Eventos adversos e queixas técnicas de tecnologias para o manejo de estomias de eliminação no Brasil / Adverse Events and Technical Complaints of Technologies for the Management of Elimination Ostomies in Brazil / Eventos adversos y quejas técnicas de tecnologías para el manejo de ostomías de eliminación en Brasil

Objetivo: Describir los eventos adversos y las quejas técnicas relacionadas con tecnologías para el manejo de ostomías de eliminación reportadas en Brasil. Método: Estudio descriptivo y transversal realizado con datos secundarios registrados en Notivisa. Los datos representan eventos adversos y quejas técnicas reportadas desde enero de 2007 hasta agosto de 2023. Se utilizaron recursos de estadística descriptiva para el análisis. Resultados: Se identificaron un total de 2.812 notificaciones, de las cuales 101 (3,6%) fueron eventos adversos y 2.711 (96,4%) quejas técnicas. El estado de São Paulo representó 884 (31,4%) de las notificaciones. Las bolsas recolectoras fueron los productos más reportados, con 2.688 (95,6%) notificaciones, incluyendo 84 (3,1%) eventos adversos y 2.604 (96,9%) quejas técnicas. En cuanto a los resultados, hubo falta de información en 2.718 (96,7%) de las notificaciones, retención urinaria en 19 (0,67%), dermatitis en 13 (0,46%) y lesiones cutáneas en 9 (0,32%). Conclusión: El número de notificaciones ha seguido aumentando en los últimos años, pero la calidad sigue siendo baja, representada por un alto índice de información omitida. Las quejas técnicas sobre las bolsas recolectoras representan el mayor número de notificaciones en Brasil. La descripción de los resultados en el uso de productos para el tratamiento de las ostomías no es clara y puede llevar a un subregistro de eventos adversos importantes, como la dermatitis. (AU)

Objetivo: Descrever os eventos adversos e as queixas técnicas de tecnologias para o manejo de estomias de eliminação notificados no Brasil. Método: Estudo transversal, descritivo, realizado por meio de dados secundários registrados no Notivisa. Os dados representam eventos adversos e queixas técnicas notificados no período de janeiro de 2007 a agosto de 2023. Para análise, utilizaram-se recursos da estatística descritiva. Resultados: Identificaram-se 2.812 notificações, das quais 101 (3,6%) eram eventos adversos e 2.711 (96,4%) queixas técnicas. O estado de São Paulo foi responsável por 884 (31,4%) notificações. As bolsas coletoras foram os produtos mais notificados, apresentando 2.688 (95,6%) notificações, sendo 84 (3,1%) eventos adversos e 2.604 (96,9%) queixas técnicas. Sobre os desfechos, verificou-se a ausência de informações em 2.718 (96,7%) notificações, 19 (0,67%) notificações de retenção urinária, 13 (0,46%) de dermatite e 9 (0,32%) de lesão cutânea. Conclusão: O número de notificações permanece em ascendência nos últimos anos; entretanto, a qualidade ainda é baixa, representada por alta taxa de omissão de informações. As queixas técnicas de bolsas coletoras representam maior número de notificações no Brasil. A descrição dos desfechos na utilização de produtos para manejo de estomias não é clara e pode gerar subnotificação de eventos adversos importantes, como a dermatite. (AU)

Objective: To describe adverse events and technical complaints involving technologies for the management of elimination ostomies reported in Brazil. Method: This cross­sectional descriptive study used secondary data recorded in the Notivisa system. The data encompass adverse events and technical complaints reported from January 2007 to August 2023. Descriptive statistical tools were used for the analysis. Results: A total of 2,812 notifications were identified, of which 101 (3.6%) were adverse events, and 2,711 (96.4%) were technical complaints. The state of São Paulo accounted for 884 (31.4%) notifications. Collection bags were the most frequently reported products, with 2,688 (95.6%) notifications, including 84 (3.1%) adverse events and 2,604 (96.9%) technical complaints. Regarding outcomes, 2,718 (96.7%) notifications lacked information, 19 (0.67%) reported urinary retention, 13 (0.46%) reported dermatitis, and 9 (0.32%) reported skin injury. Conclusion: The number of notifications has continued to rise in recent years; however, the quality remains low, as evidenced by the high rate of omitted information. Technical complaints about collection bags represent the largest number of notifications in Brazil. The description of outcomes in the use of products for ostomy management is unclear and may lead to the underreporting of significant adverse events such as dermatitis. (AU)

