ObjectiveThis paper aims to investigate and evaluate the staged efficacy and safety of the representative empirical prescription of the “Zhu Ke Jiao” theory， Qijia Rougan prescription， combined with entecavir in the treatment of hepatic fibrosis in chronic hepatitis B. MethodsA multicenter randomized controlled clinical study was conducted， and 101 patients diagnosed with chronic hepatitis B-related hepatic fibrosis （CHB-HF） who met the diagnosis and inclusion criteria were randomly assigned to an observation group （Qijia Rougan prescription + entecavir） and a control group （entecavir）. The treatment duration was 24 weeks. Liver stiffness measurement （LSM）， fibrosis-4 index （FIB-4）， portal vein diameter， hepatitis B serology， biochemical indicators， hepatic fibrosis markers in serum ［hyaluronic acid （HA）， laminin （LN）， procollagen Ⅲ peptide （PⅢP）， and type Ⅳ collagen （Ⅳ-C）］， and traditional Chinese medicine syndrome scores were used as efficacy evaluation indicators. Efficacy assessments and explorations of different staged subgroups of Qijia Rougan prescription were conducted according to LSM values based on the Metavir pathological staging standard. ResultsA total of 98 cases were included for statistical analysis， with 49 cases in the observation group and 49 in the control group. The general data of the patients in both groups were comparable. Compared with the same group before treatment， the observation group showed a significant reduction in LSM and FIB-4 （P<0.01）， as well as notable improvements in LN， Ⅳ-C， and various TCM syndrome scores （P<0.05， P<0.01）. When compared to the control group after treatment， the observation group demonstrated significant improvements in LSM， FIB-4， and various TCM syndrome score indicators （P<0.05， P<0.01）， indicating that the observation group performed better than the control group. Subgroup analysis of the regression of hepatic fibrosis stages showed that compared to the same group before treatment， the observation group had better improvement in regression of stages F2 and F3 （P<0.05）. When compared to the control group after treatment， the observation group exhibited superior improvement in regression of stage F3 （P<0.05）. No adverse events occurred in either group during the treatment period. ConclusionCompared with entecavir alone， the combination of Qijia Rougan prescription and entecavir significantly improves the degree of hepatic fibrosis and clinical TCM symptoms in patients. The optimal intervention period is primarily during stage F3， which is a potential “interception” point of the “Zhu Ke Jiao” theory.

Objective: To explore the association role of anxiety and depressive symptoms with Internet gaming disorder (IGD) and emotional-behavioral problems among junior high school students, so as to provide references for preventing the occurrence and progression of emotional-behavioral problems in middle school students. Methods: From September to October 2024, a random cluster sampling method was adopted to select 38 069 students from 28 junior high schools in 14 counties (cities and districts) and functional areas of Jining City, Shandong Province. Surveys were conducted by Nine item Internet Gaming Disorder Scale-Short Form, Generalized Anxiety Disorder-7, Patient Health Questionnaire-9, and Strengths and Difficulties Questionnaire. The correlation of emotional and behavioral issues, online game addiction, anxiety and depressive symptoms among junior high school students was analyzed by Speaman correlation analysis. Mediation analysis was used to explore the role of anxiety and depressive symptoms between IGD and emotional-behavioral problems among junior high school students. Results: The detection rates of emotional-behavioral problems, anxiety symptoms, depressive symptoms, and IGD among junior high school students were 19.24 %, 9.48%, 16.69%, and 19.68%, respectively. The scores of emotional-behavioral problems, anxiety symptoms, depressive symptoms and IGD were 10.00 (6.00, 15.00), 3.00 (0.00, 7.00), and 4.00 (1.00, 8.00), 13.00 (10.00, 19.00), respectively. There were positive correlations between each pair of emotional-behavioral problem, IGD, anxiety symptoms, and depressive symptoms scores ( r =0.51-0.81, all P <0.01). Anxiety and depressive symptoms played mediating roles between IGD and emotional-behavioral problems among junior high school students, with mediating effect values of 0.16 (95% CI =0.15-0.17) and 0.12 (95% CI =0.11-0.14), respectively (both P <0.01). Conclusions Anxiety and depressive symptoms mediate the relationship between IGD and emotional-behavioral problems among junior high school students. It is necessary to identify early signs of IGD among junior high school students, strengthen intervention for anxiety and depressive symptoms, to prevent the occurrence and development of emotional and behavioral issues.

