Objective:To develop nursing adverse events’reporting content of hospital.Methods:The study included two phases.The first phase was to develop the category and definition of nursing adverse events that need to be rep...Objective:To develop nursing adverse events’reporting content of hospital.Methods:The study included two phases.The first phase was to develop the category and definition of nursing adverse events that need to be reported through an expert meeting.The second phase was to develop every nursing adverse event’s reporting content by using the Delphi method.In total,8 experts attended the meeting and 15 experts conducted two rounds of consultation letter.Results:Nursing adverse events that need to be reported of hospital include pressure sore,fall/falling from bed,unplanned extubation,medication error,and accident.Reporting content of these events in detail had also been obtained,which was helpful for cause analysis systematically.Conclusions:The reporting content of the nursing adverse event of hospital is established,and it is a basis for further study of the development of nursing adverse event reporting and feedback system.展开更多
Background: The Spontaneous Reporting System (SRS) of the Food and Drugs Administration (FDA) of the United States of America (US), known as the FDA Adverse Event Reporting System (FAERS), is a mechanism for collectin...Background: The Spontaneous Reporting System (SRS) of the Food and Drugs Administration (FDA) of the United States of America (US), known as the FDA Adverse Event Reporting System (FAERS), is a mechanism for collecting information on safety concerns associated with the use of drugs for redress, as they are used on large scale. The data which is the subject of this paper came from the FAERS database. This paper reports on the analysis of data covering 2013 to 2018 period, but compares the observed trends in the variables during this period with that of the 2007 to 2012 period to ascertain whether the trends change over time;as this paper is, in a sense, a sequel to an earlier one with a similar title as this but covering the period 2007 to 2012. Objectives: The objectives of the study reported in this paper were to: i) explore the trends in the variables involved with the adverse events problem in the 2013 to 2018 period and compare these trends with that found in the study covering the 2007 to 2012 period;ii) determine whether or not the level of missing variable values in the 2013 to 2018 period is lower than, the same or higher than it was in the 2007 to 2012 period;iii) find out how the first twenty principal suspect drugs most cited to be involved in adverse events occurring during drug use in the 2013 to 2018 period compare with that of the 2007 to 2012 period. Methods: The Food and Drugs Administration (FDA) makes extracts from the FAERS database freely available to the public on quarterly basis. Fourteen (14) out of over fifty (50) variables contained in these extracts were reckoned to be connected with the objectives of the study and were examined using the tools of frequencies, proportions and averages, on account of the nature of the data. Results: For the period 2013 to 2018, adverse events reports submitted to the FDA (US) more than doubled (2.1 times), accounting for an annual average growth rate of 15.8 %, which is considerably lower than the annual average growth rate of 22.1% for the 2007 to 2012 period. However, the reported number of cases for 2015 was 53.8% more than that of 2014. Consistent with the results for 2007 to 2012 period, the 2013 to 2018 period saw Female subjects accounting for over 60% of the annual and the overall number of reports. Overall, non-health professionals appear to have a slight edge over health professionals in reporting adverse drug events in the 2013 to 2018 period, with an indication that reports from non-health professionals are on the decline and that from health professionals is on the rise. Non-health professionals and health professionals were almost equally likely to report adverse events in the 2007 to 2012 period. Also, the findings for the 2013 to 2018 period suggest that the older one gets the more vulnerable one becomes to adverse events associated with drug use, which is consistent with the findings for the 2007 to 2012 period. Conclusion: The dangers that come with the use of drugs is an evolving one and therefore there is the need to examine SRS data from time to time so that emerging drug safety concerns can be dealt with timeously.展开更多
Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conduc...Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conducted in order to collect data about patients, drugs, suspected adverse events and notifiers. Suspected adverse events were classified using Med DRA 19.1. Notification’s circumstances were classified into Public Health Programs’ campaigns and routine practice. Data were collated into Excel spreadsheet and processed with SPSS software. Key Findings: Regional distribution is irregular. Of the 322 collected report forms, paramedics have notified 60.8% of the cases. Adult patients were the most represented (70.2%). Public Health Programs campaigns provided 72.6% versus 27.4% for routine practice including Neglected Tropical Diseases (41.4%), immunization (27.7%), tuberculosis (25.9%) and 4.5% for HIV. Skin disorders were the most prevalent suspected adverse events (147 sheets;45.7%) followed by general disorders and administration site disorders (29.8%) and gastro-intestinal disorders (12.7%). General anti-infective drugs for systemic use, antiparasites, and insecticides were the most reported class of medications (161 sheets;44.7%). Conclusions: A thorough follow-up of pharmacovigilance launched activities is needed to build a sustainable adverse effect’s surveillance system and routine practice has to be strengthened.展开更多
