Objective To improve and refine the relevant regulations and guiding principles of warnings on drug instructions and labels in China.Methods This paper sorted out the drug instructions of small molecule anti-tumor drugs listed by the U.S.Food and Drug Administration(FDA)from 2005 to 2022,included the drugs mentioned in the QT interval prolongation risk,analyzed the clinical research and QT research results,and sorted out the identification and warning rules of the instructions.Results A total of 35 drugs were included,4 drugs wrote the risk of QT interval prolongation in the black box warning,21 drugs were wrote in the warning and precautions position,6 drugs were wrote in the adverse reaction section,and 2 drugs were only described under clinical pharmacology section.According to the severity of the QT interval prolongation caused by the drug and whether there were serious clinical consequences,they were displayed in the warnings(black box warnings),precautions(warnings and precautions)and adverse reactions in the instructions.Conclusion The aim of this article is to provide a reference for the writing of QT risk warning information of the instructions of domestic drug production enterprises and regulatory departments.It is recommended to clarify the severity of drug safety and the location of the instructions in clinical research,and continue to carry out safety monitoring and update the instructions in time after listing.

Objective This study sought to establish a non-alcoholic fatty liver disease(NAFLD)model in Wistar-SD hypercholesterolemia(WSHc)rats induced by a high-fat diet and to reveal the pathogenesis of NAFLD in these rats through the Srebp-1 gene.Methods After 2 weeks of dietary treatment,thirty 6-week-old WSHc rats were divided into High-fat control group,HFD+AAV no load group,and HFD+AAV group,with 10 rats in each group.The HFD+AAV no load group and HFD+AAV group were intravenously injected with a vector virus and an shRNA-containing virus,respectively.WSHc rats were fed with a normal fat diet as a normal control group.Serum levels of ALT,AST,TBIL,ALP,TBA,GLU,CHOL,and TG were measured every 2 weeks.After a further 8 weeks of feeding,the rats were euthanized and livers were excised for HE staining,Oil Red O staining,Masson staining,and Sirius red staining to observe the morphology,lipid deposition,and fibrosis of the liver tissues.RT-qPCR was performed to detect the expression of lipid metabolism-related genes namely Srebp-1,Aacs,FASN and LDLR in the livers.Furthermore,hepatocytes were isolated,cultured,and divided into a normal control group and a high-fat control group.Next,expression of the Srebp-1 gene was detected by RT-qPCR.Srebp-1 knockout(KO)hepatocytes were constructed,then TG content was detected and the lipid accumulation was observed by Oil Red O staining.Results After 10 weeks of high-fat diet treatment,serum ALT(P＜0.001),ALP(P＜0.001),TBA(P＜0.05),GLU(P＜0.001),and CHOL(P＜0.001)significantly increased in WSHc rats.Abnormal lipid deposition with formation of large vacuolar lipid droplets and fibrotic lesions in livers were observed.The mRNA expression of Srebp-1 noticeably increased in WSHc rats(P＜0.001).Moreover,compared with the high-fat control group,the ALT(P＜0.05)and GLU(P＜0.01)in the HFD+AAV group decreased,and liver lipid deposition and the formation of large vacuolar lipid droplets were alleviated.Expressions of genes such as FASN(P＜0.05)and LDLR(P＜0.01)were significantly upregulated.Additionally,there was a significant increase in the expression of Srebp-1 in hepatocytes of the high-fat control group(P＜0.001),while after Srebp-1 gene knockout,cellular TG levels decreased and the degree of lipid droplet aggregation was reduced.Conclusions The Srebp-1 gene plays a regulatory role in hepatic lipid metabolism and deposition,modulating the expression of lipid metabolism-related genes in WSHc rats with NAFLD.In vitro experiments demonstrated that downregulation of Srebp-1 alleviates lipotoxic injury in hepatocytes,suggesting that the development of NAFLD in WSHc rats is closely associated with abnormally high expressions of the Srebp-1 gene.