Eventos adversos em crianças submetidas a cirurgias orofaciais / Adverse events in children submitted to orofacial surgery / Eventos adversos en niños sometidos a cirugía orofacial

Objetivo: Identificar os eventos adversos no pós-operatório imediato de queiloplastia e/ou palatoplastia em crianças e comparar os eventos identificados aos notificados ao Núcleo de Segurança do Paciente. Métodos: Estudo descritivo, retrospectivo e quantitativo, realizado em um hospital público e terciário brasileiro. Os dados foram coletados por meio da descrição nos registros de enfermagem e comparados aos notificados ao Núcleo de Segurança do Paciente, referente a junho e dezembro de 2019. Os resultados foram submetidos a análise estatística descritiva. Resultados: A amostra constou de 203 crianças, das quais 51% (n=103) apresentaram evento adverso. Foram identificados 176 eventos adversos, de 8 tipos, com prevalência da laringite pós-extubação (n=50; 28%), edema de língua (n=34; 19%) e lesão de comissura labial (n=25; 14%). Destes, apenas 5% (n=9) foram notificados ao Núcleo de Segurança do Paciente. Conclusão: Os eventos adversos prevalentes se relacionaram a cavidade oral e tecidos adjacentes, e a subnotificação foi expressiva. (AU)

Objective: To identify adverse events in the immediate postoperative period of cheiloplasty and/or palatoplasty in children and compare the identified events to those notified to the Patient Safety Center. Methods: Descriptive, retrospective and quantitative study, carried out in a Brazilian public and tertiary hospital. Data were collected through descriptions in nursing records and compared to those notified to the Patient Safety Center, referring to June and December 2019. The results were subjected to descriptive statistical analysis. Results: The sample consisted of 203 children, of which 51% (n=103) had an adverse event. A total of 176 adverse events of 8 types were identified, with prevalence of post-extubation laryngitis (n=50; 28%), tongue edema (n=34; 19%) and labral commissure lesion (n=25; 14%). Of these, only 5% (n=9) were notified to the Patient Safety Center. Conclusion: The prevalent adverse events were related to the oral cavity and adjacent tissues, and underreporting was significant. (AU)

Objetivo: Identificar eventos adversos en el postoperatorio inmediato de queiloplastia y/o palatoplastia en niños y comparar los eventos identificados con los notificados al Centro de Seguridad del Paciente. Métodos: Estudio descriptivo, retrospectivo y cuantitativo, realizado en un hospital público y terciario brasileño. Los datos se recolectaron mediante descripciones en registros de enfermería y se compararon con los notificados al Centro de Seguridad del Paciente, referidos a junio y diciembre de 2019. Los resultados fueron sometidos a análisis estadístico descriptivo. Resultados: La muestra estuvo conformada por 203 niños, de los cuales el 51% (n = 103) tuvo un evento adverso. Se identificaron un total de 176 eventos adversos de 8 tipos, con prevalencia de laringitis posextubación (n=50; 28%), edema de lengua (n=34; 19%) y lesión de la comisura del labrum (n=25; 14%). De estos, solo el 5% (n=9) fueron notificados al Centro de Seguridad del Paciente. Conclusion: Los eventos adversos prevalentes se relacionaron con la cavidad bucal y los tejidos adyacentes y el subregistro fue significativo. (AU)

Data mining of hematological adverse events related to antibody-drug conjugate based on FAERS / 药物流行病学杂志

Objective Based on the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database,data mining was conducted on hematological adverse events related to antibody drug conjugates(ADC),providing reference for the safe use of ADC drugs in clinical practice.Methods The report data from the third quarter of 2011 to the fourth quarter of 2022 were retrieved from the FAERS database.After data cleaning such as deduplication and name standardization,extract hematological adverse events related to ADC,and use report odds ratio method and the information component method for signal detection.Results A total of 101 610 adverse event reports were extracted,with 8 ADC drugs as the primary suspected drugs,and 5 768 ADC related hematological adverse event reports.Among them,3 423 cases of agranulocytosis were involved,and the signal intensity from strong to weak were sacituzumab govitecan(SG),gemtuzumab ozogamicin(GO),brentuximab vedotin(BV),polatuzumab vedotin(PV),enfortumab vedotin(EV),trastuzumab deruxtecan(TD),inotuzumab ozogamicin(IO)and ado-trastuzumab emtansine(TDM-1).There were 2 327 cases hematopoietic cell deficiency,with signals ranging from strong to weak were IO,SG,BV,EV,PV,TD,TDM-1,and GO.Report with clinical outcome of death of ADC drug related hematological adverse events included BV 179(16.84％),TDM-1 102(13.01％),TD 88(27.08％),GO 12(16.90％),IO 8(11.59％),EV 54(24.32％),PV 22(27.16％),and SG 84(21.05％).Adverse event time analysis showed that the number of events on the first day of TD,IO,and SG medication accounts for ≥ 40％of the total number of cases.The median time of hematological adverse events in TD,GO,IO,EV,PV,and SG was within one treatment course(21 days).Conclusion Attention should be paid to the risk of ADC drug-related hematological adverse event,during the clinical medication process,blood cell count changes should be closely monitored,and any abnormalities should be promptly diagnosed and treated.

