Your browser doesn't support javascript.
loading
Mostrar: 20 | 50 | 100
Resultados 1 - 20 de 159.904
Filtrar
1.
Rev Lat Am Enfermagem ; 28: e3369, 2020.
Artículo en Inglés, Portugués, Español | MEDLINE | ID: mdl-33053078

RESUMEN

OBJECTIVE: to evaluate the effectiveness of ginge (Zingiber officinale) in reducing blood sugar and lipid levels in people with type 2 diabetes. METHOD: a randomized and double-blind clinical trial conducted with people with type 2 diabetes in primary care facilities. The study included individuals aged between 20 and 80 years old, using oral antidiabetic drugs and with HbA1c levels between 6.0% and 10%. The participants were paired 1:1, allocated in two distinct groups, and randomized in blocks, based on their HbA1c levels. In the experimental group, the participants used 1.2g of ginger and, in the control group, 1.2g of placebo, daily for 90 days. The primary outcome was a reduction in fasting blood sugar and HbA1c, and the secondary outcome was a reduction in lipids and HOMA-IR. 103 individuals completed the study, 47 in the experimental group and 56 in the control group. RESULTS: the participants in the experimental group showed a greater reduction in the blood glucose and total cholesterol values compared to the control group. CONCLUSION: the use of ginger can help in the treatment of people with diabetes, and data support the inclusion of this herbal drug in the clinical practice of nurses. RBR-2rt2wy.


Asunto(s)
Diabetes Mellitus Tipo 2 , Jengibre , Adulto , Anciano , Anciano de 80 o más Años , Glucemia , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Método Doble Ciego , Humanos , Hipoglucemiantes , Persona de Mediana Edad , Adulto Joven
5.
J Contemp Dent Pract ; 21(6): 609-614, 2020 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-33025927

RESUMEN

AIM: This clinical study aimed to evaluate the efficacy of a toothpaste containing a proprietary REFIX technology (Regenerador + Sensitive DentalClean, Rabbit Corp) against dentin hypersensitivity. MATERIALS AND METHODS: Fifty-three volunteers who fulfilled the inclusion criteria and signed the consent form were included. They were examined for dentin hypersensitivity. The participants received a 1-second blast of air, and the tooth sensitivity, from 0 to 10, was immediately evaluated using a visual analog scale (VAS). Then, the participants brushed their teeth with the multifunctional toothpaste, and dentin hypersensitivity was tested a second time using the same scale. The participants continued to use the toothpaste three times a day for 1 week, after which dentin hypersensitivity was recorded for the third time. Data were statistically analyzed using analysis of variance (ANOVA) and Tukey's test (α = 0.05). RESULTS: The mean patient age was 40 years, and 70% of the 53 subjects were female. There was a significant reduction in dentin hypersensitivity immediately after using the toothpaste and after 1 week. The baseline mean patient-reported pain score was severe (6.5 ± 2.4). Immediately after the first use of the toothpaste, the mean reported pain significantly decreased to mild pain (2.5 ± 2.5) (p < 0.05). After 1 week of consistent use of the toothpaste, the pain score reduced significantly (0.7 ± 1.2) (p < 0.05), and most participants reported no pain, demonstrating the effectiveness of the REFIX technology against dentin hypersensitivity. CONCLUSION: This clinical trial shows that the use of the phosphate-based desensitizing toothpaste containing REFIX technology significantly reduces dentin hypersensitivity after 1 week of consistent use. CLINICAL SIGNIFICANCE: The absence of pain, a desired clinical condition in patients with dentin hypersensitivity, was reached with the use of desensitizing toothpaste containing REFIX technology after 1 week of use. Such condition positively impacts quality of life, providing a healthier daily routine for patients.


Asunto(s)
Desensibilizantes Dentinarios , Sensibilidad de la Dentina , Pastas de Dientes , Arginina , Carbonato de Calcio , Desensibilizantes Dentinarios/uso terapéutico , Sensibilidad de la Dentina/tratamiento farmacológico , Sensibilidad de la Dentina/prevención & control , Método Doble Ciego , Femenino , Fluoruros , Humanos , Calidad de Vida , Fluoruro de Sodio , Cepillado Dental , Pastas de Dientes/uso terapéutico , Resultado del Tratamiento
6.
Medicine (Baltimore) ; 99(41): e22318, 2020 Oct 09.
Artículo en Inglés | MEDLINE | ID: mdl-33031270

