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1.
Cephalalgia ; 44(8): 3331024241267316, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-39127462

RESUMEN

BACKGROUND: Data on drug-induced reversible cerebral vasoconstriction syndrome (RCVS) are scarce. We aimed to describe RCVS characteristics with drugs previously identified as associated with RCVS and investigate potential signals related to other drugs. METHODS: VigiBase® was queried for all reports of RCVS until 31 May 2023. A descriptive study was performed on reports concerning drug classes known to precipitate RCVS. To identify new drugs, a disproportionality analysis was conducted. RESULTS: In total, 560 reports were included. RCVS occurred in patients aged between 45-64 years (40%) and 18-44 years (35%), mainly in females (72.5%). Drugs were antidepressants (38.4%), triptans (6.4%), nasal decongestants (3.7%) and immunosupressants (8.7%). In 50 cases, antidepressants were in association with drugs known to precipitate RCVS. The median time to onset was 195 days for antidepressants and much shorter (1-10 days) for triptans, nasal decongestants and immunosuppressants. The outcome was favorable in 87% of cases, and fatal in 4.4%. We found a disproportionality signal with 14 drugs: glucocorticoids, bupropion, varenicline, mycophenolic acid, aripiprazole, trazodone, monoclonal antibodies (erenumab, ustekinumab and tocilizumab), leuprorelin and anastrozole. CONCLUSIONS: The present study confirms the role of vasoconstrictors in the onset of RCVS, particularly when used in combination and found potential signals, which may help clinicians envisage an iatrogenic etiology of RCVS.


Asunto(s)
Farmacovigilancia , Humanos , Femenino , Persona de Mediana Edad , Masculino , Adulto , Adolescente , Adulto Joven , Vasoespasmo Intracraneal/inducido químicamente , Vasoespasmo Intracraneal/epidemiología , Antidepresivos/efectos adversos , Descongestionantes Nasales/efectos adversos , Inmunosupresores/efectos adversos , Triptaminas/efectos adversos , Anciano
2.
Eur Arch Otorhinolaryngol ; 281(10): 5255-5259, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-38740578

RESUMEN

BACKGROUND: Rhinitis medicomentosa (RM) is a form of non-allergic rhinitis caused by the use of nasal decongestants for longer than the recommended duration. Because of this problem of use, addiction to the drug occurs in individuals. In our study, we aimed to evaluate the susceptibility of RM patients to substance addiction. METHODS: The study was planned as a prospective, multicentric study between September 2022 and September 2023. Patients diagnosed with RM were included in the study. Beck depression scale, Drug use disorders identification test, Substance Abuse Proclivity Scale were applied to the patients participating in the study. The research data were analyzed electronically with SPSS program version 25. RESULTS: The study included 86 patients with an average age of 31 years. The average duration of medication use was 22 months. Age, gender, duration of nasal congestion, duration of drug use and smoking were not independent predictors for depression and substance use tendency. CONCLUSION: The relationship between RM and addictive substances is not clear. The tendency to use drugs did not increase in RM patients. In the light of these data, we think that there is no need for a practice other than routine functioning in the use of drugs and similar substances that are likely to cause addiction in RM patients.


Asunto(s)
Descongestionantes Nasales , Rinitis , Trastornos Relacionados con Sustancias , Humanos , Masculino , Femenino , Adulto , Trastornos Relacionados con Sustancias/epidemiología , Trastornos Relacionados con Sustancias/psicología , Trastornos Relacionados con Sustancias/complicaciones , Estudios Prospectivos , Rinitis/psicología , Rinitis/complicaciones , Descongestionantes Nasales/efectos adversos , Persona de Mediana Edad , Adulto Joven , Adolescente
3.
Ann Allergy Asthma Immunol ; 127(3): 342-348.e2, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-34000435