A meta-analysis of safety of mindfulness-based stress reduction therapy and mindfulness-based cognitive therapy / 中国心理卫生杂志

Objective:To systematically review the adverse events and relatedfactors ofmindfulness-based stress reduction therapy(MBSR)and mindfulness-based cognitive therapy(MBCT).Methods:By searching the randomized controlled trails of adverse events and adverse effects of MBSR and MBCT from PubMed,CINAHL,Embase,Web of Science,Scopus,Proquest,ScienceDirect,PsycINFO databases and unpublished studies and grey literature,and traces the references and related journals of the included studies.The databases were searched from inception to June 1,2022.Meta analysis was performed by using RevMan 5.4 softwareto calculate combined odds radio(OR)and 95％CI.Results:Fifteen literatures with a total of 2 841 subjects were included in the study.The results of meta-analysis showed that there were statistically significant differences in the incidence of adverse events or adverse reactions between theMBSR and MBCT group and the control group(OR=2.48,95％CI:1.09-1.61,P＜0.05).The mindfulness-based intervention methods(only MBSR,OR=9.04,95％CI:5.34-15.30),the un-derlying diseases of the participants(complicated with mental disorders,OR=1.49,95％CI:1.12-1.97;compli-cated with physical diseases,OR=8.65,95％CI:5.17-14.45),exercise intensity(once a week for 8 weeks,each time more than 2 hours,OR=1.43,95％CI:1.04-1.96)and the level of mindfulness therapists(did not underg-one standardized training,OR=1.96,95％CI:1.20-3.23)were factors that may affect the occurrence of adverse events or adverse reactions in the process of MBSR and MBCT.Conclusion:During the MBSR and MBCT thera-py,there may be occur adverse events or adverse effects.

Date mining and analysis of adverse events of levofloxacin in children:a real world study based on FAERS database / 中国药师

Objective To search for the reports of adverse events of levofloxacin use in children using the FAERS database,and to mine and analyze the data to provide reference for safe clinical use.Methods The data reported of adverse events of levofloxacin use in children from January 1,2004 to June 30,2023 were retrieved through the OpenVigil 2.1 platform,and the relevant data were analyzed based on the reporting odds ratio(ROR)method.Results A total of 484 cases of adverse events of levofloxacin in children were retrieved,and 94 positive risk signals were found.The main systemic organs involved were various musculoskeletal and connective tissues,gastrointestinal system,systemic and administration sites,and the top five positive signals were Dimycodes infection(ROR=822.87),tendon pain(ROR=563.71),Mycobacterium ulcers infection(ROR=352.65),tendon rupture(ROR=341.91),and immune reconstitution inflammatory syndrome-related tuberculosis(ROR=310.84).The top five positive signals not mentioned in the label were Mycobacterium ulcerans infection(ROR=352.65),immune reconstitution inflammatory syndrome-associated tuberculosis(ROR=310.84),central nervous system tuberculoma(ROR=102.85),linear IgA disease(ROR=82.68),and increased intracranial pressure(ROR=32.46).Conclusion In addition to the known adverse events,levofloxacin is used in children,and the risk signal intensity of adverse reactions such as increased intracranial pressure and tuberculosis-related diseases is high,so it is recommended to carefully select and strengthen relevant safety monitoring.

