Signal mining and analysis of adverse drug event signals of darolutamide / 中国药房

OBJECTIVE To explore and analyze the adverse drug event （ADE） signals of darolutamide and provide a reference for its clinical safe use. METHODS ADEs related to darotamide were collected based on the US FDA adverse event reporting system （FAERS） database from the third quarter of 2019 to the third quarter of 2022. Data mining and analysis were conducted by the report odds ratio （ROR） and proportional reporting ratio （PRR） methods. RESULTS A total of 565 ADE reports related to darolutamide were extracted， 356 ADE reports about darolutamide as the primary suspected drug were included， 38 ADE signals with darolutamide as the primary suspected drug were excavated， involving 15 system organ class （SOC）， mainly concentrated in patients over 65 years old. The SOC of darotamide ADE signal mainly focused on various examinations， systemic diseases and various reactions at the administration site， benign/malignant tumors or those with unknown nature （including cystic and polypoid）， kidney and urinary system diseases. A total of 13 ADE signals not mentioned in the instructions included increased prostate-specific antigen， dysphagia， cognitive impairment， erectile dysfunction， rhabdomyolysis， gynecomastia and decreased platelet count， etc. CONCLUSIONS When using darolutamide， in addition to ADE in the drug instruction， we should pay close attention to potential ADE， such as increased prostate-specific antigen， rhabdomyolysis， gynecomastia and decreased platelet count， so as to avoid drug withdrawal or organ damage caused by ADE.

Data mining and analysis for ADE signals of three third-generation tetracycline antibiotics / 中国药房

OBJECTIVE To excavate the adverse drug event （ADE） signals of three third-generation tetracycline antibiotics （tigecycline， omadacycline， eravacycline） based on FDA adverse event reporting system （FAERS）， and to provide reference for the safe use of them. METHODS The ADE reports of tigecycline， omadacycline and eravacycline from the first quarter of 2005 to the second quarter of 2023 were retrieved from FAERS database. The ADE signals of 3 kinds of drugs were mined by the method of reporting odds ratio method and the proportional reporting ratio method. RESULTS Totally 2 538 ADE reports with tigecycline， omadacycline and eravacycline as the primary suspected drugs were obtained， including 2 135 tigecycline ADE reports， 349 omadacycline ADE reports and 54 eravacycline ADE reports. A total of 131 ADE positive signals of tigecycline were mined， involving 19 system organ classes （SOCs）， mainly concentrated in investigations， hepatobiliary system， blood and lymphatic system， and gastrointestinal system， etc； the preferred terminologies （PT） with intense signal were hypofibrinogenaemia and blood fibrinogen decreased. Fourteen ADE signals were not mentioned in the drug instruction， such as renal failure， acute kidney injury and hemorrhage. Totally 24 ADE positive signals of omadacycline were mined， involving 6 SOCs， mainly concentrated in the gastrointestinal system and various examinations； the PTs with intense signals were tooth discoloration， jet-like vomiting and loose feces， etc. ADE signals were not mentioned in the drug instructions， included lip swelling， gastroesophageal reflux disease， eosinophilia， skin discoloration， feces softening， and night sweats. Five ADE positive signals of eravacycline were mined， involving 4 SOCs， mainly concentrated in various examinations， gastrointestinal system， etc. The most intense ADE signals were blood fibrinogen decreased and hypofibrinogenaemia. CONCLUSIONS ADE of the gastrointestinal system are mostly identified in the three third-generation tetracycline antibiotics， especially pancreatitis caused by tigecycline and gastroesophageal reflux disease caused by oral administration of omadacycline. The liver function， renal function （for tigecycline） and coagulation function （for tigecycline， eravacycline） should be monitored biyiliang@hotmail.com regularly during medication， so as to prevent the occurrence of serious ADE.

Signal mining and analysis for adverse events of avatrombopag based on FAERS / 陆军军医大学学报

Objective To mine the adverse drug events(ADE)signal of avatrombopag,an effective drug for thrombocytopenia treatment,based on real world data in order to provide reference for its clinical safety application.Methods The OpenVigil2.1 pharmacovigilance platform was used to obtain the ADE report data of avatrombopag from May 2018 to March 2023 in the database of FDA adverse event reporting system(FAERS).The ADE signals were classified and described by the system organ class(SOC)and preferred term(PT)of the ADE terminology set in the Medical Dictionary for Regulatory Activities(MedDRA),and reporting odds ratio(ROR)and UK Medicines and Healthcare Products Regulatory Agency(MHRA)comprehensive standard were used to detect the positive ADE signals.Results A total of 1 879 ADE reports related to avatrombopag were obtained,24 SOCs were involved,and 28 positive ADE signals were detected at PT level.Among these signals,the strongest ones were renal vein thrombosis,portal vein thrombosis and graft versus host disease,while the reports accounting for the largest numbers were headache,fatigue and asthenia.There were 8 ADE signals discovered newly,that is,seasonal allergy,back disorder,musculoskeletal discomfort,flatulence,hypersomnia,rash macular,emotional disorder,and rhinorrhoea.Conclusion For clinical use of avatrombopag,clinicians should not only concern the risk of thrombosis,but also pay close attention to ADE signals such as seasonal allergy,back disorder,musculoskeletal discomfort,flatulence,hypersomnia,rash macular,emotional disorder,and rhinorrhoea that are not documented in the instructions.

