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.Analysis of clinical manifestations and prognosis of primary systemic light chain amyloidosis with liver involvement
Tongtong QIAO ; Yang LIU ; Nan PENG ; Lizhong GONG ; Xuelin DOU ; Lei WEN ; Jin LU
Chinese Journal of Hepatology 2024;32(3):222-227
Objective:To summarize the clinical manifestations and prognostic factors of patients with hepatic amyloidosis in a single center.Methods:The clinical data of 28 primary systemic light chain amyloidosis cases with liver involvement in our center from October 2012 to January 2023 were retrospectively analyzed. The main clinical manifestations and prognostic factors were studied. Statistical analysis were performed using the χ 2 test, Fisher's exact test, Wilcoxon rank test, or Kaplan-Meier survival curve log-rank test according to the different data. Results:The main clinical manifestations of patients with liver involvement were abdominal distension, hepatomegaly, and edema. CD56 and chemokine receptor 4 protein expression accounted for 52% (13/25) and 56% (14/25). 64.3% (9/14) patients were combined with t (11,14), and 21.4% (3/14) patients were positive for 1q21 (+), and no patients were detected with del(17p). Univariate analysis showed that Mayo 2004 and 2012 stages and total bilirubin (TBil) ≥34.2 μmol/L were associated with progression-free survival and overall survival. The median progression-free survival and overall survival were significantly inferior in patients with TBil≥34.2μmol/L group (0.178 years, 0.195 years) than with the TBil<34.2μmol/L group (0.750 years, 3.586 years) ( P ?0.05). Conclusion:Mayo stage and hyperbilirubinemia are inferior prognostic factors for patients with primary systemic light chain amyloidosis accompanied with liver involvement.
3.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.
4.Efficacy and safety analysis of a combination regimen with BCL-2 inhibitor in relapsed/refractory primary systemic light chain amyloidosis with t(11;14) from a single center
Aili ZHAI ; Yang LIU ; Nan PENG ; Lizhong GONG ; Xuelin DOU ; Lei WEN ; Jin LU
Chinese Journal of Internal Medicine 2023;62(11):1323-1328
Objective:To explore the efficacy and safety of BCL-2 inhibitor-based treatment in patients with relapsed/refractory t (11; 14) primary systemic light chain amyloidosis.Methods:This was a retrospective case series study. Ten patients with relapsed/refractory t(11;14) primary systemic light chain amyloidosis who had all received treatment with a combination regimen including the BCL-2 inhibitor venetoclax from January 2018 to November 2022 at the Hematology Department of Peking University People′s Hospital were included. Adverse events, and hematological and organ responses were evaluated.Results:The median age of the ten enrolled patients was 59 (range 41-78) years, and the male to female ratio was 8∶2. Except for one patient, a very good partial or better response was achieved in 8/9 patients and one patient obtained a partial response. The overall response rate was 100%. The median time to achieve a hematological response was 60 (range 24-236) days. At least one organ response was observed in 7/9 patients. With a median follow-up of 18 months, one patient experienced hematological progression and one patient died. Grade 3 adverse events included lymphocytopenia (3 cases), anemia (1 case), diarrhea (1 case), and appendicitis (1 case). One patient died of pulmonary fungal infection two months after completion of treatment, which was not excluded as being treatment related.Conclusion:A combination regimen including BCL-2 inhibitors in patients with relapsed/refractory t(11;14) primary systemic light chain amyloidosis is a potentially safe and effective treatment option that warrants further investigation.
5.Interpretation of expert consensus for the American Gastroenterological Association clinical practice update on de-prescribing of proton pump inhibitors
Xuelin SUN ; Yatong ZHANG ; Pengfei JIN ; Xin HU
Chinese Journal of Geriatrics 2022;41(12):1419-1423
In 2022, the American Gastroenterological Association(AGA)published an expert consensus on the AGA's clinical practice update on PPI prescription cancellation in the Journal of Gastroenterology.In view of the excessive and unreasonable use of proton pump inhibitors(PPIs), experts were organized to formulate a set of ten practical suggestions on how to guide outpatient patients to reduce and stop using PPI.Based on the current situation of PPI use in China and the needs of clinical practice, this paper interpreted the consensus from the perspective of pharmacists, so as to provide reference for further regulating the rational use of PPI and reducing the excessive use and adverse reactions of PPI.
6.Comparison of management models of chronic noncommunicable diseases in China and abroad
Xuelin SUN ; Dongfang QIAN ; Zixuan ZHANG ; Xin HU ; Pengfei JIN
Chinese Journal of Geriatrics 2022;41(5):614-618
The management model of chronic noncommunicable diseases(chronic diseases)in the elderly is related to the outcome and outcome of patients.The main advantages of chronic disease management in foreign countries are the burden of medical insurance, the interconnection of medical institutions in a limited scope, the primary health workers leading, and the active participation of patients.Although the form of chronic disease management in the community is also included in China and guidance documents have been issued, there is still a need for improvement in policy implementation, information system, community resources and patient education.
