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1.
J Am Acad Dermatol ; 90(3): 485-493, 2024 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-37852306

RESUMO

BACKGROUND: Genital psoriasis can be stigmatizing, is highly prevalent among patients with psoriasis, and has limited treatment options. Apremilast is a unique oral immunomodulating phosphodiesterase 4 inhibitor approved for psoriasis treatment. OBJECTIVE: To assess the efficacy and safety of apremilast 30 mg twice daily in patients with genital psoriasis. METHODS: DISCREET, a phase 3, placebo-controlled trial (NCT03777436), randomized patients with moderate-to-severe genital psoriasis (stratified by affected body surface area <10% or ≥10%) to apremilast or placebo for a 16-week period, followed by an apremilast extension period. Week 16 results are presented. RESULTS: Patients were randomized to apremilast (n = 143) or placebo (n = 146). At Week 16, 39.6% and 19.5% of apremilast and placebo patients, respectively, achieved a modified static Physician Global Assessment of Genitalia response (primary endpoint; score of 0/1, ≥2-point reduction); treatment difference was significant (20.1%, P = .0003). Improvements in genital signs and symptoms, skin involvement, and quality of life were observed. Common treatment-emergent adverse events were diarrhea, headache, nausea, and nasopharyngitis. LIMITATIONS: Lack of active-comparator. CONCLUSIONS: Apremilast demonstrated statistically and clinically meaningful genital Physician Global Assessment responses and improvement of signs, symptoms, severity, and quality of life in this first randomized, controlled study of an oral systemic treatment in patients with genital psoriasis.


Assuntos
Psoríase , Qualidade de Vida , Talidomida/análogos & derivados , Humanos , Anti-Inflamatórios não Esteroides/efeitos adversos , Índice de Gravidade de Doença , Psoríase/diagnóstico , Psoríase/tratamento farmacológico , Psoríase/induzido quimicamente , Método Duplo-Cego , Genitália , Resultado do Tratamento
2.
N Engl J Med ; 381(20): 1918-1928, 2019 11 14.
Artigo em Inglês | MEDLINE | ID: mdl-31722152

RESUMO

BACKGROUND: The small-molecule phosphodiesterase 4 inhibitor apremilast modulates cytokines that are up-regulated in Behçet's syndrome. In a phase 2 trial involving patients with Behçet's syndrome, apremilast reduced the incidence and severity of oral ulcers. Data on the efficacy and safety of apremilast in patients with Behçet's syndrome who had active oral ulcers and had not previously received biologic agents are limited. METHODS: In a phase 3 trial, we randomly assigned, in a 1:1 ratio, patients who had Behçet's syndrome with active oral ulcers but no major organ involvement to receive either apremilast at a dose of 30 mg or placebo, administered orally, twice daily for 12 weeks, followed by a 52-week extension phase. The primary end point was the area under the curve (AUC) for the total number of oral ulcers during the 12-week placebo-controlled period (with lower values indicating fewer ulcers). There were 13 secondary end points, including complete response of oral ulcers, change from baseline in pain associated with oral ulcers, disease activity, and change from baseline in the Behçet's Disease Quality of Life score (range, 0 to 30, with higher scores indicating greater impairment in quality of life). Safety was also assessed. RESULTS: A total of 207 patients underwent randomization (104 patients to the apremilast group and 103 to the placebo group). The AUC for the number of oral ulcers was 129.5 for apremilast, as compared with 222.1 for placebo (least-squares mean difference, -92.6; 95% confidence interval [CI], -130.6 to -54.6; P<0.001). The change from baseline in the Behçet's Disease Quality of Life score was -4.3 points in the apremilast group, as compared with -1.2 points in the placebo group (least-squares mean difference, -3.1 points; 95% CI, -4.9 to -1.3). Adverse events with apremilast included diarrhea, nausea, and headache. CONCLUSIONS: In patients with oral ulcers associated with Behçet's syndrome, apremilast resulted in a greater reduction in the number of oral ulcers than placebo but was associated with adverse events, including diarrhea, nausea, and headache. (Funded by Celgene; ClinicalTrials.gov number, NCT02307513.).


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Síndrome de Behçet/tratamento farmacológico , Úlceras Orais/tratamento farmacológico , Inibidores da Fosfodiesterase 4/uso terapêutico , Talidomida/análogos & derivados , Administração Oral , Adulto , Anti-Inflamatórios não Esteroides/efeitos adversos , Área Sob a Curva , Síndrome de Behçet/complicações , Método Duplo-Cego , Feminino , Humanos , Masculino , Úlceras Orais/etiologia , Inibidores da Fosfodiesterase 4/efeitos adversos , Qualidade de Vida , Talidomida/efeitos adversos , Talidomida/uso terapêutico
3.
Mod Rheumatol ; 32(2): 413-421, 2022 Feb 28.
Artigo em Inglês | MEDLINE | ID: mdl-34894266

