To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems， including insufficient safety information in package inserts， amplified medication risks in special populations， and non-standard clinical practices， thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China （2019 revision） and the GB/T 1.1—2020 standard， a systematic search was performed in the Chinese Pharmacopoeia （2020 edition）， the Catalog of Medicines Covered by Medical Insurance （2022 edition）， Chinese databases ［China Network of Knowledge Infrastructure （CNKI）， Wanfang Data （Wanfang）， and VIP journal resource integration service platform （VIP）］， and international databases （Cochrane Library， PubMed， and EMbase）. Guideline outlines were developed through questionnaire surveys， expert interviews， and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine （TCM） incompatibility， as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia （2020 edition） and 58 from the Catalog of Medicines Covered by Medical Insurance （2022 edition）. Safety-related items in the corresponding package inserts were collected， and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting， and opinions from 61 external experts were solicited. A pharmacovigilance framework was established， covering the full chain of "monitoring， identification， assessment， and control". Based on seven anatomical sites， including nasal， ocular， and oral mucosa， a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions"， "Contraindications"， and "Precautions"， clinical procedure standardization in healthcare institutions， risk control， and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration， filling the current gap in international pharmacovigilance standards in this field， while offering technical support for safety management across the full life cycle of medicines for mucosal administration.

To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems， including insufficient safety information in package inserts， amplified medication risks in special populations， and non-standard clinical practices， thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China （2019 revision） and the GB/T 1.1—2020 standard， a systematic search was performed in the Chinese Pharmacopoeia （2020 edition）， the Catalog of Medicines Covered by Medical Insurance （2022 edition）， Chinese databases ［China Network of Knowledge Infrastructure （CNKI）， Wanfang Data （Wanfang）， and VIP journal resource integration service platform （VIP）］， and international databases （Cochrane Library， PubMed， and EMbase）. Guideline outlines were developed through questionnaire surveys， expert interviews， and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine （TCM） incompatibility， as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia （2020 edition） and 58 from the Catalog of Medicines Covered by Medical Insurance （2022 edition）. Safety-related items in the corresponding package inserts were collected， and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting， and opinions from 61 external experts were solicited. A pharmacovigilance framework was established， covering the full chain of "monitoring， identification， assessment， and control". Based on seven anatomical sites， including nasal， ocular， and oral mucosa， a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions"， "Contraindications"， and "Precautions"， clinical procedure standardization in healthcare institutions， risk control， and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration， filling the current gap in international pharmacovigilance standards in this field， while offering technical support for safety management across the full life cycle of medicines for mucosal administration.

Objective:To evaluate the efficacy of combined cricopharyngeal myotomy (CPM) and autologous fat injection laryngoplasty (AFIL) in the management of dysphagia secondary to glossopharyngeal and vagal nerve injury.Methods:This retrospective cohort study collected the clinical data of 18 patients with persistent dysphagia due to glossopharyngeal and vagus nerve injuries, who underwent concurrent cricopharyngeal myotomy (CPM) and autologous fat injection laryngoplasty (AFIL) at the Department of Otolaryngology, Peking Union Medical College Hospital, from January 2017 to December 2024. Pre-and postoperative assessments included electronic flexible laryngoscope, the Chinese version of Swallow Quality-of-Life Questionnaire (CSWAL-QOL), videofluoroscopic swallowing study (VFSS), body weight changes, and nasogastric tube (NGT) removal status with routine follow-up. The comparison of swallowing function before and after surgery was conducted using paired samples t-test and χ2 test. Results:The study cohort comprised 10 male and 8 female patients, with ages ranging from 33 to 70 years (mean±SD: 53.8±10.5). All surgical procedures were completed successfully without complications. During the 6-to 24-month follow-up period, 10 of the 13 patients who were initially nasogastric tube-dependent achieved successful decannulation. Compared with preoperative values, postoperative measurements demonstrated statistically significant improvements across all parameters: mean body weight increased from (56.95±9.14) kg to (59.22±8.72) kg ( t=3.689 , P<0.01), CSWAL-QOL scores improved from 91.89±17.81 to 130.83±25.42 ( t=6.921 , P<0.01), while, both VFSS scales showed marked reductions (VFSS-SWAL: 6.78±1.40 to 3.39±1.61, t=-8.001, P<0.01; PAS: 6.56±1.15 to 2.94±1.26, t=-10.114, P<0.01). Conclusions:Combined CPM and AFIL represents an effective surgical approach for dysphagia following glossopharyngeal and vagal nerve injury, thereby demonstrating significant improvements in both swallowing function and quality of life.

