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1.
Chemosphere ; 287(Pt 1): 131954, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34478968

RESUMO

Nowadays, air pollution due to urbanization and reduction of forestry is emerging as a serious threat to humans and the environment. According to the World Health Organization, respiratory diseases are the third most mortality factor in the world. Chemical research organizations and industries are producing a large number of new chemical compounds continuously. Although toxicity testing of those chemicals on animals is costly, resource and time consuming, these data cannot be properly extrapolated to humans and other animals, and also these raise ethical issues. In this background, we have developed Quantitative Structure-Activity Relationship (QSAR) models using the No Observed Adverse Effect Concentration (NOAEC) as the endpoint to assess inhalation toxicity of diverse organic chemicals, commonly used and exposed by us in our daily life. No Observed Adverse Effect Concentration (NOAEC) can be used for long term toxicity studies towards the human inhalation risk assessment, as recommended by Organization for Economic Co-operation and Development (OECD) in guidance document 39. A particular QSAR model may not be equally effective for prediction of all query compounds from a given set of compounds; therefore, we have developed multiple models, which are robust, sound and well predictive from the statistical point of view to forecast the NOAEC values for the new untested compounds. Subsequently the validated individual models were employed to generate consensus models, in order to improve the quality of predictions and to reduce prediction errors. We have investigated some crucial structural features from these models which may regulate inhalation toxicity for newly produced molecules. Thus, our developed models may help in toxicity assessment towards reducing the health hazards for new chemicals.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Relação Quantitativa Estrutura-Atividade , Animais , Humanos , Compostos Orgânicos , Medição de Risco , Testes de Toxicidade
2.
BMC Health Serv Res ; 21(1): 1231, 2021 Nov 13.
Artigo em Inglês | MEDLINE | ID: mdl-34774053

RESUMO

BACKGROUND: The prediction of the real-world cost of adverse drug reactions (ADRs) has historically relied on the data from randomized controlled trials (RCT). However, trial conditions do not always reflect the real-world applications of pharmaceutical products; hence, they may not accurately portray the actual risks of ADRs associated with them. The objective of this study is two-fold: (a) demonstrate whether and how post-market and RCT ADR data could lead to different conclusions for a set of drugs of interest, and (b) evaluate the potential economic impact of the post-market ADRs associated with those drugs. METHODS: We selected two TNF-α inhibitor biologics, infliximab and adalimumab, and used the Canada Vigilance Adverse Reaction (CVAR) online database as a source of post-market ADR data. Adverse reaction data from RCTs were obtained from ClinicalTrials.gov . Direct healthcare costs associated with adverse reactions were obtained from Canadian Institute for Health Information (CIHI) or Interactive Health Data Application, Alberta. We calculated post-market ADR rates and compared them with those found in the randomized controlled trials of these two drugs. Using the post-market data, we estimated the costs associated with serious ADRs from three perspectives: patient, health system, and societal. RESULTS: For both drugs, the post-market and RCT data exhibited significantly different adverse reaction rates for several different clinical outcomes. As a general trend, more serious adverse reactions, such as death, appeared to have a higher rate in post-market applications compared to the clinical trials. The estimated average annual economic burden of the severe adverse reaction outcomes ranged from $10 million to $20 million for infliximab and $6 million to $19 million for adalimumab. CONCLUSIONS: The frequency and severity of post-market adverse reactions associated with pharmaceutical products may significantly differ from those detected in the clinical trials. Despite possible methodological differences, this is due to the fact that post-market data reflect the externalities of the real-world that are absent in RCTs. The economic burden of adverse reactions can be substantial, and the cost calculated using post-market data is better reflective of the cost of ADRs in the real-world.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmacoeconomia , Adalimumab/efeitos adversos , Sistemas de Notificação de Reações Adversas a Medicamentos , Alberta , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Infliximab/efeitos adversos
3.
Anticancer Res ; 41(11): 5827-5834, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34732458

