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Importance: Several interventions exist for treating myopia progression in children. While these interventions' efficacy has been studied, their cost-effectiveness remains unknown and has not been compared. Objective: To determine cost-effective options for controlling myopia progression in children. Design, Setting, and Participants: In this cost-effectiveness analysis, a Markov model was designed to compare the cost-effectiveness of interventions for controlling myopia progression over 5 years from a societal perspective in a simulated hypothetical cohort of patients aged 10 years with myopia. Myopia interventions considered included atropine eye drops, 0.05% and 0.01%, defocus incorporated multiple segment spectacles, outdoor activity, soft contact lenses (daily disposable and multifocal), rigid gas-permeable contact lenses, progressive addition lenses, bifocal spectacle lenses, orthokeratology, highly aspherical lenslets (HALs), and red light therapy; all interventions were compared with single-vision lenses. Deterministic and probabilistic sensitivity analysis determined the association of model uncertainties with the cost-effectiveness. Costs were obtained from the charges of the Hospital Authority of Hong Kong and The Chinese University of Hong Kong Eye Center. Main Outcome and Measures: The mean costs (in US dollars) per child included the cost of hospital visits, medications, and optical lenses. The outcomes of effectiveness were the annual spherical equivalent refraction (SER) and axial length (AL) reductions. Incremental cost-effectiveness ratios (ICERs) were calculated for each strategy relative to single-vision lenses over a time horizon of 5 years. Results: Outdoor activity, atropine (0.05%), red light therapy, HALs, and orthokeratology were cost-effective. The ICER of atropine, 0.05%, was US $220/SER reduction; red light therapy, US $846/SER reduction; and HALs, US $448/SER reduction. Outdoor activity yielded a savings of US $5/SER reduction and US $8/AL reduction. Orthokeratology resulted in an ICER of US $2376/AL reduction. Conclusions and Relevance: These findings suggest that atropine eye drops, 0.05%, and outdoor activity are cost-effective for controlling myopia progression in children. Though more expensive, red light therapy, HALs, and orthokeratology may also be cost-effective. The use of these interventions may help to control myopia in a cost-effective way.
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Análisis de Costo-Efectividad , Miopía , Humanos , Niño , Miopía/terapia , Refracción Ocular , Atropina/uso terapéutico , Soluciones OftálmicasRESUMEN
CONTEXT: Effect size estimates for the association between vitamin D concentrations in maternal blood during pregnancy and in cord blood vary widely across studies, but no meta-analysis has been conducted to ascertain this association. OBJECTIVE: The aim of this systematic review was to estimate the pooled effect size for the association between circulating 25-hydroxyvitamin D (25[OH]D) concentrations, a marker of vitamin D status, in maternal blood during pregnancy and in cord blood. DATA SOURCES: The PubMed, Embase, and Web of Science databases were searched from their inception to February 2021. DATA EXTRACTION: Following the application of prespecified inclusion and exclusion criteria, 94 articles were eligible for full-text review, which was conducted by 2 authors independently. A third author was consulted when necessary and consensus reached. In total, 26 articles, which comprised 30 studies and 6212 mother-infant dyads, were included. Methodological quality was assessed using a modified version of the Joanna Briggs Institute's Critical Appraisal Checklist for Studies Reporting Prevalence Data. Correlation coefficient (r) values for the association between maternal serum 25(OH)D concentrations during pregnancy and in cord blood were extracted. DATA ANALYSIS: The r values were pooled using random-effects meta-analyses. Sensitivity and subgroup analyses were performed to investigate sources of heterogeneity. The pooled r for all studies was 0.72 (95%CI, 0.64-0.79), indicating high heterogeneity (I2â =â 95%, Pâ <â 0.01). After influential and outlier studies were removed, the pooled r for 9 studies was 0.70 (95%CI, 0.66-0.74), which resulted in a substantial reduction in heterogeneity (I2â =â 41%, P=0.10). CONCLUSION: The findings support a positive and large correlation between maternal vitamin D concentrations during pregnancy and vitamin D concentrations in cord blood. SYSTEMATIC REVIEW REGISTRATION: PROSPERO registration number CRD42021273348.
