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2.
Surg Today ; 53(10): 1173-1180, 2023 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-37212930

RESUMO

PURPOSE: To investigate the effects of preoperative steroid administration, including dosage, on complications after gastrectomy for gastric cancer. METHODS: We reviewed patients who underwent gastrectomy for gastric and esophagogastric junctional adenocarcinoma between 2013 and 2019 at the Department of Gastrointestinal Surgery, The University of Tokyo. RESULTS: Among the total 764 patients eligible for inclusion in the study, 17 were on steroid medication preoperatively (SD group) and 747 were not (ND group). The hemoglobin, serum albumin levels, and respiratory functions were significantly lower in the SD group than in the ND group. The incidence of postoperative complications classified as Clavien-Dindo (C-D) ≥ 2 was significantly greater in the SD group than in the ND group (64.7% vs. 25.6%, p < 0.001). Intra-abdominal infection (35.2% vs. 9.6%, p < 0.001) and anastomotic leakage (11.8% vs. 2.1%, p < 0.001) occurred more frequently in the SD group than in the ND group. On multiple logistic regression analysis for C-D ≥ 3 postoperative complications, the odds ratio for oral steroid use ≥ 5 mg per day as prednisolone had the highest value, of 13.0 (95% confidence interval 2.46-76.2, p < 0.01). CONCLUSION: Preoperative oral steroid use was identified as an independent risk factor for postoperative complications after gastrectomy for gastric cancer. Furthermore, the complication rate appears to increase as the oral steroid dosage is increased.


Assuntos
Gastrectomia , Complicações Pós-Operatórias , Esteroides , Neoplasias Gástricas , Humanos , Gastrectomia/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Estudos Retrospectivos , Esteroides/administração & dosagem , Esteroides/uso terapêutico , Neoplasias Gástricas/cirurgia
3.
Turk Neurosurg ; 33(2): 326-333, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-36799281

RESUMO

AIM: To investigate the demographic, clinical and radiological findings associated with treatment success after interlaminar epidural steroid injection (ILESI) in radicular pain induced by cervical disc herniation. MATERIAL AND METHODS: In this retrospective study, the data of patients who received cervical ILESI between January 2017 and June 2021 were screened. Of 223 patients, 92 with unilateral radicular neck pain due to cervical disc herniation were included. Demographic data, symptom duration, and numerical rating scale scores at baseline, at three weeks, three months, and six months after treatment were collected from the medical records of the patients. Disc herniation level, cervical axis, disc height, presence and degree of spinal canal and neural foraminal stenosis, vertebral endplate signal change, and definitive presence of uncovertebral and facet osteoarthritis were evaluated using cervical spine magnetic resonance imaging. Treatment success was determined as ?50% reduction in pain scores at six months compared to baseline. RESULTS: Data of 92 patients (27 men, 65 women) were included. The mean age was 50.82 ± 10.22 years, and the median symptom duration was 12 (4.25 to 20) months. At six months after ILESI, treatment was successful in 58 (58.7%) patients and unsuccessful in 34 (41.3%) patients. Multivariable logistic regression analysis was performed to identify the factors associated with treatment success at six months post-injection. In the final model, neural foraminal stenosis (non-severe vs. severe) and spinal canal stenosis (non-severe vs. severe) were significantly associated with the treatment success (OR=3.02, 95% CI=1.40?10.95, p=0.009; OR=5.31, 95% CI=1.77?15.85, p=0.003). CONCLUSION: Treatment success of cervical ILESI at six months is favorable. However, the presence of severe neural foraminal and spinal canal stenosis is associated with a reduced likelihood of treatment success.


Assuntos
Deslocamento do Disco Intervertebral , Radiculopatia , Estenose Espinal , Esteroides , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Constrição Patológica , Injeções Epidurais/métodos , Deslocamento do Disco Intervertebral/complicações , Deslocamento do Disco Intervertebral/diagnóstico por imagem , Deslocamento do Disco Intervertebral/tratamento farmacológico , Cervicalgia/diagnóstico por imagem , Cervicalgia/tratamento farmacológico , Cervicalgia/etiologia , Radiculopatia/diagnóstico por imagem , Radiculopatia/tratamento farmacológico , Radiculopatia/complicações , Estudos Retrospectivos , Estenose Espinal/complicações , Estenose Espinal/diagnóstico por imagem , Estenose Espinal/tratamento farmacológico , Esteroides/administração & dosagem , Esteroides/uso terapêutico , Resultado do Tratamento
4.
Comput Math Methods Med ; 2022: 6756676, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35586672