RESUMO

BACKGROUND/AIM: Recently, the number of patients with cancer receiving outpatient chemotherapy using oral anticancer drugs has increased, but the currently available outpatient cancer chemotherapy is not safer than that available before. The present study aimed to identify risk factors associated with unplanned acute care (UAC) requiring outpatient chemotherapy-related consultation and hospitalisation. PATIENTS AND METHODS: We conducted a case- control study among 1,674 patients who received oral anticancer drug treatment either alone or in combination with injectable anticancer drugs at National Cancer Center Hospital East, Japan, between December 1, 2014, and November 30, 2015. RESULTS: Body mass index (BMI) was identified as a risk factor for UAC during chemotherapy. Patients with a BMI of <18.5 kg/m2, classified as underweight according to the World Health Organization classification of nutritional status, had a significantly higher risk of UAC. CONCLUSION: A low BMI immediately before the occurrence of chemotherapy-related UAC is a risk factor for adverse effects; therefore, underweight patients need more careful monitoring and supportive care.


Assuntos
Assistência Ambulatorial , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/terapia , Neoplasias/tratamento farmacológico , Administração Oral , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Índice de Massa Corporal , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologia , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Fatores de Tempo , Resultado do Tratamento
4.
Enferm Clin (Engl Ed) ; 31(6): 363-370, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34756240

RESUMO

OBJECTIVE: This study aimed to gain knowledge of the nurses' involvement in the spontaneous report of suspected adverse drug reactions (ADR) in the Spanish Pharmacovigilance System for Medicinal Products for Human Use (SEFV-H), describing the principal characteristics of the reported cases, identifying points of improvement. METHODS: A descriptive observational retrospective study was based on the data from FEDRA, the database created by the SEFV-H. The sample taken was the spontaneous adverse drug reactions reported to SEFV-H by nurses during the first 6 months of the 2018. RESULTS: Complete data was provided by 6,370 suspicions of ADR reported to SEFV-H by all healthcare professionals. Only 4,8% of the samples were taken by nurses, 62,7% came from medical centers. The majority of the ADR were not considered a serious disease (78%). The most frequently adverse drug reactions reported by nurses were local reactions. The patients most involved were children and vaccines were the most reported drugs (58,3%), followed by the intravenous contrast agents used in diagnostic tests. CONCLUSIONS: Nurses report very few cases to SEFV-H and are mostly related to the administration of vaccines and are sent by nurses working in the out-of-hospital setting. Most cases are not serious and usually report known adverse reactions to the suspected drug. This observed under-notification raises the need to promote increased pharmacovigilance training among these notifying nurses so that they can continue to report, and also for those who do not do so in their daily practice, so that they can begin to do so.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Criança , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Farmacovigilância , Estudos Retrospectivos , Espanha
5.
Nihon Yakurigaku Zasshi ; 156(6): 364-369, 2021.
Artigo em Japonês | MEDLINE | ID: mdl-34719571

RESUMO

In vivo cardiovascular experiments as part of safety pharmacology studies have been developed for small molecule drug candidates to maximize detection power for potential undesirable pharmacodynamic effects of a drug candidate on physiological functions, and have been established with appropriate expertise. Conscious freely-moving telemeterized non-rodents are generally used for the in vivo cardiovascular experiments. The technology and evaluation best practices for the experiments have been optimized by multiple researchers and as a result, the experiments considerably contribute to the estimation of cardiovascular risks for humans. In addition, as described in ICH E14&S7B Q&A draft, non-clinical studies are gaining importance in the integrated risk assessment for QT prolongation in humans, and high quality data obtained in non-clinical studies are being required. This manuscript introduces actual technology and evaluation for in vivo cardiovascular safety pharmacology studies based on Japan activity for Improvement of Cardiovascular Evaluation by Telemetry system (J-ICET), which is one of the working groups hosted by Japanese Safety Pharmacology Society.