BACKGROUND Bevacizumab is an antiangiogenic agent,and that synergizes with chemotherapeutic drugs.When used in combination therapies,Bevacizumab is associated with adverse events such as hemorrhage,gastrointestinal pe...BACKGROUND Bevacizumab is an antiangiogenic agent,and that synergizes with chemotherapeutic drugs.When used in combination therapies,Bevacizumab is associated with adverse events such as hemorrhage,gastrointestinal perforation,delayed wound healing,and pneumothorax.However,the molecular mechanisms underlying these adverse events are not fully understood.CASE SUMMARY A 45-year-old female with multiple lung metastases that were derived from primary breast cancer,was placed on Bevacizumab+paclitaxel therapy,since this combination has a potent antitumor effect.She reported dyspnea before cycle 3,day 1 and we therefore ran a chest X-ray,which detected a right pneumothorax.The coronal plane computed tomography revealed that one solid mass rapidly necrosed and was replaced by a cavity that passed through the bronchus in the right lower lobe.The cavity eventually ruptured the pleura and made the bronchopleural fistula that led to this pneumothorax.Thoracic cavity drainage using an intercostal catheter was performed.On the 7th day of drainage,the patient was discharged from our hospital on recovery.Recurrence of pneumothorax was not reported,and continuation of chemotherapy was made possible by changing the regimen.CONCLUSION Patients with lung metastases surrounding the bronchi and on the pleura should be monitored for pneumothorax by Bevacizumab-containing chemotherapies.展开更多
BACKGROUND For advanced lung squamous cell carcinoma,immune checkpoint inhibitors(ICIs)have been regarded as one of the optimal therapies.While immune-related adverse events(ir AEs)are common in ICI treatment,cutaneou...BACKGROUND For advanced lung squamous cell carcinoma,immune checkpoint inhibitors(ICIs)have been regarded as one of the optimal therapies.While immune-related adverse events(ir AEs)are common in ICI treatment,cutaneous toxicities are among the most common ir AEs.Most immune-related skin toxicity grades are low,and the prognosis is good.However,Stevens-Johnson syndrome(SJS)is a rare but extremely severe cutaneous adverse drug reaction with high mortality.CASE SUMMARY We report a rare case of SJS induced by pembrolizumab.The case involved a 68-year-old female who was diagnosed with advanced squamous cell carcinoma of the lung.SJS appeared after one cycle of immunotherapy combined with chemotherapy.After treatment with prednisone hormone symptoms,antiinfection,gamma globulin,and antipruritic agents,the skin toxicity of the patients gradually decreased and eventually disappeared.Although the antitumor treatment was stopped due to serious adverse reactions,the tumor of the patient remained stable for nearly half a year after one cycle of immune therapy combined with chemotherapy,which also corroborates the delayed effect of immunotherapy.CONCLUSION We believe our report can provide some references for the treatment of SJS and the treatment of immune-related adverse reactions.展开更多
Background: α1-Adrenoceptor blockers (α1Bs) are used for the treatment of benign prostatic hyperplasia and hypertension, but they are known to cause hypotension-related adverse events. The objective of the present s...Background: α1-Adrenoceptor blockers (α1Bs) are used for the treatment of benign prostatic hyperplasia and hypertension, but they are known to cause hypotension-related adverse events. The objective of the present study was to evaluate the onset time profiles for syncope associated with the use of α1Bs. Methods: We analyzed the data obtained from?the Japanese Adverse Drug Event Report (JADER) database for a period from April 2004 until November 2016 and calculated reporting odds ratios (RORs) for eight α1Bs available on the Japanese market, using disproportionality analysis. Moreover, time information recorded in the JADER database was analyzed to evaluate the onset times of adverse events. Results: In total, 186,724 reports for males older than 20 years were analyzed. Significant RORs for syncope, with 95% confidence intervals, were obtained for naftopidil (2.53, 1.81 - 3.53), silodosin (4.24, 2.37 - 5.20), and tamsulosin (2.22, 1.75 - 2.81). The median onset times of syncope for naftopidil, silodosin, and tamsulosin were 37, 26, and 108 days, respectively. The shape parameters obtained by fitting the data for the three α1Bs to the Weibull distribution were all less than 1.0, indicating that all these drugs could be classified as the early failure type. The cumulative incidence rates showed that the onset times of syncope tended to be similar among the three α1Bs. Conclusions: Patients treated with selective α1Bs should be closely monitored for 100 days, especially in the first 20 to 40 days after initiation of silodosin or naftopidil. This information may be useful for patients and healthcare professionals in preventing syncope due to the use of selective α1Bs.展开更多