RESUMO

OBJECTIVES: Apremilast efficacy and safety was assessed in a prespecified subgroup of Japanese patients with oral ulcers associated with Behçet's syndrome from a Phase 3 randomized, placebo-controlled, double-blind study of apremilast (RELIEF). METHODS: The primary end point was area under the curve for number of oral ulcers during the 12-week placebo-controlled phase (AUCWk0-12). Key secondary end points were change from baseline in oral ulcer pain, complete oral ulcer resolution, and measures of disease activity and quality of life (QoL). RESULTS: Thirty-nine Japanese patients were randomised (apremilast 30 mg BID: n = 19; placebo: n = 20). Improvements at Week 12 were observed for apremilast vs. placebo in AUCWk0-12 for the number of oral ulcers (115.9 vs. 253.3; nominal P = 0.0168); 57.9% vs. 25.0% achieved complete oral ulcer resolution, 47.4% vs. 0.0% achieved oral ulcer resolution by Week 6 and maintained oral ulcer-free status for ≥6 additional weeks; mean change from baseline in BSAS was -10.5 vs. 0.5. Favourable effects were observed for apremilast vs. placebo in other secondary end points, including QoL. Clinical benefits were sustained over 28 weeks of continued apremilast treatment. Adverse events were consistent with apremilast's known safety profile. CONCLUSIONS: Apremilast reduced the number of oral ulcers and overall disease activity in this Japanese subgroup with Behçet's syndrome.


Assuntos
Síndrome de Behçet , Qualidade de Vida , Anti-Inflamatórios não Esteroides , Síndrome de Behçet/complicações , Síndrome de Behçet/tratamento farmacológico , Método Duplo-Cego , Humanos , Japão , Talidomida/análogos & derivados
4.
Clin Exp Rheumatol ; 39 Suppl 132(5): 80-87, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34622764

RESUMO

OBJECTIVES: This study assessed the efficacy and safety of apremilast for the oral ulcers associated with Behçet's syndrome (BS) up to 64 weeks. METHODS: The phase 3, double-blind, placebo-controlled RELIEF study randomised adult patients with active BS to placebo or apremilast 30 mg twice daily for 12 weeks, followed by an extension phase with all patients receiving apremilast through Week 64 and 4-week post-treatment follow-up (upon treatment discontinuation). The primary endpoint was area under the curve for the number of oral ulcers over 12 weeks (AUCWk0-12), reflecting the number of oral ulcers over time and accounting for their recurring-remitting course. Oral ulcer number, complete and partial responses, pain and disease activity and quality of life (QoL) were also assessed throughout the study. RESULTS: A total of 207 participants were randomised and received at least one dose of study medication; 178 entered the extension phase and 143 completed Week 64. AUCWk0-12 was significantly lower with apremilast versus placebo (p<0.0001), and oral ulcers number, pain, complete/partial responses, disease activity and QoL with apremilast versus placebo showed improvements at Week 12, which were maintained through Week 64. The most common adverse events were diarrhoea, nausea, headache and upper respiratory tract infection; no new safety concerns were observed with longer-term apremilast exposure. CONCLUSIONS: In patients with oral ulcers associated with BS, apremilast was efficacious and benefits were sustained up to 64 weeks with continued treatment. Apremilast was well tolerated, and safety was consistent with its known safety profile.


Assuntos
Síndrome de Behçet , Úlceras Orais , Adulto , Anti-Inflamatórios não Esteroides/efeitos adversos , Síndrome de Behçet/complicações , Síndrome de Behçet/diagnóstico , Síndrome de Behçet/tratamento farmacológico , Humanos , Úlceras Orais/tratamento farmacológico , Úlceras Orais/etiologia , Qualidade de Vida , Talidomida/análogos & derivados
5.
BMC Womens Health ; 20(1): 101, 2020 05 11.
Artigo em Inglês | MEDLINE | ID: mdl-32393366

RESUMO

BACKGROUND: The postoperative severity of symptoms among women with breast cancer affects their quality of life (QoL). Although it is recommended that performing shoulder-arm exercise 30 min/day can alleviate symptoms and improve the QoL, there is little research on the mediating effects of performing shoulder-arm exercise 30 min/day on the postoperative severity of symptoms and QoL among patients with breast cancer. METHODS: A cross-sectional study was conducted 2 ~ 4 months after surgery on women diagnosed with breast cancer but with no distant metastasis and who had undergone breast cancer surgery for the first time. A structured questionnaire was employed which included a severity of symptoms scale, performing shoulder-arm exercise for 30 min/day, a QoL scale, demographic characteristics, and medical status. RESULTS: In total, 117 women with breast cancer completed the survey. The severity of symptoms and performing shoulder-arm exercise 30 min/day separately affected the QoL (B = -0.447, standard error (SE) = 0.050, p < 0.001; B = 15.666, SE = 4.542, p = 0.001, respectively). In model 3, performing shoulder-arm exercise for 30 min/day played a partial mediating role in the relationship of the severity of symptoms and QoL (R2 = 0.51, F = 5.41, p < 0.001). CONCLUSIONS: During 2 ~ 4 months after surgery, regular shoulder-arm exercise for 30 min/day could decrease the effect of the severity of symptoms on the QoL among women with breast cancer. Clinical healthcare providers may inform and educate patients as to the benefits of regular shoulder-arm exercise for 30 min/day.