Assuntos
Sistema Cardiovascular , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Síndrome do QT Longo , Farmacologia , Avaliação Pré-Clínica de Medicamentos , Humanos , Tecnologia
6.
J Infus Nurs ; 44(6): 331-338, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34753152

RESUMO

Teprotumumab was the first and only medication approved by the US Food and Drug Administration for the treatment of thyroid eye disease in January 2020. Thyroid eye disease is a complex autoimmune inflammatory disease that can be sight-threatening, debilitating, and disfiguring to affected patients. Although biologic therapies are a preferred treatment option for many complex immunologic and oncologic conditions, their use in ophthalmology and endocrinology may be more novel. The goals of this article are to introduce this new therapeutic option; discuss its mechanism of action, indications for use, administration protocol, infusion precautions, and informed consent; and review common side effects and management.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Oftalmopatia de Graves , Anticorpos Monoclonais Humanizados , Humanos , Consentimento Livre e Esclarecido
9.
J Chem Inf Model ; 61(11): 5386-5394, 2021 11 22.
Artigo em Inglês | MEDLINE | ID: mdl-34757743

RESUMO

In silico assessment of drug toxicity is becoming a critical step in drug development. Conventional ligand-based models are limited by low accuracy and lack of interpretability. Further, they often fail to explain cellular mechanisms underlying structure-toxicity associations. We addressed these limitations by incorporating target profile as an intermediate connecting structure to toxicity. To accommodate for high-dimensional feature space, we developed a pipeline named TargetTox that can identity a subset of predictive features. We implemented TargetTox to study 569 targets and 815 adverse events. The features identified by TargetTox comprise less than 10% of the original feature space; nevertheless, they accurately predicted binding outcomes for 377 targets and toxicity outcomes for 36 adverse events. We demonstrated that predictive targets tend to be differentially expressed in the tissue of toxicity. We also rediscovered key cellular functions associated with cardiotoxicity from the predictive targets, as well as markers of skin and liver diseases. Furthermore, we found evidence supporting diagnostic and therapeutic applications of some predictive targets in hepatotoxicity and nephrotoxicity. Our findings highlighted the critical role of predictive targets in cellular mechanisms leading to toxicity. In general, our study improved the interpretability of toxicity prediction without sacrificing accuracy. Our novel pipeline may benefit future studies of high-dimensional data sets.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Biomarcadores , Simulação por Computador , Humanos
11.
J Assoc Physicians India ; 69(11): 11-12, 2021 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-34781620

RESUMO

Prescribing is always a risky proposition with a varied degree of vulnerability embedded in the act. It is therefore important to do a perfect balancing in favor of benefit against harm. Deprescribing is the planned and supervised process of dose reduction or stopping of prescribed medications, aimed at correcting inappropriate polypharmacy and improving patient outcomes. Informed reconciliation for potential deprescribing need should be a norm in all patients receiving many medications for multiple chronic comorbidities and is best done in partnership with the prescribing physician. Judicious deprescribing through clinical pharmacological review ensures better patient outcomes. We present here a case series from our experience in clinical pharmacology outpatients' department (OPD), highlighting how de-prescribing helps achieving better patient outcomes.


Assuntos
Desprescrições , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Farmacologia Clínica , Humanos , Assistência de Longa Duração , Polimedicação
12.
Lancet Oncol ; 22(11): 1541-1559, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34600602

