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1.
Article | IMSEAR | ID: sea-226738

RÉSUMÉ

Background: Adverse drug reactions (ADRs) pose a substantial cost to global healthcare systems. The heterogeneous patient demographics and healthcare environments of district residency programmes (DRPs) provide special possibilities for detecting trends of ADRs. In order recognize recurring trends and related variables, this study will examine ADR incidents that occur during DRPs. Methods: A prospective observational research with forty-three patients was carried out. Standardized reporting forms were used to gather data on ADRs, and descriptive statistical techniques were used to analyse the results. We evaluated medication information, patient demographics, and ADR features to seek for patterns and potential causes. Results: Preliminary analysis revealed a diverse range of ADRs observed during DRPs, spanning various severity levels and therapeutic classes. Common ADRs included gastrointestinal disturbances, allergic reactions, and central nervous system effects. Factors such as patient age, polypharmacy, and comorbidities emerged as potential predictors of ADR occurrence. Conclusions: The panorama of ADRs seen during DRPs is clarified by this study, underscoring the significance of careful monitoring, and reporting mechanisms in these initiatives. Gaining insight into ADR trends and related variables can help in improving patient safety, simplifying drug management plans, and directing future educational initiatives for medical professionals.

2.
Article | IMSEAR | ID: sea-226719

RÉSUMÉ

Background: Adverse drug reaction (ADR) is considered a common cause of prolonged hospitalization and death among patients. Pharmacovigilance is essential in the surveillance of adverse drug reactions. The responsibility of a healthcare professional is to report any adverse reaction that occurs with the use of drugs. This helps in providing a database and improving the safety of patients. The aim of the study was to determine the incidence of ADR, assess causality, severity, and preventability of the submitted adverse drug reactions, increase the awareness of preventability of adverse drug reactions in health care professionals by conducting regular workshops on ADR, and document occurrence of a rare ADR. Methods: A retrospective observational study was conducted to assess the ADR reported to the ADR monitoring Centre, for the past 6 years included in the study. The data were entered into Microsoft excel and analyzed using descriptive statistics. Mean and standard deviation were calculated for the categorical data. Drugs were classified according to the class. Reactions were analyzed using scales and presented in descriptive statistics. Results: A total of 95 ADR reports were received and reported. These ADRs were associated with a total of 108 drugs that were prescribed- the occurrence of ADRs dominated among females 60% (57). Antimicrobials were causing the highest number of adverse reactions 21 (19.44%) and antituberculosis drugs and radiocontrast media were associated with the following larger number of the ADRs 19 (17.59%). Intravenous at 40% was the most common route related to the development of ADR. The most common ADR caused by antimicrobials was rash (9), antitubercular therapy commonly caused hepatitis, and chills and rigors were more common with radiocontrast media. Most of the reactions observed in the patients were moderate reactions at 52.63% with 3.16% fatal ones. Conclusions: In this study, the predominant causative drugs associated with ADR were antimicrobials, antitubercular drugs, and radiocontrast media. The number of ADRs reported though was less there was a wide range of drugs causing ADR that were reported which gave a broader spectrum for analysis. There is a requirement for active monitoring of ADRs to understand the occurrence as well as help in prevention.