Background: Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. TransferonTM is DLE manufactured...Background: Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. TransferonTM is DLE manufactured by National Polytechnic Institute (IPN), and is registered by Mexican health-regulatory authorities as an immunomodulatory drug and commercialized nationally. The proposed mechanism of action of TransferonTM is induction of a Th1 immunoregulatory response. Despite that it is widely used, to date there are no reports of adverse events related to the clinical safety of human DLE or TransferonTM. Objective: To assess the safety of TransferonTM in a large group of patients exposed to DLE as adjuvant treatment. Methods: We included in this study 3844 patients from our Clinical Immunology Service at the Unit of External Services and Clinical Research (USEIC), IPN. Analysis was performed from January 2014 to November 2014, searching for clinical adverse events in patients with immune-mediated diseases and treated with TransferonTM as an adjuvant. Results: In this work we observed clinical nonserious adverse events (AE) in 1.9% of patients treated with TransferonTM (MD 1.9, IQR 1.7 - 2.0). AE were 2.8 times more frequently observed in female than in male patients. The most common AE were headache in 15.7%, followed by rash in 11.4%, increased disease-related symptomatology in 10%, rhinorrhea in 7.1%, cough in 5.7%, and fatigue in 5.7% of patients with AE. 63% of adverse event presentation occurred from day 1 to day 4 of treatment with TransferonTM, and mean time resolution of adverse events was 14 days. In 23 cases, the therapy was stopped because of adverse events and no serious adverse events were observed in this study. Conclusion: TransferonTM induced low frequency of nonserious adverse events during adjuvant treatment. Further monitoring is advisable for different age and disease groups of patients.展开更多
Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational u...Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events(ADEs)reported in the American Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.Methods In total,4796 cases of atezolizumab ADEs reported in the American FAERS database from 2017 to 2019 were retrospectively analyzed.Results The top three ADEs were febrile neutropenia(3.7%),anemia(2.9%),and acute renal failure(2.3%).In addition,the incidence rates of some ADEs were significantly different according to sex and age.The systematic organ classification of atezolizumab ADEs involved 32 systems,among which the top three were blood and lymphatic system disorders(585 cases,12.2%),gastrointestinal disorders(433 cases,9.0%),and infections and infestations(401 cases,8.4%).The reporting odds ratio(ROR)method was used to detect the ADR signals of atezolizumab.The ROR(95%confidence interval)of the top ADE,febrile neutropenia,was 39.236(33.757–45.604).In addition,we found 121 cases of complications associated with immune-related ADEs.Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those mentioned in the instructions for atezolizumab use,suggesting that atezolizumab has an acceptable and controllable drug effect.展开更多
BACKGROUND Immune checkpoint inhibitors(ICIs)are therapeutic agents for advanced and metastatic non-small cell lung cancer(NSCLC)with high clinical antitumor efficacy.However,immune-related adverse events occur in 20%...BACKGROUND Immune checkpoint inhibitors(ICIs)are therapeutic agents for advanced and metastatic non-small cell lung cancer(NSCLC)with high clinical antitumor efficacy.However,immune-related adverse events occur in 20%of these patients and often requiring treatment with immunosuppressive agents,such as corticosteroids.Consequently,this may increase the risk of patients to opportunistic infections.Pneumocystis jirovecii pneumonia(PJP),a rare but serious opportunistic infection typically observed in patients with human immunodeficiency virus,can also occur in cancer patients undergoing long-term glucocorticoid treatment.CASE SUMMARY We report a case of a 56-year-old male with squamous NSCLC treated with triplimab combined with paclitaxel,carboplatin,and radical thoracic radiation therapy.Following this regimen,he developed acute kidney injury(AKI)with elevated creatinine levels.After concurrent radical chemoradiotherapy ended,he developed a grade 3 immune-related AKI.High-dose corticosteroids were administered to treat AKI,and renal function gradually recovered.Corticosteroids were reduced to a dose of 10 mg prednisone equivalent daily eight weeks later;however,he developed severe pneumonia with spontaneous pneumothorax.Next-generation sequencing of the bronchoscopic lavage revealed PJP co-infection with herpes simplex virus 1 and cytomegalovirus.The inflammation was more severe in areas exposed to radiation.Piperacillin-tazobactam,acyclovir,sulfamethoxazole,and trimethoprim were used to control the infection.The patient recovered,and immunotherapy was terminated.CONCLUSION PJP is rare but can occur in patients with ICI adverse events and should be differentiated from tumor progression or immune-related adverse events.Thoracic radiation may increase risk,necessitating careful monitoring and prevention.展开更多
