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1.
J Contemp Dent Pract ; 24(12): 991-997, 2023 Dec 01.
Artículo en Inglés | MEDLINE | ID: mdl-38317398

RESUMEN

AIM: Lesbian, gay, bisexual, transgender, and queer (LGBTQ), female sex workers (FSW), and heterogenders are those unconventional groups of the society who are identified with major unacceptance. Thus, the present study is conducted to assess and compare the oral health status, substance abuse pattern and nicotine dependence using Fagerstrom nicotine dependence scale (FNDP) among the LGBTQ, FSW, and heterogender in a defined location of Gautam Buddha Nagar, district in West U.P. MATERIALS AND METHODS: The present exploratory research included three study groups, the LGBTQ, FSW, and heterogenders (HG) residing in the same habitat. Purposive snowball sampling was conducted for the accessibility of the unapproachable population in the defined geographical location at Gautam Budha Nagar, district in West Uttar Pradesh. The data collection of a total of 177 participants was done using a pre-validated, pretested proforma consisting of three different parts including WHO oral health assessment form for adults, 2013, questionnaire regarding pattern of substance abuse and FNDS. Data were recorded and statistically analyzed using SPSS. RESULTS: Prevalence of oral health disorders including dental caries, periodontal disease as well as oral mucosal lesions were more commonly found among the LGBTQ participants followed by FSW and the differences were found to be statistically significant. In context of altered habits, 100% of the participants in the present study were reported with smokeless tobacco habits whereas majority of the FSW were reported with a habit of smoking tobacco. CONCLUSION: In addition to belonging to ethnic and sexual minority, and having minimal or low education status, and low socioeconomic status, the present study groups are reported to have suboptimal access to quality healthcare and are further reported with high level of substance abuse as well as nicotine dependence. CLINICAL SIGNIFICANCE: The present study is an attempt to provide base line data for further research and provide data to the policy makers so as to increase the healthcare access to the present groups. How to cite this article: Sharma S, Shukla S, Kamate SK, et al. An Exploratory Research Comparing Oral Health, Pattern of Substance Abuse and Nicotine Dependence among LGBT, Female Sex Workers and Heterogenders. J Contemp Dent Pract 2023;24(12):991-997.


Asunto(s)
Caries Dental , Enfermedades de la Boca , Trabajadores Sexuales , Minorías Sexuales y de Género , Trastornos Relacionados con Sustancias , Tabaquismo , Adulto , Humanos , Femenino , Tabaquismo/epidemiología , Salud Bucal , Trastornos Relacionados con Sustancias/epidemiología
2.
Am J Dent ; 34(3): 132-136, 2021 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-34143582

RESUMEN

PURPOSE: To evaluate the effect of cigarette smoke on the surface roughness and color stability of three different soft denture liners. METHODS: Three commonly used commercially available, chair-side, long-term vinyl polysiloxane soft denture liners were used for this study [Sofreliner Tough (S) Soft, Silagum Comfort Soft Relining, and GC Reline Soft\. Thirty disk-shaped specimens of each material, with a diameter of 25 mm and thickness of 2 mm, were fabricated. Initial color and surface roughness readings were recorded. The specimens of each group were randomly divided into two groups (n= 15): the control group (C) and the study group (S). The control group specimens were stored in distilled water and the study group samples were exposed to cigarette smoke in a custom-made smoking chamber. Final color and surface roughness readings were recorded. A single operator performed all the measurements. The differences in color and surface roughness were calculated. Statistical analysis was performed using two-way ANOVA, post-hoc Tukey test, and paired t-test. For all the analyses, a P< 0.05 was regarded as statistically significant. RESULTS: After exposure to smoke, all groups showed a significantly perceptible color change (ΔE > 3.7). The greatest color change was seen in the Silagum group (ΔE= 8.94 ± 0.42), followed by the Sofreliner group (ΔE= 7.85 ± 0.47), with the least change in the GC reline group (ΔE= 3.87 ± 0.46). The mean color change after smoke exposure showed a statistically significant difference among all three study groups. The highest change in surface roughness was observed in the Silagum group (ΔR= 0.687 ± 0.14) followed by the GC reline group (ΔR= 0.265 ± 0.12), with the least change in the Sofreliner group (ΔR= 0.238 ± 0.06). There was a statistically significant difference between each group before and after exposure to smoke. Exposure to cigarette smoke caused significant changes in the color and surface roughness of all three soft denture liners tested in this study. The extent of these changes varied for each material. CLINICAL SIGNIFICANCE: Proper selection of soft denture liners is essential to avoid premature replacement, due to esthetic and hygiene reasons in cigarette smokers.


