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Risk factors of adverse drug reaction from non-steroidal anti-inflammatory drugs in Shanghai patients with arthropathy

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Acta Pharmacologica Sinica 2004年第3期25卷 103-111页

作者： Wen SHI2,Yong-ming WANG,Shao-li LI3,Min YAN3,Duan Li,Bin-yan CHEN,Neng-neng CHENG Department of Pharmacology,School of Pharmacy,Fudan University,Shanghai 200032 The center for drug reevaluation and 3 The center for adverse drug reaction monitoring,State Food and drug Administration,Beijing 100061,China Department of Pharmacology School of Pharmacy Fudan University 上海 200032 the center for drug reevaluation and the center for adverse drug reaction monitoring State Food and Drug Administration 北京 100061

AIM: The study was to screen the possible risk factors of adverse drug reaction (ADR) induced by non-steroidal anti-inflammatory drugs (NSAIDs) in Shanghai patients with arthropathy. METHODS: The subjects were ran- domly selected from a database of outpatients with arthropathy from 9 main hospitals in Shanghai. A door to door retrospective epidemiological survey was used to collect demographic information about the patients, both indi- vidual and familial. This included data on their medical histories, lifestyle and dietary habits, history of smoking and alcohol consumption, history of drug therapy, quality of life (QOL) prior to NSAIDs intake, history of NSAIDs therapy and its ADR events, etc. Descriptive statistical methods and univariate analysis were also used to identify possible risk factors for ADRs induced by NSAIDs. RESULTS: Of the 1002 patients surveyed, the average length of NSAIDs intake was 2 years. ADR incidence from different NSAIDs was high, in a range from 46.7 %-66.2 %. In general, the candidate risk factors for ADRs were different for each NSAID. Each of the candidate risk factors were defined and studied in order to evaluate its role in the determination of ADRs from NSAIDs. “Family history of ADRs caused by NSAIDs” was found to be a significant risk factor for the four commonly used NSAIDs: meloxicam, diclofenac, nimesulide, and nabumetone. CONCLUSION: A retrospective epidemiological survey was useful in detecting the risk factors for ADRs caused by NSAIDs. The study found that different NSAIDs might have different risk factors and that there is no single risk factor universally applicable to all NSAIDs.

关键词： non-steroidal anti-inflammatory drugs adverse drug reaction risk factors retrospective studies quality of life

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Evidence-based expert consensus on clinical management of safety of Bruton’s tyrosine kinase inhibitors(2024)

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Chinese Journal of Cancer Research 2024年第3期36卷 240-256页

作者： Zaiwei Song Dan Jiang Lingling Yu Yixuan Chen Daobin Zhou Yue Li Depei Wu Lingli Zhang Liyan Miao Jun Ma Jun Zhu Hongmei Jing Rongsheng Zhao the Steering Committee,the Consensus Panel and the Evidence Synthesis Group Evidence-based Pharmacy Professional Committee of Chinese Pharmaceutical Association(CPA) Hospital Pharmacy Professional Committee of Chinese Pharmaceutical Association(CPA) Division of Therapeutic drug monitoring of Chinese Pharmacological Society(CPS) Expert Committee on Lymphoma of Chinese Society of Clinical Oncology(CSCO) Expert Committee on Leukemia of Chinese Society of Clinical Oncology(CSCO) Society of Integrative Cardio-Oncology of China Anti-Cancer Association(CACA) Chinese Society of Hematology of Chinese Medical Association(CMA) Hospital Pharmacy Professional Committee of Cross-Straits Medicine Exchange Association(SMEA) Department of Pharmacy Peking University Third HospitalBeijing 100191China Institute for drug Evaluation Peking University Health Science CenterBeijing 100191China Therapeutic drug monitoring and Clinical Toxicology center Peking UniversityBeijing 100191China Department of Pharmacy Administration and Clinical Pharmacy School of Pharmaceutical SciencesPeking UniversityBeijing 100191China Department of Hematology Peking Union Medical College HospitalChinese Academy of Medical Sciences and Peking Union Medical CollegeBeijing 100005China Department of Cardiology the First Affiliated HospitalHarbin Medical UniversityHarbin 150001China Department of Hematology the First Affiliated Hospital of Soochow UniversitySuzhou 215006China Department of Pharmacy Evidence-based Pharmacy CenterWest China Second HospitalSichuan UniversityChengdu 610041China Department of Pharmacy the First Affiliated Hospital of Soochow UniversitySuzhou 215006China Department of Hematology and Oncology Harbin Institute of Hematology and OncologyHarbin 150010China Key Laboratory of Carcinogenesis and Translational Research(Ministry of Education/Beijing) Department of LymphomaPeking University Cancer Hospital&InstituteBeijing 100142China Department of Hematology Peking University Third HospitalBeijing 100191China 不详

