1.Practice and evaluation of pharmacists’participation in long-term MTM models for stroke patients based on family doctor system
Lu SHI ; Chun LIU ; Lian TANG ; Jingjing LI ; Sudong XUE ; Yanxia YU ; Wenwen LI ; Keren YU ; Jianhui XUE ; Wen MA ; Hongzhi XUE
China Pharmacy 2025;36(9):1129-1134
OBJECTIVE To investigate the clinical efficacy of integrating pharmacists into family health teams (FHTs) for long-term medication therapeutical management (MTM) in stroke patients, and empirically evaluate the service model. METHODS A pharmacist team, jointly established by clinical and community pharmacists from the Affiliated Suzhou Hospital of Nanjing Medical University (hereinafter referred to as “our hospital”), developed a pharmacist-supported MTM model integrated into FHTs. Using a prospective randomized controlled design, 170 stroke patients discharged from our hospital (July 2022-December 2023) and enrolled in FHTs at Suzhou Runda Community Hospital were randomly divided into trial group (88 cases) and control group (82 cases) according to random number table. The control group received routine FHTs care (without pharmacist involvement in the team collaboration), while the trial group xhz8405@126.com received 12-month MTM services supported by pharmacists via an information platform. These services specifically included innovative interventions such as personalized medication regimen optimization based on the MTM framework, dynamic medication adherence management, medication safety monitoring, a home medication assessment system, and distinctive service offerings. Outcomes of the 2 grousp were compared before and after intervention, involving medication adherence (adherence rate, adherence score), compliance rates for stroke recurrence risk factors [blood pressure, low-density lipoprotein cholesterol (LDL-C)], and incidence of adverse drug reactions (ADR). RESULTS After 12 months, the trial group exhibited significantly higher medication adherence rates, improved adherence scores, higher compliance rates for blood pressure and LDL-C targets compared to the control group (P<0.05). The incidence of ADR in the trial group (4.55%) was significantly lower than that in the control group (8.11%), though the difference was not statistically significant (P> 0.05). CONCLUSIONS Pharmacist involvement in FHTs to deliver MTM services significantly enhances medication adherence and optimizes risk factor for stroke recurrence, offering practical evidence for advancing pharmaceutical care in chronic disease management under the family doctor system.
2.Comparison of in vivo pharmacokinetics of six active constituents from Shaoyao Gancao Decoction in normal and gastric ulcer rats
He-Rong LI ; Yang JIN ; Huan ZHANG ; Tian-Tai WU ; Jian WEN ; Chao TANG ; Xue-Yi CHENG ; Wen LIU
Chinese Traditional Patent Medicine 2024;46(11):3572-3578
AIM To compare the in vivo pharmacokinetics of paeoniflorin,paeoniflorin,liquiritin,isoliquiritin,liquiritigenin and glycyrrhizic acid from Shaoyao Gancao Decoction in normal and gastric ulcer rats.METHODS Six rats were randomly assigned into two groups,after which the 75%ethanol-induced gastric ulcer model was established,the gastric tissues were collected.Twelve rats were randomly assigned into two groups and given intragastric administration(9.9 g/kg),after which blood collection was made at different time points,UPLC-MS/MS method was adopted in the determination of plasma concentrations,and main pharmacokinetic parameters were calculated.RESULTS Prolonged Tmax(P<0.05,P<0.01)of various active constituents,prolonged T1/2,MRT0-t(P<0.05,P<0.01),increased Cmax,AUC(P<0.05,P<0.01)and decreased Vd/F,CL/F(P<0.05,P<0.01)of paeoniflorin,increased Cmax,AUC(P<0.05,P<0.01)and decreased CL/F(P<0.05)of albiflorin,prolonged MRT(P<0.05),increased AUC(P<0.05)and decreased CL/F(P<0.01)of liquiritin,prolonged MRT(P<0.05,P<0.01)and decreased Vd/F(P<0.05)of isoliquiritin,no obviously changed pharmacokinetic parameters(except for Tmax)of liquiritigenin(P>0.05),and prolonged T1/2,MRT0-∞(P<0.05,P<0.01),increased Cmax,AUC(P<0.05,P<0.01)and decreased CL/F(P<0.01)of glycyrrhizic acid were observable in the model group as compared with those in the normal group.CONCLUSION Gastric ulcer exhibits certain influences on the velocities and degrees of in vivo absorption and metabolism of active constituents from Shaoyao Gancao Decoction.