Objective To gain insights into the biological characteristics of different populations of Culex tritaeniorhynchus within and around the Yellow Sea wetland from the perspective of the occurrence of resistance, we investigated the levels of resistance to deltamethrin and kdr gene mutation in the wetland and its peripheral areas. Methods Specimens were collected from Cx. tritaeniorhynchus populations at two monitoring sites in the Rare Bird National Nature Reserve and Tiaozi Ni Wetland Scenic Area, and also from two populations in Yancheng City and the Liuhe District of Nanjing, and the resistance of these mosquitoes to deltamethrin was determined using the CDC biotest bottle method. For each concentration of deltamethrin assessed, a random subset of exposed specimens was selected for amplification of the kdr gene fragment, followed by Sanger sequencing to identify and analyze resistance-associated mutations. Results The LC50 levels of deltamethrin among mosquitoes from the four populations in Luhe, Yancheng, the Rare Bird National Nature Reserve and the Tiaozi Ni Wetland Scenic Area were 2.048 5, 7.798 2, 3.473 3, and 17.695 5 mg/mL, respectively, with corresponding concentrations of deltamethrin ranging from 0.005 to 5.000,0.050 to 50.000,0.050 to 25.000 and 0.050 to 50.000 mg/mL, respectively. Furthermore, the ranges of the KT50 values were 11.76-107.43, 67.05-216.30,29.77-107.43 and 28.40-329.51 min; the 1-h knockdown rates were 34.58%-99.15%, 9.52%-43.80%, 55.09%-73.01%, and 10.09%-68.07%; and the 24-h mortality rates were 12.15%-67.52%,9.52%-79.56%,13.17%-82.21%, and 11.01%-78.99%, respectively. With respect to kdr gene mutation, we assayed a total of 63,70,59, and 57 mosquitoes for the four populations, for which we detected L1014F mutation frequencies of 14.29%, 35.00%, 20.34%, and 31.58%, respectively, with a majority of these mutations being heterozygous for resistance. In addition, five adult mosquitoes were identified has having synonymous mutations at site 1011[i. e. , AAT(asparagine)mutation to AAC(asparagine)]. Conclusions Our findings revealed the clear resistance of Cx. tritaeniorhynchus to deltamethrin in the Yancheng region of the Yellow Sea wetland, and the resistance phenotype and kdr frequency of Cx. tritaeniorhynchus in the wetland environment were comparable to those of Cx. tritaeniorhynchus in the wetland environment, thereby indicating that the resistance of different populations of Cx. tritaeniorhynchus was homogeneous under the pressure of different insecticide selection within and around the wetland. However, the underlying mechanisms need to be further studied.

Objective To evaluate the feasibility of intravesical instillation of urokinase and heparin sodium in the treatment of bladder clot irrigation.Methods This report discusses the diagnosis and treatment of three patients with bladder blood clot tamponade confirmed by abdominal and pelvic computed tomography(CT)scans enrolled from our hospital during Jun. to Sep. 2024, and discuss the relevant literature.Results A solution containing urokinase(20 000 IU)and heparin sodium(125 000 U)was instilled through a three-way catheter and retained for 30 minutes before drainage. Complete clot dissolution was achieved in all cases, with immediate relief of hypogastric distension and pain. Post-procedural CT showed restored bladder lumen patency. Hemoglobin levels decreased by 2-5 g/L without complications.Conclusion This preliminary trial demonstrated that intravesical instillation of urokinase-heparin provides a safe and effective minimally invasive alternative for bladder clot in irrigation cases.

