Your browser doesn't support javascript.
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 150.495
Filtrar
1.
Zhejiang Da Xue Xue Bao Yi Xue Ban ; 48(3): 282-288, 2019 May 25.
Artigo em Chinês | MEDLINE | ID: mdl-31496160

RESUMO

OBJECTIVE: To determine the effect of trimetazidine on cardiac function and exercise tolerance in primary hypertension patients with type 2 diabetic. METHODS: In this randomized, double-blind, placebo-controlled prospective study, 60 primary hypertensive patients with diabetic were equally assigned into two groups, patients received trimetazidine (20 mg, 3 times a day) or placebo for 1 year. Echocardiography, cardiopulmonary exercise testing were performed; and the plasma N terminal pro B type natriuretic peptide (NT-ProBNP), hr-CRP, TNF-α, angiotensin Ⅱ and endothelin concentration were determined before and after treatment. RESULTS: In trimetazidine group, the left ventricular mass index, the mitral flow velocity E wave to A wave ratio (E/A), the peak early diastolic velocity (VE) to late diastolic velocity (VA) ratio (VE/VA) and the peak systolic velocity (Vs) were significantly improved, the plasma NT-ProBNP level was significantly decreased, and the exercise time, metabolic equivalent, maximal oxygen uptake and anaerobic threshold were significantly increased (all P<0.05); plasma concentration of hr-CRP, TNF-α, angiotensin Ⅱ and endothelin were significantly reduced after trimetazidine treatment, compared with baseline (all P<0.05) and with placebo (all P<0.05). There were no significant differences in any of above parameters after treatment in placebo group (all P>0.05). No severe adverse reaction was observed in both groups. CONCLUSIONS: For patients with both hypertension and diabetes, trimetazidine can improve cardiac function and increase exercise tolerance.


Assuntos
Complicações do Diabetes , Diabetes Mellitus , Tolerância ao Exercício , Coração , Hipertensão , Trimetazidina , Complicações do Diabetes/complicações , Diabetes Mellitus/tratamento farmacológico , Método Duplo-Cego , Tolerância ao Exercício/efeitos dos fármacos , Coração/efeitos dos fármacos , Humanos , Hipertensão/complicações , Hipertensão/tratamento farmacológico , Peptídeo Natriurético Encefálico/sangue , Estudos Prospectivos , Resultado do Tratamento , Trimetazidina/farmacologia , Trimetazidina/uso terapêutico , Vasodilatadores/farmacologia , Vasodilatadores/uso terapêutico
2.
J Appl Oral Sci ; 27: e20180564, 2019 Jul 29.
Artigo em Inglês | MEDLINE | ID: mdl-31365710

RESUMO

OBJECTIVE: Studies on the oral health of individuals with intellectual disability (ID) have identified problems that include a high prevalence of periodontal disease. The use of probiotics to treat periodontal disease has been the focus of considerable research, and bovine milk fermented with Lactobacillus rhamnosus L8020 (L8020 yogurt) has been shown to reduce the oral prevalence of four periodontal pathogens. The aim of this randomized, double-blind, placebo-controlled trial was to compare the effects of L8020 yogurt (test group) with those of placebo yogurt (placebo group) on the papillary-marginal-attached (PMA) index, gingival index (GI), and probing depth (PD) in 23 individuals with ID. METHODOLOGY: All patients were required to consume the allocated yogurt after breakfast for 90 days. PMA index and GI scores as well as PDs were assessed before the start of yogurt consumption (baseline), after 45 and 90 days of consumption, and 30 days after the cessation of consumption. Student's t-test, Mann-Whitney U test or Fisher's exact test was used for inter-group comparisons, and the mixed effect model of repeated measurements was used for data analysis. RESULTS: The decrease in PMA index score was significantly greater in the test group than in the placebo group (p<0.001). The GI score also decreased during the study, with a tendency for greater decrease in the test group. Furthermore, decreases in PD between baseline, 45 and 90 days tended to be greater in the test group than in the placebo group. CONCLUSION: These results suggest that regular consumption of bovine milk fermented with L. rhamnosus L8020 can lower the risk of periodontal disease in individuals with ID.


Assuntos
Deficiência Intelectual/fisiopatologia , Lactobacillus rhamnosus , Leite , Doenças Periodontais/prevenção & controle , Iogurte , Adulto , Animais , Método Duplo-Cego , Feminino , Humanos , Deficiência Intelectual/complicações , Masculino , Pessoa de Meia-Idade , Doenças Periodontais/patologia , Índice Periodontal , Valores de Referência , Reprodutibilidade dos Testes , Fatores de Risco , Estatísticas não Paramétricas , Fatores de Tempo , Resultado do Tratamento , Adulto Jovem
3.
N Engl J Med ; 381(6): 531-542, 2019 08 08.
Artigo em Inglês | MEDLINE | ID: mdl-31390500

