1.Optimization of drug management model for investigator-initiated trial with benchmarking analysis
Yufei XI ; Tianxiao WANG ; Xue ZHANG ; Yingzhuo DING ; Li YAN ; Feng JIANG ; Xiangui HE ; Jiannan HUANG ; Qin LI
China Pharmacy 2025;36(3):280-284
		                        		
		                        			
		                        			OBJECTIVE To optimize the management model of drugs used in investigator-initiated trial (IIT). METHODS With benchmarking analysis, based on the practical work experience of a tertiary specialized hospital in the field of IIT drug management in Shanghai, a thorough review was conducted, involving relevant laws, regulations, and academic literature to establish benchmark criteria and the evaluation standards. Starting from the initiation of IIT projects, a detailed comparative analysis of key processes was carried out, such as the receipt, storage, distribution, use and recycling of drugs for trial. The deficiencies in the current management of IIT drugs were reviewed in detail and a series of optimization suggestions were put forward. RESULTS It was found that the authorized records of drug management were missing, the training before project implementation was insufficient, and the records of receipt and acceptance of IIT drugs were incomplete. In light of these existing problems, improvement measures were put forward, including strengthening the training of drug administrators and stipulating that only drug administrators with pharmacist qualifications be eligible to inspect and accept drugs, etc. The related systems were improved, and 17 key points of quality control for the management of IIT drugs were developed. CONCLUSIONS A preliminary IIT drug management system for medical institutions has been established, which helps to improve the institutional X2023076) framework of medical institutions in this field.
		                        		
		                        		
		                        		
		                        	
2.Influencing factors for autism spectrum disorder in Chinese children: a meta analysis
CHEN Xi ; YANG Hongsheng ; LI Wei ; ZHAI Rui ; JIANG Yanlin ; WANG Junhong
Journal of Preventive Medicine 2025;37(2):181-188
		                        		
		                        			Objective:
		                        			To systematically evaluate the influencing factors for autism spectrum disorder (ASD) in Chinese children, so as to provide the evidence for risk prediction and intervention of ASD.
		                        		
		                        			Methods:
		                        			The publications pertaining to the influencing factors for ASD in Chinese children were retrieved from CNKI, Wanfang Data, VIP, PubMed and Embase database from inception to August 2024. A meta-analysis was performed using R package version 4.4.1. Sensitivity analysis was performed using the "leave-one-out" evaluation procedure. Publication bias was assessed using Egger regression test.
		                        		
		                        			Results:
		                        			A total of 38 high-quality articles out of 9 015 articles were finally included, covering 149 607 individuals, with 5 974 cases of ASD. The meta-analysis showed that demographic factors including family history of related diseases (OR=14.958), maternal age of ≥35 years (OR=2.287) and parental history of hazardous occupations (OR=3.511); pregnancy-related factors including history of abortion (OR=5.832), no folate supplementation before and during pregnancy (OR=4.566), tobacco exposure before and during pregnancy (OR=2.596), history of other adverse exposures before and during pregnancy (OR=3.533), history of infectious diseases during pregnancy (OR=3.753), history of non-infectious diseases during pregnancy (OR=2.563), psychological problems during pregnancy (OR=3.864), history of medication during pregnancy (OR=6.651), adverse environmental exposures during pregnancy (OR=3.754), severe pregnancy reactions (OR=5.082), abnormal perinatal period (OR=2.987), cesarean delivery (OR=1.659), other perinatal adverse factors (OR=3.856), history of neonatal asphyxia (OR=2.792) and neonatal jaundice (OR=3.687); parenting factors including non-exclusive breastfeeding (OR=2.510), early/excessive screen exposure (OR=3.589) and feeding problems (OR=3.113); and individual factors including being male (OR=3.333) and history of convulsions/epilepsy (OR=7.035) were influencing factors for ASD in Chinese children.
		                        		
		                        			Conclusions
		                        			The prevalence of ASD in Chinese children is primarily associated with 23 influencing factors, including family history of related diseases, history of abortion, no folate supplementation before and during pregnancy, medication during pregnancy, early/excessive screen exposure and history of convulsions/epilepsy.
		                        		
		                        		
		                        		
		                        	
3.Relevance between parental psychological control and Internet gaming disorder in middle school students
WANG Xi, JIANG Hong, WANG Lina, ZHANG Hua, ZHANG Wei, MA Le
Chinese Journal of School Health 2025;46(4):544-547
		                        		
		                        			Objective:
		                        			To analyze the relationship between parental psychological control and Internet Gaming Disorder (IGD) among junior high school students, so as to provide evidence for preventing IGD development in adolescents.
		                        		