7.Analysis of the efficacy and safety of plerixafor combined with G-CSF in plasma cell disease mobilization
Wenbing DUAN ; Xuelin DOU ; Wen LEI ; Fengrong WANG ; Xiaojun HUANG ; Jin LU
Chinese Journal of Hematology 2021;42(1):21-26
Objective:To analyze the effect and safety of plerixafor combined with G-CSF mobilization in plasma cell disease.Methods:The clinical baseline data, success rate of collection, and adverse reactions of consecutive cases of plasma cell disease were analyzed retrospectively, where the patients received plerixafor combined with G-CSF for autologous hematopoietic stem cell mobilization in Peking University People's Hospital from January 2018 to December 2019.Results:Forty-nine patients with plasma disease were included, of which 39 (79.6% ) were multiple myeloma, 8 (16.3% ) were amyloidosis, and 2 (4.1% ) were monoclonal gammopathy of renal significance. A total of 16 patients (32.7% ) had renal insufficiency, and 7 patients (14.3% ) had previous collection failure. The median times of apheresis was 1 (1-3) , median days of apheresis was 2 (1-3) days, 47 patients (95.9% ) were successfully collected for once, and the success rate of collection for twice was 100% after using plerixafor for mobilization. In 16 patients with renal insufficiency, collection was successful in 5 patients (31.3% ) on the first day, while aphresis was required in 8 patients (50% ) on the second day and 3 (18.8% ) on the third day. The main adverse reactions were fatigue, insomnia, abdominal pain, diarrhea, dizziness, and arthralgia. A total of 37 patients underwent autologous hematopoietic stem cell transplantation with 11 (8-13) days for neutrophil engraftment, and 11 (9-26) days for platelet engraftment.Conclusions:Plerixafor combined with G-CSF has a high success rate in mobilizaion of autologous hematopoietic stem cells in patients with plasma cell disease with minimum side effects, even in patients with renal insufficiency.
8.Associations of single nucleotide polymorphisms of UCP genes with diabetic retinopathy in Chinese Han population
Peiyao, JIN ; Zhiqiang, LI ; Xian, XU ; Jiangnan, HE ; Jianhua, CHEN ; Xun, XU ; Xuan, DU ; Xuelin, BAI ; Bo, ZHANG ; Xiangui, HE ; Lina, LU ; Jianfeng, ZHU ; Yongyong, SHI ; Haidong, ZOU
Chinese Journal of Experimental Ophthalmology 2017;35(8):737-742
Background Researches showed that elevatory blood glucose level results in long-term damage of cells and tissue,or metabolic memory phenomenon,and manipulation of hyperglycemic memory is a good approach in the prevention of diabetic complications.However,its mechanism is not clear.It is speculated that the pathogenesis of diabetic retinopathy (DR) in diabetic patients may be associated to related mechanisms.Uncoupling proteins (UCPs) can decrease the production of reactive oxygen species (ROS),which may be related to DR.Objective This study was to explore the association between DR and the single nucleotide polymorphisms (SNPs) of UCP genes in Chinese Han population with type 2 diabetes.Methods A cross-sectional study was performed.This study was approved by Ethic Committee of Affiliated First Hospital of Shanghai Jiao Tong University and complied with Declaration of Helsinki,and written informed consent was obtained from each subject prior to any medical examination.One thousand eight hundreds and seventy-five patients with type 2 diabetes mellitus were enrolled in Xinjing district of Shanghai city by cluster sampling from November 2014 to January 2015.The demographic and medical baseline characteristics,ocular examination and laboratory tests were obtained and periphery blood of 2 ml was collected for extraction of DNA.Eight tag SNPs of UCP1,three tag SNPs of UCP2,and seven tag SNPs of UCP3 were selected as marker locus for the detection of genotype by Sequenom Mass ARRAY.Matrix-assisted laser desorption ionization-time of flight (MALDI-TOF) mass spectrometry platform were used for genotyping.Hardy-Weinberg equilibrium (HWE) analysis,allele and genotype frequencies,haplotype analysis,and association tests for DR and SNPs were performed by SAS and SHEsis software.Results A total of 530 DR patients were checked out from 1 875 subjects with type 2 diabetes mellitus,with the detection rate of 28.27%.rs660339 locn of UCP2 gene and rs1626521,rs668514 locus of UCP3 gene appeared to have low detectable rates,and the secondary allele base frequency of rs632862 in UCP2 gene was <0.01 and rs15763 of UCP3 gene was unmatched with HWE,therefore,these locus analysis was not included.In 13 SNPs locus included in the analysis,only 2 SNPs of UCP1 gene were related to DR.Compared with the non-diabetic retinopathy (NDR) patients,the G allele frequency of rs10011540 was increased (P =0.03,OR =1.31,95 % confidence interval[CI] =1.03-1.67,and T allele frequency of rs3811787 was decreased (P=0.04,OR=0.86,95% CI=0.75-0.99) in DR patients.Genotyping detection showed that the C/C and A/A frequencies of rs3811790 in UCP1 gene were significantly more and C/A frequency was less in DR patients than those in NDR patients (all at P<0.01).The logistic regression analysis indicated an association of SNPs of rs10011540 and rs3811787 with DR independent from glucose and disease duration.Conclusions The SNPs of rs10011540 and rs3811787 locus in UCP1 gene are associated with DR in Chinese type 2 diabetes patients.
