1.Survey on the perception and current status of drug risk management in medical institutions
Xuelin SUN ; Mingqing XING ; Zixuan ZHANG ; Wenjing ZHAO ; Dongfang QIAN ; Yan LIANG ; Li XU ; Pengfei JIN ; Yatong ZHANG
China Pharmacy 2025;36(1):7-12
OBJECTIVE To know about the perception and current status of drug risk management among pharmacists in Chinese medical institutions, providing insights and recommendations for enhancing the drug risk management system in medical institutions. METHODS A questionnaire survey was conducted across 28 provinces, cities, and autonomous regions; stratified radom sampling was employed to study the population of medical workers and pharmaceutical professionals in medical institutions nationwide. The survey included information on the survey population, the current status of drug risk management implementation in medical institutions, the cognition, definition and process of drug risk management related concepts, and the content and mode of drug risk management work in medical institutions. Finally, suggestions were collected from various medical institutions on the system construction of drug risk management. Descriptive statistical analysis was adopted to summarize the obtained data. RESULTS A total of 446 questionnaires were collected in this survey, including 420 valid questionnaires and 26 invalid questionnaires. The questionnaire collection rate was 100%,and the effective rate was 94.17%. 51.19% of the respondents No.2020YFC2009001)。 based their understanding of drug risk management on Management Measures for Adverse Drug Reaction Reports and Monitoring, while 87.38% recognized the need for drug risk management throughout the drug use process. 63.33% of the participants stated that their medical institutions had dedicated positions related to drug risk management, with the highest proportion (72.17%) was in third-grade class A medical institutions. 66.43% reported implementing risk management across all drug use stages. Suggestions for the development of drug risk management systems in medical institutions by the research participants focused on enhancing guiding documents, clarifying concepts, establishing information-sharing mechanisms. CONCLUSIONS The overall awareness of drug risk management in China’s medical institutions is high, with practices in place across various stages in multiple forms. However, there remains a need to strengthen institutional documents, management regulations, system development, and information-sharing mechanisms to improve collaborative governance, improve drug management levels, and ensure patient safety.
2.The correlation between abnormal metabolic indexes and the severity of coronary artery lesions in patients with acute coronary syndrome
Yajun ZHAO ; Ming LIU ; Yuxiang DAI ; Xiaopan LI ; Xuelin CHENG ; Qizhe WANG ; Ru LIU ; Yaxin XU ; Sunfang JIANG
Chinese Journal of Clinical Medicine 2025;32(3):441-448
Objective To explore the influencing factors of coronary artery lesion severity in patients with acute coronary syndrome (ACS). Methods Clinical data of ACS patients admitted to Zhongshan Hospital, Fudan University from December 2017 to December 2019 were consecutively collected. The modified Gensini score was used to assess the severity of coronary artery lesions. Univariate and multivariate linear regression analyses were performed to identify independent factors associated with coronary artery lesion severity. Results A total of 1 689 ACS patients were included, with an average age of (64.04±11.45) years; 1 353 (80.11%) were male, and the mean modified Gensini score was (8.12±4.03). Multivariate linear regression analysis revealed that sex (β=0.97, P=0.001), age (β=0.03, P=0.021), estimated glomerular filtration rate (eGFR; β=-0.03, P<0.001), low-density lipoprotein cholesterol (LDL-C; β=0.58, P<0.001), apolipoprotein A1 (Apo A1; β=-1.28, P=0.012), lipoprotein(a) [Lp(a); β=0.001, P=0.033], and glycated hemoglobin A1C (HbA1C; β=0.45, P<0.001) were independent influencing factors of the modified Gensini score. Conclusions Metabolic indicators, including Apo A1, LDL-C, HbA1C, and Lp(a), may serve as risk factors for coronary artery lesion severity in ACS patients, with Apo A1 demonstrating the strongest impact.