Assuntos
Braço/fisiopatologia , Neoplasias da Mama/reabilitação , Exercício Físico/psicologia , Qualidade de Vida/psicologia , Ombro/fisiopatologia , Atividades Cotidianas , Adulto , Idoso , Neoplasias da Mama/psicologia , Neoplasias da Mama/cirurgia , Estudos Transversais , Exercício Físico/fisiologia , Feminino , Humanos , Mastectomia , Pessoa de Meia-Idade , Período Pós-Operatório , Índice de Gravidade de Doença , Inquéritos e Questionários
6.
Environ Toxicol ; 33(5): 587-593, 2018 May.
Artigo em Inglês | MEDLINE | ID: mdl-29436100

RESUMO

Colorectal cancer (CRC) is one of the most common cancers and causes of cancer-related death. There are several first-line chemotherapeutic drugs used to treat CRC. Oxaliplatin (OXA) is an alkylating cytotoxic agent that is usually combined with other chemotherapeutic drugs to treat stage II and stage III CRC. However, cancer cells commonly acquire multidrug resistance (MDR), which is a major obstruction to cancer treatment. Recent studies have shown that natural components from traditional Chinese medicine or foods that have many biological functions may be new adjuvant therapies in clinical trials. We challenged LoVo CRC cell lines with OXA in a dose-dependent manner to create an OXA-resistant model. The expression of ABCG2 was significantly higher, and levels of endoplasmic reticulum (ER) stress markers were lower than those Parental cells. However, Lupeol, which is found in fruits and vegetables, has been shown to have bioactive properties, including anti-tumor properties that are relevant to many diseases. In our study, Lupeol downregulated cell viability and activated cell apoptosis. Moreover, Lupeol decreased the expression of ABCG2 and activated ER stress to induce OXA-resistant cell death. Importantly, the anti-tumor effect of Lupeol in OXA-resistant cells was higher than that of LoVo Parental cells. In addition, we also confirmed our results with a xenograft animal model, and the tumor size significantly decreased after Lupeol injections. Our findings show that Lupeol served as a strong chemoresistant sensitizer and could be a new adjuvant therapy method for chemoresistant patients.


Assuntos
Membro 2 da Subfamília G de Transportadores de Cassetes de Ligação de ATP/genética , Apoptose/efeitos dos fármacos , Neoplasias Colorretais/patologia , Resistencia a Medicamentos Antineoplásicos/efeitos dos fármacos , Estresse do Retículo Endoplasmático , Proteínas de Neoplasias/genética , Compostos Organoplatínicos/uso terapêutico , Triterpenos Pentacíclicos/farmacologia , Animais , Apoptose/genética , Morte Celular/efeitos dos fármacos , Morte Celular/genética , Linhagem Celular Tumoral , Sobrevivência Celular/efeitos dos fármacos , Sobrevivência Celular/genética , Neoplasias Colorretais/tratamento farmacológico , Neoplasias Colorretais/genética , Regulação para Baixo/efeitos dos fármacos , Regulação para Baixo/genética , Resistencia a Medicamentos Antineoplásicos/genética , Estresse do Retículo Endoplasmático/efeitos dos fármacos , Estresse do Retículo Endoplasmático/genética , Regulação Neoplásica da Expressão Gênica/efeitos dos fármacos , Humanos , Camundongos , Camundongos Nus , Oxaliplatina , Transdução de Sinais/efeitos dos fármacos , Transdução de Sinais/genética , Ensaios Antitumorais Modelo de Xenoenxerto
7.
Int J Mol Sci ; 19(6)2018 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-29857545

RESUMO

Myocardial apoptosis and fibrosis represent important contributing factors for development of hypertension-induced heart failure. The present study aims to investigate the potential effects of Eriobotrya japonica leaf extract (EJLE) against hypertension-induced cardiac apoptosis and fibrosis in spontaneously hypertensive rats (SHRs). Twelve-week-old male rats were randomly divided into four different groups; control Wistar Kyoto (WKY) rats, hypertensive SHR rats, SHR rats treated with a low dose (100 mg/kg body weight) of EJLE and SHR rats treated with a high dose (300 mg/kg body weight) of EJLE. Animals were acclimatized for 4 weeks and thereafter were gastric fed for 8 weeks with two doses of EJLE per week. The rats were then euthanized following cardiac functional analysis by echocardiography. The cardiac tissue sections were examined by Terminal Deoxynucleotidyl Transferase-Mediated Deoxyuridine Triphosphate (dUTP) Nick End-Labeling (TUNEL) assay, histological staining and Western blotting to assess the cardio-protective effects of EJ in SHR animals. Echocardiographic measurements provided convincing evidence to support the ability of EJ to ameliorate crucial cardiac functional characteristics. Furthermore, our results reveal that supplementation of EJLE effectively attenuated cardiac apoptosis and fibrosis and also enhanced cell survival in hypertensive SHR hearts. Thus, the present study concludes that EJLE potentially provides cardio-protective effects against hypertension-induced cardiac apoptosis and fibrosis in SHR animals.


