1.Interpretation of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Wenxi PENG ; Meng QIAO ; Lianxin WANG ; Yuanyuan LI ; Xiuhui LI ; Xin CUI ; Zijia CHEN ; Xinyi CHEN ; Yi DENG ; Yanming XIE ; Zhifei WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(6):152-160
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.
2.Cloning and functional characterization of PhNAL1b from Petunia× hybrida cv. Mitchell Diploid.
Xurong YAO ; Tongrui LIU ; Lili DONG ; Xinyi DENG
Chinese Journal of Biotechnology 2025;41(2):869-880
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*
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Plant Proteins/metabolism*
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Diploidy
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Gene Expression Regulation, Plant
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Cloning, Molecular
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Promoter Regions, Genetic
3.Practice of navigation bronchoscopy and artificial intelligence in the basic navigational bronchoscopy skills and technique training
Dingpei HAN ; Xinyi WANG ; Yanli XU ; Xijia FENG ; Yu ZHANG ; Lihua DENG ; Xiaoyang LI ; Hecheng LI
Chinese Journal of Medical Education Research 2024;23(10):1326-1330
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.
4.Modulating gut microbiota improves neurological function and depressive symptoms in rats with post-stroke depression
Xinyi LI ; Yujie LIU ; Kechong DENG ; Yikui HU
Journal of Southern Medical University 2024;44(2):405-410
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.
5.Modulating gut microbiota improves neurological function and depressive symptoms in rats with post-stroke depression
Xinyi LI ; Yujie LIU ; Kechong DENG ; Yikui HU
Journal of Southern Medical University 2024;44(2):405-410
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.
6.Cognition and participation intention of patient-reported outcomes in patients with lower limb deep vein thrombosis: a qualitative study
Ranxun AN ; Yuan XU ; Lei WANG ; Yu WANG ; Haibo DENG ; Jianhua SUN ; Xiaojie WANG ; Liyun ZHU ; Qiaodan LU ; Xinyi ZHOU ; Yufen MA
Chinese Journal of Modern Nursing 2024;30(1):95-100
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.
7.Development of the PICC-related Thrombosis Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses and its reliability and validity
Ning ZHANG ; Yuan XU ; Haibo DENG ; Lei WANG ; Liyun ZHU ; Qiaodan LU ; Ranxun AN ; Xinyi ZHOU ; Yu WANG ; Jianhua SUN ; Yufen MA ; Xiaojie WANG
Chinese Journal of Modern Nursing 2024;30(4):453-460
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.
8.Progress in research on quality-sensitive indicators for prevention nursing care of venous thromboembolism
Ning ZHANG ; Yuan XU ; Liyun ZHU ; Xinyi ZHOU ; Ranxun AN ; Qiaodan LU ; Yu WANG ; Haibo DENG ; Lei WANG ; Jianhua SUN ; Yufen MA ; Xiaojie WANG
Chinese Journal of Modern Nursing 2024;30(8):1004-1009
Quality-sensitive indicators in nursing, as standards for evaluating nursing quality management, can quantitatively determine nursing outcomes. This article provides a comprehensive review of the framework and content of quality-sensitive indicators for venous thromboembolism (VTE) prevention nursing care. The indicators are discussed from three dimensions: structure, process, and outcome. The aim is to provide a reference for the future development of unified and standardized quality-sensitive indicators for VTE prevention nursing care, in order to guide clinical nurses in standardized preventive practices.
9.Progress in research on risk assessment models for cancer-associated thrombosis
Haoran SHI ; Qiaodan LU ; Yuan XU ; Xiaojie WANG ; Haibo DENG ; Lei WANG ; Jianhua SUN ; Yu WANG ; Liyun ZHU ; Ranxun AN ; Xinyi ZHOU ; Yufen MA
Chinese Journal of Modern Nursing 2024;30(8):1010-1017
Cancer-associated thrombosis (CAT) is a common complication and cause of death in cancer patients. Accurately and efficiently identifying high-risk groups for CAT using risk assessment models and implementing targeted early prevention is key. Although numerous CAT risk assessment models currently exist, their predictive capabilities vary across different populations. This article provides a comprehensive review of CAT risk assessment models and their application status, aiming to offer a reference for clinical nursing staff to understand and choose appropriate risk assessment tools.
10.Development of the Cancer-associated Thrombosis Prevention Knowledge, Attitude and Practice Questionnaire for Nurses and its reliability and validity tests
Haoran SHI ; Yuan XU ; Xiaojie WANG ; Haibo DENG ; Lei WANG ; Jianhua SUN ; Yu WANG ; Liyun ZHU ; Qiaodan LU ; Ranxun AN ; Xinyi ZHOU ; Yufen MA
Chinese Journal of Modern Nursing 2024;30(16):2124-2130
Objective:To develop the Cancer-associated Thrombosis (CAT) Prevention Knowledge, Attitude and Practice Questionnaire for Nurses, and conduct reliability and validity tests.Methods:This study was a questionnaire development study. Guided by the theory of knowledge, attitude, and practice, an initial CAT Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses was formed through literature review, group discussion, two rounds of expert consultation, and pre-survey. From April to May 2023, convenience sampling was used to select 700 in-service nurses from Chinese Academy of Medical Sciences & Peking Union Medical College as the research subject, and the reliability and validity of the questionnaire were tested.Results:A total of 700 questionnaires were distributed, and 593 valid questionnaires were collected, with a valid response rate of 84.71% (593/700). The final version of the CAT Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses included three dimensions of knowledge, attitude, and practice, with a total of 39 items. The scale-level content validity index ( S- CVI) was 1.000, with an average S- CVI of 0.971 and an item-level CVI (I- CVI) of 0.860 to 1.000. Exploratory factor analysis extracted a total of seven common factors, with a cumulative variance contribution rate of 77.376%. The total Cronbach's α coefficient of the questionnaire was 0.937, and the Cronbach's α coefficients for each dimension were 0.923, 0.987, and 0.979. The half reliability coefficient was 0.984. After two weeks, the reliability coefficients for each dimension of retesting were 0.959, 1.000, and 0.994. Conclusions:The CAT Prevention Knowledge, Attitude, and Practice Questionnaire for Nurses developed in this study has good reliability and validity, and can be used as an evaluation tool for the cognition of clinical nurses in CAT prevention.

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