Neurogenic bladder(NB)is one of the most challenging urinary system disorders,with spinal cord injury(SCI)being an important etiological factor.Animal models provide crucial tools for investigating the pathogenesis,therapeutic strategies,and novel drug screening for NB subsequent to SCI.We reviewed and synthesized recent literature on NB animal models after SCI from both domestic and international sources.This review summarizes and analyzes research advancements using these models in terms of animal species,SCI segments,modeling techniques,and evaluation indicators,with the aim of offering insights and guidance for future experimental research based on animal models of NB following SCI.

Objective To analyze the status of 2 649 suspected pertussis patients in Xi'an and the changes in laboratory diagnostic indi-cators.Methods 2 649 patients with suspected pertussis who visited the Second Affiliated Hospital of Xi'an Jiaotong University from June 2023 to May 2025 were collected as the research subjects.Nasopharyngeal swabs were collected from the patients,and pertussis nucleic acid was detected by polymerase chain reaction(PCR)-fluorescence probe method.Laboratory diagnostic indicators were an-alyzed.Results Among the 2 649 samples tested,250 were positive for pertussis nucleic acid,with a positive detection rate of 9.44%.The detection rate in male patients was 9.37%(127/1 356),and in female patients was 9.51%(123/1 293),with difference no was statis-tically significant between the two groups(χ2=0.019,P=0.894).There was a statistically significant difference in the positive detection rate among different age groups(χ2=46.473,P<0.05),with the highest positive detection rate in the 7～19 age group(14.98%).The prevalence of pertussis showed a seasonal characteristic with a peak from April to September.21.2%(53/250)of the positive patients were mixed infections.In the 1～14 age group,the white blood cell count(WBC),lymphocyte percentage(LYMP%),and lymphocyte count(LYMP#)in the pertussis infection group were higher than those in the Mycoplasma pneumoniae(MP)infection group(t=10.179,5.819,8.614)and the Respiratory syncytial virus(RSV)infection group(t=16.570,2.618,7.185),and the differences were statistically significant(all P<0.01),respectively.In the＞14 age group,the LYMP%and LYMP#in the pertussis infection group were higher than those in the MP infection group(t=3.275,2.319)and the RSV infection group(t=2.401,4.617),and the differences were statistically significant(all P<0.05),respectively.Conclusion The pertussis infection status in Xi'an area from 2023 to 2025 shows significant char-acteristics in terms of age,season and laboratory test results.It is necessary to further improve the pertussis surveillance system in this area,optimize the clinical diagnosis and treatment process and strengthen the vaccination work of pertussis vaccine.

AIM To establish an HPLC-MS/MS method for the simultaneous content determination of dehydrodiisoeugenol,eugenol,costiolactone,dehydrocostiolactone,quercetin,isorhamnetin,luteolin,caffeic acid,gallic acid,protocatechuic acid,ellagic acid and kaempferol in Anshen Buxin Liuwei Pills,and to make chemical pattern recognition.METHODS The analysis was performed on a 35 ℃ thermostatic Shim-pack GST-HP C18 column(2.1 mm × 100 mm,3 μm),with the mobile phase comprising of methanol-water(containing 0.1％formic acid)flowing at 0.25 mL/min in a gradient elution manner,and electron spray ionization source was adopted in positive and negative ion scanning with multiple reaction monitoring mode.Subsequently,cluster analysis,principal component analysis and orthogonal partial least square-discriminant analysis were performed.RESULTS Twelve constituents showed good linear relationships within their own ranges(r≥0.999 0),whose average recoveries were 95.38％-105.00％with the RSDs of 1.91％-5.14％.Thirteen batches of samples were clustered into 3 types,ellagic acid,dehydrocodenolactone,dehydrodiisoeugenol,protocatechuic acid,gallic acid,quercetin and kaempferol were taken as potential quality differential markers.CONCLUSION This accurate,sensitive,stable and reproducible method can be used for the quality control and evaluation of Anshen Buxin Liuwei Pills.