RESUMO

BACKGROUND: The majority of patients with metastatic castration-resistant prostate cancer (mCRPC) will have disease progression of a uniformly fatal disease. mCRPC is driven by both activated androgen receptors and elevated intratumoural androgens; however, the current standard of care is therapy that targets a single androgen signalling mechanism. We aimed to investigate the combination treatment using apalutamide plus abiraterone acetate, each of which suppresses the androgen signalling axis in a different way, versus standard care in mCRPC. METHODS: ACIS was a randomised, placebo-controlled, double-blind, phase 3 study done at 167 hospitals in 17 countries in the USA, Canada, Mexico, Europe, the Asia-Pacific region, Africa, and South America. We included chemotherapy-naive men (aged ≥18 years) with mCRPC who had not been previously treated with androgen biosynthesis signalling inhibitors and were receiving ongoing androgen deprivation therapy, with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and a Brief Pain Inventory-Short Form question 3 (ie, worst pain in the past 24 h) score of 3 or lower. Patients were randomly assigned (1:1) via a centralised interactive web response system with a permuted block randomisation scheme (block size 4) to oral apalutamide 240 mg once daily plus oral abiraterone acetate 1000 mg once daily and oral prednisone 5 mg twice daily (apalutamide plus abiraterone-prednisone group) or placebo plus abiraterone acetate and prednisone (abiraterone-prednisone group), in 28-day treatment cycles. Randomisation was stratified by presence or absence of visceral metastases, ECOG performance status, and geographical region. Patients, the investigators, study team, and the sponsor were masked to group assignments. An independent data-monitoring committee continually monitored data to ensure ongoing patient safety, and reviewed efficacy data. The primary endpoint was radiographic progression-free survival assessed in the intention-to-treat population. Safety was reported for all patients who received at least one dose of study drug. This study is completed and no longer recruiting and is registered with ClinicalTrials.gov, number NCT02257736. FINDINGS: 982 men were enrolled and randomly assigned from Dec 10, 2014 to Aug 30, 2016 (492 to apalutamide plus abiraterone-prednisone; 490 to abiraterone-prednisone). At the primary analysis (median follow-up 25·7 months [IQR 23·0-28·9]), median radiographic progression-free survival was 22·6 months (95% CI 19·4-27·4) in the apalutamide plus abiraterone-prednisone group versus 16·6 months (13·9-19·3) in the abiraterone-prednisone group (hazard ratio [HR] 0·69, 95% CI 0·58-0·83; p<0·0001). At the updated analysis (final analysis for overall survival; median follow-up 54·8 months [IQR 51·5-58·4]), median radiographic progression-free survival was 24·0 months (95% CI 19·7-27·5) versus 16·6 months (13·9-19·3; HR 0·70, 95% CI 0·60-0·83; p<0·0001). The most common grade 3-4 treatment-emergent adverse event was hypertension (82 [17%] of 490 patients receiving apalutamide plus abiraterone-prednisone and 49 [10%] of 489 receiving abiraterone-prednisone). Serious treatment-emergent adverse events occurred in 195 (40%) patients receiving apalutamide plus abiraterone-prednisone and 181 (37%) patients receiving abiraterone-prednisone. Drug-related treatment-emergent adverse events with fatal outcomes occurred in three (1%) patients in the apalutamide plus abiraterone-prednisone group (2 pulmonary embolism, 1 cardiac failure) and five (1%) patients in the abiraterone-prednisone group (1 cardiac failure and 1 cardiac arrest, 1 mesenteric arterial occlusion, 1 seizure, and 1 sudden death). INTERPRETATION: Despite the use of an active and established therapy as the comparator, apalutamide plus abiraterone-prednisone improved radiographic progression-free survival. Additional studies to identify subgroups of patients who might benefit the most from combination therapy are needed to further refine the treatment of mCRPC. FUNDING: Janssen Research & Development.


Assuntos
Acetato de Abiraterona/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Prednisona/uso terapêutico , Neoplasias de Próstata Resistentes à Castração/tratamento farmacológico , Tioidantoínas/uso terapêutico , Idoso , Antagonistas de Receptores de Andrógenos/uso terapêutico , Método Duplo-Cego , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/terapia , Humanos , Masculino , Metástase Neoplásica , Intervalo Livre de Progressão , Neoplasias de Próstata Resistentes à Castração/mortalidade , Neoplasias de Próstata Resistentes à Castração/patologia , Inibidores da Síntese de Esteroides/uso terapêutico , Taxa de Sobrevida
14.
Lancet Oncol ; 22(11): 1582-1596, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34655533