3.Mechanism of Modified Tianwang Buxindan on Skin of Sleep-deprived Mice Through PI3K/Akt/Nrf2 Signaling Pathway
Juanping CHEN ; Yuan PENG ; Xuemin HONG ; Li YANG ; Bo XU ; Chong ZHANG ; Xuelin GUO
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(11):120-128
ObjectiveTo observe the effect of modified Tianwang Buxindan (MTBD) on the skin of sleep-deprived (SD) mice and investigate its mechanism. MethodSixty 2-month-old female Kunming mice were randomly divided into a blank group, a model group, a vitamin C (VC, 0.08 g·kg-1), and MTBD low-, medium-, and high-dose groups (6.5, 12.5, 25 g·kg-1). Except for the blank group, the other groups were subjected to SD mouse model induction (using multiple platform water environment method for 18 hours of sleep deprivation daily from 15:00 to next day 9:00), continuously for 14 days, and caffeine (CAF, 7.5 mg·kg-1) was injected intraperitoneally from the 2nd week onwards, continuously for 7 days. While modeling, the blank group and the model group were administered with normal saline (0.01 mL·g-1), and the other groups received corresponding drugs for treatment. On the day of the experiment, general observations were recorded (such as body weight, spirit, fur, and skin). After sampling, skin tissue pathological changes were observed under an optical microscope using hematoxylin-eosin (HE) and Masson staining methods. Skin thickness and skin moisture content were measured. Biochemical assay kits were used to detect skin hydroxyproline (HYP) content, skin and serum superoxide dismutase (SOD) activity, and malondialdehyde (MDA) content. Enzyme-linked immunosorbent assay (ELISA) was used to detect serum interleukin (IL)-6, tumor necrosis factor (TNF)-α, and IL-1β levels in mice. Western blot was used to detect skin tissue type Ⅰ collagen (ColⅠ), type Ⅲ collagen (ColⅢ), phosphatidylinositol 3-kinase (PI3K), phosphorylated (p)-PI3K, protein kinase B (Akt), p-Akt, nuclear factor E2-related factor 2 (Nrf2), heme oxygenase (HO)-1, and nuclear factor (NF)-κB protein expression. ResultCompared with the blank group, the model group showed varying degrees of changes. In general, signs of aging such as reduced body weight (P<0.01), listlessness, dull fur color, and formation of wrinkles on the skin appeared. Tissue specimen testing revealed skin thinning, flattening of the dermoepidermal junction (DEJ), and reduced collagen fibers under the optical microscope. Skin thickness and moisture content decreased, skin tissue HYP content significantly decreased (P<0.01), skin and serum SOD activity significantly decreased (P<0.01), and MDA content significantly increased (P<0.01). Serum IL-6, TNF-α, and IL-1β levels significantly increased (P<0.01). Skin ColⅠ, ColⅢ, p-PI3K/PI3K, p-Akt/Akt, Nrf2, and HO-1 protein expression significantly decreased (P<0.05, P<0.01), and NF-κB expression increased (P<0.01). Compared with the model group, the VC group and the MTBD low-dose group showed increased skin moisture content, HYP content, SOD activity, and ColⅠ, ColⅢ, p-PI3K/PI3K protein expression (P<0.05, P<0.01), and decreased serum MDA content (P<0.05). In addition, a decrease in serum IL-6 and IL-1β levels was detected in the MTBD low-dose group (P<0.05), while the above indicators in the MTBD medium- and high-dose groups improved (P<0.05, P<0.01). ConclusionSleep deprivation accelerates the aging process of the skin in SD model mice. MTBD can improve this phenomenon, exerting anti-inflammatory and antioxidant effects, and its mechanism of action may be related to the activation of the PI3K/Akt/Nrf2 signaling pathway.