BACKGROUND Since the advent of the 20th century,alongside the progression of medical science and technological advancements,immunotherapy has emerged as a pivotal thera-peutic approach for tumor patients subsequent to...BACKGROUND Since the advent of the 20th century,alongside the progression of medical science and technological advancements,immunotherapy has emerged as a pivotal thera-peutic approach for tumor patients subsequent to undergoing radiotherapy and chemotherapy.Arimab(camrelizumab),a flagship drug in the realm of immuno-therapy,functions as a monoclonal antibody specifically targeting the progra-mmed death protein 1(PD-1).This drug engages with the human PD-1 receptor,effectively inhibiting the PD-1/programmed death ligand 1 signaling pathway.This inhibition results in the restoration of T cell activity and the induction of an anti-tumour response.However,it is noteworthy that such interference could lead to immune-related adverse events resembling autoimmune reactions.The grow-ing availability and clinical use of immune checkpoint inhibitors have raised sig-nificant clinical concerns regarding their safety.Numerous instances of immune-related adverse reactions and the associated management strategies have been extensively reported.Timely identification and diagnosis,coupled with multidi-sciplinary consultation and the prompt administration of immunosuppressants,can effectively address severe immune-related adverse reactions.CASE SUMMARY Arimab(camrelizumab),a monoclonal antibody targeting programmed death protein 1(PD-1),disrupts the PD-1/programmed death ligand 1(PD-L1)inter-action,reactivating T cell function and triggering anti-tumor immunity.However,this disruption may trigger immune-mediated adverse events akin to autoim-mune disorders.Approximately 2.8%of such events manifest as immune-related dermatologic reactions,with 0.7%classified as grade 3,which are infrequently documented.Here,this study describes a case of grade 3 bullous dermatitis occur-ring 15 days after initiating camrelizumab therapy.The patient,a 67-year-old male with oesophageal squamous cell carcinoma,received camrelizumab plus paclitaxel alongside chemotherapy and radiotherapy in early 2022.Due to disease progression,maintenance monotherapy with camrelizumab(200 mg)commenced in June 2022.On the fourth cycle,15 days into treatment,the patient presented with an immune-checkpoint inhibitor-related rash,despite unremarkable test results.Dermatology and pharmacy consultations were conducted,leading to glucocorticoid therapy,topical interventions,and supportive care.Gastric mucosal protection,nutritional supplementation,and other adjunctive treatments were also provided.The patient's symptoms resolved within 15 days post-discharge,resulting in discontinuation of camrelizumab.Like other PD-1 inhibitors,camrelizumab is associated with immune-mediated dermatitis.Thus,optimal management of these events requires a multidisciplinary approach,vigilant monitoring,regular evalua-tions,prompt glucocorticoid administration,and specialized dermatologic care.CONCLUSION The increasing adoption of immune checkpoint inhibitors in clinical practice has prompted substantial concerns about their safety profile.A wide range of immune-related adverse events and corresponding management stra-tegies have been well-documented.Early recognition and accurate diagnosis,combined with interdisciplinary collaboration and swift initiation of immunosuppressive therapy,are essential in managing severe immune-related adverse reactions effectively.This report details the treatment trajectory and outcome of a case involving immune-related cutaneous adverse reactions,providing pertinent clinical insights for future cases.展开更多
BACKGROUND The programmed cell death protein 1 inhibitor pembrolizumab has become a key treatment for various cancers,including triple-negative breast cancer.However,it is associated with immune-related adverse events...BACKGROUND The programmed cell death protein 1 inhibitor pembrolizumab has become a key treatment for various cancers,including triple-negative breast cancer.However,it is associated with immune-related adverse events,including rare but serious neurological complications such as Guillain-Barrésyndrome(GBS).GBS is a potentially life-threatening autoimmune disorder characterized by muscle weakness and paralysis.We present a unique case of pembrolizumab-induced GBS to highlight the importance of recognizing this complication and managing it promptly in patients receiving immune checkpoint inhibitors.CASE SUMMARY A 69-year-old woman with a medical history of hypertension,anxiety,depression,and stage IIIB triple-negative breast cancer treated with pembrolizumab,carboplatin,and paclitaxel,presented to the emergency department with a 1-month history of tingling,lower extremity weakness,and shooting pain.Symptoms progressed to global weakness,ascending paralysis,and double vision.Neurological examination revealed significant lower extremity weakness and sensory deficits.Magnetic resonance imaging of the lumbar spine and cerebrospinal fluid analysis confirmed GBS.Initial treatment with intravenous immunoglobulin led to relapse,requiring additional intravenous immunoglobulin and high-dose glucocorticoids.The patient’s condition improved,pembrolizumab therapy was permanently discontinued,and she was discharged to a rehabilitation facility.CONCLUSION Pembrolizumab can induce GBS,necessitating early recognition,prompt diagnosis,and multidisciplinary management to prevent serious complications.展开更多
文摘Objective:To develop nursing adverse events’reporting content of hospital.Methods:The study included two phases.The first phase was to develop the category and definition of nursing adverse events that need to be reported through an expert meeting.The second phase was to develop every nursing adverse event’s reporting content by using the Delphi method.In total,8 experts attended the meeting and 15 experts conducted two rounds of consultation letter.Results:Nursing adverse events that need to be reported of hospital include pressure sore,fall/falling from bed,unplanned extubation,medication error,and accident.Reporting content of these events in detail had also been obtained,which was helpful for cause analysis systematically.Conclusions:The reporting content of the nursing adverse event of hospital is established,and it is a basis for further study of the development of nursing adverse event reporting and feedback system.