RESUMEN

BACKGROUND: Although it is known that oral antihistamine-pseudoephedrine combination tablets have a faster onset than intranasal corticosteroid sprays in the treatment of allergic rhinitis after the first dose, the magnitude of change has not been measured in a comparative manner. Furthermore, the sensation of sprayed liquid in the nose may lead patients to mistakenly believe that intranasal steroid sprays work instantly. OBJECTIVE: To evaluate, numerically, nasal airflow changes provided by a single dose of loratadine-pseudoephedrine tablet (LP) and fluticasone propionate nasal spray (FP) in participants experiencing allergic rhinitis symptoms, including nasal congestion. METHODS: This single-center, double-blinded, placebo-controlled, crossover study evaluated objective nasal airflow changes in patients with a documented sensitivity to ragweed pollen. Participants were randomized to receive 1 of 4 treatment sequences, and their peak nasal inspiratory flow (PNIF) was measured in a span of 4 hours after pollen exposure in an environmental exposure unit. RESULTS: Average change in PNIF was 31% with LP in the course of the study, significantly greater than with placebo and FP (12% and 15%, respectively; P < .001). Nevertheless, FP did not produce a significant change compared with its placebo. At hour one post-dose, LP had a clinically significant 31% increase in PNIF, whereas FP only yielded an 8.6% increase (P < .001). Measurable nasal airflow improvements are associated with the opening of nasal passages, allowing congested patients to breathe more freely. CONCLUSION: A single dose of LP quickly and significantly (P < .001) improved nasal airflow after ragweed pollen challenge in an environmental exposure unit. Comparatively, FP did not display this same benefit. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03443843.


Asunto(s)
Antialérgicos/administración & dosificación , Fluticasona/administración & dosificación , Loratadina/administración & dosificación , Descongestionantes Nasales/administración & dosificación , Seudoefedrina/administración & dosificación , Rinitis Alérgica/tratamiento farmacológico , Administración Intranasal , Adulto , Antialérgicos/efectos adversos , Estudios Cruzados , Método Doble Ciego , Combinación de Medicamentos , Femenino , Fluticasona/efectos adversos , Humanos , Loratadina/efectos adversos , Masculino , Persona de Mediana Edad , Cavidad Nasal/fisiología , Descongestionantes Nasales/efectos adversos , Rociadores Nasales , Seudoefedrina/efectos adversos , Fenómenos Fisiológicos Respiratorios , Rinitis Alérgica/fisiopatología , Comprimidos , Adulto Joven
4.
Rhinology ; 58(3): 233-240, 2020 Jun 01.
Artículo en Inglés | MEDLINE | ID: mdl-31904029

RESUMEN

BACKGROUND: the primary end point of our study was to define risk factors and identify the underlying conditions that may have led to the abuse of vasoconstrictors in rhinitis medicamentosa. Moreover, we analysed factors that may influence the vasoconstrictors discontinuation. METHODOLOGY: this was a prospective case-control observational study. Cases and controls were evaluated at the baseline in order define factors that may have influenced onset of rhinitis medicamentosa. They were re-evaluated at 3 months to verify symptoms control and drug discontinuation. Finally, they underwent a phone call questionnaire after 12 months regarding drug discontinuation. A potential bias of our study is that evaluating discontinuation we included subjects treated differently according to the main diagnosis. RESULTS: patients with rhinitis medicamentosa were more frequently smokers than controls, they had higher mean HAMA scores and positive psychiatric diseases history. Additionally, we frequently detected a local inflammation at nasal cytology in patients with rhinitis medicamentosa. A significant improvement in all nasal symptoms scores was observed in cases and controls but 29.4% of cases did not discontinue the vasoconstrictors. Two major factors negatively influenced discontinuation: positive nasal cytology and pathological HAMA score. CONCLUSION: we observed that positive local inflammation, anxiety and smoking habit correlate positively with vasoconstrictors abuse. In addition, we demonstrated that anxiety and local inflammation were the most important factors impairing drug discontinuation.