Objective:To construct a machine learning classification prediction model using planning-omics (planomics) features to predict the γ pass rate of intensity-modulated radiotherapy (IMRT) plan dose verification in fixed-field thoracic tumors, and evaluate the application of planomics in radiotherapy quality assurance.Methods:The fixed-field IMRT plans of 240 patients with chest tumors admitted to Department of Radiotherapy, Henan Cancer Hospital from August 2022 to March 2023 were retrospectively analyzed. All plans underwent dose verification using the electronic portal imaging system detector on the Varian accelerator to collect field dose data. The dose verification results were analyzed through Portal Dosimetry in the treatment planning system of Eclipse. The γ pass rate standard was set at 2%/2 mm with a 10% dose threshold. From the planning documents, 48 conventional planning features, 2476 planomics features, and the combination of the previous two feature sets were extracted. Subsequently, an auto-encoder classification model was constructed. To evaluate the classification efficacy of various feature sets, 20 random train-test divisions were conducted by calculating the area under the receiver operating characteristic curve (AUC) values along with the accuracy rates.Results:After the feature selection, 2 conventional features and 16 planomics features were finally selected. In the testing set, the AUC values for the model using combined features, planomics features, and conventional planned features were 0.802±0.030, 0.740±0.069, and 0.673±0.083, respectively. In contrast, in the training set, these AUC values were 0.844±0.074, 0.816±0.047, and 0.687±0.036, respectively. The accuracy rates were 0.752±0.083, 0.703±0.110, and 0.648±0.081 in the testing set, and 0.753±0.098, 0.751±0.075, and 0.624±0.054 in the training set for the combined, planomics, and conventional planning feature sets, respectively.Conclusions:For thoracic fixed-field adjusted radiotherapy planning, the machine learning method based on planomics features can be utilized to build a classification model for predicting the γ pass rate. Combining planomics features with conventional planned features can enhance the predictive performance of the classification models.

Based on WANG Xugao's"thirty liver-regulating methods,"this paper summarized the clinical thinking of treating diabetic kidney disease from the liver.The liver is closely associated with the pathogenesis of diabetic kidney disease,including internal heat,essence depletion,latent wind,and the accumulation and dissipation of a conglomeration of kidney collateral zhengjia.WANG Xugao's"thirty liver-regulating methods"comprehensively reveals the physiological and pathological changes of the liver,as well as clinical approaches for liver treatment.Liver qi stagnation can lead to the generation of internal heat,liver stagnation and deficiency can cause essence depletion and collateral obstruction,and disharmony of the liver wood can cause internal wind disturbance,which all contribute to the progression of diabetic kidney disease at different stages.Treatment generally follows the essence of"thirty liver-regulating methods."In the early stage,treatment should focus on treating liver heat by soothing the liver qi,clearing the liver fire,and removing damp-heat to resolve stagnation and heat.In the middle stage,treatment should focus on treating liver deficiency by nourishing the liver yin to clear heat,replenishing the essence and blood to tonify deficiency,and promoting blood circulation to remove stasis,thereby strengthening the foundation and nurturing the primal essence.In the later stage,treatment should focus on treating liver wind to prevent complications and improve the patient's quality of life.Throughout the entire process,liver collaterals are treated using pungent herbs to invigorate qi and open the liver channels,relieving blood stasis and promoting circulation.In conjunction with the above methods,flexible selection of effective formulas and drug pairs should be used,each addressing specific treatment goals.