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Deficiencia de Vitamina D , Embarazo , Femenino , Humanos , Deficiencia de Vitamina D/epidemiología , Sangre Fetal , Suplementos Dietéticos , Vitamina D , VitaminasRESUMEN
BACKGROUND: Diabetes mellitus is a common comorbidity of atrial fibrillation (AF), which can complicate the management of AF. The pharmacology of oral anticoagulants (OACs) have been implicated in pathogenesis of diabetes, but the relationship between different OACs and risk of diabetes remains unexamined. This study aimed to evaluate the risk of diabetes with use of different OACs in AF patients. METHODS: Population-based retrospective cohort study using an electronic healthcare database managed by the Hong Kong Hospital Authority. Patients newly diagnosed with AF from 2014 through 2018 and prescribed OACs were included and followed till December 31, 2019. Inverse probability of treatment weighting based on the propensity score (PS) is used to address potential bias due to nonrandomized allocation of treatment. The risks ofdiabetes were compared between different new OAC users using propensity score-weighted cumulative incidence differences (CID). RESULTS: There were 13,688 new users of OACs (warfarin: n = 3454; apixaban: n = 3335; dabigatran: n = 4210; rivaroxaban: n = 2689). The mean age was 75.0 (SD, 11.2), and 6,550 (47.9%) were women. After a median follow-up of 0.93 years (interquartile range, 0.21-1.92 years), 698 incident diabetes cases were observed. In Cox-regression analysis, dabigatran use was significantly associated with reduced risk of diabetes when compared with warfarin use [HR 0.69 (95% CI 0.56-0.86; P < 0.001)], with statistically insignificant associations observed for use of apixaban and rivaroxaban. The corresponding adjusted CIDs at 2 years after treatment with apixaban, dabigatran, and rivaroxaban users when compared with warfarin were - 2.06% (95% CI - 4.08 to 0.16%); - 3.06% (95% CI - 4.79 to - 1.15%); and - 1.8% (- 3.62 to 0.23%). In head-to-head comparisons between women DOAC users, dabigatran was also associated with a lower risk of diabetes when compared with apixaban and rivaroxaban. CONCLUSIONS: Among adults with AF receiving OACs, the use of dabigatran had the lowest risk of diabetes when compared with warfarin use.
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Anticoagulantes/administración & dosificación , Antitrombinas/administración & dosificación , Fibrilación Atrial/tratamiento farmacológico , Dabigatrán/administración & dosificación , Diabetes Mellitus/epidemiología , Inhibidores del Factor Xa/administración & dosificación , Pirazoles/administración & dosificación , Piridonas/administración & dosificación , Rivaroxabán/administración & dosificación , Warfarina/administración & dosificación , Administración Oral , Anciano , Anciano de 80 o más Años , Anticoagulantes/efectos adversos , Antitrombinas/efectos adversos , Fibrilación Atrial/diagnóstico , Fibrilación Atrial/epidemiología , Dabigatrán/efectos adversos , Bases de Datos Factuales , Diabetes Mellitus/inducido químicamente , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/prevención & control , Inhibidores del Factor Xa/efectos adversos , Femenino , Hong Kong/epidemiología , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Pirazoles/efectos adversos , Piridonas/efectos adversos , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Rivaroxabán/efectos adversos , Factores Sexuales , Factores de Tiempo , Resultado del Tratamiento , Warfarina/efectos adversosRESUMEN