文摘Background: The Spontaneous Reporting System (SRS) of the Food and Drugs Administration (FDA) of the United States of America (US), known as the FDA Adverse Event Reporting System (FAERS), is a mechanism for collecting information on safety concerns associated with the use of drugs for redress, as they are used on large scale. The data which is the subject of this paper came from the FAERS database. This paper reports on the analysis of data covering 2013 to 2018 period, but compares the observed trends in the variables during this period with that of the 2007 to 2012 period to ascertain whether the trends change over time;as this paper is, in a sense, a sequel to an earlier one with a similar title as this but covering the period 2007 to 2012. Objectives: The objectives of the study reported in this paper were to: i) explore the trends in the variables involved with the adverse events problem in the 2013 to 2018 period and compare these trends with that found in the study covering the 2007 to 2012 period;ii) determine whether or not the level of missing variable values in the 2013 to 2018 period is lower than, the same or higher than it was in the 2007 to 2012 period;iii) find out how the first twenty principal suspect drugs most cited to be involved in adverse events occurring during drug use in the 2013 to 2018 period compare with that of the 2007 to 2012 period. Methods: The Food and Drugs Administration (FDA) makes extracts from the FAERS database freely available to the public on quarterly basis. Fourteen (14) out of over fifty (50) variables contained in these extracts were reckoned to be connected with the objectives of the study and were examined using the tools of frequencies, proportions and averages, on account of the nature of the data. Results: For the period 2013 to 2018, adverse events reports submitted to the FDA (US) more than doubled (2.1 times), accounting for an annual average growth rate of 15.8 %, which is considerably lower than the annual average growth rate of 22.1% for the 2007 to 2012 period. However, the reported number of cases for 2015 was 53.8% more than that of 2014. Consistent with the results for 2007 to 2012 period, the 2013 to 2018 period saw Female subjects accounting for over 60% of the annual and the overall number of reports. Overall, non-health professionals appear to have a slight edge over health professionals in reporting adverse drug events in the 2013 to 2018 period, with an indication that reports from non-health professionals are on the decline and that from health professionals is on the rise. Non-health professionals and health professionals were almost equally likely to report adverse events in the 2007 to 2012 period. Also, the findings for the 2013 to 2018 period suggest that the older one gets the more vulnerable one becomes to adverse events associated with drug use, which is consistent with the findings for the 2007 to 2012 period. Conclusion: The dangers that come with the use of drugs is an evolving one and therefore there is the need to examine SRS data from time to time so that emerging drug safety concerns can be dealt with timeously.
文摘Objectives: To assess the received suspected adverse events occurring upon treatment with drugs and vaccines, at National Centre for Pharmacovigilance, in Togo, from 2009 to 2016. Methods: A crossover study was conducted in order to collect data about patients, drugs, suspected adverse events and notifiers. Suspected adverse events were classified using Med DRA 19.1. Notification’s circumstances were classified into Public Health Programs’ campaigns and routine practice. Data were collated into Excel spreadsheet and processed with SPSS software. Key Findings: Regional distribution is irregular. Of the 322 collected report forms, paramedics have notified 60.8% of the cases. Adult patients were the most represented (70.2%). Public Health Programs campaigns provided 72.6% versus 27.4% for routine practice including Neglected Tropical Diseases (41.4%), immunization (27.7%), tuberculosis (25.9%) and 4.5% for HIV. Skin disorders were the most prevalent suspected adverse events (147 sheets;45.7%) followed by general disorders and administration site disorders (29.8%) and gastro-intestinal disorders (12.7%). General anti-infective drugs for systemic use, antiparasites, and insecticides were the most reported class of medications (161 sheets;44.7%). Conclusions: A thorough follow-up of pharmacovigilance launched activities is needed to build a sustainable adverse effect’s surveillance system and routine practice has to be strengthened.
