To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

This study aimed to comprehensively examine the association of gallstones, cholecystectomy, and cancer risk. Multivariable logistic regressions were performed to estimate the observational associations of gallstones and cholecystectomy with cancer risk, using data from a nationwide cohort involving 239 799 participants. General and gender-specific two-sample Mendelian randomization (MR) analysis was further conducted to assess the causalities of the observed associations. Observationally, a history of gallstones without cholecystectomy was associated with a high risk of stomach cancer (adjusted odds ratio (aOR)=2.54, 95% confidence interval (CI) 1.50-4.28), liver and bile duct cancer (aOR=2.46, 95% CI 1.17-5.16), kidney cancer (aOR=2.04, 95% CI 1.05-3.94), and bladder cancer (aOR=2.23, 95% CI 1.01-5.13) in the general population, as well as cervical cancer (aOR=1.69, 95% CI 1.12-2.56) in women. Moreover, cholecystectomy was associated with high odds of stomach cancer (aOR=2.41, 95% CI 1.29-4.49), colorectal cancer (aOR=1.83, 95% CI 1.18-2.85), and cancer of liver and bile duct (aOR=2.58, 95% CI 1.11-6.02). MR analysis only supported the causal effect of gallstones on stomach, liver and bile duct, kidney, and bladder cancer. This study added evidence to the causal effect of gallstones on stomach, liver and bile duct, kidney, and bladder cancer, highlighting the importance of cancer screening in individuals with gallstones.
Humans ; Mendelian Randomization Analysis ; Gallstones/complications* ; Female ; Male ; Cholecystectomy/statistics & numerical data* ; Middle Aged ; Risk Factors ; Aged ; Adult ; Neoplasms/etiology* ; Stomach Neoplasms/epidemiology*

Crigler-Najjar syndrome (CNS) and Gilbert syndrome (GS; OMIM: 143500) are rare autosomal recessive diseases that cause unconjugated hyperbilirubinemia due to decreased UGT1A1 enzyme activity. Crigler-Najjar syndrome type 2 (CNS2; OMIM: 606785) increases the risk of gallbladder stone formation and cholecystitis, while GS seldom causes health issues. We found a 28-year-old male patient with recurring right upper abdomen pain who experienced persistent jaundice from birth. CNS2 with gallbladder stones and cholecystitis was diagnosed after genetic testing revealed rare double homozygous mutations A(TA)₇TAA (rs3064744) and P229Q (rs35350960) in the UGT1A1 gene. After pedigree investigation, we found that the patient's parents with modestly increased bilirubin had compound heterozygous mutations A(TA)₇TAA and P229Q, which were GS. Bioinformatics analysis showed that A(TA)₇TAA is in the TATA-box region of the gene UGT1A1 promoter, affecting gene transcriptional initiation, whereas P229Q modifies protein three-dimensional structure and may be harmful. In this pedigree, double homozygous mutations have a more severe phenotype than compound heterozygous mutations. Inherited causes of hyperbilirubinemia should be suspected after ruling out biliary obstruction, and early bilirubin reduction (< 103 µmol/L (6 mg/dL)) may reduce the risk of complications like cholecystitis in CNS2 patients, though further studies with longer follow-up are needed to confirm this observation.
Humans ; Male ; Glucuronosyltransferase/genetics* ; Adult ; Crigler-Najjar Syndrome/complications* ; Cholecystitis/etiology* ; Homozygote ; Mutation ; Pedigree