Evaluation of analgesic effect of nalbuphine in patients with non-mechanical ventilation in intensive care unit: a multi-center randomized controlled trail / 中华急诊医学杂志

Objective:To analyze the efficacy and safety of nalbuphine for analgesia in patients with non-mechanical ventilation in intensive care unit (ICU).Methods:From December 2018 to August 2021, a multicenter randomized controlled clinical study was conducted to select non-mechanical ventilation patients with analgesic needs admitted to ICU of four hospitals in Henan Province and Guizhou Province. Patients were randomly assigned to nalbuphine group and fentanyl group. The nalbuphine group was given continuous infusion of nalbuphine [0.05~0.20 mg/(kg·h)], and the fentanyl group was given continuous infusion of fentanyl [0.5~2.0 μg/(kg·h)]. The analgesic target was critical-care pain observation tool (CPOT) score<2. The observation time was 48 hours. The primary endpoint was CPOT score, the secondary endpoints were Richmond agitation-sedation score (RASS), ICU length of stay, adverse events, and proportion of mechanical ventilation. The quantitative data of the two groups were compared by t test or Mann-Whitney U test. The enumeration data were compared by chi square test or Fisher exact probability method. The data at different time points between groups were compared by repeated measures analysis of variance. Results:A total of 210 patients were enrolled, including 105 patients in the nalbuphine group and 105 patients in the fentanyl group. There was no significant difference in baseline data between the two groups (all P>0.05). There was no significant difference in CPOT score between nalbuphine group and fentanyl group at each time point after medication ( P>0.05), the CPOT score of both groups at each time point after medication was significantly lower than that before medication, and the analgesic target could be achieved and maintained 2 hours after medication. There was no significant difference in RASS between the two groups at each time point after medication ( P>0.05), which was significantly lower than that before medication, and the target sedative effect was achieved 2 hours after medication. There was no significant difference in ICU length of stay between nalbuphine group and fentanyl group [5.0(4.0,7.5) d vs. 5.0(4.0,8.0) d, P=0.504]. The incidence of delirium, nausea and vomiting, abdominal distension, pruritus, vertigo and other adverse events in the nalbuphine group was lower than that in the fentanyl group (all P<0.05). There was no significant difference in the incidence of other adverse events such as deep sedation, hypotension and bradycardia between the two groups (all P>0.05). The incidence of respiratory depression in nalbuphine group was not significantly different from that in fentanyl group ( P>0.05), but the proportion of mechanical ventilation was significantly lower than that in the fentanyl group [1.9% (2/105) vs. 8.6%(9/105), P=0.030]. Conclusions:Nalbuphine could be used for analgesia in ICU patients with non-mechanical ventilation. The target analgesic effect could be achieved within 2 hours, and it had a certain sedative effect with a low incidence of adverse reactions.

Analysisand countermeasure research on adverse event data in a grade-a tertiary children's hospital / 现代医院

Objective To analyze the adverse event data from 2020 to 2022 in a Grade-A tertiary children's specialty hospital,and put forward thoughts and suggestions on the management of adverse events.Methods Using descriptive analysis,Spearman rank correlation,and other methods to analyze 1 157 adverse events from 2020 to 2022 in a tertiary children's specialty hospital,analyzing various aspects such as event categories,severity,patient gender,and age.Results Among the reported ad-verse events,medical document errors accounted for the largest proportion(47.67％),and most of the events were grade Ⅲevents,and the severity was negatively correlated with the patient's age.Conclusion This study suggests emphasizing the man-agement of medical document writing,enhancing the proactivity of medical staff in reporting adverse events,promoting the initia-tion of activities to improve medical quality,and accelerating the research and development of automated tools for adverse event screening,building a management mindset for adverse event prevention.