文摘BACKGROUND Bevacizumab is an antiangiogenic agent,and that synergizes with chemotherapeutic drugs.When used in combination therapies,Bevacizumab is associated with adverse events such as hemorrhage,gastrointestinal perforation,delayed wound healing,and pneumothorax.However,the molecular mechanisms underlying these adverse events are not fully understood.CASE SUMMARY A 45-year-old female with multiple lung metastases that were derived from primary breast cancer,was placed on Bevacizumab+paclitaxel therapy,since this combination has a potent antitumor effect.She reported dyspnea before cycle 3,day 1 and we therefore ran a chest X-ray,which detected a right pneumothorax.The coronal plane computed tomography revealed that one solid mass rapidly necrosed and was replaced by a cavity that passed through the bronchus in the right lower lobe.The cavity eventually ruptured the pleura and made the bronchopleural fistula that led to this pneumothorax.Thoracic cavity drainage using an intercostal catheter was performed.On the 7th day of drainage,the patient was discharged from our hospital on recovery.Recurrence of pneumothorax was not reported,and continuation of chemotherapy was made possible by changing the regimen.CONCLUSION Patients with lung metastases surrounding the bronchi and on the pleura should be monitored for pneumothorax by Bevacizumab-containing chemotherapies.
文摘BACKGROUND For advanced lung squamous cell carcinoma,immune checkpoint inhibitors(ICIs)have been regarded as one of the optimal therapies.While immune-related adverse events(ir AEs)are common in ICI treatment,cutaneous toxicities are among the most common ir AEs.Most immune-related skin toxicity grades are low,and the prognosis is good.However,Stevens-Johnson syndrome(SJS)is a rare but extremely severe cutaneous adverse drug reaction with high mortality.CASE SUMMARY We report a rare case of SJS induced by pembrolizumab.The case involved a 68-year-old female who was diagnosed with advanced squamous cell carcinoma of the lung.SJS appeared after one cycle of immunotherapy combined with chemotherapy.After treatment with prednisone hormone symptoms,antiinfection,gamma globulin,and antipruritic agents,the skin toxicity of the patients gradually decreased and eventually disappeared.Although the antitumor treatment was stopped due to serious adverse reactions,the tumor of the patient remained stable for nearly half a year after one cycle of immune therapy combined with chemotherapy,which also corroborates the delayed effect of immunotherapy.CONCLUSION We believe our report can provide some references for the treatment of SJS and the treatment of immune-related adverse reactions.
文摘Background: α1-Adrenoceptor blockers (α1Bs) are used for the treatment of benign prostatic hyperplasia and hypertension, but they are known to cause hypotension-related adverse events. The objective of the present study was to evaluate the onset time profiles for syncope associated with the use of α1Bs. Methods: We analyzed the data obtained from?the Japanese Adverse Drug Event Report (JADER) database for a period from April 2004 until November 2016 and calculated reporting odds ratios (RORs) for eight α1Bs available on the Japanese market, using disproportionality analysis. Moreover, time information recorded in the JADER database was analyzed to evaluate the onset times of adverse events. Results: In total, 186,724 reports for males older than 20 years were analyzed. Significant RORs for syncope, with 95% confidence intervals, were obtained for naftopidil (2.53, 1.81 - 3.53), silodosin (4.24, 2.37 - 5.20), and tamsulosin (2.22, 1.75 - 2.81). The median onset times of syncope for naftopidil, silodosin, and tamsulosin were 37, 26, and 108 days, respectively. The shape parameters obtained by fitting the data for the three α1Bs to the Weibull distribution were all less than 1.0, indicating that all these drugs could be classified as the early failure type. The cumulative incidence rates showed that the onset times of syncope tended to be similar among the three α1Bs. Conclusions: Patients treated with selective α1Bs should be closely monitored for 100 days, especially in the first 20 to 40 days after initiation of silodosin or naftopidil. This information may be useful for patients and healthcare professionals in preventing syncope due to the use of selective α1Bs.
