correlated with BMI ( rs=0.338, P<0.001). There were no significant correlations between E value and BMI, LiSA value and ALBI score (all P>0.05). Univariate analysis showed that differences of age, BMI, ablation parameters, E value, and LiSA value in the two groups were statistically significant (all P<0.05). Multivariate analysis showed that E value, LiSA value, and ablation time were independent predictors of hepatic dysfunction after ablation (all P<0.05). AUC was 0.892 indicating high accuracy in the predictive model based on above indicators. Conclusions:Under the real-time ultrasound guidance, a non-invasive liver function injury prediction model based on ViTE and LiSA technology can offer personalized predictions for ablative perioperative changes in liver function among HBV-related HCC patients.

Objective To evaluate the application of three deep learning algorithms in automatic segmentation of clinical target volumes (CTVs) in high-dose-rate brachytherapy after surgery for endometrial carcinoma. Methods A dataset comprising computed tomography scans from 306 post-surgery patients with endometrial carcinoma was divided into three subsets: 246 cases for training, 30 cases for validation, and 30 cases for testing. Three deep convolutional neural network models, 3D U-Net, 3D Res U-Net, and V-Net, were compared for CTV segmentation. Several commonly used quantitative metrics were employed, i.e., Dice similarity coefficient, Hausdorff distance, 95th percentile of Hausdorff distance, and Intersection over Union. Results During the testing phase, CTV segmentation with 3D U-Net, 3D Res U-Net, and V-Net showed a mean Dice similarity coefficient of 0.90 ± 0.07, 0.95 ± 0.06, and 0.95 ± 0.06, a mean Hausdorff distance of 2.51 ± 1.70, 0.96 ± 1.01, and 0.98 ± 0.95 mm, a mean 95th percentile of Hausdorff distance of 1.33 ± 1.02, 0.65 ± 0.91, and 0.40 ± 0.72 mm, and a mean Intersection over Union of 0.85 ± 0.11, 0.91 ± 0.09, and 0.92 ± 0.09, respectively. Segmentation based on V-Net was similarly to that performed by experienced radiation oncologists. The CTV segmentation time was < 3.2 s, which could save the work time of clinicians. Conclusion V-Net is better than other models in CTV segmentation as indicated by quantitative metrics and clinician assessment. Additionally, the method is highly consistent with the ground truth, reducing inter-doctor variability and treatment time.

Objective:To evaluate the diagnostic efficacy and practicality of the Jaundice color card (JCard) as a screening tool for neonatal jaundice.Methods:Following the standards for reporting of diagnostic accuracy studies (STARD) statement, a multicenter prospective study was conducted in 9 hospitals in China from October 2019 to September 2021. A total of 845 newborns who were admitted to the hospital or outpatient department for liver function testing due to their own diseases. The inclusion criteria were a gestational age of ≥35 weeks, a birth weight of ≥2 000 g, and an age of ≤28 days. The neonate′s parents used the JCard to measure jaundice at the neonate′s cheek. Within 2 hours of the JCard measurement, transcutaneous bilirubin (TcB) was measured with a JH20-1B device and total serum bilirubin (TSB) was detected. The Pearson′s correlation analysis, Bland-Altman plots and the receiver operating characteristic (ROC) curve were used for statistic