3.
Chin. j. integr. med ; Chin. j. integr. med;(12): 99-106, 2024.
Article de Anglais | WPRIM | ID: wpr-1010327

RÉSUMÉ

OBJECTIVE@#To assess the risk of aristolochic acid (AA)-associated cancer in patients with AA nephropathy (AAN).@*METHODS@#A retrospective study was conducted on patients diagnosed with AAN at Peking University First Hospital from January 1997 to December 2014. Long-term surveillance and follow-up data were analyzed to investigate the influence of different factors on the prevalence of cancer. The primary endpoint was the incidence of liver cancer, and the secondary endpoint was the incidence of urinary cancer during 1 year after taking AA-containing medication to 2014.@*RESULTS@#A total of 337 patients diagnosed with AAN were included in this study. From the initiation of taking AA to the termination of follow-up, 39 patients were diagnosed with cancer. No cases of liver cancer were observed throughout the entire follow-up period, with urinary cancer being the predominant type (34/39, 87.17%). Logistic regression analysis showed that age, follow-up period, and diabetes were potential risk factors, however, the dosage of the drug was not significantly associated with urinary cancer.@*CONCLUSIONS@#No cases of liver cancer were observed at the end of follow-up. However, a high prevalence of urinary cancer was observed in AAN patients. Establishing a direct causality between AA and HCC is challenging.


Sujet(s)
Humains , Études rétrospectives , Incidence , Carcinome hépatocellulaire , Tumeurs du foie/épidémiologie , Maladies du rein/induit chimiquement , Acides aristolochiques/effets indésirables
4.
Article de Chinois | WPRIM | ID: wpr-1023161

RÉSUMÉ

Safer drug use relies on the sustained vigilance and continual awareness of all individuals,and drug benefit-risk communication plays a pivotal role in facilitating this process.Foreign exploration on drug benefit-risk communication started relatively earlier.Upon scrutinizing the websites of drug regulatory authorities in the United States and Europe Union,it appears that these regions have established comprehensive communication regulation and practice systems,developed strategic plans and guidance,and communicated with healthcare professionals,patients and the public via various tools and channels,mainly including drug statutory information,new safety information,potential safety signals,etc.In China,drug benefit-risk communication is involved in the legislation,but the relevant guidelines and specific implementation rules are still lacking,and the evidence-based communication research and communication tools are relatively insufficient.We could learn from the experience of other countries,which involves enhancing regulatory implementation,establishing a communication framework,developing scientific evidence,assessing communication effectiveness,refining communication tools,and diminishing information barriers,in order to ultimately support patient and health care professionals to make informed decisions about medication.

5.
Article | IMSEAR | ID: sea-216075

RÉSUMÉ

A 26-year-old Malaysian woman (childbearing age) attended a private primary care clinic with a known case of gastroesophageal reflux disease (GERD) and complained of persistent nausea and a few episodes of vomiting. She had no known drug allergy, no surgical history, no hospitalization in the last two years, was a non-smoker, and no history of drug or alcohol abuse. The patient was prescribed Tab metoclopramide 10 mg TDS and Tab ranitidine 150 mg BD for five days. About 30 min after oral administration of both medicines, her eyes rolled involuntary upward, leading to lateral deviation of the eyes, and mouth jaws clenched as if “dislocated jaws.” The patient was immediately brought into an emergency department (ED) of a public tertiary care hospital. A drug challenge test was done which resulted in the withdrawal of metoclopramide. The accompanied sister later disclosed that the patient had taken metoclopramide and ranitidine from a private clinic earlier in the day. The patient self-assumed to have a sudden seizure, due to excessive hot weather and dehydration. A slow intravenous infusion of 50 mg/mL diphenhydramine hydrochloride in 0.9% w/v NaCl 100 mL was administered stat. Consequently, the symptoms vanished after approximately 30 min of the therapy, devoid of relapse. The patient was discharged from ED post 8 hours of monitoring with complete recovery. Physicians frequently prescribe metoclopramide to treat nausea and vomiting, which may cause adverse drug reaction of acute dystonic oculogyric crisis (OGC). Due to its unwanted and unpredictable extrapyramidal symptoms, metoclopramide should be prescribed and dispensed with caution. Thorough history taking at ED is imperative for correct early diagnosis and treatment, as metoclopramide-induced dystonic OGC has a high probability of confusion with other causes of dystonia such as conversion and seizures, encephalitis, tetanus, and hypercalcemic tetany.