RESUMEN

INTRODUCTION: The market for dietary supplements in the sports sector has been growing rapidly for several years, though there is still lacking evidence regarding their claimed benefits. One group is that of nitric oxide increasing supplements, so-called "NO-boosters," which are claimed to improve the supply of oxygen and nutrients to the muscle by enhancing vasodilation.The aim of this study was to investigate 3 of these supplements in healthy male athletes for their muscle perfusion-enhancing potential using contrast-enhanced ultrasound (CEUS). METHODS: This placebo-controlled, double-blind, randomized cross-over trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Three commercial NO enhancing products including 300 mg of the specific green tea extract VASO6 and a combination of 8 g L-citrulline malate and 3 g L-arginine hydrochloride will be examined for their potential to increase muscular perfusion in 30-male athletes between 18 and 40 years and will be compared with a placebo. On each of the 3 appointments CEUS of the dominant biceps muscle will be performed at rest and after a standardized resistance training. Every athlete receives each of the 3 supplements once after a wash-out period of at least 1 week. Perfusion will be quantified via VueBox quantification software. The results of CEUS perfusion measurements will be compared intra- and interindividually and correlated with clinical parameters. DISCUSSION: The results of this study may help to establish CEUS as a suitable imaging modality for the evaluation of potentially vasodilatory drugs in the field of sports. Other supplements could also be evaluated in this way to verify the content of their advertising claims. TRIAL REGISTRATION: German Clinical Trials Register (DRKS), ID: DRKS00016972, registered on 25.03.2019.


Asunto(s)
Arginina/administración & dosificación , Citrulina/administración & dosificación , Músculo Esquelético/irrigación sanguínea , Músculo Esquelético/diagnóstico por imagen , , Ultrasonografía/métodos , Adolescente , Adulto , Medios de Contraste , Estudios Cruzados , Suplementos Dietéticos , Método Doble Ciego , Humanos , Masculino , Ensayos Clínicos Controlados Aleatorios como Asunto , Vasodilatación
7.
Lancet Oncol ; 21(10): 1283-1295, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-33002436

RESUMEN

BACKGROUND: HER2-positive metastatic breast cancer is incurable and new treatments are needed. Addition of atezolizumab to trastuzumab emtansine might potentiate anticancer immunity and enhance the HER2-targeted cytotoxic activity of trastuzumab emtansine. We aimed to test this combination in HER2-positive advanced breast cancer that had progressed after previous treatment with trastuzumab and a taxane. METHODS: The KATE2 study is a randomised, double-blind, placebo-controlled, phase 2 study at 68 centres from nine countries across Asia, Australia, North America, and western Europe. Eligible patients were adults (aged ≥18 years) with an Eastern Cooperative Oncology Group performance status of 0 or 1 and centrally confirmed, measurable, HER2-positive advanced breast cancer previously treated with trastuzumab and a taxane. Patients were randomly assigned (2:1) either trastuzumab emtansine (3·6 mg/kg of bodyweight) plus atezolizumab (1200 mg) or trastuzumab emtansine plus placebo; all study drugs were administered by intravenous infusion every 3 weeks. Randomisation was done via an interactive voice and web response system using a permuted block scheme (block size of six) and was stratified by PD-L1 status, world region, and liver metastases. Patients, investigators, and study team members were masked to treatment allocation. The primary endpoint was investigator-assessed progression-free survival in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT02924883, and the study has been completed. FINDINGS: Between Sept 26, 2016, and Aug 7, 2017, 330 patients were screened for the study, of whom 202 were randomly allocated either atezolizumab (n=133) or placebo (n=69). At the recommendation of the independent data monitoring committee, treatment assignment was unmasked on Dec 11, 2017, due to futility and the numerically higher frequency of adverse events among patients assigned atezolizumab. This date was set as the clinical cutoff for the primary analysis. Median follow-up was 8·5 months (IQR 6·1-11·5) for patients assigned atezolizumab and 8·4 months (5·3-11·1) for those assigned placebo. Median progression-free survival was 8·2 months (95% CI 5·8-10·7) for patients assigned atezolizumab versus 6·8 months (4·0-11·1) for those assigned placebo (stratified hazard ratio 0·82, 95% CI 0·55-1·23; p=0·33). The most common grade 3 or worse adverse events were thrombocytopenia (17 [13%] among 132 patients who received atezolizumab vs three [4%] among 68 who received placebo), increased aspartate aminotransferase (11 [8%] vs two [3%]), anaemia (seven [5%] vs 0), neutropenia (six [5%] vs three [4%]), and increased alanine aminotransferase (six [5%] vs two [3%]). Serious adverse events occurred in 43 (33%) of 132 patients who received atezolizumab and 13 (19%) of 68 patients who received placebo. One patient who received atezolizumab died due to a treatment-related adverse event (haemophagocytic syndrome). INTERPRETATION: Addition of atezolizumab to trastuzumab emtansine did not show a clinically meaningful improvement in progression-free survival and was associated with more adverse events. Further study of trastuzumab emtansine plus atezolizumab is warranted in a subpopulation of patients with PD-L1-positive, HER2-positive advanced breast cancer. FUNDING: F Hoffman-La Roche.