Asunto(s)
Alineadores Dentales , Color , Ensayo de Materiales , Humo , Fumar , Propiedades de Superficie , Nicotiana
3.
Int J Paediatr Dent ; 31(4): 459-467, 2021 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-32762050

RESUMEN

BACKGROUND: There is a need to validate OHRQoL measures in Hindi to assess the OHRQoL of Indian children. AIM: To develop a Hindi version of the CPQ11-14 and to appraise its validity and reliability for use among North Indian children aged 11-14 years. DESIGN: The cross-culturally adapted Hindi version of CPQ11-14 was achieved by forward translation, backward translation, committee review, and pretesting. A total of 1000 children were recruited from schools, chosen by two-stage cluster random sampling technique. After completing the self-administered questionnaire CPQ11-14 by the child, oral examination was conducted using decayed/missing/filled teeth (DMFT) index, malocclusion index, and Dean's fluorosis index. Test-retest reliability was checked on 100 participants after one week. RESULTS: The floor effect was present in 3.6% individuals, and there was no ceiling effect. Cronbach's alpha for the overall CPQ11-14 scale was 0.963. Intra-class correlation (ICC) coefficient was 0.952 for the entire scale. Cronbach's alpha value for test-retest was 0.918. There was a non-significant change in domain-level and overall median CPQ11-14 scores with an increase in DMFT scores. For malocclusion and fluorosis, there was a statistically significant increase in overall and domain-level scores with increased severity scores. CPQ11-14 and individual domains significantly correlated with both the global questions. CONCLUSION: Hindi version of CPQ11-14 is a reliable scale to assess OHRQoL in Hindi speaking 11- to 14-year-old children.


Asunto(s)
Comparación Transcultural , Salud Bucal , Adolescente , Niño , Humanos , Percepción , Psicometría , Calidad de Vida , Reproducibilidad de los Resultados , Instituciones Académicas , Encuestas y Cuestionarios
4.
Natl Med J India ; 33(5): 302-305, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-34213461

RESUMEN

Background: . Availability of donated organs may save lives of people with end-stage disease. However, multiple barriers exist for obtaining donated organs such as insufficient knowledge and lack of a positive attitude towards organ donation. We assessed the knowledge and attitude regarding organ donation among faculty members of a university in India. Methods: . We did this observational, cross-sectional study from December 2017 to January 2018. A structured, close-ended questionnaire consisting of 20 items was used to assess knowledge, attitude and practices regarding organ donation. Data for 170 participants were analysed using SPSS version 21. Unpaired t-test was used to compare the knowledge and attitude score among different variables. Results: . A statistically significant difference was found between the attitude score of graduate and postgraduate faculty (p=0.003), as well as between graduate and doctoral faculty (p=0.001). We found that 5.3% of participants had already donated organs, 12.9% had pledged to donate and 63.5% of participants had expressed willingness to donate organs. Conclusions: . There is a need to increase the knowledge regarding organ donation as most people have a good attitude towards organ donation, but their knowledge was insufficient and at times inaccurate.


Asunto(s)
Obtención de Tejidos y Órganos , Universidades , Estudios Transversales , Docentes , Conocimientos, Actitudes y Práctica en Salud , Humanos , Percepción , Encuestas y Cuestionarios
5.
Diabetologia ; 62(3): 373-386, 2019 03.
Artículo en Inglés | MEDLINE | ID: mdl-30593607