Bruton’s tyrosine kinase inhibitors(BTKis)have revolutionized the treatment of B-cell ***,safety issues related to the use of BTKis may hinder treatment continuity and further affect clinical efficacy.A comprehensive and systematic expert consensus from a pharmacological perspective is lacking for safety issues associated with BTKi treatment.A multidisciplinary consensus working group was established,comprising 35 members from the fields of hematology,cardiovascular disease,cardio-oncology,clinical pharmacy,and evidencebased *** evidence-based expert consensus was formulated using an evidence-based approach and the Delphi *** Joanna Briggs Institute Critical Appraisal(JBI)tool and Grading of Recommendations Assessment,Development,and Evaluation(GRADE)approach were used to rate the quality of evidence and grade the strength of recommendations,*** consensus provides practical recommendations for BTKis medication based on nine aspects within three domains,including the management of common adverse drug events such as bleeding,cardiovascular events,and hematological toxicity,as well as the management of drug-drug interactions and guidance for special *** multidisciplinary expert consensus could contribute to promoting a multi-dimensional,comprehensive and standardized management of BTKis.

关键词： Consensus BTK inhibitors safety adverse drug events drug-drug interactions

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Predictive Model of Oxaliplatin-induced Liver Injury Based on Artificial Neural Network and Logistic Regression

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Journal of Clinical and Translational Hepatology 2023年第7期11卷 1455-1464页

作者： Rui Huang Yuanxuan Cai Yisheng He Zaoqin Yu Li Zhao Tao Wang Xiaofang Shangguan Yuhang Zhao Zherui Chen Yunzhou Chen Chengliang Zhang School of Pharmacy Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubeiChina Ciechanover Institute of Precision and Regenerative Medicine School of MedicineThe Chinese University of Hong Kong-ShenzhenShenzhenGuangdongChina Tongji Hospital Tongji Medical CollegeHuazhong University of Science and TechnologyWuhanHubeiChina Hubei center for adverse drug reaction/adverse drug Event monitoring WuhanHubeiChina National center for adverse drug reaction monitoring BeijingChina School of Statistics and Mathematics Zhongnan University of Economics and LawWuhanHubeiChina

Background and Aims:Identifying potential high-risk groups of oxaliplatin-induced liver injury(OILI)is valuable,but tools are *** artificial neural network(ANN)and logistic regression(LR)models will be developed to predict the risk of ***:The medical information of patients treated with oxaliplatin between May and November 2016 at 10 hospitals was collected *** used the updated Roussel Uclaf causality assessment method(RUCAM)to identify cases of OILI and summarized the patient and medication ***,the ANN and LR models for predicting the risk of OILI were developed and ***:The incidence of OILI was 3.65%.The median RUCAM score with interquartile range was 6(4,9).The ANN model performed similarly to the LR model in sensitivity,specificity,and *** discrimination,the area under the curve of the ANN model was larger(0.920>0.833,p=0.019).In calibration,the ANN model was slightly *** important predictors of both models overlapped partially,including age,chemotherapy regimens and cycles,single and total dose of OXA,glucocorticoid drugs,and antihistamine ***:When the discriminative and calibration ability was given priority,the ANN model outperformed the LR model in predicting the risk of *** chemotherapy drugs in oxaliplatin-based chemotherapy regimens could have different degrees of impact on *** suspected that OILI may be idiosyncratic,and chemotherapy dose factors may be weakly *** making on prophylactic medications needs to be carefully considered,and the actual preventive effect needed to be supported by more evidence.

关键词： Oxaliplatin Liver injury adverse drug reaction RUCAM Pharmacovigilance

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Clinical Features of Oxaliplatin-induced Hypersensitivity reactions in Chinese Patients: A Retrospective Multicenter Analysis

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Current Medical Science 2021年第4期41卷 827-831页

作者： Min LI Chen JIANG Jing-wen YANG Zao-qin YU Wei LI Li ZHAO Qiu-yan SONG Cheng-liang ZHANG Dong LIU Department of Pharmacy Tongji HospitalTongji Medical CollegeHuazhong University of Science and TechnologyWuhan 430030China Hubei center for adverse drug reaction monitoring Wuhan 430030China People's Hospital ofYuxi City Yuxi 653100China