RESUMO

BACKGROUND: Familial chylomicronemia syndrome is a rare genetic disorder that is caused by loss of lipoprotein lipase activity and characterized by chylomicronemia and recurrent episodes of pancreatitis. There are no effective therapies. In an open-label study of three patients with this syndrome, antisense-mediated inhibition of hepatic APOC3 mRNA with volanesorsen led to decreased plasma apolipoprotein C-III and triglyceride levels. METHODS: We conducted a phase 3, double-blind, randomized 52-week trial to evaluate the safety and effectiveness of volanesorsen in 66 patients with familial chylomicronemia syndrome. Patients were randomly assigned, in a 1:1 ratio, to receive volanesorsen or placebo. The primary end point was the percentage change in fasting triglyceride levels from baseline to 3 months. RESULTS: Patients receiving volanesorsen had a decrease in mean plasma apolipoprotein C-III levels from baseline of 25.7 mg per deciliter, corresponding to an 84% decrease at 3 months, whereas patients receiving placebo had an increase in mean plasma apolipoprotein C-III levels from baseline of 1.9 mg per deciliter, corresponding to a 6.1% increase (P<0.001). Patients receiving volanesorsen had a 77% decrease in mean triglyceride levels, corresponding to a mean decrease of 1712 mg per deciliter (19.3 mmol per liter) (95% confidence interval [CI], 1330 to 2094 mg per deciliter [15.0 to 23.6 mmol per liter]), whereas patients receiving placebo had an 18% increase in mean triglyceride levels, corresponding to an increase of 92.0 mg per deciliter (1.0 mmol per liter) (95% CI, -301.0 to 486 mg per deciliter [-3.4 to 5.5 mmol per liter]) (P<0.001). At 3 months, 77% of the patients in the volanesorsen group, as compared with 10% of patients in the placebo group, had triglyceride levels of less than 750 mg per deciliter (8.5 mmol per liter). A total of 20 of 33 patients who received volanesorsen had injection-site reactions, whereas none of the patients who received placebo had such reactions. No patients in the placebo group had platelet counts below 100,000 per microliter, whereas 15 of 33 patients in the volanesorsen group had such levels, including 2 who had levels below 25,000 per microliter. No patient had platelet counts below 50,000 per microliter after enhanced platelet-monitoring began. CONCLUSIONS: Volanesorsen lowered triglyceride levels to less than 750 mg per deciliter in 77% of patients with familial chylomicronemia syndrome. Thrombocytopenia and injection-site reactions were common adverse events. (Funded by Ionis Pharmaceuticals and Akcea Therapeutics; APPROACH Clinical Trials.gov number, NCT02211209.).


Assuntos
Apolipoproteína C-III/antagonistas & inibidores , Hiperlipoproteinemia Tipo I/tratamento farmacológico , Oligonucleotídeos/uso terapêutico , RNA Mensageiro/antagonistas & inibidores , Trombocitopenia/induzido quimicamente , Triglicerídeos/sangue , Adulto , Idoso , Análise de Variância , Apolipoproteína C-III/sangue , Apolipoproteína C-III/genética , Método Duplo-Cego , Feminino , Humanos , Hiperlipoproteinemia Tipo I/sangue , Injeções Subcutâneas/efeitos adversos , Masculino , Pessoa de Meia-Idade , Oligonucleotídeos/administração & dosagem , Oligonucleotídeos/efeitos adversos , Contagem de Plaquetas , Adulto Jovem
4.
Rev Col Bras Cir ; 46(3): e20192175, 2019 Aug 05.
Artigo em Português, Inglês | MEDLINE | ID: mdl-31389524

RESUMO

OBJECTIVE: to evaluate the feasibility of abbreviated fasting in oncologic colorectal surgeries, as well as the impact on the surgical outcome of the patients. METHODS: prospective randomized comparative study with patients undergoing elective colorectal cancer surgeries from May to September 2017. Patients were randomized electronically into two groups according to the preoperative fast to be adopted: conventional or abbreviated. RESULTS: of the 33 patients included, 15 followed the abbreviated fasting protocol and 18 the conventional fasting. Both groups had comparable profiles. No patient underwent mechanical preparation of the colon. In 69.7% of the cases, surgery involved low rectal dissection. The procedures were equivalent in relation to intraoperative variables and severe complications. The time to achieve complete oral intake was shorter for abbreviated fasting (10 versus 16 days, p=0.001), as well as the length of inhospital stay (2 versus 4 days, p=0.009). Hospital costs were lower in the abbreviated fasting (331 versus 682 reais, p<0.001). The univariable analysis revealed a correlation between complete oral intake and abbreviated fasting [HR 0.29 (IC95%: 0.12-0.68] and abdominal distension [HR 0.12 (IC95% 0.01-0.94)]. After multivariable analysis, abbreviated fasting presented a lower time for complete oral intake [HR 0.39 (IC95%: 0.16-0.92]. CONCLUSION: the abbreviated preoperative fasting favors the metabolic-nutritional recovery, reducing the time for complete oral intake. The implementation of the abbreviation protocol reduces hospital admission costs.