Risk factors for perfusionist-related near-miss event: A retrospective cohort study in a single center / 中国胸心血管外科临床杂志

@#Objective To explore the risk factors and countermeasures of the perfusionist-related near-miss event (NME) in cardiopulmonary bypass (CPB). Methods The clinical data of the patients who underwent cardiac surgery in the Department of Cardiovascular Surgery, Nanfang Hospital, Southern Medical University from March 2020 to July 2021 were retrospectively analyzed. According to whether NME occurred during the operation, the patients were divided into an NME group and a non-NME group. The clinical data of the two groups were compared, and the risk factors for NME were analyzed. Results A total of 702 patients were enrolled, including 424 males and 278 females with a median age of 56.0 years. There were 125 patients in the NME group and 577 patients in the non-NME group. The occurrence rate of NME was 17.81%. Univariate analysis showed that there were statistical differences between the two groups in the gender, body surface area, CPB time, European system for cardiac operative risk evaluation score, emergency surgery, type of surgery, night CPB initiation, modified ultrafiltration use, multi-device control, average operation time, et al. (all P<0.05). The above variables were dimensionality reduction processed by least absolute shrinkage and selection operator regression, and the λ of minimum mean square error of 10-fold cross validation was 0.014. The variables of the corresponding model were selected as follows: multi-device control, night CPB initiation, minimum hematocrit, modified ultrafiltration use, CPB time. The results of multivariate logistic regression showed that night CPB initiation [OR=9.658, 95%CI (4.735. 19.701), P<0.01] and CPB time [OR=1.003, 95%CI (1.001, 1.006), P=0.014] were independent risk factors for NME. Conclusion Night CPB initiation and CPB time are independent risk factors for NME during CPB, which should be recognized and early warned in clinical work.

Research progress of SARS-CoV-2 vaccine-related ocular adverse events / 国际眼科杂志(Guoji Yanke Zazhi)

Since 2019, severe acute respiratory syndrome coronavirus 2(SARS-CoV-2)infection has been widespread in the world, causing about 770 million infecting and 6.9 million deaths. Vaccines against SARS-CoV-2 infection have become the main way to prevent the severe SARS-CoV-2. The use of SARS-CoV-2 vaccine has substantial protection against the serious consequences of SARS-CoV-2 infection, but multiple systemic adverse reactions can occur after the use of SARS-CoV-2 vaccine. More and more studies have shown that SARS-CoV-2 vaccine caused lesions of ocular conjunctiva, cornea, sclera, uvea, retina and optic nerve tissue and resulted in damage to visual function. In this paper, the classification and characteristics of SARS-CoV-2 vaccines and related studies on ocular tissue lesions were reviewed, hoping to better understand the ocular adverse reactions of SARS-CoV-2 vaccine and provide some theoretical guidance for the prevention and treatment of ocular tissue damage caused by SARS-COV-2 vaccine.

Difference analysis of ADE signal for irinotecan in adults and children / 中国药房

OBJECTIVE To mine and analyze the post-marketing adverse drug event （ADE） signals of irinotecan in adults and children populations， and to provide a reference for clinical safe medication. METHODS ADE reports of irinotecan from the first quarter of 2004 to the first quarter of 2023 in the US FDA adverse event reporting system database were extracted and the risk signals of irinotecan were detected through the reporting odds ratio and proportional reporting ratio. Statistical analysis was performed for ADE reports and signals of patients aged＜18 years （children） and ≥18 years （adults）. RESULTS A total of 8 013 ADE reports with irinotecan as the primary suspect drug were identified， including 7 656 and 357 ADE reports in adults and children， respectively. A total of 518 and 75 ADE signals were detected in the adults and children， and the mainly involved systems and organs including gastrointestinal disorders， blood and lymphatic system disorders， systemic disorders and various reactions at the administration site， etc. Most of the top 20 ADE signals in terms of frequency were documented in the drug instructions of irinotecan. New ADE signals in adults included peripheral neuropathy， oral mucosal inflammation， pulmonary embolism， epidermal nevus syndrome and reproductive toxicity， while hypertension， progressive neoplasms， tumor lysis syndromes， and embolism were new ADE signals in children. CONCLUSIONS The above new suspected high-risk signals not mentioned in the instructions should raise a high level of alertness in clinical practice of irinotecan.