RESUMO

Although PTX has been identified as an effective drug for nasopharyngeal carcinoma (NPC) therapy, it has serious side effects in the human body. Previous studies have shown that timosaponin AIII (TSAIII) can inhibit the malignant progression of NPC cells. This study investigated the active mechanism of the combination of TSAIII and paclitaxel (PTX) on NPC. Cellular viability, apoptosis, apoptotic factors, and RAP1 signaling regulators were detected in the PNC cells (CNE-1 and HNE-2) and the subcutaneous CNE-1 transplanted nude mice treated with PTX or/and TSAIII. The results showed that TSAIII notably strengthened the inhibitory effect of PTX on the proliferation of NPC cells CNE-1 and HNE-2; upregulated the expression of Bax B-cell lymphoma 2 (Bcl-2)/Bcl-xL-associated death promoter (Bad), and Ras-associated protein1 (RAP1) GTPase activating protein (Rap1GAP); inhibited the level of Bcl-2, RAP1, and Ras guanine nucleotide releasing protein (RasGRP2); and significantly enhanced the promoting effect of PTX on apoptosis in the CNE-1 and HNE-2 cells. Besides, TSAIII strengthened the inhibitory effect of PTX on xenograft tumor in nude mice without adverse reactions. In conclusion, the combination administration of TSAIII and PTX had a significantly therapeutic effect on NPC and avoided the PTX's side effects, which may have acted as a new direction for the study of therapeutic approaches for NPC clinically.


Assuntos
Fatores de Troca do Nucleotídeo Guanina , Carcinoma Nasofaríngeo , Neoplasias Nasofaríngeas , Animais , Protocolos de Quimioterapia Combinada Antineoplásica/farmacologia , Apoptose/efeitos dos fármacos , Linhagem Celular Tumoral , Proliferação de Células/efeitos dos fármacos , Fatores de Troca do Nucleotídeo Guanina/antagonistas & inibidores , Fatores de Troca do Nucleotídeo Guanina/metabolismo , Humanos , Camundongos , Camundongos Nus , Carcinoma Nasofaríngeo/tratamento farmacológico , Carcinoma Nasofaríngeo/metabolismo , Carcinoma Nasofaríngeo/patologia , Neoplasias Nasofaríngeas/tratamento farmacológico , Neoplasias Nasofaríngeas/metabolismo , Neoplasias Nasofaríngeas/patologia , Paclitaxel/administração & dosagem , Saponinas/administração & dosagem , Transdução de Sinais/efeitos dos fármacos , Esteroides/administração & dosagem , Ensaios Antitumorais Modelo de Xenoenxerto
5.
Actas dermo-sifiliogr. (Ed. impr.) ; 113(3): 294-299, Mar. 2022. ilus, tab
Artigo em Espanhol | IBECS | ID: ibc-206411

RESUMO

La necrólisis epidérmica tóxica es la reacción secundaria a medicamentos más grave dentro del espectro de las reacciones mucocutáneas. El tratamiento multidisciplinario es clave para disminuir la mortalidad de los pacientes, además de la suspensión del fármaco causal. Existen pocos estudios de tratamientos farmacológicos en pacientes con necrólisis epidérmica tóxica en Latinoamérica que combinen el uso de esteroides sistémicos e inmunoglobulina intravenosa (IgIV). Describimos 6 casos de pacientes con necrólisis epidérmica tóxica tratados con esteroides sistémicos e IgIV en un hospital de referencia dermatológica en Ciudad de México. Ningún paciente falleció ni presentó complicaciones a corto y mediano plazo de seguimiento. En la mayoría de los casos se empleó una dosis de IgIV de 1g/kg por 3-5 días y 1g de metilprednisolona por 3-5 días. El tiempo de ingreso hospitalario fue de 14,8 días. La combinación de esteroides sistémicos e IgIv parece ser una opción segura en pacientes con necrólisis epidérmica tóxica (AU)


Toxic epidermal necrolysis is the most serious mucocutaneous adverse drug reaction. Multidisciplinary treatment and withdrawal of the causative drug are key to reducing mortality. Few studies have analyzed the use of systemic corticosteroids and intravenous immunoglobulins (IVIG) in patients with toxic epidermal necrolysis in Latin America. We describe our experience with 6 cases treated at a dermatology referral hospital in Mexico City. None of the patients died or developed complications in the short or medium term. The most widely used regimen was a combination of IVIG 1 g/kg for 3 to 5 days and methylprednisolone 1 g for 3 to 5 days. Mean hospital stay was 14.8 days. The combined use of systemic corticosteroids and IVIG seems to be a safe treatment option for patients with toxic epidermal necrolysis (AU)