6.
J. biomed. eng ; Sheng wu yi xue gong cheng xue za zhi;(6): 257-264, 2023.
Article de Chinois | WPRIM | ID: wpr-981537

RÉSUMÉ

Macaque is a common animal model in drug safety assessment. Its behavior reflects its health condition before and after drug administration, which can effectively reveal the side effects of drugs. At present, researchers usually rely on artificial methods to observe the behavior of macaque, which cannot achieve uninterrupted 24-hour monitoring. Therefore, it is urgent to develop a system to realize 24-hour observation and recognition of macaque behavior. In order to solve this problem, this paper constructs a video dataset containing nine kinds of macaque behaviors (MBVD-9), and proposes a network called Transformer-augmented SlowFast for macaque behavior recognition (TAS-MBR) based on this dataset. Specifically, the TAS-MBR network converts the red, green and blue (RGB) color mode frame input by its fast branches into residual frames on the basis of SlowFast network and introduces the Transformer module after the convolution operation to obtain sports information more effectively. The results show that the average classification accuracy of TAS-MBR network for macaque behavior is 94.53%, which is significantly improved compared with the original SlowFast network, proving the effectiveness and superiority of the proposed method in macaque behavior recognition. This work provides a new idea for the continuous observation and recognition of the behavior of macaque, and lays the technical foundation for the calculation of monkey behaviors before and after medication in drug safety evaluation.


Sujet(s)
Animaux , Alimentations électriques , Macaca , 35416
7.
Article de Chinois | WPRIM | ID: wpr-1014597

RÉSUMÉ

AIM: To evaluate the risk of drug-related dysphagia in elder people based on the FDA Adverse Event Reporting System (FAERS). METHODS: We collected the reports of dysphagia in elder people (Age≥65) from 2004 quarter 1 through 2022 quarter 2 of FAERS by Open Vigil 2.1 database. The reported odds ratio (ROR) and the proportional reported ratio (PRR) were calculated to detect the adverse reaction signal of drug-induced dysphagia in elder people. Signal generation standard of ROR: number of reports≥3 with the lower limit of 95% confidence interval (CI) of the ROR value>1, PRR≥2 and c

8.
Acta Pharmaceutica Sinica B ; (6): 2483-2509, 2023.
Article de Anglais | WPRIM | ID: wpr-982856

RÉSUMÉ

New drug discovery is under growing pressure to satisfy the demand from a wide range of domains, especially from the pharmaceutical industry and healthcare services. Assessment of drug efficacy and safety prior to human clinical trials is a crucial part of drug development, which deserves greater emphasis to reduce the cost and time in drug discovery. Recent advances in microfabrication and tissue engineering have given rise to organ-on-a-chip, an in vitro model capable of recapitulating human organ functions in vivo and providing insight into disease pathophysiology, which offers a potential alternative to animal models for more efficient pre-clinical screening of drug candidates. In this review, we first give a snapshot of general considerations for organ-on-a-chip device design. Then, we comprehensively review the recent advances in organ-on-a-chip for drug screening. Finally, we summarize some key challenges of the progress in this field and discuss future prospects of organ-on-a-chip development. Overall, this review highlights the new avenue that organ-on-a-chip opens for drug development, therapeutic innovation, and precision medicine.

9.
Article de Chinois | WPRIM | ID: wpr-998983

RÉSUMÉ

Crohn’s Disease (CD) is a destructive, relapsing and remitting chronic inflammatory bowel disease that usually progresses to irreversible intestinal structural and functional changes, such as intestinal lumen stenosis, fistula formation and perianal lesions, severely affecting the quality of life of patients. This review summarized the research progress on the mechanism, clinical application and safety of upadacitinib in the treatment of CD. Upadacitinib can increase the clinical remission and endoscopic response rates in patients with CD, improve the long-term outcome of CD patients and provide a new idea for the treatment of CD patients by using biological agents.

