1.Literature analysis of clinical features and risk factors of drug-induced hypofibrinogenemia
Xiao WEN ; Le CAI ; Ao GAO ; Man ZHU
China Pharmacy 2025;36(13):1648-1654
OBJECTIVE To explore clinical characteristics and risk factors of drug-induced hypofibrinogenemia, providing a reference for rational clinical drug use. METHODS Retrospective case analyses literature on drug-induced hypofibrinogenemia were collected from domestic and international databases from their inception to December 31, 2024. The patients’ gender, age, fibrinogen (FIB) levels before and after treatment, drug types, the incidence of drug-induced hypofibrinogenemia, time of occurrence, bleeding rates, clinical manifestations, risk factors, and protective factors were all analyzed. RESULTS A total of 40 retrospective case analysis studies were included, involving 17 313 patients. Patient age ranged from 0.83 to 78.40 years, with males accounting for 16.90%-81.00%. The involved drugs comprised 5 categories and 13 specific agents, including tigecycline, snake venom hemocoagulase, tocilizumab, and alteplase, etc. The incidence of drug-induced hypofibrinogenemia ranged from 0 to 100%, occurring between 2 hours and 9 months after drug administration, and FIB levels rebounded in most patients after drug discontinuation. The bleeding rate varied from 0% to 91.30%, including epistaxis, airway bleeding, gastrointestinal bleeding, and cerebral hemorrhage. Risk factors included high drug dosage, prolonged treatment duration, abdominal infection, advanced age, and low baseline FIB levels. Protective factors were only mentioned in studies on tigecycline, including skin and soft tissue infections and high baseline FIB levels. CONCLUSIONS Drug-induced hypofibrinogenemia is commonly associated with tigecycline, hemocoagulase, and tocilizumab. Its clinical features vary depending on the drug, and risk factors include high drug dosage, prolonged treatment, low baseline FIB levels, and advanced age. For high-risk medications, individualized medication management and monitoring of FIB levels are recommended.
2.Clinical Efficacy and Mechanism of Shengmai Jiuxin Decoction in Treating Chronic Heart Failure with Qi and Yin Deficiency, Yang Deficiency, and Blood Stasis
Yiming YAO ; Hongjun ZHU ; Yang ZHAO ; Man SHI ; Yujin GONG ; Yuan WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):151-158
ObjectiveTo investigate the clinical efficacy and potential mechanism of Shengmai Jiuxin decoction in the treatment of acute decompensated heart failure (ADHF) with the traditional Chinese medicine (TCM) pattern of Qi and Yin deficiency, Yang deficiency, and blood stasis. MethodsA total of 68 patients diagnosed with ADHF of Qi and Yin deficiency, Yang deficiency, and blood stasis type were randomly assigned to an observation group (34 cases) and a control group (34 cases). Both groups received conventional Western medical treatment, while the observation group was additionally administered Shengmai Jiuxin decoction. Parameters compared before and after treatment included: TCM syndrome score, TCM syndrome efficacy, New York Heart Association (NYHA) functional classification, left ventricular ejection fraction (LVEF), N-terminal pro-B-type natriuretic peptide (NT-proBNP), six-minute walk distance (6MWD), hypoxia-inducible factor-1 alpha (HIF-1α), vascular endothelial growth factor A (VEGF-A), Caspase-3, and the number of rehospitalizations for heart failure within one month after discharge. ResultsThere were no significant differences in sex, age, vital signs, or underlying diseases between the two groups. Compared with baseline, both groups exhibited significant reductions in TCM syndrome scores, NT-proBNP, and HIF-1α levels (P<0.01), as well as significant increases in 6MWD, LVEF, VEGF-A, and Caspase-3 levels (P<0.05, P<0.01). After treatment, the observation group showed significantly greater reductions in TCM syndrome score, NT-proBNP, HIF-1α, and Caspase-3 levels compared with the control group (P<0.05) and significantly greater increases in 6MWD, TCM syndrome efficacy, and VEGF-A levels (P<0.05). No significant differences were observed between the groups in NYHA functional classification, LVEF, or the number of rehospitalizations for heart failure within one month after discharge. No drug-related adverse events were reported in either group during the treatment period. ConclusionShengmai Jiuxin decoction can improve cardiac function and clinical symptoms in patients with ADHF of Qi and Yin deficiency, Yang deficiency, and blood stasis type. Its mechanisms may be related to the regulation of the HIF-1 signaling pathway by modulating targets such as HIF-1α, VEGF-A, and Caspase-3.