A case of pituitary crisis caused by cadonilimab treatment of advanced gastric cancer / 药物流行病学杂志

A 75-year-old female patient with gastric cancer received cadonilimab(500 mg,iv,d1)combined with albumin-bound paclitaxel(300 mg,iv,d2)and tegafur,gimeracil and oteracil potassium(40 mg,po,bid,d2-15)and 21 days was a cycle.Admission examination at the end of 4 cycles of treatment,laboratory tests showed adrenocorticotropic hormone＜1.00 pg,mL-1,cortisol 0.42 μg·dL-1 and serum sodium 131 mmol·L-1.Immune checkpoint inhibitor-related hypophysitis was diagnosed,and pituitary crisis was developed on the 4th day.The diagnosis of hypophysitis concurrent with pituitary crisis was considered to be related to cadonilimab.High-dose glucocorticoids replacement and symptomatic treatment such as rehydration to maintain electrolyte imbalance were given.On the 9th day after admission,the patient was basically in remission.The administration of cadonilimab may cause pituitary crisis,which is relatively rare in clinical practice.This case reminds that the possibility of hypophysitis when patients emerge with the symptom of fatigue and anorexia along with hyponatremia.Assessment of endocrine gland function,correct diagnosis and proper therapy are of significant clinical value to improve the patients'prognosis.

Signal Mining Study of Adverse Reaction Associated with Allopurinol and Febuxostat Based on FDA Adverse Events Reporting System(FAERS)Database / 医药导报

Objective To conduct signal mining of adverse events(AEs)of allopurinol and febuxostat based on FAE-RS database,and to explore their potential drug risks and promote rational and safe clinical drug use.Methods The adverse event report data of febuxostat and allopurinol in 22 quarters from the first quarter of 2017 to the second quarter of 2022 were ex-tracted from FAERS database,and the signal mining of febuxostat and allopurinol adverse events(AE)was carried out using ROR method and PRR method.Results There were 5 060 AE reports for allopurinol,concentrated in patients aged≥60 years,in-volving 25 items of system organ classification(SOC),mainly in skin and subcutaneous tissue diseases(40.01%).It was found that 12 SOC categories were not mentioned in the instructions.For febuxostat,there were 905 AE reports,involving 17 SOC items,mainly in cardiac organ diseases(40.17%),and 2 items were not involved in the instructions.Allopurinol and febuxostat were as-sociated with infection and infectious diseases(5.51%,0.49%)and hepatobiliary diseases(5.35%,0.87%),However,these as-sociations were included in the instructions of allopurinol.Allopurinol was associated with the reproductive system and breast dis-eases(0.55%),pregnancy,puerperium and perinatal conditions(0.03%),but febuxostat was not found to be involved in the a-bove SOC.Conclusion The inclusion of adverse reactions in the instructions for allopurinol is relatively inadequate compared to buprostat,and the newly discovered involvement of systemic organs and AE can provide a reference for improving allopurinol in-structions.This study found that allopurinol and febuxostat allopurinol and febuxostat involved system differences,which can pro-vide reference for clinical individualized treatment.

Construction and verification of a clinical fall prevention information system) / 中华护理杂志

Objective The clinical fall prevention information system is developed and its effect is verified,pro-viding references for the prevention of clinical falls through information technology.Methods Based on the screen-ing-assessment-intervention-evaluation process recommended by the toolkit,a clinical fall prevention information sys-tem was constructed through the steps of team formation and group discussion.The system includes 2 modules of fall prevention clinical practice and fall adverse event management,and 5 basic functions of fall risk assessment,structured risk point screening,personalized intervention measures,evaluation report and intervention prescription,and adverse event reporting.From September to December 2021,the system was tested in 6 departments with a high incidence of falls in a tertiary A hospital in Chongqing,and the application effect of the system was verified from 5 aspects:friendliness of the system interface,professional guidance,improvement of patient participation,reduction of fall incidence and injury rate.Results 68.9％of nurses thought that the system was user-friendly;82.7％thought that the system was professional and instructive;75.3％thought that the system could improve patients'participation in fall prevention.After trial of the system,the incidence of falls and injury decreased,but the statistical difference was not obvious(P＞0.05).Conclusion This system realized multi-team cooperation to jointly pay attention to pa-tients'falls,and it was well recognized by nurses in terms of professional guidance and improving patients'partici-pation in fall prevention.At the same time,due to the short trial and verification time,narrow scope and small sample size of this system,its fall prevention effect needs to be further promoted and verified.

Construction and validation of risk prediction model for serious adverse events in adult patients with congenital heart disease complicated with pulmonary hypertension after cardiac catheterization / 中国胸心血管外科临床杂志