analysis.Results:Out of the 854 newborns, 445 were male and 409 were female; 46 were born at 35-36 weeks of gestational age and 808 were born at ≥37 weeks of gestational age. Additionally, 432 cases were aged 0-3 days, 236 cases were aged 4-7 days, and 186 cases were aged 8-28 days. The TSB level was (227.4±89.6) μmol/L, with a range of 23.7-717.0 μmol/L. The JCard level was (221.4±77.0) μmol/L and the TcB level was (252.5±76.0) μmol/L. Both the JCard and TcB values showed good correlation ( r=0.77 and 0.80, respectively) and agreements (96.0% (820/854) and 95.2% (813/854) of samples fell within the 95% limits of agreement, respectively) with TSB. The JCard value of 12 had a sensitivity of 0.93 and specificity of 0.75 for identifying a TSB ≥205.2?μmol/L, and a sensitivity of 1.00 and specificity of 0.35 for identifying a TSB ≥342.0?μmol/L. The TcB value of 205.2?μmol/L had a sensitivity of 0.97 and specificity of 0.60 for identifying TSB levels of 205.2 μmol/L, and a sensitivity of 1.00 and specificity of 0.26 for identifying TSB levels of 342.0 μmol/L. The areas under the ROC curve (AUC) of JCard for identifying TSB levels of 153.9, 205.2, 256.5, and 342.0 μmol/L were 0.96, 0.92, 0.83, and 0.83, respectively. The AUC of TcB were 0.94, 0.91, 0.86, and 0.87, respectively. There were both no significant differences between the AUC of JCard and TcB in identifying TSB levels of 153.9 and 205.2 μmol/L (both P>0.05). However, the AUC of JCard were both lower than those of TcB in identifying TSB levels of 256.5 and 342.0 μmol/L (both P<0.05). Conclusions:JCard can be used to classify different levels of bilirubin, but its diagnostic efficacy decreases with increasing bilirubin levels. When TSB level are ≤205.2 μmol/L, its diagnostic efficacy is equivalent to that of the JH20-1B. To prevent the misdiagnosis of severe jaundice, it is recommended that parents use a low JCard score, such as 12, to identify severe hyperbilirubinemia (TSB ≥342.0 μmol/L).

Objective:To investigate clinical and laboratory characteristics of secondary hemophagocytic lymphohistiocytosis (sHLH) associated with secondary cutaneous T-cell lymphoma (CTCL) .Methods:CTCL patients with clinically suspected sHLH were collected from Department of Hematology, Wuhan No.1 Hospital from January 2016 to October 2021, and were evaluated according to the HLH-2004 diagnostic criteria and HScore.Results:Seven CTCL patients were confirmedly diagnosed with sHLH, including 2 with primary cutaneous γδT-cell lymphoma (PC-GDTCL) , 3 with cutaneous extranodal natural killer/T-cell lymphoma (C-ENKTCL) , and 2 with primary cutaneous anaplastic large cell lymphoma (PC-ALCL) . All the 7 patients received chemotherapy, but 6 died finally, and the median overall survival duration was 26.5 days (range: 14 - 60 days) after the confirmed diagnosis of CTCL complicated by sHLH. HLH-related gene mutations, which were located in the PRF1 and LYST genes, were identified in 2 patients; lymphoma-related gene mutations were identified in the KRAS and KMT2D genes in 1 PC-GDTCL patient,and in the JAK3 and SAMHD1 genes in another PC-GDTCL patient.Conclusions:CTCL complicated by sHLH usually progresses rapidly, so early diagnosis and treatment are needed. Bone marrow biopsy and mutation screening of lymphoma- and HLH-related genes at initial diagnosis and during disease progression may facilitate early diagnosis.