3.Risk factors analysis and clinical prediction model construction of adenomatous polyps in patients with colorectal melanoma melanosis coli
Xue ZHANG ; Zuo TANG ; Xin YE ; Li-Ming WEN
Modern Interventional Diagnosis and Treatment in Gastroenterology 2024;29(2):126-134
Objective To explore the risk factors for the occurrence of adenomatous polyps in melanosis coli(MC),and to construct and validate a risk prediction model for the occurrence of adenomatous polyps in MC.Methods The clinical data of patients with melanosis coli who underwent colonoscopy in our hospital were retrospectively analyzed.The related risk factors,including gender,age,smoking history,drinking history,hypertension history,diabetes history,melanosis degree and so on,were collected.Establish a column chart model for predicting the risk of adenomatous polyps using R language,evaluate the model through C-index,calibration curve,and decision curve analysis(DCA),and validate the model internally using Bootstrap method.Results Gender,degree of melanosis,homocysteine,HbA1c,TSH,fecal occult blood,gallstones or polyps,HP infection were the independent influencing factors of adenomatous polyps in patients with melanosis of large intestine.The model had a good discrimination in predicting the risk of adenomatous polyps in patients with colorectal melanosis.Hosmer Lemeshow goodness of fit test showed that the P values of the training set and the validation set were 0.157 and 0.179,respectively(both<0.05),indicating that the model fitted well.When the threshold probability of the training set and the validation level were both 0%to 100%,patients with melanosis of the colon may benefit from clinical intervention.Conclusion The risk model established by the above risk factors has good discrimination and good fit,which can provide reference for clinical decision-making.
4.Modification and implementation of digital operating room based on hospital LAN
Wen-Jun TANG ; Ming LU ; Xue-Ya LIANG
Chinese Medical Equipment Journal 2024;45(4):93-97
The basic situation of the digital operating room in some hospital was introduced,and the necessity and requirements for the modification of the digital operating room were described.The overall structure and signal transmission and control mode were expounded for the modified digital operating room based on hospital LAN.The configuration schemes and application effects of the digital operating room before and after the modification were compared.It's pointed out that the modified digital operating room provided a convenient clinical environment and enhanced the quality of surgical relay and academic conferences while improving the working efficiency.References were given for the construction of digital operating rooms of other hospitals.[Chinese Medical Equipment Journal,2024,45(4):93-97]
5.A multi-center epidemiological study on pneumococcal meningitis in children from 2019 to 2020
Cai-Yun WANG ; Hong-Mei XU ; Gang LIU ; Jing LIU ; Hui YU ; Bi-Quan CHEN ; Guo ZHENG ; Min SHU ; Li-Jun DU ; Zhi-Wei XU ; Li-Su HUANG ; Hai-Bo LI ; Dong WANG ; Song-Ting BAI ; Qing-Wen SHAN ; Chun-Hui ZHU ; Jian-Mei TIAN ; Jian-Hua HAO ; Ai-Wei LIN ; Dao-Jiong LIN ; Jin-Zhun WU ; Xin-Hua ZHANG ; Qing CAO ; Zhong-Bin TAO ; Yuan CHEN ; Guo-Long ZHU ; Ping XUE ; Zheng-Zhen TANG ; Xue-Wen SU ; Zheng-Hai QU ; Shi-Yong ZHAO ; Lin PANG ; Hui-Ling DENG ; Sai-Nan SHU ; Ying-Hu CHEN
Chinese Journal of Contemporary Pediatrics 2024;26(2):131-138
Objective To investigate the clinical characteristics and prognosis of pneumococcal meningitis(PM),and drug sensitivity of Streptococcus pneumoniae(SP)isolates in Chinese children.Methods A retrospective analysis was conducted on clinical information,laboratory data,and microbiological data of 160 hospitalized children under 15 years old with PM from January 2019 to December 2020 in 33 tertiary hospitals across the country.Results Among the 160 children with PM,there were 103 males and 57 females.The age ranged from 15 days to 15 years,with 109 cases(68.1% )aged 3 months to under 3 years.SP strains were isolated from 95 cases(59.4% )in cerebrospinal fluid cultures and from 57 cases(35.6% )in blood cultures.The positive rates of SP detection by cerebrospinal fluid metagenomic next-generation sequencing and cerebrospinal fluid SP antigen testing were 40% (35/87)and 27% (21/78),respectively.Fifty-five cases(34.4% )had one or more risk factors for purulent meningitis,113 cases(70.6% )had one or more extra-cranial infectious foci,and 18 cases(11.3% )had underlying diseases.The most common clinical symptoms were fever(147 cases,91.9% ),followed by lethargy(98 cases,61.3% )and vomiting(61 cases,38.1% ).Sixty-nine cases(43.1% )experienced intracranial complications during hospitalization,with subdural effusion and/or empyema being the most common complication[43 cases(26.9% )],followed by hydrocephalus in 24 