@#Objective To construct a risk prediction score model for serious adverse event (SAE) after cardiac catheterization in patients with adult congenital heart disease (ACHD) and pulmonary hypertension (PH) and verify its predictive effect. Methods The patients with PH who underwent cardiac catheterization in Wuhan Asian Heart Hospital Affiliated to Wuhan University of Science and Technology from January 2018 to January 2022 were retrospectively collected. The patients were randomly divided into a model group and a validation group according to the order of admission. The model group was divided into a SAE group and a non-SAE group according to whether SAE occurred after the catheterization. The data of the two groups were compared, and the risk prediction score model was established according to the results of multivariate logistic regression analysis. The discrimination and calibration of the model were evaluated using the area under the receiver operating characteristic (ROC) curve and the Hosmer-Lemeshow test, respectively. Results A total of 758 patients were enrolled, including 240 (31.7%) males and 518 (68.3%) females, with a mean age of 43.1 (18.0-81.0) years. There were 530 patients in the model group (47 patients in the SAE group and 483 patients in the non-SAE group) and 228 patients in the validation group. Univariate analysis showed statistical differences in age, smoking history, valvular disease history, heart failure history, N-terminal pro-B-type natriuretic peptide, and other factors between the SAE and non-SAE groups (P<0.05). Multivariate analysis showed that age≥50 years, history of heart failure, moderate to severe congenital heart disease, moderate to severe PH, cardiac catheterization and treatment, surgical general anesthesia, and N-terminal pro-B-type natriuretic peptide≥126.65 pg/mL were risk factors for SAE after cardiac catheterization for ACHD-PH patients (P<0.05). The risk prediction score model had a total score of 0-139 points and patients who had a score>50 points were high-risk patients. Model validation results showed an area under the ROC curve of 0.937 (95%CI 0.897-0.976). Hosmer-Lemeshow goodness-of-fit test: χ2=3.847, P=0.797. Conclusion Age≥50 years, history of heart failure, moderate to severe congenital heart disease, moderate to severe PH, cardiac catheterization and treatment, general anesthesia for surgery, and N-terminal pro-B-type natriuretic peptide≥126.65 pg/mL were risk factors for SAE after cardiac catheterization for ACHD-PH patients. The risk prediction model based on these factors has a high predictive value and can be applied to the risk assessment of SAE after interventional therapy in ACHD-PH patients to help clinicians perform early intervention.

Surveillance of adverse events following immunization in Shaanxi Province,2010-2021 / 中国生物制品学杂志

@#Objective To analyze the surveillance quality and characteristics of adverse events following immunization(AEFIs)in Shaanxi Province,from 2010 to 2021.Methods The vaccine doses administered data and AEFI data reported from 2010 to 2021 in Shaanxi Province were collected through the National Immunization Program Information Management System and AEFI information management system,and descriptive epidemiological methods were used for analysis.Results A total of 24 057 AEFIs were reported from 2010 to 2021 in Shaanxi Province.The average annual reported incidence of AEFI in 2014-2021 was 18.998 per 100 000 doses,with 17.998,0.702,and 0.112 per 100 000 doses for common vaccine reactions,rare vaccine reactions,and serious rare vaccine reactions,respectively.The incidence of AEFI was high from May to August,with an average of 26.304 per 100 000 doses.There were 69.83% of the cases reported by the children younger than 1 year old.In Expanded Program on Immunization vaccines,the incidence of AEFI in DTaP(diphtheria,tetanus and acellular pertussis combined vaccine)was the highest(57.948 per 100 000 doses),and the incidence of rare vaccine reactions in MR,MMR and MM(measles and rubella vaccine,measles mumps and rubella vaccine,measles and mumps combined vaccine)was the highest(1.875 per 100 000 doses).In non-Expanded Program on Immunization vaccines,the incidence of AEFI in DTaP-Hib(diphtheria,tetanus and acellular pertussis,inactivated poliomyelitis and haemophilus influenzae type b conjugate combined vaccine)was the highest(37.073 per 100 000 doses),and the incidence of rare vaccine reactions in MPV-ACYW135(group A,C,Y and W123 meningococcal polysaccharide vaccine)was the highest(2.392 per 100 000 doses).In common vaccine reactions,the fever/local redness and swelling/local induration were the main clinical diagnosis(22.481 per 100 000 doses).In rare vaccine reactions,allergic rash was the main clinical diagnosis(0.473 per 100 000 doses).Conclusion The sensitivity of AEFI surveillance system in Shaanxi Province is increasing year by year,and the vaccines have good safety,with common vaccine reactions as the main ones and serious rare vaccine reactions as the rare ones.There were differences in AEFI surveillance levels in different prefecture-level cities,so it is still necessary to strengthen the training.

Risk signals mining for Fluocinolone acetonide intravitreal implants based on Hainan Province Franchised Drug Monitoring System and FAERS / 中国药房