Assuntos
Anti-Hipertensivos/farmacologia , Apoptose/efeitos dos fármacos , Eriobotrya/química , Exsudatos de Plantas/farmacologia , Animais , Biomarcadores , Sobrevivência Celular , Modelos Animais de Doenças , Fibrose/tratamento farmacológico , Fibrose/etiologia , Fibrose/patologia , Testes de Função Cardíaca , Hipertensão/tratamento farmacológico , Hipertensão/etiologia , Hipertensão/fisiopatologia , Masculino , Miocárdio/metabolismo , Miocárdio/patologia , Miócitos Cardíacos/efeitos dos fármacos , Miócitos Cardíacos/metabolismo , Ratos , Ratos Endogâmicos SHR , Transdução de Sinais
8.
Br J Clin Pharmacol ; 75(5): 1255-64, 2013 May.
Artigo em Inglês | MEDLINE | ID: mdl-23078631

RESUMO

AIM: To assess the bioequipotency of equimolar doses of idraparinux (2.5 mg) and idrabiotaparinux (3.0 mg). METHOD: In a phase I study, 48 healthy male volunteers were randomized to a single subcutaneous injection of idrabiotaparinux or idraparinux, followed by plasma sampling over 27 days. In a prospective substudy of the phase III EQUINOX trial, 228 patients treated for acute symptomatic deep vein thrombosis received idrabiotaparinux or idraparinux once weekly for 6 months. Plasma sampling was performed within 5 days following the last injection. The primary pharmacodynamic endpoint was the inhibition of activated factor X (FXa) activity. Maximal anti-FXa activity (Amax) and area under anti-FXa activity vs. time curve (AAUC) were calculated. Safety and tolerability were also assessed. RESULTS: In both studies, pharmacodynamic anti-FXa vs. time profiles of idrabiotaparinux and idraparinux were superimposable. Ratio estimates (90% confidence intervals [CIs]) for idrabiotaparinux : idraparinux were 0.96 (0.89, 1.04) for Amax and 0.95 (0.87, 1.04) for AAUC in the phase I study, and 1.11 (1.00, 1.22) for Amax and 1.06 (0.96, 1.16) for AAUC at month 6 in the EQUINOX substudy. Idrabiotaparinux and idraparinux were considered bioequipotent because 90% CIs were within the pre-specified interval (0.80, 1.25). Study treatments were well tolerated. CONCLUSION: Pharmacodynamic parameters reported after single dose in healthy volunteers and after repeated once weekly dosing in patients demonstrated the bioequipotency of idrabiotaparinux and idraparinux based on FXa inhibition. These outcomes support the use of an idrabiotaparinux dose bioequipotent to an idraparinux dose in large clinical trials, and the possibility to substitute idrabiotaparinux to idraparinux for the treatment of venous thromboembolism.


Assuntos
Anticoagulantes/farmacocinética , Biotina/análogos & derivados , Inibidores do Fator Xa , Oligossacarídeos/farmacocinética , Trombose Venosa/tratamento farmacológico , Adolescente , Adulto , Anticoagulantes/farmacologia , Área Sob a Curva , Biotina/farmacocinética , Biotina/farmacologia , Fator Xa/metabolismo , Humanos , Masculino , Pessoa de Meia-Idade , Oligossacarídeos/farmacologia , Equivalência Terapêutica , Trombose Venosa/metabolismo , Adulto Jovem
9.
Am J Clin Dermatol ; 24(5): 809-820, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37316690

RESUMO

BACKGROUND: Since US FDA approval in 2014, apremilast has consistently demonstrated a favorable benefit-risk profile in 706,585 patients (557,379 patient-years of exposure) worldwide across approved indications of plaque psoriasis, psoriatic arthritis, and Behçet's syndrome; however, long-term exposure across these indications has not been reported. OBJECTIVE: The aim of this study was to conduct a pooled analysis of apremilast data from 15 clinical studies with open-label extension phases, focusing on long-term safety. METHODS: We analyzed longer-term safety and tolerability of apremilast 30 mg twice daily across three indications for up to 5 years, focusing on adverse events of special interest, including thrombotic events, malignancies, major adverse cardiac events (MACE), serious infections, and depression. Data were pooled across 15 randomized, placebo-controlled studies and divided into placebo-controlled or all-apremilast-exposure groups. Treatment-emergent adverse events (TEAEs) were assessed. RESULTS: Overall, 4183 patients were exposed to apremilast (6788 patient-years). Most TEAEs were mild to moderate in the placebo-controlled period (96.6%) and throughout all apremilast exposure (91.6%). TEAE rates of special interest were similar between treatment groups in the placebo-controlled period and remained low throughout all apremilast exposure. Exposure-adjusted incidence rates per 100 patient-years during all apremilast exposure were MACE, 0.30; thrombotic events, 0.10; malignancies, 1.0; serious infections, 1.10; serious opportunistic infections, 0.21; and depression, 1.78. Safety findings were consistent across indications and regions. No new safety signals were identified. CONCLUSIONS: The incidence of serious TEAEs and TEAEs of special interest was low despite long-term exposure, further establishing apremilast as a safe oral option for long-term use across indications with a favorable benefit-risk profile. CLINICAL TRIAL REGISTRATION: NCT00773734, NCT01194219, NCT01232283, NCT01690299, NCT01988103, NCT02425826, NCT03123471, NCT03721172, NCT01172938, NCT01212757, NCT01212770, NCT01307423, NCT01925768, NCT00866359, NCT02307513.