Assuntos
Humanos , Masculino , Feminino , Adulto , Idoso de 80 Anos ou mais , Imunoglobulinas/administração & dosagem , Fatores Imunológicos/administração & dosagem , Esteroides/administração & dosagem , Síndrome de Stevens-Johnson/tratamento farmacológico , Administração Intravenosa
6.
Actas dermo-sifiliogr. (Ed. impr.) ; 113(3): t294-t299, Mar. 2022. ilus, tab
Artigo em Inglês | IBECS | ID: ibc-206412

RESUMO

Toxic epidermal necrolysis is the most serious mucocutaneous adverse drug reaction. Multidisciplinary treatment and withdrawal of the causative drug are key to reducing mortality. Few studies have analyzed the use of systemic corticosteroids and intravenous immunoglobulins (IVIG) in patients with toxic epidermal necrolysis in Latin America. We describe our experience with 6 cases treated at a dermatology referral hospital in Mexico City. None of the patients died or developed complications in the short or medium term. The most widely used regimen was a combination of IVIG 1g/kg for 3–5 days and methylprednisolone 1g for 3–5 days. Mean hospital stay was 14.8 days. The combined use of systemic corticosteroids and IVIG seems to be a safe treatment option for patients with toxic epidermal necrolysis (AU)


La necrólisis epidérmica tóxica es la reacción secundaria a medicamentos más grave dentro del espectro de las reacciones mucocutáneas. El tratamiento multidisciplinario es clave para disminuir la mortalidad de los pacientes, además de la suspensión del fármaco causal. Existen pocos estudios de tratamientos farmacológicos en pacientes con necrólisis epidérmica tóxica en Latinoamérica que combinen el uso de esteroides sistémicos e inmunoglobulina intravenosa (IgIV). Describimos 6 casos de pacientes con necrólisis epidérmica tóxica tratados con esteroides sistémicos e IgIV en un hospital de referencia dermatológica en Ciudad de México. Ningún paciente falleció ni presentó complicaciones a corto y mediano plazo de seguimiento. En la mayoría de los casos se empleó una dosis de IgIV de 1g/kg por 3-5 días y 1g de metilprednisolona por 3-5 días. El tiempo de ingreso hospitalario fue de 14,8 días. La combinación de esteroides sistémicos e IgIv parece ser una opción segura en pacientes con necrólisis epidérmica tóxica (AU)


Assuntos
Humanos , Masculino , Feminino , Adulto , Idoso de 80 Anos ou mais , Imunoglobulinas/administração & dosagem , Fatores Imunológicos/administração & dosagem , Esteroides/administração & dosagem , Síndrome de Stevens-Johnson/tratamento farmacológico , Administração Intravenosa
8.
Viruses ; 14(2)2022 01 31.
Artigo em Inglês | MEDLINE | ID: mdl-35215893

RESUMO

INTRODUCTION: This study investigated the spontaneous clinical course of patients with endomyocardial biopsy (EMB)-proven lymphocytic myocarditis and cardiac human herpesvirus 6 (HHV6) DNA presence, and the effectiveness of steroid-based intervention in HHV6-positive patients. RESULTS: 756 heart failure (HF) patients underwent an EMB procedure to determine the underlying cause of unexplained HF. Low levels of HHV6 DNA, detectable by nested PCR only, were found in 10.4% of the cases (n = 79) of which 62% (n = 49) showed myocardial inflammation. The spontaneous course of patients with EMB-proven HHV6 DNA-associated lymphocytic myocarditis (n = 26) showed significant improvements in the left ventricular ejection fraction (LVEF) and clinical symptoms, respectively, in 15/26 (60%) patients, 3-12 months after disease onset. EMB mRNA expression of components of the NLRP3 inflammasome pathway and protein analysis of cardiac remodeling markers, analyzed by real-time PCR and MALDI mass spectrometry, respectively, did not differ between HHV6-positive and -negative patients. In another cohort of patients with ongoing symptoms related to lymphocytic myocarditis associated with cardiac levels of HHV6-DNA copy numbers <500 copies/µg cardiac DNA, quantified by real-time PCR, the efficacy and safety of steroid-based immunosuppression for six months was investigated. Steroid-based immunosuppression improved the LVEF (≥5%) in 8/10 patients and reduced cardiac inflammation in 7/10 patients, without an increase in cardiac HHV6 DNA levels in follow-up EMBs. CONCLUSION: Low HHV6 DNA levels are frequently detected in the myocardium, independent of inflammation. In patients with lymphocytic myocarditis with low levels of HHV6 DNA, the spontaneous clinical improvement is nearby 60%. In selected symptomatic patients with cardiac HHV6 DNA copy numbers less than 500 copies/µg cardiac DNA and without signs of an active systemic HHV6 infection, steroid-based therapy was found to be effective and safe. This finding needs to be further confirmed in large, randomized trials.