RESUMEN

AIMS/HYPOTHESIS: Cardiovascular disease is the leading cause of morbidity and mortality in people with type 2 diabetes. MEDI4166 is a proprotein convertase subtilisin/kexin type 9 (PCSK9) antibody and glucagon-like peptide-1 (GLP-1) analogue fusion molecule designed to treat patients with type 2 diabetes who are at risk for cardiovascular disease. In this completed, first-in-human study, we evaluated the safety and efficacy of single or multiple doses of MEDI4166 in participants with type 2 diabetes. METHODS: In this phase 1 study that was conducted across 11 clinics in the USA, eligible adults had type 2 diabetes, a BMI of ≥25 kg/m2 to ≤42 kg/m2, and LDL-cholesterol levels ≥1.81 mmol/l. Participants were randomised 3:1 to receive MEDI4166 or placebo using an interactive voice/web response system, which blinded all participants, investigators and study site personnel to the study drug administered. In 'Part A' of the study, five cohorts of participants received a single s.c. injection of MEDI4166 at 10 mg, 30 mg, 100 mg, 200 mg or 400 mg, or placebo. 'Part B' of the study consisted of three cohorts of participants who received an s.c. dose of MEDI4166 once weekly for 5 weeks at 50 mg, 200 mg or 400 mg, or placebo. The primary endpoint in Part A was safety. The co-primary endpoints in Part B were change in LDL-cholesterol levels and area under the plasma glucose concentration-time curve (AUC0-4h) post-mixed-meal tolerance test (MMTT) from baseline to day 36. The pharmacokinetics and immunogenicity of MEDI4166 were also evaluated. RESULTS: MEDI4166 or placebo was administered to n = 30 or n = 10 participants, respectively, in Part A of the study, and n = 48 or n = 15 participants, respectively, in Part B. The incidence of treatment-emergent adverse events (TEAEs) were comparable between MEDI4166 and placebo in both Part A (60% vs 50%) and Part B (79% vs 87%) of the study. Common TEAEs with MEDI4166 included injection-site reactions, diarrhoea and headache; there was no evidence for dose-related increases in TEAEs. In Part B of the study, at all tested doses of MEDI4166, there was a significant decrease in LDL-cholesterol levels vs placebo (least squares mean [95% CI]; MEDI4166 50 mg, -1.25 [-1.66, -0.84]; MEDI4166 200 mg, -1.97 [-2.26, -1.68]; MEDI4166 400 mg, -1.96 [-2.23, -1.70]; placebo, -0.03 [-0.35, 0.28]; all p < 0.0001). However, there were no clinically relevant reductions or significant differences between MEDI4166 vs placebo in glucose AUC0-4h post-MMTT (least squares mean [95% CI]; MEDI4166 50 mg, -10.86 [-17.69, -4.02]; MEDI4166 200 mg, -4.23 [-8.73, 0.28]; MEDI4166 400 mg, -2.59 [-7.14, 1.95]; placebo, -4.84 [-9.95, 0.28]; all p > 0.05). MEDI4166 was associated with a pharmacokinetic profile supportive of weekly dosing and an overall treatment-induced anti-drug antibody-positive rate of 22%. CONCLUSIONS/INTERPRETATION: MEDI4166 was associated with an acceptable tolerability profile and significantly decreased LDL-cholesterol levels in a dose-dependent manner in overweight or obese patients with type 2 diabetes. However, there were no significant reductions in postprandial glucose levels at any dose of MEDI4166. TRIAL REGISTRATION: ClinicalTrials.gov NCT02524782 FUNDING: This study was funded by MedImmune LLC, Gaithersburg, MD, USA.


Asunto(s)
Anticuerpos/uso terapéutico , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hipoglucemiantes/uso terapéutico , Obesidad/tratamiento farmacológico , Sobrepeso/tratamiento farmacológico , Proproteína Convertasa 9/inmunología , Diabetes Mellitus Tipo 2/complicaciones , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Obesidad/complicaciones , Sobrepeso/complicaciones , Resultado del Tratamiento
6.
Lancet ; 391(10140): 2607-2618, 2018 06 30.
Artículo en Inglés | MEDLINE | ID: mdl-29945727

RESUMEN

BACKGROUND: Weight loss is often key in the management of obese or overweight patients with type 2 diabetes, yet few treatments for diabetes achieve clinically meaningful weight loss. We aimed to assess the efficacy, tolerability, and safety of treatment with MEDI0382, a balanced glucagon-like peptide-1 and glucagon receptor dual agonist developed to provide glycaemic control and weight loss, in patients with type 2 diabetes. METHODS: This randomised, placebo-controlled, double-blind, combined multiple-ascending dose (MAD) and phase 2a study was done at 11 study sites (hospitals and contract research organisations) in Germany. We enrolled patients aged 18-65 years with controlled type 2 diabetes (glycated haemoglobin A1c [HbA1c] levels of 6·5-8·5% at screening) and a body-mass index between 27 kg/m2 and 40 kg/m2. An interactive web-response system was used to randomly assign patients to receive MEDI0382 or placebo. Patients were randomly assigned 2:1 in cohorts A-C and 3:1 in cohorts D and E in the MAD portion of the study, and 1:1 in the phase 2a portion. Randomisation was done by a contracted third-party operator who was not involved in the clinical operations of the study. The pharmacists, participants, and study site personnel involved in treating and assessing participants were masked to treatment allocation. Patients received once-daily subcutaneous injections of the study drug at doses of no more than 300 µg for 22 days or less in the MAD portion of the study, and a dose of no more than 200 µg for 41 days or less in the phase 2a portion. The two primary endpoints of the phase 2a portion were the change from baseline to day 41 in glucose area under the curve at 0-4 h (AUC0-4 h) after a mixed-meal tolerance test (MMTT), assessed in all participants who received at least one dose of study drug and whose measurements were taken at baseline and day 41, and change from baseline in bodyweight, assessed in the intention-to-treat (ITT) population. Safety analyses were done in all participants who received any study drug analysed according to the treatment they received. This study is registered with ClinicalTrials.gov, number NCT02548585. FINDINGS: Patients were recruited between Dec 9, 2015, and Feb 24, 2017. 61 patients were randomly assigned to the MAD part of the study (42 to MEDI0382 and 19 to placebo). 51 patients were randomly assigned to the phase 2a part, of whom 25 were randomly assigned to MEDI0382 and 26 to placebo. In the phase 2a study, three patients in the MEDI0382 group and one in the placebo group discontinued, all as a result of adverse events. 22 (88%) patients in the MEDI0382 group and 25 (96%) in the placebo group received at least one dose and had measurements taken at baseline and day 41. Glucose AUC0-4 h post MMTT decreased significantly with MEDI0382 versus placebo (least squares [LS] mean -32·78% [90% CI -36·98 to -28·57] vs -10·16% [-14·10 to -6·21], and the mean difference was -22·62% [-28·40 to -16·85]; p<0·0001). In the ITT population, reduction in bodyweight was significantly greater with MEDI0382 than with placebo (LS mean -3·84 kg [90% CI -4·55 to -3·12] vs -1·70 kg [-2·40 to -1·01] and mean difference of 2·14 kg [-3·13 to -1·31]; p=0·0008). The proportion of patients who had a treatment-emergent adverse event (TEAE) was similar between treatment groups (22 [88%] of 25 in the MEDI0382 group vs 23 [88%] of 26 in the placebo group); gastrointestinal disorders (18 [72%] vs 13 [40%]) and decreased appetite (five [20%] vs none) occurred more frequently with MEDI0382 than placebo. No participants in the MEDI0382 group had a grade 3 or worse TEAE (vs two [8%] in the placebo group). INTERPRETATION: MEDI0382 has the potential to deliver clinically meaningful reductions in blood glucose and bodyweight in obese or overweight individuals with type 2 diabetes. FUNDING: MedImmune.