10.
Health SA Gesondheid (Print) ; 28: 1-9, 2023. figures, tables
Article de Anglais | AIM | ID: biblio-1524369

RÉSUMÉ

Background: The World Health Organization (WHO) guidelines recommend the empiric treatment of infections before definitive treatment begins. However, ethical concerns limit the availability of clinical trials in neonates and paediatrics to fully ascertain the safety profile of antibiotics in these populations. Aim: This study aimed to quantify the use of antibiotics among neonates and paediatrics and commented on the use, rationale and appropriateness of antibiotics prescribed. Setting: A secondary level public sector hospital located in Durban, KwaZulu-Natal. Methods: Demographic and treatment information of neonates and paediatrics were collected retrospectively from January 2022 to June 2022. Data were obtained from patient files and extracted for analysis using Microsoft Excel®. Analytical and descriptive statistics were used to analyse patient demographics and treatment variables. Results: A total of 568 antibiotics, issued to 389 patients, were reviewed. Penicillins (40.1%), aminoglycosides (24.3%) and combination penicillin-beta-lactam inhibitors (23.3%) were identified as the most frequently prescribed antibiotics for inpatients. Most antibiotics prescribed to inpatients were for complications associated with pre-term birth (66.9%). Combination penicillin-beta-lactam inhibitors (34.7%), penicillins (29.5%) and cephalosporins (29.5%) were the most frequently prescribed antibiotics to outpatients. A correlation was found between the route of administration and the duration of therapy; the intravenous route (63.6%) was preferred over the oral route (36.4%) for administration. Conclusion: Many broad-spectrum antibiotics were prescribed, thus increasing the risk of resistance. Antibiotics were being prescribed according to the guidelines; however, there is still a need for therapeutic drug monitoring to ensure the continuation of rational drug use. Contribution: There was evidence of rational use of antibiotics in the public hospital (KwaZulu-Natal), in keeping with economic and availability factors.


Sujet(s)
Mâle , Femelle
11.
Article de Espagnol | LILACS-Express | LILACS | ID: biblio-1440697

RÉSUMÉ

Introducción: la detección oportuna y la evaluación de las reacciones adversas de los medicamentos es cada vez más importante. En Cuba existe la necesidad de profundizar y extender con alcance nacional los estudios de Farmacovigilancia, por tal motivo se expone como objetivo fundamentar sustentados en la estadística el uso de estudios de farmacovigilancia para la detección, registro, notificación y evaluación de las sospechas de las reacciones adversas de los medicamentos valorando su seguridad. Desarrollo: se brinda un resumen de tipos de estudios de farmacovigilancia con ejemplos de objetivos de investigaciones realizadas y publicadas en revistas científicas posibles a considerar y aplicar a las condiciones reales que tenga cada investigador, se presentan variables que ya han sido establecidas en otros estudios que se deben tener en cuenta para estudiar seguridad de los medicamentos y técnicas estadísticas teniendo en cuenta los tipos de variables a relacionar. Conclusiones: se concluye que resulta un logro científico conocer formas de profundizar y extender los estudios de Farmacovigilancia para tomar conocimiento de la seguridad de los fármacos y promover un uso racional, científico y adecuado de los mismos, en beneficio de la comunidad.


Introduction: timely detection and evaluation of adverse drug reactions is increasingly important. In Cuba there is a need to deepen and extend pharmacovigilance studies nationwide. That is why it is stated, based on statistics, the use of studies for the detection, registration, notification and evaluation of suspected adverse drug events, assessing their safety. Development: a summary of types of pharmacovigilance studies is provided with examples of objectives of research works already done and published in scientific magazines likely to consider and use in actual conditions each researcher has, and there are also presented variables that have already been established in other studies, which must be taken into account to study drug safety and statistical techniques considering the types of variables to be related. Conclusion: it is concluded that knowing ways to deepen and spread the Pharmacovigilance studies in order to be aware of drug safety and foster their rational, scientific and adequate use in the interests of the community is indeed a scientific accomplishment.