Difference analysis of ADE signal for irinotecan in adults and children / 中国药房

OBJECTIVE To mine and analyze the post-marketing adverse drug event （ADE） signals of irinotecan in adults and children populations， and to provide a reference for clinical safe medication. METHODS ADE reports of irinotecan from the first quarter of 2004 to the first quarter of 2023 in the US FDA adverse event reporting system database were extracted and the risk signals of irinotecan were detected through the reporting odds ratio and proportional reporting ratio. Statistical analysis was performed for ADE reports and signals of patients aged＜18 years （children） and ≥18 years （adults）. RESULTS A total of 8 013 ADE reports with irinotecan as the primary suspect drug were identified， including 7 656 and 357 ADE reports in adults and children， respectively. A total of 518 and 75 ADE signals were detected in the adults and children， and the mainly involved systems and organs including gastrointestinal disorders， blood and lymphatic system disorders， systemic disorders and various reactions at the administration site， etc. Most of the top 20 ADE signals in terms of frequency were documented in the drug instructions of irinotecan. New ADE signals in adults included peripheral neuropathy， oral mucosal inflammation， pulmonary embolism， epidermal nevus syndrome and reproductive toxicity， while hypertension， progressive neoplasms， tumor lysis syndromes， and embolism were new ADE signals in children. CONCLUSIONS The above new suspected high-risk signals not mentioned in the instructions should raise a high level of alertness in clinical practice of irinotecan.

Prediction of Risk of Cardiac Adverse Events After Chemotherapy Based on Acoustic Cardiography-Blood Index Nomogram / 肿瘤防治研究

Objective To evaluate the risk of cardiac adverse events in patients with malignant tumors after chemotherapy by using a combination of acoustic cardiography and blood indices. Methods A total of 171 patients with malignant tumor who received chemotherapy were included. They were divided into cardiac adverse event group and non-cardiac adverse event group in accordance with whether cardiac adverse events occurred after chemotherapy. The general data, blood indices before chemotherapy, and acoustic cardiography-related indices in the early stage (1-3 cycles) of chemotherapy of the two groups were analyzed. The possible influencing factors were determined by binary logistic regression analysis, and the nomogram was drawn. The receiver operating characteristic (ROC) curve was used to evaluate the prediction ability of the nomogram. Results Cardiac adverse events occurred in 44 of 171 patients with malignant tumors after chemotherapy, and the incidence of cardiac adverse events was 25.73%. Binary logistic regression results showed that age, red blood cell distribution width (RDW) before chemotherapy, activated partial thromboplastin time (APTT), and electromechanical activation time (EMAT) at the early stage of chemotherapy were independent predictors of cardiac adverse events in chemotherapy patients. The area under the ROC curve of the nomogram was 0.768 (95%CI: 0.693-0.843, P<0.001). Conclusion A nomogram based on age, pre-chemotherapy RDW, APTT, and EMAT at the early stage of chemotherapy is useful for early assessment of the risk of cardiac adverse events in chemotherapy patients.

Signal mining and evaluation of adverse events of four biological agents for the treatment of inflammatory bowel disease / 中国药房

OBJECTIVE To provide reference for safe drug use in the clinic by mining the adverse drug event （ADE） signals of 4 kinds of biological agents for the treatment of inflammatory bowel disease （IBD）. METHODS ADE data of infliximab， adalimumab， ustekinumab and vedolizumab were collected from the FDA adverse event reporting system between the first quarter in 2004 and the fourth quarter in 2022， and were mined by using reporting odds ratio （ROR） method and proportional reporting ratio （PRR） method. The system organ class （SOC） was used for the classification and statistics of drug ADE terminology. RESULTS & CONCLUSIONS A total of 65 173， 247 894， 37 596 and 6 134 ADE reports were retrieved for the above 4 biologic agents， involving 1 664， 1 731， 588， 303 ADE signals and 27， 27， 24， 26 SOC， respectively. The largest number of ADE reported of infliximab were various musculoskeletal and connective tissue diseases， and the signal intensity of disseminated tuberculosis was stronger. The largest number of ADE reported of adalimumab were systemic disease and various reactions at the administration site， and the signal intensity of papular at the injection site was stronger. The largest number of ADE reported of ustekinumab were various injuries， poisoning and operation complications， and the signal intensity of latent tuberculosis was slightly stronger. The largest number of ADE reported of vedolizumab were systemic diseases and various reactions at the administration site， and the signal intensity of shorter treatment response time was stronger. When clinically administering the four drugs， it is crucial to pay close attention to common ADEs and other ADE not mentioned in the drug label. For infliximab， clinicians should exercise caution due to the potential risk of synovitis and basal cell carcinoma； when prescribing adalimumab， caution should be exercised due to ADEs related to synovitis and hernia； for ustekinumab， the ADE associated with hepatobiliary diseases should be vigilant； for vedolizumab， clinicians should be vigilant for blood in the stool， increasing frequency of defecation. Except for ustekinumab， the other 3 biological agents also require attention for ADE associated with pregnancy.