RESUMO

BACKGROUND: In the primary analysis of the phase 3 MAIA trial (median follow-up 28·0 months), a significant improvement in progression-free survival was observed with daratumumab plus lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in transplantation-ineligible patients with newly diagnosed multiple myeloma. Here, we report the updated efficacy and safety results from a prespecified interim analysis for overall survival. METHODS: MAIA is an ongoing, multicentre, randomised, open-label, phase 3 trial that enrolled patients at 176 hospitals in 14 countries across North America, Europe, the Middle East, and the Asia-Pacific region. Eligible patients were aged 18 years or older, had newly diagnosed multiple myeloma, had an Eastern Cooperative Oncology Group performance status score of 0-2, and were ineligible for high-dose chemotherapy with autologous stem-cell transplantation because of their age (≥65 years) or comorbidities. Patients were randomly assigned (1:1) using randomly permuted blocks (block size 4) by an interactive web response system to receive 28-day cycles of intravenous daratumumab (16 mg/kg, once per week during cycles 1-2, once every 2 weeks in cycles 3-6, and once every 4 weeks thereafter) plus oral lenalidomide (25 mg on days 1-21 of each cycle) and oral dexamethasone (40 mg on days 1, 8, 15, and 22 of each cycle; daratumumab group) or lenalidomide and dexamethasone alone (control group). Randomisation was stratified by International Staging System disease stage, geographical region, and age. Neither patients nor investigators were masked to treatment assignment. The primary endpoint was progression-free survival, which was centrally assessed, and a secondary endpoint was overall survival (both assessed in the intention-to-treat population). The safety population included patients who received at least one dose of the study treatment. The results presented here are from a prespecified interim analysis for overall survival, for which the prespecified stopping boundary was p=0·0414. This trial is registered with ClinicalTrials.gov, NCT02252172. FINDINGS: Between March 18, 2015, and Jan 15, 2017, 952 patients were assessed for eligibility, of whom 737 patients were enrolled and randomly assigned to the daratumumab group (n=368) or the control group (n=369). At a median follow-up of 56·2 months (IQR 52·7-59·9), median progression-free survival was not reached (95% CI 54·8-not reached) in the daratumumab group versus 34·4 months (29·6-39·2) in the control group (hazard ratio [HR] 0·53 [95% CI 0·43-0·66]; p<0·0001). Median overall survival was not reached in either group (daratumumab group, 95% CI not reached-not reached; control group, 95% CI 55·7-not reached; HR 0·68 [95% CI 0·53-0·86]; p=0·0013). The most common (>15%) grade 3 or higher treatment-emergent adverse events were neutropenia (197 [54%] patients in the daratumumab group vs 135 [37%] patients in the control group), pneumonia (70 [19%] vs 39 [11%]), anaemia (61 [17%] vs 79 [22%]), and lymphopenia (60 [16%] vs 41 [11%]). Serious adverse events occurred in 281 (77%) patients in the daratumumab group and 257 (70%) patients in the control group. Treatment-related deaths occurred in 13 (4%) patients in the daratumumab group and ten (3%) patients in the control group. INTERPRETATION: Daratumumab plus lenalidomide and dexamethasone increased overall survival and progression-free survival in patients ineligible for stem-cell transplantation with newly diagnosed multiple myeloma. There were no new safety concerns. Our results support the frontline use of daratumumab plus lenalidomide and dexamethasone for patients with multiple myeloma who are ineligible for transplantation. FUNDING: Janssen Research & Development.


Assuntos
Anticorpos Monoclonais/uso terapêutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Dexametasona/uso terapêutico , Lenalidomida/uso terapêutico , Mieloma Múltiplo/tratamento farmacológico , Mieloma Múltiplo/mortalidade , Idoso , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/diagnóstico , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Humanos , Masculino , Intervalo Livre de Progressão , Taxa de Sobrevida
15.
BMC Health Serv Res ; 21(1): 1042, 2021 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-34600523