Asunto(s)
Diabetes Mellitus Tipo 2/tratamiento farmacológico , Péptido 1 Similar al Glucagón/administración & dosificación , Hipoglucemiantes/administración & dosificación , Obesidad/tratamiento farmacológico , Péptidos/administración & dosificación , Pérdida de Peso/efectos de los fármacos , Adulto , Anciano , Glucemia/efectos de los fármacos , Índice de Masa Corporal , Diabetes Mellitus Tipo 2/complicaciones , Método Doble Ciego , Femenino , Péptido 1 Similar al Glucagón/efectos adversos , Hemoglobina Glucada/efectos de los fármacos , Humanos , Hipoglucemiantes/efectos adversos , Inyecciones Subcutáneas , Masculino , Persona de Mediana Edad , Obesidad/complicaciones , Péptidos/efectos adversos
7.
J Contemp Dent Pract ; 20(3): 318-323, 2019 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-31204324

RESUMEN

AIM: To evaluate the efficacy of irrigation of periodontal pockets by using ozonated water and 0.2% chlorhexidine (CHX) gluconate as adjuncts to scaling and root planing in the management of chronic periodontitis. MATERIALS AND METHODS: For the present study, 20 patients in the age group of 30-60 years, suffering from chronic periodontitis presenting with at least one site with an almost similar pocket depth of 4-6 mm in both the quadrants of maxillary arch was taken. Irrigation was done after 2 weeks of scaling and root planning on the same day with ozonated water and 0.2% chlorhexidine gluconate for two and half minutes. The clinical parameters like gingival index, probing pocket depth (PPD) and clinical attachment level (CAL) were recorded for both the groups at the baseline visit.They were subsequently recalled after 4 weeks and 3 months interval from the baseline visit. Data thus collected was compiled and put to statistical analysis. RESULTS: The present study showed significant results in both the groups with regards to the improvement in the clinical parameters. When comparison was made between the two groups, ozonated water showed slightly better improvement than the chlorhexidine group. However, a statistically significant difference was seen only with Plaque score. CONCLUSION: Subgingival irrigation with ozonized water is beneficial than present conventional therapeutic modalities. Ozonated water restricts the formation of dental plaque and reduces the number of subgingival pathogens thereby treating periodontal diseases. CLINICAL SIGNIFICANCE: Ozone therapy is proving to be a new useful treatment modality which offers great benefits to the patients. The strong antimicrobial power of ozone, along with its ability to stimulate the circulatory system and modulate the immune response, makes it a remedial agent of choice in the treatment of various infectious oral diseases. The study was conducted to justify the routine use of ozone as a treatment modality in effective management of periodontal diseases.