Objective Explore a comprehensive and multi-level set of passive defensive medical governance strate-gies.Methods Literature related to passive defensive medical governance was retrieved,and the Ucinet social net-work analysis software was utilized to calculate indicators such as the frequency and centrality of passive defensive medical governance strategies,thereby understanding the importance of these strategies.Results The formed set of negative defensive medical governance strategies covers three levels social cogniton,institutional mechanisms and doctor-patient relationship.Among them,there are 5 governance strategies at the social cognition level,24 governance strategies at the institutional mechanism level,and 12 governance strategies at the doctor-patient rela-tionship level,totaling 41 governance strategies.Conclusion The constructed set of passive defensive medical governance strategies is scientific,practical,and comprehensive in content,providing a reference framework for medical institutions to govern passive defensive medical behaviors.

Objective Based on the WSR methodology,a three-dimensional integrated perspective of Wuli,Shi-li,and Renli dimensions was used to sort out the logical relationships and architectures among negative defensive medical governance strategies,forming the priority governance strategies for improving negative defensive medical care.Methods Based on the literature research method and the expert consultation method,the governance strate-gy and the conceptual connotation of WSR are classified into items,and the role relationship in the complex sys-tem of passive defensive medical governance is clarified through the WSR methodology.Results A collection of 40 negative defensive medicine governance strategies has been developed,comprising 8 strategies in the Wuli dimen-sion,23 strategies in the Shili dimension,and 9 strategies in the Renli dimension.Conclusion The WSR methodology provides a three-dimensional systemic perspective for governance strategies against negative defen-sive medicine.Addressing this issue requires comprehensive and systematic governance strategies.

Urinary incontinence is the most common complication after radical prostatectomy.Traditional Chinese medicine treatments for this disease,such as acupuncture,are diverse and have definite therapeutic effects.The disease is located in the bladder,and its etiology and pathogenesis are mostly related to the dysfunction of the kidney,spleen,triple energizer and other viscera.In view of the insufficiency of kidney essence,decline of the gate of vitality fire(mingmen fire),Qi deficiency leading to impaired bladder containment,compounded by obstruction of meridians from pathogenic factors including blood stasis,damp-heat,and phlegm turbidity.The"Shuanggu Yitong"acupuncture achieves"Dual fortification"through tonifying the kidney and primordial qi consolidation,combined with spleen strengthening and qi supplementation.Additionally,"purging"targets the elimination of blood stasis,phlegm turbidity,damp-heat and other solid evils.This integrated approach combines acupuncture and moxibustion modalities with reinforcing-reducing needle manipulation techniques,simultaneously addressing both the symptoms and root causes of the problem.By coordinating pathogen elimination with constitutional regulation,this method demonstrates favorable therapeutic outcomes in clinical practice and is worthy of further clinical promotion.