Objective To observe the effects of electroacupuncture(EA)on TGF-β1/Smads signaling pathway and epithelial-mesenchymal transition(EMT)related proteins in rats with neurogenic bladder(NB)after spinal cord injury;To explore the possible mechanism of EA in improving NB fibrosis.Methods Totally 36 female SD rats were randomly selected,with 10 rats in the sham-operation group and the remaining 26 rats undergoing complete transection of the spinal cord beneath the T8 vertebrae to establish a NB rat model.The modeling rats were randomly divided into model group and EA group,with 10 rats in each group.EA group was applied to"Ciliao","Zhongji"and"Sanyinjiao",20 min per time,once a day for 7 days.The general condition of the rats in each group was observed,the ultrasound index of the bladder was detected by ultrasound technique,the bladder function of the rats was detected by urodynamics,the body mass of the rats and the wet weight of the bladder were recorded,and the bladder index was calculated.HE staining was used to observe bladder tissue morphology,the degree of bladder tissue fibrosis and bladder wall thickness were detected by Masson staining.The positive expressions of E-cadherin,N-cadherin and Vimentin in bladder tissue were detected by immunohistochemistry.The protein expressions of TGF-β1,p-Smad2/3,E-cadherin,N-cadherin and Vimentin were detected by Western blot.Results Compared with the sham-operation group,the upper and lower diameter,anteroposterior diameter,transverse diameter,bladder volume of the model group significantly increased(P<0.001),the maximum bladder pressure,leak point pressure difference,perfusion time and maximum bladder capacity significantly increased(P<0.001),the bladder index increased significantly(P<0.001),the bladder epithelial cells were thickened and arranged irregularly,the bladder collagen volume fraction and bladder wall thickness significantly increased(P<0.001),the expressions of TGF-β1,p-Smad2/3,N-cadherin and Vimentin in bladder tissue increased(P<0.01),and the expression of E-cadherin decreased(P<0.001).Compared with the model group,the upper and lower diameter,anteroposterior diameter,transverse diameter,bladder volume of the EA group decreased significantly(P<0.05),the maximum bladder pressure,leak point pressure difference,perfusion time and maximum bladder capacity significantly decreased(P<0.05),the bladder index significantly decreased(P<0.05),the thickness of the bladder epithelial cell layer became thinner and arranged more neatly,and the bladder collagen volume fraction and bladder wall thickness of the bladder were significantly reduced(P<0.05),the expressions of TGF-β1,p-Smad2/3,N-cadherin and Vimentin in bladder tissue significantly decreased(P<0.05),and the expression of E-cadherin significantly increased(P<0.05).Conclusion EA may reduce the EMT of bladder epithelial cells and decrease the degree of bladder tissue fibrosis by inhibiting the activation of the TGF-β1/Smads signaling pathway,thereby improving bladder function in NB rats after spinal cord injury.

Objective To evaluate the efficacy of the venous thromboembolism(VTE)digital risk prevention and control platform based on whole-process closed-loop management for the quality management of VTE in Peking University Shenzhen Hospital.Methods The data of 360 718 hospitalized patients from 2021 to 2024 were collected to analyze the rate of VTE risk assessment,the proportion of VTE intermediate and high-risk patients,the rate of VTE prophylaxis implementation(physical/pharmacological),and the VTE outcome indexes,and the differences between groups were verified using the Cochran-Armitage χ2 trend test.Results The VTE initial risk assessment rate,the implementation rate of VTE physical prophylaxis,and the rate of VTE pharmacological prophylaxis all showed an upward trend;the incidence rate of hospital correlated VTE,and the incidence rate of VTE in hospitalized surgical patients all showed a downward trend.Conclusion The establishment of the VTE digital risk prevention and control intelligent platform can effectively improve the level of standardized prevention and treatment of in-hospital VTE and the efficacy of quality management,and provide a digital management paradigm for the implementation of the national healthcare quality and safety improvement goals and the monitoring indicators of surgical quality and safety improvement actions.