Assuntos
Neoplasias Colorretais/cirurgia , Procedimentos Cirúrgicos Eletivos/economia , Jejum , Cuidados Pré-Operatórios/métodos , Idoso , Neoplasias Colorretais/economia , Método Duplo-Cego , Feminino , Custos Hospitalares , Humanos , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Período Pós-Operatório , Estudos Prospectivos
5.
JAMA ; 322(7): 622-631, 2019 08 20.
Artigo em Inglês | MEDLINE | ID: mdl-31429896

RESUMO

Importance: Psychotic depression is a severely disabling and potentially lethal disorder. Little is known about the efficacy and tolerability of continuing antipsychotic medication for patients with psychotic depression in remission. Objective: To determine the clinical effects of continuing antipsychotic medication once an episode of psychotic depression has responded to combination treatment with an antidepressant and antipsychotic agent. Design, Setting, and Participants: Thirty-six week randomized clinical trial conducted at 4 academic medical centers. Patients aged 18 years or older had an episode of psychotic depression acutely treated with sertraline plus olanzapine for up to 12 weeks and met criteria for remission of psychosis and remission or near-remission of depressive symptoms for 8 weeks before entering the clinical trial. The study was conducted from November 2011 to June 2017, and the final date of follow-up was June 13, 2017. Interventions: Participants were randomized either to continue olanzapine (n = 64) or switch from olanzapine to placebo (n = 62). All participants continued sertraline. Main Outcomes and Measures: The primary outcome was risk of relapse. Main secondary outcomes were change in weight, waist circumference, lipids, serum glucose, and hemoglobin A1c (HbA1c). Results: Among 126 participants who were randomized (mean [SD] age, 55.3 years [14.9 years]; 78 women [61.9%]), 114 (90.5%) completed the trial. At the time of randomization, the median dosage of sertraline was 150 mg/d (interquartile range [IQR], 150-200 mg/d) and the median dosage of olanzapine was 15 mg/d (IQR, 10-20 mg/d). Thirteen participants (20.3%) randomized to olanzapine and 34 (54.8%) to placebo experienced a relapse (hazard ratio, 0.25; 95% CI, 0.13 to 0.48; P < .001). The effect of olanzapine on the daily rate of anthropometric and metabolic measures significantly differed from placebo for weight (0.13 lb; 95% CI, 0.11 to 0.15), waist circumference (0.009 inches; 95% CI, 0.004 to 0.014), and total cholesterol (0.29 mg/dL; 95% CI, 0.13 to 0.45) but was not significantly different for low-density lipoprotein cholesterol (0.04 mg/dL; 95% CI, -0.01 to 0.10), high-density lipoprotein cholesterol (-0.01 mg/dL; 95% CI, -0.03 to 0.01), triglyceride (-0.153 mg/dL; 95% CI, -0.306 to 0.004), glucose (-0.02 mg/dL; 95% CI, -0.12 to 0.08), or HbA1c levels (-0.0002 mg/dL; 95% CI, -0.0021 to 0.0016). Conclusions and Relevance: Among patients with psychotic depression in remission, continuing sertraline plus olanzapine compared with sertraline plus placebo reduced the risk of relapse over 36 weeks. This benefit needs to be balanced against potential adverse effects of olanzapine, including weight gain. Trial Registration: ClinicalTrials.gov Identifier: NCT01427608.


Assuntos
Transtornos Psicóticos Afetivos/tratamento farmacológico , Antipsicóticos/uso terapêutico , Transtorno Depressivo Maior/tratamento farmacológico , Olanzapina/uso terapêutico , Adolescente , Adulto , Idoso , Antidepressivos/uso terapêutico , Antipsicóticos/efeitos adversos , Transtorno Depressivo Maior/psicologia , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Olanzapina/efeitos adversos , Modelos de Riscos Proporcionais , Prevenção Secundária , Sertralina/uso terapêutico , Adulto Jovem
6.
Zhonghua Nei Ke Za Zhi ; 58(8): 560-565, 2019 Aug 01.
Artigo em Chinês | MEDLINE | ID: mdl-31365976

RESUMO

Objectives: To evaluate the effectiveness and safety of peramivir trihydrate in patients with influenza. Methods: This was a randomized, double-blind, double-dummy, placebo and positive control, multicenter clinical trial, comparing peramivir trihydrate with oseltamivir and placebo. The inclusive criteria were 15-70 years old, onset within 48 h, positive rapid influenza antigen test, and febrile (>38℃) accompanied with at least two associated symptoms. The severe cases complicated with chronic pulmonary and cardiac diseases, malignancies, organ transplantation, hemodialysis, uncontrolled diabetes, immunocompromised status, pregnancy and coexistence of bacterium infections were excluded. All patients were randomized 2∶2∶1 to receive peramivir, oseltamivir and placebo respectively. The primary endpoint was the disease duration, the secondary endpoints included time to normal axillary temperature and normal living activities, viral response, and adverse effects. Results: Following informed consent, 133 patients were included in this study. Four patients were exclude due to missing medical records, not fitting inclusion or exclusion criteria and poor compliance. A total of 129 patients were finally analyzed, including 49 cases, 54 cases and 26 cases in peramivir group, oseltamivir group and placebo group. The median disease duration were 96 (76, 120) hours, 105 (90,124) hours, and 124 (104, 172) hours in three groups respectively (P>0.05) . The time to normal axillary temperature, normal living activities and viral response were not significantly different in three groups (P>0.05) . Conclusion: The value of antiviral therapy in patients with mild influenza needs to be further determined.