Asunto(s)
Ado-Trastuzumab Emtansina/uso terapéutico , Anticuerpos Monoclonales Humanizados/uso terapéutico , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Receptor ErbB-2/metabolismo , Antineoplásicos Inmunológicos/uso terapéutico , Neoplasias de la Mama/patología , Método Doble Ciego , Resistencia a Antineoplásicos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Receptor de Muerte Celular Programada 1/metabolismo , Análisis de Supervivencia , Resultado del Tratamiento
15.
Zhongguo Zhong Yao Za Zhi ; 45(15): 3497-3504, 2020 Aug.
Artículo en Chino | MEDLINE | ID: mdl-32893536

RESUMEN

To evaluate the economy and applicability of Jinye Baidu Granules in the treatment of acute upper respiratory tract infection, a randomized, double-blind, positive drug parallel control clinical trial was conducted in this study. Stratified block random, double-blind and double simulation test was used. The experimental group took Jinye Baidu Granules, 10 g/time, three times a day, and Compound Shuanghua Granules placebo, 6 g/time, four times a day. The control group took Compound Shuanghua Granules, 6 g/time, 4 times a day, and Jinye Baidu Granules placebo, 10 g/time, 3 times a day. The course of treatment was 5 days. The total cost of this study included direct medical cost and indirect medical cost. The incremental cost-effect analysis method was used for evaluation. Treeage Pro software was used to build a pharmaco-economics model and make statistical analysis. Patients from 10 hospitals were divided into experimental group(304 cases) and control group(302 cases). The baseline values of age, sex ratio, clinical symptoms and signs scores, and important physical examination indexes of the two groups were compared. After 5 days of treatment, the cost per capita of the experimental group was(388.06±94.17) Yuan, and that of the control group was(378.47±95.46) Yuan. The cost of direct medical treatment per capita was(271.24±54.11) Yuan for the experimental group and(264.88±112.71) Yuan for the control group. The average cost of indirect medical treatment was(116.82±82.75) Yuan in the experimental group and(113.59±87.77) Yuan in the control group, with no significant difference in the cost of medical treatment per capita, the cost of direct medical treatment per capita and the cost of indirect medical treatment per capita between both groups. The results of incremental cost-effect analysis based on the total score difference in symptoms and signs after 5 days of treatment showed that ICER=23.39 Yuan/score, which was less than the willingness to pay 100 Yuan/score determined through expert interviews. The experimental group had economic advantages over the experimental group, with the economic probability of 53%. Sensitivity analysis supported the robustness of the results. The results of incremental cost-effect analysis based on the total recovery rate of symptoms and signs showed that compared with the experimental group, the control group had lower cost, better effect and absolute economic advantage, with a corresponding probability of 55%. Based on the above results, it is concluded that there is no significant difference in economic outcome between Jinye Baidu Gra-nules and Compound Shuanghua Granules in the treatment of acute upper respiratory tract infection.


Asunto(s)
Infecciones del Sistema Respiratorio , Análisis Costo-Beneficio , Método Doble Ciego , Humanos , Mercadotecnía
16.
Bone Joint J ; 102-B(9): 1151-1157, 2020 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-32862676

RESUMEN

AIMS: Tranexamic acid (TXA) has been shown to reduce blood loss and transfusion requirements in patients undergoing orthopaedic surgery. There remains a lack of prospective evidence for the use of TXA in patients undergoing periacetabular osteotomy (PAO). The purpose of this study was to determine if intravenous (IV) TXA is effective in reducing calculated blood loss and transfusions after PAO. METHODS: This was a single-centre prospective double-blind placebo-controlled randomized trial of 81 patients aged 12 to 45 years undergoing elective PAO by a single surgeon. The intervention group (n = 40) received two doses of IV TXA of a maximum 1 g in each dose; the control group (n = 41) received two doses of 50 ml 0.9% saline IV. The primary outcome was perioperative calculated blood loss. Secondary outcomes included allogenic transfusions and six-week postoperative complications. RESULTS: There were no differences in demographics or intraoperative variables between study groups. The TXA group demonstrated lower mean calculated blood loss (1,265 ml, (SD 321) vs 1,515 ml, (SD 394); p = 0.002) and lower frequency of allogenic transfusion (10%/n = 4 vs 37%/n = 15; p = 0.008). Regression analyses associated TXA use with significant reductions in calculated blood loss (p < 0.001) and transfusion (p = 0.007) after adjusting for age, sex, body mass index, preoperative haemoglobin, cell-saver volume, intraoperative mean arterial blood pressure, and operating time. No patients suffered venous thromboembolic complications. CONCLUSION: In this trial, IV TXA decreased postoperative calculated blood loss by 293 ml and reduced the frequency of allogenic transfusions by 73% (37% vs 10%) following PAO. TXA may be safe and effective for reducing blood loss in patients undergoing PAO. Cite this article: Bone Joint J 2020;102-B(9):1151-1157.