Asunto(s)
Rinitis , Estudios de Casos y Controles , Humanos , Descongestionantes Nasales/efectos adversos , Mucosa Nasal , Estudios Prospectivos , Rinitis/inducido químicamente , Rinitis/tratamiento farmacológico , Rinitis/epidemiología
5.
Eur Arch Otorhinolaryngol ; 276(11): 3123-3130, 2019 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-31468129

RESUMEN

OBJECTIVE: Rhinitis medicamentosa is drug-induced rhinitis which occurs by prolonged and overdose usage of topical nasal decongestants. There is not much of treatment choice rather than nasal steroids. In this pathological study, we have been aimed to represent the healing effects of xylitol on damaged nasal mucosa due to rhinitis medicamentosa. METHOD: 30 Wistar rats were separated into 5 groups. During 2 months, oxymetazoline was given to the first group, and saline was given to second group intranasally. First and second group animals were examined at the end of 2 months and rhinitis medicamentosa was detected. Oxymetazoline was given to the third, fourth, and fifth groups during 2 months. Then xylitol solution, mometasone, and saline were applied, respectively, for 15 days. After the experiment, rats' nasal mucosas were evaluated histopathologically. RESULTS: Xylitol and mometasone were found to be more effective than the control group in terms of histopathological changes. Effectivity of xylitol and mometasone was compared and not a significant value was determined. CONCLUSIONS: According to the results, xylitol solution is effective as mometasone, usable and well-priced in the treatment of rhinitis medicamentosa. More comprehensive and ultrastructural studies on animals and human studies with rhinometric evaluation should be performed.


Asunto(s)
Furoato de Mometasona/administración & dosificación , Descongestionantes Nasales/efectos adversos , Mucosa Nasal , Oximetazolina/efectos adversos , Rinitis , Xilitol/administración & dosificación , Administración Intranasal , Animales , Antiinflamatorios/administración & dosificación , Modelos Animales de Enfermedad , Masculino , Descongestionantes Nasales/administración & dosificación , Mucosa Nasal/efectos de los fármacos , Mucosa Nasal/patología , Ratas , Ratas Wistar , Rinitis/inducido químicamente , Rinitis/patología , Rinitis/terapia , Edulcorantes/administración & dosificación , Tiempo , Resultado del Tratamiento
6.
Minerva Pediatr ; 71(2): 110-115, 2019 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30808088

RESUMEN

BACKGROUND: Nasal congestion represents a troublesome health issue which is especially and invalidating in children. Effective nasal drugs, such as sympathomimetic drugs, are usually forbidden in children under 12 years of age because of their potential systemic adverse effects. Hypertonic nasal physiological solutions have recently been successfully used to decongest nasal mucosa in children: its mechanical activity has been universally recognized as safe and effective and it represents a well-established, useful treatment in children. METHODS: We have retrospectively analyzed a case series of 40 children treated for 4 days (96 hours) with a new class 1s medical device nasal hypertonic spray containing Pirometaxine™ (Narlisim™) in outpatient affected by nasal congestion due to common cold. Every child was evaluated on a 3-point symptom assessment scale (0: no symptom; 1: mild symptom; 2: moderate symptom; 3: severe symptom) at the beginning of the trial (T0) and after 48 (T1) and 96 hours (T2). The symptoms assessed were nasal obstruction, nasal secretion, headache, flash of cold, pharyngodynia, cough, and sneeze. RESULTS: The results, in terms of short-term efficacy to control nasal obstruction (T1 vs. T0: P<0.0001; T2 vs. T0: P<0.0001), nasal secretion (T1 vs. T0: P<0.0001; T2 vs. T0: P<0.0001) and all the symptoms related to common cold have supported the efficacy of this hypertonic nasal solution. No adverse events have been pointed out during the trial supporting the safety of this new nasal hypertonic approach. CONCLUSIONS: The absence of adverse events after 48-96 hours along with the short-term effectiveness of this new treatment seems to represent a new, safe option to treat children affected by nasal congestion secondary to common cold. Considering the current lack of safe treatments for children under 12 years of age, Narlisim™ can be considered as a useful short-term option to control nasal congestion in children.