4.Bibliometric analysis of researches on liver organoids
Canli XU ; Wenxing HE ; Lei WANG ; Fangting WU ; Jiahui WANG ; Xuelin DUAN ; Tiejian ZHAO ; Bin ZHAO ; Yang ZHENG
Chinese Journal of Tissue Engineering Research 2024;28(7):1099-1104
BACKGROUND:In recent years,the development of liver organoids has made it a hot spot in the field of international liver disease research,but there is still no article on the bibliometric analysis of liver organoids. OBJECTIVE:To explore the hot trends in liver organoids in the last 20 years based on bibliometrics and visualization analysis. METHODS:We searched the articles about liver organoids in the Web of Science Core Collection from January 1,2002 to November 12,2022.Origin,Office,and CiteSpace software were used for bibliometrics and visualization analysis.We statistically analyzed the number of annually published articles,countries,institutions,authors,journals,and keywords of the articles by generating charts. RESULTS AND CONCLUSION:The number of articles,citation frequency,institutions and personnel involved in the research about liver organoids showed an overall upward trend in the last 20 years,indicating that the field was growing rapidly and attention was increasing.The USA had published the most papers and had the strongest influence in this field.Although it had invested a lot of time and energy,the number of papers published by a single research institution in the USA was not the highest among many research institutions.China was second only to the USA in the number of publications,with the Chinese Academy of Sciences and Fudan University leading the list.Utrecht University in the Netherlands was the institution with the most publications.Clevers H was the author with the highest number of articles.The article with the highest co-citation frequency was"Long-term culture of genome-stable bipotent stem cells from adult human liver".The main fields of study for liver organoids were Molecular Science,Biology,and Immunology.The most frequently occurring keywords were stem cell,in vitro,and culture.The research hotspots in the liver organoids field were mainly focused on in vitro stem cell three-dimensional culture,differentiation and gene expression.
5.Hospital Centralized Monitoring of Post-market Clinical Safety of Naoxintong Capsules in 7 345 Patients
Chunxiao LI ; Xiao LING ; Xuelin LI ; Jinfa TANG ; Yuhuan CHEN ; Hui ZHANG ; Tao XU ; Yantao JIN ; Bo ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(17):157-165
ObjectiveTo evaluate the clinical safety of Naoxintong (NXT) capsules after marketing, find out the potential risk factors of the drug as soon as possible, and reveal the incidence, nature, and clinical manifestations of the adverse events (ADE) and adverse reactions (ADR) of NXT capsules, so as to provide a basis for safe use of the drug in clinical practice. MethodA prospective, large-sample, multi-center observational cohort study was conducted to monitor all the 7 345 inpatients and outpatients orally taking NXT in 14 hospitals in China from January to December in 2018, with at least one follow-up. The demographic characteristics, disease type, NXT medication, ADR occurrence, characteristics, and prognosis of the patients were collected. SPSS 23.0 was used for single-factor and multivariate logistic regression to predict the influencing factors of ADR. ResultThe male and female patients accounted for similar proportions. There were 5 081 patients (79.40%) aged ≥60 years and 3 153 patients (49.27%) with body mass index (BMI) exceeding the normal standard. There were 344 (5.38%) patients with a history of allergy to medicines and food, 9 (0.14%) patients with a family history of allergy, and 52 (0.81%) patients with a history of allergic diseases. The ADRs associated with NXT occurred in 22 patients, with the incidence of 0.34%. The clinical manifestations of ADR appeared in 31 cases, involving 10 organs/systems, of which gastrointestinal system damage was the most common (17, 54.84%). All ADRs were mild or moderate. Most ADRs (19, 86.36%) occurred within 4 weeks after administration. The patients with alleviated NXT-associated ADRs accounted for 81.82%. No indicators related to significant increases in ADR risks were found. ConclusionNXT is well tolerated in the general population. The hospital centralized monitoring for the clinical safety of oral Chinese patent drugs based on HIS data and Web tracking and follow-up system is an essential means for the post-market research on the safety of drugs.