文摘Background: Dialyzable leukocyte extracts (DLE) are heterogeneous mixtures of peptides less than 10 kDa in size that are used as immunomodulatory adjuvants in immune-mediated diseases. TransferonTM is DLE manufactured by National Polytechnic Institute (IPN), and is registered by Mexican health-regulatory authorities as an immunomodulatory drug and commercialized nationally. The proposed mechanism of action of TransferonTM is induction of a Th1 immunoregulatory response. Despite that it is widely used, to date there are no reports of adverse events related to the clinical safety of human DLE or TransferonTM. Objective: To assess the safety of TransferonTM in a large group of patients exposed to DLE as adjuvant treatment. Methods: We included in this study 3844 patients from our Clinical Immunology Service at the Unit of External Services and Clinical Research (USEIC), IPN. Analysis was performed from January 2014 to November 2014, searching for clinical adverse events in patients with immune-mediated diseases and treated with TransferonTM as an adjuvant. Results: In this work we observed clinical nonserious adverse events (AE) in 1.9% of patients treated with TransferonTM (MD 1.9, IQR 1.7 - 2.0). AE were 2.8 times more frequently observed in female than in male patients. The most common AE were headache in 15.7%, followed by rash in 11.4%, increased disease-related symptomatology in 10%, rhinorrhea in 7.1%, cough in 5.7%, and fatigue in 5.7% of patients with AE. 63% of adverse event presentation occurred from day 1 to day 4 of treatment with TransferonTM, and mean time resolution of adverse events was 14 days. In 23 cases, the therapy was stopped because of adverse events and no serious adverse events were observed in this study. Conclusion: TransferonTM induced low frequency of nonserious adverse events during adjuvant treatment. Further monitoring is advisable for different age and disease groups of patients.
文摘Objective In this study,we aimed to determine the incidence of adverse drug reactions(ADRs)of atezolizumab,identify ADR signals that are significantly related to atezolizumab,and provide a reference for the rational use of atezolizumab in the clinic through the statistical analysis of its adverse drug events(ADEs)reported in the American Food and Drug Administration(FDA)Adverse Event Reporting System(FAERS)database.Methods In total,4796 cases of atezolizumab ADEs reported in the American FAERS database from 2017 to 2019 were retrospectively analyzed.Results The top three ADEs were febrile neutropenia(3.7%),anemia(2.9%),and acute renal failure(2.3%).In addition,the incidence rates of some ADEs were significantly different according to sex and age.The systematic organ classification of atezolizumab ADEs involved 32 systems,among which the top three were blood and lymphatic system disorders(585 cases,12.2%),gastrointestinal disorders(433 cases,9.0%),and infections and infestations(401 cases,8.4%).The reporting odds ratio(ROR)method was used to detect the ADR signals of atezolizumab.The ROR(95%confidence interval)of the top ADE,febrile neutropenia,was 39.236(33.757–45.604).In addition,we found 121 cases of complications associated with immune-related ADEs.Conclusion The ADRs of atezolizumab reported in the FAERS database were consistent with those mentioned in the instructions for atezolizumab use,suggesting that atezolizumab has an acceptable and controllable drug effect.
基金Supported by Shandong Natural Science Foundation,No.ZR2021QH034China Postdoctoral Science Foundation,No.2023M731305.
文摘BACKGROUND Immune checkpoint inhibitors(ICIs)are therapeutic agents for advanced and metastatic non-small cell lung cancer(NSCLC)with high clinical antitumor efficacy.However,immune-related adverse events occur in 20%of these patients and often requiring treatment with immunosuppressive agents,such as corticosteroids.Consequently,this may increase the risk of patients to opportunistic infections.Pneumocystis jirovecii pneumonia(PJP),a rare but serious opportunistic infection typically observed in patients with human immunodeficiency virus,can also occur in cancer patients undergoing long-term glucocorticoid treatment.CASE SUMMARY We report a case of a 56-year-old male with squamous NSCLC treated with triplimab combined with paclitaxel,carboplatin,and radical thoracic radiation therapy.Following this regimen,he developed acute kidney injury(AKI)with elevated creatinine levels.After concurrent radical chemoradiotherapy ended,he developed a grade 3 immune-related AKI.High-dose corticosteroids were administered to treat AKI,and renal function gradually recovered.Corticosteroids were reduced to a dose of 10 mg prednisone equivalent daily eight weeks later;however,he developed severe pneumonia with spontaneous pneumothorax.Next-generation sequencing of the bronchoscopic lavage revealed PJP co-infection with herpes simplex virus 1 and cytomegalovirus.The inflammation was more severe in areas exposed to radiation.Piperacillin-tazobactam,acyclovir,sulfamethoxazole,and trimethoprim were used to control the infection.The patient recovered,and immunotherapy was terminated.CONCLUSION PJP is rare but can occur in patients with ICI adverse events and should be differentiated from tumor progression or immune-related adverse events.Thoracic radiation may increase risk,necessitating careful monitoring and prevention.