		                        			Methods:
		                        			From August 2019 to February 2020, a survey was conducted among 1 169 junior high school students from three middle schools in Xian using stratified cluster sampling. The Parental Psychological Control Scale and IGD Scale were administered to assess parental psychological control and IGD prevalence. Univariate and binary Logistic regression analyses were used to explore IGD risk factors and their correlation with parental psychological control.
		                        		
		                        			Results:
		                        			The detection rate of IGD in middle school students was 19.9%(184/1 169). Multivariate Logistic regression revealed that compared to those with lower parental psychological control scores(≤21 points), students with higher parental psychological control scores (>21 points) had a higher risk of IGD (OR=1.82, 95%CI=1.21-2.74), a 1.58fold higher risk of selfperceived gaming addiction (95%CI=1.07-2.30), as well as reduced likelihood of seeking external help to reduce gaming time (OR=0.66, 95%CI=0.47-0.94) (P<0.05).
		                        		
		                        			Conclusions
		                        			Parental psychological control may elevate the risks of IGD and selfperceived addiction while diminishing proactive helpseeking behaviors to reduce gaming time. Parents should enhance communication with adolescents and provide positive guidance to mitigate potential gamingrelated harms.
		                        		
		                        		
		                        		
		                        	
4.Research Advance of Chinese Medicine in Treating Atherosclerosis: Focus on Lipoprotein-Associated Phospholipase A2.
Lu-Ming WANG ; Wen-Lan ZHANG ; Nuan LYU ; Yan-Rong SUO ; Lin YANG ; Bin YU ; Xi-Juan JIANG
Chinese journal of integrative medicine 2024;30(3):277-288
		                        		
		                        			
		                        			As a serious cardiovascular disease, atherosclerosis (AS) causes chronic inflammation and oxidative stress in the body and poses a threat to human health. Lipoprotein-associated phospholipase A2 (Lp-PLA2) is a member of the phospholipase A2 (PLA2) family, and its elevated levels have been shown to contribute to AS. Lp-PLA2 is closely related to a variety of lipoproteins, and its role in promoting inflammatory responses and oxidative stress in AS is mainly achieved by hydrolyzing oxidized phosphatidylcholine (oxPC) to produce lysophosphatidylcholine (lysoPC). Moreover, macrophage apoptosis within plaque is promoted by localized Lp-PLA2 which also promotes plaque instability. This paper reviews those researches of Chinese medicine in treating AS via reducing Lp-PLA2 levels to guide future experimental studies and clinical applications related to AS.
		                        		
		                        		
		                        		
		                        			Humans
		                        			;
		                        		
		                        			1-Alkyl-2-acetylglycerophosphocholine Esterase
		                        			;
		                        		
		                        			Medicine, Chinese Traditional
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		                        			Atherosclerosis/drug therapy*
		                        			;
		                        		
		                        			Lipoproteins
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		                        			Plaque, Atherosclerotic
		                        			;
		                        		
		                        			Biomarkers
		                        			
		                        		
		                        	
5.Consensus statement on research and application of Chinese herbal medicine derived extracellular vesicles-like particles (2023 edition).
Qing ZHAO ; Tong WANG ; Hongbin WANG ; Peng CAO ; Chengyu JIANG ; Hongzhi QIAO ; Lihua PENG ; Xingdong LIN ; Yunyao JIANG ; Honglei JIN ; Huantian ZHANG ; Shengpeng WANG ; Yang WANG ; Ying WANG ; Xi CHEN ; Junbing FAN ; Bo LI ; Geng LI ; Bifeng LIU ; Zhiyang LI ; Suhua QI ; Mingzhen ZHANG ; Jianjian ZHENG ; Jiuyao ZHOU ; Lei ZHENG ; Kewei ZHAO
Chinese Herbal Medicines 2024;16(1):3-12
		                        		