6.Severity and multiple indexes of jaundice in ABO hemolytic disease of fetus and newborn: a comparative analysis
Ronghua XU ; Xingyu HOU ; Chunhua XIONG ; Yaping XING ; Xuelin JI ; Xiaofeng XU ; Ping LI
Chinese Journal of Blood Transfusion 2023;36(8):693-696
【Objective】 To explore the correlation between the severity of jaundice in ABO hemolytic disease of fetus and newborn (HDFN) and multiple indicators, in order to achieve accurate diagnosis, timely treatment, and prevent complications in ABO HDFN. 【Methods】 From March 2020 to February 2023, a total of 283 ABO HDFN in our hospital were classified into mild, moderate and severe groups based on total bilirubin levels. The differences in basic data, relevant laboratory indicators and the agglutination intensity of the three hemolysis tests were analyzed and compared. 【Results】 In the severe group, 75% (12/16) were male infants, which was significantly higher compared to 37.5% (57/152) in the moderate group (P<0.05). The values (mg/dL) of transcutaneous jaundice in the mild, moderate and severe groups were:forehead 9.88±1.93 vs 12.34±2.01 vs 15.56±2.69, face 10.25±2.27 vs 13.28±2.32 vs 15.99±2.86, chest 9.67±2.16 vs 12.51±2.11 vs 15.33±2.36, respectively. The values(µmol/L) of direct bilirubin (DBIL) and indirect bilirubin (IBIL) were 9.87±2.06 vs 11.90±2.59 vs 16.12±4.73, and 159.36±37.55 vs 252.98±30.52 vs 353.76±55.68, respectively, and the differences between the mild, moderate and severe groups were statistically significant (all P<0.05) . The creatine kinase (CK) values(unit/L) of mild, moderate and severe groups were 664.15±498.26 vs 500.51 ±451.63 vs 402.63±224.27, and the difference between the mild group and the other two groups was statistically significant (P<0.05) . There was no statistically significant difference in the agglutination intensity of the three hemolysis tests among HDFN with different severity of jaundice. 【Conclusion】 Clinicians can predict the severity of jaundice in light of gender, transcutaneous jaundice, DBIL, IBIL and CK of ABO HDFN, for further and graded treatment, so as to avoid the sequelae or even life-threatening consequences caused by ABO HDFN.
7.Analysis of the relationship between serum ficolin-3, ALA level and gestational diabetes
Huanzhen ZHOU ; Xuelin XU ; Xiaoxiao YU ; Rongrong XUAN ; Jiajie LI
Chinese Journal of Endocrine Surgery 2022;16(2):196-200
Objective:To investigate the relationship between serum fibrous gel protein-3 (ficolin-3) and serum alanine (ALA) levels and gestational diabetes (GDM) .Methods:A total of 98 pregnant women with GDM admitted to our hospital from Jan. 2020 to Aug. 2020 were selected as the observation group, and 98 healthy pregnant women undergoing physical examination during the same period were taken as the control group. The level of serum ficolin-3 was measured by enzyme-linked immunosorbent assay (ELISA) , and the level of serum ALA was measured by high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) . The two groups were compared in terms of serum ficolin-3, ALA levels and biochemical indicators (hemoglobin (HbA1c) , total cholesterol (TC) , high-density lipoprotein cholesterol (HDL-C) , low-density lipoprotein cholesterol (LDL-C) , serum total protein (TP) , serum urea (SU) levels) , and pregnancy outcomes. Pearson method was used to analyze the correlation between serum ficolin-3 and ALA levels and various biochemical indexes. Univariate analysis and binary logistic regression analysis were used to investigate the risk factors of GDM.Results:Serum ficolin-3, HbA1c, and SU levels in the observation group were all higher than that in the control group. Serum ALA level was lower than that in the control group, and the difference was statistically significant ( P<0.05) . TC, HDL-C, LDL-C, TPT showed no significant difference between the two groups ( P>0.05) . In the observation group, serum ficolin-3 was positively correlated with HbA1c and Su, and serum ALA was negatively correlated with HbA1c and SU ( P < 0.05) . The incidence of adverse outcomes including gestational neonatal asphyxia, neonatal jaundice, giant size, and amniotic fluid contamination in the observation group (26.53%) was higher than that in the control group (12.24%) , The difference was statistical significant ( P<0.05) . The univariate analysis showed that GDM was associated with age, weight gain during pregnancy, serum ficolin-3, ALA, HbA1c, SU, family history of diabetes ( P<0.05) ; Binary logistics regression analysis found that age ≥28 years, weight gain≥ 14 kg, serum ficolin-3≥24ng/ml, HbA1c 6.0%, and a family history of diabetes were risk factors for GDM, while serum ALA≥1.9 μg/ml was a protective factor of GDM, ( P<0.05) . Conclusion:The increase of serum ficolin-3 and the decrease of ALA level in pregnant women are risk factors of GDM, and have an adverse impact on the final delivery outcome