Asunto(s)
Acetábulo/cirugía , Antifibrinolíticos/administración & dosificación , Pérdida de Sangre Quirúrgica/prevención & control , Transfusión Sanguínea/estadística & datos numéricos , Osteotomía , Hemorragia Posoperatoria/prevención & control , Ácido Tranexámico/administración & dosificación , Administración Intravenosa , Adolescente , Adulto , Niño , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Adulto Joven
18.
Vestn Otorinolaringol ; 85(4): 46-50, 2020.
Artículo en Ruso | MEDLINE | ID: mdl-32885637

RESUMEN

OBJECTIVE: To evaluate the efficacy of the drug Frinozol (nasal spray phenylephrinein 0.25% + cetirizine 0.25%) comparison with Rinostop Extra (nasal spray oxymetazoline 0.05%) in relation to nasal symptoms of rhinosinusitis, evaluated on rating scales, when using these drugs intranasally for 7 days in patients with acute viral and post-viral rhinosinusitis of mild (VAS 0-3) and moderate (VAS 3-7). PATIENTS AND METHODS: The randomized open-label study included 60 ambulatory patients (men and women aged 18 to 60 years) with a verified diagnosis of acute rhinosinusitis (ARS) lasting no more than 120 hours. 1 group of patients took Frinozol (nasal spray phenylephrinein 0.25% + cetirizine 0.25%) for 2 sprays per each nostril 3 times a day for 7 days; 2 group - Rinostop Extra (nasal spray oxymetazoline 0.05%) at the same dose and the therapy regimen. We evaluated 3 visits (day 1, day 3, and day 7) with an ENT examination on each of them; questionnaires on the 1st and 3rd visits of nasal symptoms (nasal obstruction, rhinorrhea, hyposmia) on the visual analog scale (VAS) and Clinical Global Impression Scale-CGI. Active anterior rhinomanometry (AAR) was performed on the 1st, 2nd and 3rd visits using the PTS-14P-01 rhinomanometer Rinolan before and 20 minutes after the use of the drugs Frinozol and oxymetazoline 0.05%.


Asunto(s)
Obstrucción Nasal/tratamiento farmacológico , Rinitis/tratamiento farmacológico , Administración Intranasal , Adolescente , Adulto , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Descongestionantes Nasales/uso terapéutico , Oximetazolina/uso terapéutico , Adulto Joven
19.
Medicine (Baltimore) ; 99(38): e22332, 2020 Sep 18.
Artículo en Inglés | MEDLINE | ID: mdl-32957403

RESUMEN

The pelvic organ prolapse (POP) repair systems used in China are imported and expensive. Our aim was to compare the efficacy and safety of a self-developed pelvic floor repair system versus the Avaulta system.This was a multicenter, randomized, parallel-group, noninferiority trial of 132 patients with POP stage ≥II from the Tongji Hospital Affiliated to Tongji University and the General Hospital of Ningxia Medical University enrolled from 02/2014 to 03/2015. The patients were randomized 1:1 to POP repair using the self-developed system or the Avaulta system. Perioperative conditions, POP quantification, pelvic floor impact questionnaire-7, and prolapse quality of life questionnaires, gynecological ultrasound, and postoperative complications were compared. Patients were followed at 1.5, 3, and 6 months.According to the POP quantification scores obtained at 6 months after surgery, the cure rates of the self-developed and Avaulta groups were 98.3% and 100.0%, respectively (P > .999). At 6 months follow-up, the pelvic floor impact questionnaire-7 scores of the self-developed and Avaulta groups were both improved (P < .001 vs baseline), with no between-group difference observed (P = .488). There were no differences between the 2 groups for subjective symptoms of POP (all P > .05). There were no significant differences between the 2 groups regarding complications (all P > .05).The self-developed pelvic reconstruction system is safe and effective for the treatment of POP and improves the patients' quality of life, without difference compared to the Avaulta system.