Asunto(s)
Resfriado Común/tratamiento farmacológico , Sulfato de Cobre/administración & dosificación , Obstrucción Nasal/tratamiento farmacológico , Ácido Pirrolidona Carboxílico/administración & dosificación , Adolescente , Niño , Preescolar , Sulfato de Cobre/efectos adversos , Combinación de Medicamentos , Humanos , Descongestionantes Nasales/administración & dosificación , Descongestionantes Nasales/efectos adversos , Rociadores Nasales , Ácido Pirrolidona Carboxílico/efectos adversos , Estudios Retrospectivos , Factores de Tiempo , Resultado del Tratamiento
7.
Ir Med J ; 112(2): 874, 2019 02 14.
Artículo en Inglés | MEDLINE | ID: mdl-30875167

RESUMEN

Aim Report successful application of UV endonasal phototherapy as a treatment for severe rhinitis medicamentosa and allergic rhinitis. Methods Allergic rhinitis confirmed by history and skin prick testing; rhinitis medicamentosa based on history. Both confirmed at nasendoscopy. Symptom score before & after treatment. Introduction of Rhinolight endonasal u/v phototherapy for allergic rhinitis. Single patient report. Results Successful remission of Rhinitis Medicamentosa confirmed with patient after eight sessions Rhinolight endonasal phototherapy. Use of nasal decongestant dropped from 2 bottles/daily x 4 years to zero. Symptoms reduced from 25 pre-treatment to 6 post-treatment. Rhinitis medicamentosa is clinically characterized by nasal congestion without rhinorrhea, postnasal drip, or sneezing that begins after using a nasal decongestant for more than 3 days. Treatment involves discontinuation of the offending drug. Discussion Rhinolight endonasal phototherapy is a new treatment for allergic rhinitis and offered as last resort for a patient with untreated allergic rhinitis and overuse of topical decongestants. Patient reports a significant improvement in symptoms with cessation of topical decongestant. Report a successful application of UV endonasal phototherapy as a treatment for severe rhinitis medicamentosa against a background of long standing allergic rhinitis.


Asunto(s)
Descongestionantes Nasales/efectos adversos , Rinitis Alérgica/inducido químicamente , Rinitis Alérgica/radioterapia , Terapia Ultravioleta/métodos , Adulto , Humanos , Masculino , Descongestionantes Nasales/administración & dosificación , Mucosa Nasal/patología , Rociadores Nasales , Rinitis Alérgica/patología , Índice de Severidad de la Enfermedad , Resultado del Tratamiento
8.
Int J Clin Pharmacol Ther ; 56(12): 604-611, 2018 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-30220290

RESUMEN

OBJECTIVE: Evaluate effects of a multisymptom tablet on cold and flu symptoms within 4 hours post-administration. MATERIALS AND METHODS: This was a randomized, double-blind, placebo-controlled study in adults with cold and flu symptoms. Eligible participants with at least moderate common cold or flu symptoms and symptom onset ≤ 48 hours before screening were assigned to a single multiple-active-ingredient tablet (containing paracetamol, pseudoephedrine hydrochloride, dextromethorphan hydrobromide, and chlorpheniramine maleate) or placebo tablet. Participants rated severity of each symptom (sore throat, headache, extremity pain, nasal congestion, sneezing, runny nose, and cough) from 0 (absent) to 3 (severe) at 15 and 30 minutes and 1, 2, 3, and 4 hours post administration. The total symptom score (TSS) was calculated as the sum of the individual symptom scores (primary endpoint). Participants rated global response to treatment on a scale from 0 (ineffective) to 4 (excellent). Adverse events (AEs) were recorded throughout. RESULTS: Of 53 participants randomized, 52 received active tablet (n = 25) or placebo tablet (n = 27). Change from baseline in TSS throughout the 4-hour post-administration period was similar between groups. An efficacy criterion of 30% decrease in TSS at assessment points was not met (range, -1.91 to 8.94%). There were also no significant differences between groups in mean symptom scores for individual symptoms or global response to treatment. Four non-serious treatment-emergent adverse events occurred. CONCLUSION: In this exploratory pilot study, a multisymptom cold and flu tablet was well tolerated but did not differ from placebo tablet with regard to onset of action following a single dose.
.