Assuntos
Antivirais/uso terapêutico , Ciclopentanos/uso terapêutico , Guanidinas/uso terapêutico , Influenza Humana/tratamento farmacológico , Oseltamivir/uso terapêutico , Adolescente , Adulto , Idoso , Método Duplo-Cego , Humanos , Influenza Humana/diagnóstico , Pessoa de Meia-Idade , Resultado do Tratamento , Adulto Jovem
7.
Medicine (Baltimore) ; 98(31): e16539, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31374015

RESUMO

BACKGROUND: Chronic stable angina (CSA) is a cardiovascular disease with high prevalence. At present, drug treatment is still the main measure of stable angina pectoris. Traditional Chinese medicine has a long history in the treatment of CSA. Qi stagnation and Blood stasis syndrome is a common syndrome of CSA. Xinnaoning (XNN) capsule is considered as an effective adjuvant treatment for CSA with the efficacy of promoting qi and blood circulation but lack of high-quality clinical evidence. The purpose of this study is to evaluate the efficacy and safety of XNN capsule compared with placebo by clinical trial. METHODS: This multicenter, randomized, double-blind, placebo-controlled trial will be conducted with a total of 240 participants diagnosed with chronic stable angina (qi stagnation and blood stasis syndrome). The participants will be randomized (1:1) into groups receiving either XNN or placebo for 12 weeks. After a 2-week run-in period, they will receive either XNN or placebo (3 pills, 3 times daily) for 12 weeks on the basis of conventional therapy. The primary outcomes include changes in the integral scores of angina symptoms. The secondary outcome measures include changes in the total score of traditional Chinese medicine syndrome, severity grading of angina pectoris, the number of angina pectoris per week, nitroglycerin dosage, score of seattle angina scale, serum homocysteine, incidence of cardiovascular events. Safety outcomes will also be assessed. Adverse events will be monitored throughout the trial. RESULTS: This study will investigate whether XNN capsule can alleviate clinical symptoms, and improve quality of life of patients with chronic stable angina (qi stagnation and blood stasis syndrome). The results of this study will provide clinical evidence for the application of XNN capsule in the treatment of chronic stable angina. TRIAL REGISTRATION: ClinicalTrials.gov: NCT03914131.


Assuntos
Angina Estável/terapia , Adulto , Idoso , Análise de Variância , Distribuição de Qui-Quadrado , Angiografia Coronária/métodos , Método Duplo-Cego , Feminino , Homocisteína/análise , Homocisteína/sangue , Humanos , Masculino , Medicina Tradicional Chinesa/métodos , Medicina Tradicional Chinesa/normas , Pessoa de Meia-Idade , Placebos , Inquéritos e Questionários , Resultado do Tratamento
11.
Bone Joint J ; 101-B(8): 929-940, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31362561

RESUMO

AIMS: Patient-specific instrumentation of total knee arthroplasty (TKA) is a technique permitting the targeting of individual kinematic alignment, but deviation from a neutral mechanical axis may have implications on implant fixation and therefore survivorship. The primary objective of this randomized controlled study was to compare the fixation of tibial components implanted with patient-specific instrumentation targeting kinematic alignment (KA+PSI) versus components placed using computer-assisted surgery targeting neutral mechanical alignment (MA+CAS). Tibial component migration measured by radiostereometric analysis was the primary outcome measure (compared longitudinally between groups and to published acceptable thresholds). Secondary outcome measures were inducible displacement after one year and patient-reported outcome measures (PROMS) over two years. The secondary objective was to assess the relationship between alignment and both tibial component migration and inducible displacement. PATIENTS AND METHODS: A total of 47 patients due to undergo TKA were randomized to KA+PSI (n = 24) or MA+CAS (n = 23). In the KA+PSI group, there were 16 female and eight male patients with a mean age of 64 years (sd 8). In the MA+CAS group, there were 17 female and six male patients with a mean age of 63 years (sd 7). Surgery was performed using cemented, cruciate-retaining Triathlon total knees with patellar resurfacing, and patients were followed up for two years. The effect of alignment on tibial component migration and inducible displacement was analyzed irrespective of study group. RESULTS: There was no difference over two years in longitudinal migration of the tibial component between the KA+PSI and MA+CAS groups (reaching median maximum total point motion migration at two years of 0.40 mm for the KA+PSI group and 0.37 mm for the MA+CAS group, p = 0.82; p = 0.68 adjusted for age, sex, and body mass index (BMI) for all follow-ups). Both groups had mean migrations below acceptable thresholds. There was no difference in inducible displacement (p = 0.34) or PROMS (p = 0.61 for the Oxford Knee Score) between groups. There was no correlation between alignment and tibial component migration or alignment and inducible displacement. These findings support non-neutral alignment as a viable option with this component, with no evidence that it compromises fixation. CONCLUSION: Kinematic alignment using patient-specific instrumentation in TKA was associated with acceptable tibial component migration, indicating stable fixation. These results are supportive of future investigations of kinematic alignment. Cite this article: Bone Joint J 2019;101-B:929-940.