Objective:To explore the impact of endoscopic retrograde cholangiopancreatography (ERCP) combined with electrohydraulic lithotripsy on liver function and energy metabolism in patients with extrahepatic biliary stones.Methods:A prospective study was conducted on 85 patients with extrahepatic biliary stones treated in four tertiary grade A hospitals (the First Affiliated Hospital of Air Force Medical University, Baoji Central Hospital, Xi′an No. 1 Hospital Wenli Hospital, and Affiliated Hospital of North China University of Science and Technology) from January 2020 to January 2024. They were divided into a control group ( n=43, treated with ERCP) and a combined group ( n=42, treated with ERCP combined with electrohydraulic lithotripsy) using a random number table. The main evaluation indicators included liver function, energy metabolism parameters, stress levels, and postoperative complications. Results:There were no statistically significant differences in liver function indicators, energy metabolism parameters, or stress levels between the two groups before surgery (all P>0.05). At 3 days after surgery, liver function indicators in both groups were lower than those before surgery, and the liver function indicators in the combined group were all lower than those in the control group (all P<0.05). At 1 day after surgery, REE in both groups was higher than that before surgery, and RQ was lower than that before surgery; the REE in the combined group was lower than that in the control group, and the RQ in the combined group was higher than that in the control group (all P<0.05). At 3 days after surgery, the levels of Cor and ACTH in both groups were higher than those before surgery, and the Cor and ACTH in the combined group were lower than those in the control group (all P<0.05). The incidence of postoperative complications in the combined group was significantly lower than that in the control group ( P<0.05). Conclusions:ERCP combined with electrohydraulic lithotripsy can effectively improve liver function and energy metabolism, reduce inflammatory response in patients with extrahepatic biliary stones, and is safe for treatment, which is suitable for clinical promotion and application.

To analyze the standard establishment approach and compilation rationale for metallic pharmaceutical packaging standard development in the 2025 edition of the Pharmacopeia of the People's Republic of China.This article systematically explained the background and process of establishing the guiding principles for metallic materials and containers used in pharmaceutical packaging in the Chinese Pharmacopoeia through basic information,relevant domestic and international standards,the establishment of key quality attributes of metallic pharmaceutical packaging materials,and the construction of metallic pharmaceutical packaging material standards.The newly established guidelines,the Pharmacopeia of the People's Republic of China 9625,prioritized product critical quality attributes(CQAs)and real-world applicability.This dual emphasis on rigidity and adaptability enhances drug safety,meets the regulatory requirements,and promotes the globalization and scientific advancement of China's pharmaceutical packaging industry.

Objective:To explore the impact of endoscopic retrograde cholangiopancreatography (ERCP) combined with electrohydraulic lithotripsy on liver function and energy metabolism in patients with extrahepatic biliary stones.Methods:A prospective study was conducted on 85 patients with extrahepatic biliary stones treated in four tertiary grade A hospitals (the First Affiliated Hospital of Air Force Medical University, Baoji Central Hospital, Xi′an No. 1 Hospital Wenli Hospital, and Affiliated Hospital of North China University of Science and Technology) from January 2020 to January 2024. They were divided into a control group ( n=43, treated with ERCP) and a combined group ( n=42, treated with ERCP combined with electrohydraulic lithotripsy) using a random number table. The main evaluation indicators included liver function, energy metabolism parameters, stress levels, and postoperative complications. Results:There were no statistically significant differences in liver function indicators, energy metabolism parameters, or stress levels between the two groups before surgery (all P>0.05). At 3 days after surgery, liver function indicators in both groups were lower than those before surgery, and the liver function indicators in the combined group were all lower than those in the control group (all P<0.05). At 1 day after surgery, REE in both groups was higher than that before surgery, and RQ was lower than that before surgery; the REE in the combined group was lower than that in the control group, and the RQ in the combined group was higher than that in the control group (all P<0.05). At 3 days after surgery, the levels of Cor and ACTH in both groups were higher than those before surgery, and the Cor and ACTH in the combined group were lower than those in the control group (all P<0.05). The incidence of postoperative complications in the combined group was significantly lower than that in the control group ( P<0.05). Conclusions:ERCP combined with electrohydraulic lithotripsy can effectively improve liver function and energy metabolism, reduce inflammatory response in patients with extrahepatic biliary stones, and is safe for treatment, which is suitable for clinical promotion and application.