Assuntos
Artrite Psoriásica , Síndrome de Behçet , Neoplasias , Psoríase , Humanos , Artrite Psoriásica/tratamento farmacológico , Síndrome de Behçet/tratamento farmacológico , Psoríase/tratamento farmacológico , Resultado do Tratamento , Ensaios Clínicos Controlados Aleatórios como Assunto
10.
J Clin Nurs ; 21(1-2): 70-9, 2012 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-21702860

RESUMO

AIM: To examine changes in quality of life among patients with breast cancer and factors related to it, during the first three months after diagnosis. BACKGROUND: Numerous studies have examined quality of life among cancer survivors or among patients with cancer after aggressive treatment; such research has demonstrated that quality of life in the third month after surgery can significantly predict quality of life in the long run. In contrast, changes in quality of life causes among patients during the acute treatment phase have not been well studied. DESIGN: Prospective longitudinal study. METHODS: Newly diagnosed patients with breast cancer were recruited during 2008-2009. Sixty-one cases completed the four data collections on the day before operation and one, two and three months after surgery. Data were collected using the Functional Living Index-Cancer, Symptom Distress Scale, the Self-Efficacy Scale and a 0-10 Anxiety Numeric Rating Scale. Generalized Estimating Equations were applied for data analysis. RESULTS: There were significant changes in quality of life over the three months following surgery, and the worst quality of life was observed in the first month after surgery. Less advanced stages of cancer, lower anxiety, less symptom distress and higher perceived self-efficacy in the preoperative interview could significantly predict which patients experienced more positive quality of life trends. Fatigue, limited shoulder function and perceived poor appearance were the most significant factors predicting changes of quality of life. CONCLUSION: Preoperative physical and psychological factors, as well as sense of self-efficacy for managing the cancer, are important factors for predicting changes in patients' quality of life. RELEVANCE TO CLINICAL PRACTICE: Healthcare providers should be alert to factors contributing to changes of quality of life among patients receiving chemotherapy. Interventions based on these results should be developed and their effectiveness tested for their impact on breast cancer patients' quality of life. Clinical interventions based on these results should be developed to improve breast cancer patients' quality of life.


Assuntos
Neoplasias da Mama/fisiopatologia , Qualidade de Vida , Adulto , Feminino , Humanos , Estudos Longitudinais , Pessoa de Meia-Idade , Taiwan
11.
RMD Open ; 8(2)2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35798511

RESUMO

OBJECTIVE: To assess apremilast's impact on patient quality of life (QoL) in active Behçet's syndrome and correlations between improvement in patients' QoL and efficacy measures in the phase 3 RELIEF study. METHODS: QoL measures included Behçet's Disease QoL (BDQoL), 36-Item Short-Form Health Survey V.2 (SF-36v2) Physical/Mental Component Summary (PCS/MCS) and eight subscale scores, focusing on Physical Functioning (PF). Pearson's correlation coefficients assessed relationships between efficacy endpoints (oral ulcer count, oral ulcer pain, Behçet's Syndrome Activity Scale (BSAS), Behçet's Disease Current Activity Form (BDCAF)) and QoL endpoints for apremilast at Week 12. RESULTS: Apremilast (n=104) demonstrated significantly greater improvements versus placebo (n=103) in SF-36v2 PCS (3.1 vs 0.9), MCS (4.6 vs ─0.7) and PF (2.9 vs 0.14), respectively (all p<0.05). Mild correlations were observed in improvements of SF-36v2 measures (PCS, MCS, PF) with oral ulcer count (r=-0.11, PCS), and change in oral ulcer pain from baseline (r=-0.28, PCS; r=-0.10, PF) and BSAS (r=-0.38, PCS; r=-0.20, PF; r=-0.16, MCS). Correlations among BDCAF and SF-36v2 components and BDQoL were variable. BDQoL showed mild/moderate correlations with SF-36v2 components (r=-0.18, PCS; r=-0.13, PF; r=-0.45, MCS). CONCLUSIONS: Apremilast was associated with significant improvements in QoL measures of SF-36v2 PCS, MCS and PF and BDQoL in patients with Behçet's syndrome. Correlations of improvement among QoL endpoints support the beneficial clinical effects of apremilast in Behçet's syndrome. TRIAL REGISTRATION NUMBER: NCT02307513.


Assuntos
Síndrome de Behçet , Úlceras Orais , Síndrome de Behçet/complicações , Síndrome de Behçet/tratamento farmacológico , Humanos , Úlceras Orais/complicações , Úlceras Orais/tratamento farmacológico , Dor , Qualidade de Vida , Talidomida/análogos & derivados
12.
Support Care Cancer ; 19(5): 647-56, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-20422230

RESUMO

PURPOSE: The purposes of this two-phase study were to (1) develop and examine the content validity and feasibility of the Chinese-version cancer needs questionnaire, short form, head and neck cancer-specific version (CNQ-SF-hn) (phase I), and (2) examine its psychometric characteristics as supported by reliability and construct validity (phase II) in oral cavity cancer patients in Taiwan. METHODS: Newly diagnosed oral cavity cancer patients (N = 206) were recruited from a medical center in northern Taiwan. Data were analyzed using descriptive statistics and psychometric analyses. RESULTS: The results showed that the CNQ-SF-hn (1) had good internal consistency reliability for the overall scale and subscales; (2) had good 1-week test-retest reliability (correlation = 0.80) for the overall scale; (3) had construct validity, supported by six clearly identified factors explaining 74.87% of the variance; and (4) had convergent validity, supported by correlations among its subscales and related scales, as well as by discriminating care needs according to undergoing versus not undergoing reconstructive surgery and cancer stage. CONCLUSIONS: The Chinese-version CNQ-SF-hn is a psychometrically satisfactory instrument. Further validation is suggested for its factor structure and different head and neck cancers.


