Validation of the 10-Item Unilateral Vocal Fold Paralysis-Handicap Index quality of life questionnaire.

OBJECTIVES: To validate and test the reliability of the 10-Item Unilateral Vocal Fold Paralysis-Voice Handicap Index (UVFP-HI-10) quality of life (QoL) questionnaire for patients with UVFP. DESIGN: Prospective describe study based on perceptive surveys. PARTICIPANTS: We recruited 61 patients with UVFP and 53 healthy individuals comprised the control group. MAIN OUTCOME MEASURES: Both the patients and controls completed the UVFP-HI-10 questionnaire. A statistical analysis was performed to assess the internal consistency and validity of the survey. In addition, maximum phonation time (MPT) was used to objectively measure patient QoL. RESULTS: Internal consistency was high (α = .914) and the correlation with MPT was significant (rs = -0.722). The estimated marginal mean in the discriminant validity study was around seven times higher in the UVFP group compared to the controls. The UVFP-HI-10 cut-off value was more than 0.9 and the sensitivity and specificity were more than 0.8. CONCLUSIONS: The UVFP-HI-10 is a self-administered patient-reported outcome questionnaire with a high reliability and excellent criterion-based validity. This questionnaire can be used to evaluate specific clinical complaints (e.g., vocalisation, swallowing, and breathing) in terms of their impact on QoL in patients with UVFP. Thus, its use is appropriate as a basic assessment tool as part of a specific UVFP treatment protocol.

Diagnosis and management with botulinum toxin in 11 cases of laryngeal synkinesis.

Laryngeal synkinesis is a vocal fold movement disorder produced by a misdirected reinnervation after a recurrent laryngeal nerve injury. Its symptoms differ greatly between patients, requiring diverse therapeutical approaches. We aim to describe our experience in the diagnosis and treatment of different laryngeal synkinesis presentations. 11 patients diagnosed between 2011 and 2014 in a tertiary referral center with laryngeal synkinesis confirmed by laryngeal electromyography were included in our study. All medical records and laryngoscopic and electromyographic data were reviewed retrospectively. Four patients had previous unilateral vocal fold palsy and seven had a bilateral palsy with different degrees of clinical involvement. All of them showed paradoxical movements during inhalation in videofibrolaryngoscopic examination. Laryngeal electromyography confirmed the diagnosis of laryngeal synkinesis. Dyspnea was the main presentation symptom. Three patients with mild symptoms were not treated. Patients with unilateral vocal fold immobility were successfully treated with periodic botulinum toxin injections. Patients with bilateral immobility had a good initial response to botulinum toxin, although in some of them, a posterior cordectomy had to be finally performed. In conclusion, laryngeal synkinesis is a heterogeneous clinic entity that appears in patients with unilateral or bilateral vocal fold paralysis. Videofibrolaryngoscopy and laryngeal electromyography are essential to a correct diagnosis. Botulinum toxin injections are the main treatment for symptomatic cases, even if in bilateral palsy cases more aggressive treatments are often required.

Laryngeal Dystonia, Dystonic Tremor and Vocal Tremor: Three Different Entities.

OBJECTIVE: The main objective of this study was to compare the demographic and clinical characteristics of patients with laryngeal dystonia (LD), dystonic tremor (DT), and vocal tremor (VT). STUDY DESIGN: This was a retrospective longitudinal study. METHODS: Data analysis from every patient diagnosed with LD, DT, or VT from January 1, 2010, to September 30, 2022, at a tertiary hospital center. Differential diagnosis between these entities was clinical (clinical history, voice assessment, and endoscopy) and confirmed by laryngeal electromyography. RESULTS: A total of 87 patients were included in this study: 50 patients with LD, 23 with DT, and 14 with VT. Age at diagnosis was significantly lower in patients with LD, with a mean age of 56.2 years when compared to DT (67.6 years; P = 0.002) and VT (70.5 years; P = 0.009). Furthermore, VT had a higher female prevalence (92.9%) when compared with LD (52%; P = 0.011). LD was mainly adductor, with only two patients diagnosed with abductor LD, and DT was adductor in every case. Tremor direction in patients with VT was horizontal in 50% and mixed (horizontal + vertical) in 50%, while in DT was mixed in 65.2% and horizontal in 34.8%. LD was more commonly an isolated laryngeal movement disorder (78%) when compared to DT (47.8%; P = 0.015) or VT (28.5%; P < 0.001), which were more often secondary to generalized neurological disorders. There were no differences between groups on Voice Handicap Index-10, self-reported grade of dysphonia on a visual analogic scale (0-10), maximum phonation time, and G, R, B, A, and I in the GRBAS-I scale at diagnosis (P > 0.05). S was significantly higher in LD when compared to VT (P < 0.001) and nonsignificantly higher than in DT (P = 0.075). CONCLUSIONS: LD, DT, and VT seem to be different entities with different demographics and clinical characteristics.