Introdução: a detecção e avaliação oportunas de reações adversas a medicamentos está se tornando cada vez mais importante. Em Cuba há uma necessida de de aprofundar e ampliar os estudos de farmacovigilância com âmbito nacional, por esta razão é declarado como um objetivo fundamentar com base em estatísticas o uso de estudos de farmacovigilância para a detecção, registro, notificação e avaliação de suspeitas de reações adversas de medicamentos que avaliam sua segurança. Desenvolvimento: um resumo dos tipos de estudos de farmacovigilância é fornecido com exemplos de objetivos de pesquisa realizados e publicados em possíveis revistas científicas a serem consideradas e aplicadas às condições reais que cada pesquisador possui, variáveis que já foram estabelecidas em outros estudos que devem ser levadas em conta para estudar a segurança de medicamentos e técnicas estatísticas levando em conta os tipos de variáveis a serem relacionadas. Conclusões: conclui-se que é uma conquista científica conhecer formas de aprofundar e ampliar os estudos de farmacovigilância para tomar conhecimento da segurança dos medicamentos e promover um uso racional, científico e adequado dos mesmos, em benefício da comunidade.

12.
Rev. peru. med. exp. salud publica ; 39(1): 91-97, ene.-mar. 2022. tab, graf
Article de Espagnol | LILACS | ID: biblio-1389933

RÉSUMÉ

RESUMEN El estudio tuvo como objetivo evaluar el conocimiento, las actitudes y prácticas de un grupo de profesionales de la salud sobre la farmacovigilancia en el contexto de la COVID-19 en el Seguro Social de Salud del Perú (EsSalud). Se realizó un análisis secundario descriptivo de una base de datos que incluía las respuestas de una encuesta en línea realizada por el Centro de Referencia Institucional de Farmacovigilancia y Tecnovigilancia de EsSalud. De 144 participantes, el 66% mostró alto nivel de conocimiento y el 81,2%, actitud positiva; sin embargo, el 71,5% tuvo un inadecuado nivel de práctica de farmacovigilancia. Si bien los profesionales de EsSalud demostraron tener alto conocimiento y actitud positiva para implementar farmacovigilancia, esto no se ve reflejado en la práctica de esta actividad en la época de pandemia por el SARS-CoV-2. Se deben emplear estrategias para integrar a la farmacovigilancia en las actividades asistenciales en beneficio de la seguridad del paciente.


ABSTRACT The study aimed to evaluate a group of health professionals' knowledge, attitudes, and practices on pharmacovigilance in the context of COVID-19 in the Peruvian Social Health Insurance (EsSalud). A descriptive secondary analysis was carried out on a database that included responses from an online survey conducted by the Institutional Referral Center for Pharmacovigilance and Technovigilance of EsSalud. Of 144 participants, 66% showed a high level of knowledge and 81.2% had a positive attitude; however, 71.5% had an inadequate level of pharmacovigilance practice. Although EsSalud professionals demonstrated a high level of knowledge and positive attitude to implement pharmacovigilance, this is not reflected in the practice of this activity during the SARS-CoV-2 pandemic. Strategies should be implemented to integrate pharmacovigilance into healthcare activities to benefit patient safety.


Sujet(s)
Humains , Mâle , Femelle , Personnel de santé , Pharmacovigilance , COVID-19 , Connaissances, attitudes et pratiques en santé , Prestations des soins de santé , Assurance maladie
13.
China Pharmacy ; (12): 1814-1819, 2022.
Article de Chinois | WPRIM | ID: wpr-936484