ObjectiveTo realize the automatic recognition of the slicing angles of Fritillariae Thunbergii Bulbus （FTB） based on the improved YOLOv7-tiny algorithm. MethodFirstly， a diverse dataset of FTB images， totaling 16 000 pictures， with various angles was constructed. Furthermore， improvements were made to YOLOv7-tiny by replacing standard convolutions with ghost convolution （GhostConv）， incorporating the coordinate attention （CA） mechanism as a preferred addition， substituting some activation functions with HardSwish function for decreasing the floating point operations. Additionally， a penalty term for angle recognition error was integrated into the loss function， and modifications were made to the non-maximum suppression （NMS） strategy to address cases where multiple detection results were associated with the same target. In order to verify the effectiveness of different improvement points on the optimization of the algorithm model， ablation experiments were carried out on all the improvement points， and the effectiveness of the improvement points was proved by comparing the prediction results before and after the addition of a certain improvement point on the basis of the original model or the model with the addition of an improvement point that has been verified to be effective， in order to evaluate the improvement of the indexes. ResultThe number of parameters required for the improved slicing angle recognition algorithm of FTB was about 55.4% of the original algorithm， and the amount of computation was about 59.4% of the original algorithm. The mAP@0.5［mean average precision at an intersection over union（IoU） of 0.5］ increased by 12.2%， the mean absolute error（MAE） of the recognized angle was 5.02°， representing a reduction of 4.58° compared to the original algorithm. In the experimental environment of this paper， the average recognition time per image was as low as 8.7 ms， significantly faster than the average human reaction time. ConclusionThis study， by utilizing the improved YOLOv7-tiny algorithm， achieves effective slicing angle recognition of FTB with high accuracy and more lightweight， which provides a novel approach for stable and precise automated slicing of FTB， thereby providing valuable insights into the automation of processing other traditional Chinese medicines.

The paper summarizes the imaging evaluation methods for assessing the degree of carotid artery stenosis and analyzes the unique advantages and limitations of various imaging techniques in vascular imaging based on existing guidelines and consensus.The paper focuses on reviewing the clinical applications of several novel ultrasound technologies,including the use of advanced hemodynamic parameters such as blood flow dispersion(Tur index)and wall shear stress(WSS).Carotid artery stenosis is closely associated with cardiovascular disease.Although non-invasive and radiation-free ultrasound technology has certain limitations in diagnostic accuracy to a certain extent,with the continuous emergence of advanced functions such as ultrasound hemodynamics and vascular elasticity,the combination of multi-modality and multi-parameter ultrasound is expected to become an important method for efficient diagnosis of arterial stenosis in the future.

Objective:This study aims to explore the temporal trend of Low Anterior Resection Syndrome (LARS) and its symptoms after laparoscopic anterior resection for rectal cancer.Methods:A retrospective cohort study design was employed. The study included primary rectal (adenocarcinoma) cancer patients who underwent laparoscopic anterior resection at Tongji Hospital, Huazhong University of Science and Technology, between January 1, 2010, and December 31, 2020. Complete medical records and follow-up data at 3, 6, 9, 12, and 18 months postoperatively were available for all patients. A total of 1454 patients were included, of whom 1094 (75.2%) were aged ≤65 years, and 597 (41.1%) were females. Among them, 1040 cases (71.5%) had an anastomosis-to-anus distance of 0-5cm, and 86 cases (5.9%) received neoadjuvant treatment. All patients completed the Chinese version of the LARS questionnaire and their LARS occurrence and specific symptom information were recorded at 3, 6, 9, 12, and 18 months postoperatively. Considering past literature and clinical experience, further subgroup analyses were performed to explore the potential impact factors on severe LARS, including anastomosis level, preoperative neoadjuvant therapy, postoperative adjuvant therapy, and the presence of preventive stoma.Results:The occurrence rates of LARS at 3, 6, 9, 12, and 18 months postoperatively were 78.5% (1142/1454), 71.4% (1038/1454), 55.0% (799/1454), 45.7% (664/1454), and 45.7% (664/1454), respectively (χ 2=546.180 , P<0.001). No statistically significant difference was observed between the 12-month and 18-month time points ( P>0.05). When compared with the symptoms at 3 months, the occurrence rates of gas incontinence [1.7% (24/1454) vs. 33.9% (493/1454)], liquid stool incontinence [3.9% (56/1454) vs. 41.9% (609/1454)], increased stool frequency [79.6% (1158/1454) vs. 95.9% (1395/1454)], stool clustering [74.3% (1081/1454) vs. 92.9% (1351/1454)], and stool urgency [46.5% (676/1454) vs. 78.7% (1144/1454)] in the LARS symptom spectrum were significantly alleviated at 12 months (all P<0.05) and remained stable beyond 12 months (all P>0.05). With the extension of postoperative time, the incidence rates of severe LARS exhibited a decreasing trend in different subgroups, of anastomosis level, preoperative neoadjuvant therapy, postoperative adjuvant therapy, and the presence of preventive stoma, and reached stability at 12 months postoperatively (all P>0.05). Conclusion:LARS and its specific symptom profile showed a trend of gradual improvement over time up to 1 year postoperatively, and stabilized after more than 1 year. Increased stool frequency and stool clustering are the most common features of abnormal bowel dys function, which improve slowly after surgery.