Asunto(s)
Antiinfecciosos Locales , Periodontitis Crónica , Adulto , Clorhexidina/análogos & derivados , Raspado Dental , Humanos , Persona de Mediana Edad , Agua
8.
J Assoc Physicians India ; 66(7): 48-49, 2018 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-31325262

RESUMEN

BACKGROUND: Post Herpetic neuralgia (PHN) is neuropathic pain that occurs after herpes zoster infection. Several treatments have been suggested in the management of PHN. This study evaluates the efficacy of subcutaneous injection of botulinum toxin in patients suffering from PHN. METHODS: Nineteen patients suffering from PHN for more than 2 months were enrolled in the study. The severity of pain was assessed by visual analog scale (VAS). A total dose 500 units of BTX-A was injected around the site of pain. This was administered in about 25 sub-cutaneous injection around the site, delivering approximately 20U/ml of BTX-A per injection. The patients were followed at 1,2, 3,4,12 and 16 weeks after the administration of the drug. RESULTS: The mean age was 56 years (age range 36 to 63) for non-pregnant patients. The two pregnant patients of age 28 and 32 year old who were in their 28 and 30 weeks of gestation were also included. The mean duration of PHN was 4.78 wks. At each visit VAS was used to evaluate the degree of pain (0: painless; 10: maximum pain). There was a significant reduction in the severity of pain after the injection. CONCLUSIONS: Botulinum toxin significantly decreases the severity of pain in PHN patients and last for 4-6 month of the period. This decrease is less prominent by passing time.


Asunto(s)
Toxinas Botulínicas/uso terapéutico , Neuralgia Posherpética/tratamiento farmacológico , Adulto , Toxinas Botulínicas/administración & dosificación , Herpes Zóster , Humanos , Inyecciones Subcutáneas , Persona de Mediana Edad , Neuralgia
9.
Int J Clin Pharmacol Ther ; 55(7): 606-620, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-28590244

RESUMEN

OBJECTIVE: Tralokinumab, administered as two 1-mL subcutaneous injections every 2 weeks, at the target dose 300 mg, has been shown to improve lung function in patients with asthma. This study evaluated the pharmacokinetic (PK) and tolerability profile of tralokinumab 300 mg when administered by different rates of subcutaneous injection, as part of a pilot investigation of new injection regimens. METHODS: This phase I study randomized 60 healthy adults to receive 300 mg tralokinumab, as two 1-mL subcutaneous injections, each delivered over 10 seconds, or one 2-mL injection delivered over 10 seconds (12 mL/min), 1 minute (2 mL/min), or 12 minutes (0.167 mL/min). RESULTS: No differences in the PK profile of tralokinumab were observed between cohorts. Immediately following injection, injection-site pain intensity (mean (SD)) was lowest following 0.167 mL/min injection (5.1 mm (8.0) via visual analog scale (VAS)) and greatest following 12 mL/min injection (41 mm (27.7) via VAS); with mean injection-site pruritus intensity low for all participants. Two types of local injection-site reactions were observed: erythema (58.3%) and hematoma/bleeding (18.3%). All treatment-emergent adverse events were mild. CONCLUSIONS: Tralokinumab 300 mg is well tolerated, with comparable PK, when administered by a single 2-mL injection at different rates of subcutaneous injection vs. two 1-mL injections.
.


Asunto(s)
Antiasmáticos/administración & dosificación , Antiasmáticos/farmacocinética , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales/farmacocinética , Adulto , Anciano , Antiasmáticos/efectos adversos , Anticuerpos Monoclonales/efectos adversos , Eritema/etiología , Femenino , Voluntarios Sanos , Hematoma/etiología , Hemorragia/etiología , Humanos , Inyecciones Subcutáneas , Masculino , Persona de Mediana Edad , Dolor/etiología , Proyectos Piloto , Método Simple Ciego , Adulto Joven
10.
Pulm Pharmacol Ther ; 35: 19-27, 2015 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26474679

RESUMEN

BACKGROUND: Despite extensive use of inhaled corticosteroid/long-acting ß2-agonist combinations in asthma, limited data evaluating dose-response for this combination class are available. The benefits of dose escalation and nature of patient subgroups likely to benefit are thus ill-defined. METHOD: In this randomised, double-blind, 8-week study the effects of two dose levels (100/10 and 500/20 µg b.i.d.) of a fixed combination of fluticasone/formoterol (flutiform(®)) were compared in 309 patients. Treatment effects upon spirometric and symptom-based endpoints were examined in the overall population and in two subgroups defined a priori by % predicted FEV1 at baseline (≥40-≤60% ["severe" airways obstruction] and >60-≤80% ["moderate" airways obstruction]). RESULTS: No dose-response was evident for spirometric outcomes (FEV1, FEV1 AUC0-12, PEFR) either overall or in either subgroup. At variance with the spirometric data, statistically significant dose-dependent differences were seen for nocturnal outcomes and consistent numerical differences were found across multiple symptom-based outcomes (symptom scores, sleep scores, rescue medication use, asthma control days, AQLQ scores, exacerbations); greater effects were noted with the higher dose of fluticasone/formoterol. Between-group differences for the overall population were driven by treatment effect differences in the "severe" subgroup. CONCLUSION: In this exploratory comparison a high dose of fluticasone/formoterol in asthmatic patients appears to provide additional improvement in symptom-based rather than spirometric outcomes. Additional benefits from high versus low dose treatment are most likely in patients with severe airway obstruction, although the doses at which ceiling effects are attained may vary between individuals. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00734318; EudraCT number: 2007-001633-34.