Quality of the singing voice in sopranos. Influence of the text and the musical accompaniment in the opera singing.

INTRODUCTION AND OBJECTIVES: Opera singing voice uses different technical tools for artistic purposes. We want to define if the quality of the sung sound is affected by an aware work on the musical accompaniment and the text. We analyse the acoustic signal and the subjective perception. The pitch studied in the soprano voice is A4 (880 Hz) with the vowel /a/. We have chosen a tone and a vowel that can be generated by different strategies in terms of phonoresonance adjustments. MATERIALS AND METHODS: We have carried out a prospective study with 20 sopranos, without voice pathology, who have sung a phrase from the aria Deh, vieni non tarda and another from the aria Dove sono i bei momenti from the opera Le nozze di Figaro, by W.A. Mozart. First, each phrase sung spontaneously was recorded and then a second time, after a proposed work on the content of the text and musical aspects of the accompaniment such as: rhythm, harmony, texture and direction of the phrase. The participants prolonged the emission of the A4 for more than three seconds, maintaining the context of the sentence. The acoustic signal has been analysed using the PRAAT programme and a VAS (Visual Analogue Scale) questionnaire has been used to collect subjective perceptions. RESULTS: The mean age was 36 ± 11 years (range between 20 and 58) and the mean number of years singing was 17 ± 12 years (range between 3 and 35). No statistically significant differences were found, although an improvement in the VAS was seen in the second sentence after the intervention. CONCLUSIONS: The acoustic analysis parameters are stable, and the VAS tends to improve when an awareness of the text and the instrumental accompaniment is carried out.

Is Immobile vocal fold Related to the Spinal Accessory Nerve Agenesis?: A Case Report.

The spinal accessory nerve innervates the sternocleidomastoid and trapezius muscles, but the internal branch from the spinal accessory nerve is also contributing to the motor innervation of the larynx. For the first time, we report a case of an impairment of sternocleidomastoid, trapezius, and thyroarytenoid muscles from the same side. In our case, the anatomical variant that can explain this situation implies the cranial roots and some fibers from the spinal roots of the spinal accessory nerve to form the internal branch. In the case of agenesis of these spinal roots, the muscles reliant on it would be missing. For this reason, it is advisable to rule out laryngeal problems in patients with sternocleidomastoid and/or trapezius muscles impairment.

Pediatric Palliative Care at Home: A Prospective Study on Subcutaneous Drug Administration.

CONTEXT: The subcutaneous route is a useful alternative for drug administration in palliative care. Although there is scientific evidence on its use in adult patients, the literature in pediatric palliative care is almost nonexistent. OBJECTIVES: To describe the experience of a pediatric palliative care unit (PPCU) with in-home subcutaneous drug administration symptom control. METHODS: Prospective observational study of patients receiving home-based subcutaneous treatment administered as part of a PPCU treatment regimen over 16 months. Analysis includes demographic and clinical variables and treatment received. RESULTS: Fifty-four different subcutaneous lines were inserted in the 15 patients included, mainly in the thigh (85.2%). The median time of needle in situ was 5.5 days (range: 1-36 days). A single drug was administered in 55.7% of treatments. The most frequently used drugs were morphine chloride (82%) and midazolam (55.7%). Continuous subcutaneous infusion was the predominant administration route (96.7%), with infusion rates oscillating between 0.1 mL/h and 1.5 mL/h. A statistically significant relationship was found between the maximum infusion rate and induration onset. Of the 54 lines placed, 29 (53.7%) had an associated complication requiring line removal. The primary cause for removal was insertion-site induration (46.3%). Subcutaneous lines were mainly used to manage pain, dyspnea, and epileptic seizures. CONCLUSION: In the pediatric palliative care patients studied, the subcutaneous route is most frequently used for administering morphine and midazolam in continuous infusion. The main complication was induration, especially with longer dwell times or higher infusion rates. However, further studies are required to optimize management and prevent complications.

Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project. / Mapa de utilización de mezclas analgésicas por vía parenteral en España. Proyecto MEDPAIN.

OBJETIVE: This study is the first part of the MEDPAIN project "Update of analgesic parenteral admixtures: studies of use, compatibility and stability", and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. METHODS: Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020-April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. RESULTS: A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 =4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. According to the definition of AM in this study, there were finally 137 different combinations mainly with two drugs (40.6%), but also with three (37.7%), four (15.2%) and five ingredients (6.5%). CONCLUSION: This study reveals the wide variability in current clinical practice and shows which are the most used analgesic parenteral admixtures in our country.

[Translated article] Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project.

OBJECTIVE: This study is the first part of the MEDPAIN project "Update of analgesic parenteral admixtures: studies of use, compatibility and stability", and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. METHODS: Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020 - April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. RESULTS: A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 = 4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. According to the definition of AM in this study, there were finally 137 different combinations mainly with two drugs (40.6%), but also with three (37.7%), four (15.2%) and five ingredients (6.5%). CONCLUSION: In conclusion, this study reveals the wide variability in current clinical practice and shows which are the most used analgesic parenteral admixtures in our country.

Vocal fold immobility with normal LEMG: A range of possibilities.

OBJECTIVE: The objective of this paper is to study the etiology of vocal fold immobility with non-pathological LEMG. METHODS: A retrospective study was performed on patients who presented with vocal fold immobility and underwent LEMG from 2009 to 2017. Those patients with normal LEMG findings were selected. The different causes of vocal fold impairment were studied. RESULTS: Of the 120 patients included in this study, 15 had a normal LEMG recording. The different etiologies of vocal fold immobility were idiopathic, central nervous system damage, iatrogenic, and external compression. CONCLUSIONS: Vocal fold immobility and vocal fold paralysis are not equal terms. Vocal fold immobility with normal LEMG has a heterogeneous group of causes. It is not correct to assume that the major cause of immobility in patients with normal LEMG is always cricoarytenoid joint fixation.

Laryngeal electromyography, a useful tool in difficult cases of pediatric laryngeal mobility disorders.

INTRODUCTION: Pediatric laryngeal mobility disorders constitute a challenge in terms of diagnosis and treatment, especially in small children and those complex patients with prior history of prolonged intubation or surgery. Laryngeal electromyography (L-EMG) may help to distinguish vocal fold paralysis from fixation. MATERIAL AND METHODS: Ten children with laryngeal mobility disorders (including bilateral vocal fold immobility (BVFI) or unilateral vocal fold immobility (UVFI) with contralateral hypomobility) underwent suspension laryngoscopy and L-EMG between July 2019 and March 2021. The EMG data were acquired simultaneously in both thyroarytenoid muscles. Anesthesia was lightened until volitional activity appeared like cough, cry or spontaneous Valsalva maneuver. RESULTS: We found secondary airway lesions in 2 patients and 3 vocal fold fixation. L-EMG recordings were pathologic in 4 patients (3 moderate and 1 severe nerve lesion). No recurrent laryngeal nerve injury was found in congenital BVFI cases. The data from both suspension laryngoscopy and L-EMG recordings influenced clinical decision-making. CONCLUSIONS: L-EMG adds value to suspension laryngoscopy in the management of pediatric patients with laryngeal mobility disorders. Selected cases such as patients with iatrogenic BVFI, UVFI with associated contralateral hypomobility or patients with combined pathologies may obtain the greatest benefit.

Vocal fold immobility with normal LEMG: A range of possibilities.

OBJECTIVE: The objective of this paper is to study the etiology of vocal fold immobility with non-pathological LEMG. METHODS: A retrospective study was performed on patients who presented with vocal fold immobility and underwent LEMG from 2009 to 2017. Those patients with normal LEMG findings were selected. The different causes of vocal fold impairment were studied. RESULTS: Of the 120 patients included in this study, 15 had a normal LEMG recording. The different etiologies of vocal fold immobility were idiopathic, central nervous system damage, iatrogenic, and external compression. CONCLUSIONS: Vocal fold immobility and vocal fold paralysis are not equal terms. Vocal fold immobility with normal LEMG has a heterogeneous group of causes. It is not correct to assume that the major cause of immobility in patients with normal LEMG is always cricoarytenoid joint fixation.