Safety study of 23-valent pneumococcal polysaccharide vaccine in Hebei Province / 公共卫生与预防医学

Objective To analyze the occurrence characteristics of adverse events following immunization (AEFI) of 23-valent pneumococcal polysaccharide vaccine (PPSV-23) in Hebei Province and to evaluate the safety of the vaccine. Methods AEFI cases related to vaccination of PPSV-23 in Hebei Province from January 1, 2020 to December 31, 2022 were collected through the AEFI surveillance module of Chinese Center for Disease Control and Prevention Information System. The incidence of reported AEFI cases were then analyzed and compared. Results The reported incidence rate of AEFI of PPSV-23 was 56.12 /100,000 doses, and the incidence rate of adverse reactions was 55.50 /100 000 doses. The incidence rate of common adverse reactions was 53.94/100 000 doses, and the incidence rate of rare adverse reactions was 1.56/100 000 doses. Most of the reported AEFI cases caused by PPSV-23 were common adverse reactions, which occurred mainly within one day after vaccination, and the overall regression was positive. Conclusion The 23-valent pneumococcal polysaccharide vaccine used in Hebei Province is safe，but its safety monitoring still needs to be strengthened.

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.

Clinical Studies on Thyroid Dysfunction Caused by Immune Checkpoint Inhibitors in Tumor Patients / 昆明医科大学学报

Objective To investigate the clinical characteristics and risk factors of thyroid dysfunction(TD)in malignant tumor patients treated with immune checkpoint inhibitors(ICIs).Methods A total of 157 cancer patients who were hospitalized and received ICIs treatment in the First People's Hospital of Yunnan Province from January 2019 to June 2022 were collected and divided into the normal thyroid function group and abnormal thyroid function group based on whether TD had occurred.Fifty-eight patients with the normal thyroid function and 58 patients with the abnormal thyroid function were selected,and 58 healthy adults who underwent the physical examination in our hospital were randomly selected as the control group.The baseline data on the gender,age,tumor and ICIs type,history of surgery before medication,history of radiotherapy and chemotherapy,and the related indicators of liver and kidney function,blood lipids,thyroid hormone levels and so on were collected.The relevant indicators of the three groups were statistically analyzed,and the normal thyroid function group and abnormal thyroid function group were compared to evaluate the clinical characteristics and related risk factors of TD caused by ICIs.Results 1.Among 157 patients treated with ICIs,58 cases(36.9%)had thyroid dysfunction,including 39 cases of hypothyroidism(including subclinical hypothyroidism),9 cases of hyperthyroidism(including subclinical hyperthyroidism),and 10 cases of pure related antibody abnormality.2.The analysis of the data of the normal thyroid function group,the abnormal thyroid function group and the control group showed that the age,thyroid stimulating hormone(TSH),and thyroid function of the three groups were significantly different.TSH)baseline level,free triiodothyronine(FT3)baseline level and aspartate transaminase(AST)baseline level were statistically different(P<0.05).There were significant differences in TSH baseline and radiotherapy history between the normal thyroid function group and the abnormal thyroid function group(P<0.05);Multivariate analysis showed that the radiotherapy history(OR=7.291,95% CI= 1.579-33.663,P<.05),baseline TSH level(OR=3.917,95% CI= 1.697-9.038,P<0.05)were the independent risk factors for thyroid dysfunction in cancer patients after ICIs treatment.Conclusion Hypothyroidism is the most common type of TD caused by ICIs in cancer patients.The baseline TSH level and the history of radiotherapy are the independent risk factors for thyroid dysfunction.

Meta-analysis of the efficacy of tyrosine kinase inhibitor in radioiodine-refractory differentiated thyroid carcinoma / 中国现代医生

