Efficacy and Safety of Ciprofloxacin Plus Fluocinolone in Otitis Media With Tympanostomy Tubes in Pediatric Patients: A Randomized Clinical Trial.

Importance: Acute otitis media with tympanostomy tubes (AOMT) in children commonly presents with otorrhea and negatively affects their daily activities. Objective: To evaluate the efficacy and safety of topical ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution relative to ciprofloxacin, 0.3%, otic solution alone and fluocinolone acetonide, 0.025%, otic solution alone in the treatment of AOMT in children. Design, Setting, and Participants: Two twin multicenter, randomized, double-blind clinical trials with identical designs were conducted from June 24, 2011, through June 23, 2014, at ear, nose, and throat pediatric practices, general practices, hospitals, and clinical research centers. The study population comprised 662 children (331 in each trial) with AOMT in at least 1 ear who presented with moderate or severe purulent otorrhea for 3 weeks or less. Data analyses were performed on an intention-to-treat basis. Interventions: Patients were randomly assigned to receive ciprofloxacin plus fluocinolone, ciprofloxacin alone, or fluocinolone alone twice daily for 7 days and were evaluated on days 1 (baseline), 3 to 5 (undergoing therapy), 8 to 10 (end of therapy), and 18 to 22 (test of cure). Main Outcomes and Measures: The primary efficacy measure was time to cessation of otorrhea. The principal secondary end point was sustained microbiological cure, defined as eradication or presumed eradication at end-of-therapy and test-of-cure visits. Results: A total of 662 children participating in the 2 studies were randomized to receive ciprofloxacin plus fluocinolone (n = 223), ciprofloxacin alone (n = 221), or fluocinolone alone (n = 218). The median age was 2.5 years (range, 0.6-12.7 years). The median time to cessation of otorrhea was 4.23 days (95% CI, 3.65-4.95 days) in patients receiving ciprofloxacin plus fluocinolone compared with 6.95 days (95% CI, 5.66-8.20 days) in those receiving ciprofloxacin and not estimable findings in those receiving fluocinolone alone (P < .001). The clinical cure rate at the test-of-cure visit was 80.6% in the ciprofloxacin plus fluocinolone group, 67.4% in the ciprofloxacin group (difference, 13.2%; 95% CI, 5.0%-21.4%; P = .002), and 47.6% in the fluocinolone group (difference, 33.0%; 95% CI, 24.0%-42.0%; P < .001). The sustained microbiological cure rate was 79.7% in the ciprofloxacin plus fluocinolone group vs 67.7% in the ciprofloxacin group (difference, 12.0%; 95% CI, 0.8%-23.0%; P = .04) and 37.6% in the fluocinolone group (difference, 42.1%; 95% CI, 29.3%-54.8%; P < .001). Only 7 (3.1%) of the patients receiving ciprofloxacin plus fluocinolone, 8 (3.6%) of the patients receiving ciprofloxacin, and 10 (4.7%) of the patients receiving fluocinolone presented with adverse events related to study medication. Conclusions and Relevance: The combination of ciprofloxacin plus fluocinolone is more effective than treatment with ciprofloxacin or fluocinolone alone for AOMT, and it is safe and well tolerated in children. Trial Registration: clinicaltrials.gov Identifiers: NCT01395966 and NCT01404611.

[Pathophysiology of healing]. / Fisiopatología de la cicatrización.

Treatment of wounds is part of the daily practice of the nursing staff and the knowledge of the physiology of healing, as well as modern treatment techniques are of great importance to provide the most effective and rapid healing method. The response of living tissues to injury constitutes the basis for understanding the process of healing. A reset of the total or partial integrity of tissues is part of a basic response. An alteration of the barrier of tissues can cause a loss of homeostasis generating a State of systemic hipermetabolism. Therefore, any wound caused a discontinuity of epithelium covering the body, triggers a cascade of events in a process to achieve that protection barrier will not disintegrate. These events will allow the regeneration of the tissue that has suffered the injury; forming a scar tissue that has the ability to maintain the barrier protection and support of the elements that it protects. Defined as scarring, to a natural repair process ofa wound by forming a scar. It is important to make a reminder of how you act reparative physiological mechanisms i.e. the cascade of healing processes, it is important to take into account these repair mechanisms to know the basis of how tissues work so you can assess and diagnose the alterations to this patient, in order to apply a right and proper treatment according to the needs of the patient.

Fisiopatología de la Cicatrización / Pathophysiology of healing

El tratamiento de las heridas forma parte de la práctica diaria del personal de enfermería y el conocimiento de la fisiología de la cicatrización, así como de las técnicas modernas de tratamiento, resulta de gran importancia para proporcionar el método más eficaz y rápido de curación. La respuesta de los tejidos vivos a la lesión constituye la base para entender el proceso de la cicatrización. Un restablecimiento de la integridad total o parcial de los tejidos forma parte de una respuesta básica. Una alteración de la barrera de los tejidos provocará una pérdida de la homeostasis generando un estado de hipermetabolismo sistémico. Por tanto, toda herida que causa una discontinuidad del epitelio de revestimiento en el organismo, desencadena una cascada de eventos en un proceso por lograr que la barrera de protección no se desintegre. Estos eventos permitirán la regeneración del tejido que ha sufrido la lesión, formando un tejido cicatrizal que tenga la capacidad de mantener la barrera de protección y sostén de los elementos que preserva. Se define como cicatrización a un proceso natural de reparación de una herida mediante la formación de una cicatriz. Es importante recordar cómo actúan los mecanismos fisiológicos reparadores, es decir, los procesos de la cascada de la cicatrización, ya que es importante tener en cuenta estos mecanismos de reparación para conocer la base de cómo funcionan los tejidos y así poder valorar y diagnosticar las alteraciones que el paciente presente, con el fin de aplicar un tratamiento correcto y adecuado de acuerdo a las necesidades del enfermo (AU)