Asunto(s)
Acetaminofén/administración & dosificación , Analgésicos no Narcóticos/administración & dosificación , Antitusígenos/administración & dosificación , Clorfeniramina/administración & dosificación , Resfriado Común/tratamiento farmacológico , Dextrometorfano/administración & dosificación , Antagonistas de los Receptores Histamínicos H1/administración & dosificación , Gripe Humana/tratamiento farmacológico , Descongestionantes Nasales/administración & dosificación , Seudoefedrina/administración & dosificación , Acetaminofén/efectos adversos , Administración Oral , Adulto , Analgésicos no Narcóticos/efectos adversos , Antitusígenos/efectos adversos , China , Clorfeniramina/efectos adversos , Resfriado Común/diagnóstico , Resfriado Común/virología , Dextrometorfano/efectos adversos , Método Doble Ciego , Combinación de Medicamentos , Femenino , Antagonistas de los Receptores Histamínicos H1/efectos adversos , Humanos , Gripe Humana/diagnóstico , Gripe Humana/virología , Masculino , Persona de Mediana Edad , Descongestionantes Nasales/efectos adversos , Satisfacción del Paciente , Proyectos Piloto , Seudoefedrina/efectos adversos , Inducción de Remisión , Comprimidos , Factores de Tiempo , Resultado del Tratamiento
9.
Vestn Otorinolaringol ; 83(2): 46-50, 2018.
Artículo en Ruso | MEDLINE | ID: mdl-29697655

RESUMEN

Undesirable effects of the application of the intransal vasoconstricting medications are a frequent occurrence in the pediatric practice. The objective of the present study was to evaluate the role of the intranasal vasoconstricting medications in the structure of the means and methods currently available for the treatment of toxicological pathologies based at a multi-field clinical hospital. The retrospective analysis of the medical histories of the patients admitted to the toxicological department and annual reports for the period from 2015 to 2016 was undertaken. The study has demonstrated that intoxication associated with the use of the intranasal vasoconstricting medications was the most common cause of hospitalization of the children in the toxicological departments. Intoxication of this origin accounted for 15-20% of the total number of toxicological pathologies among the children. The cases of intoxication are most frequently documented in the group of children at the age between 1 and 3 years. The risk of the undesirable serious complications is especially high after the application of naphazoline-based intranasal vasoconstricting medications (71.7-77.4% of all the cases of intoxication with these products). It is concluded that the use of intranasal vasoconstricting medications in the pediatric practice should be carried out under the strict control, with the naphazoline-based preparations being totally excluded from the application.


Asunto(s)
Trastornos Químicamente Inducidos , Nafazolina , Descongestionantes Nasales , Obstrucción Nasal/tratamiento farmacológico , Administración Intranasal/métodos , Trastornos Químicamente Inducidos/diagnóstico , Trastornos Químicamente Inducidos/etiología , Trastornos Químicamente Inducidos/prevención & control , Preescolar , Femenino , Humanos , Lactante , Masculino , Nafazolina/administración & dosificación , Nafazolina/efectos adversos , Descongestionantes Nasales/administración & dosificación , Descongestionantes Nasales/efectos adversos , Obstrucción Nasal/epidemiología , Estudios Retrospectivos , Medición de Riesgo , Federación de Rusia/epidemiología
10.
J Biol Regul Homeost Agents ; 31(4 Suppl 2): 55-62, 2017 12 27.
Artículo en Inglés | MEDLINE | ID: mdl-29202563