Objective:This study aims to explore the temporal trend of Low Anterior Resection Syndrome (LARS) and its symptoms after laparoscopic anterior resection for rectal cancer.Methods:A retrospective cohort study design was employed. The study included primary rectal (adenocarcinoma) cancer patients who underwent laparoscopic anterior resection at Tongji Hospital, Huazhong University of Science and Technology, between January 1, 2010, and December 31, 2020. Complete medical records and follow-up data at 3, 6, 9, 12, and 18 months postoperatively were available for all patients. A total of 1454 patients were included, of whom 1094 (75.2%) were aged ≤65 years, and 597 (41.1%) were females. Among them, 1040 cases (71.5%) had an anastomosis-to-anus distance of 0-5cm, and 86 cases (5.9%) received neoadjuvant treatment. All patients completed the Chinese version of the LARS questionnaire and their LARS occurrence and specific symptom information were recorded at 3, 6, 9, 12, and 18 months postoperatively. Considering past literature and clinical experience, further subgroup analyses were performed to explore the potential impact factors on severe LARS, including anastomosis level, preoperative neoadjuvant therapy, postoperative adjuvant therapy, and the presence of preventive stoma.Results:The occurrence rates of LARS at 3, 6, 9, 12, and 18 months postoperatively were 78.5% (1142/1454), 71.4% (1038/1454), 55.0% (799/1454), 45.7% (664/1454), and 45.7% (664/1454), respectively (χ 2=546.180 , P<0.001). No statistically significant difference was observed between the 12-month and 18-month time points ( P>0.05). When compared with the symptoms at 3 months, the occurrence rates of gas incontinence [1.7% (24/1454) vs. 33.9% (493/1454)], liquid stool incontinence [3.9% (56/1454) vs. 41.9% (609/1454)], increased stool frequency [79.6% (1158/1454) vs. 95.9% (1395/1454)], stool clustering [74.3% (1081/1454) vs. 92.9% (1351/1454)], and stool urgency [46.5% (676/1454) vs. 78.7% (1144/1454)] in the LARS symptom spectrum were significantly alleviated at 12 months (all P<0.05) and remained stable beyond 12 months (all P>0.05). With the extension of postoperative time, the incidence rates of severe LARS exhibited a decreasing trend in different subgroups, of anastomosis level, preoperative neoadjuvant therapy, postoperative adjuvant therapy, and the presence of preventive stoma, and reached stability at 12 months postoperatively (all P>0.05). Conclusion:LARS and its specific symptom profile showed a trend of gradual improvement over time up to 1 year postoperatively, and stabilized after more than 1 year. Increased stool frequency and stool clustering are the most common features of abnormal bowel dys function, which improve slowly after surgery.