Treatment of wounds is part of the daily practice of the nursing staff and the knowledge of the physiology of healing, as well as modern treatment techniques are of great importance to provide the most effective and rapid healing method. The response of living tissues to injury constitutes the basis for understanding the process of healing. A reset of the total or partial integrity of tissues is part of a basic response. An alteration of the barrier of tissues can cause a loss of homeostasis generating a State of systemic hipermetabolism. Therefore, any wound caused a discontinuity of epithelium covering the body, triggers a cascade of events in a process to achieve that protection barrier will not disintegrate. These events will allow the regeneration of the tissue that has suffered the injury; forming a scar tissue that has the ability to maintain the barrier protection and support of the elements that it protects. Defined as scarring, to a natural repair process of a wound by forming a scar. It is important to make a reminder of how you act reparative physiological mechanisms i.e. the cascade of healing processes, it is important to take into account these repair mechanisms to know the basis of how tissues work so you can assess and diagnose the alterations to this patient, in order to apply a right and proper treatment according to the needs of the patient (AU)

Tinnitus retraining therapy: prognosis factors.

INTRODUCTION: Tinnitus retraining therapy (TRT) is, nowadays, one of the most extended treatments for tinnitus control. The goal is the habituation to a nonsignificative signal, that is, tinnitus, first, eliminating its reaction and, second, minimizing its perception. PURPOSE: The objective of this study is to identify the factors that could improve or reduce the efficacy of TRT. MATERIALS AND METHODS: A prospective nonrandomized clinical assay (n = 137) was conducted. Three parameters were considered for tinnitus evaluation at 1-year follow-up: patient self-evaluation, visual analogue scale for intensity, and Tinnitus Handicap Inventory. RESULTS: Tinnitus retraining therapy group improved at 1-year follow-up, considering the 3 parameters. The most important factor of failure to TRT efficacy has been the refuse to instrumentation when it was required, according to TRT recommendations. Tinnitus Handicap Inventory score in this group did not show any improvement (P = .009). Highest scores of tinnitus intensity (visual analogue scale) and handicap (Tinnitus Handicap Inventory) before treatment as well as the most disabled diagnosis (sudden deafness and Meniere's disease) had better response to TRT. Jastreboff's treatment categories, longer presence of tinnitus, existence of hyperacusis or hearing loss, type of prosthesis used, duration of the treatment, and index of assistance to our follow-up program were not related to the effectiveness of TRT. CONCLUSIONS: Tinnitus retraining therapy has demonstrated to be an effective treatment of tinnitus. More severe tinnitus are susceptible to get better response with this approach. Instrumentation, when recommended, is mandatory to obtain a higher relief of this symptom (EMB rating: B-2).

Long-term clinical trial of tinnitus retraining therapy.

OBJECTIVE: To demonstrate the efficacy of tinnitus retraining therapy (TRT) for tinnitus relief compared to a waiting list group and a partially treated group (patients that refused prosthesis adaptation). STUDY DESIGN: Prospective non-randomised clinical assay (n = 158). Visual analogue scale (VAS) for intensity and the Tinnitus Handicap Inventory (THI) were evaluated at 12-month period. RESULTS: Eighty two percent of the patients that followed TRT improved their tinnitus according to their self-evaluation. THI score was reduced from 48% to 32% and VAS decreased from 6.6 to 5.3 after one year (p < 0.05). TRT patients showed a higher improvement on their tinnitus, THI and VAS scores when compared with the waiting list patients and with patients that refused prosthesis adaptation when recommended (p < 0.05). CONCLUSIONS: TRT improved tinnitus in 82% of the subjects and statistically reduced THI and VAS scores after 12 months. TRT has shown to be more effective than a waiting list group and partially treated patients. EBM RATING: B-2.

Influence of Temperature of Incubation on Staphylococcus aureus Growth and Enterotoxin Production in Homemade Mayonnaise.

Homemade mayonnaise, in which pH had been adjusted to a range between 5.0 and 5.8 by the addition of vinegar, was inoculated with eight Staphylococcus aureus strains known to be enterotoxigenic. They were incubated for a maximum of 7 days at 22, 28, 37, and 44°C. Periodically, staphylococcal growth and pH were determined. Mayonnaise samples were examined on d 7 for the presence of enterotoxins A, B, C, and D. Staphylococcal growth was higher at 22°C (average log10 7.21 cfu/g), than at the other temperatures tested (log10 7.15, 6.77, and 5.93 cfu/g, respectively for 28, 37, and 44°C), suggesting a better growth in mayonnaise at low room temperature. Enterotoxin synthesis took place mainly at 28°C, as 33.3% of the total enterotoxins produced were detected at this temperature. However, some strains synthesized high amounts of enterotoxin even at 22°C.