RESUMEN

This study was designed to prospectively evaluate the role of nebulized hyaluronic acid (HA) administered for 10 days as treatment for patients with rhinitis medicamentosa (RM). RM is a pathological condition of the nasal mucosa induced by prolonged, excessive or improper use of topical decongestants. It is characterized by persistent nasal congestion that can lead the patient to increase the frequency of application and the quantity of the substance being applied, resulting in dependence on topical nasal decongestants. Twenty-five patients were treated with HA nebulized via Spray-sol twice a day for 10-days (T1) (HA Spray-sol treatment group). Subsequently, after 3 days of washout, patients were treated with physiological saline nebulized via Spray-sol twice a day for 10 days. (T2) (saline Spray-sol treatment group). The HA Spray-sol treatment group (tp) significantly improved visual analogue scale (VAS) scores (T0=6.25±1.64 vs T1=3.91±1.30; p less than 0.05), whereas there was no statistically significant difference in the saline Spray-sol treatment group (tp) (p>0.05), results confirmed by the anterior active rhinomanometry (AAR) data (HA Spray-sol tp T0=1.193±0.83 vs T1=0.44±0.25, p less than 0.05; saline Spray-sol tp (p>0.05). An improvement in the Global Rhinitis Score (GRS) was recorded in both groups (T0=15.37±5.16 vs T1=5.54±3.23, p less than 0.05; saline Spray-sol tp T0=15.37±5.16 vs T2=10. 7±5.43; p less than 0.05). Both groups showed a significant reduction in mucosal oedema and nasal secretions. Patients treated with HA Spray-sol reduced or even eliminated (11/25 patients) the use of topical decongestant within 10 days of treatment with HA. The results of this study suggest nebulized topical 9-mg sodium hyaluronate plays a pivotal role in the management of RM.


Asunto(s)
Ácido Hialurónico/administración & dosificación , Ácido Hialurónico/uso terapéutico , Descongestionantes Nasales/administración & dosificación , Descongestionantes Nasales/efectos adversos , Rinitis/inducido químicamente , Rinitis/tratamiento farmacológico , Administración por Inhalación , Administración Intranasal , Edema/tratamiento farmacológico , Humanos , Ácido Hialurónico/farmacología , Mucosa Nasal/efectos de los fármacos , Mucosa Nasal/patología , Nebulizadores y Vaporizadores
11.
Prescrire Int ; 26(181): 98-101, 2017 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-30730661

RESUMEN

Posterior reversible encephalopathy syndrome (PRES) is a serious neurological disorder consisting of headache, visual disturbances, seizures, impaired consciousness and radiological evidence of poster- ior cerebral oedema. It is occasionally complicated by cerebral haemorrhage or ischaemia. The main known risk factors for PRES are hypertension, pre-eclampsia, eclampsia, acute kid- ney injury and numerous drugs. The main drugs implicated are antineoplastics, in particular VEGF inhibitors, immunosuppressants, and drugs that can increase blood pressure or fluid and sodium retention. The disorders usually resolve without sequelae within days once the causal factor has been elim- inated.


Asunto(s)
Inhibidores de la Angiogénesis/efectos adversos , Antineoplásicos/efectos adversos , Inmunosupresores/efectos adversos , Síndrome de Leucoencefalopatía Posterior/inducido químicamente , Vasoconstrictores/efectos adversos , Corticoesteroides/efectos adversos , Antiinflamatorios no Esteroideos/efectos adversos , Bevacizumab/efectos adversos , Humanos , Descongestionantes Nasales/efectos adversos , Inhibidores de Proteínas Quinasas/efectos adversos , Receptores de Factores de Crecimiento Endotelial Vascular , Proteínas Recombinantes de Fusión/efectos adversos , Sorafenib/efectos adversos , Factor A de Crecimiento Endotelial Vascular/antagonistas & inhibidores
12.
Vestn Otorinolaringol ; 82(3): 84-90, 2017.
Artículo en Ruso | MEDLINE | ID: mdl-28631690

RESUMEN

This paper summarizes the currently accepted concepts of the pathogenetic mechanisms underlying the morphological and functional changes in intranasal mucosa of the patients having a long history of the application of the long-acting topical vasoconstrictor agents. The author presents the data illustrating the effectiveness of various methods for the pharmacotherapeutic treatment of medically-induced rhinitis.