Assuntos
Artroplastia do Joelho/métodos , Prótese do Joelho , Osteoartrite do Joelho/cirurgia , Falha de Prótese/etiologia , Cirurgia Assistida por Computador , Idoso , Artroplastia do Joelho/instrumentação , Fenômenos Biomecânicos , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
12.
Medicine (Baltimore) ; 98(31): e16674, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31374046

RESUMO

BACKGROUND AND OBJECTIVE: A recent striking advance in the treatment of depression has been the finding of rapid antidepressant effects in over 70% of patients with treatment-resistant depression (TRD) using ketamine. However, the potential risk of addiction may limit its clinical use. Recent research revealed that blockade of N-methyl-D-aspartate receptor (NMDAR) dependent bursting activity in the lateral habenula (LHb) could mediate the fast antidepressant effects of ketamine. Further, LHb bursting plays an important role in the pathophysiology of depression that requires both NMDARs and low-voltage-sensitive T-type calcium channels (T-VSCCs). Ethosuximide, which is used to treat absence seizures, is a T-VSCCs inhibitor, may be a novel drug candidate for depression. The objective of this clinical trial is to investigate the efficacy and safety of ethosuximide in patients with TRD. DESIGN: The study is a single center, randomized, double-blind, placebo-controlled, parallel-group, two-stage clinical trial. Forty patients with TRD will be randomly assigned to Group A (treatment group) or Group B (control group). In the first stage ethosuximide or placebo will be given for 2 weeks. In the second stage, escitalopram (or another antidepressant if escitalopram has been used before) will be given for the next 4 weeks for all trial patients to ensure effective treatment. The primary outcome measure is the Montgomery-Åsberg Depression Rating Scale (MADRS) scores. Secondary outcome measures include the Quick Inventory of Depressive Symptomatology-Self Report score, Hamilton Anxiety Rating Scale scores, individual scores of MADRS, and Young Mania Rating Scale scores. All these scales are measured at baseline and at each treatment visit. Two-way repeated measures analysis of variance is used to analyze the study outcomes. DISCUSSION: A statistical analysis plan is employed to enhance the transparency of the clinical trial and reduce the risks of outcome reporting bias and data-driven results.


Assuntos
Antidepressivos/uso terapêutico , Transtorno Depressivo Resistente a Tratamento/tratamento farmacológico , Etossuximida/uso terapêutico , Método Duplo-Cego , Etossuximida/farmacologia , Humanos , Escalas de Graduação Psiquiátrica , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento
13.
Medicine (Baltimore) ; 98(31): e16680, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31374049

RESUMO

BACKGROUND: Colorectal Adenomatous Polyp (CAP) was one precursor of colorectal cancer (CRC) and having a high chance of developing into CRC. There was a lack of conclusive chemoprevention evidences to prevention new CAP occurrence in post-polypectomy. Xiaoai Jiedu Decoction, Chinese National Medical Professor (Zhou Zhongying)'s experience formula, has been used to treat new CAP occurrence in post-polypectomy from the 20th century in China. However, clinical research of Xiaoai Jiedu Decoction in the treatment of CAP recurrence was lack. We design this study to evaluate the efficacy and safety of Xiaoai Jiedu Decoction in the treatment of new CAP occurrence in post-polypectomy on colonoscopy. METHODS/DESIGN: A randomized, controlled, blind and multicenter trial to evaluate the efficacy and safety of Xiaoai Jiedu Decoction is proposed. CAP patients (after complete polypectomy under colonoscopy) will be randomly assigned into Xiaoai Jiedu Decoction group and Xiaoai Jiedu Decoction mimetic agent group. Patients will receive 6-course treatments and a 2-year follow-up. Follow-up colonoscopy will be anticipated to perform in 1 and 2 years after the baseline examinations. The primary outcome measure is the new CAP occurrence in 1 and 2 years. The secondary outcome measure is the occurrence of advanced adenoma in 1 and 2 years. DISCUSSION: This study will provide objective evidences to evaluate the efficacy and safety of Xiaoai Jiedu Decoction as an adjuvant treatment for new CAP occurrence in post-polypectomy. TRIAL REGISTRATION: NCT03616444.


Assuntos
Pólipos Adenomatosos/prevenção & controle , Neoplasias Colorretais/prevenção & controle , Medicamentos de Ervas Chinesas/uso terapêutico , Medicina Tradicional Chinesa , Lesões Pré-Cancerosas/prevenção & controle , Método Duplo-Cego , Humanos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Controlados Aleatórios como Assunto
14.
Medicine (Baltimore) ; 98(31): e16710, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31374063

