1.Optimizing the whole-process quality control system of intravenous drug distribution center based on failure mode and effect analysis
Wei WEI ; Mingxia ZHANG ; Yanping ZHOU ; Lan YAN ; Peng TIAN ; Xia FENG
Journal of Pharmaceutical Practice and Service 2026;44(6):322-328
Objective To explore the application effect of a standardized management method based on failure mode and effect analysis (FMEA) in optimizing the whole-process quality control system of the intravenous admixture service (PIVAS). Methods The quality control management system of the PIVAS was optimized by establishing six quality control groups led by the head nurse, with full participation of pharmacy, nursing, and logistical staff, ensuring comprehensive coverage and traceability of all quality control links. Each group conducted risk priority number (RPN) scoring for potential failure modes in their respective quality control processes, and targeted improvement measures were formulated based on the scoring results. The RPN values of failure modes and quality control-related evaluation indicators before and after implementation were compared to achieve closed-loop management. Results After one year of management, the RPN values of the six major failure modes significantly decreased compared to those before implementation (P<0.05). The compounding error rate dropped to 0.13%, the dispensing error rate decreased to 0.95%, the compounding efficiency increased to 98%, the delivery time was shortened by 0.45 h per batch, the intervention rate for irrational prescriptions rose to 94.87%, satisfaction improved to 96.78%, and the participation rate of quality control personnel reached 95.36% (P<0.05). Conclusion FMEA-based identification of potential failure modes in the whole-process quality control system of the IVAS, combined with risk quantification and targeted interventions, significantly reduced high-risk failure modes, improved compounding accuracy and efficiency, and ensured the safety of clinical intravenous medication and the effectiveness of healthcare quality management.
2.Optimizing the whole-process quality control system of intravenous drug distribution center based on failure mode and effect analysis
Wei WEI ; Mingxia ZHANG ; Yanping ZHOU ; Lan YAN ; Peng TIAN ; Xia FENG
Journal of Pharmaceutical Practice and Service 2026;44(6):322-328
Objective To explore the application effect of a standardized management method based on failure mode and effect analysis (FMEA) in optimizing the whole-process quality control system of the intravenous admixture service (PIVAS). Methods The quality control management system of the PIVAS was optimized by establishing six quality control groups led by the head nurse, with full participation of pharmacy, nursing, and logistical staff, ensuring comprehensive coverage and traceability of all quality control links. Each group conducted risk priority number (RPN) scoring for potential failure modes in their respective quality control processes, and targeted improvement measures were formulated based on the scoring results. The RPN values of failure modes and quality control-related evaluation indicators before and after implementation were compared to achieve closed-loop management. Results After one year of management, the RPN values of the six major failure modes significantly decreased compared to those before implementation (P<0.05). The compounding error rate dropped to 0.13%, the dispensing error rate decreased to 0.95%, the compounding efficiency increased to 98%, the delivery time was shortened by 0.45 h per batch, the intervention rate for irrational prescriptions rose to 94.87%, satisfaction improved to 96.78%, and the participation rate of quality control personnel reached 95.36% (P<0.05). Conclusion FMEA-based identification of potential failure modes in the whole-process quality control system of the IVAS, combined with risk quantification and targeted interventions, significantly reduced high-risk failure modes, improved compounding accuracy and efficiency, and ensured the safety of clinical intravenous medication and the effectiveness of healthcare quality management.
3.A qualitative study of the pregnancy and childbirth experience of pregnant and maternal women with the third child
Jiaai XIA ; Congshan PU ; Chunjian SHAN ; Xuan GU ; Xiangdi ZHANG ; Yan SHAN ; Mingying LÜ ; Ying WANG ; Linlin XIE ; Hui ZHOU
Chinese Journal of Nursing 2025;60(1):24-30
Objective To explore the deeper understanding of the pregnancy and delivery experience of three-child pregnant and matemal women,and to provide a basis for healthcare personnel to provide more systematic,safe,and targeted perinatal healthcare services and care measures for three-child pregnant and matemal women.Methods Purposive sampling method was used to select 17 cases of three-child pregnant and matemal women who were admitted and delivered in a tertiary level-A matemal and child healthcare hospital in Nanjing from August 2022 to June 2023 for semi-structured interviews,and Colaizzi 7-step process of analyzing,summarizing,and refining the themes was used.Results A total of 4 themes were extracted,including determination of willingness to become pregnant,perceived risks of childbirth,perceived benefits to themselves and their families,diversified support needs.Conclusion The establishment of pregnancy intention of three-child pregnant women is affected by many factors.Relevant departments should actively implement the supporting measures of the three-child birth policy;healthcare workers should strengthen perinatal healthcare services for three-child mothers to reduce the risk of giving birth,actively strengthen their sense of benefits related to pregnancy,and establish a whole process of support system to promote the health of mothers and infants.