BACKGROUND: Rheumatoid arthritis (RA), a chronic systemic autoimmune disease, is characterized by synovitis and progressive damage to the bone and cartilage of the joints, leading to disability and reduced quality of life. This study was a randomized clinical trial comparing the outcomes between withdrawal and dose reduction of tofacitinib in patients with RA who achieved sustained disease control. METHODS: The study was designed as a multicenter, open-label, randomized controlled trial. Eligible patients who were taking tofacitinib (5 mg twice daily) and had achieved sustained RA remission or low disease activity (disease activity score in 28 joints [DAS28] ≤3.2) for at least 3 months were enrolled at six centers in Shanghai, China. Patients were randomly assigned (1:1:1) to one of three treatment groups: continuation of tofacitinib (5 mg twice daily); reduction in tofacitinib dose (5 mg daily); and withdrawal of tofacitinib. Efficacy and safety were assessed up to 6 months. RESULTS: Overall, 122 eligible patients were enrolled, with 41 in the continuation group, 42 in the dose-reduction group, and 39 in the withdrawal group. After 6 months, the percentage of patients with a DAS28-erythrocyte sedimentation rate (ESR) of <3.2 was significantly lower in the withdrawal group than that in the reduction and continuation groups (20.5%, 64.3%, and 95.1%, respectively; P  < 0.0001 for both comparisons). The average flare-free time was 5.8 months for the continuation group, 4.7 months for the dose reduction group, and 2.4 months for the withdrawal group. CONCLUSION: Withdrawal of tofacitinib in patients with RA with stable disease control resulted in a rapid and significant loss of efficacy, while standard or reduced doses of tofacitinib maintained a favorable state. TRIAL REGISTRATION Chictr.org, ChiCTR2000039799.
Humans ; Quality of Life ; China ; Arthritis, Rheumatoid/drug therapy* ; Piperidines/therapeutic use* ; Treatment Outcome ; Antirheumatic Agents/therapeutic use* ; Pyrroles/therapeutic use*

Management and treatment of terminal metastatic castration-resistant prostate cancer (mCRPC) remains heavily debated. We sought to investigate the efficacy of programmed cell death 1 (PD-1) inhibitor plus anlotinib as a potential solution for terminal mCRPC and further evaluate the association of genomic characteristics with efficacy outcomes. We conducted a retrospective real-world study of 25 mCRPC patients who received PD-1 inhibitor plus anlotinib after the progression to standard treatments. The clinical information was extracted from the electronic medical records and 22 patients had targeted circulating tumor DNA (ctDNA) next-generation sequencing. Statistical analysis showed that 6 (24.0%) patients experienced prostate-specific antigen (PSA) response and 11 (44.0%) patients experienced PSA reduction. The relationship between ctDNA findings and outcomes was also analyzed. DNA-damage repair (DDR) pathways and homologous recombination repair (HRR) pathway defects indicated a comparatively longer PSA-progression-free survival (PSA-PFS; 2.5 months vs 1.2 months, P = 0.027; 3.3 months vs 1.2 months, P = 0.017; respectively). This study introduces the PD-1 inhibitor plus anlotinib as a late-line therapeutic strategy for terminal mCRPC. PD-1 inhibitor plus anlotinib may be a new treatment choice for terminal mCRPC patients with DDR or HRR pathway defects and requires further investigation.
Male ; Humans ; Prostate-Specific Antigen ; Treatment Outcome ; Prostatic Neoplasms, Castration-Resistant/drug therapy* ; Immune Checkpoint Inhibitors/therapeutic use* ; Retrospective Studies

Objective: To observe the expansion rule of directional skin and soft tissue expander (hereinafter referred to as expander) in abdominal scar reconstruction. Methods: A prospective self-controlled study was conducted. Twenty patients with abdominal scar who met the inclusion criteria and admitted to Zhengzhou First People's Hospital from January 2018 to December 2020 were selected by random number table method, including 5 males and 15 females, aged 12-51 (31±12) years, with 12 patients of type Ⅰ scar and 8 patients of type Ⅱ scar. In the first stage, two or three expanders with rated capacity of 300-600 mL were placed on both sides of the scar, of