BACKGROUND: It is unclear whether anticoagulant type is associated with the risk for osteoporotic fracture, a deleterious complication of anticoagulants among patients with atrial fibrillation (AF). OBJECTIVE: To compare the risk for osteoporotic fracture between anticoagulants. DESIGN: Population-based cohort study. SETTING: Territory-wide electronic health record database of the Hong Kong Hospital Authority. PARTICIPANTS: Patients newly diagnosed with AF between 2010 and 2017 who received a new prescription for warfarin or a direct oral anticoagulant (DOAC) (apixaban, dabigatran, or rivaroxaban). Follow-up ended on 31 December 2018. MEASUREMENTS: Osteoporotic hip and vertebral fractures in anticoagulant users were compared using propensity score-weighted cumulative incidence differences (CIDs). RESULTS: There were 23 515 patients identified (3241 apixaban users, 6867 dabigatran users, 3866 rivaroxaban users, and 9541 warfarin users). Overall mean age was 74.4 years (SD, 10.8), ranging from 73.1 years (warfarin) to 77.9 years (apixaban). Over a median follow-up of 423 days, 401 fractures were identified (crude event number [weighted rate per 100 patient-years]: apixaban, 53 [0.82]; dabigatran, 95 [0.76]; rivaroxaban, 57 [0.67]; and warfarin, 196 [1.11]). After 24-month follow-up, DOAC use was associated with a lower risk for fracture than warfarin use (apixaban CID, -0.88% [95% CI, -1.66% to -0.21%]; dabigatran CID, -0.81% [CI, -1.34% to -0.23%]; and rivaroxaban CID, -1.13% [CI, -1.67% to -0.53%]). No differences were seen in all head-to-head comparisons between DOACs at 24 months (apixaban vs. dabigatran CID, -0.06% [CI, -0.69% to 0.49%]; rivaroxaban vs. dabigatran CID, -0.32% [CI, -0.84% to 0.18%]; and rivaroxaban vs. apixaban CID, -0.25% [CI, -0.86% to 0.40%]). LIMITATION: Residual confounding is possible. CONCLUSION: Among patients with AF, DOAC use may result in a lower risk for osteoporotic fracture compared with warfarin use. Fracture risk does not seem to be altered by the choice of DOAC. These findings may help inform the benefit-risk assessment when choosing between anticoagulants. PRIMARY FUNDING SOURCE: The University of Hong Kong and University College London Strategic Partnership Fund.
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Dabigatrán/uso terapéutico , Fracturas Osteoporóticas/epidemiología , Pirazoles/uso terapéutico , Piridonas/uso terapéutico , Rivaroxabán/uso terapéutico , Warfarina/uso terapéutico , Anciano , Anticoagulantes/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Estudios de Cohortes , Femenino , Estudios de Seguimiento , Fracturas de Cadera/epidemiología , Hong Kong/epidemiología , Humanos , Masculino , Fracturas de la Columna Vertebral/epidemiología , Accidente Cerebrovascular/prevención & controlRESUMEN
INTRODUCTION: The risk of liver injury in patients with atrial fibrillation (AF) using nonvitamin K antagonist oral anticoagulants (NOACs) has not been previously examined using liver function tests as the primary outcome in the real-world setting. This study assessed the association between NOACs (dabigatran, rivaroxaban, and apixaban) and warfarin and the risk of liver injury, as defined by laboratory tests. METHODS: Patients newly diagnosed with AF and prescribed NOACs or warfarin between 2010 and 2016, identified using the Hong Kong Clinical Database and Reporting System, were matched on age, sex, health status scores, comorbidities, and medications by propensity score on a 1:1 ratio. Risk of liver injury, defined as laboratory test values >3 times the upper limit of normal of alanine aminotransferase or aspartate aminotransferase and >2 times the upper limit of normal of total bilirubin, was compared between NOAC and warfarin users using Cox proportional hazards regression. RESULTS: After propensity score matching, 13,698 patients were included, of which 141 (2.1%) NOAC users and 232 (3.4%) warfarin users developed liver injury. The hazard ratio (HR) for NOAC vs warfarin users was 0.71 (95% confidence interval: 0.58-0.89). When comparing individual NOACs, only dabigatran (hazard ratio: 0.63; 95% confidence interval: 0.48-0.82) was associated with a lower risk of liver injury. DISCUSSION: Among patients with AF, NOACs as a group, and dabigatran alone were associated with a significantly lower risk of laboratory-based liver injury when compared with warfarin. However, liver injury occurs more frequently in real-world practice than in NOAC randomized controlled trials.