Assuntos
Herpesvirus Humano 6/fisiologia , Imunossupressores/administração & dosagem , Miocardite/tratamento farmacológico , Miocardite/virologia , Infecções por Roseolovirus/tratamento farmacológico , Infecções por Roseolovirus/virologia , Esteroides/administração & dosagem , Adulto , Idoso , Biópsia , Estudos de Coortes , DNA Viral/genética , Feminino , Dosagem de Genes , Herpesvirus Humano 6/genética , Herpesvirus Humano 6/isolamento & purificação , Humanos , Masculino , Pessoa de Meia-Idade , Miocardite/imunologia , Miocardite/fisiopatologia , Proteína 3 que Contém Domínio de Pirina da Família NLR/genética , Proteína 3 que Contém Domínio de Pirina da Família NLR/imunologia , Infecções por Roseolovirus/imunologia , Infecções por Roseolovirus/fisiopatologia , Volume Sistólico
11.
J Am Soc Nephrol ; 33(2): 401-419, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34880074

RESUMO

BACKGROUND: Rituximab is the standard therapy for childhood-onset complicated frequently relapsing or steroid-dependent nephrotic syndrome (FRNS/SDNS). However, most patients redevelop FRNS/SDNS after peripheral B cell recovery. METHODS: We conducted a multicenter, randomized, double-blind, placebo-controlled trial to examine whether mycophenolate mofetil (MMF) administration after rituximab can prevent treatment failure (FRNS, SDNS, steroid resistance, or use of immunosuppressive agents or rituximab). In total, 39 patients (per group) were treated with rituximab, followed by either MMF or placebo until day 505 (treatment period). The primary outcome was time to treatment failure (TTF) throughout the treatment and follow-up periods (until day 505 for the last enrolled patient). RESULTS: TTFs were clinically but not statistically significantly longer among patients given MMF after rituximab than among patients receiving rituximab monotherapy (median, 784.0 versus 472.5 days, hazard ratio [HR], 0.59; 95% confidence interval [95% CI], 0.34 to 1.05, log-rank test: P=0.07). Because most patients in the MMF group presented with treatment failure after MMF discontinuation, we performed a post-hoc analysis limited to the treatment period and found that MMF after rituximab prolonged the TTF and decreased the risk of treatment failure by 80% (HR, 0.20; 95% CI, 0.08 to 0.50). Moreover, MMF after rituximab reduced the relapse rate and daily steroid dose during the treatment period by 74% and 57%, respectively. The frequency and severity of adverse events were similar in both groups. CONCLUSIONS: Administration of MMF after rituximab may sufficiently prevent the development of treatment failure and is well tolerated, although the relapse-preventing effect disappears after MMF discontinuation.


Assuntos
Imunossupressores/administração & dosagem , Ácido Micofenólico/administração & dosagem , Síndrome Nefrótica/tratamento farmacológico , Rituximab/administração & dosagem , Adolescente , Criança , Pré-Escolar , Método Duplo-Cego , Esquema de Medicação , Quimioterapia Combinada , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Síndrome Nefrótica/imunologia , Recidiva , Esteroides/administração & dosagem , Fatores de Tempo , Falha de Tratamento , Resultado do Tratamento
12.
J Hepatol ; 76(3): 506-517, 2022 03.
Artigo em Inglês | MEDLINE | ID: mdl-34740705