which at least one expander had rated capacity of 500 mL (as the follow-up observation object). After the sutures were removed, water injection treatment was started, with the expansion time of 4 to 6 months. After the water injection volume reached 2.0 times of the rated capacity of expander, abdominal scar excision+expander removal+local expanded flap transfer repair was performed in the second stage. The skin surface area at the expansion site was measured respectively when the water injection volume reached 1.0, 1.2, 1.5, 1.8, and 2.0 times of the rated capacity of expander, and the skin expansion rate of the expansion site at corresponding multiples of expansion (1.0, 1.2, 1.5, 1.8, and 2.0 times) and adjacent multiple intervals (1.0-1.2, 1.2-1.5, 1.5-1.8, and 1.8-2.0 times) were calculated. The skin surface area of the repaired site at 0 (immediately), 1, 2, 3, 4, 5, and 6 months after operation, and the skin shrinkage rate of the repaired site at different time points (1, 2, 3, 4, 5, and 6 months after operation) and different time periods (0-1, 1-2, 2-3, 3-4, 4-5, and 5-6 months after operation) were calculated. Data were statistically analyzed with analysis of variance for repeated measurement and least significant difference-t test. Results: Compared with the expansion of 1.0 time ((287.6±2.2) cm² and (47.0±0.7)%), the skin surface area and expansion rate of the expansion site of patients ((315.8±2.1), (356.1±2.8), (384.9±1.6), and (386.2±1.5) cm², (51.7±0.6)%, (57.2±0.6)%, (60.4±0.6)%, and (60.5±0.6)%) were significantly increased when the expansion reached 1.2, 1.5, 1.8, and 2.0 times (with t values of 46.04, 90.38, 150.14, 159.55, 45.11, 87.83, 135.82, and 118.48, respectively, P<0.05). Compared with the expansion of 1.2 times, the skin surface area and expansion rate of the expansion site of patients were significantly increased when the expansion reached 1.5, 1.8, and 2.0 times (with t values of 49.82, 109.64, 122.14, 144.19, 49.51, and 105.85, respectively, P<0.05). Compared with the expansion of 1.5 times, the skin surface area and expansion rate of the expansion site of patients were significantly increased when the expansion reached 1.8 times (with t values of 38.93 and 39.22, respectively, P<0.05) and 2.0 times (with t values of 38.37 and 38.78, respectively, P<0.05). Compared with the expansion of 1.8 times, the skin surface area and expansion rate of the expansion site of patients both had no statistically significant differences when the expansion reached 2.0 times (with t values of 4.71 and 4.72, respectively, P>0.05). Compared with the expansion of 1.0-1.2 times, the skin expansion rate of the expansion site of patient was significantly increased when the expansion reached 1.2-1.5 times (t=6.95, P<0.05), while the skin expansion rate of the expansion site of patient was significantly decreased when the expansion reached 1.5-1.8 and 1.8-2.0 times (with t values of 5.89 and 40.75, respectively, P<0.05). Compared with the expansion of 1.2-1.5 times, the skin expansion rate of the expansion site of patient was significantly decreased when the expansion reached 1.5-1.8 and 1.8-2.0 times (with t values of 10.50 and 41.92, respectively, P<0.05). Compared with the expansion of 1.5-1.8 times, the skin expansion rate of the expansion site of patient was significantly decreased when the expansion reached 1.8-2.0 times (t=32.60, P<0.05). Compared with 0 month after operation, the skin surface area of the repaired site of patient at 1, 2, 3, 4, 5, and 6 months after operation was significantly decreased (with t values of 61.66, 82.70, 96.44, 102.81, 104.51, and 102.21, respectively, P<0.05). Compared with 1 month after operation, the skin surface area of the repaired site of patient was significantly decreased at 2, 3, 4, 5, and 6 months after operation (with t values of 37.37, 64.64, 69.40, 72.46, and 72.62, respectively, P<0.05), while the skin shrinkage rate was significantly increased (with t values of 32.29, 50.00, 52.67, 54.76, and 54.62, respectively, P<0.05). Compared with 2 months after operation, the skin surface area of the repaired site of patient was significantly decreased at 3, 4, 5, and 6 months after operation (with t values of 52.41, 60.41, 70.30, and 65.32, respectively, P<0.05), while