RESUMO

BACKGROUND: Dry eye disease (DED) is a chronic ocular surface disease that affects hundreds of millions of people worldwide. Although 0.05% cyclosporine ophthalmic emulsion (CsA OE) has long been prescribed in the U.S. for the treatment of DED, it is not commercially available in China. Our study aims to compare the efficacy and safety profile of 0.05% CsA OE versus vehicle in Chinese patients with moderate to severe DED. METHODS: This was a multicenter, randomized, double-masked, 2-parallel-arm, 3-month phase III study. Patients with moderate to severe DED were randomized to receive twice-daily 0.05% CsA OE or its vehicle, along with unpreserved hypromellose eye drops 3 times per day. Patients were followed up at day 7, 28, 56, and 84, as well as 2 weeks after the medications were discontinued for safety assessment. RESULTS: A total of 240 patients were randomized. The overall effective rate (OER) and efficacy index were significantly better in the CsA OE than vehicle group at all follow up times (all P < .05), and the OER of CsA OE and vehicle group at month 3 was 70.6% and 27.8%, respectively (P < .001) (primary endpoint). The patients in CsA OE group displayed a significant improvement in dry eye symptoms from day 28 and ocular surface test results from day 7 (all P < .05). The ocular surface disease index scores of 0.05% CsA OE treated patients were significantly better than those treated with vehicle control at day 56 and 84 (P = .0061 and <.001, respectively). Drug related adverse events (AEs) were recorded in 6(5%) and 3(2.5%) patients in the CsA OE and vehicle groups respectively (P = .4061) with ocular pain as the most frequently reported AEs, and it was mostly mild to moderate. There were no detrimental effects on visual acuity, intraocular pressure, or vital signs. CONCLUSIONS: Twice-daily instillation of 0.05% CsA OE was effective and well tolerated for the treatment of moderate to severe DED in Chinese population during the 3 months of the study.


Assuntos
Ciclosporina/administração & dosagem , Síndromes do Olho Seco/tratamento farmacológico , Soluções Oftálmicas/administração & dosagem , Adulto , China , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Resultado do Tratamento
15.
Rev Assoc Med Bras (1992) ; 65(7): 982-987, 2019 Aug 05.
Artigo em Inglês | MEDLINE | ID: mdl-31389509

RESUMO

OBJECTIVE: A clinical, placebo-controlled, randomized, double-blind trial with two parallel groups. OBJECTIVE: to evaluate the efficacy of ropivacaine injection in each belly of the anterior and middle scalene muscles, guided by ultrasonography, in the treatment of Nonspecific Thoracic Outlet Syndrome (TOS) compared to cutaneous pressure. METHODS: 38 patients, 19 in the control group (skin pressure in each belly of the anterior and middle scalene muscles) and 19 in the intervention group (ropivacaine). Subjects with a diagnosis of Nonspecific Thoracic Outlet Syndrome, pain in upper limbs and/or neck, with no radiculopathy or neurological involvement of the limb affected due to compressive or encephalic root causes were included. The primary endpoint was functionality, evaluated by the Disabilities of the Arm, Shoulder, and Hand - DASH scale validated for use in Brasil. The time of the evaluations were T0 = before the intervention; T1 = immediately after; T2 = 1 week; T3 = 4 weeks; T4 = 12 weeks; for T1, the DASH scale was not applied. RESULTS: Concerning the DASH scale, it is possible to affirm with statistical significance (p> 0.05) that the intervention group presented an improvement of functionality at four weeks, which was maintained by the 12th week. CONCLUSION: In practical terms, we concluded that a 0.375% injection of ropivacaine at doses of 2.5 ml in each belly of the anterior and middle scalene muscles, guided by ultrasonography, in the treatment of Nonspecific Thoracic Outlet Syndrome helps to improve function.


Assuntos
Anestésicos Locais/administração & dosagem , Injeções Intramusculares/métodos , Músculos do Pescoço/efeitos dos fármacos , Ropivacaina/administração & dosagem , Síndrome do Desfiladeiro Torácico/tratamento farmacológico , Ultrassonografia de Intervenção/métodos , Método Duplo-Cego , Feminino , Humanos , Masculino , Fatores de Tempo , Resultado do Tratamento
16.
Medicine (Baltimore) ; 98(33): e16772, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415378

RESUMO

BACKGROUND: Pneumoperitoneum and steep Trendelenburg position during robot-assisted laparoscopic prostatectomy (RALP) can increase intracranial pressure (ICP). Dexmedetomidine, a highly selective alpha-2 adrenergic receptor agonist, can cause cerebral vasoconstriction and decrease cerebral blood flow by stimulating the postsynaptic alpha-2 adrenergic receptors on cerebral blood vessels. However, the effects of dexmedetomidine on ICP are controversial and have not been evaluated during RALP under the establishment of pneumoperitoneum in the steep Trendelenburg position. Therefore, we evaluated the effect of dexmedetomidine on optic nerve sheath diameter (ONSD) as a surrogate for assessing ICP during RALP. METHODS: Patients were randomly allocated to receive dexmedetomidine (n = 63) (loading dose, 1 µg/kg for 10 minutes and continuous infusion, 0.4 µg/kg/hr) or normal saline (n = 63). The ONSD was measured at 10 minutes after induction of anesthesia in the supine position (T1), 30 minutes (T2) and 60 minutes (T3) after establishment of pneumoperitoneum in the steep Trendelenburg position, and at closing the skin in the supine position (T4). Hemodynamic and respiratory variables were measured at every time point. RESULTS: ONSDs at T2, T3, and T4 were significantly smaller in the dexmedetomidine group than in the control group (5.26 ±â€Š0.25 mm vs 5.71 ±â€Š0.26 mm, 5.29 ±â€Š0.24 mm vs 5.81 ±â€Š0.23 mm, and 4.97 ±â€Š0.24 mm vs 5.15 ±â€Š0.28 mm, all P <.001). ONSDs at T2, T3, and T4 were significantly increased compared to T1 in both groups. Hemodynamic and respiratory variables, except heart rate, did not significantly differ between the 2 groups. The bradycardia and atropine administration were not significantly different between the 2 groups. CONCLUSION: Dexmedetomidine attenuates the increase of ONSD during RALP, suggesting that intraoperative dexmedetomidine administration may effectively attenuate the ICP increase during pneumoperitoneum in the Trendelenburg position.