Asunto(s)
Prolapso de Órgano Pélvico/cirugía , Procedimientos Quirúrgicos Reconstructivos/métodos , Anciano , China , Método Doble Ciego , Femenino , Humanos , Persona de Mediana Edad , Calidad de Vida , Procedimientos Quirúrgicos Reconstructivos/efectos adversos , Mallas Quirúrgicas , Encuestas y Cuestionarios , Resultado del Tratamiento
20.
Lancet ; 396(10255): 909-917, 2020 09 26.
Artículo en Inglés | MEDLINE | ID: mdl-32979978

RESUMEN

BACKGROUND: Chronic pelvic pain affects 2-24% of women worldwide and evidence for medical treatments is scarce. Gabapentin is effective in treating some chronic pain conditions. We aimed to measure the efficacy and safety of gabapentin in women with chronic pelvic pain and no obvious pelvic pathology. METHODS: We performed a multicentre, randomised, double-blind, placebo-controlled randomised trial in 39 UK hospital centres. Eligible participants were women with chronic pelvic pain (with or without dysmenorrhoea or dyspareunia) of at least 3 months duration. Inclusion criteria were 18-50 years of age, use or willingness to use contraception to avoid pregnancy, and no obvious pelvic pathology at laparoscopy, which must have taken place at least 2 weeks before consent but less than 36 months previously. Participants were randomly assigned in a 1:1 ratio to receive gabapentin (titrated to a maximum dose of 2700 mg daily) or matching placebo for 16 weeks. The online randomisation system minimised allocations by presence or absence of dysmenorrhoea, psychological distress, current use of hormonal contraceptives, and hospital centre. The appearance, route, and administration of the assigned intervention were identical in both groups. Patients, clinicians, and research staff were unaware of the trial group assignments throughout the trial. Participants were unmasked once they had provided all outcome data at week 16-17, or sooner if a serious adverse event requiring knowledge of the study drug occurred. The dual primary outcome measures were worst and average pain scores assessed separately on a numerical rating scale in weeks 13-16 after randomisation, in the intention-to-treat population. Self-reported adverse events were assessed according to intention-to-treat principles. This trial is registered with the ISRCTN registry, ISCRTN77451762. FINDINGS: Participants were screened between Nov 30, 2015, and March 6, 2019, and 306 were randomly assigned (153 to gabapentin and 153 to placebo). There were no significant between-group differences in both worst and average numerical rating scale (NRS) pain scores at 13-16 weeks after randomisation. The mean worst NRS pain score was 7·1 (standard deviation [SD] 2·6) in the gabapentin group and 7·4 (SD 2·2) in the placebo group. Mean change from baseline was -1·4 (SD 2·3) in the gabapentin group and -1·2 (SD 2·1) in the placebo group (adjusted mean difference -0·20 [97·5% CI -0·81 to 0·42]; p=0·47). The mean average NRS pain score was 4·3 (SD 2·3) in the gabapentin group and 4·5 (SD 2·2) in the placebo group. Mean change from baseline was -1·1 (SD 2·0) in the gabapentin group and -0·9 (SD 1·8) in the placebo group (adjusted mean difference -0·18 [97·5% CI -0·71 to 0·35]; p=0·45). More women had a serious adverse event in the gabapentin group than in the placebo group (10 [7%] of 153 in the gabapentin group compared with 3 [2%] of 153 in the placebo group; p=0·04). Dizziness, drowsiness, and visual disturbances were more common in the gabapentin group. INTERPRETATION: This study was adequately powered, but treatment with gabapentin did not result in significantly lower pain scores in women with chronic pelvic pain, and was associated with higher rates of side-effects than placebo. Given the increasing reports of abuse and evidence of potential harms associated with gabapentin use, it is important that clinicians consider alternative treatment options to off-label gabapentin for the management of chronic pelvic pain and no obvious pelvic pathology. FUNDING: National Institute for Health Research.


Asunto(s)
Analgésicos/efectos adversos , Analgésicos/uso terapéutico , Dolor Crónico/tratamiento farmacológico , Gabapentina/efectos adversos , Gabapentina/uso terapéutico , Dolor Pélvico/tratamiento farmacológico , Adolescente , Adulto , Método Doble Ciego , Femenino , Humanos , Uso Fuera de lo Indicado , Resultado del Tratamiento , Adulto Joven
SELECCIÓN DE REFERENCIAS
DETALLE DE LA BÚSQUEDA