Asunto(s)
Descongestionantes Nasales , Rinitis , Administración Intranasal , Manejo de la Enfermedad , Humanos , Descongestionantes Nasales/administración & dosificación , Descongestionantes Nasales/efectos adversos , Mucosa Nasal/patología , Mucosa Nasal/fisiopatología , Rinitis/inducido químicamente , Rinitis/diagnóstico , Rinitis/fisiopatología , Rinitis/terapia
13.
Ann Allergy Asthma Immunol ; 116(1): 66-71, 2016 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-26560899

RESUMEN

BACKGROUND: Over-the-counter phenylephrine hydrochloride (PEH) is used for relief of nasal congestion caused by allergic rhinitis; however, data to support its efficacy are lacking. The US Food and Drug Administration recommended clinical trials to evaluate the efficacy and safety of PEH in patients with this condition. OBJECTIVE: To evaluate the efficacy and safety of PEH 30-mg modified-release (MR) tablets in patients with nasal congestion caused by allergic rhinitis in a multicenter, randomized, double-blinded, placebo-controlled, 2-arm, parallel-group study. METHODS: Eligible adults at least 18 years old with documented hypersensitivity to fall pollen allergens were randomized to PEH-MR or placebo every 12 hours for 7 days from August 30 to October 12, 2011. The primary end point was mean change from baseline during the entire treatment period in daily reflective nasal congestion score. Secondary end points included changes in other symptom score assessments, time to maximal effect, duration of effect, and quality of life. Safety assessments included adverse events, serious adverse events, vital signs, physical examination, and electrocardiograms. RESULTS: Of 575 patients, 288 received PEH-MR and 287 received placebo. No significant beneficial difference was detected between PEH-MR and placebo for the primary end point (PEH-MR, mean -0.394, SD 0.4880; placebo, mean -0.412, SD 0.5383; P = .2655). Likewise, no significant differences were observed for most secondary end points or quality of life. Overall, 89 of 575 patients (15.5%), equally distributed between the PEH-MR and placebo groups, experienced at least 1 treatment-emergency adverse event. CONCLUSION: PEH-MR 30-mg tablets taken orally every 12 hours for 7 days is not more efficacious than placebo in relieving nasal congestion caused by allergic rhinitis. TRIAL REGISTRATION: clinicaltrials.gov, identifier NCT01413958, protocol CL2011-06.


Asunto(s)
Descongestionantes Nasales/administración & dosificación , Fenilefrina/administración & dosificación , Rinitis Alérgica Estacional/tratamiento farmacológico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Preparaciones de Acción Retardada/administración & dosificación , Preparaciones de Acción Retardada/efectos adversos , Preparaciones de Acción Retardada/uso terapéutico , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Descongestionantes Nasales/efectos adversos , Descongestionantes Nasales/uso terapéutico , Fenilefrina/efectos adversos , Fenilefrina/uso terapéutico , Comprimidos , Resultado del Tratamiento , Adulto Joven
14.
Cochrane Database Syst Rev ; 10: CD009612, 2016 Oct 17.
Artículo en Inglés | MEDLINE | ID: mdl-27748955