OBJECTIVE To explore the risk signals of Fluocinolone acetonide intravitreal implants and promote safe and rational drug use for patients. METHODS Based on the data from the Hainan Province Franchised Drug Adverse Reaction Monitoring Subsystem （hereinafter referred to as the “Franchised Drug Monitoring System”） and the FDA Adverse Event Reporting System （FAERS）， the adverse drug reaction （ADR）/adverse drug event （ADE） reports of Fluocinolone acetonide intravitreal implants were coded by using system organ classification and preferred terminology， and relevant patient information was collected. Risk signal mining was carried out by using the reporting odds ratio （ROR） method and the comprehensive standards method of the UK Medicines and Healthcare Products Regulatory Agency （hereinafter referred to as the “MHRA method”）. RESULTS Among the 72 reports of Fluocinolone acetonide intravitreal implants received by the Franchised Drug Monitoring System， the ratio of male to female was 1∶1.4， the patient’s age was mainly distributed between 18 and 64 years old； ADR/ADE affected 5 systemic organs， with eye organ diseases accounting for 87.7%； among them， there were 9 new and general ADR reports （12.5%） and 4 severe ADR reports （5.6%）； ROR method and MHRA method both identified three risk signals： cataracts， glaucoma， and high intraocular pressure. Among the 244 reports received by the FAERS database， the ratio of male to female was 1∶1.5； ADR/ADE damage affected 10 systemic organs， with 46.1% suffering from various injuries， poisoning， and operational complications， and 32.0% suffering from product problems； there were 20 severe ADR reports （8.2%）； ROR method and MHRA method both identified 19 risk signals， including implantation complications， medication system issues， etc. CONCLUSIONS When using Fluocinolone acetonide intravitreal implants in clinical practice， in addition to paying attention to eye ADR/ADE such as high intraocular pressure， cataracts， and glaucoma， attention should also be paid to the potential risks caused by ADE due to product quality and unreasonable use.

Mining and analysis of acalabrutinib-induced ADE risk signals based on FDA adverse event reporting system / 中国药房

OBJECTIVE To provide reference for the clinically safe application of acalabrutinib by mining and analyzing the risk signals of adverse drug events （ADE）. METHODS The acalabrutinib-induced ADE reports were extracted from the U.S. FDA adverse event reporting system using the OpenVigil 2.1 platform from November 1， 2017 to March 31， 2023. The reporting odds ratio （ROR） method and composite criteria method from the Medicines and Healthcare Products Regulatory Agency （MHRA） were used for detection of ADE signals. RESULTS There were 7 869 ADE reports of acalabrutinib as the primary suspect drug and 142 ADE positive signals were detected from them， involving 20 system organ classes， which was generally consistent with the ADE recorded in the drug instruction of acalabrutinib， mainly involving general disorders and administration site conditions， various inspection， blood and lymphatic system disorders， various neurological disorders and cardiac disorders. In addition， this study identified several new potential ADE signals that were not mentioned in the drug instruction， including sudden cardiac death， pulmonary toxicity， tumor lysis syndrome， pleural effusion， dyspepsia， gastroesophageal reflux disease， bone pain， decreased blood pressure， and abnormal blood sodium， etc. CONCLUSIONS When using acalabrutinib， in addition to paying attention to the ADE recorded in its instructions， the risk of serious ADE that may lead to death， such as sudden cardiac death and pulmonary toxicity， should also be evaluated to avoid or reduce the occurrence of ADE as much as possible.

Analysis of Data from Reports on Medical Device Faults in Drug-Device Combinations in Japan / 医薬品情報学

Objective: Analysis of data from reports of medical device faults in drug-device combinations (DDCs) can prevent adverse events caused by errors and lead to improvements. However, there is a paucity of published articles reporting the analysis of data on faults in DDCs. The aim of this study was to analyze data of faults in these medical devices in Japan.Methods: The review summarized information from the Pharmaceuticals and Medical Devices Agency data on “case reports of suspected failures of the mechanical and instrumental parts of DDCs” reported between 25 November 2014 and 31 July 2022. Information was collected from public documents on “year reported”, “age”, “gender”, “trade name”, “generic name”, “mechanical device part name”, “mechanical device part failure status”, and “hazard” and “outcome”.Results: There were approximately 1,300 reports of medical device faults in DDCs over the study period, with the number increasing year by year. Five device parts (insulin pen injectors, pre-filled syringes, drug and vaccine injectors, disposable hypodermic needles, and intrauterine contraceptive devices) accounted for 90% of the reports. We found that there was a considerable amount of missing data on reportable items such as age and gender of the patient. Our analysis also showed that 90% of the medical device fault reports involving DDCs were related to malfunction or breakage.Conclusion: In order to use DDCs more safely and effectively it is important to review reports and analyse data of faults in these devices.

