The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines （hereinafter referred to as the Guidelines） is first specialized in the field of drug safety for oral Chinese patent medicines （OCPMs） in China. Rooted in China's healthcare context， the Guidelines address the unique usage patterns and risk characteristics of OCPMs， filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines， and to promote the standardized development of pharmacovigilance practices for OCPMs， this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting， the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment， the Guidelines were examined from three dimensions of formulation components， medication behaviors， and population to address complex safety issues arising from medicinal constituents， irrational use， and individual susceptibility. In the area of risk control， the analysis focused on context-based interventions and dynamic closed-loop management strategies， exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore， this paper evaluated the applied value of the Guidelines and identified implementation challenges， such as insufficient capacity at the primary-care level and limited digital infrastructure. In response， the study proposed optimization strategies including establishing a dynamic updating mechanism， strengthening training at the grassroots level， and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders （including manufacturers）， pharmaceutical distributors， healthcare institutions， and research organizations， ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.

Narrow leaf 1 (NAL1) plays an important role in plant branching, while little is known about the roles of this gene in petunias. In this study, PhNAL1b was cloned from Petunia×hybrida cv. Mitchell Diploid, with a total length of 1 767 bp, encoding a protein composed of 588 amino acid residues and containing the peptidase S64 domain. The PhNAL1b promoter region contained several elements involved in the responses to auxin, jasmonic acid, abscisic acid, and light. The expression analysis showed that PhNAL1b had the highest expression level in roots and the lowest expression level in flowers, and its transcription could be inhibited by decapitation and cytokinin. The subcellular localization analysis showed that PhNAL1b was located in the nucleus and was a nuclear protein. Virus-induced gene silencing was employed to downregulate the expression of PhNAL1b, which resulted in significant increases in branch number and plant height. The results indicated that PhNAL1b played an important role in regulating the branching of petunias. This study lays a foundation for revealing the mechanism of NAL1 in regulating branch development and provides genetic resources for plant architecture improvement.
Petunia/growth & development* ; Plant Proteins/metabolism* ; Diploidy ; Gene Expression Regulation, Plant ; Cloning, Molecular ; Promoter Regions, Genetic

Objective The risk evaluation indicators for the occurrence of diaphragm dysfunction in ICU patients was constructed to provide a reference for the establishment of the disease risk evaluation tools for diaphragm dysfunction.Methods The literature related to diaphragm dysfunction from CNKI,Wanfang Data,PubMed,Embase and Web of Science from the establishment of databases to November 11 th,2022 was systematically searched.After the first draft was determined through the literature review method,the first draft of the indicators was revised by brainstorming,with the opinions of 10 medical and nursing experts from May to June 2023.From June to July 2023,the content and weight of risk evaluation indicators of diaphragmatic dysfunction in ICU patients were determined through expert letter inquiry and hierarchical analysis.Results 35 experts completed the first round of letter inquiry,and 34 experts completed the second round of letter inquiry.The recovery rates of the valid questionnaires in the 2 rounds of expert correspondence were 92.1％and 97.1％,respectively,and the expert authority coefficients were 0.884 and 0.904,respectively,and the Kendall harmony coefficients of all indicators were 0.356～0.570 and 0.369～0.604,respectively(all P＜0.001).The final constructed risk evaluation indicators of diaphragm dysfunction in ICU patients includes 7 first-level indicators,34 secondary indicators and 34 tertiary indicators.Conclusion The risk evaluation index of diaphragm dysfunction in ICU patients constructed in this study is comprehensive,specific,scientific and applicable,which can guide medical staff to conduct early risk evaluation of diaphragm function in ICU patients,and provide references for the establishment of disease risk assessment tools for diaphragm function.

Objective To evaluate the effect of modulating gut microbiota for improving brain injury in rats with post-stroke depression.Methods Adult SD rats were randomized into normal control,middle cerebral artery occlusion(MCAO),post-stroke depression(PSD),PSD with fecal transplantation,PSD with antibiotics(rifaximin),PSD with probiotics(lactobacilli),and PSD with fluoxetine treatment groups(n=9).Neurological function scores of the rats were determined,and the changes in sugar water preference and immobility time in forced swimming test were observed;plasma levels of trimethylamine N-oxide(TMAO)and hydrogen sulfide(H2S)were detected with ELISA,Occludin,and the expressions of occludin,caudin-5 and IgG proteins I the brain tissues were determined using Western blotting.Results Compared with those in the control group,the rats in MCAO and PSD groups had significantly increased neurological function scores,TMAO level,the ratio of TMAO/H2S,and immobility time in forced swimming test with a lowered level of H2S(P<0.05).These changes were more obvious in PSD rats,which also exhibited a reduced sugar water preference with increased IgG protein and decreased occluding and caudin-5 expressions in the brain tissue(P<0.05).TMAO/H2S ratio in PSD rats was positively correlated with neurological function score(R2=0.3235,P=0.0269)and immobility time in swimming(R2=0.6290,P=0.0004)and negatively with sugar water preference(R2=-0.4534,P=0.0059).Treatment with fecal transplantation,antibiotics,probiotics and fluoxetine all significantly reduced neurological function scores,immobility time in forced swimming,TMAO/H2S ratio,and IgG protein expression and increased sugar water preference and brain occludin and caudin-5 expressions of the PSD rats(P<0.05).Conclusion In PSD rats,TMAO/H2S ratio is correlated with neurological function score,immobility time in forced swimming and sugar water preference,and modulating intestinal flora can improve neurological function and depressive symptoms and improve the integrity of the blood-brain barrier.