RESUMO

BACKGROUND: Genetic testing has potential roles in identifying whether an individual would have risk of adverse drug reactions (ADRs) from a particular medicine. Robust cost-effectiveness results on genetic testing would be useful for clinical practice and policy decision-making on allocating resources effectively. This study aimed to update a systematic review on economic evaluations of pharmacogenetic testing to prevent ADRs and critically appraise the quality of reporting and sources of evidence for model input parameters. METHODS: We searched studies through Medline via PubMed, Scopus and CRD's NHS Economic Evaluation up to October 2019. Studies investigating polymorphism-based pharmacogenetic testing, which guided drug therapies to prevent ADRs, using economic evaluation methods were included. Two reviewers independently performed data extraction and assessed the quality of reporting using the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) guidelines and the quality of data sources using the hierarchy of evidence developed by Cooper et al. RESULTS: Fifty-nine economic evaluations of pharmacogenetic testing to avoid drug-induced ADRs were found between 2002 and 2018. Cost-utility and cost-effectiveness analyses were the most common methods of economic evaluation of pharmacogenetic testing. Most studies complied with the CHEERS checklist, except for single study-based economic evaluations which did not report uncertainty analysis (78%). There was a lack of high-quality evidence not only for estimating the clinical effectiveness of pharmacogenetic testing, but also baseline clinical data. About 14% of the studies obtained clinical effectiveness data of testing from a meta-analysis of case-control studies with direct comparison, which was not listed in the hierarchy of evidence used. CONCLUSIONS: Our review suggested that future single study-based economic evaluations of pharmacogenetic testing should report uncertainty analysis, as this could significantly affect the robustness of economic evaluation results. A specific ranking system for the quality of evidence is needed for the economic evaluation of pharmacogenetic testing of ADRs. Differences in parameters, methods and outcomes across studies, as well as population-level and system-level differences, may lead to the difficulty of comparing cost-effectiveness results across countries.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Testes Farmacogenômicos , Análise Custo-Benefício , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Testes Genéticos , Humanos , PubMed
16.
Zhonghua Gan Zang Bing Za Zhi ; 29(9): 830-836, 2021 Sep 20.
Artigo em Chinês | MEDLINE | ID: mdl-34638200

RESUMO

Objective: To mine the signals of adverse drug reaction (ADR) of entecavir and tenofovir by using the US FDA Adverse Event Reporting System (FAERS) database, so as to provide reference for the safe clinical use of these two drugs. Methods: Reporting odds ratio (ROR) and proportion of report ratio (PRR) method were used to conduct data mining on the 26 quarterly reports of the US Food and Drug Administration Adverse Event Reporting System (FAERS) database between the fourth quarter of 2012 to the first quarter of 2019. The ADR descriptive terminology in the report were standardized by using the World Health Organization Adverse Reaction Terminology (System-Organ Class). ROR and PRR methods common signals were screened. Results: 104 and 187 signals of ADR of entecavir and tenofovir dipivoxil were obtained by ROR and PRR methods. The main screened system-organ classes affected by signals of ADR of entecavir were systemic damage, hepatobiliary system damage, and urinary system damage. The main screened system-organ classes affected by signals of ADR of tenofovir were urinary system damage, skeletal and musculoskeletal system damage, and metabolic and nutritional disorders. Conclusion: The mining signals of adverse drug reaction of entecavir and tenofovir dipivoxil indicate that these two drugs can cause female reproductive system damage, fetal abnormalities, neonatal and infant abnormalities, and male reproductive system damage. However, in addition to the above-mentioned ADR, the ADR instruction manual excludes entecavir and tenofovir dipivoxil primarily for respiratory and visual system damage, and the tenofovir disoproxil primarily for skin and appendage damage, and hearing and vestibular function damage. Therefore, in clinical medication management, it is suggested to pay close attention to the choice of drugs for special population infected with HBV, monitor possible ADR during medication course, and provide pharmacological monitoring to achieve personalized medication.


Assuntos
Sistemas de Notificação de Reações Adversas a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Feminino , Guanina/análogos & derivados , Humanos , Recém-Nascido , Masculino , Tenofovir/efeitos adversos , Estados Unidos/epidemiologia , United States Food and Drug Administration
17.
Acta Gastroenterol Belg ; 84(3): 497-499, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34599575