9.Impact of the re-modified Sugiura procedure on portal hemodynamics and liver function in cirrhotic patients with portal hypertension
Jiangbo GONG ; Lida WU ; Xuelin JIN ; Shiyu ZHAO ; Jizong XU ; Jianxin JIANG
Chinese Journal of Hepatobiliary Surgery 2017;23(2):90-94
Objective To evaluate the impact of the re-modified Sugiura procedure on portal hemodynamics and liver function in cirrhotic patients with portal hypertension.Methods Forty patients with cirrhosis and portal hypertension who underwent the re-modified Sugiura procedure in the Yichang Second People's Hospital from June 2006 to October 2014 were studied.Changes in the free portal pressure (FPP),portal venous flow (PVF) and liver functions before and after operation were analyzed.Results (1) The FPP at different phases of the operation (after opening the abdomen,after splenectomy,and after devascularization) were (43.2 ± 1.8) cmH2O,(34.8 ± 1.6) cmH2O and (35.2 ± 1.7) cmH2O,respectively.There were significant differences in FPP between the phases of after splenectomy and after opening the abdomen,as well as after devascularization and after opening the abdomen (P < 0.05).There was no significant difference in FPP between after devascularization and after splenectomy (P > O.05).(2) The PVF,which were measured with Doppler sonography at 4 time points (preoperative 1 day,postoperative 10 days,postoperative 6 months,postoperative 18 months),were (1 420.4 ± 137.7) ml/min,(1 205.2 ± 126.7) ml/min,(875.8 ± 118.0) ml/min and (893.8 ± 114.7) n1/min,respectively.There were significant differences in PVF between postoperative 10 days and preoperative 1 day,between postoperative 6 months and postoperative 10 days,as well as between postoperative 18 months and preoperative 1 day (P <0.05).There was no significant difference in PVF between postoperative 18 months and postoperative 6 months (P >0.05).(3)The liver functions were evaluated using the Child-Pugh score at 4 time points (preoperative 1 day,postoperative 10 days,postoperative 6 months,postoperative 18 months).There were no significant differences among the time points,(P > 0.05).Conclusion The re-modified Sugiura's procedure durably,appropriately and effectively reduced the PVF and FPP,but it did not have any negative effects on the liver functions of patients with cirrhosis.
10.Comparison of immune effects between hepatitis B-BCG combined vaccine and hepatitis B vaccine
Lijie JIN ; Xiaolin ZHAO ; Xuan LUO ; Yan CAI ; Xuelin DONG ; Wei LI
Chinese Journal of Immunology 2001;0(10):-
Objective:To compare immune effects of hepatitis B-BCG combined vaccine and hepatitis B vaccine.Methods:The vaccines were administered to the guinea pig at 0, 1, 2 months. The tests were divided into three parts. The immune effects were compared in three kinds of the combined vaccine and hepatitis B vaccine(Part One), in three lots of the combined vaccine and hepatitis B vaccine(Part Two), in the group of combined vaccine and the group of hepatitis B vaccine and BCG(Part Three). After 1 month of each vaccine dose, serum specimens were measured for anti-HBs by ELISA.Results:The several studies have documented the serum anti-HBs concentritious in the group of combined vaccine in first dose were lower than those of the group of control, and the data showed no significantly difference. However, anti-HBs levels of the combined vaccine group in second vaccine dose and third vaccine dose were higher than those of the control group, and this difference was no longer statistically significant in group of combined vaccine and control, and among groups of combined vaccine.Conclusion:The immune efficacy of HBsAg in group of combined vaccine is similar to the group of hepatitis B vaccine in three doses immunization schedules.

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