RESUMO

BACKGROUND & AIMS: EDP-305 is an oral farnesoid X receptor (FXR) agonist under development for the treatment of non-alcoholic steatohepatitis (NASH). Herein, we aimed to assess the efficacy, safety and tolerability of EDP-305 in patients with fibrotic NASH. METHODS: In this double-blind phase II study, patients with fibrotic NASH (without cirrhosis), diagnosed by historical biopsy or phenotypically, were randomized to EDP-305 1 mg, EDP-305 2.5 mg, or placebo, for 12 weeks. The primary endpoint was mean change in alanine aminotransferase (ALT) from baseline to Week 12, and the key secondary endpoint was mean change in liver fat content from baseline to Week 12. RESULTS: Between January 2018 and July 2019, 134 patients were randomized and 132 were evaluated. At Week 12, the least squares mean reductions from baseline in ALT for patients receiving 2.5 mg EDP-305 and 1 mg EDP-305 were -27.9 U/L (95% CI 0.03 to 24.9; p = 0.049) and -21.7 U/L (-5.8 to 18.3: p = 0.304), respectively, compared to -15.4 U/L for those receiving placebo. Absolute liver fat reduction was -7.1% (2.0-7.5; p = 0.0009) with 2.5 mg EDP-305, -3.3% with EDP-305 1 mg, and -2.4% with placebo. The most common (≥5%) adverse events were pruritus, nausea, vomiting, diarrhea, headache, and dizziness. Pruritus occurred in 50.9%, 9.1%, and 4.2% of patients in the 2.5 mg, 1 mg, and placebo groups, respectively, and led to study drug discontinuation in 20.8% of patients in the 2.5 mg group and 1.8% in the 1 mg group. CONCLUSIONS: EDP-305 reduced ALT levels and liver fat content, providing support for a longer-term trial assessing histological endpoints in patients with NASH. CLINICALTRIALS. GOV NUMBER: NCT03421431 LAY SUMMARY: Non-alcoholic fatty liver disease is a chronic hepatic disease that can progress to non-alcoholic steatohepatitis (NASH), which is associated with an increased risk of cirrhosis and liver cancer. Results from this phase II study support continued development of EDP-305, an oral farnesoid X receptor agonist, for the treatment of patients with NASH.


Assuntos
Relação Dose-Resposta a Droga , Hepatopatia Gordurosa não Alcoólica/tratamento farmacológico , Esteroides/administração & dosagem , Administração Oral , Adulto , Análise de Variância , Canadá , Método Duplo-Cego , Feminino , França , Alemanha , Humanos , Fígado/patologia , Masculino , Pessoa de Meia-Idade , Nova Zelândia , Placebos , Receptores Citoplasmáticos e Nucleares/administração & dosagem , Receptores Citoplasmáticos e Nucleares/uso terapêutico , Esteroides/uso terapêutico , Resultado do Tratamento , Reino Unido , Estados Unidos
14.
Otolaryngol Head Neck Surg ; 166(2): 249-259, 2022 02.
Artigo em Inglês | MEDLINE | ID: mdl-34058895

RESUMO

OBJECTIVE: We investigated the incidence of tympanic membrane (TM) perforations induced after intratympanic steroid injection (ITSI) in patients with sudden sensorineural hearing loss (SSNHL) through a systematic review and meta-analysis. DATA SOURCES: PubMed, Embase, and MEDLINE. REVIEW METHODS: Primary database searches were performed, and 1901 records were identified. After removal of 1802 articles through abstract screening, the remaining 99 full-text journals were assessed for eligibility to be included in the study. Fifty-eight studies that used either ventilation tubing (VT) or tympanocentesis (TC) for ITSI were selected for analysis. The subjects were divided into VT and TC groups. The rate of TM perforation after ITSI in 2 groups, sites of ITSI, needle gauge, and influence on residual hearing were investigated. RESULTS: The cohorts comprised patients who underwent VT (n = 257, 9.6%) and TC (n = 2415, 90.4%). The proportion of TM perforation after ITSI in each group was 0.073 (95% CI, 0.0469-0.1113) and 0.010 (95% CI, 0.0045-0.0215), respectively, which suggested that the VT group showed a significantly higher TM perforation rate than the TC group (P < .001). In the subgroup analyses, there was no significant difference in the odds ratio for the rate of TM perforation according to the injection site and needle gauge for TC. The proportion of surgical repair showed no significant difference between the 2 groups. CONCLUSION: ITSI via VT may have a significantly higher risk of TM perforation than ITSI via TC, although those are relatively small overall. ITSI should be performed in the direction to minimize possible adverse effects.