RESUMO

Pneumatosis Intestinalis (PI) is a rare radiological finding defined as the presence of extra-luminal gas within the intestinal wall. Several anti-tumor drugs can induce a damage of the gastrointestinal walls as an adverse effect, causing loss of mucosal integrity and endoluminal gas diffusion, responsible for PI development. We retrospectively analyzed 8 cases of PI detected through radiological imaging in oncologic patients undergoing various therapeutic regimens: five patients were receiving chemotherapy, two molecular targeted therapy (MTT) and one immunotherapy. Three patients were asymptomatic and pneumatosis was incidentally detected at routinary follow-up CT and then treated conservatively. Five patients presented acute abdomen symptoms and in these cases bowel perforation was the cause of death. Our experience confirms PI and perforation as rare complications of drug toxicity, especially in oncologic patients treated with combinations of different anticancer drugs and documented the second reported case of PI associated with atezolizumab and alectinib single administration.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Perfuração Intestinal , Pneumatose Cistoide Intestinal , Humanos , Perfuração Intestinal/induzido quimicamente , Perfuração Intestinal/diagnóstico por imagem , Pneumatose Cistoide Intestinal/induzido quimicamente , Pneumatose Cistoide Intestinal/diagnóstico por imagem , Estudos Retrospectivos , Perfuração Espontânea
18.
Orv Hetil ; 162(40): 1610-1618, 2021 10 03.
Artigo em Húngaro | MEDLINE | ID: mdl-34601458

RESUMO

Összefoglaló. A dohányzás jelenleg is az egyik legjelentosebb népegészségügyi probléma hazánkban. Az orvosi szakterületek többségében elokerül a dohányzásleszokás-támogatás kérdése. Ezért az orvostársadalom számára az aktuális gyógyszeres terápiás ismeretek összefoglalása hasznos lehet. A jelen közleményben a leszokástámogatás elsodlegesen választandó gyógyszeres terápiáját tekintjük át a legújabb összefoglalók és irányelvek szerint. A gyógyszeres lehetoségek közül jelenleg a vareniklin és a nikotinpótló terápia választandó elsoként, nemcsak a leszokás, hanem az ártalomcsökkentés tekintetében is. A legújabb kutatási eredmények szerint a kis dózisú vareniklin hatékonysága megközelíti a standard adagolás hatékonyságát, ugyanakkor kevesebb mellékhatás jelentkezik. A nikotinpótló kezeléssel kapcsolatban ki kell emelni, hogy egyre több tudományos evidencia áll a transdermalis és oralis készítmények kombinálása mellett, szemben a monoterápiával. A kis dózisú vareniklin, illetve a nikotinpótló terápia akkor is segítséget nyújt a naponta elszívott cigaretták mérséklésében, ha a kliens nem kíván leszokni, de a dohányzás ártalmait csökkentené. A nikotinerg rendszeren kívül más módon ható gyógyszerek szerepe is felmerült. Egyre több összefoglaló támogatja az antidepresszívumok használatát a nikotinfüggoség kezelésében. Ezek közül a bupropion használatával kapcsolatban van a legtöbb adat, amelyrol tudjuk, hogy kombinálható a nikotinpótló terápiával és a vareniklinnel is. A gyógyszeres terápiát minden esetben tanácsos magatartásorvoslási módszerekkel, illetve adherenciát fokozó intervenciókkal kombinálni. Ezenkívül a szakellátási szint bevonása is javasolt, hogy a leheto legtöbb segítséget kapja meg a páciens a leszokáshoz. Orv Hetil. 2021; 162(40): 1610-1618. Summary. Smoking is still one of the most significant public health problems in Hungary. The issue of smoking cessation support comes up in most medical specialties. Therefore, a summary of the current pharmacotherapeutic knowledge may prove useful to the medical community. In this paper, we review the first-line pharmacotherapy for smoking cessation based on the latest summaries and guidelines. Regarding the smoking cessation agents, varenicline and nicotine replacement therapy are currently the primary choice, not only in terms of cessation but also in terms of harm reduction. The results of previous studies suggest that the efficacy of low dose varenicline is close to that of standard dosing, with fewer side effects. With regard to nicotine replacement therapy, it should be emphasized that there is an increasing scientific evidence for the combination of transdermal and oral formulations as opposed to monotherapy. Low dose varenicline and nicotine replacement therapy also help reduce the number of cigarettes smoked daily if the client does not want to quit but would reduce the harms of smoking. The role of medications acting in other ways than the nicotinergic system has also emerged. An increasing number of reviews support the use of antidepressants in the treatment of nicotine addiction. Of these, most data are available on the use of bupropion, which is known to be combined with nicotine replacement therapy and varenicline. In all cases, it is advisable to combine pharmacotherapy with behavioral therapy as well as interventions that increase adherence. In addition, it is also recommended to include specific therapeutic interventions in order to get as much help as possible for the patient to quit smoking. Orv Hetil. 2021; 162(40): 1610-1618.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Abandono do Hábito de Fumar , Humanos , Saúde Pública , Fumar , Dispositivos para o Abandono do Uso de Tabaco
19.
J Nepal Health Res Counc ; 19(2): 362-366, 2021 Sep 06.
Artigo em Inglês | MEDLINE | ID: mdl-34601531