Objective The characteristics of oxaliplatin-induced hypersensitivity reactions(HSRs)in Chinese patients were investigated to provide a reference for patients treated with *** The study reviewed the records of patients who developed oxaliplatin-induced HSRs in 17 hospitals from May 2016 to May *** collected and analyzed the basic information,history of oxaliplatin administration and premedication treatments,chemotherapy cycles,HSR symptoms,and the management and outcomes of these *** Oxaliplatin-induced HSRs were recorded in 137 patients who had been treated with oxaliplatin-containing *** different chemotherapy regimens were *** median infusion cycle when oxaliplatin-induced HSRs occurred was 7,and HSRs occurred during or shortly after oxaliplatin *** of the patients experienced grade 1 or grade 2 HSRs with mild symptoms of pruritis(49.64%),flushing(46.72%),chest discomfort(26.28%),and urticaria(25.55%).The majority of the patients completely recovered from HSRs following treatment with antihistamines and *** patients completed chemotherapy with oxaliplatin after the symptoms resolved with proper *** The results indicate that oxaliplatin-induced HSRs remain an important issue in safely and successfully fulfilling oxaliplatin-containing *** studies are needed to analyze the risk factors and establish prophylaxis for such reactions.

关键词： oxaliplatin hypersensitivity reaction retrospective study multicenter

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Symptom distress and interference among cancer patients with osteoradionecrosis of jaw: A cross-sectional study

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International Journal of Nursing Sciences 2019年第3期6卷 278-282页

作者： Dongye Yang Feng Zhou Xinyu Fu Jinsong Hou Liting Lin Qiuyu Huang Chao Hsing Yeh Guanghua School of Stomatology Hospital of StomatologySun Yat-sen UniversityGuangdong Provincial Key Laboratory of StomatologyGuangzhouChina center for adverse drug reaction monitoring of Chengdu SichuanChina Johns Hopkins School of Nursing BaltimoreUSA

Objective:Osteoradionecrosis of the jaws(ORNJ)is among the most serious oral complications of head and neck cancer treatment with radiation *** study aimed to examine the level of symptom distress and interference of ORNJ in head and neck cancer patients in ***:A cross-sectional study was conducted to profile patient reported symptom *** hospitalized ORNJ patients were *** completed the MD Anderson Symptom Inventory-Head and Neck Module-Chinese ***:The percentage of participants who reported that they experienced at least one type of symptom was 97.9%,and 85.2%patients reported *** 10 most severe symptoms were as follows:limited mouth opening,problem with teeth/gums,difficulty swallowing/chewing,dry mouth,oral malodor,difficulty with voice/speech,dental ulcer,tinnitus/ear obstruction,skin pain/burning/rash,and difficulty *** problem of limited mouth opening was more severe in patients with longer time to onset of ORNJ after *** interference of patients positively correlated with core symptoms(r=0.612),head and neck symptoms(r=0.709),and ORNJ symptoms(r=0.440)(P<0.01).The longer time to the onset of ORNJ after radiotherapy was positively and significantly correlated with symptom distress(r=0.479,P<0.001),and mouth opening correlated negatively with symptom distress(r=-0.298,P=0.003).Conclusions:ORNJ patients suffered mainly from limited mouth opening and other maxillofacial *** problem of limited mouth opening was more severe in patients with longer time to onset of ORNJ after *** patients commonly had symptom distress,which influenced their quality of life.

关键词： Head and neck neoplasms Nursing care Signs and symptoms Osteoradionecrosis of jaws

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Landscape of Hepatobiliary adverse drug reactions Related to Preparations Containing Psoraleae Fructus and Its Application in Pharmacovigilance

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Chinese Journal of Integrative Medicine 2021年第11期27卷 832-837页

作者： GE Fei-lin NIU Ming HAN Zi-xin CAO Jun-ling WANG Jia-bo BAI Zhao-fang SONG Hai-bo GUO Yu-ming XIAO Xiao-he School of Chinese Materia Medica Beijing University of Chinese MedicineBeijing100029China Department of Hepatology Fifth Medical Center of Chinese PLA General HospitalBeijing100039China Department of Pharmacy Dongfang Hospital Affiliated to Beijing University of Chinese MedicineBeijing100078China center for drug reevaluation National Medical Products AdministrationBeijing100022China