the skin shrinkage rate was significantly increased (with t values of 52.97, 59.29, 69.68, and 64.50, respectively, P<0.05). Compared with 3 months after operation, the skin surface area of the repaired site of patient was significantly decreased at 4, 5, and 6 months after operation (with t values of 5.53, 38.00, and 38.52, respectively, P<0.05), while the skin shrinkage rate was significantly increased (with t values of 25.36, 38.59, and 37.47, respectively, P<0.05). Compared with 4 months after operation, the skin surface area (with t values of 41.10 and 50.50, respectively, P>0.05) and skin shrinkage rate (with t values of 48.09 and 50.00, respectively, P>0.05) of the repaired site of patients at 5 and 6 months after operation showed no statistically significant differences. Compared with 5 months after operation, the skin surface area and skin shrinkage rate of the repaired site of patient at 6 months after operation showed no statistically significant differences (with t values of 9.40 and 9.59, respectively, P>0.05). Compared with 0-1 month after operation, the skin shrinkage rate of the repaired site of patient at 1-2, 2-3, 3-4, 4-5, and 5-6 months after operation was significantly decreased (with t values of 13.56, 40.00, 49.21, 53.97, and 57.68, respectively, P<0.05). Compared with 1-2 months after operation, the skin shrinkage rate of the repaired site of patients at 2-3, 3-4, 4-5, and 5-6 months after operation was significantly decreased (with t values of 12.37, 27.72, 30.16, and 31.67, respectively, P<0.05). Compared with 2-3 months after operation, the skin shrinkage rate of the repaired site of patients at 3-4, 4-5, and 5-6 months after operation was significantly decreased (with t values of 33.73, 41.31, and 54.10, respectively, P<0.05). Compared with 3-4 months after operation, the skin shrinkage rate of the repaired site of patient at 4-5 and 5-6 months after operation showed no statistically significant differences (with t values of 10.90 and 23.60, respectively, P>0.05). Compared with 4-5 months after operation, the skin shrinkage rate of the repaired site of patient at 5-6 months after operation showed no statistically significant difference (t=20.90, P>0.05). Conclusions: The expander can effectively expand the abdominal skin, thus repairing the abdominal scar deformity. Maintained expansion for one month after the water injection expansion reaches 1.8 times of the rated capacity of the expander can be set as a phase Ⅱ operation node.
Female ; Male ; Humans ; Cicatrix/surgery* ; Prospective Studies ; Tissue Expansion Devices ; Skin ; Abdominal Wall

OBJECTIVE: To explore the genotyping characteristics of human fecal Escherichia coli( E. coli) and the relationships between antibiotic resistance genes (ARGs) and multidrug resistance (MDR) of E. coli in Miyun District, Beijing, an area with high incidence of infectious diarrheal cases but no related data. METHODS: Over a period of 3 years, 94 E. coli strains were isolated from fecal samples collected from Miyun District Hospital, a surveillance hospital of the National Pathogen Identification Network. The antibiotic susceptibility of the isolates was determined by the broth microdilution method. ARGs, multilocus sequence typing (MLST), and polymorphism trees were analyzed using whole-genome sequencing data (WGS). RESULTS: This study revealed that 68.09% of the isolates had MDR, prevalent and distributed in different clades, with a relatively high rate and low pathogenicity. There was no difference in MDR between the diarrheal (49/70) and healthy groups (15/24). CONCLUSION We developed a random forest (RF) prediction model of TEM.1 + baeR + mphA + mphB + QnrS1 + AAC.3-IId to identify MDR status, highlighting its potential for early resistance identification. The causes of MDR are likely mobile units transmitting the ARGs. In the future, we will continue to strengthen the monitoring of ARGs and MDR, and increase the number of strains to further verify the accuracy of the MDR markers.
Humans ; Escherichia coli/genetics* ; Escherichia coli Infections/epidemiology* ; Multilocus Sequence Typing ; Genotype ; Beijing ; Drug Resistance, Multiple, Bacterial/genetics* ; Anti-Bacterial Agents/pharmacology* ; Diarrhea ; Microbial Sensitivity Tests