RESUMO

BACKGROUND: Different bowel preparation regimens are available. Currently we are giving the entire preparation on the day of colonoscopy. Multiple studies have shown splitting the regimen might improve the quality of bowel preparation with lesser side effects and better compliance. The study was done to compare the efficacy and tolerability of split bowel preparation regimen with non-split dosing regimen. METHODS: Single centered observational comparative study was done in a tertiary care hospital. One hundred ninety eight patients requiring elective colonoscopy were assigned to receive one of the two preparations (split versus morning) prior to colonoscopy. Main outcomes were bowel preparation quality and patient compliance and tolerability. RESULTS: There was no significant difference between the two regimen for the mean total Boston Bowel Preparation Scale (6.79VS 6.74,P value -0.777).Patient compliance was better for split dosing compared to single dosing (99 vs 5 p value-<0.001).There were more side effects in the single dosage compared to split dosing except for sleep disturbance which was more in split dosing. CONCLUSIONS: The study found that split-dose and single dose polyethylene glycol solution for bowel preparation before colonoscopy had similar efficacy in the quality of bowel preparation. Split-dose polyethylene glycol appears to be superior to single-dose PEG for patient compliance and side effects.


Assuntos
Colonoscopia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Procedimentos Cirúrgicos Eletivos , Humanos , Nepal , Cooperação do Paciente
20.
BMJ Open ; 11(10): e050675, 2021 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-34598987

RESUMO

OBJECTIVES: We aim to describe the frequency and type of adverse drug reactions (ADRs) in patients on statins in published studies from Latin American (LATAM) countries. DESIGN: Scoping review. METHODS: A literature search was conducted in three databases (PubMed, EMBASE and LILACS) in addition to a manual search in relevant journals from LATAM universities or medical societies. A snowballing technique was used to identify further references. Randomised controlled trials (RCTs) and observational studies between 2000 and 2020 were included. Studies were considered eligible if they included adults on statin therapy from LATAM and reported data on ADRs. Data on ADRs were abstracted and presented by study design. RESULTS: Out of 8076 articles, a total of 20 studies were included (7 RCTs and 13 observational studies). We identified three head-to-head statin RCTs, two statin-versus-policosanol RCTs and only two placebo-controlled trials. The statin-related ADRs frequency ranged from 0% to 35.1% in RCTs and 0% to 28.4% in observational studies. The most common ADRs were muscle-related events including myalgia and elevated creatine phosphokinase. Other reported ADRs were gastrointestinal symptoms, headache and altered fasting plasma glucose. CONCLUSIONS: We identified differences in the frequency of ADRs in both observational studies and RCTs from LATAM countries. This could be due to the absence of standard definitions and reporting of ADRs as well as differences among the study's interventions, population characteristics or design. The variability of ADRs and the absence of definitions are similar to studies from other geographical locations. Further placebo-controlled trials and real-world data registries with universal definitions should follow.


Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Inibidores de Hidroximetilglutaril-CoA Redutases , Adulto , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Humanos , Inibidores de Hidroximetilglutaril-CoA Redutases/efeitos adversos , América Latina/epidemiologia
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