Objective To analyze clinical feature and information of medication to explore the risk signals of preparations containing Psoraleae Fructus(BGZP)related with hepatobiliary adverse drug reactions(ADR),in order to reinforce *** A retrospective study was conducted based on hepatobiliary ADR related with BGZP from the China adverse drug reaction monitoring System in years from January 2012 to December *** and general ADRs were analyzed and *** There were 355 cases of hepatobiliary ADR related to *** the amount of cases and the proportion of serious ADR showed an increasing growth by years(Pdrug use,including overdose,repeated medication,and combination of multiple *** were 190 cases which used BGZP(non-combination),and they were mainly for common in diseases caused by abnormal immune activation(accounting for 40.53%of the total cases).Especially at the age group with the most cases with age of 41–50 years,the cases associated with immunological diseases of female were obviously more than that of male(Pdrug usage duration and dosage and the occurrence of hepatobiliary *** may be similar with idiosyncratic drug-induced liver injury,and recommended that BGZP should be used with more caution under monitoring liver function,especially in female patients with immunological diseases.

关键词： drug safety hepatobiliary adverse drug reaction Psoraleae Fructus pharmacovigilance

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Pretreatment and analysis techniques development of TKIs in biological samples for pharmacokinetic studies and therapeutic drug monitoring

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Journal of Pharmaceutical Analysis 2024年第4期14卷 439-459页

作者： Lan Chen Yuan Zhang Yi-Xin Zhang Wei-Lai Wang De-Mei Sun Peng-Yun Li Xue-Song Feng Yue Tan School of Pharmacy China Medical UniversityShenyang110122China Institute of Pharmacology and Toxicology Institution National Engineering Research Center for Strategic DrugsBeijing100850China Department of Gastroenterology Shengjing Hospital of China Medical UniversityShenyang110022China

Tyrosine kinase inhibitors(TKIs)have emerged as the first-line small molecule drugs in many cancer therapies,exerting their effects by impeding aberrant cell growth and proliferation through the modulation of tyrosine kinase-mediated signaling ***,there exists a substantial inter-individual variability in the concentrations of certain TKIs and their metabolites,which may render patients with compromised immune function susceptible to diverse infections despite receiving theoretically efficacious anticancer treatments,alongside other potential side effects or adverse ***,an urgent need exists for an up-to-date review concerning the biological matrices relevant to bioanalysis and the sampling methods,clinical pharmacokinetics,and therapeutic drug monitoring of different *** paper provides a comprehensive overview of the advancements in pretreatment methods,such as protein precipitation(PPT),liquid-liquid extraction(LLE),solid-phase extraction(SPE),micro-SPE(μ-SPE),magnetic SPE(MSPE),and vortex-assisted dispersive SPE(VA-DSPE)achieved since *** also highlights the latest analysis techniques such as newly developed high performance liquid chromatography(HPLC)and high-resolution mass spectrometry(HRMS)methods,capillary electrophoresis(CE),gas chromatography(GC),supercritical fluid chromatography(SFC)procedures,surface plasmon resonance(SPR)assays as well as novel nanoprobes-based biosensing *** addition,a comparison is made between the advantages and disadvantages of different approaches while presenting critical challenges and prospects in pharmacokinetic studies and therapeutic drug monitoring.

关键词： TKIs Microextraction technique HRMS methods Pharmacokinetic studies Therapeutic drug monitoring

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Active Vaccine Safety Surveillance: Global Trends and Challenges in China

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Health Data Science 2021年第1期2021卷 159-168页

作者： Zhike Liu Ruogu Meng Yu Yang Keli Li Zundong Yin Jingtian Ren Chuanyong Shen Zijian Feng Siyan Zhan Department of Epidemiology and Biostatistics Peking University Health Science CenterBeijingChina National Institute of Health Data Science Peking UniversityBeijingChina National Immunization Programme Chinese Center for Disease Control and PreventionBeijingChina center for drug reevaluation National Medical Products AdministrationBeijingChina

*** great success in vaccine-preventable diseases has been accompanied by vaccine safety *** has caused vaccine hesitancy to be the top 10 in threats to global *** comprehensive understanding of adverse events following immunization should be entirely based on clinical trials and postapproval *** has increasingly been recognized worldwide that the active surveillance of vaccine safety should be an essential part of immunization programs due to its complementary advantages to passive surveillance and clinical *** the present study,the framework of vaccine safety surveillance was summarized to illustrate the importance of active surveillance and address vaccine hesitancy or safety ***,the global progress of active surveillance systems was reviewed,mainly focusing on population-based or hospital-based active *** these successful paradigms,the practical and reliable ways to create robust and similar systems in China were discussed and presented from the perspective of available databases,methodology challenges,policy supports,and ethical *** the inevitable trend of the global vaccine safety ecosystem,the establishment of an active surveillance system for vaccine safety in China is urgent and *** process can be accelerated with the consensus and cooperation of regulatory departments,research institutions,and data owners.