Off-Label and Unlicensed Drugs in Pediatric Palliative Care: A Prospective Observational Study.

CONTEXT: Off-label and unlicensed use of drugs is a widespread practice in pediatric care because of the lack of specific efficacy and safety data and the absence of formulations adapted to the needs of these individuals. Pediatric patients with a life-limiting illness frequently receive drugs under these conditions, although no studies have established the prevalence of this practice. OBJECTIVES: To describe the prevalence, indications, and most common uses of off-label and unlicensed drugs in a pediatric palliative care unit (PPCU). METHODS: A prospective cross-sectional observational study carried out between January and October 2019. RESULTS: About 85 patients involving 1198 prescriptions were analyzed. A total of 39.6% were off label, and 12.9% were unlicensed. All received at least one off-label drug, with a median of five per patient (interquartile range 3-7), and 81.2% received at least one unlicensed drug. A total of 36.1% of the prescriptions were considered off label because of indication, 33.8% because of dosage, and 26.6% because of age. The main drugs used off label were oral morphine, oral levetiracetam, inhaled albuterol, sublingual ondansetron, oral tizanidine, sublingual fentanyl, and oral diazepam. The main symptoms treated with off-label drugs were dyspnea, pain, and nausea/vomiting. CONCLUSION: More than half of the prescriptions in this PPCU were off label or unlicensed. Treatment indication was one of the main reasons for off-label use. Administration of compounded preparations was common in patients with a life-limiting illness.

Clinical experience with patients with spasmodic dysphonia and primary Meige syndrome. / Experiencia clínica en pacientes con síndrome de Meige primario y disfonía espasmódica.

INTRODUCTION: Meige syndrome (MS) is part of the group of segmental cranial dystonias, which affect more than two cranial muscle groups. Specifically, blepharospasm is associated with another cranial dystonia (oromandibular, cervical or laryngeal). The aim of this paper was to report our experience in patients with spasmodic dysphonia (SD) associated with primary MS. MATERIAL AND METHODS: A retrospective study involving 8 patients between May 2010 and June 2015. Variables recorded were: age, sex, associated dystonia, electromyographic pattern in laryngeal muscles and treatment given. Outcomes after treatment were assessed using GRBAS(i) scale and VHI-30 questionnaire, always provided by the same examiner. RESULTS: Fifty-six patients with MS were treated in the Neurology Department. Eight patients of 56 were diagnosed with SD (prevalence of 14%). All of our patients had adductor SD. The median age was 71years. All the patients were treated with intralaryngeal botulinum toxin under electromyographic control. Clinically relevant improvements were found after treatment on both the GRBAS(i) scale and the VHI-30 questionnaire. CONCLUSION: In the study of SD, we should always rule out an association with MS. From the point of view of otorhinolaryngology, the joint use of the GRBAS(i) scale and the VHI-30 questionnaire are useful, reliable and efficient methods for assessing progress and response to treatment. Laryngeal infiltration under electromyographic control with botulinum toxin is the therapeutic alternative that provides better results. The management of SD associated with MS does not differ from isolated SD.

Mapa de utilización de mezclas analgésicas por vía parenteral en España. Proyecto MEDPAIN / Map of use of parenteral analgesic admixtures in Spain. MEDPAIN project