Signal mining and analysis of temozolomide adverse events based on FAERS datadase / 中国药师

Objective To mine temozolomide-related adverse drug event(ADE)signals in the real world and to provide a reference for the safe clinical use of temozolomide.Methods The U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)was used to collect the ADE reporting data of temozolomide in the FAERS database from January 1,2004 to December 31,2022.The signal mining was performed using the report ratio method and Bayesian confidence interval progressive neural network method to analyze the occurrence of ADE.Results In the database,there were 24 725 ADE reports with temozolomide as the primary suspected drug,and a total of 300 ADE signals were identified,involving 23 system organ categories,and the top 5 were blood and lymphatic system diseases,systemic diseases and various reactions of administration sites,various examinations,various neurological diseases,various injuries,poisoning and procedural complications etc.the most frequently reported ADE signals included thrombocytopenia,low platelet count,neutral granulocytopenia,pancytopenia,convulsive attacks,and febrile neutropenia.42 new suspected adverse reactions were discovered,which were not recorded in the instructions,such as pseudomonas skin infection,herpetic meningoencephalitis,hypoglossal nerve paralysis,porokeratosis,etc.Conclusion The common adverse reactions of temozolomide in the real world are generally consistent with the instructions,but some new suspicious adverse reactions have been discovered.During clinical drug use,special attention should be paid to these new adverse reactions,and it is recommended to monitor patients'adverse reactions and take appropriate measures in a timely manner.

Discussion on hot topics and promotion paths for post-market surveillance and supervise of medical consumables based on non-active medical devices / 中国医学装备

Objective:To explore the research hotspots and effective promotion paths of post market surveillance and supervise of medical consumables with non-active medical devices.Methods:Data mining methods were used to collect related journal literatures and documents from the websites of China regulatory institutions and the China National Knowledge Infrastructure(CNKI),order sub item data of medical device adverse event reports,extract the MeSH element words of literatures and documents,perform bibliometric analysis and visual display.Results:The number of medical devices adverse event reports in China has been increasing year by year,reaching 694 866 in 2022,in the four statistical years from 2019 to 2022,the number of reports on non-active medical devices and IVD reagents also showed a parallel increasing trend,accounting for about 65.00% of the total number of adverse event reports on medical devices in the year.The bibliometric analysis of journal literature shows that research in this field has received varying degrees of participation from regulatory institutions,universities,medical institutions,and enterprises.Regulatory institutions have contributed 46 articles,accounting for 56.79% of the total number of articles,followed by 28 articles from universities.The co-occurrence analysis shows that hot topic is focused in 5 clusters:quality management,risk management,international experiences discussion and adverse event surveillance and re-evaluation and real-world research.China regulatory institutions attach great importance to post market surveillance and supervise,and have issued more than 20 relevant documents since 2006,focusing on specific topics and gradually deepening around safety and effectiveness.Conclusion:The post market surveillance and supervise of medical devices,especially medical consumables based on non-active medical devices,need to be promoted synchronously in three dimensions:regulatory institutions,medical institutions,and enterprises.Universities,research institutes,and industry organizations should work in coordinating to strengthen the collection,identification,and active surveillance of risk signals based on adverse event surveillance,safety evaluation based on risk management,and conducting real-world research,research and develop risk control and corrective and preventive measures.

Surveillance of adverse event following immunization with 13-valent pneumococcal polysaccharide conjugate vaccine in Jiaxing City / 预防医学

Objective@#To investigate the incidence of adverse event following immunization (AEFI) with 13-valent pneumococcal polysaccharide conjugate vaccine (PCV13) in Jiaxing City, Zhejiang Province, so as to provide insights into safety monitoring and evaluation of PCV13.@*Methods@#Surveillance data of AEFI with PCV13 in Jiaxing City from 2020 to 2022 were collected from the AEFI Monitoring Information Management System of the Immunization Planning System of Chinese Disease Prevention and Control Information System, including demographic information, vaccination time, time of AEFI occurrence and clinical symptoms, and the reported incidence, population and district distribution, and clinical symptoms of AEFI with PCV13 were descriptively analyzed.@*Results@#Totally 455 cases of AEFI with PCV13 were reported in Jiaxing City from 2020 to 2022, with a reported incidence rate of 232.33/105 doses. There were 431, 21 and 3 cases of general, abnormal, coincidence and psychogenic reactions, with reported incidence rates of 220.07/105 doses, 10.72/105 doses and 1.53/105 doses, respectively, and no reports of causal reaction, vaccine quality accident and vaccination accident. The AEFI cases included 258 boys and 197 girls, with a boy/girl ratio of 1.31∶1, and 288 children at ages of less than a year (63.30%). The largest number of AEFI was reported in Haining City (87 cases, 19.12%), and there were 349 AEFI cases (76.70%) within 24 hours following vaccination. The clinical symptoms mainly included redness and swelling, fever and induration, with reported incidence rates of 132.76/105 doses (260 cases), 109.27/105 doses (214 cases), and 55.66/105 doses (109 cases), respectively. There were 450 cases cured and 5 cases improved in 455 cases of AEFI.@*Conclusions@#General reaction is the predominant AEFI in Jiaxing City from 2020 to 2022, with mild symptoms. Most AEFI occurs within 24 hours following vaccination, and has a good prognosis.