Objective To evaluate the effect of modulating gut microbiota for improving brain injury in rats with post-stroke depression.Methods Adult SD rats were randomized into normal control,middle cerebral artery occlusion(MCAO),post-stroke depression(PSD),PSD with fecal transplantation,PSD with antibiotics(rifaximin),PSD with probiotics(lactobacilli),and PSD with fluoxetine treatment groups(n=9).Neurological function scores of the rats were determined,and the changes in sugar water preference and immobility time in forced swimming test were observed;plasma levels of trimethylamine N-oxide(TMAO)and hydrogen sulfide(H2S)were detected with ELISA,Occludin,and the expressions of occludin,caudin-5 and IgG proteins I the brain tissues were determined using Western blotting.Results Compared with those in the control group,the rats in MCAO and PSD groups had significantly increased neurological function scores,TMAO level,the ratio of TMAO/H2S,and immobility time in forced swimming test with a lowered level of H2S(P<0.05).These changes were more obvious in PSD rats,which also exhibited a reduced sugar water preference with increased IgG protein and decreased occluding and caudin-5 expressions in the brain tissue(P<0.05).TMAO/H2S ratio in PSD rats was positively correlated with neurological function score(R2=0.3235,P=0.0269)and immobility time in swimming(R2=0.6290,P=0.0004)and negatively with sugar water preference(R2=-0.4534,P=0.0059).Treatment with fecal transplantation,antibiotics,probiotics and fluoxetine all significantly reduced neurological function scores,immobility time in forced swimming,TMAO/H2S ratio,and IgG protein expression and increased sugar water preference and brain occludin and caudin-5 expressions of the PSD rats(P<0.05).Conclusion In PSD rats,TMAO/H2S ratio is correlated with neurological function score,immobility time in forced swimming and sugar water preference,and modulating intestinal flora can improve neurological function and depressive symptoms and improve the integrity of the blood-brain barrier.

Objective In this study,Knoevenagel derivatives of curcumin were synthesized,and their oil-water partition coefficient were determined.Our aim is to provide an experimental basis for further development of curcumin derivatives.Methods Two Knoevenagel derivatives of curcumin,including 4-(thiophen-2-ylidene)curcumin(3a)and 4-(pyridine-4-ylidene)curcumin(3b),were obtained by using the methylene group of curcumin as the modification site and purified by column chromatography.The structures of these derivatives were confirmed by nuclear magnetic resonance spectroscopy(NMR),infrared(IR)and high-resolution liquid mass spectrometry(HRLC-MS).The oil-water partition coefficient of the derivatives in n-octanol aqueous solution was determined by quantitative analysis using HPLC.Results Knoevenagel derivatives of curcumin were successfully synthesis.The oil-water partition coefficients(lgPap)of curcumin derivatives 3a and 3b are 0.96 and 0.82,respectively.Compared with the oil-water partition coefficient of curcumin(lgPap=3.85),it suggested that curcumin derivatives showed better water solubility than curcumin.Conclusion Compared to the curcumin prototype,Knoevenagel derivatives of curcumin increased water solubility and improved bioavailability.Thus,it may provide experimental basis for introducing heteroarylene moiety of the methylene position of curcumin to enhance pharmacological activity.

Objective:To investigate the effects of navigation bronchoscopy and artificial intelligence in the standardized training of residents on basic bronchoscopy skills, with the goal of enhancing their practical abilities.Methods:We selected 26 trainees (14 on standardized training of residents and 12 on standardized training of specialists) who participated in the basic navigational bronchoscopy skills and technique training (NBSTAT) at Ruijin Hospital, Shanghai Jiao Tong University School of Medicine from September 2023 to January 2024. The training was structured around a modular curriculum with navigation as the core design concept, consisting of five modules: lesion identification, precise localization, route planning, navigation operation, and real-time error correction. Theoretical teaching and skill practice were combined. The skill proficiency of the trainees was assessed using the Ruijin Hospital bronchoscopy simulation training system and the electromagnetic navigation bronchoscopy system. SPSS 26.0 was used to perform the t-test and Wilcoxon rank-sum test for comparisons. Results:After the training, the trainees as a whole showed significant improvements in practicing the skills, with the simulated operation time was reduced from (125.08±48.16) seconds to (77.69±24.75) seconds, the number of errors decreased from 1 to 0, the total score increased from (60.77±15.01) to (75.19±17.63), and the navigation operation time was reduced from 3 (3, 4) minutes to 2 (2, 3) minutes (all P<0.05). There were no significant differences in these assessment items between resident trainees and specialist trainees. The satisfaction rate of the trainees with the training reached 100.00%. Conclusions:The curriculum is effective in basic bronchoscopy skill training, remarkably enhancing the bronchoscopy skills of resident and specialist physicians, which is a useful approach for physicians to cope with the continuous development of diagnostic and therapeutic techniques for pulmonary diseases.