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Anticoagulantes/uso terapéutico , Fibrilación Atrial/tratamiento farmacológico , Enfermedad Hepática Inducida por Sustancias y Drogas/etiología , Dabigatrán/efectos adversos , Pirazoles/efectos adversos , Piridonas/efectos adversos , Rivaroxabán/efectos adversos , Warfarina/efectos adversos , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Dabigatrán/uso terapéutico , Bases de Datos Factuales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Puntaje de Propensión , Pirazoles/uso terapéutico , Piridonas/uso terapéutico , Riesgo , Rivaroxabán/uso terapéutico , Warfarina/uso terapéuticoRESUMEN
BACKGROUND: Melatonin is widely available either on prescription for the treatment of sleep disorders or as an over-the-counter dietary supplement. Melatonin has also recently been licensed in the UK for the short-term treatment of jetlag. Little is known about the potential for adverse events (AEs), in particular AEs resulting from long-term use. Concern has been raised over the possible risks of exposure in certain populations including pre-adolescent children and patients with epilepsy or asthma. OBJECTIVES: The aim of this systematic review was to assess the evidence for AEs associated with short-term and longer-term melatonin treatment for sleep disorders. METHODS: A literature search of the PubMed/Medline database and Google Scholar was conducted to identify randomised, placebo-controlled trials (RCTs) of exogenous melatonin administered for primary or secondary sleep disorders. Studies were included if they reported on both the types and frequencies of AEs. Studies of pre-term infants, studies of < 1 week in duration or involving single doses of melatonin and studies in languages other than English were excluded. Findings from open-label studies that raised concerns relating to AE reports in patients were also examined. Studies were assessed for quality of reporting against the Consolidated Standards of Reporting Trials (CONSORT) checklist and for risk of bias against the Cochrane Collaboration risk-of-bias criteria. RESULTS: 37 RCTs met criteria for inclusion. Daily melatonin doses ranged from 0.15 mg to 12 mg. Subjects were monitored for up to 29 weeks, but most studies were of much shorter duration (4 weeks or less). The most frequently reported AEs were daytime sleepiness (1.66%), headache (0.74%), other sleep-related AEs (0.74%), dizziness (0.74%) and hypothermia (0.62%). Very few AEs considered to be serious or of clinical significance were reported. These included agitation, fatigue, mood swings, nightmares, skin irritation and palpitations. Most AEs either resolved spontaneously within a few days with no adjustment in melatonin, or immediately upon withdrawal of treatment. Melatonin was generally regarded as safe and well tolerated. Many studies predated publication of the CONSORT checklist and consequently did not conform closely to the guidelines. Similarly, only eight studies were judged 'good' overall with respect to the Cochrane risk-of-bias criteria. Of the remaining papers, 16 were considered 'fair' and 13 'poor' but publication of almost half of the papers preceded that of the earliest version of the guidelines. CONCLUSION: Few, generally mild to moderate, AEs were associated with exogenous melatonin. No AEs that were life threatening or of major clinical significance were identified. The scarcity of evidence from long-term RCTs, however, limits the conclusions regarding the safety of continuous melatonin therapy over extended periods. There are insufficient robust data to allow a meaningful appraisal of concerns that melatonin may result in more clinically significant adverse effects in potentially at-risk populations. Future studies should be designed to comply with appropriate quality standards for RCTs, which most past studies have not.