Efficacy and safety of dimethyl fumarate in the treatment of multiple sclerosis：a meta-analysis / 中国药房

OBJECTIVE To evaluate the efficacy and safety of dimethyl fumarate （DMF） in the treatment of multiple sclerosis （MS）. METHODS Retrieved from CBM， Web of Science， PubMed， the Cochrane Library， Embase， CNKI， Wanfang Data， and VIP， randomized controlled trials （RCTs） about DMF （trial group） versus other drugs or placebo （control group） were collected. After data screening and extraction， quality evaluation， meta-analysis was conducted by using RevMan 5.3 software. RESULTS A total of 6 literature were included， involving 638 patients. Results of meta-analysis showed that the proportion of patients with lesion changes after treatment in the trial group was lower than control group [MD＝－0.65， 95%CI（－1.27， －0.02）， P＝0.04]； there was no statistical significance in recurrence rate [RR＝1.06， 95%CI（0.52，2.17）， P＝0.88]， the proportion of patients with new lesions after treatment [RR＝1.05， 95%CI（0.62，1.80）， P＝0.85]， expanded disability status scale after treatment [MD＝0.02，95%CI （－0.18， 0.23）， P＝0.82]， the incidence of adverse events [RR＝1.33， 95%CI（0.97， 1.84）， P＝0.08] or severe adverse events [RR＝0.95，95%CI（0.48，1.90），P＝0.89] between 2 groups. Results of sensitivity analysis showed the study obtained unstable recurrence rate and the incidence of adverse events， while other results were robust. CONCLUSIONS DMF can control the lesion progression in MS patients to some extent and doesn’t increase the incidence of adverse events and serious adverse events， but there is no significant advantage in reducing the recurrence rate and controlling the disability progression.

Detección de eventos adversos en pacientes internados en clínica médica utilizando la herramienta Global Trigger Tool / Detection of adverse events in patients interned in medical clinic using the Global Trigger Tool

Resumen Introducción : El Global Trigger Tool (GTT) es una herramienta que identifica con precisión los eventos adversos, estos representan un problema relevante y prevenible en los hospitales. Métodos : Estudio de corte transversal basado en la revisión retrospectiva de historias clínicas aleatorizadas utilizando el GTT. Resultados : Se detectaron 161 eventos adversos (EA): 51 por cada 100 admisiones, 66 por cada 1000 días pa ciente y 30% de admisiones con EA. Los disparadores más frecuentes fueron del módulo cuidados, 25% com plicaciones asociadas al uso de procedimientos, 10% úlceras por presión y 9% infecciones asociadas a la atención. La presencia de EA tuvo asociación estadís ticamente significativa con estancia mayor a 5 días, y asociación moderada con edad y número de disparado res. En cuanto al daño, 78% de los pacientes presentaron eventos leves y 4% eventos fatales. En el análisis con cur vas ROC, los disparadores con mayor área bajo la curva fueron: complicación de procedimientos (0.70), úlceras por presión (0.61) y código de respuesta rápida (0.60). Discusión : Los eventos por 100 admisiones fueron superiores a la bibliografía pero no hubo diferencias en eventos por cada 1000 días paciente. Los casos fatales se produjeron por enfermedades infecciosas respiratorias en pacientes con comorbilidades, necesidad de sonda nasogástrica y deterioro cognitivo. Se destaca la escasa aplicación de la herramienta en hospitales públicos, y la implementación de análisis de disparadores con cur vas ROC. Conocer la frecuencia y el tipo de evento más frecuente permitirá implementar medidas que mejoren la seguridad de los pacientes.

Abstract Introduction : The Global Trigger Tool (GTT) is a tool that accurately identifies adverse events that represent a significant problem in hospitals. Methods : Cross-sectional study based on retrospec tive review of randomized medical records using the GTT tool. Results : A total of 161 adverse events (AEs) were detected: 51 events per 100 admissions, 66 per 1000 patient-days, and 30% of admissions with AEs. The most frequent triggers were from the care module, with 25% complications associated with the use of procedures, 10% pressure ulcers, and 9% care-associated infections. The presence of AEs had a statistically significant asso ciation with a stay of more than 5 days, and a moderate association with age and number of triggers. Regarding the damage, 78% of the patients presented mild events and 4% fatal events. The ROC curves analysis showed that the triggers with the greatest area under the curve were: procedural complication (0.70), pressure ulcers (0.61) and rapid response code (0.60). Discussion : The number of events per 100 admis sions was higher than that reported in the literature, but there were no differences in events per 1000 patient-days. Fatal cases were caused by respiratory infectious diseases in patients with comorbidities, nasogastric tube needs and cognitive decline. The study highlights the scarce use of the tool in public hospitals and the implementation of trigger analysis with ROC curves. Knowing the frequency and the most frequent type of event will allow the implementation of measures that improve patient safety.