Assuntos
Agonistas de Receptores Adrenérgicos alfa 2/farmacologia , Dexmedetomidina/farmacologia , Hipertensão Intracraniana/prevenção & controle , Pressão Intracraniana/efeitos dos fármacos , Nervo Óptico/efeitos dos fármacos , Agonistas de Receptores Adrenérgicos alfa 2/administração & dosagem , Idoso , Dexmedetomidina/administração & dosagem , Método Duplo-Cego , Decúbito Inclinado com Rebaixamento da Cabeça , Humanos , Período Intraoperatório , Laparoscopia , Masculino , Nervo Óptico/diagnóstico por imagem , Prostatectomia , Procedimentos Cirúrgicos Robóticos , Resultado do Tratamento
17.
Medicine (Baltimore) ; 98(33): e16778, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31415381

RESUMO

BACKGROUND: Tenofovir disoproxil fumarate (TDF) has been widely recommended as a first-line antiviral agent to treat chronic hepatitis B (CHB). Qingzhong and Viread, formulations of TDF commercialized by Jiangsu Chia-tai Tianqing Pharmaceutical Co Ltd and GlaxoSmithKline, respectively, have both been approved by the State Food and Drug Administration, China. This study analyzed the efficacy and safety of these 2 TDF agents in Chinese patients with CHB. METHODS: In this multicenter, randomized, double-blind, double-dummy, noninferiority phase 3 clinical trial (ClinicalTrials.gov identifier: NCT02287857), 330 Chinese patients with CHB [hepatitis B envelope antigen-positive (HBeAg) (+): 232] were randomly assigned to receive Qingzhong (group A: 161 patients) or Viread (group B: 169 patients) 300 mg once daily for 48 weeks. Subsequently, all patients were administered Qingzhong 300 mg once daily from week 49 to week 240. The primary end point was the degree of decline of plasma hepatitis B virus (HBV) DNA levels at week 48 and the secondary endpoints were viral suppression, normalization of alanine aminotransferase (ALT) levels, hepatitis B surface antigen (HBsAg)/HBeAg loss or seroconversion, and virological breakthrough. RESULTS: Among patients with CHB who were HBeAg (+), the mean HBV DNA titer decreased similarly between the groups at week 48. The percentages of patients who achieved undetectable HBV DNA were similar between the groups (85.11% and 82.35% in groups A and B, respectively) and similar losses of HBeAg and HBeAg seroconversion rates were achieved. Moreover, for patients with CHB who were HBeAg (-), reductions in HBV DNA were similar. Among all patients with CHB, the rates of normalization of ALT and the loss of HBsAg were similar. The overall incidence of adverse events was comparable between the groups. CONCLUSION: In conclusion, the 48-week administration of Qingzhong showed noninferior efficacy and safety profiles compared to Viread in Chinese patients with CHB.


Assuntos
Antivirais/uso terapêutico , Hepatite B Crônica/tratamento farmacológico , Tenofovir/uso terapêutico , Adolescente , Adulto , Idoso , Antivirais/administração & dosagem , China , Método Duplo-Cego , Esquema de Medicação , Composição de Medicamentos , Feminino , Antígenos E da Hepatite B/sangue , Hepatite B Crônica/sangue , Humanos , Masculino , Pessoa de Meia-Idade , Tenofovir/administração & dosagem , Resultado do Tratamento , Adulto Jovem
18.
Medicine (Baltimore) ; 98(34): e16952, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31441893

RESUMO

BACKGROUND: Botulinum toxin type A (BoNTA) is known to prevent fibroblast proliferation and expression of transforming growth factor beta 1 (TGF-ß1). It also induces temporary muscle paralysis and decreases tension vectors. Fibroblasts induce scar contracture and hypertrophy by producing collagen fibers in wound healing processes. The aim of this study is to identify the effect of BoNTA on the scar formation. METHODS: Forty-five patients with forehead laceration were enrolled in this study and randomized into 2 groups with or without injection of BoNTA. When the patients presented to the clinic to remove the stitches, BoNTA was injected to the BoNTA group with 24 patients and saline was injected to the control group with 21 patients. The BoNTA was injected on dermal layer with 5 IU/cm. After that, follow-up was done in 1, 3, and 6 months. The scars were analyzed with the patient and observer scar assessment scale, Stony Brook scar evaluation scales (SBSESs), and visual analog scale (VAS) and analyzed with independent T-test, along with clinical photographs, cutometer, and biopsies. RESULTS: In all scar scales, the scores changed into favorable direction in both groups and the changes were larger in BoNTA group compared with the control group. On SBSES and VAS, better improvements on BoNTA group showed statistical significance. Skin biopsy showed less collagen deposition on dermal layer in BoNTA group. CONCLUSION: Improvement of aesthetic, functional, and emotional aspect of the scar formation in the groups treated with BoNTA was illustrated. The application of BoNTA may be expanded to prevent hypertrophic scar after trauma, burns, or operations.