8.Research progress in impurity control of ursodeoxycholic acid
Xuelin SUN ; Wenfeng XU ; Xin HU
China Pharmacy 2022;33(21):2681-2684
Ursodeoxycholic acid (UDCA)is a natural hydrophilic bile acid derived from cholesterol ,which has a low content in human body ,and can be used for the treatment of gallstones ,cholestatic liver disease ,fatty liver and so on . Due to the differences in the synthesis process ,source of active pharmaceutical ingredients (API)and impurity control standards of UDCA at home and abroad ,the author summarized the synthesis process of UDCA at home and abroad by searching relevant literature ,and analyzed the impurity sources and impurity control standards of API . The results showed that the pharmacopoeia of the United States,the United Kingdom and Europe put forward clear requirements on the synthesis route and impurity control of UDCA ,and formulated corresponding impurity control standards . However,synthesis process and impurity detection standards of UDCA were relatively simple in China . It is suggested that domestic research institutions constantly improve impurity spectrum ,promote the synthesis process ,and improve the quality detection standards of UDCA ,so as to provide a reference for pharmaceutical study and reasonable clinical application of UDCA .
9.Effect of sodium octanoate on renal-intestinal ischemia-reperfusion injury after resuscitation from traumatic cardiac arrest in pigs
Xuelin YANG ; Qi CHEN ; Tengda ZHOU ; Qingli CHEN ; Jiefeng XU ; Guangju ZHOU ; Mao ZHANG
Chinese Journal of Trauma 2022;38(12):1123-1131
Objective:To investigate the effect of sodium octanoate on renal-intestinal ischemia- reperfusion injury (IRI) after resuscitation from traumatic cardiac arrest in pigs.Methods:Twenty-two miniature piglets with a body weight of (37.6±2.5)kg were divided into three groups according to the random-number table method: normal group ( n=7), IRI group ( n=7) and IRI-treated group ( n=8). A renal-intestinal IRI model of the pig was established by allowing femoral artery to bleed through blood pump at a rate of 2 ml·kg -1·min -1 until cardiac arrest, followed by whole blood transfusion through the femoral vein at a rate of 5 ml·kg -1·min -1 after observation for 6 minutes, and 50% of total blood loss was reinfused before resuscitation. Both the IRI group and IRI-treated group were with IRI model, while normal group was just monitored without induction of IRI. Besides, IRI-treated group was injected intravenously with sodium octanoate (30 mg/kg) for 1 hour at 5 minutes after restoration of spontaneous circulation (ROSC). (1) The rate of resuscitation success, survival rate at 4, 24 hours after resuscitation, blood loss when reaching cardiac arrest criteria and resuscitation time when reaching the ROSC criteria were compared in the three groups. (2) Levels of serum creatinine (SCr), urea nitrogen (BUN), intestinal fatty acid binding protein (iFABP) and diamine oxidase (DAO) were measured before resuscitation and at 1, 2, 4, 24 hours after resuscitation. (3) The animals were sacrificed at 24 hours post-resuscitation to harvest renal and intestinal tissues rapidly. TUNEL test was applied for the cellular apoptosis index. Prussian blue was used to detect the rate of iron deposition. Western blot analysis was used to measure levels of glutathione peroxidase 4 (GPX4) and acyl-CoA synthetase long-chain family member4 (ACSL4). Results:In three groups, all pigs survived. There was no significant difference in blood loss or resuscitation time between IRI group and IRI-treated group (all P>0.05). There was no significant difference in levels of SCr, BUN, iFABP or DAO before resuscitation and at 1, 2, 4, 24 hours after resuscitation in normal group (all P>0.05). But their levels were gradually