Assuntos
Necessidades e Demandas de Serviços de Saúde , Neoplasias Bucais/psicologia , Qualidade de Vida , Inquéritos e Questionários , Adulto , Idoso , China , Estudos de Viabilidade , Feminino , Neoplasias de Cabeça e Pescoço/psicologia , Humanos , Masculino , Pessoa de Meia-Idade , Psicometria , Reprodutibilidade dos Testes , Taiwan
13.
Cancer Nurs ; 44(4): E221-E228, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-32132368

RESUMO

BACKGROUND: Worldwide, colorectal cancer is the third most common cancer in men and the second in women. The main surgical methods for colorectal cancer patients include a conventional open colectomy and laparoscopic-assisted colectomy. Laparoscopic-assisted colectomy is associated with less blood loss, faster recovery of bowel function, and shorter hospital stays. OBJECTIVE: The aim of this study was to compare the quality of life and symptom severity in patients with colorectal cancer 1 month after conventional open colectomy or laparoscopic-assisted colectomy. METHODS: A comparative cross-sectional study design was conducted from September 2015 to May 2016. Participants were recruited through convenience sampling from the surgical outpatient department of a medical center in Northern Taiwan; 33 patients underwent each type of surgery. RESULTS: The laparoscopic-assisted colectomy group scored 9.39 points higher in quality of life and lower in symptom severity by 14.88 points than the conventional open colectomy group (P = .03 and P = .05, respectively). Both groups reported low symptom severity; "changes in bowel habits" was the symptom with the highest severity. The conventional open colectomy group had higher insomnia and worried about their future more than did the laparoscopic-assisted colectomy group. CONCLUSIONS: Patients who received the laparoscopic-assisted colectomy procedure reported a better quality of life and lower symptom severity than those who received the conventional open colectomy surgical method. IMPLICATIONS FOR PRACTICE: Patients who will have a conventional open colectomy will likely need enhanced management of symptoms and attention to their quality of life.


Assuntos
Sobreviventes de Câncer/psicologia , Colectomia/psicologia , Laparoscopia/psicologia , Qualidade de Vida/psicologia , Adulto , Idoso , Colectomia/métodos , Neoplasias Colorretais/cirurgia , Estudos Transversais , Feminino , Humanos , Laparoscopia/métodos , Masculino , Pessoa de Meia-Idade , Taiwan , Resultado do Tratamento
14.
J Rheumatol ; 48(8): 1259-1267, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33589554

RESUMO

OBJECTIVE: To evaluate the efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in patients with active ankylosing spondylitis (AS). METHODS: This phase III, multicenter, double-blind, placebo-controlled study (ClinicalTrials.gov: NCT01583374) randomized patients with active AS (1:1:1) to placebo, apremilast 20 mg twice daily, or apremilast 30 mg twice daily for 24 weeks, followed by a long-term extension phase (up to 5 yrs). The primary endpoint was Assessment of the Spondyloarthritis international Society 20 (ASAS20) response at Week 16. The effect of treatment on radiographic outcomes after 104 weeks was assessed using the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS). RESULTS: In total, 490 patients with active AS were randomized in the study (placebo: n = 164; apremilast 20 mg twice daily: n = 163; apremilast 30 mg twice daily: n = 163). The primary endpoint of ASAS20 response at Week 16 was not met (placebo: 37%; apremilast 20 mg twice daily: 35%; apremilast 30 mg twice daily: 33%; P = 0.44 vs placebo). At Week 104, mean (SD) changes from baseline in mSASSS were 0.83 (3.6), 0.98 (2.2), and 0.57 (1.9) in patients initially randomized to placebo, apremilast 20 mg twice daily, and apremilast 30 mg twice daily, respectively. The most frequently reported adverse events through Week 104 were diarrhea, nasopharyngitis, upper respiratory infection, and nausea. CONCLUSION: No clinical benefit was observed with apremilast treatment in patients with active AS. The safety and tolerability of apremilast were consistent with its known profile.


Assuntos
Inibidores da Fosfodiesterase 4 , Espondilite Anquilosante , Método Duplo-Cego , Humanos , Inibidores da Fosfodiesterase 4/efeitos adversos , Índice de Gravidade de Doença , Espondilite Anquilosante/diagnóstico por imagem , Espondilite Anquilosante/tratamento farmacológico , Talidomida/efeitos adversos , Talidomida/análogos & derivados , Resultado do Tratamento
15.
J Adv Nurs ; 66(5): 1142-50, 2010 May.
Artigo em Inglês | MEDLINE | ID: mdl-20337797

RESUMO

AIM: This paper is a report of psychometric testing of the Arm Exercise Promotion Scale. BACKGROUND: Patients with breast cancer having mastectomy are taught postoperative arm exercises during hospitalization; however, clinical observations suggest that patients infrequently practise them. It is important to develop an instrument that can be easily applied to evaluate women's motivation for arm exercises. METHOD: An instrument validation design with a cross-sectional survey was conducted during 2008-09. The previously developed 15-item Likert-type Arm Exercise Promotion Scale was further tested for test-retest reliability, internal consistency reliability, theoretically supported construct validity, and concurrent validity. A total of 94 patients with breast cancer were recruited to the study. RESULTS: The Arm Exercise Promotion Scale has satisfactory internal consistency reliability (Cronbach's alpha 0.88) and a test-retest reliability of 0.90. Three theoretically supported factors were abstracted by principal component analysis: perceived benefits, learning support and situational support. These factors were inter-correlated and statistically significantly correlated with arm exercise behaviour, indicating concurrent and construct validity. CONCLUSION: There is strong evidence to further support the Arm Exercise Promotion Scale as a valid instrument in assessing factors which promote arm exercises with patients with breast cancer. Future longitudinal clinical studies using this scale could add knowledge about the experiences of carrying out arm exercises in patients with breast cancer across time.