RÉSUMÉ

OBJECTIVE To evaluate the efficiency of drug safet y supervision in China after issuing a series of new policies in 2018,and to provide the suggestions for optimizing the construction of drug safety supervision system in China and narrowing regional differences. METHODS The panel data of input-output indexes of 18 provinces in 7 administrative regions were collected from the official website of provincial drug regulatory departments ,the open platform of budget and final accounts and the official website of National Bureau of Statistics. Data envelopment analysis (DEA)model and Malmquist index were adopted to conduct an empirical analysis on the efficiency of drug safety supervision in China during 2019-2020. RESULTS & CONCLUSIONS DEA analysis showed that during 2019-2020,the overall technical efficiency (TE)of drug safety supervision in China was lower than 1.000,which didn ’t meet effective DEA. Only Liaoning ,Guangdong and Guangxi had TE of 1.000,indicating significant differences in efficiency of drug safety supervision in different regions. The results of Malmquist index analysis showed that the overall efficiency of drug safety regulation in China was declining ,among which insufficient regulatory capacity supported by technology and large loss of professional personnel were the main factors ,and the improvement of drug regulatory departments ’ management and supervision level could ensure the improvement of overall regulatory efficiency. The current scale of drug supervision in nearly half of provinces (8/18)was close to the optimal state. It is necessary to strengthen the infrastructure construction and pay attention to the training of professional talents to optimize the drug regulatory team ;strengthen the innovation of supervision technology and improve the construction of technological support system ;rationally allocate regulatory resources and balance regional regulation according to local conditions to improve the construction of drug safety supervision system in China.

14.
Chin. j. integr. med ; Chin. j. integr. med;(12): 138-144, 2022.
Article de Anglais | WPRIM | ID: wpr-922567

RÉSUMÉ

OBJECTIVE@#To compare the safety differences between Chinese medicine (CM) and Western medicine (WM) based on Chinese Spontaneous Reporting Database (CSRD).@*METHODS@#Reports of adverse events (AEs) caused by CM and WM in the CSRD between 2010 and 2011 were selected. The following assessment indicators were constructed: the proportion of serious AEs (PSE), the average number of AEs (ANA), and the coverage rate of AEs (CRA). Further comparisons were also conducted, including the drugs with the most reported serious AEs, the AEs with the biggest report number, and the 5 serious AEs of interest (including death, anaphylactic shock, coma, dyspnea and abnormal liver function).@*RESULTS@#The PSE, ANA and CRA of WM were 1.09, 8.23 and 2.35 times higher than those of CM, respectively. The top 10 drugs with the most serious AEs were mainly injections for CM and antibiotics for WM. The AEs with the most reports were rash, pruritus, nausea, dizziness and vomiting for both CM and WM. The proportions of CM and WM in anaphylactic shock and coma were similar. For abnormal liver function and death, the proportions of WM were 5.47 and 3.00 times higher than those of CM, respectively.@*CONCLUSION@#Based on CSRD, CM was safer than WM at the average level from the perspective of adverse drug reactions.


Sujet(s)
Humains , Chine , Effets secondaires indésirables des médicaments/épidémiologie , Injections , Médecine traditionnelle chinoise
15.
Journal of Clinical Hepatology ; (12): 1183-1187, 2022.
Article de Chinois | WPRIM | ID: wpr-924804

RÉSUMÉ

Drug-induced liver injury (DILI) is one of the common adverse drug reactions and is the main cause of withdrawal of drugs after marketing, which has attracted more and more attention of the public, and herb-induced liver injury (HILI) is a special type of DILI. In recent years, the frequent occurrence of HILI not only seriously endangers the health of patients, but also causes the controversy over the safety of traditional Chinese medicine. Therefore, this article reviews the potential risk factors for HILI from the three aspects of "patient", "drug", and "use", so as to provide a basis for the objective identification, prevention, and control of HILI and a reference for the construction of traditional Chinese medicine pharmacovigilance system represented by liver injury.