3.Clinical Efficacy and Mechanism of Shengmai Jiuxin Decoction in Treating Chronic Heart Failure with Qi and Yin Deficiency, Yang Deficiency, and Blood Stasis
Yiming YAO ; Hongjun ZHU ; Yang ZHAO ; Man SHI ; Yujin GONG ; Yuan WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):151-158
ObjectiveTo investigate the clinical efficacy and potential mechanism of Shengmai Jiuxin decoction in the treatment of acute decompensated heart failure (ADHF) with the traditional Chinese medicine (TCM) pattern of Qi and Yin deficiency, Yang deficiency, and blood stasis. MethodsA total of 68 patients diagnosed with ADHF of Qi and Yin deficiency, Yang deficiency, and blood stasis type were randomly assigned to an observation group (34 cases) and a control group (34 cases). Both groups received conventional Western medical treatment, while the observation group was additionally administered Shengmai Jiuxin decoction. Parameters compared before and after treatment included: TCM syndrome score, TCM syndrome efficacy, New York Heart Association (NYHA) functional classification, left ventricular ejection fraction (LVEF), N-terminal pro-B-type natriuretic peptide (NT-proBNP), six-minute walk distance (6MWD), hypoxia-inducible factor-1 alpha (HIF-1α), vascular endothelial growth factor A (VEGF-A), Caspase-3, and the number of rehospitalizations for heart failure within one month after discharge. ResultsThere were no significant differences in sex, age, vital signs, or underlying diseases between the two groups. Compared with baseline, both groups exhibited significant reductions in TCM syndrome scores, NT-proBNP, and HIF-1α levels (P<0.01), as well as significant increases in 6MWD, LVEF, VEGF-A, and Caspase-3 levels (P<0.05, P<0.01). After treatment, the observation group showed significantly greater reductions in TCM syndrome score, NT-proBNP, HIF-1α, and Caspase-3 levels compared with the control group (P<0.05) and significantly greater increases in 6MWD, TCM syndrome efficacy, and VEGF-A levels (P<0.05). No significant differences were observed between the groups in NYHA functional classification, LVEF, or the number of rehospitalizations for heart failure within one month after discharge. No drug-related adverse events were reported in either group during the treatment period. ConclusionShengmai Jiuxin decoction can improve cardiac function and clinical symptoms in patients with ADHF of Qi and Yin deficiency, Yang deficiency, and blood stasis type. Its mechanisms may be related to the regulation of the HIF-1 signaling pathway by modulating targets such as HIF-1α, VEGF-A, and Caspase-3.
4.Establishment of a standardized management model for postoperative anti-osteoporosis medication in patients with brittle fractures
Hao LIU ; Yinglin YANG ; Le CAI ; Shu LI ; Man ZHU ; Mengli CHEN
China Pharmacy 2025;36(15):1926-1930
OBJECTIVE To investigate the establishment and promotion of a new standardized management model for anti- osteoporosis medication after fragility fracture surgery by resident clinical pharmacists, and provide references for resident pharmacists to carry out clinical pharmaceutical services. METHODS From July 2023 to March 2024,595 post-brittle fracture surgery patients were enrolled. Using the PDCA (plan-do-check-act) cycle,resident clinical pharmacists identified issues and conducted investigations in clinical practice. Through integrating clinical pharmacist intervention services before, during and after treatment, a medication treatment pathway was developed, thereby establishing a standardized management model for anti- osteoporosis treatment following fragility fracture surgery. Leveraging the National Brittle Fracture Big Data Platform (under the National Clinical Research Center for Orthopedics and Sports Rehabilitation), a dedicated data module was constructed, providing big data support to evaluate the efficacy of this pharmaceutical care model. RESULTS Continuous PDCA cycle driven improvements significantly increased the proportion of osteoporosis diagnosis (from 9% before intervention to 81%) and proportion of drug treatment (from 4% to 75%).The proportions of bone density and bone metabolism testing also rose markedly,positively impacting long-term patient outcomes. CONCLUSIONS The establishment of a standardized management model for anti- osteoporosis treatment following fragility fracture surgery by resident clinical pharmacists has enhanced clinicians’ diagnostic and therapeutic capabilities for osteoporosis, ensures rational medication use in osteoporosis patients, and demonstrates significant potential for widespread adoption and application.
5.Agile governance perspective on occupational health in evolving pharmaceutical research and development models
Xia ZHANG ; Ying TANG ; Man YU ; Jian CHEN ; Surong ZHU
Journal of Environmental and Occupational Medicine 2025;42(10):1247-1251
The rapid development of the pharmaceutical research and development (R&D) has brought new challenges to occupational health management, including the high uncertainty in the R&D process, emerging hazards, and compliance complexities associated with novel business models. Traditional management approaches exhibit limitations in effectively addressing the occupational health risks associated with these challenges. Based on the perspective of agile governance, this paper proposed an optimized pathway characterized by dynamic response, adaptive flexibility, and multi-stakeholder collaboration. It further offered countermeasures and recommendations from three aspects: concept renewal, mechanism innovation, and tool empowerment, aiming to provide reference for the effective management and control of occupational health risks in the innovation and development of the pharmaceutical R&D industry.