Relación entre las variantes genéticas UGT y HLA y eventos adversos asociados al uso de lamotrigina. Revisión sistemática

Introducción: La lamotrigina (LTG) es un fármaco antiepiléptico aromático, en los humanos se usa principalmente en el campo de la neurología y psiquiatría. Existen eventos adversos (EA), secundarios al uso de anticonvulsivantes, por ejemplo, la necrólisis epidérmica tóxica (NET), y el síndrome de Steven Johnson (SSJ), su incidencia está estimada en 1 de 1000 a 10000 exposiciones con una mortalidad mayor al 35 %. Objetivo: Describir la relación entre la presentación de eventos adversos y los polimorfismos de la UGT y HLA en pacientes que usaron lamotrigina. Metodología: Se realizó una revisión sistemática de la literatura, incluyendo una búsqueda en las bases de datos, con estudios del tipo ensayos clínicos controlados aleatorizados y estudios observacionales de cohortes, casos y controles. Resultados: La búsqueda inicial encontró un total de 96 artículos, de los cuales luego de aplicar los criterios de inclusión y exclusión quedaron 8. Conclusiones: Al momento del desarrollo de este estudio, no hay suficiente evidencia que relacione como factor de causalidad las variantes de las HLA y UGT con la predicción de los eventos adversos (EA), con el uso de lamotrigina. Además, es importante decir que en Colombia no tenemos estudios, y que no conocemos estas variantes genéticas por lo tanto la extrapolación no se puede realizar, llevando a recomendar que se deben hacer estudios en población colombiana con las variantes planteadas como posibles relacionadas con los EA a lamotrigina.

Introduction: Lamotrigine (LTG) is an aromatic antiepileptic drug, mainly used in humans in the field of neurology and psychiatry. There are secondary adverse events (AEs) related to the use of anticonvulsants, for example, toxic epidermal necrolysis (TEN) and Steven Johnson syndrome (SJS). Their incidence is estimated at 1 in 1,000 to 10,000 exposures with a mortality greater than 35%. Objective: To describe the relationship between the presentation of adverse events and UGT and HLA polymorphisms in patients who used lamotrigine. Methodology: A systematic review of the literature was carried out, including a database search, with studies such as randomized controlled clinical trials and observational cohort and case-control studies. Results: The initial search found a total of 96 articles. After applying the inclusion and exclusion criteria, only 8 were considered. Conclusions: At the time of the development of this study, there was not enough evidence to relate HLA and UGT variants as a causal factor to predict adverse events (AEs) due to the use of lamotrigine. Furthermore, it is important to say that in Colombia there are no studies, and that we do not know these genetic variants, therefore it is not possible to extrapolate it. Thus the recommendation is that studies should be carried out in the Colombian population using variants proposed as possibly relating AEs. to lamotrigine.

Hepatotoxicidad inducida por clozapina: reporte de caso y revisión breve de la literatura

Introducción: Los antipsicóticos son medicamentos que pueden producir elevaciones transitorias de las enzimas hepáticas. La clozapina es un antipsicótico atípico usado en el tratamiento de la esquizofrenia refractaria a los antipsicóticos convencionales y existe evidencia que puede producir elevaciones de las transaminasas hepáticas, expresión de dafño hepático con patrón hepatocelular. Métodos: Reporte de caso y revisión no sistemática de la literatura relevante. Presentación del caso: Una mujer de 39 años con diagnóstico de esquizofrenia paranoide acudió a un servicio de urgencias de un hospital general por náuseas, vómitos e ictericia que apareció tras el inicio de clozapina. No hubo mejoría clínica de la paciente durante la hospitalización, que falleció a los 44 días de su ingreso. Revisión de la literatura: La clozapina puede elevar las cifras de función hepática de manera transitoria y asintomática. Hay criterios clínicos para recomendar la suspensión de este antipsicótico. Conclusiones: Este caso es el tercero en la literatura que registra un desenlace fatal tras un cuadro de hepatotoxicidad inducido por clozapina. © 2021 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España, S.L.U. Todos los derechos reservados.

Introduction: Antipsychotics are drugs that can produce transient elevations of hepatic enzymes. Clozapine is an atypical antipsychotic used in treatment-resistant schizophrenia and there is evidence that it can produce elevations of hepatic transaminases, expression of liver damage in a hepatocellular pattern. Methods: Case report and non-systematic review of the relevant literature. Case presentation: A 39-year-old woman with a diagnosis of paranoid schizophrenia attended the emergency department of a general hospital for nausea, vomiting and jaundice that appeared after the initiation of clozapine. There was no clinical improvement during hospitalization, and death occurred after 44 days. Literature review: Clozapine can increase the liver enzyme levels transiently and asymptomatically; however, there are clinical criteria that recommend the withdrawal of the antipsychotic. Conclusions: This is the third case reported in the literature of a fatal outcome of clozapine-induced hepatotoxicity.