16.
China Pharmacy ; (12): 257-262, 2022.
Article de Chinois | WPRIM | ID: wpr-913080

RÉSUMÉ

OBJECTIVE To provide reference for clarifying the action and development direction of China ’s drug safety governance. METHODS Based on governance theory ,an analysis framework of “Motivation-Sharing-Performance and Feedback ” was established to explain the mechanism of cross-sector collaboration governance of drug safety. By constructing the action framework of national drug safety governance of “3 stages+1 incubation period ”,the connotation of each stage and possible challenges were analyzed ,and improvement suggestions were put forward. RESULTS & CONCUSIONS The obstacles that restricted the effectiveness of drug safety governance in China were mainly due to insufficient information ,resource mobilization and power sharing. Therefore ,the“basic collaboration stage ”should expand the scope of information sharing and involve non-governmental entities ;the“legislative coordination stage ”should focuse on the provision of formal legal systems so that non-governmental forces can play a necessary role in governance activities ;the“deepening of the coordination stage ”should promote the formal integration of social forces into governance system ,and truly realize the transition from “passive participation ” to self-management. It is recommended to continuously improve the construction of drug safety governance system in China in terms of governance norms ,communication mechanisms ,capacity development based on a holistic perspective.

17.
Article de Chinois | WPRIM | ID: wpr-955423

RÉSUMÉ

Objective:To investigate the effects of bevacizumab injection on immune function and drug safety in patients with non-small-cell lung cancer (NSCLC).Methods:A total of 80 NSCLC patients admitted to Liaocheng Second People′s Hospital from August 2018 to August 2020 were selected as study subjects. They were divided into the observation group and the control group by random number table method, each group with 40 cases. The control group received routine chemotherapy and the observation group received bevacizumab injection as adjuvant therapy on the bases of control group. Short-term efficacy, serum T lymphocyte subsets, vascular endothelial growth factor (VEGF), basic fibroblast growth factor (b-FGF) levels and the incidence of adverse reactions were compared between the two groups.Results:The total effective rate and disease control rate in the observation group were significantly higher than those in the control group: 77.5%(31/40) vs. 55.0%(22/40), 92.5%(37/40) vs. 75.0%(30/40), χ2 = 4.53, 4.50, P<0.05. After the treatment, the levels of CD 3+, CD 4+, CD 8+ and CD 4+/CD 8+ in the observation group were increased ( P<0.05), while those in the control group were decreased ( P<0.05), the levels of CD 3+, CD 4+, CD 8+ and CD 4+/CD 8+ in the observation group after treatment were higher than those in the control group ( P<0.05). After the treatment, the levels of serum VEGF and b-FGF in both groups were decreased ( P<0.05), and the above indicators in the observation group were significantly lower than those in the control group ( P<0.05). The rate of adverse reactions in two groups had no significant differences ( P>0.05). Conclusions:Bevacizumab injection is safe and effective in the treatment of NSCLC, which can significantly improve the immune function of patients and reduce their serum VEGF and b-FGF levels.

18.
Article de Chinois | WPRIM | ID: wpr-904764

RÉSUMÉ

Objective To analyze the current situation of off-label drug use for tic disorder in a tertiary maternity and child hospital, so as to promote clinical safe and rational drug use. Methods Through the hospital information system, the pediatric outpatient prescriptions diagnosed with tic disorder from July 2019 to August 2020 were selected, and the prescriptions of off-label use was evaluated according to the 2020 off-label drug management regulations. Results A total 1251 pediatric prescriptions diagnosed with tic disorder were collected. The incidence of off-label drug use was 29.58%. The main types of off-label were over-indications and over-age. The main varieties of off-label drug use were risperidone tablets (47.84%) and aripiprazole tablets (43.74%). Conclusion The off-label use of drug for tic disorder in pediatric outpatient department of our hospital is relatively common,and it is necessary to standardize the management of off-label drug use to ensure rational drug use.