Asunto(s)
Antiasmáticos/administración & dosificación , Antiasmáticos/uso terapéutico , Asma/tratamiento farmacológico , Fluticasona/administración & dosificación , Fluticasona/uso terapéutico , Fumarato de Formoterol/administración & dosificación , Fumarato de Formoterol/uso terapéutico , Adulto , Anciano , Antiasmáticos/efectos adversos , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Combinación de Medicamentos , Determinación de Punto Final , Femenino , Fluticasona/efectos adversos , Fumarato de Formoterol/efectos adversos , Humanos , Masculino , Persona de Mediana Edad , Pruebas de Función Respiratoria , Espirometría , Resultado del Tratamiento
11.
Br J Clin Pharmacol ; 80(6): 1337-49, 2015 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-26182954

RESUMEN

AIMS: Tralokinumab, an investigational human immunoglobulin G4 monoclonal antibody, potently and specifically neutralizes interleukin-13, a central mediator of asthma. Tralokinumab has shown improvements in clinical endpoints in adults with uncontrolled asthma. The present study explored the pharmacokinetics (PK) and safety of a single tralokinumab dose, and utilized a population PK modelling and simulation approach to evaluate the optimal dosing strategy for adolescents. METHODS: Adolescent subjects with asthma, using daily controller medication, received a single subcutaneous dose of tralokinumab 300 mg. Safety, immunogenicity and PK data were collected during a 57-day follow-up. A population PK model was developed using data from the present study and prior studies in adults. Simulations were performed to evaluate dose adjustment requirements for adolescents. RESULTS: Twenty adolescents (12-17 years) were enrolled; all completed the study. No clinically relevant safety findings or antidrug antibodies were detected. PK parameters were similar to those observed in adults. PK modelling showed that body weight was a minor predictor of tralokinumab PK; after incorporating body weight into the PK model, a 15% (nonparametric 95% confidence interval 5%, 26%) lower clearance was found in adolescents compared with adults [173 (151, 209) vs. 204 (191, 229) ml day(-1)]. Simulations showed no therapeutically relevant differences in exposures between adolescent and adult populations, and similar PK profiles for weight-based (4 mg kg(-1)) and fixed (300 mg) fortnightly subcutaneous doses of tralokinumab. CONCLUSION: Single-dose administration of tralokinumab 300 mg in adolescents was well tolerated, with a PK profile similar to that in adults. Exposure predictions suggest that dose adjustment is not required for adolescents.


Asunto(s)
Anticuerpos Monoclonales/farmacocinética , Asma/tratamiento farmacológico , Adolescente , Anticuerpos Monoclonales/administración & dosificación , Anticuerpos Monoclonales/efectos adversos , Asma/fisiopatología , Niño , Femenino , Volumen Espiratorio Forzado , Humanos , Masculino , Modelos Biológicos
12.
Int J Adolesc Med Health ; 36(1): 105-110, 2024 Feb 01.
Artículo en Inglés | MEDLINE | ID: mdl-38349076

RESUMEN

OBJECTIVES: The present study was conducted to assess tobacco use and its effect on Oral Health-Related Quality of Life (OHRQoL) in Indian adolescents. METHODS: The present study was conducted on 1,600 13-14 year old adolescents from the schools of Modinagar, western Uttar Pradesh, India selected using stratified random sampling technique. OHRQoL was assessed using Hindi version of Child Perceptions Questionnaire (CPQ). Information regarding demographic, socioeconomic and oral health measures was also collected from the study participants. Tobacco use was assessed through questions derived from Global Youth Tobacco Survey (GYTS) questionnaire. Influence of predictor variables on tobacco use was evaluated using multilevel Poisson regression model. RESULTS: The tobacco use among the study population was 8.1 % and CPQ scores were 9.15±0.32. Adolescents who used tobacco had worse OHRQoL scores. Low socioeconomic status, presence of dental caries, absence of regular dental visits (last 6 months) were associated with increased regular consumption of tobacco products. CONCLUSIONS: The findings of the present study play an important role in planning public health strategies to improve adolescent OHRQoL and reduce tobacco use.