		                        			
		                        			To promote the development of extracellular vesicles of herbal medicine especially the establishment of standardization, led by the National Expert Committee on Research and Application of Chinese Herbal Vesicles, research experts in the field of herbal medicine and extracellular vesicles were invited nationwide with the support of the Expert Committee on Research and Application of Chinese Herbal Vesicles, Professional Committee on Extracellular Vesicle Research and Application, Chinese Society of Research Hospitals and the Guangdong Engineering Research Center of Chinese Herbal Vesicles. Based on the collation of relevant literature, we have adopted the Delphi method, the consensus meeting method combined with the nominal group method to form a discussion draft of "Consensus statement on research and application of Chinese herbal medicine derived extracellular vesicles-like particles (2023)". The first draft was discussed in online and offline meetings on October 12, 14, November 2, 2022 and April and May 2023 on the current status of research, nomenclature, isolation methods, quality standards and research applications of extracellular vesicles of Chinese herbal medicines, and 13 consensus opinions were finally formed. At the Third Academic Conference on Research and Application of Chinese Herbal Vesicles, held on May 26, 2023, Kewei Zhao, convenor of the consensus, presented and read the consensus to the experts of the Expert Committee on Research and Application of Chinese Herbal Vesicles. The consensus highlights the characteristics and advantages of Chinese medicine, inherits the essence, and keeps the righteousness and innovation, aiming to provide a reference for colleagues engaged in research and application of Chinese herbal vesicles at home and abroad, decode the mystery behind Chinese herbal vesicles together, establish a safe, effective and controllable accurate Chinese herbal vesicle prevention and treatment system, and build a bridge for Chinese medicine to the world.
		                        		
		                        		
		                        		
		                        	
6.Thinking on ideological and political education in Medical Parasitology teaching
Xi ZHANG ; Shaorong LONG ; Ruodan LIU ; Peng JIANG ; Jing CUI ; Zhongquan WANG
Chinese Journal of Schistosomiasis Control 2024;36(1):87-90
		                        		
		                        			
		                        			 With the deepening reform of ideological and political education, Medical Parasitology teaching needs to update the teaching concept, change the teaching ideas, as well as keep trying to combine ideological and political education with the curriculum content closely. In addition to teaching students’ basic knowledge and practical skills, teachers are needed to cultivate their moral literacy and political awareness through course teaching, so as to provide the basis for students’ subsequent adaptations to social environments and jobs. Currently, the study of ideological and political education in Medical Parasitology teaching is still in the exploratory stage. Therefore, colleges and universities need to carry out effective construction of ideological and political education in Medical Parasitology teaching, in order to achieve good teaching outcomes and provide insights into ideological and political education in teaching. 
		                        		
		                        		
		                        		
		                        	
		                				7.An unprecedented pair of Z /E  isomeric pyridinium compound from the aqueous extract of Aspongopus chinensis  Dallas
		                			
		                			Chun-jiang WANG ; Can-xi YANG ; Ling-xi REN ; Shao LIU ; Yue-ping JIANG
Acta Pharmaceutica Sinica 2024;59(1):166-169
		                        		
		                        			
		                        			 A novel pair of 
		                        		
		                        	
8.Impact of pembrolizumab combined with chemotherapy on angiogenesis and circulating endothelial cells in patients with advanced non-small cell lung cancer
Xi JIANG ; Yongcun WU ; Yan LIANG ; Li CHU ; Yingxin DUAN ; Lijun WANG ; Junjie HUO
Journal of International Oncology 2024;51(2):89-94
		                        		