Assuntos
Traumatismos do Braço/reabilitação , Terapia por Exercício/psicologia , Mastectomia/reabilitação , Psicometria , Adulto , Idoso , Traumatismos do Braço/etiologia , Feminino , Promoção da Saúde/métodos , Promoção da Saúde/normas , Humanos , Pessoa de Meia-Idade , Motivação , Reprodutibilidade dos Testes , Taiwan
16.
Pulm Circ ; 9(2): 2045894019848644, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30997864

RESUMO

Riociguat, a first-in-class soluble guanylate cyclase stimulator, is approved for the treatment of pulmonary arterial hypertension (PAH), a serious potential complication of human immunodeficiency virus (HIV) infection. This open-label study investigated the pharmacokinetic drug-drug interaction potential of antiretroviral therapies on riociguat exposure in HIV-infected adults. HIV-infected adults without PAH on stable antiretroviral regimens (efavirenz/emtricitabine/tenofovir disoproxil, emtricitabine/rilpivirine/tenofovir disoproxil, elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil, abacavir/dolutegravir/lamivudine, or a ritonavir-boosted triple regimen) for ≥ 6 weeks received a single riociguat dose (0.5 mg). Riociguat pharmacokinetics and safety were assessed; pharmacokinetics was compared with historical healthy volunteer data. Of 41 participants treated (n = 8 in each arm, except n = 9 in the ritonavir-boosted triple regimen arm), 40 were included in the pharmacokinetic analyses. Riociguat median tmax was 1.00-1.27 h, with comparable maximum concentration (Cmax) across the five background antiretroviral groups. Riociguat exposure was highest with abacavir/dolutegravir/lamivudine, followed by elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil > emtricitabine/rilpivirine/tenofovir disoproxil > ritonavir-boosted triple regimen > efavirenz/emtricitabine/tenofovir disoproxil; riociguat area under the plasma concentration versus time curve (AUC) was approximately threefold higher with abacavir/dolutegravir/lamivudine than efavirenz/emtricitabine/tenofovir disoproxil. Compared with historical data, riociguat exposure in HIV-infected adults was similar when co-administered with efavirenz/emtricitabine/tenofovir disoproxil, slightly increased when administered with ritonavir-boosted triple regimen and increased by approximately threefold when administered with abacavir/dolutegravir/lamivudine. Riociguat was well tolerated, with no new safety findings. Riociguat was well tolerated in adults with HIV on stable background antiretroviral therapy although an apparent increase in AUC of riociguat was observed in patients receiving abacavir/dolutegravir/lamivudine. Patients should be monitored closely during riociguat initiation and dose adjustment for signs and symptoms of hypotension.

17.
PLoS One ; 14(2): e0211451, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-30716088

RESUMO

BACKGROUND: Only a few studies exist on the resilience of divorced women. Furthermore, relevant instruments for assessing the resilience of divorced immigrant Southeast Asian women are rare. Accordingly, the aim of this study was to develop and examine a new Resilience Scale-Chinese version (RS-C) that is specific to divorced immigrant Southeast Asian women in Taiwan. METHODS: The study was conducted in two phases. In phase 1, 20 items were used to evaluate face and content validities. In phase 2, a cross-sectional study was conducted. In total, 118 immigrant women participated in this study and were recruited from three nongovernmental organizations providing services for immigrants in Taipei City and Miaoli and Chiayi Counties. Psychometric properties of the instrument (i.e., internal consistency, test-retest reliability, item-to-total correlation, construct validity, and convergent validity) were examined. Significance was set at p < 0.05 for all statistical tests. RESULTS: The final 16-item RS-C resulted in a three-factor model. The three factors, namely personal competence, family identity, and social connections, were an acceptable fit for the data and explained 54.60% of the variance. Cronbach's α of the RS-C was 0.85, and those of its subscales ranged from 0.77 to 0.82. The correlation value of the test-retest reliability was 0.87. The RS-C was significantly associated with the General Self-Efficacy scale and the Chinese Health Questionnaire-12. CONCLUSION: The RS-C is a brief and specific self-report tool for evaluating the resilience of divorced immigrant Southeast Asian women and demonstrated adequate reliability and validity in this study. This RS-C instrument has potential applications in both clinical practice and research with strength-based resiliency interventions. However, additional research on the RS-C is required to further establish its reliability and validity.