Objetivo: este estudio corresponde a la primera etapa del proyecto MEDPAIN «Actualización de mezclas analgésicas por vía parenteral: estudios de utilización, compatibilidad y estabilidad», y tiene por objetivo la elaboración de un mapa a nivel nacional del empleo de mezclas analgésicas en los hospitales y los centros sociosanitarios. Material y método estudio transversal, basado en una encuesta dirigida a farmacéuticos hospitalarios, durante el período diciembre 2020 - abril 2021. Se diseñó un cuestionario multirrespuesta en la plataforma RedCap® para su difusión a través de la lista de distribución de la Sociedad Española de Farmacia Hospitalaria. Se definió mezcla analgésica como la combinación de 2 o más principios activos, de los cuales al menos uno es analgésico. Una misma combinación de fármacos a distintas concentraciones, o administrada por diferentes vías, se consideró una misma mezcla a efectos de este estudio. Se registraron variables relacionadas con el centro participante y otras relacionadas con las mezclas analgésicas: composición farmacológica de la mezcla, vía de administración, frecuencia de uso, indicación, tipo de paciente (adulto/pediátrico), ámbito en el que se utiliza (hospitalario/domicilio) y lugar de preparación. Resultados se recibieron un total de 67 encuestas válidas (55,4%) procedentes de 13 comunidades autónomas. Los 67 centros sanitarios comunicaron un total de 462 mezclas analgésicas. La mediana de mezclas informadas por centro participante fue de 6 (RIC p25-p75 = 4,0-9,0). La mayoría de las mezclas notificadas se utilizan en adultos (93,9%) y en el ámbito hospitalario (91,8%); mayoritariamente se trata de mezclas protocolizadas y de uso frecuente. El 21,4% se preparan en el servicio de farmacia. En las mezclas descritas aparecen 26 fármacos distintos; predominan los analgésicos opioides, presentes en el 87,4% de las mezclas. El fármaco coadyuvante más frecuente es el midazolam. ... (AU)

Objetive: This study is the first part of the MEDPAIN project “Update of analgesic parenteral admixtures: studies of use, compatibility and stability”, and its goal is to develop a national map about the use of analgesic parenteral admixtures in healthcare settings. Methods Observational study, based on a survey aimed at Spanish hospital pharmacists, during the period December 2020–April 2021. The questionnaire was designed in the RedCap® platform and disseminated through the Spanish Society of Hospital Pharmacy distribution list. An analgesic parenteral admixture (AM) was defined as the combination of two or more drugs, with at least one of them being an analgesic. The same combination of active ingredients, at different concentration and/or administered by different routes, was considered as a unique AM in this study. Some registered endpoints were related to the characteristics of the healthcare settings participating in the study, and others were related to the AM, such as drugs, doses and concentration range, route of administration, frequency of use, indication and type of patient (adult/pediatric) and where they are prepared. Results A total of 67 valid surveys from healthcare settings of 13 Spanish Autonomous Communities were received. They reported 462 AM. Every healthcare center informed an average of 6 AM (ICR p25-p75 =4.0-9.0). Most of the reported mixtures were used in adults (93.9%) at hospital settings (91.8%), and they were mostly protocolized and frequently used. The 21.4% of them were compounded at the Pharmacy service. The AM included 26 different drugs, with opioid analgesics being present at the 87.4% of them. Midazolam was the most usual adjuvant drug. ... (AU)

Inmovilidad de cuerdas vocales con electromiografía laríngea normal: un abanico de posibilidades / Vocal fold immobility with normal LEMG: A range of possibilities

Objective: The objective of this paper is to study the etiology of vocal fold immobility with non-pathological LEMG. Methods: A retrospective study was performed on patients who presented with vocal fold immobility and underwent LEMG from 2009 to 2017. Those patients with normal LEMG findings were selected. The different causes of vocal fold impairment were studied. Results: Of the 120 patients included in this study, 15 had a normal LEMG recording. The different etiologies of vocal fold immobility were idiopathic, central nervous system damage, iatrogenic, and external compression. Conclusions: Vocal fold immobility and vocal fold paralysis are not equal terms. Vocal fold immobility with normal LEMG has a heterogeneous group of causes. It is not correct to assume that the major cause of immobility in patients with normal LEMG is always cricoarytenoid joint fixation. (AU)

Objetivo: El propósito de este artículo es estudiar la etiología de la inmovilidad de las cuerdas vocales con una EMG laríngea no patológica. Métodos: Se ha realizado un estudio retrospectivo de pacientes con inmovilidad de cuerdas vocales a los que se les hizo EMG laríngea desde 2009 a 2017. Se seleccionaron los pacientes con EMG laríngea normal. Se estudiaron las diferentes causas de inmovilidad de las cuerdas vocales. Resultados: De los 120 pacientes incluidos en el estudio, 15 tuvieron un resultado de EMG laríngea normal. Las diferentes etiologías de inmovilidad de las cuerdas vocales fueron idiopáticas, lesiones del sistema nervioso central, causas iatrogénicas y compresión externa. Conclusiones: La inmovilidad de cuerdas vocales y la parálisis de cuerdas vocales no son términos equivalentes. La inmovilidad de cuerdas vocales con EMG laríngea normal tiene un grupo de causas heterogéneo. No es correcto asumir que la principal causa de inmovilidad de cuerdas vocales en pacientes con EMG laríngea normal sea siempre la fijación cricoaritenoidea. (AU)

Laryngeal Electromyography for Prognosis of Vocal Fold Paralysis.