cases(15.0% ),brain abscess in 23 cases(14.4% ),and cerebral hemorrhage in 8 cases(5.0% ).Subdural effusion and/or empyema and hydrocephalus mainly occurred in children under 1 year old,with rates of 91% (39/43)and 83% (20/24),respectively.SP strains exhibited complete sensitivity to vancomycin(100% ,75/75),linezolid(100% ,56/56),and meropenem(100% ,6/6).High sensitivity rates were also observed for levofloxacin(81% ,22/27),moxifloxacin(82% ,14/17),rifampicin(96% ,25/26),and chloramphenicol(91% ,21/23).However,low sensitivity rates were found for penicillin(16% ,11/68)and clindamycin(6% ,1/17),and SP strains were completely resistant to erythromycin(100% ,31/31).The rates of discharge with cure and improvement were 22.5% (36/160)and 66.2% (106/160),respectively,while 18 cases(11.3% )had adverse outcomes.Conclusions Pediatric PM is more common in children aged 3 months to under 3 years.Intracranial complications are more frequently observed in children under 1 year old.Fever is the most common clinical manifestation of PM,and subdural effusion/emphysema and hydrocephalus are the most frequent complications.Non-culture detection methods for cerebrospinal fluid can improve pathogen detection rates.Adverse outcomes can be noted in more than 10% of PM cases.SP strains are high sensitivity to vancomycin,linezolid,meropenem,levofloxacin,moxifloxacin,rifampicin,and chloramphenicol.[Chinese Journal of Contemporary Pediatrics,2024,26(2):131-138]
6.Investigation and disposal of a cluster of suspected neonatal bloodstream infection with carbapenem-resistant Klebsiella pneumoniae
Yu-Lin LI ; Wen-Ting CHEN ; Xue-Yun LI ; Chan NIE ; Song-Tao HAN ; Li-Yuan CHEN ; Lan TANG ; Zhen-Yu WANG ; Ya-Hui LI ; Yan XU ; Xia MU
Chinese Journal of Infection Control 2024;23(8):1031-1036
Objective To investigate the causes of a cluster of suspected neonatal carbapenem-resistant Klebsiella pneumoniae(CRKP)bloodstream infection(BSI)in the neonatal department of a hospital,and provide references for the effective control of the occurrence of healthcare-associated infection(HAI).Methods Epidemiological in-vestigation on 3 neonates with CRKP BSI in the neonatal department from January 31 to February 6,2023 was per-formed.Specimens from environmental object surfaces were taken for environmental hygiene monitoring,and effec-tive control measures were taken according to the risk factors.Results From January 31 to February 6,2023,a to-tal of 60 neonates were admitted in the neonatal department,including 16 with peripherally inserted central venous catheter(PICC).Three neonates had CRKP BSI,with a incidence of 5.00%.There were 33 hospitalized neonates on the day(February 7)when the cluster of HAI was reported,with a prevalence rate of 9.09%(3/33).CRKP BSI rate in the neonatal department of this hospital from January 31 to February 6,2023 was higher than that in 2022(P<0.001).The incubators of the 3 neonates with CRKP BSI were in the same ward and adjacent to each other.The first neonate with CRKP BSI(who developed BSI on January 31)underwent PICC maintenance on Feb-ruary 4,and the other 2 neonates with PICC maintenance immediately following the first one also developed CRKP BSI.CRKP were isolated from blood culture of all 3 neonates,and antimicrobial susceptibility testing results were consistent.Conclusion The occurrence of the cluster event of neonatal CRKP BSI may be related to the failure of strict implementation of aseptic procedures during PICC maintenance and cross contamination among items.
7.Discussion of the methodology and implementation steps for assessing the causality of adverse event
Hong FANG ; Shuo-Peng JIA ; Hai-Xue WANG ; Xiao-Jing PEI ; Min LIU ; An-Qi YU ; Ling-Yun ZHOU ; Fang-Fang SHI ; Shu-Jie LU ; Shu-Hang WANG ; Yue YU ; Dan-Dan CUI ; Yu TANG ; Ning LI ; Ze-Huai WEN
The Chinese Journal of Clinical Pharmacology 2024;40(2):299-304
The assessment of adverse drug events is an important basis for clinical safety evaluation and post-marketing risk control of drugs,and its causality assessment is gaining increasing attention.The existing methods for assessing the causal relationship between drugs and the occurrence of adverse reactions can be broadly classified into three categories:global introspective methods,standardized methods,and probabilistic methods.At present,there is no systematic introduction of the operational details of the various methods in the domestic literature.This paper compares representative causality assessment methods in terms of definition and concept,methodological steps,industry evaluation and advantages and disadvantages,clarifies the basic process of determining the causality of adverse drug reactions,and discusses how to further improve the adverse drug reaction monitoring and evaluation system,with a view to providing a reference for drug development and pharmacovigilance work in China.