4.Analysis of dynamic change patterns of six mycotoxin contents during the fermentation of Massa Medicata Fermentata
Shuang WANG ; Li ZHOU ; Hai-yan SHI ; Xia ZHAO ; Yan-wei CUI ; Hua-yin BAO ; Nan XU
Chinese Traditional Patent Medicine 2025;47(3):740-744
AIM To analyze the dynamic change patterns of aflatoxin B1,aflatoxin B2,aflatoxin G1,aflatoxin G2,T-2 toxin and deoxynivalenol contents during the fermentation of Massa Medicata Fermentata.METHODS The analysis was performed on a 40 ℃ thermostatic Waters ACQUITY UPLC HSS T3 column(100 mm×2.1 mm,1.8 μm),with the mobile phase comprising of 0.01%formic acid-[acetonitrile-methanol(1∶1)]flowing at 0.3 mL/min,and electron spray ionization source was adopted in positive ion scanning with multiple reaction monitoring mode.RESULTS Six mycotoxins showed good linear relationships within their own ranges(R2>0.998 0),whose average recoveries were 76.1%-119.3%with the RSDs of 0.49%-9.27%,and except for deoxynivalenol,their contents demonstrated the trends of growing out of nothing and gradually increasing.CONCLUSION The risk of mycotoxin infection exists in the fermentation of Massa Medicata Fermentata.This simple,efficient,rapid and sensitive method can provide a reference for whole-process monitoring the fermentation process for Massa Medicata Fermentata.
5.Effect of donepezil combined with hypoxia on CYP3A4 and its safety-evaluation
Xiao-xia HAN ; Yue-xin LI ; Wei TENG ; Fang WANG ; Hai-ying HONG ; Ze-shuai YI ; Ying SONG ; Yu-yan ZHOU ; Bao-xin LI ; Pan FAN
Chinese Pharmacological Bulletin 2025;41(12):2354-2361
Aim To investigate the regulatory mecha-nisms of donepezil on the expression and enzymatic ac-tivity of cytochrome P450 3A4(CYP3A4),elucidate the synergistic impact of hypoxia on CYP3A4 function,and reveal its potential association with drug-induced cardiotoxicity,particularly QT interval prolongation.Methods Western blot,co-immunoprecipitation,and gene knockdown techniques were employed to evaluate the effects of donepezil and hypoxia on CYP3A4 pro-tein expression.CYP3A4 enzymatic activity was as-sessed using an in vitro incubation system with rat liver microsomes combined with high-performance liquid chromatography(HPLC),and the half-maximal inhib-itory concentration(IC50)was determined.Results Donepezil(10 μmol·L-1)and hypoxia reduced CYP3A4 protein expression to 31.75%and 45.90%of the control levels,respectively.Both interventions activated the gp78-mediated ubiquitin-proteasome path-way,significantly increasing CYP3A4 ubiquitination levels by 2.1-fold compared to the control group,thereby promoting proteasomal degradation.Donepezil inhibited CYP3A4 enzyme activity with an IC50 of 83.4μmol·L-1,and hypoxia synergistically enhanced this inhibitory effect,reducing the IC50 to 20.79 μmol·L-1.Conclusion Donepezil downregulates CYP3A4 function through dual mechanisms involving ubiquitin-mediated proteasomal degradation and direct enzymatic inhibition.Hypoxia potentiates this effect,leading to impaired metabolism of CYP3A4 substrate drugs,ele-vated plasma drug concentrations(1.6-2.3-fold in-crease compared to normal metabolic conditions),and an increased risk of QT interval prolongation and other forms of cardiotoxicity.
6.Survey on current cognition status of patient-based real-time quality control
Xia LOU ; Mengxue LV ; Xueling SHANG ; Xueying TONG ; Yan JIANG ; Hongping BA ; Rui ZHOU
Chinese Journal of Clinical Laboratory Science 2025;43(8):574-578
Objective To survey the awareness and intended adoption of patient-based real-time quality control(PBRTQC)among medical laboratories,thereby providing a basis for subsequent research and promotion efforts.Methods An electronic questionnaire was distributed via the Questionnaire Star system to collect participants' general information,their knowledge,attitudes,and practices regarding PBRTQC,as well as their implementation willingness.Results A total of 161 valid questionnaires were collected.The sur-vey revealed that fewer than 50%of laboratory staff had basic knowledge of PBRTQC,and their confidence in establishing and applying PBRTQC in their own laboratories was low.However,they acknowledged its potential to enhance quality management.Key concerns and support needs for PBRTQC promotion include professional implementation guidelines and policy support,reliable third-party evalu-ations,software and hardware support,and user training.Conclusion The laboratory staff accepted the value of PBRTQC and gener-ally held a positive attitude toward its application.Future efforts should focus on developing standardized guidelines,refining evaluation methods,advancing software and hardware,and enhancing knowledge dissemination,technical training and other actions related to guiding the practical implementation thereby facilitating the wider adoption of PBRTQC.