Assuntos
Adaptação Psicológica , Divórcio/psicologia , Emigrantes e Imigrantes/psicologia , Psicometria/métodos , Traduções , Adulto , Sudeste Asiático , Feminino , Humanos , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Fatores Socioeconômicos , Inquéritos e Questionários , Taiwan
18.
Cancers (Basel) ; 11(10)2019 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-31623173

RESUMO

Colorectal cancer (CRC) is the second leading cause of cancer-related illness worldwide and one of the most common malignancies. Therefore, colorectal cancer research and cases have gained increasing attention. Oxaliplatin (OXA) is currently used in first-line chemotherapy to treat stage III and stage IV metastatic CRC. However, patients undergoing chemotherapy often develop resistance to chemo drugs being used. Evidence has confirmed that microRNAs regulate downstream genes in cancer biology and thereby have roles related to tumor growth, proliferation, invasion, angiogenesis, and multi-drug resistance. The aim of our study is to establish whether miR-31-5p is an oncogene in human colorectal cancers that are resistant to OXA and further confirm its malignant phenotype-associated target molecule. From the results of miRNA microarray assay, we establish that miR-31-5p expression was upregulated in oxaliplatin-resistant (OR)-LoVo cells compared with parental LoVo cells. Moreover, through in vitro and in vivo experiments, we demonstrate that miR-31-5p and large tumor suppressor kinase 2 (LATS2) were inversely related and that miR-31-5p and Forkhead box C1 (FOXC1) were positively correlated in the same LoVo or OR-LoVo cells. Importantly, we reveal a novel drug-resistance mechanism in which the transcription factor FOXC1 binds to the miR-31 promoter to increase the expression of miR31-5p and regulate LATS2 expression, resulting in cancer cell resistance to OXA. These results suggest that miR-31-5p may be a novel biomarker involved in drug resistance progression in CRC patients. Moreover, the FOXC1/miR31-5p/LATS2 drug-resistance mechanism provides new treatment strategies for CRC in clinical trials.

19.
J Pain Symptom Manage ; 35(5): 524-34, 2008 May.
Artigo em Inglês | MEDLINE | ID: mdl-18280104

RESUMO

The purpose of this randomized, controlled clinical trial was to preliminarily examine the effects of a three-week walking exercise program (WEP) on fatigue-related experiences of acute myelogenous leukemia (AML) patients receiving chemotherapy. Eligible AML patients were randomly assigned to either an experimental group (n=11), which received 12 minutes of WEP per day, five days per week for three consecutive weeks, or to a control group (n=11), which received standard ward care. Effects of the WEP were assessed by seven indicators: worst and average fatigue intensities, fatigue interference with patients' daily life, 12-minute walking distance, overall symptom distress, anxiety, and depressive status. All patients were evaluated four times: before chemotherapy (baseline or Day 1), Day 7, Day 14, and Day 21 of chemotherapy. Data were analyzed by Generalized Estimating Equation and revealed that AML patients in the three-week WEP group had a significantly greater increase in 12-minute walking distance than the control group. Patients in the WEP also had lower levels of fatigue intensity and interference, symptom distress, anxiety, and depressive status than the control group. Although preliminary, our results strongly suggest that three weeks of systematic walking exercise is clinically feasible for AML patients undergoing chemotherapy and can effectively improve their fatigue-related experiences.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Terapia por Exercício , Fadiga/etiologia , Fadiga/terapia , Leucemia Mieloide Aguda/complicações , Caminhada/fisiologia , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Ansiedade/complicações , Ansiedade/psicologia , Depressão/complicações , Depressão/psicologia , Fadiga/psicologia , Feminino , Humanos , Leucemia Mieloide Aguda/tratamento farmacológico , Masculino , Pessoa de Meia-Idade
20.
Chin J Physiol ; 49(2): 110-6, 2006 Apr 30.
Artigo em Inglês | MEDLINE | ID: mdl-16830793

RESUMO

Epidemiologic studies reported that the prevalence of hereditary non-polyposis colon cancer (HNPCC) in male is about 1.5-fold higher than that in female. Decreases in circulatory estradiol (E2) have been reported to downregulate the expression of E2 receptor (ER) and significantly increase the risk of colorectal cancer. Patients that received E2 replacement therapy were found to have a reduction in the incidence of colon adenoma and carcinoma. Furthermore, significant decreases in the expression of ER have been found in colorectal cancer specimens. These data strongly suggest the protective roles of E2 and ER against colorectal cancer. However, the mechanisms remain unexplored. LoVo cells were transient transfected to overexpress ER-beta, DNA fragmentation and caspase activity assay were performed to evaluate apoptotic effects. Western blotting was used to evaluate protein levels, and luciferase activity assay to measure the TNF-alpha promoter activity. Our data clearly demonstrated that E2 and ER-beta alone could upregulate p21 and p27 proteins, which further activate caspase-8 and caspase-9 to induce apoptosis in LoVo cell, and the ER-beta. effects were enhanced by E2. However, overexpressed ER-beta did not influence the expression and promoter activity of TNF-alpha. In addition, E2 and overexpressed ER-beta downregulated the beta-catenin proteins which cause the downregulation of its target genes, cyclin D1 and Rb, to inhibit the cell cycle and cell proliferation. The results indicate that overexpressed ER-beta may induce LoVo cell apoptosis and anti-proliferation by increasing p53 signaling in a ligand-dependent manner, and without hTNF-alpha involvement. Efforts aiming at enhancing ER-beta expression and/or activity may prove to be an attractive alternative therapy against colorectal cancer.


Assuntos
Apoptose , Neoplasias do Colo/metabolismo , Neoplasias do Colo/patologia , Receptor beta de Estrogênio/metabolismo , Transdução de Sinais , Proteína Supressora de Tumor p53/metabolismo , Linhagem Celular Tumoral , Receptor beta de Estrogênio/genética , Humanos , Ligantes , Proteínas Recombinantes/metabolismo , Regulação para Cima
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