8.Analyse 113 cases of chimeric antigen receptor T cell therapy products containing B-cell receptor-related protein CD19 from clinical trials individual case safety expedited reports and risk management
Min LIU ; Yan CHEN ; Wen-Ya TANG ; Feng XUE ; Hai-Xue WANG
The Chinese Journal of Clinical Pharmacology 2024;40(18):2757-2760
The chimeric antigen receptor T cell(CAR-T)therapy products approved for market and under development mainly targets the B-cell receptor-related protein CD19.This paper relies on the pharmacovigilance database during clinical trials of the Center for Drug Evaluation National Medical Products Administration.We retrospectively analyzed the 113 individual case safety expedited reports of suspected unexpected serious adverse reactions of CAR-T cell therapy products containing B-cell receptor-rolated protein CD19 from domestic clinical trials received from January 1,2021 to May 20,2024.Strengthen risk management according to product characteristics.It is expected that through this paper,the sponsors can improve the pharmacovigilance regime and system,timely report according to the requirements,strengthen the risk communication with the regulatory authorities,form a joint force with the regulatory authorities,and jointly do a good job in risk management during clinical trials.
9.Status on domestic clinical trials of chimeric antigen receptor T cell therapy products containing B-cell receptor-related protein CD19
Min LIU ; Yan CHEN ; Wen-Ya TANG ; Feng XUE ; Hai-Xue WANG
The Chinese Journal of Clinical Pharmacology 2024;40(19):2909-2912
In recent years,chimeric antigen receptor T cell(CAR-T)therapeutic products have shown good efficacy in the treatment of blood tumors,and breakthroughs have also been made in the treatment of solid tumors and autoimmune diseases.In order to further understand the clinical research and development progress of CAR-T products,this paper mainly uses the drug clinical trial registration and information publication platform of the Center for Drug Evaluation National Medical Products Administration as the information source,and focuses on the statistical analysis of the clinical trial progress of domestic CAR-T cell therapy products containing the targeted B-cell receptor-related protein CD19.It is hoped to further improve the quality and efficiency of clinical research and development of CAR-T cell therapy products,strengthen the sponsor's awareness of main responsibility,and timely update trial information to protect the rights and interests of subjects during clinical trials.
10.Leukocyte cell-derived chemotaxin 2(LECT2)regulates liver ischemia-reperfusion injury
Dong MENG-QI ; Xie YUAN ; Tang ZHI-LIANG ; Zhao XUE-WEN ; Lin FU-ZHEN ; Zhang GUANG-YU ; Huang ZHI-HAO ; Liu ZHI-MIN ; Lin YUAN ; Liu FENG-YONG ; Zhou WEI-JIE
Liver Research 2024;8(3):165-171
Background and aim:Hepatic ischemia-reperfusion injury(IRI)is a significant challenge in liver trans-plantation,trauma,hypovolemic shock,and hepatectomy,with limited effective interventions available.This study aimed to investigate the role of leukocyte cell-derived chemotaxin 2(LECT2)in hepatic IRI and assess the therapeutic potential of Lect2-short hairpin RNA(shRNA)delivered through adeno-associated virus(AAV)vectors. Materials and methods:This study analyzed human liver and serum samples from five patients under-going the Pringle maneuver.Lect2-knockout and C57BL/6J mice were used.Hepatic IRI was induced by clamping the hepatic pedicle.Treatments included recombinant human LECT2(rLECT2)and AAV-Lect2-shRNA.LECT2 expression levels and serum biomarkers including alanine aminotransferase(ALT),aspartate aminotransferase(AST),creatinine,and blood urea nitrogen(BUN)were measured.Histological analysis of liver necrosis and quantitative reverse-transcription polymerase chain reaction were performed. Results:Serum and liver LECT2 levels were elevated during hepatic IRI.Serum LECT2 protein and mRNA levels increased post reperfusion.Lect2-knockout mice had reduced weight loss;hepatic necrosis;and serum ALT,AST,creatinine,and BUN levels.rLECT2 treatment exacerbated weight loss,hepatic necrosis,and serum biomarkers(ALT,AST,creatinine,and BUN).AAV-Lect2-shRNA treatment significantly reduced weight loss,hepatic necrosis,and serum biomarkers(ALT,AST,creatinine,and BUN),indicating thera-peutic potential. Conclusions:Elevated LECT2 levels during hepatic IRI increased liver damage.Genetic knockout or shRNA-mediated knockdown of Lect2 reduced liver damage,indicating its therapeutic potential.AAV-mediated Lect2-shRNA delivery mitigated hepatic IRI,offering a potential new treatment strategy to enhance clinical outcomes for patients undergoing liver-related surgeries or trauma.

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