Objective To investigate the effect of tyrosine kinase inhibitor(TKI)on radioiodine-refractory differentiated thyroid carcinoma(RAI-rDTC).Methods Literature related to RAI-rDTC was retrieved from Wanfang Data,CNKI,VIP,PubMed,Cochrane,EmBase and Medline databases until December 31,2021.Literature quality and experimental bias were referred to the Cochrane quality risk assessment table,and Meta-analysis was performed using RevMan 5.3 software.Results A total of 1384 patients were included in 6 studies.The results of Meta-analysis showed that the median progress free survive(HR=0.30,95%CI:0.18-0.50,P<0.00001)and overall survival(HR=0.70,95%CI:0.57-0.88,P=0.002)in treatment group were significantly longer than those in control group.There was no significant difference in complete response between two groups(RR=3.31,95%CI:0.41-26.89,P=0.26).The partial response in treatment group was significantly higher than that in control group(RR=15.97,95%CI:3.48-73.17,P=0.0004).The incidence of TKI-related adverse reactions above grade 3 in treatment group was significantly higher than that in control group(RR=2.91,95%CI:1.70-4.96,P<0.0001).Conclusion TKI can significantly prolong progress free survive and overall survival in patients with RAI-rDTC,but there are still many adverse reactions.It is necessary to comprehensively evaluate the health status of patients before medication.

Efficacy of venetoclax combined with azacitidine in the treatment of patients with newly diagnosed unfit acute myeloid leukemia / 中国现代医生

Objective To observe the efficacy and safety of VA regimen(venetoclax + azacitidine)in the treatment of patients with newly diagnosed unfit acute myeloid leukemia(AML).Methods From April 2021 to February 2023,55 unfit AML patients who were treated with VA regimen in the First Affiliated Hospital of Anhui Medical University were retrospectively analysed.The therapeutic efficacy and safety of VA regimen were evaluated.Results The median treatment courses of AML patients was 3(1-10),and complete response(CR)/CR with incomplete blood count recovery(CRi)rate was 78.2%and minimal residual(MRD)negative conversion rate was 61.8%after the first treatment course.CR/CRi rate and MRD negative conversion rate increased gradually with the increase of treatment course.Patients with IDH1/IDH2,NPM1,ASXL1 mutations and without TP53 mutations responded well to the VA regimen.The median follow-up time was 9.1(1.2-24.0)months.39 patients survived and 16 patients died.The median overall survival(OS)was 17.4 months.Patients with CR/CRi had significantly longer OS duration than patients with partial response or non-response(P<0.001).Almost all patients had different degrees of anemia,thrombocytopenia,leukopenia.In terms of non-hematological adverse events,infection was the most common.Conclusion The VA regimen achieved a higher treatment response rate in newly diagnosed unfit AML patients,and partial response patients could quickly obtain negative MRD.IDH1/IDH2,ASXL1,NPM1,TP53 mutations may be the predictors of patient outcomes.

Chemo-resistant gestational trophoblastic neoplasia and the use of immunotherapy: A case report and review of literature

@#This is the first reported case of the use of immunotherapy in chemo-resistant Gestational Trophoblastic Neoplasia (GTN) in the country. A 41-year-old, Gravida 4 Para 3 (3013) with a diagnosis of GTN, Stage III: WHO risk score of 13 (Choriocarcinoma) was initially managed with 10 cycles of multiple agent Etoposide, Methotrexate, Actinomycin D- Cyclophosphomide and Vincristine (EMACO) and 19 cycles of Etoposide, Cisplatin- Etoposide Methotrexate and Actinomycin D (EP-EMA). With continuous rise in beta human chorionic gonadotropin (ßhCG) levels, the patient was referred to a Trophoblastic Disease Center where there was note of tumor progression to the brain. She was started on third-line salvage chemotherapy of Paclitaxel and Carboplatin (PC) with concomitant whole brain irradiation completing three cycles after which chemoresistance was again diagnosed with increasing hCG titers and increase in the number and size of the pulmonary masses which were deemed unresectable. Immunotherapy was started with Pembrolizumab showing a good response with marked fall in ßhCG levels. The onset of immune-related adverse events (irAEs) caused a marked delay in subsequent cycles of immunotherapy. With management of the irAEs, two more cycles of Pembrolizumab with fifty percent dose reduction were given with corresponding drop in ßhCG levels. However, the patient subsequently developed gram-negative septicemia with possible hematologic malignancy and finally succumbed to massive pulmonary embolism. The case highlights the importance of prompt diagnosis and referral to a Trophoblastic Disease Center and the use of immunotherapy in chemo-resistant GTN.