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Melatonina/efectos adversos , Melatonina/uso terapéutico , Trastornos del Sueño-Vigilia/tratamiento farmacológico , Sueño/efectos de los fármacos , Humanos , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: This review describes the safety of deferoxamine (DFO), deferiprone (DFP), deferasirox (DFX) and combined therapy in young patients less than 25 yr of age with haemoglobinopathies. METHODS: Searches in electronic literature databases were performed. Studies reporting adverse events associated with iron chelation therapy were included. Study and reporting quality was assessed using AHRQ Risk of Bias Assessment Tool and McMaster Quality Assessment Scale of Harms. Prospective clinical studies were pooled in a random-effects meta-analysis of proportions. RESULTS: Safety data of 2040 patients from 34 studies were included. Ninety-two case reports of 246 patients were identified. DFX (937 patients) and DFP (667 patients) possess the largest published safety evidence. Fewer studies on combination regimens are available. Increased transaminases were seen in all regimens (3.9-31.3%) and gastrointestinal disorders with DFP and DFX (3.7-18.4% and 5.8-18.8%, respectively). Therapy discontinuations due to adverse events were low (0-4.1%). Reporting quality was selective and poor in most of the studies. CONCLUSION: Iron chelation therapy is generally safe in young patients, and published data correspond to summary of product characteristics. Each iron chelation regimen has its specific safety risks. DFO seems not to be associated with serious adverse effects in recommended doses. In DFP and DFX, rare, but serious, adverse reactions can occur. Data on combined therapy are scarce, but it seems equally safe compared to monotherapy.
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Hemoglobinopatías/complicaciones , Quelantes del Hierro/efectos adversos , Sobrecarga de Hierro/tratamiento farmacológico , Sobrecarga de Hierro/etiología , Terapia por Quelación , Quimioterapia Combinada , Hemoglobinopatías/terapia , Humanos , Quelantes del Hierro/administración & dosificación , Reacción a la TransfusiónRESUMEN
UNLABELLED: There is a lack of knowledge regarding the incidence of serious adverse drug reactions (ADR) to the oral iron chelator deferiprone in Chinese children with transfusion-dependent thalassaemia. In this retrospective population-based cohort study, paediatric thalassaemia patients in Hong Kong were screened for serious and medically important adverse events related to deferiprone therapy using diagnosis codes, laboratory data and hospital admissions. Potential ADRs were assessed by reviewing concomitant medications, diagnoses and laboratory data and evaluated using standardised causality assessment. Eighty-seven patients contributing 169.8 person-years were included. Thirty ADRs were identified in 21 patients. Most ADRs (56.0%) occurred in the first three months of therapy. Neutropenia occurred in 11 patients (12.6%; incidence rate 6.5 per 100 patient-years) and severe neutropenia (agranulocytosis) was observed in 5 patients (5.7%, incidence rate 2.9 per 100 patient-years). Other identified ADRs involve severe arthropathy, elevated liver enzymes and mild thrombocytopenia. In conclusion, the safety profile of DFP therapy in Chinese children suffering from transfusion-dependent thalassaemia is in line with previous studies of non-Chinese children. However, unlike previous studies, we observed a relatively high incidence of agranulocytosis and neutropenia in patients with simultaneous combined therapy. Hence close monitoring for white blood cell counts is advised in Chinese children under combined iron chelation therapy. Further prospective clinical and pharmacogenetic studies are required to better evaluate this important safety signal. KEY POINTS: ⢠Half of the identified ADRs related to deferiprone therapy occurred during the first three months of treatment. ⢠A relatively high incidence of agranulocytosis and neutropenia. Hence close monitoring for white blood cell counts is advised in Chinese children under combined iron chelation therapy.