Assuntos
Perda Auditiva Neurossensorial/tratamento farmacológico , Injeção Intratimpânica/efeitos adversos , Esteroides/administração & dosagem , Esteroides/efeitos adversos , Perfuração da Membrana Timpânica/etiologia , Humanos , Fatores de Risco
15.
Acta Radiol ; 63(1): 67-75, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-33435714

RESUMO

BACKGROUND: There are no consensus and guidelines on the optimal interval of repeat epidural steroid injections (ESI) for patients with lumbar herniated intervertebral disc (HIVD) who respond to initial ESI. PURPOSE: To evaluate the effectiveness of ESI in patients with HIVD under a "wait-and-see" policy, i.e. as-needed injections not on a predetermined schedule. MATERIAL AND METHODS: A total of 592 patients with lumbar HIVD received spine injections between January and December 2017. After excluding patients with excellent (no pain) or poor (>70% residual symptoms) response in the two- or three-week pain assessment, the data of 141 responders were analyzed (60 men, 73 women; age = 50.55±17.25 years). We divided patients into wait-and-see (n=124) and early repeat-ESI (n=17) groups, who received repeat ESIs within three weeks. Evaluations of characteristics and outcomes were performed with the chi-square test or independent Student's t-test. RESULTS: Six patients (4.8%) in the wait-and-see group and 1 (5.9%) in the early repeat-ESI group underwent operation within one year (P=0.85). A mean of 1.52±0.82 ESIs was performed in the wait-and-see and a mean of 2.29±0.47 ESIs in the early repeat-ESI group over one year (P<0.001). The time interval between the first and second ESIs was longer in the wait-and-see group than in the early repeat-ESI group (97.15 vs. 15.47 days, P<0.001). Seventy-eight patients (62.9%) in the wait-and-see group could control their pain with a single ESI. CONCLUSION: A "wait-and-see" policy could be an effective pain management option for patients with lumbar HIVD who respond to initial ESI.


Assuntos
Injeções Epidurais , Deslocamento do Disco Intervertebral/tratamento farmacológico , Esteroides/administração & dosagem , Esquema de Medicação , Feminino , Fluoroscopia , Humanos , Deslocamento do Disco Intervertebral/diagnóstico por imagem , Vértebras Lombares/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Fatores de Tempo
17.
Acta Ophthalmol ; 100(2): e491-e501, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-34180149

RESUMO

PURPOSE: To evaluate and compare the effectiveness of endoscopic trans-ethmosphenoid optic canal decompression (ETOCD) and steroid pulse therapy (SPT) for indirect traumatic optic neuropathy (ITON). DESIGN: Prospective interventional case series. METHODS: Total 140 monocular ITON patients from January 2017 to June 2019 were recruited, including 100 patients received ETOCD (56 patients received ETOCD only and 44 patients received ETOCD combined with SPT before surgery), and 40 patients received SPT only. Their visual acuity (VA) and visual evoked potential (VEP) were analysed before and after treatments. Initial VA, lag time, causes of injuries and age were analysed for evaluating prognosis of treatment. RESULTS: In contrast with patients received SPT only (15/40 = 38%), the effective rate of patients received ETOCD only and patients received ETOCD combined with SPT were both significantly better (46/56 = 82%, p < 0.001 and 30/44 = 68%, p = 0.005). Whether with SPT before ETOCD or not, after ETOCD, patients with VA improvement showed no significant difference. And 59/76 (77.6%) patients showed improvement within 24 hours. Patients who had residual visions achieved higher effective rate than those with no light perception (56/58 = 97% and 20/42 = 48%; p < 0.001) after ETOCD. For patients with long lag time of 21-90 days, 23/32 (72%) patients presented with vision improvement. Moreover, VEP was significantly improved after ETOCD. No severe complications were observed. CONCLUSIONS: Endoscopic trans-ethmosphenoid optic canal decompression (ETOCD) is an effective and safe therapy for ITON, which is more effective than SPT. Even for patients with failure in responding to SPT, the successfully physical decompression is the most effective way to rescue optical nerve from permanent damage.


Assuntos
Descompressão Cirúrgica/métodos , Traumatismos do Nervo Óptico/cirurgia , Pulsoterapia/métodos , Esteroides/administração & dosagem , Potenciais Evocados Visuais , Humanos , Estudos Prospectivos , Acuidade Visual
18.
Eur J Drug Metab Pharmacokinet ; 47(1): 49-56, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34635989