OBJECTIVE: This study aimed to determine the value of laryngeal electromyography in the prognosis of vocal fold paralysis. STUDY DESIGN: This is a retrospective descriptive study. MATERIALS AND METHODS: This study included 80 patients diagnosed with unilateral or bilateral vocal fold paralysis on flexible laryngoscopy between 2002 and 2014 in a tertiary medical center. Laryngeal electromyography using a standardized protocol was performed; the outcome measures were classified and analyzed into two groups according to the degree of injury. Group 1 included patients with mild to moderate injury, and group 2 included patients with severe to complete injury. Prognosis was correlated with vocal fold motion recovery status with a minimum of 6 months of follow-up since the symptoms onset using positive and negative predictive values. RESULTS: Sixty patients showed acute or chronic recurrent laryngeal neuropathy in laryngeal electromyography. Twelve of 41 patients included in group 1 recovered motion, and 30 of 35 patients included in group 2 did not recover, resulting in 88.2% of positive predictive value and 35.7% of negative predictive value. CONCLUSIONS: Our data confirm that laryngeal electromyography is a useful clinical tool in predicting poor recovery in patients with vocal fold paralysis. It allows identification of candidates for early intervention.

[Off-label and unlicensed drug use: Results from a pilot study in a pediatric intensive care unit]. / Utilización de medicamentos en condiciones off-label y unlicensed: resultados de un estudio piloto realizado en una unidad de cuidados intensivos pediátricos.

PURPOSE: To analyze the prevalence of use of off-label and unlicensed drugs in a pediatric intensive care unit of a University Hospital. METHOD: An observational, descriptive, prospective six week pilot study in a Pediatric Intensive Care Unit. Hospitalized patients aged between 0 and 18 years were included. Each prescribed drug was evaluated taking into account indication and condition of use, according to the information available on the Summary of Product Characteristics established by the European Medicines Agency. A sequential algorithm was defined allowing drug classification in unlicensed, off-label or approved. RESULTS: Forty-two patients were included. A total of 696 prescriptions, involving 102 different drugs, were analyzed. All patients had at least one off-label prescription, and a median of 8.9 off-label prescriptions was obtained. Of the total prescriptions, 8.6% were unlicensed and 53.9% corresponded to off-label use. The main reason for off-label use was by indication, followed by age and dose. A lineal tendency between off-label drug use and patient age was observed, where off-label use increased as patient age decreased. The drugs most commonly used off-label were: atropine, etomidate, dipyrone and ranitidine, and unlicensed drugs: spironolactone, sildenafil, acetazolamide and hydrochlorothiazide. CONCLUSION: Pediatric Intensive Care Units are characterized by a high ratio of off-label and unlicensed prescriptions. The scarce number of studies performed in this specific and complex sub-population added inconveniency to the current lack of data on safety and efficacy for drugs in paediatrics. Performing studies with these characteristics allows us to document practice on paediatric drug utilisation are required.

Molecular and phenotypic typing of Staphylococcus aureus isolates from rabbit meat.

Twenty-six Staphylococcus aureus isolates were recovered from rabbit carcasses and cuts during a period of seven months. Samples from 51 different animals, flocks and farms were obtained from five establishments in four Spanish provinces. To determine their diversity and possible origin, isolates were typed by three molecular and three phenotypic methods. PFGE, with the highest discrimination index (D=0.966), identified 19 patterns (more than one band difference) and 10 types (more than three band differences). Based on > or = 90% similarity, RAPD (D=0.877) produced nine patterns while ribotyping (D=0.786) produced seven types. On the basis of biotyping (D=0.644), 11 isolates belonged to human ecovars and 15 to the non-host-specific crystal violet type C (NHS CV:C) biotypes. By direct phage typing (D=0.761), 17 isolates were lysed by human phages into groups II (8 isolates), III (5 isolates), I/III (2 isolates) and V (2 isolates). The overall resistance to antimicrobials (D=0.783) was 76.9%, with most isolates being resistant to tetracycline (61.5%) and penicillin G (26.9%). PFGE showed that samples from each processing plant carried different S. aureus types, some of them persisting over time. There also was evidence of interestablishment dissemination of genetically related clones, most of them belonging to the PFGE type A and phenotype "NHS CV:C biotypes-3A/3C/55/71 phage type", which is highly virulent for European commercial rabbitries. The ubiquity of the virulent phenotype, as well as the high incidence of resistance to antibiotics with application in human medicine, is a matter of concern in public and animal health.