increased at 1, 2, 4, 24 hours after resuscitation from that before resuscitation in IRI group and IRI-treated group (all P<0.01). Among three groups, levels of SCr, BUN, iFABP and DAO had no significant difference before resuscitation (all P>0.05), but showed obvious increase in IRI group and the IRI-treated group at 1, 2, 4, 24 hours after resuscitation compared with normal group, especially in IRI group (all P<0.01). In normal group, IRI group and IRI-treated group after 24 hours for resuscitation, the cellular apoptosis index of renal tissues was (2.3±0.8)%, (44.0±5.4)% and (13.8±4.3)%; the cellular apoptosis index of intestinal tissues was (2.6±0.9)%, (61.3±10.4)% and (20.8±3.7)%; the rate of iron deposition of renal tissues was (0.6±0.1)%, (3.9±1.0)% and (1.7±0.3)%; the rate of iron deposition of intestinal tissues was (0.8±0.1)%, (4.9±0.9)% and (2.1±0.5)% (all P<0.01). The cellular apoptosis index and rate of iron deposition of both renal and intestinal tissues were the highest in IRI group. The renal-intestinal expression of GPX4 in IRI group and IRI-treated group was lower than that in normal group at 24 hours after resuscitation (all P<0.05), with the lowest in IRI group. The renal-intestinal expression of ACSL4 in IRI group and IRI-treated group was higher than that in normal group at 24 hours after resuscitation (all P< 0.01), with the highest in IRI group. Conclusion:Sodium octanoate can reduce renal-intestinal IRI after resuscitation from traumatic cardiac arrest in pigs, the mechanism for which is probably due to that sodium octanoate can inhibit cellular apoptosis and reduce ferroptosis by regulating the expression levels of GPX4 and ACSL4.
10.Application of laparoendoscopic single-site combined with transurethral approach for unilateral retrograde nephroureterectomy
Zhonglei DENG ; Xuelin SU ; Jian SU ; Luming SHEN ; Yang ZHANG ; Lin YUAN ; Ninghong WANG ; Guojiang XU ; Ping ZHOU ; Qingyi ZHU
Chinese Journal of Urology 2020;41(11):820-824
Objective:To investigate the feasibility and safety of laparoendoscopic single-site combined with transurethral approach for unilateral retrograde nephroureterectomy in the treatment of upper urinary tract epithelial carcinoma.Methods:The clinical data of 12 patients from January 2018 to November 2019 with unilateral retrograde nephroureterectomy were analyzed retrospectively. There were 7 males and 5 females with an average age of 65.9 years, the age ranged from 50 to 78 years.There were 8 cases with left ureteral tumor, 6 cases with left renal pelvis tumor, 4 cases with right tumor(2 cases of right ureteral tumor and 2 cases of right renal pelvis tumor). Surgical methods: 1470 laser sleeve was used to remove the inner segment of the ureter bladder wall after the lower ureter was clipped through abdominal approach, and the urethra was inserted under the guidance of zebra guide wire.The operation time, intraoperative blood loss, intraoperative auxiliary cannula, postoperative hospital stay, postoperative drainage tube removal time, intraoperative and postoperative complications, postoperative pathology were recorded.Results:All of the operations were successful. The mean operation time was 194(135-260)min, the mean estimated blood loss was 50(25-100) ml, and the mean hospitalization time was 11.6(5-24)d. Among the 12 patients, 8 patients had abdominal drainage tube after operation. The mean time for drainage was 6.8(3-11)d. One patient added a 5 mm ancillary port.One patient had urinary leakage at the bladder anastomotic site, the catheter was removed 3 weeks later. The other patients had no postoperative incision infection, fever, bleeding, venous thrombosis and other related complications.No patient received blood transfusion and the pathological margin was negative. The median follow-up time was 12 months (5-15 months). One patient died of lumbar metastasis 8 months after operation, and others were neither tumor recurrence nor distant metastasis.Conclusions:The application of laparoendoscopic single-site combined with transurethral approach for unilateral retrograde nephroureterectomy in the treatment of upper urinary tract epithelial carcinoma is safe, accurate and effective, with less trauma and less bleeding. It is worth applying in clinical practice.

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