Laparoscopic subtotal cholecystectomy (LSC) has been a safe and viable alternative to conversion to laparotomy in cases of severe cholecystitis. The objective of this study is to determine the utility of intraoperative choledochoscopy in LSC for the exploration of the gallbladder, cyst duct, and subsequent stone clearance of the cystic duct in cases of severe cholecystitis. A total of 72 patients diagnosed with severe cholecystitis received choledochoscopy-assisted laparoscopic subtotal cholecystectomy (CALSC). A choledochoscopy was performed to explore the gallbladder cavity and/or cystic duct, and to extract stones using a range of techniques. The clinical records, including the operative records and outcomes, were subjected to analysis. No LSC was converted to open surgery, and no bile duct or vascular injuries were sustained. All stones within the cystic duct were removed by a combination of techniques, including high-frequency needle knife electrotomy, basket, and electrohydraulic lithotripsy. A follow-up examination revealed the absence of residual bile duct stones, with the exception of one common bile duct stone, which was extracted via endoscopic retrograde cholangiopancreatography. In certain special cases, CALSC may prove to be an efficacious treatment for the management of severe cholecystitis. This technique allows for optimal comprehension of the situation within the gallbladder cavity and cystic duct, facilitating the removal of stones from the cystic duct and reducing the residue of the non-functional gallbladder remnant.

Objective:To investigate the characteristics and clinical effects of laparoscopic pneumovesical Cohen and laparoscopic Lich-Gregoir ureteral replantations for the treatment of primary obstructive megaloureter (POM) in children.Methods:A randomized controlled study was conducted.The clinical data of 51 children with unilateral POM admitted to the First Affiliated Hospital of Zhengzhou University from October 2018 to October 2023 were collected.Random number table method was used in the selection of surgical methods.They were divided into the laparoscopic pneumovesical Cohen ureteral replantation group (group A, 22 cases) and the laparoscopic Lich-Gregoir ureteral replantation group (group B, 29 cases) according to the surgical method.The anterior-posterior diameter(APD), maximum ureteral diameter and differential renal function parameters on the affected side were measured by color Doppler ultrasound of the urinary system, and compared between and within the two groups before and after surgery.The operation time, blood loss and postoperative intubation time were compared between the two groups.The incidence of postoperative complications such as reflux, bladder spasm, urinary retention and urinary tract infection was recorded.The independent and paired sample t-tests were used for statistical analysis. Results:The operation time and hematuria duration of group B [(125.7±14.2) min, (1.5±0.6) d] were significantly shorter than those of group A [(142.6±14.7) min, (2.8±0.7) d] (all P<0.05). The APD, maximum ureteral diameter, and differential renal function on the affected side of group A were (21.7±7.9) mm, (11.6±3.2) mm, and (28.2±4.9)% before surgery, and (10.3±4.5) mm, (6.0±2.0) mm and (43.8±4.4)% after surgery, respectively.The APD, maximum ureteral diameter, and differential renal function on the affected side of group B were (21.1±5.6) mm, (11.3±4.6) mm, and (30.2±5.5)% before surgery, and (10.2±4.5) mm, (6.6±2.0) mm, and (42.4±5.2)% after surgery, respectively.There was no statistically significant difference in the values of APD, maximum ureteral diameter, and differential renal function before and after surgery between the two groups of children (all P>0.05). However, there were statistically significant differences in the values of APD, maximum ureteral diameter, and differential renal function before and after surgery between the same group of children (all P<0.01). No significant difference was found in intraoperative blood loss, postoperative intubation time, and postoperative complications between the two groups (all P>0.05). Conclusions:Both surgical methods are effective in the treatment of POM in children.Laparoscopic Lich-Gregoir ureteral replantation has advantages of less operation time compared with laparoscopic pneumovesical Cohen ureteral replantation.

Objective:To translate the Short Self-Regulation Questionnaire (SSRQ) into Chinese, and test its reliability and validity in breast cancer patients.Methods:Using the Brislin translation model, cross-cultural adaptation was conducted by combining expert consultation and a pre-survey on SSRQ. From August to December 2023, 324 breast cancer patients from Department of Breast Surgery of Peking University First Hospital were selected by convenience sampling to test the reliability and validity of SSRQ.Results:A total of 324 questionnaires were distributed and 307 valid questionnaires were recovered, with an effective recovery rate of 94.75% (307/324). The final questionnaire consisted of 30 items. The content validity index at the item level ranged from 0.80 to 1.00, and the content validity index at the scale level was 0.97. The predictive validity result showed a good model fit. The Cronbach's α coefficient for the questionnaire was 0.90, the folded reliability coefficient was 0.85, and the retest reliability coefficient was 0.79.Conclusions:SSRQ has good reliability and validity in breast cancer patients and has value for clinical promotion.