关键词： approval entirely summarized

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Appropriateness of Amikacin Dose Prescription, monitoring and Safety during Hospitalization as an Impact of Clinical Pharmacologist Intervention, in the Israeli Regional Hospital

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Journal of Biosciences and Medicines 2024年第3期12卷 337-354页

作者： Renata Shihmanter Olga Lazar Lidia Arcavi Clinical Pharmacology Unit Kaplan Medical Center Rehovot and Hebrew University Hadassah Medical School Jerusalem Israel Department of Medicine Kaplan Medical Center Rehovot and Hebrew University Hadassah Medical School Jerusalem Israel

Background: Use of inappropriate amikacin dose is one of the most important factors in inducing toxicity, prolonged hospitalization as well as in increasing patient’s mortality. Objective: The aims of this study are the analysis of amikacin dose, serum level and the examination of the effectiveness of the clinical pharmacologist (CP) therapeutic drug monitoring (TDM) intervention to guarantee the safety of amikacin use. Methods: This is a one-year retrospective observational chart review study, which evaluates amikacin dose, serum drug level, development of adverse effects in patients on amikacin with or without CP TDM consultation. Results: Amikacin was prescribed for 393 complex patients, with median age 83. Amikacin group (AG) included 140 (32%) courses with CP consultation (AG1) and 292 (68%) courses without CP consultation (AG2). The distribution of most study characteristics in both groups was similar including amikacin dose (9-10 mg/kg/day), renal failure (14%) and mortality (12%). Acceptance for CP consultation was in 46% of amikacin courses and dose changes were done in 63% after CP intervention. Prolonged antibiotic course (4.6 ± 1.5 vs 3.8 ± 1.6 days, p adverse effects, renal failure or mortality. Conclusions: There was no trend to reducing amikacin toxicity, days of hospitaliza tion or mortality in patients with CP consultation. CP TDM intervention was more in the management of complicated clinical situations. However, it is necessary to optimize it.

关键词： Amikacin Therapeutic drug monitoring Appropriate Clinical Pharmacologist Safety adverse Effects

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Advances and clinical applications of immune checkpoint inhibitors in hematological malignancies

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Cancer Communications 2024年第9期44卷 1071-1097页

作者： Wenyue Sun Shunfeng Hu Xin Wang Department of Hematology Shandong Provincial HospitalShandong UniversityJinanShandongP.R.China Department of Hematology Shandong Provincial Hospital Affiliated to Shandong First Medical UniversityJinanShandongP.R.China Taishan Scholars Program of Shandong Province JinanShandongP.R.China Branch of National Clinical Research center for Hematologic Diseases JinanShandongP.R.China National Clinical Research center for Hematologic Diseases the First Affiliated Hospital of Soochow UniversitySuzhouJiangsuP.R.China

Immune checkpoints are differentially expressed on various immune cells to regulate immune responses in tumor *** cells can activate the immune checkpoint pathway to establish an immunosuppressive tumor microenvironment and inhibit the anti-tumor immune response,which may lead to tumor progression by evading immune *** coinhibitory signaling pathways with immune checkpoint inhibitors(ICIs)could reinvigorate the anti-tumor immune response and promote immune-mediated eradication of tumor *** a milestone in tumor treatment,ICIs have been firstly used in solid tumors and subsequently expanded to hematological malignancies,which are in their ***,immune checkpoints have been investigated as promising biomarkers and therapeutic targets in hematological malignancies,and novel immune checkpoints,such as signal regulatory proteinα(SIRPα)and tumor necrosis factor-alpha-inducible protein 8-like 2(TIPE2),are constantly being *** ICIs have received clinical approval for clinical application in the treatment of hematological malignancies,especially when used in combination with other strategies,including oncolytic viruses(OVs),neoantigen vaccines,bispecific antibodies(bsAb),bio-nanomaterials,tumor vaccines,and cytokine-induced killer(CIK)***,the proportion of individuals with hematological malignancies benefiting from ICIs remains lower than expected due to multiple mechanisms of drug resistance and immune-related adverse events(irAEs).Close monitoring and appropriate intervention are needed to mitigate irAEs while using *** review provided a comprehensive overview of immune checkpoints on different immune cells,the latest advances of ICIs and highlighted the clinical applications of immune checkpoints in hematological malignancies,including biomarkers,targets,combination of ICIs with other therapies,mechanisms of resistance to ICIs,and irAEs,which can provide novel insight into the future

关键词： Immune checkpoint hematological malignancies biomarkers therapeutic targets drug resistance

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