Diabetic kidney disease(DKD),a prevalent complication of diabetes mellitus,remains a leading cause of end-stage renal disease.Recent research has identified lipophagy,a novel mechanism in DKD pathogenesis,drawing increasing attention in the field.This paper explores the biological connotation of the"internal heat leading to Zheng"pathogenesis based on lipophagy.The study proposes that lipophagy represents the microscopic biological correlation of liver-spleen coordination in regulating spleen transport and the ascending-descending dynamics of the middle jiao.Under persistent hyperglycemia,the suppression of lipophagic activity mirrors the traditional Chinese medicine(TCM)pathophysiological process described as"excessive fire consuming healthy qi,"whereas aberrant lipid accumulation in the kidney corresponds to the dynamic aggregation and dispersion of micro-zhengjia.Lipotoxicity,a key driver of DKD progression,is interpreted as the biological manifestation of accumulated turbidity transforming into toxicity,resulting in progressive impairment of renal essence and function.The dynamic process of lipophagy dysfunction under hyperglycemia,marked by renal microangiopathy,glomerular and tubular dysfunction,and renal fibrosis,closely mirrors the pathological evolution of"micro-zhengjia"and"internal heat leading to Zheng."Consequently,TCM strategies for DKD prevention and treatment should emphasize heat regulation,stage-specific interventions,liver-spleen harmonization,metabolic modulation,early collateral protection,and blood-activating approaches.

Objective:To describe the current status of responsive caregiving behavior of infant mothers,to analyze their influencing factors and pathways using the information-motivation-behavioral skills(IMB)model,and to provide a basis for further interventions related to responsive caregiving be-haviors and comprehensive promotion of early childhood development.Methods:This study was a cross-sectional survey using convenience sampling.Questionnaires were used to collect basic information about mothers and their infants,as well as data on mothers' responsive caregiving behavior,knowledge of re-sponsive caregiving,social support,and parenting self-efficacy.Multivariate linear regression models were employed to analyze the influencing factors of responsive caregiving behavior,and structural equa-tion modeling was used to analyze the pathways of these influencing factors.The criterion for inadequate responsive caregiving is defined as scores not exceeding the lower quartile(P25)of the total score.Results:Among 510 mothers of aged 0-12 months infants in Weifang City,the average score for respon-sive caregiving behavior was 16.41±3.99.The proportion of inadequate responsive caregiving was 25.7％.Mothers in the insufficient responsive caregiving group had lower scores in knowledge(7.70±1.41),social support(57.92±15.16),and parenting self-efficacy(30.36±6.48)compared with those in the sufficient group,with statistically significant differences(P＜0.001).Logistic regres-sion analysis indicated that the influencing factors for responsive caregiving included the level of know-ledge about responsive parenting[adjusted OR(aOR)=0.795,95％CI:0.566-0.838],social support(aOR=0.979,95％CI:0.961-0.996),and parenting self-efficacy(aOR=0.894,95％CI:0.857-0.932).Structural equation modeling revealed that knowledge of responsive caregiving(β=0.089,P=0.031),social support(β=0.153,P=0.001),and parenting self-efficacy(β=0.296,P＜0.001)were directly related to responsive caregiving behavior.Additionally,knowledge of responsive caregiving indirectly affected responsive caregiving behavior through parenting self-efficacy(β=0.095,P=0.014),and social support indirectly affected responsive caregiving behavior through parenting self-efficacy(β=0.497,P＜0.001).Conclusion:The current level of responsive caregiving behavior among mothers of 0-1-year-old infants in Weifang City is not satisfactory.Future development of responsive care-giving interventions should focus on providing caregivers with relevant knowledge of responsive caregiving based on their needs.Additionally,it is essential to offer social support from multiple aspects to enhance caregivers' parenting self-efficacy,thereby promoting improvements in responsive caregiving behavior.

We reported the clinical manifestations,radiographic characteristics and prognosis of 1 case with Mycolicibacterium wolinskyi pulmonary disease,and provided a comprehensive literature review on this disease.Using"M.wolinskyi"OR"Mycobacterium wolinskyi"OR"Mycolicibacterium wolinskyi"as search term in PubMed database,CNKI and Wanfang database up to August 26 2023,40 reports were retrieved.32 cases from the literature and 1 case of our institution were used for review.A 59-year-old female presented intermittent hemoptysis since 2015.She was diagnosed with tuberculosis and clinical symptoms continued after anti-tuberculosis treatment.After multiple cultures of mycobacterium sputum and species identification in our hospital,M.wolinskyi was finally identified.She was diagnosed with M.Wolinski pulmonary disease according to clinical symptoms,computed tomography findings as well as bacteriological examinations.Combination therapy with Azithromycin,Moxifloxacin hydrochloride and Amikacin were administered based on antimicrobial susceptibility testing.Mycobacterium sputum culture became negative after 1 month treatment and kept negative,and the patient continued this combination therapy for 12 months after first culture negative.M.wolinskyi disease is exceedingly rare in medical institutions,and clinical symptoms are different depending on different location.Most cases were infected with skin,soft tissue or bone tissue infection after trauma or surgery,and a few cases were bloodstream infection.Most patients could have a good prognosis after proper treatment.M.wolinskyi disease is rare and clinically atypical,which may lead to long-term misdiagnosis.With the increase of aged or immunosuppressed population,the diagnosis and treatment of these rare non-tuberculous mycobacterial infections deserve more attention.

