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BACKGROUND: Intention-to-treat analyses do not address adherence. Per protocol analyses treat nonadherence as a protocol deviation and assess if the intervention is effective if followed. OBJECTIVE: To determine the rate of early preterm birth (EPTB, <34 weeks gestation) and preterm birth (PTB, <37 weeks gestation) in participants who adhered to a randomly assigned docosahexaenoic acid (DHA) dose of 1000 mg/day. STUDY DESIGN: Eleven hundred women with a singleton pregnancy were enrolled before 20-weeks' gestation, provided a capsule with 200 mg/day DHA and randomly assigned to two additional capsules containing a placebo or 800 mg of DHA. In the Bayesian Adaptive Design, new randomization schedules were determined at prespecified intervals. In each randomization, the group with the most EPTB was assigned fewer participants than the other group. Adherence was defined a priori as a postpartum red blood cell phospholipid DHA (RBC-PL-DHA) ≥5.5%.and post hoc as ≥8.0% RBC-PL-DHA, the latter after examination of postpartum RBC-PL-DHA. Bayesian mixture models were fitted for gestational age and dichotomized for EPTB and PTB as a function of baseline RBC-PL-DHA and dose-adherence. Bayesian hierarchical models were also fitted for EPTB by dose adherence and quartiles of baseline RBC-PL-DHA. RESULTS: Adherence to the high dose using both RBC-PL-DHA cut points resulted in less EPTB compared to 200 mg [Bayesian posterior probability (pp) = 0.93 and 0.92, respectively]. For participants in the two lowest quartiles of baseline DHA status, adherence to the higher dose resulted in lower EPTB (≥5.5% RBC-PL-DHA, quartiles 1 and 2, pp = 0.95 and 0.96; ≥8% RBC-PL-DHA, quartiles 1 and 2, pp = 0.94 and 0.95). Using the Bayesian model, EPTB was reduced by 65%, from 3.45% to 1.2%, using both cut points. Adherence also reduced PTB before 35, 36 and 37 weeks using both cut points (pp ≥ 0.95). In general, performance of the nonadherent subgroup mirrored that of participants assigned to 200 mg. CONCLUSION: Adherence to high dose DHA reduced EPTB and PTB. The largest effect of adherence on reducing EPTB was observed in women with low baseline DHA levels. CLINICALTRIALS: gov (NCT02626299).
Asunto(s)
Nacimiento Prematuro , Femenino , Humanos , Recién Nacido , Embarazo , Teorema de Bayes , Suplementos Dietéticos , Ácidos Docosahexaenoicos , Edad Gestacional , Nacimiento Prematuro/prevención & controlRESUMEN
BACKGROUND: The purpose of this study was to determine cost of care for leg ulcers in sickle cell patients and suggest an improved modality in ulcer care. STUDY DESIGN: We performed a retrospective study of a group of sickle cell disease patients with leg ulcers. RESULTS: Eighteen patients with a leg ulcer (duration: mean, 53.7 months), sickle cell disease, and a mean of 20.7 years of age had various modalities of treatment with the only consistency in healing being a commercial moist-wound dressing. CONCLUSIONS: There is no consistency in the treatment of the sickle cell patient with a leg ulcer. Treatment with a moist dressing had the best results.
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Anemia de Células Falciformes/complicaciones , Úlcera de la Pierna/terapia , Apósitos Oclusivos/economía , Adolescente , Adulto , Arginina/análogos & derivados , Arginina/uso terapéutico , Vendas Hidrocoloidales , Butiratos/uso terapéutico , Coloides , Terapia Combinada , Análisis Costo-Beneficio , Eritropoyetina/uso terapéutico , Femenino , Costos de Hospital , Humanos , Úlcera de la Pierna/economía , Úlcera de la Pierna/fisiopatología , Tiempo de Internación/economía , Masculino , Proteínas Recombinantes/uso terapéutico , Recurrencia , Estudios Retrospectivos , Cicatrización de Heridas/fisiologíaRESUMEN
Despite a seemingly increased knowledge about the underlying causes of chronic leg ulcers, their management remains a challenge. Though some ulcers respond to various local treatment options appropriately, others seem to remain unresolved or with a chronic recurrent theme over months to years. The failure to heal these ulcers can be related to the underlying disease process, sometimes lack of patient compliance, and possibly, less than optimal treatment. Even when the exact diagnosis is made and appropriate treatment instituted, many ulcers may, nonetheless, require months of intervention. Certainly, the nonresponsive ulcer is best managed by an appropriate wound biopsy and culture, including a colony count.
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This paper describes a pilot study of chloride, nitrate, and sulphate content in thoracic and high-risk respirable fractions of airborne particles. Samples were collected at one measuring site in Zagreb in autumn 1998 and spring 1999. The results showed that almost total chloride, nitrate, and sulphate content was present in the respirable particle fraction. The average mass contribution of these pollutants to the particle mass amounted to 25%. Although chloride mass concentrations were quite low, the findings indicated that all pollutants originated from the same source.
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Contaminantes Atmosféricos/análisis , Cloruros/análisis , Nitratos/análisis , Sulfatos/análisis , Croacia , Tamaño de la Partícula , Proyectos PilotoRESUMEN
This paper presents a study on the relationship between trace metal concentrations and the state of the atmosphere at the Croatian EMEP station Puntijarka, Zagreb. PM(10) and PM(2.5) particle fractions are hazardous in terms of morbidity and hospitalization due to cardiovascular and respiratory diseases, and in terms of total mortality. In Zagreb, PM(10) and PM(2.5) monitoring started on a daily basis at a sampling site located in the northern, residential part of the city. Trace metal concentrations were determined from daily samples. Air mass back trajectories were used to determine particulate air pollution from local and remote sources. The investigation has shown a statistically significant association between air mass back trajectories and metallic air concentration levels.
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Contaminantes Atmosféricos/análisis , Aire/análisis , Cadmio/análisis , Plomo/análisis , Manganeso/análisis , Material Particulado/análisisRESUMEN
Mass concentrations of sulphur dioxide were determined in parallel 24-hour samples of ambient air at a measuring site in Zagreb during a period of eight years. The methods used were the West-Gaeke's tetrachloromercurate-pararosaniline method (TCM) and the Standard British Method (SBM). Total results for the annual intervals of measuring were analyzed statistically and also discussed separately for winter and summer periods, in order to see whether they are influenced by seasonal rhythm.
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Chronic leg ulcers may result from vasoocclusive complications associated with the decreased oxygen-carrying capacity of hemoglobin in patients with sickle cell disease or its variants. Nonsurgical management includes the use of anti-sickling drugs and chemical manipulation of the hemoglobin composition. It has been suggested that the use of recombinant human erythropoietin (r-HuEPO) may help by stimulating proliferation of red blood cell precursors; it also has been proposed that r-HuEPO may act as a growth factor to non-hematologic tissues. Surgical management is a choice of last resort, often requiring microsurgical techniques, such as free-flap transfer.