Acute pancreatitis complicated with diabetic ketoacidosis following COVID-19 mRNA vaccination: a case report / Journal of Rural Medicine

Objective: Since the onset of the coronavirus disease 2019 (COVID-19) pandemic, COVID-19 vaccination has substantially reduced mortality and hospitalization rates worldwide, with rare adverse events reported in clinical settings. Herein, we present a case of acute pancreatitis complicated by diabetic ketoacidosis (DKA) following the third COVID-19 vaccination dose.Patient: A 72-year-old male with a history of diabetes mellitus developed generalized fatigue, mild epigastric pain, nausea, and frequent vomiting after receiving the COVID-19 vaccine.Results: Blood analysis revealed elevated levels of pancreatic enzymes, hyperglycemia, and acidemia. Computed tomography revealed evidence of acute pancreatitis, leading to a diagnosis of both DKA and acute pancreatitis. Treatment with a large volume of saline and intravenous insulin improved both DKA and acute pancreatitis. After a thorough examination, no other factors capable of causing acute pancreatitis were identified. Hence, we concluded that acute pancreatitis was induced by COVID-19 vaccination.Conclusion: Acute pancreatitis is a rare but potentially life-threatening adverse event associated with COVID-19 vaccination. Delaying the treatment or diagnosis of acute pancreatitis can increase mortality risk in patients with both acute pancreatitis and DKA. Hence, it is crucial for healthcare professionals to consider the potential occurrence of acute pancreatitis and DKA following COVID-19 vaccination.

A Prospective Survey of Adverse Events in Athletes Using Press Take Needles / 全日本鍼灸学会雑誌

[Objective] The purpose of this study was to conduct a prospective survey of adverse events in athletes using press take needles (PTNs).[Methods] The survey subjects were 23 female junior-high-school basketball players, and the method was a prospective survey study. The PTNs (0.6 mm diameter; PYONEX manufactured by Seirin) were applied to a total of six sites on the anterior surfaces of the right and left thighs by the athletes themselves before practice and removed after practice. The survey of adverse events was repeated as many times as possible over a one-year period and comprised the following questions: (1) Did you experience any problems during practice today? (multiple answers); and (2) Did the PTNs negatively affect your physical performance? (single answer). The frequency of adverse events was calculated on the basis of the number of participants and the site of application.[Results] In total, 25 surveys were conducted over the one-year period, with 18 athletes participating (mean age: 13.5 years). On average, the athletes were surveyed 20.1 ± 4.1 times. The total number of participants for all 25 surveys was 362, and the total number of PTNs used was 2,172. In terms of the total number of participants, the frequency of adverse events was 20.99% (76 cases) and that of PTN-related adverse events that negatively affected physical performance was 5.80% (21 cases). In terms of the total number of PTNs used , the frequency of adverse events was 9.16% (199 cases) and that of PTN-related adverse events that negatively affected physical performance was 2.58% (56 cases). The most common adverse event was "prickling" (3.89%; 88 cases), followed by "PTN was coming off" (3.14% ; 71 cases), "bothering" (2.43%; 55 cases), and "uncomfortable feeling" (2.30%; 52 cases), whereas the number of other adverse events was very few. No adverse events requiring medical treatment occurred, and none of the　 athletes stopped practicing due to adverse events.[Discussion and Conclusion] The adverse events in athletes were mostly minor ones such as "prickling" and "uncomfortable feeling ". However, the frequency of adverse events was low, indicating that PTNs are safe for athletes.

Efficacy of 6S standard operating procedures in centralized flexible endoscopes management / 现代医院

Objective This study assesses the effect of 6S standard operation procedure(SOP)on the centralized man-agement of flexible endoscopes within a disinfection supply center.Methods A retrospective analysis was conducted on the cen-tralized management of 38 flexible endoscopes in the Disinfection and Supply Center of Foshan Maternal and Child Health Hospi-tal.From January to June 2022,the endoscopes were managed conventionally without the 6S SOP,as the routine group.From Ju-ly to December 2022,the endoscopes were managed with the 6S SOP,as the research group.The two groups were compared in terms of the adherence to cleaning and disinfection standards,pass rate of cleaning and disinfection,incidence of adverse events,and satisfaction degrees of healthcare providers.Results The research group under the 6S SOP management showed an signifi-cant improvement in the disinfection pass rate compared to the routine group,although the difference was not statistically signifi-cant.However,it presented a significant reduction in the incidence of adverse endoscopic events(P＜0.05)and a significant in-crease in healthcare provider satisfaction(P＜0.05).Conclusion The 6S SOP in the centralized management of flexible endo-scopes in the disinfection supply centers effectively enhances the quality of endoscope cleaning and disinfection,ensures their safe usage,and provides patients with efficient and secure care.