Objective:To analyze the factors associated with long-term survival after radical resection of hepatitis B virus(HBV)-associated hepatocellular carcinoma(HCC),and to construct random forest and Cox regression models,to evaluate the two models.Methods:A total of 368 patients with HBV-infected HCC who underwent radical resection were selected retrospectively.These patients were categorized as having a good prognosis(n=266)or a poor prognosis(n=102)based on their survival and mortality status.Univariate and Cox regression analysis were used to identify fac-tors that predict poor prognosis in HCC patients after surgery,and Cox regression and random forest prediction models were constructed and evaluated.Results:There were significant differences in smoking history,Child-Pugh classifica-tion,cirrhosis,microvascular invasion,TNM staging,tumor capsule integrity,platelet-to-lymphocyte ratio(PLR),regular antiviral therapy,HBV-DNA load,alpha-fetoprotein(AFP),neutrophil-to-lymphocyte ratio(NLR),systemic immune in-flammatory index(SII),and albumin-to-globulin ratio(AGR)between the two groups(P<0.05);Cox regression showed that cirrhosis,microvascular invasion,regular antiviral treatment,HBV-DNA load,NLR,PLR,SII,and AGR were related factors that negatively affected the prognosis of patients with HBV-infected HCC after surgery(P<0.05),with an AUC of 0.870 for predicting prognosis;the importance ranking obtained by the random forest model was HBV-DNA load,cirrho-sis,regular antiviral therapy,microvascular invasion,NLR,PLR,AGR,and SII,with an AUC of 0.926 for predicting prog-nosis;the AUC predicted by the random forest model was greater than that predicted by the Cox regression model(Z=2.411,P=0.016).Conclusion:HBV-DNA load,cirrhosis,regular antiviral therapy,microvascular invasion,NLR,PLR,AGR,and SII are factors that affect the poor prognosis of patients with HBV-related HCC after surgery.The random for-est prediction model constructed based on these factors has high predictive value and is superior to the Cox regression prediction model.

Objective:To investigate the influencing factors of diarrhea during early enteral nutrition(EEN)therapy in severe patients with temporary ileostomy.Method:A total of 154 patients with temporary ileostomy who received EEN in the Department of General Surgery,Jinling Hospital from November 2019 to November 2023 were included in this study.All patients were divided into two groups:the diarrhea group(n=43)and the non-diarrhea group(n=111).The clinical data of the patients were retrospectively collected and analyzed,and univariate analysis was performed to compare the differences between groups.The indicators with significant differences were subjected to multivariate logistic regression analysis to determine the influencing factors of diarrhea during EEN therapy in severe patients with temporary ileostomy.Result:Among the 154 patients,43 developed diarrhea during EEN therapy,with an incidence of 27.9%.Multivariate logistic regression analysis showed that enteral nutrition(EN)infusion rate(OR=6.342,P=0.001,95%CI:2.055～19.572),antibiotics type(OR=8.342,P=0.013,95%CI:1.577～44.119),mechanical ventilation(OR=7.011,P=0.001,95%CI:2.272～21.629),EN formulation type(OR=6.497,P=0.001,95%CI:2.177～19.392),and diabetes(OR=3.321,P=0.036,95%CI:1.080～10.215)were closely associated with EN-related diarrhea in severe patients with temporary ileostomy.Conclusion:There was a high incidence of diarrhea in severe patients with temporary ileostomy who received EEN.EN infusion rate,antibiotics use,mechanical ventilation,EN formulation type and diabetes were the influencing factors for presence of EEN-related diarrhea in the patients.Our data could provide a reference for preventing EEN-related diarrhea in severe patients with temporary ileostomy after surgery.