6.Establishment,optimization and practice of an automatic central nervous system adverse reactions monitoring module based on hospital information system data
Haiyan LI ; Daihong GUO ; Man ZHU ; Ao GAO ; Jingchuan LU ; An FU ; Chao LI ; Peng LI ; Anqi ZHAO
Chinese Journal of Pharmacoepidemiology 2024;33(9):971-977
Objective To construct a module for drug-induced central nervous system adverse reactions(CNS-ADR)within the Clinical Adverse Drug Event Active Monitoring and Intelligent Assessment Alert System-Ⅱ(ADE-ASAS-Ⅱ),and to conduct a large-scale,real-world active monitoring and evaluation of CNS-ADR specifically related to imipenem/cilastatin.Methods Based on literature review,spontaneous report evaluation,and initial word set of CNS-ADR related descriptions in electronic medical records,text recognition technology was used to construct and optimize the condition settings of the CNS-ADR automatic monitoring module.Hospitalized patients using imipenem/cilastatin were retrospectively monitored from 2017 to 2021,and the positive patients which had CNS-ADR were statistically described in terms of the demographic characteristics,CNS symptoms,and hospital departments.Results Based on a repeated testing optimization using 1 185 manually monitored results,the best setting for the determined module includes 62 sets of keywords,with a positive predictive value(PPV)of 13.63%and a recall rate of 100%.Expanding the monitoring to 8 222 medication users using this module,281 cases of positive causality were identified,with an incidence rate of 3.42%.Among them,patients over 60 years old accounted for 50.17%,and the main manifestations of CNS-ADR were epileptic seizures,headaches,mania,and delirium.Conclusion The CNS-ADR automatic monitoring module established based on ADE-ASAS-Ⅱ provides fast and reliable text data mining support for conducting real-world research on CNS-ADR.
7.Carthamus tinctorius L.extract ameliorates alcoholic liver disease by modulating PI3K/Akt/FoxO signaling pathway
Wen-Xuan WANG ; Xiang-Lei FU ; Man QI ; Fu-Rong FAN ; Fu-Rong ZHU ; Yuan-Chuang WANG ; Kai-Yue ZHANG ; Min LIU ; Sheng-Hui CHU
Chinese Pharmacological Bulletin 2024;40(6):1137-1145
Aim To investigate the effects of Cartham-us tinctorius L.extract(CTLE)on oxidative stress,lipid metabolism,and apoptosis levels of mice with al-cohol-induced liver injury and its mechanism of action.Methods The mouse model of alcohol-associated liver disease was established by chronic alcohol feeding and acute alcohol gavage.Mice were randomly divided into four groups.During the modeling period,the state changes of mice were observed every day,and their weight was recorded.At the end of modeling,blood and liver tissues were collected from each group of mice.The blood of mice was analyzed biochemically,and HE staining and Oil Red O staining were used to evaluate further the degree of pathological damage in the liver of mice.Quantitative real-time PCR(qPCR)and Western blot were applied to detect the mRNA and protein expression levels of p-PI3K,PI3K,p-Akt,Akt,p-mTOR,mTOR,p-FoxO1,FoxO1,p-FoxO3a,FoxO3a,p-FoxO4,FoxO4,BCL and BAX factors.Results Compared to the model group,the CTLE administration group showed improved hepatic patho-logical injury and reduced lipid deposition.The bio-chemical indexes in serum and liver,such as ALT,AST,TG,TC,and MDA levels were reduced,while GSH and SOD levels increased.Regulating the PI3K/Akt/FoxO pathway resulted in increased production of SOD,which reduced damage and apoptosis caused by reactive oxygen species(ROS).Conclusions CTLE can exert anti-oxidative stress and anti-apoptotic effects through the PI3K/Akt/FoxO pathway and attenuates alcoholic liver injury in mice,providing new ideas for the treatment of alcoholic liver disease and the develop-ment of related drugs.