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Sistemas de Registro de Reacción Adversa a Medicamentos , Transfusión Sanguínea , Quelantes del Hierro/efectos adversos , Piridonas/efectos adversos , Talasemia/tratamiento farmacológico , Administración Oral , Adolescente , Sistemas de Registro de Reacción Adversa a Medicamentos/tendencias , Agranulocitosis/sangre , Agranulocitosis/inducido químicamente , Agranulocitosis/epidemiología , Niño , Preescolar , China/epidemiología , Estudios de Cohortes , Deferiprona , Femenino , Humanos , Quelantes del Hierro/uso terapéutico , Masculino , Neutropenia/sangre , Neutropenia/inducido químicamente , Neutropenia/epidemiología , Vigilancia de la Población/métodos , Piridonas/uso terapéutico , Estudios Retrospectivos , Talasemia/sangre , Talasemia/epidemiologíaRESUMEN
BACKGROUND: Specialist services for the treatment of attention deficit hyperactivity disorder (ADHD) in adulthood in Hong Kong are yet to be developed. This study aims to explore the experiences of adolescents and young adults with ADHD in accessing treatment and services, coping with ADHD-related impairment, and their expectations of future treatment in Hong Kong. METHOD: Qualitative interviews were conducted with a semi-structured guide. Forty young adult patients aged between 16 and 23 were included in the study. The interview recordings were transcribed verbatim and anonymised. Data were analysed with a thematic approach based on key principles of Grounded Theory. RESULTS: Four meta-themes were developed: Accessing ADHD diagnosis and treatment services; ADHD-related impairment; Experience of ADHD treatments; and Attitudes and expectations of future ADHD treatment. The role of parents and schools were highly significant in accessing services for patients diagnosed with ADHD in childhood. In general, ADHD affected every aspect of patients' lives including academic outcome, employment, family and social relationships. Medications were the principal treatment for ADHD amongst the interviewees and were reported to be generally effective. Half of the patients received non-pharmacological treatments in childhood but these effects were reported to be temporary. There was general consensus that the needs of patients with ADHD could not be met by the current service. In particular, there is a lack of specialist service for adults with ADHD, follow-up by different clinicians, and insufficient provision of non-pharmacological treatments. CONCLUSION: The findings suggest that further development of specialist ADHD services and non-pharmacological options for young adults are essential to meet their diverse needs with a holistic approach.
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Adaptación Psicológica , Trastorno por Déficit de Atención con Hiperactividad , Accesibilidad a los Servicios de Salud , Prioridad del Paciente/psicología , Apoyo Social , Adolescente , Trastorno por Déficit de Atención con Hiperactividad/diagnóstico , Trastorno por Déficit de Atención con Hiperactividad/psicología , Trastorno por Déficit de Atención con Hiperactividad/terapia , Empleo , Necesidades y Demandas de Servicios de Salud , Hong Kong , Humanos , Masculino , Padres , Técnicas Psicológicas , Instituciones Académicas , Trabajo , Adulto JovenRESUMEN
OBJECTIVE: The present study aimed to review the literature on micronutrient deficiency and other factors influencing a deficiency status among children living in China. DESIGN: A systematic review was performed to analyse the literature. SETTING: Studies were identified through a search of PubMed and secondary references. SUBJECTS: Children living in China aged less than 18 years. RESULTS: Sixty-one articles were included. The prevalence of vitamin A deficiency decreased to approximately 10 % in 1995-2009. It increased with age but no significant difference was found between genders. The prevalence of thiamin and vitamin B12 deficiency was 10·5 % in Yunnan and 4·5 % in Chongqing provinces, respectively. Higher vitamin D deficiency rates were seen in spring and winter. The incidence of bleeding due to vitamin K deficiency was 3·3 % in 1998-2001 and more prevalent in rural areas. Both iodine deficiency and excess iodine intake were observed. Goitre rates were reported in Tibet, Jiangxi, Gansu and Hong Kong (3·5-46 %). Anaemia rates ranged from 20 % to 40 % in 2007-2011. High Se deficiency rates were found in Tibet, Shaanxi and Jiangsu. High Zn deficiency rates were also found (50-70 %) in 1995-2006. Few studies reported Ca deficiency rates (19·6-34·3 %). The degrees of deficiency for vitamin A, vitamin B12, Fe and Zn were more substantial in rural areas compared with urban areas. CONCLUSIONS: The prevalence of micronutrient deficiency rates varied. Socio-economic status, environmental factors and the Chinese diet may influence micronutrient deficiency. Public health policies should consider implementing programmes of supplementation, food fortification and nutrition education to address these deficiencies among Chinese children.