		                        			
		                        			Objective:To explore the impact of pembrolizumab combined with chemotherapy on angiogenesis and circulating endothelial cells in patients with advanced non-small cell lung cancer (NSCLC) .Methods:The retrospective analysis of clinical data from 121 patients diagnosed with advanced NSCLC who were admitted to the Second Affiliated Hospital of Xingtai Medical College from August 2021 to January 2023 was conducted. These patients were divided into a control group ( n=57) and an observation group ( n=64) based on the designated treatment protocol. Specifically, individuals in the control group received standard chemotherapy (cisplatin+paclitaxel), while those in the observation group underwent penpilimab therapy in conjunction with conventional chemotherapy. The comparative assessment encompassed short-term clinical efficacy, quality of life, immune function parameters, angiogenic factors [including endostatin, insulin-like growth factor 1 (IGF-1), and vascular endothelial growth factor (VEGF) ], circulating endothelial cells, and adverse reactions within the two groups. Results:After 6 courses of treatment, the objective response rate [67.19% (43/64) vs. 49.12% (28/57) ] and disease control rate [87.50% (56/64) vs. 70.18% (40/57) ] in observation group were higher than those in control group, with statistically significant differences ( χ2=4.06, P=0.044; χ2=5.52, P=0.019). The quality of life score of observation group [ (56.77±6.81) points] was significantly higher than that of control group [ (47.73±8.23) points], with a statistically significant difference ( t=6.61, P<0.001) ; The T cell subgroup CD3 + levels [ (63.59±9.00) % vs. (53.06±8.80%), t=6.49, P<0.001], CD4 + levels [ (46.54±8.20) % vs. (30.74±7.32) %, t=11.13, P<0.001] and CD4 +/CD8 + ratio (1.90±0.36 vs. 1.21±0.28, t=11.66, P<0.001) in observation group were significantly higher than those in control group, with statistically significant differences; Endostatin in observation group [ (48.99±3.43) μmol/L] was significantly higher than that in control group [ (31.35±3.87) μmol/L], with a statistically significant difference ( t=26.58, P<0.001), IGF-1 [ (102.31±20.35) μg/L vs. (134.98±19.02) μg/L] and VEGF [ (31.70±4.32) pg/ml vs. (58.71±5.99) pg/ml] were significantly lower in observation group than those in control group, with statistically significant differences ( t=18.73, P<0.001; t=28.14, P<0.001). The number of circulating endothelial cells in observation group [ (58.77±10.03) /ml] was significantly lower than that in control group [ (87.01±8.01) /ml], with a statistically significant difference ( t=17.20, P<0.001). During treatment, there were no statistically significant differences in the incidence of gastrointestinal reaction ( χ2=0.01, P=0.908), leukopenia ( χ2=0.64, P=0.424), thrombocytopenia ( χ2=0.28, P=0.597), anemia ( χ2=1.66, P=0.197), nephrotoxicity ( χ2=0.64, P=0.424), skin rash ( χ2=1.33, P=0.249) between the two groups. Conclusion:The combination therapy of pembrolizumab and chemotherapy for the treatment of advanced NSCLC has demonstrated noteworthy effectiveness. This regimen has the potential to enhance patients' immune functionality, ameliorate their overall quality of life, suppress angiogenesis, and exhibits a commendable profile of safety and reliability.
		                        		
		                        		
		                        		
		                        	
9.Diagnostic value of endoscopic ultrasound-guided tissue acquisition with rapid on-site evaluation performed by endoscopists in immunohistochemistry-required solid pancreatic lesions
Dingkun XIONG ; Yongru LIU ; Yunlu FENG ; Yu ZHAO ; Xi WU ; Tao GUO ; Qingwei JIANG ; Qiang WANG ; Dongsheng WU ; Shengyu ZHANG ; Yingyun YANG ; Aiming YANG
Chinese Journal of Pancreatology 2024;24(1):39-44
		                        		
		                        			
		                        			Objective:To evaluate the diagnostic value of rapid on-site evaluation (ROSE) performed by endoscopists for solid pancreatic lesions requiring tissue for immunohistochemistry (IHC) staining with different approach of endoscopic ultrasound-guided tissue acquisition (EUS-TA).Methods:After screening 1 573 cases who underwent EUS-TA operation at the Endoscopy Center of Peking Union Medical College Hospital between August 2018 and October 2022, a total of 65 cases of solid pancreatic lesions whose diagnosis rely on IHC staining was collected and summarized with clinical data of each case. Among 65 cases, there were 46 cases of pancreatic neuroendocrine tumors (PNETs), 13 cases of pancreatic solid pseudo-papillary tumors (SPTs), and 6 cases of lymphomas and mesenchymal. Patients were categorized into ROSE group (36 cases) and non-ROSE group (29 cases) according to the presence or absence of endoscopists performed ROSE during EUS-TA operation. They were further divided into subgroups of FNA-ROSE (26 cases), FNB-ROSE (10 cases), FNA-non-ROSE (24 cases) and FNB-non-ROSE (5 cases) according to the type of EUS-TA. Diagnostic accuracy and IHC success rate were compared between different groups and subgroups. Binomial logistic multifactorial regression analysis was used to evaluate the influence of ROSE and EUS-TA type on diagnostic accuracy and IHC success rate.Results:There were no statistically significant differences between ROSE group and non-ROSE group in terms of age, gender, bilirubin level, CA19-9 level, lesion site, lesion size, composition ratio of diagnosis, and surgical rate. The differences in mean size of lesions, needle gauge, location of puncturation, and number of needle pass between subgroups were not statistically significant. The diagnostic accuracy was 88.9% in ROSE group and 79.3% in non-ROSE group, and the difference between the two groups was statistically significant ( P=0.023). The diagnostic accuracy of FNA-ROSE group was higher than that of FNA-non-ROSE group (88.5% vs 75.0%), but the difference was not statistically significant ( P>0.100). The differences in diagnostic accuracy and success rate of IHC between FNB-ROSE group and FNB-non-ROSE group were not statistically significant. Binomial logistic multifactorial regression analysis did not reveal any independent influences on diagnostic accuracy. Conclusions:ROSE performed by endoscopists improved diagnostic accuracy of EUS-TA in solid pancreatic lesions requiring IHC staining, and therefore is potentially valuable for improving the diagnostic efficiency of EUS-TA for such diseases.
		                        		