Objective To observe the effects of Yinqin Qingfei Granules on oxidative injury in lung tissue of mice with mycoplasma pneumoniae infection;To explore the mechanism of the Keap1/Nrf2/HO-1 signaling pathway in it.Methods Totally 100 BALB/c mice were randomly divided into blank group,model group,Yinqin Qingfei group,Azithromycin group and combination group,with 20 mice in each group.Except for the blank group,the other groups of mice were used to establish mycoplasma pneumoniae pneumonia model through bacterial solution nasal drip,and the blank group was given the same amount of normal saline nasal drip for 3 days.After modeling,the drug groups were given corresponding drugs by gavage,the blank group and the model group were given the same amount of distilled water by gavage,and the materials were taken at 3 and 7 days after administration,respectively.HE staining was used to observe the morphology of lung tissue,ELISA was used to detect the contents of interleukin(IL)-1β and tumor necrosis factor(TNF)-α in serum,biochemical method was used to detect the contents of nitric oxide(NO),malondialdehyde(MDA),superoxide dismutase(SOD)and glutathione(GSH)in lung tissue,Western blot was used to detect the expressions of Kelch like ECH associated protein 1(Keap1),nuclear factor E2 related factor 2(Nrf2)and heme oxygenase-1(HO-1)protein in lung tissue.Results Compared with the blank group,the lungs of mice in the model group showed severe inflammatory changes on day 3 and 7,with alveolar fusion or disappearance,and lung consolidation,which were more severe on day 7;the contents of IL-1β and TNF-α in serum significantly increased(P<0.05),the contents of SOD and GSH in lung tissues significantly decreased(P<0.05),and the contents of MDA and NO significantly increased(P<0.05),the protein expression of Keap1 in lung tissues increased(P<0.05),and Nrf2 and HO-1 protein expressions decreased(P<0.05).Compared with the model group,the histopathological changes in lung tissue showed different degrees of improvement on day 3 and 7 of drug treatment in Yinqin Qingfei group,Azithromycin group and combination group groups,the serum contents of IL-1β and TNF-α were significantly decreased(P<0.05),the contents of SOD and GSH in lung tissue were significantly increased on day 7 of drug treatment(P<0.05),the contents of MDA and NO significantly decreased(P<0.05),the protein expression of Keap1 in lung tissue decreased on day 3 and 7 of drug treatment(P<0.05),and the protein expressions of Nrf2 and HO-1 increased(P<0.05).Conclusion Yinqin Qingfei Granules can regulate the level of inflammatory factors,reduce lung inflammation and oxidative damage of mice with mycoplasma pneumoniae infection.The mechanism may be related to down-regulating the expression of Keap1,up-regulating the expressions of Nrf2 and HO-1,reducing the contents of NO and MDA,improving the activities of SOD and GSH,and playing an antioxidant role.

Pediatric urological non-Hodgkin lymphoma is relatively rare.When a single renal or ureteral tumor with multiple lymph node or bone metastases is present, it is very easy to be misdiagnosed as urinary tumor with metastasis, resulting in unnecessary radical nephrectomy. This paper reports two cases of non-Hodgkin lymphoma presenting with single urinary nodules. Case 1 was diagnosed with a 4.5cm tumor in the right kidney due to fever and fatigue. CT and PET-CT showed multiple bone destruction and lymph node metastasis. Renal biopsy was performed and ALK-positive anaplastic large cell lymphoma was diagnosed. Chemotherapy was effective for 6 months. Case 2 was diagnosed with left hydronephrosis due to intermittent low back pain for 2 weeks. Ultrasound examination revealed ureteral dilation with left hydronephrosis and low echo occupying of the lower ureter. The patient had sudden blurred vision before surgery. MRI examination revealed space occupying in the right optic nerve frame, and PET-CT found multiple bone, lymph nodes and nerve invasion. A lymph node biopsy was performed and Burkitt lymphoma was diagnosed. After 6 months of chemotherapy and radiotherapy, the tumor shrank significantly.

Artificial intelligence(AI)has emerged as a cutting-edge technology leading the future and is a key engine for China's development.In the innovation and research of medical devices,AI has provided critical support in the areas of intelligent diagnostic assistance,intelligent therapeutic assis-tance,intelligent monitoring,life support,et al.Ma-chine learning-enabled device software functions(ML-DSFs)have become an essential component of many medical devices.Recently,the United States Food and Drug Administration(FDA)released a draft guidance titled"Marketing Submission Rec-ommendations for a Predetermined Change Con-trol Plan for Artificial Intelligence/Machine Learn-ing(AI/ML)-Enabled Device Software Functions(Draft)."that aimed to provide a forward-looking approach to foster the development of ML medical devices.By supporting iterative updates through modifications,this approach ensures the continu-ous safety and effectiveness of the devices.This guidance represents the latest in regulatory direc-tion and is especially beneficial for enhancing the quality and efficiency of clinical trials for AI prod-ucts.Therefore,we plan to provide a detailed intro-duction and interpretation of the guidance,with the aim of learning from international advanced regulatory concepts and experiences to promote the development of ML-DSFs with more profound international influence.