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Anemia Ferropénica/epidemiología , Desnutrición/epidemiología , Micronutrientes/deficiencia , Deficiencia de Vitamina A/epidemiología , Deficiencia de Vitamina B 12/epidemiología , Deficiencia de Vitamina D/epidemiología , Adolescente , Anemia Ferropénica/sangre , Niño , Preescolar , China/epidemiología , Dieta , Humanos , Lactante , Recién Nacido , Yodo/sangre , Yodo/deficiencia , Desnutrición/sangre , Micronutrientes/sangre , Estado Nutricional , Prevalencia , Salud Pública , Población Rural , Estaciones del Año , Factores Socioeconómicos , Deficiencia de Vitamina A/sangre , Deficiencia de Vitamina B 12/sangre , Deficiencia de Vitamina D/sangre , Zinc/sangre , Zinc/deficienciaRESUMEN
OBJECTIVES: Ciclosporin and sirolimus, two immunosuppressive agents with narrow therapeutic windows, are mainly metabolized by Cytochrome 3A4 (CYP3A4). A clinical case of toxic blood levels of these drugs after the consumption of a '24-flavours' tea was reported. This study aims to identify the causative ingredients of the 24-flavour herbal tea in the inhibition of CYP3A4 metabolism. METHODS: Two commercially available 24-flavour tea products purchased in Hong Kong and the six plant constituents were tested for their CYP3A4 inhibitory effects utilizing an in-vitro fluorometric assay. KEY FINDINGS: Of the commercially available teas available in Hong Kong, the most potent inhibitory effect was observed with the tea consumed in the initial clinical case. Of the six universal constituents, chrysanthemum exhibited the greatest inhibitory effect, with an IC50 of 95.7 µg/ml. Dandelion, liquorice and bishop's weed have IC50 of 140.6, 148.4 and 185.5 µg/ml, respectively. Field mint and Japanese honeysuckle have weaker inhibitory effect on CYP3A4 with IC50 of 1153.3 and 1466.3 µg/ml. CONCLUSIONS: This study confirms the possible implication of herbal tea constituents in the inhibition of ciclosporin and sirolimus' CYP3A4 metabolism. Combined usage of herbal teas with drug should be closely monitored.
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Ciclosporina/farmacocinética , Citocromo P-450 CYP3A/metabolismo , Medicamentos Herbarios Chinos/farmacología , Interacciones de Hierba-Droga , Magnoliopsida , Sirolimus/farmacocinética , Bebidas , Chrysanthemum , Glycyrrhiza , Houttuynia , Humanos , TaraxacumRESUMEN
BACKGROUND: The efficacy of three dietary treatments for ADHD has been repeatedly tested in randomized controlled trials (RCTs). These interventions are restricted elimination diets (RED), artificial food colour elimination (AFCE) and supplementation with free fatty acids (SFFA). There have been three systematic reviews and associated meta-analyses of the RCTs for each of these treatments. SCOPE: The aim of this review is to critically appraise the studies on the dietary treatments of ADHD, to compare the various meta-analyses of their efficacy that have been published and to identify where the design of such RCTs could be improved and where further investigations are needed. FINDINGS: The meta-analyses differ in the inclusion and exclusion criteria applied to potentially eligible studies. The range of average effect sizes in standard deviation units is RED (0.29-1.2), AFCE (0.18-0.42) and SFFA (0.17-0.31). The methodology of many of the trials on which the meta-analyses are based is weak. CONCLUSIONS: Nevertheless, there is evidence from well-conducted studies for a small effect of SFFA. Restricted elimination diets may be beneficial, but large-scale studies are needed on unselected children, using blind assessment and including assessment of long-term outcome. Artificial food colour elimination is a potentially valuable treatment but its effect size remains uncertain, as does the type of child for whom it is likely to be efficacious. There are additional dietary supplements that have been used with children with ADHD. A systematic search identified 11 RCTs that investigated the effects of these food supplements. Despite positive results for some individual trials, more studies are required before conclusions can be reached on the value in reducing ADHD symptoms of any of these additional supplements.