Asunto(s)
Caries Dental , Niño , Adolescente , Humanos , Caries Dental/epidemiología , Calidad de Vida , Uso de Tabaco/epidemiología , India/epidemiología , Salud Bucal
13.
Cureus ; 16(5): e60774, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38903299

RESUMEN

Chronic traumatic ulcers (CTUs) of the oral cavity are frequently brought on by repeated mechanical stress, such as biting or friction from dental appliances, or sharp or broken carious teeth. Although they are frequently disregarded, patients with nonhealing ulcers in the mouth should have CTUs taken into consideration. This report highlights the significance of differential diagnosis and suitable treatment options by discussing a case of a CTU that persisted on the tongue's right lateral border.

14.
J Pharm Bioallied Sci ; 16(Suppl 1): S504-S506, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38595406

RESUMEN

Aim: In order to manage pediatric dental patients, this study set out to assess the effectiveness of two distraction techniques: audio and virtual reality (VR) with tell, show, and do technique (TSD). Materials and Methods: Forty-five children aged 6-10 years were selected for the present randomized control trial. They were split into three groups at random. Group 1 control group: tell-show-do, Group 2: audio distraction, and Group 3: VR distraction. Both pretreatment and postoperative anxiety levels were measured by modified Venham's anxiety rating scale (MVARS). Results: In each of the three groups, there was a statistically significant difference between the child's pre- and post-treatment anxiety levels. VR distraction group experienced the greatest reduction in anxiety. Conclusion: All three methods were similarly successful at lowering anxiety while virtual reality distraction outperformed compared to other techniques.

16.
J Cancer Res Ther ; 18(Supplement): S165-S169, 2022 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-36510959

RESUMEN

Objectives: To cross-culturally adapt and determine reliability and validity of the Hindi version of the Summated Xerostomia Inventory (SXI-H). Background: Xerostomia is common among older individuals and patients with head and neck radiation or autoimmune diseases, and it can affect their oral as well as systemic quality of life. To assess the perception of this condition, SXI-H can be used. Materials and Methods: This was a multi-centric cross-sectional observational study of volunteers suffering from hypo-salivation in three tertiary care cancer hospitals in Delhi, India. The English version of Summated Xerostomia Inventory (SXI-5) was translated into Hindi according to standard guidelines and field tested. The Hindi version of SXI-5 (SXI-H) was tested on 120 patients with xerostomia. All the participants signed the informed consent form before being interviewed with SXI-H. Thirty participants were interviewed again after 15 days. A global question was asked for criteria validity. Data were analyzed through IBM SPSSTM Statistics for windows version 24. Significance was set at P ≤ 0.05. Results: Overall SXI-H score of sample was 11.48 ± 2.29. Cronbach's α value was 0.81. The correlation between the SXI-H summary score and the standard question was 0.79 (95% CI 0.65-0.74). It was found that the intra-class correlation coefficient value for the test-retest reliability was 0.90 and scores for individual question ranged from 0.41 to 0.76. Conclusion: The SXI-H demonstrated excellent psychometric properties and can be considered a valid tool for assessing xerostomia in a dry mouth patient.


Asunto(s)
Neoplasias de Cabeza y Cuello , Xerostomía , Humanos , Reproducibilidad de los Resultados , Calidad de Vida , Encuestas y Cuestionarios , Estudios Transversales , Xerostomía/diagnóstico , Xerostomía/etiología , Neoplasias de Cabeza y Cuello/radioterapia
17.
Rev Environ Health ; 2022 Sep 14.
Artículo en Inglés | MEDLINE | ID: mdl-36103211

RESUMEN

Tobacco is the only consumer product that kills half its users yearly. The challenges posed by tobacco control are limitless especially in a country like India where in addition to smoked forms, other smokeless forms of tobacco are also highly prevalent. Apart from being a health hazard tobacco is also a great environmental hazard. Policies for controlling tobacco use also include policy to prevent people from second hand smoke, which is aimed at improvement of air quality. According to the National Non-Communicable Disease Monitoring Survey, 2017-18, daily tobacco use was 32.8% in adults (18-69 years) and 3.1% in adolescents (15-17 years). Overall reduction in tobacco users by 8.1 Million was seen from GATS-1 to GATS-2, and prevalence amongst youth decreased from 18.4 to 12.4%. GYTS-4 (2019) revealed that 8.5% of students, 9.6% of boys and 7.4% of girls-currently used any tobacco products. This makes tobacco control a priority in India. Tobacco control consists of different approaches such as educational, healthcare, legislative, regulatory and fiscal. In the present article we traverse nearly five decades and decode the evolution of legislative, regulatory and fiscal approaches to Tobacco Control in India. A critical evaluation of all these approaches is described in the format of the MPOWER strategy for Tobacco Control which stands for Monitoring Tobacco use, Preventing people from Second Hand Smoke, Offering help to quit, Waring regarding ill effects of tobacco, Enforcing bans and Raising taxes on tobacco products.