RESUMO

BACKGROUND AND OBJECTIVES: As the prevalence of some gynecological conditions depends on patient characteristics such as race/ethnicity, it is important to study therapies for these conditions in diverse populations. The study described in this article was conducted to investigate the safety, tolerability, and pharmacokinetics of vilaprisan, a selective progesterone receptor modulator, in Japanese women in Japan. It supplements two comparable studies that were conducted in healthy postmenopausal European and Chinese women, respectively. METHODS: In this exploratory randomized, placebo-controlled, double-blind, ascending-dose study, five groups of healthy postmenopausal Japanese women received vilaprisan as immediate-release tablets (1, 5, or 15 mg as a single dose or 1 or 5 mg/day for 28 days) or placebo tablets (single dosing: 8 subjects/dose step, thereof 2 subjects randomized to placebo; multiple dosing: 12 subjects/dose step, thereof 4 subjects randomized to placebo). Blood samples for pharmacokinetic profiles were collected over 14-19 days. Safety assessments were based on adverse event data, vital signs, electrocardiograms, clinical laboratory tests, and transvaginal ultrasound examinations. RESULTS: 48 participants were randomized, treated, and analyzed. Vilaprisan was rapidly absorbed, reaching maximum plasma concentrations (Cmax) between 1 and 3 h post dose. Post maximum, plasma concentrations rapidly declined, indicating pronounced distribution into tissues. The exposure of vilaprisan increased roughly dose-proportionally: The geometric mean (geometric coefficients of variation) areas under the concentration time curves from time zero to infinity (AUC∞) after single administration of 1, 5, or 15 mg vilaprisan were 67 µg·h/l (34%), 249 µg·h/l (15%), and 788 µg·h/l (37%), respectively. The AUC in the dosing interval after multiple administrations (AUC24,md) of 1 mg/day was 76 µg·h/l (59%), and the AUC24,md after 5 mg/day was 311 µg·h/l (20%). Geometric mean Cmax values also increased roughly dose-proportionally: They amounted to 6 µg/l (22%), 16 µg/l (33%), and 52 µg/l (27%) after single administration and to 8 µg/l (28%) and 31 µg/l (22%) after multiple administrations of the above doses. Mild adverse events were observed, similar to those observed in other clinical studies of vilaprisan. CONCLUSIONS: Overall, vilaprisan was safe and well tolerated. The exposure in Japanese women was similar to that observed in European and Chinese women in separate studies. TRIAL REGISTRATION: 15 Nov 2011 (no registration number assigned).


Assuntos
Pós-Menopausa , Congêneres da Progesterona/farmacocinética , Esteroides/farmacocinética , Administração Oral , Idoso , Área Sob a Curva , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Humanos , Pessoa de Meia-Idade , Congêneres da Progesterona/administração & dosagem , Congêneres da Progesterona/sangue , Receptores de Progesterona/metabolismo , Esteroides/administração & dosagem , Esteroides/sangue
19.
Am J Otolaryngol ; 43(1): 103221, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-34536925

RESUMO

PURPOSE: The purpose of this study was to measure the incidence of complications in sudden sensorineural hearing loss (SSNHL) patients treated with intra-tympanic steroid injection (ITSI) and compare hearing recovery rates. MATERIALS AND METHODS: 123 patients with unilateral SSNHL receiving ITSIs were included in this study. Post-ITSI complications were documented including otalgia, dysgeusia, vertigo (duration>1 h), and persistent eardrum perforation. The pain intensity was evaluated with visual analog scale (VAS). Hearing was measured before ITSI and at 1 month after the final ITSI. We compared our patients' hearing threshold between presence and absence of different complications. RESULTS: 47.2% patients experienced post-injection otalgia with the average VAS score 3.2 (range 2-6). Five (4.1%) and six (4.9%) patients exhibited vertigo and persistent eardrum perforations, respectively. The patients were divided into three groups based on the absence of complications and the presence of vertigo and eardrum perforation. The hearing threshold improvements did not differ significantly among the three groups (p = 0.366). Although the difference was not significant (p = 0.664), the proportion of patients experiencing post-ITSI vertigo who were on contemporaneous oral steroids was lower than the proportion of non-vertigo patients on such steroids. CONCLUSION: The incidences of otalgia, vertigo, and persistent eardrum perforation in SSNHL patients treated with ITSI were 47.2%, 4.1% and 4.9%, respectively. We found no association between concurrent oral steroid use and the incidence of post-ITSI eardrum perforation or vertigo. Although statistical significance was lacking, patients who did not take contemporaneous oral steroids may have a higher rate of prolonged post-ITSI vertigo.