文摘BACKGROUND Since the advent of the 20th century,alongside the progression of medical science and technological advancements,immunotherapy has emerged as a pivotal thera-peutic approach for tumor patients subsequent to undergoing radiotherapy and chemotherapy.Arimab(camrelizumab),a flagship drug in the realm of immuno-therapy,functions as a monoclonal antibody specifically targeting the progra-mmed death protein 1(PD-1).This drug engages with the human PD-1 receptor,effectively inhibiting the PD-1/programmed death ligand 1 signaling pathway.This inhibition results in the restoration of T cell activity and the induction of an anti-tumour response.However,it is noteworthy that such interference could lead to immune-related adverse events resembling autoimmune reactions.The grow-ing availability and clinical use of immune checkpoint inhibitors have raised sig-nificant clinical concerns regarding their safety.Numerous instances of immune-related adverse reactions and the associated management strategies have been extensively reported.Timely identification and diagnosis,coupled with multidi-sciplinary consultation and the prompt administration of immunosuppressants,can effectively address severe immune-related adverse reactions.CASE SUMMARY Arimab(camrelizumab),a monoclonal antibody targeting programmed death protein 1(PD-1),disrupts the PD-1/programmed death ligand 1(PD-L1)inter-action,reactivating T cell function and triggering anti-tumor immunity.However,this disruption may trigger immune-mediated adverse events akin to autoim-mune disorders.Approximately 2.8%of such events manifest as immune-related dermatologic reactions,with 0.7%classified as grade 3,which are infrequently documented.Here,this study describes a case of grade 3 bullous dermatitis occur-ring 15 days after initiating camrelizumab therapy.The patient,a 67-year-old male with oesophageal squamous cell carcinoma,received camrelizumab plus paclitaxel alongside chemotherapy and radiotherapy in early 2022.Due to disease progression,maintenance monotherapy with camrelizumab(200 mg)commenced in June 2022.On the fourth cycle,15 days into treatment,the patient presented with an immune-checkpoint inhibitor-related rash,despite unremarkable test results.Dermatology and pharmacy consultations were conducted,leading to glucocorticoid therapy,topical interventions,and supportive care.Gastric mucosal protection,nutritional supplementation,and other adjunctive treatments were also provided.The patient's symptoms resolved within 15 days post-discharge,resulting in discontinuation of camrelizumab.Like other PD-1 inhibitors,camrelizumab is associated with immune-mediated dermatitis.Thus,optimal management of these events requires a multidisciplinary approach,vigilant monitoring,regular evalua-tions,prompt glucocorticoid administration,and specialized dermatologic care.CONCLUSION The increasing adoption of immune checkpoint inhibitors in clinical practice has prompted substantial concerns about their safety profile.A wide range of immune-related adverse events and corresponding management stra-tegies have been well-documented.Early recognition and accurate diagnosis,combined with interdisciplinary collaboration and swift initiation of immunosuppressive therapy,are essential in managing severe immune-related adverse reactions effectively.This report details the treatment trajectory and outcome of a case involving immune-related cutaneous adverse reactions,providing pertinent clinical insights for future cases.
文摘BACKGROUND The programmed cell death protein 1 inhibitor pembrolizumab has become a key treatment for various cancers,including triple-negative breast cancer.However,it is associated with immune-related adverse events,including rare but serious neurological complications such as Guillain-Barrésyndrome(GBS).GBS is a potentially life-threatening autoimmune disorder characterized by muscle weakness and paralysis.We present a unique case of pembrolizumab-induced GBS to highlight the importance of recognizing this complication and managing it promptly in patients receiving immune checkpoint inhibitors.CASE SUMMARY A 69-year-old woman with a medical history of hypertension,anxiety,depression,and stage IIIB triple-negative breast cancer treated with pembrolizumab,carboplatin,and paclitaxel,presented to the emergency department with a 1-month history of tingling,lower extremity weakness,and shooting pain.Symptoms progressed to global weakness,ascending paralysis,and double vision.Neurological examination revealed significant lower extremity weakness and sensory deficits.Magnetic resonance imaging of the lumbar spine and cerebrospinal fluid analysis confirmed GBS.Initial treatment with intravenous immunoglobulin led to relapse,requiring additional intravenous immunoglobulin and high-dose glucocorticoids.The patient’s condition improved,pembrolizumab therapy was permanently discontinued,and she was discharged to a rehabilitation facility.CONCLUSION Pembrolizumab can induce GBS,necessitating early recognition,prompt diagnosis,and multidisciplinary management to prevent serious complications.