8.Expression of lysyl oxidase family in the retina of the acute ocular hypertension rat
Man YANG ; Cheng-Min DENG ; Wei TAN ; Xin JIN ; Xiao-Yan ZHU
Journal of Regional Anatomy and Operative Surgery 2024;33(5):378-382
Objective To observe the changes of expression of lysyl oxidase family(LOXs)on the retina in acute ocular hypertension(AOH)rats.Methods The SD adult male rats were randomly divided into the control group(CON group)and the AOH group.The rats in the CON group were fed normally without any treatment,and the rats in the AOH group were established AOH model by anterior chamber perfusion.All rats were sacrificed after 2 weeks and retinal tissues were collected.The expression of LOXs[including lysyl oxidase(LOX)and lysyl oxidase-like proteins of LOXL1,LOXL2,LOXL3,LOXL4],and the expression of extracellular matrix(ECM)proteins of Collagen 1/3/4 a1(Col1/3/4 a1),Elastin(Eln),and Fibulin1/4(Fbn 1/4)in the retinal tissues were detected by qRT-PCR.The localiza-tion of LOXs in rat retina was detected by immunohistochemistry.The expression of LOX in retina was detected by Western blot.Results LOXs were expressed to varying degrees in all layers of the rat retina,LOX was mainly expressed in the retinal ganglion cell layer,nerve fiber layer,inner plexiform layer and outer plexiform layer;LOXL1 was mainly expressed in the inner plexiform layer,outer plexiform layer and vascular wall;LOXL2 was mainly expressed in retinal ganglion cell layer,inner plexiform layer and inner nuclear layer;LOXL4 was mainly expressed in the inner plexiform layer and inner nuclear layer;while LOXL3 was only expressed in the vascular wall.Compared with the CON group,the expression of LOX,Col1a1 and Eln in the retina of rats in the AOH group were significantly increased(P<0.05),and there was no significantly significant difference in the expression of LOXL1,LOXL2,LOXL3,LOXL4,Col3a1,Col4a1,Fbn1,Fbn4 mRNAs in the retina of rats between the two groups(P>0.05).Conclusion LOX is highly expressed in the retina of AOH rats,which may be involved in the pathological process of retinal injury caused by high intraocular pressure through ECM remodeling.
9.Qualitative study on early exercise rehabilitation experience and needs of elderly patients with total hip arthroplasty
Xiaoxia ZHU ; Man XU ; Sijia ZHAO ; Hong WU ; Huan ZHANG ; Liqin FU ; Jinxia JIANG ; Jing WU
Chinese Journal of Modern Nursing 2024;30(13):1745-1749
Objective:To understand the real experience and needs of early exercise rehabilitation in elderly patients with total hip arthroplasty (THA), so as to provide a preliminary basis for intervention research to meet the needs of patients.Methods:Using the purposive sampling method, a total of 12 elderly patients with THA from the First Affiliated Hospital of Naval Medical University from June to September 2021 were selected as the research objects for semi-structured in-depth interviews. Colaizzi 7-step method was used to analyze, summarize and extract the data.Results:The early exercise rehabilitation experience and needs of elderly THA patients could be summarized into four themes such as postoperative exercise being a difficult journey, the need for professional support, the need for external support and internally driven needs and 14 sub themes.Conclusions:There are various problems and needs for early exercise rehabilitation in elderly patients undergoing THA. It is necessary to strengthen communication among doctors, nurses and patients, understand their true feelings and provide personalized care and rehabilitation guidance to improve their treatment experience and enhance their satisfaction.
10.Study on the Experimental Methodology of Plasma Clot Retraction
Yang-Gan LUO ; Zi-Han LU ; Han-Jing LIAO ; Dou-Dou HAO ; Man-Jing HUANG ; Zhi-Xiang ZHU
Journal of Experimental Hematology 2024;32(4):1271-1277
Objective:To explore the key factors affecting plasma clot retraction and optimize the experimental method of plasma clot retraction,in order to study the regulation of platelet function and evaluate the modulatory effects of drugs on plasma clot retraction.Methods:The effects of different concentrations of thrombin,Ca2+and platelets on plasma clot retraction were studied,and the detection system of plasma clot retraction was optimized.The availability of the detection system was then validated by analyzing the regulatory effects of multiple signaling pathway inhibitors on plasma clot retraction.Results:Through the optimization study of multiple factors,platelet rich plasma(PRP)containing 0.5 mmol/L Ca2+and 40 × 109/L platelets was treated with 0.2 U/ml thrombin to perform plasma clot retraction analysis.After treatment with thrombin for 15 min,plasma clot retracted significantly.After treatment with thrombin for 30 min,the percentage of plasma clot retraction was more than 50%.The regulatory effects of multiple signaling pathway inhibitors on plasma clot retraction were studied in this detection system.PKC inhibitor Go 6983 exhibited a significant inhibitory effect on plasma clot retraction,while PI3K inhibitor Ly294002 and p38 MAPK inhibitor SB203580 slightly suppressed plasma clot retraction.Conclusion:PRP containing 0.5 mmol/L Ca2+and 40 × 109/L platelets can be induced with 0.2 U/ml thrombin to conduct plasma clot retraction analysis,which can be used to study the regulation of platelet function and evaluate the modulatory effects of drugs on plasma clot retraction.

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