7.Adenoid cystic carcinoma of the cervix:6 cases report and literature review
Ting JIANG ; Ying-xin GONG ; Miao MA ; Yan XU ; Jia-min ZHOU ; Jing-xin DING ; Xiao-xia LIU
Fudan University Journal of Medical Sciences 2025;52(1):139-142
Adenoid cystic carcinoma(ACC)of the cervix is a rare and highly aggressive subtype of cervical cancer,accounting for less than 1%of all cervical cancer cases.ACC predominantly affects postmenopausal women over the age of 60,with postmenopausal vaginal bleeding being the most common symptom.Diagnosis of ACC primarily relies on histopathological examination and immunohistochemical analysis.Although there is currently no standard treatment protocol,surgical resection combined with radiotherapy or concurrent chemoradiotherapy is considered to be an effective approach.However,the effectiveness is limited,particularly in advanced cases,which generally have a poor prognosis.The treatment and prognosis of ACC are closely related to tumor staging,perineural invasion,and margin status.This paper discusses the clinical data and follow-up of six ACC patients treated at our institution,and goes through a literature review,examines its clinical features and treatment outcomes,underscores the critical importance of early diagnosis and individualized treatment.
8.Exploration of the Clinical Relevance of Gut Microbiota to Myocardial Infarction Based on the Microbiota-gut-heart Axis
Yan CHEN ; Xia WANG ; Hang XU ; Lin ZHOU
Herald of Medicine 2025;44(12):2022-2029
Myocardial infarction(MI)is one of the most common cardiovascular diseases(CVD)in clinic.Its morbidity,disability rate and mortality are remain high,making it an urgent challenge to address.In recent years,a growing number of studies have found that gut microbiota and their metabolites are closely related to the occurrence and development of MI.Some gut metabolites such as trimethylamine N-oxide(TMAO)and phenylacetylglutamine(PAGln)can predict major adverse cardiovascular events(MACE),including MI.In this review,the effects of gut microbiota on MI were investigated based on microbial-gut-heart-axis(MGHA).The results showed that plasma concentrations of gut metabolites(short-chain fatty acids,TMAO,PAGln、bile acids)had significant clinical correlation with MI,and had different effects on the occurrence of MI.Additionally,drug therapy,fecal microbial transplantation,changes in living and eating habits can all affect the composition of gut microbiota and the concentration of metabolites,thus providing new insights for the treatment of MI.
9.Exploration of the Clinical Relevance of Gut Microbiota to Myocardial Infarction Based on the Microbiota-gut-heart Axis
Yan CHEN ; Xia WANG ; Hang XU ; Lin ZHOU
Herald of Medicine 2025;44(12):2022-2029
Myocardial infarction(MI)is one of the most common cardiovascular diseases(CVD)in clinic.Its morbidity,disability rate and mortality are remain high,making it an urgent challenge to address.In recent years,a growing number of studies have found that gut microbiota and their metabolites are closely related to the occurrence and development of MI.Some gut metabolites such as trimethylamine N-oxide(TMAO)and phenylacetylglutamine(PAGln)can predict major adverse cardiovascular events(MACE),including MI.In this review,the effects of gut microbiota on MI were investigated based on microbial-gut-heart-axis(MGHA).The results showed that plasma concentrations of gut metabolites(short-chain fatty acids,TMAO,PAGln、bile acids)had significant clinical correlation with MI,and had different effects on the occurrence of MI.Additionally,drug therapy,fecal microbial transplantation,changes in living and eating habits can all affect the composition of gut microbiota and the concentration of metabolites,thus providing new insights for the treatment of MI.
10.Analysis of risk factors and establishment of a prediction model for endometrial cancer in postmenopausal bleeding
Jing WANG ; Qiaoyun ZHOU ; Muyu WANG ; Yu XIAO ; Dongmei SONG ; Yan GUO ; Enlan XIA ; Tinchiu LI ; Xiaowu HUANG
Journal of Capital Medical University 2025;46(1):143-149
Objective To establish a method for predicting the risk of endometrial cancer(EC)and endometrial atypical hyperplasia(AH)in women with postmenopausal bleeding(PMB)by collecting clinical data on routine medical history.Methods The clinical data of a total of 408 PMB patients admitted to Fuxing Hospital,Capital Medical University were consecutively collected in this retrospective study from December 2013 to December 2023.According to the results of endometrial pathology,patients were divided into case group and control group.EC and AH were included in the malignant group(case group)and the other endometrial pathologies were included in the non-malignant group(control group).Clinical data,including clinical history,high risk factors,and common gynecological ultrasound measurement indicators,were collected and studied by univariate and multivariate Logistic regression analysis.Results The mean age of 408 patients was(60.4±7.8)years.A total of 74 cases(18.1%)were in case group and 334 cases(81.9%)were in control group.Based on Logistic regression analysis,the best predictors of endometrial malignant lesions were selected to create a"LRDNT"(light bleeding,recurrent bleeding,diabetes,non-uniform echogenicity & thickness)model.LRDNT scores range from 0 to 22.The score of LRDNT ≥15 has the largest Yoden index,and the sensitivity to predict endometrial malignant lesions is 79.73%,the specificity is 80.84%,and the prediction accuracy is 80.64%.Conclusions The risk prediction model LRDNT,which combines clinical information and common gynecological ultrasound measurement indicators of PMB patients,can help clinicians classify patients at high and low risk of endometrial malignant lesions,and optimize the strategy of diagnosis and treatment.

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