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Trastorno por Déficit de Atención con Hiperactividad/dietoterapia , Niño , Suplementos Dietéticos , Ácidos Grasos no Esterificados/administración & dosificación , Humanos , Proyectos de Investigación , Resultado del TratamientoRESUMEN
OBJECTIVE: Nonpharmacological treatments are available for attention deficit hyperactivity disorder (ADHD), although their efficacy remains uncertain. The authors undertook meta-analyses of the efficacy of dietary (restricted elimination diets, artificial food color exclusions, and free fatty acid supplementation) and psychological (cognitive training, neurofeedback, and behavioral interventions) ADHD treatments. METHOD: Using a common systematic search and a rigorous coding and data extraction strategy across domains, the authors searched electronic databases to identify published randomized controlled trials that involved individuals who were diagnosed with ADHD (or who met a validated cutoff on a recognized rating scale) and that included an ADHD outcome. RESULTS: Fifty-four of the 2,904 nonduplicate screened records were included in the analyses. Two different analyses were performed. When the outcome measure was based on ADHD assessments by raters closest to the therapeutic setting, all dietary (standardized mean differences=0.21-0.48) and psychological (standardized mean differences=0.40-0.64) treatments produced statistically significant effects. However, when the best probably blinded assessment was employed, effects remained significant for free fatty acid supplementation (standardized mean difference=0.16) and artificial food color exclusion (standardized mean difference=0.42) but were substantially attenuated to nonsignificant levels for other treatments. CONCLUSIONS: Free fatty acid supplementation produced small but significant reductions in ADHD symptoms even with probably blinded assessments, although the clinical significance of these effects remains to be determined. Artificial food color exclusion produced larger effects but often in individuals selected for food sensitivities. Better evidence for efficacy from blinded assessments is required for behavioral interventions, neurofeedback, cognitive training, and restricted elimination diets before they can be supported as treatments for core ADHD symptoms.
Asunto(s)
Trastorno por Déficit de Atención con Hiperactividad/terapia , Estimulantes del Sistema Nervioso Central/uso terapéutico , Dietoterapia , Psicoterapia , Adolescente , Trastorno por Déficit de Atención con Hiperactividad/diagnóstico , Trastorno por Déficit de Atención con Hiperactividad/psicología , Terapia Conductista , Niño , Preescolar , Trastornos del Conocimiento/diagnóstico , Trastornos del Conocimiento/psicología , Trastornos del Conocimiento/terapia , Terapia Cognitivo-Conductual , Terapia Combinada , Ácidos Grasos no Esterificados/administración & dosificación , Colorantes de Alimentos/administración & dosificación , Colorantes de Alimentos/efectos adversos , Hipersensibilidad a los Alimentos/complicaciones , Hipersensibilidad a los Alimentos/terapia , Humanos , Neurorretroalimentación , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: Intravenous administration of proton pump inhibitors after endoscopic treatment of bleeding peptic ulcers has been shown to decrease the rate of recurrent bleeding and the need for subsequent surgery. Yet there is a relative lack of formal assessment of this practice. The aim of this study was to examine the cost-effectiveness of this therapy by using standard pharmacoeconomic methods. METHODS: The present study was performed in conjunction with a randomized controlled clinical trial that included 232 patients who received either omeprazole (80 mg intravenous bolus followed by infusion at 8 mg/hour for 72 hours) or placebo after hemostasis was achieved endoscopically. A cost-effectiveness analysis was performed to evaluate the different outcomes of the trial. All related direct medical costs were identified from patient records. Cost-effectiveness ratios were calculated. RESULTS: Analysis by the Kolmogorov-Smirnov test showed that the direct medical cost in the omeprazole group was lower than that for the placebo group. Cost-effectiveness ratios for omeprazole and placebo groups were, respectively, HK$ 28,764 (US$ 3688) and HK$ 36,992 (US$ 4743) in averting one episode of recurrent bleeding in one patient after initial hemostasis was achieved endoscopically. CONCLUSIONS: Intravenous administration of high-dose omeprazole appears to be a cost-effective therapy in reducing the recurrence of bleeding and need for surgery in patients with active bleeding ulcer after initial hemostasis is obtained endoscopically.