Rabbit meat as a source of bacterial foodborne pathogens.

Even though worldwide production of rabbit meat is >1,000,000 tons, little information is available for rabbit meat microbiology. This study provides data on the prevalence of Salmonella, Escherichia coli O157:H7, Yersinia enterocolitica, Listeria spp., motile Aeromonas spp., and Staphylococcus aureus on rabbit meat. A total of 24 rabbit carcasses from two abattoirs and 27 rabbit meat packages from supermarket displays were examined. In addition to culturing methods, associated virulence genes were investigated by PCR in suspect isolates and samples. Neither Salmonella nor E. coli O157:H7 was detected. All samples were negative for virulence-associated invA, stx1, and stx2 genes. At one abattoir, two carcasses (3.9%) carried Y. enterocolitica yst-, and two were positive for the yst gene, although viable Y. enterocolitica cells were not recovered from these samples. Seven samples (13.7%) were contaminated with Listeria. Of them, three were positive for hly and iap genes (Listeria monocytogenes hly+ / iap+), two carried Listeria seeligeri, one carried Listeria ivanovii, and one carried Listeria innocua. For detectable motile Aeromonas spp. (average count, 1.77 +/- 0.62 log CFU/g), the contamination rate was 35.3%, although ca. 90% of the samples were positive for the aerA and/or hlyA genes. The majority of aeromonad isolates were Aeromonas hydrophila aerA+ / hlyA+. Aeromonas caviae, Aeromonas popoffii, Aeromonas schubertii, and the two biovars of Aeromonas veronii were also isolated. The prevalence of S. aureus contamination (average count, 1.37 +/- 0.79 log CFU/g) was 52.9%. Among 27 S. aureus isolates, two harbored genes for staphylococcal enterotoxin B (seb), and two harbored genes for staphylococcal enterotoxin C (sec). The remaining isolates were negative for sea, seb, sec, sed, and see.

Incidence, radioresistance, and behavior of Psychrobacter spp. in rabbit meat.

The relative incidence of Psychrobacter spp. in rabbit meat, the radioresistance of these bacteria, and the growth of nonirradiated and irradiated psychrobacter isolates, alone and in coculture, during chilled storage of inoculated sterile rabbit meat was investigated. Psychrobacter spp. accounted for 4.2% of the storage psychrotrophic flora of 30 rabbit carcasses. The radiation D10-values of 10 Psychrobacter isolates, irradiated at 4 degrees C in minced rabbit meat, ranged from 0.8 to 2.0 kGy, with significant (P < 0.05) differences among strains. Over 12 days of storage at 4 degrees C, pure cultures of two nonirradiated psychrobacter strains (D10 = 2 kGy) were capable of substantial increases (up to 3 log CFU/g) in sterile rabbit meat, but when the fastest growing strain was cocultured with Pseudomonas fluorescens and Brochothrix thermosphacta isolates, maximum cell densities and growth rates were significantly (P < 0.01) lower. After irradiation (2.5 kGy) of pure cultures in sterile rabbit meat, surviving cells of both Psychrobacter strains decreased for a period of 5 to 7 days and then resumed multiplication that, at day 12, resulted in a similar increase (1.6 to 1.7 log CFU/g) over initial survivor numbers. When irradiated in combination with the spoilage bacteria, one of the strains required 12 days to reach initial numbers. In conclusion, Psychrobacter spp. are radioresistant nonsporeforming bacteria with a low relative incidence among the storage flora of rabbit meat, unable to compete with food spoilage bacteria in this ecosystem and apparently not a major contributor to the spoilage of rabbit meat after irradiation.