Assuntos
Toxinas Botulínicas Tipo A/administração & dosagem , Cicatriz Hipertrófica/prevenção & controle , Testa/lesões , Lacerações/terapia , Fármacos Neuromusculares/administração & dosagem , Adulto , Toxinas Botulínicas Tipo A/farmacologia , Método Duplo-Cego , Feminino , Fibroblastos/efeitos dos fármacos , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/farmacologia , Estudos Prospectivos , Técnicas de Sutura , Resultado do Tratamento , Escala Visual Analógica , Adulto Jovem
19.
Medicine (Baltimore) ; 98(34): e16956, 2019 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-31441895

RESUMO

BACKGROUND: Knee osteoarthritis (KOA) is a common disease in elderly individuals. Many medications for KOA have the potential to cause side effects. We used Juglandis semen complex extract (JCE) consisting of 4 herbs derived from Cheong-A-Won, which has been commonly used for KOA treatment. In this study, we will evaluate whether JCE improves symptoms in patients with KOA and will identify the changes in the inflammation factor. METHODS: This study will be a single-center, randomized, double-blind, and placebo-controlled trial. Three groups, JCE 1000 mg, 2000 mg, and placebo, will be randomly allocated. Total duration of the clinical trial will be 12 to 14 weeks. Study participants will be followed up every 6 weeks and the effect and safety will be assessed at the 2, 3, and 4 visit. All participants were asked to maintain a dosage schedule for this protocol. The primary outcomes will be measured using Korean Western Ontario and McMaster Universities Questionnaire and the secondary outcomes will include pain Visual analog scale score, EuroQol Five Dimensions questionnaire, Patient Global Impression of Change, and the changes in the laboratory test parameters of inflammation. Repeated-measure analysis will be used to measure primary efficacy based on full analysis set. DISCUSSION: This study has limited inclusion and exclusion criteria and a well-controlled intervention, and it will be the first randomized controlled trial to assess the efficacy and safety of JCE in patients with KOA. This study provides insights into the mechanisms that explain the therapeutic effects of JCE in KOA and will lay the groundwork for further studies.


Assuntos
Osteoartrite do Joelho/tratamento farmacológico , Extratos Vegetais/administração & dosagem , Método Duplo-Cego , Humanos , Medicina Tradicional Coreana/métodos , Projetos Piloto , Ensaios Clínicos Controlados Aleatórios como Assunto , República da Coreia
20.
Pharm Res ; 36(10): 146, 2019 Aug 08.
Artigo em Inglês | MEDLINE | ID: mdl-31396727

RESUMO

PURPOSE: CTB-001, a recently developed generic version of bivalirudin, an FDA-approved anticoagulant used for prophylaxis and treatment of cardiovascular diseases, has shown good efficacy and safety in clinical trials. We characterized the pharmacokinetics (PK) and pharmacodynamics (PD) of CTB-001 by modeling and simulation analysis. METHODS: PK/PD data were collected from a randomized, double-blind, placebo-controlled, single-dose, dose-escalation phase 1 study conducted in 24 healthy Korean male subjects. PK/PD analysis was conducted sequentially by nonlinear mixed-effects modeling implemented in NONMEM®. Monte-Carlo simulations were conducted for PK, activated partial thromboplastin time (aPTT), prothrombin time (PT), and thrombin time (TT). RESULTS: The CTB-101 PK was best described by a three-compartment linear model with a saturable binding peripheral compartment. All PD endpoints showed dose-response relationship, and their changes over time paralleled those of CTB-101 concentrations. A simple maximum effect model best described the aPTT, PT in INR, PT in seconds, and TT, whereas an inhibitory simple maximum effect model best described PT in percentages. The maximum duration of effect of CTB-001 on aPTT prolongation was 52.1 s. CONCLUSIONS: The modeling and simulation analysis well-characterized the PK and PD of CTB-001 in healthy Koreans, which will be valuable for identifying optimal dosing regimens of CBT-001.


Assuntos
Anticoagulantes/farmacologia , Hirudinas/farmacologia , Modelos Biológicos , Fragmentos de Peptídeos/farmacologia , Adulto , Anticoagulantes/farmacocinética , Simulação por Computador , Relação Dose-Resposta a Droga , Método Duplo-Cego , Medicamentos Genéricos , Hirudinas/farmacocinética , Humanos , Masculino , Método de Monte Carlo , Fragmentos de Peptídeos/farmacocinética , Tempo de Protrombina , Proteínas Recombinantes/farmacocinética , Proteínas Recombinantes/farmacologia , Resultado do Tratamento , Adulto Jovem
SELEÇÃO DE REFERÊNCIAS
DETALHE DA PESQUISA