Objective: Self-determination theory (SDT) deems that people have three causality orientations: autonomy orientation, control orientation, and impersonal orientation. Previous studies suggested that lower autonomy orientation or higher control and impersonal orientations may be associated with more addictive behaviors. Our study aimed to investigate if these associations exist in Internet gaming disorder (IGD), and if sensation seeking, anxiety, and depression could influence the associations between causality orientations and IGD symptoms. Methods: A total of 1,400 college students completed the Internet Gaming Disorder Scale, General Causality Orientation Scale, Brief Sensation Seeking Scale, Generalized Anxiety Disorder Scale, and Patient Health Questionnaire. Correlation, multiple linear regressions, structural equation model (SEM) analyses, and moderation analyses were conducted to explore the associations. Results: The control and impersonal orientations were positively associated with IGD symptoms, while the autonomy orientation was negatively associated with them. Moreover, SEM analyses showed that the autonomy-IGD relationship was totally mediated by anxiety and depression, the impersonal-IGD relationship was partially mediated by anxiety, and the control-IGD relationship was partially mediated by depression. Finally, the effects of causality orientations on IGD were moderated by sensation seeking. Conclusion Overall, autonomy orientation is linked to fewer gaming problems, whereas control and impersonal orientations are associated with more gaming problems. Moreover, the relationships between causality orientations and IGD symptoms are mediated by anxiety and depression and moderated by sensation seeking. Our findings inform theory on the motivations of gaming behaviors and may shed light on the prevention and intervention of IGD from the perspective of SDT.

Objective:To explore the cognition and intention of patients with lower limb deep vein thrombosis (DVT) to participate in patient-reported outcomes (PROs), so as to provide references for the promotion, application, and practice of PROs in lower limb DVT patients in China.Methods:This study adopted the phenomenological qualitative research method. From February to June 2023, 13 lower limb DVT patients admitted to Peking Union Medical College Hospital were selected for semi-structured in-depth interviews. Colaizzi 7-step analysis method was used for analyzing and summarizing data.Results:Thirteen patients with lower limb DVT highly recognized their own value in participating in PROs, namely health benefits, prevention of DVT complications, and reduction of disease uncertainty. Lower limb DVT patients expected to receive support from healthcare professionals, families, and portable and simplified reporting formats to promote their participation in PROs. From the patient 's own perspective, they perceived that insufficient attention to DVT caused by lack of awareness of the hazards of DVT and limited understanding of PROs made it difficult for them to participate in PROs. Conclusions:Lower limb DVT patients have a high intention to participate in PROs. The application and promotion of PROs in lower limb DVT patients in China require joint support from various sectors of society, among which strengthening effective health education for patients and their families and providing multi-channel reporting forms are the key to promoting of PROs.

Objective:To construct a tool to evaluate the knowledge, attitude, and practice of nurses in the prevention of thrombosis related to peripherally inserted central catheter (PICC) .Methods:From December 2022 to April 2023, based on the theory of knowledge, attitude, and practice, a preliminary draft of the PICC-related Thrombosis Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses was formed through systematic literature review, two rounds of Delphi expert consultations, and pre-survey. In May 2023, convenience sampling was used to select 573 nurses from Chinese Academy of Medical Sciences & Peking Union Medical College Hospital as the research subject for a survey to conduct item analysis, validity testing, and reliability testing on the questionnaire.Results:The final version of the PICC-related Thrombosis Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses included 20 knowledge items, 10 attitude items, and 10 practice items. In the content validity of the questionnaire, the average content validity index was 0.984, the overall consensus content validity index was 0.850, and the item level content validity index was 0.857 to 1.000. Exploratory factor analysis extracted three common factors with eigenvalues>1.000, with a cumulative variance contribution rate of 64.540% and factor loadings of 0.450 to 0.908 for each item. The total Cronbach's α coefficient of the questionnaire was 0.895, the half reliability coefficient was 0.947, and the retest reliability coefficient was 0.966.Conclusions:The PICC-related Thrombosis Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses has good reliability and validity, and can be used to evaluate PICC-related thrombosis prevention knowledge, attitude, and practice among nurses.