18.
J Clin Med ; 11(3)2022 Jan 26.
Artículo en Inglés | MEDLINE | ID: mdl-35160081

RESUMEN

People living with sickle cell disease (SCD) face intermittent acute pain episodes due to vaso-occlusion primarily treated palliatively with opioids. Hemolysis of sickle erythrocytes promotes release of heme, which activates inflammatory cell adhesion proteins on endothelial cells and circulating cells, promoting vaso-occlusion. In this study, plasma-derived hemopexin inhibited heme-mediated cellular externalization of P-selectin and von Willebrand factor, and expression of IL-8, VCAM-1, and heme oxygenase-1 in cultured endothelial cells in a dose-responsive manner. In the Townes SCD mouse model, intravenous injection of free hemoglobin induced vascular stasis (vaso-occlusion) in nearly 40% of subcutaneous blood vessels visualized in a dorsal skin-fold chamber. Hemopexin administered intravenously prevented or relieved stasis in a dose-dependent manner. Hemopexin showed parallel activity in relieving vascular stasis induced by hypoxia-reoxygenation. Repeated IV administration of hemopexin was well tolerated in rats and non-human primates with no adverse findings that could be attributed to human hemopexin. Hemopexin had a half-life in wild-type mice, rats, and non-human primates of 80-102 h, whereas a reduced half-life of hemopexin in Townes SCD mice was observed due to ongoing hemolysis. These data have led to a Phase 1 clinical trial of hemopexin in adults with SCD, which is currently ongoing.

19.
J Educ Health Promot ; 10: 266, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34485563

RESUMEN

BACKGROUND: The objective was to assess the prevalence and the associated demographic factors of stress, anxiety, and depression among undergraduate (UG) Indian dental students and determine whether the pattern is different in government-run institutions and those managed by private authorities. MATERIALS AND METHODS: A cross-sectional study was conducted among dental UG students from five dental colleges. Snowball sampling was used to approach 776 potential participants, resulting in a complete response from 507 students. The questionnaire consisted of demographic data; year of study; type of college; accommodation; and Depression, Anxiety, and Stress Scale (DASS)-42. Descriptive data and inferential statistics were obtained. Chi-square test was applied for categorical data to test for significance, and higher analysis was done using multiple linear regression. RESULTS: Females and males comprised 71.8% (n = 364) and 28.2% (n = 143) of the study population, respectively. The prevalence of anxiety was highest (66.86%, n = 339), followed by depression (57.39%, n = 291) and stress (43.99%, n = 223). In terms of severity also, anxiety was the most prevalent condition as more than one-fourth of the students presented with severe and very severe scores in this aspect (25.43%, n = 129) compared to depression (14.39%, n = 73) and stress (10.09%, n = 51). Regression analysis revealed age as a strong positive predictor for all the three conditions, while staying in the hostel was a positive predictor for anxiety and stress. Being female was also an independent predictor for the high prevalence of stress. CONCLUSION: Stress, anxiety, and depression are highly prevalent among Indian dental students. Clinical students and interns have a higher prevalence of stress than preclinical students. Age, being female, and staying in the hostel are positive predictors for the severity of stress. There is no significant difference between government and private colleges, regarding the prevalence of any psychological condition.

20.
J Indian Soc Periodontol ; 25(5): 427-431, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34667387

RESUMEN

BACKGROUND: Periodontal disease is one of the leading causes of tooth loss in the geriatric population. Assessment of periodontal disease in a population is an important step in planning effective prevention and control programs for periodontal disease. Therefore, a study was carried out in old-age homes of Delhi to assess the periodontal status of 65-74-year-old elderly and recommend interventions to improve their periodontal health. MATERIALS AND METHODS: A cross-sectional study was conducted among 464 elderly from old-age homes of Delhi. Periodontal health status of the participants was determined using the WHO oral health assessment form. Community Periodontal Index (CPI) and loss of attachment (LOA) were recorded. Collected data were analyzed using SPSS version 23. Chi-square test was used to determine statistically significant difference among CPI scores and LOA according to age and gender. P ≤ 0.05 was considered statistically significant. RESULTS: The result of the study showed that 25.4% of the elderly had healthy periodontium, 71.1% had a periodontal pocket of 6 mm or more, and 2.40% had a pocket depth of 4-5 mm. Around 36% had 6-8 mm LOA and 34.70% had 9-11 mm LOA. The difference between CPI scores among gender and age group was not significant (P = 0.20, P = 0.096). However, the difference among gender for LOA was found significant (P = 0.014). CONCLUSION: The results from this study show that periodontal health of elderly residing in old-age homes is very poor. The periodontal status of this population can be enhanced by special collaborative efforts from the government and various nongovernmental organizations toward preventive and curative periodontal health services.

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