		                        		
		                        		
		                        	
10.Application of the excellent doctor-oriented teaching evaluation method in the clinical teaching of dermatology and venereology
Ting LIU ; Ruimin JIANG ; Yujuan WANG ; Xi DUAN ; Jia HE ; Jie CHEN ; Liang LIU
Chinese Journal of Medical Education Research 2024;23(3):391-396
		                        		
		                        			
		                        			Objective:To investigate the application value of the teaching evaluation method guided by cultivating "excellent doctors" in the clinical teaching of dermatology and venereology.Methods:A non-simultaneous control study was conducted, and the medical students who received theoretical learning and clinical internship in Department of Dermatology and Venereology, Affiliated Hospital of North Sichuan Medical College, from March 2020 to February 2022, were enrolled as subjects. According to the order of enrollment, 32 students who were enrolled from March 2020 to February 2021 were set up as control group, and 31 students who were enrolled from March 2021 to February 2022 were set up as experimental group. The students in the control group received lecture-based learning, and those in the experimental group received clinical teaching using a teaching and evaluation method guided by cultivating "excellent doctors". After the course ended, the two groups were compared in terms of the scores of theoretical knowledge and operation skills, clinical thinking ability [Self-Assessment of Clinical Reasoning and Reflection (SACRR)], core competence [Mini-Clinical Evaluation Exercise (Mini CEX)], and degree of satisfaction with teaching. SPSS 25.0 software was used to perform the independent samples t-test, the Mann-Whitney U test, the chi-square test, and the rank sum test. Results:One student in the control group voluntarily withdrew from the study, and one student in the experimental group did not complete the contents of internship. Finally, 31 students in the control group and 30 in the experimental group were included in the study. After 4 weeks of internship, compared with the control group, the experimental group had significantly higher scores of theoretical knowledge (88.00±4.30 vs. 85.71±4.12, t=2.12, P=0.040) and operation skills (91.87±3.99 vs. 88.23±3.84, t=3.63, P<0.05). After 4 weeks of internship, compared with the control group, the experimental group had significantly higher information systematization score (47.23±3.11 vs. 45.16±3.00), analysis problem score (34.87±2.30 vs. 31.29±2.30), truth finding score (16.30±1.49 vs. 14.45±1.52), reflective ability score [3.50 (3.00, 4.00) vs. 3.00 (3.00, 3.00)], and total score of SACRR (101.87±4.47 vs. 93.90±4.47), with significant differences between the two groups ( t/ Z=2.65, 6.17, 4.79, 3.15, and 6.96, all P<0.05). After 4 weeks of internship, the experimental group had a significantly better core competence than the control group ( Z=2.12, P=0.030); compared with the control group, the experimental group had significantly higher classroom teaching score (20.17±1.98 vs. 18.45±2.23, t=3.17, P<0.05), clinical practice score (19.83±2.10 vs. 17.65±2.17, t=4.00, P<0.05), learning plan score (18.63±2.24 vs. 17.03±2.15, t=2.85, P<0.05), teaching resource score (20.07±1.82 vs. 18.58±2.00, t=3.04, P<0.05) and total score (78.70±3.67 vs. 71.71±4.13, t=6.98, P<0.05). Conclusions:The application of the teaching and evaluation method guided by cultivating "excellent doctors" in the clinical teaching of dermatology and venereology can improve clinical theoretical knowledge, practical operation skills, clinical thinking ability, and core ability among interns and thus help to improve teaching quality. Therefore, it holds promise for clinical application.
		                        		
		                        		
		                        		
		                        	
            

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