Assuntos
Otopatias/epidemiologia , Perda Auditiva Neurossensorial/tratamento farmacológico , Perda Auditiva Súbita/tratamento farmacológico , Injeção Intratimpânica/efeitos adversos , Esteroides/administração & dosagem , Esteroides/efeitos adversos , Adolescente , Adulto , Idoso , Idoso de 80 Anos ou mais , Otopatias/induzido quimicamente , Dor de Orelha/induzido quimicamente , Feminino , Audição/efeitos dos fármacos , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Prognóstico , Recuperação de Função Fisiológica , Estudos Retrospectivos , Perfuração da Membrana Timpânica/induzido quimicamente , Vertigem/induzido quimicamente , Adulto Jovem
20.
Rev. Soc. Esp. Dolor ; 28(6): 325-331, Nov-Dic. 2021. ilus, tab, graf
Artigo em Espanhol | IBECS | ID: ibc-227854

RESUMO

Objetivo: Estudiar la influencia del catastrofismo sobre el dolor lumbar crónico radicular y evaluar sus cambios a la inyección epidural de esteroides. Además, estudiar la relación entre catastrofismo y la respuesta al tratamiento. Material y métodos: Se realizó un estudio prospectivo sobre 52 pacientes con lumbociatálgia crónica unilateral, a los que se le realizó una inyección epidural lumbar de esteroides. En 39 de ellos se valoró en condiciones basales y al mes del procedimiento, el dolor y el catastrofismo mediante el Inventario Abreviado de Dolor y la Escala de Catastrofismo. Se definó como "respon­dedores" a los pacientes con disminución de 2 puntos o más en la intensidad del dolor. Para el catastrofismo se consideró un score de 30 como severo. Un valor de p < 0,05 se consideró de significancia estadística. Resultados: El catastrofismo total fue mayor en mujeres que en hombres. Se encontró una correlación lineal positiva moderada entre catastrofismo, intensidad del dolor e índice de interferencia, estadísticamente significativa. En los 39 pacientes tratados, se encontró una disminución estadísticamente significativa de la intensidad, interferencia funcional del dolor y catastrofismo total. Dieciseis pacientes se considera­ron respondedores. En estos, el índice de intensidad disminuyó de 7,8 ± 0,8 a 3,9 ± 3,1 (50 % de porcentaje de cambio, p = 0,0001); la interferencia funcional del dolor evaluada por el índice de interferencia disminuyó de 8,2 ± 1,6 a 5,0 ± 3,8 (40 % de cambio, p = 0,0027) y el catastrofismo total disminuyó de 37 ± 13 a 17,5 ± 16 (57 % de cambio, p < 0,0001). El catastrofismo total previo no mostró diferencias entre los pacientes respondedores y no respondedores a las inyecciones epidurales de esteroides. Conclusiones: La inyección epidural de esteroides en pacientes con dolor lumbar radicular crónico resultó efectiva para disminuir el dolor y sus repercusiones funcionales...(AU)


Objetive: The aim of this study was to investigate the relationship existent between pain catastrophism and pain intensity and pain interference, in patients with lumbosacral radicular pain. The effect on catastrophism of epidural steroid injections was also asessed. Material an methods: A prospective study was conducted on 52 patients with unilateral lumbosacral radi­cular pain. In 39 of them, the Brief Pain Inventory and the Catastrophism Scale was applied before and one month afer a epidural steroid injection. Responderes to treatment ere defined with a decrease of 2 points or more in pain intensity. For catastrophism, a score of 30 was considered severe. A value of p < 0.05 was taken as statistical significance. Results: Catastrophism was significantly higher in women. Moderate and statistically significant positive linear correlations between pain intensity, pain interference and catastrophism were found. In treated patients, a significant decrease in pain intensity, pain interference and catastrophism were observed. Sixteen patients were considered treatment responders. In them, pain intensity and catastrophism had a clinical and statistically significant reduction. Score of Intensity was reduced from 7.8 ± 0.8 to 3.9 ± 3.1 (50 % of change percentage, p = 0.0001), functional interfe­rence of pain evaluated by Score of Interference from 8.2 ± 1.6 to 5.0 ± 3.8 (40 % of change percentage, p = 0.0027) and Total Catastrophism from 37 ± 13 to 17.5 ± 16 (57 % of change percentage, p < 0.0001). No difference were found in Total Catastrophism evaluated before the proceduresl between responders and no responders to epidural steroid injections. Conclusions: Epidural steroid injections was effective in reducing pain in 41 % of controlled patients. The decrease in pain was accompanied by a reduction in Total Catastrophism, which showed to be a dynamic cons­truct, capable of being modified by interventional pain treatments...(AU)


Assuntos
Humanos , Masculino , Feminino , Catastrofização/tratamento farmacológico , Esteroides/administração & dosagem , Injeções Epidurais , Dor Lombar/tratamento farmacológico , Resultado do Tratamento , Medição da Dor , Dor/tratamento farmacológico , Manejo da Dor/métodos , Estudos Prospectivos
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