19.
China Pharmacy ; (12): 2012-2018, 2021.
Article de Chinois | WPRIM | ID: wpr-886587

RÉSUMÉ

OBJECTIVE: To mine and evaluate the post-marketing safety alert signals of pegaspargase (PEG-ASP) and L-asparaginase (L-ASP),and compare the safety differences between them ,so as to provide reference for clinical safe and rational drug use. METHODS : The adverse drug event (ADE) reports of PEG-ASP and L-ASP issued by FDA adverse event reporting system from Jan. 1st,2004-Jun. 30th,2020 were retrieved. BCPNN method was used to mine the safety signals of these two drugs under the condition that the lower limit of information component (IC-2SD)>0 and the number of events ≥3. The medium and strong signals of two drugs with IC -2SD≥1.5 were evaluated and compared in 8 system organ class,such as gastrointestinal system ,hepatobiliary system ,blood and lymphatic system ,blood vessels and lymphatic vessels , nervous system ,immune system ,metabolism and nutrition ,various examinations. IC value of specific ADE signal and its 95% confidence interval were analyzed by time scanning spectrum. RESULTS & CONCLUSIONS :The reports of PEG-ASP and L-ASP as suspected drugs were 2 324 and 3 824;67 and 68 medium and strong signals were included ,respectively. In gastrointestinal system,the common strong signal of PEG-ASP and L-ASP was necrotic pancreatitis. In hepatobiliary system ,both of them showed strong signal in venoocclusive liver disease ,and this ADE was not included in the drug instruction. In blood and lymphatic system , common strong signals of the two drugs were febrile neutropenia ,coagulation disorder ,neutropenia and febrile bone marrow regeneration disorder ;in blood vessels and lymphatic vessels ,in addition to haemodynamic instability ,IC values of other signals of L-ASP were higher than those of PEG-ASP. In nervous system ,IC values of other signals of L-ASP were higher than those of PEG-ASP except for intracranial haemorrhage. In immune system ,anaphylactic reaction was a medium signal for L-ASP but was a strong signal for PEG-ASP. In metabolism and nutritional diseases ,except for tumor lysis syndrome ,IC values of other signals of L-ASP were higher than those of PEG-ASP. The results of time scanning spectrum showed that the signals of necrotic pancreatitis and coagulation disorder of PEG-ASP were stable ,while the signals of veno occlusive liver disease and hypersensitivity were unstable and needed to be observed ;above four signals of L-ASP were stable signals. When using PEG-ASP or L-ASP clinically , close attention should be paid to the safety problems such as hypersensitivity ,coagulation disorder ,thrombosis,necrotic pancreatitis,venoocclusive liver disease and hypoproteinemia.

20.
Article de Chinois | WPRIM | ID: wpr-886887

RÉSUMÉ

Objective To explore the effect of CYP2C19 gene polymorphism on clopidogrel plasma concentration, rate of platelet inhibition and safety. Methods We screen the patients who took clopidogrel after PCI in our hospital, according to the inclusion and exclusion criteria. Blood samples were collected on the 6th day after clopidogrel administration. Clopidogrel blood concentration was determine by RP-HPLC. The CYP2C19 genotype was detected by non-amplified immune hybridization. The rate of platelet inhibition was evaluated by the thromboelastogram. The results were analyzed by SPSS 20.0 software. Results A total of 87 patients were recruited, including 46 males and 41 females. Among them, 34 cases were fast metabolism. 38 cases were medium metabolism. 15 cases were slow metabolism. The result showed that there was no significant difference in drug concentration between fast and intermediate metabolism(P=0.667). There was a significant difference in drug concentration between slow metabolism and fast metabolism or medium metabolism(P<0.05). Analysis of variance and chi-square test showed that CYP2C19 gene polymorphism has a significant effect on clopidogrel platelet inhibition rate and safety (P<0.05). Conclusion Guiding clopidogrel clinical medication based on CYP2C19 genotype alone does not necessarily achieve better therapeutic effects. CYP2C19 genotype detection and blood concentration monitoring can be combined to guide the clinical individualized administration of clopidogrel

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