RESUMEN

BACKGROUND: Many treatments for the common cold exist and are sold over-the-counter. Nevertheless, evidence on the effectiveness and safety of nasal decongestants is limited. OBJECTIVES: To assess the efficacy, and short- and long-term safety, of nasal decongestants used in monotherapy to alleviate symptoms of the common cold in adults and children. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 6, June 2016), which contains the Cochrane Acute Respiratory Infections (ARI) Specialised Register, MEDLINE (1946 to July 2016), Embase (2010 to 15 July 2016), CINAHL (1981 to 15 July 2016), LILACS (1982 to July 2016), Web of Science (1955 to July 2016) and clinical trials registers. SELECTION CRITERIA: Randomised controlled trials (RCTs) and cluster-RCTs investigating the effectiveness and adverse effects of nasal decongestants compared with placebo for treating the common cold in adults and children. We excluded quasi-RCTs. DATA COLLECTION AND ANALYSIS: Three review authors independently extracted and summarised data on subjective measures of nasal congestion, overall patient well-being score, objective measures of nasal airway resistance, adverse effects and general recovery. One review author acted as arbiter in cases of disagreement. We categorised trials as single and multi-dose and analysed data both separately and together. We also analysed studies using an oral or topical nasal decongestant separately and together. MAIN RESULTS: We included 15 trials with 1838 participants. Fourteen studies included adult participants only (aged 18 years and over). In six studies the intervention was a single dose and in nine studies multiple doses were used. Nine studies used pseudoephedrine and three studies used oxymetazoline. Other decongestants included phenylpropanolamine, norephedrine and xylometazoline. Phenylpropanolamine (or norephedrine) is no longer available on the market therefore we did not include the results of these studies in the meta-analyses. Eleven studies used oral decongestants; four studies used topical decongestants.Participants were included after contracting the common cold. The duration of symptoms differed among studies; in 10 studies participants had symptoms for less than three days, in three studies symptoms were present for less than five days, one study counted the number of colds over one year, and one study experimentally induced the common cold. In the single-dose studies, the effectiveness of a nasal decongestant was measured on the same day, whereas the follow-up in multi-dose studies ranged between one and 10 days.Most studies were conducted in university settings (N = eight), six at a specific university common cold centre. Three studies were conducted at a university in collaboration with a hospital and two in a hospital only setting. In two studies the setting was unclear.There were large differences in the reporting of outcomes and the reporting of methods in most studies was limited. Therefore, we judged most studies to be at low or unclear risk of bias. Pooling was possible for a limited number of studies only; measures of effect are expressed as standardised mean differences (SMDs). A positive SMD represents an improvement in congestion. There is no defined minimal clinically important difference for measures of subjective improvement in nasal congestion, therefore we used the SMDs as a guide to assess whether an effect was small (0.2 to 0.49), moderate (0.5 to 0.79) or large (≥ 0.8).Single-dose decongestant versus placebo: 10 studies compared a single dose of nasal decongestant with placebo and their effectiveness was tested between 15 minutes and 10 hours after dosing. Seven of 10 studies reported subjective symptom scores for nasal congestion; none reported overall patient well-being. However, pooling was not possible due to the large diversity in the measurement and reporting of symptoms of congestion. Two studies recorded adverse events. Both studies used an oral decongestant and each of them showed that there was no statistical difference between the number of adverse events in the treatment group versus the placebo group.Multi-dose decongestant versus placebo: nine studies compared multiple doses of nasal decongestants with placebo, but only five reported on the primary outcome, subjective symptom scores for nasal congestion. Only one study used a topical decongestant; none reported overall patient well-being. Subjective measures of congestion were significantly better for the treatment group compared with placebo approximately three hours after the last dose (SMD 0.49, 95% confidence interval (CI) 0.07 to 0.92; P = 0.02; GRADE: low-quality evidence). However, the SMD of 0.49 only indicates a small clinical effect. Pooling was based on two studies, one oral and one topical, therefore we were unable to assess the effects of oral and topical decongestants separately. Seven studies reported adverse events (six oral and one topical decongestant); meta-analysis showed that there was no statistical difference between the number of adverse events in the treatment group (125 per 1000) compared to the placebo group (126 per 1000). The odds ratio (OR) for adverse events in the treatment group was 0.98 (95% CI 0.68 to 1.40; P = 0.90; GRADE: low-quality evidence). The results remained the same when we only considered studies using an oral decongestant (OR 0.95, 95% CI 0.65 to 1.39; P = 0.80; GRADE: low-quality evidence). AUTHORS' CONCLUSIONS: We were unable to draw conclusions on the effectiveness of single-dose nasal decongestants due to the limited evidence available. For multiple doses of nasal decongestants, the current evidence suggests that these may have a small positive effect on subjective measures of nasal congestion in adults with the common cold. However, the clinical relevance of this small effect is unknown and there is insufficient good-quality evidence to draw any firm conclusions. Due to the small number of studies that used a topical nasal decongestant, we were also unable to draw conclusions on the effectiveness of oral versus topical decongestants. Nasal decongestants do not seem to increase the risk of adverse events in adults in the short term. The effectiveness and safety of nasal decongestants in children and the clinical relevance of their small effect in adults is yet to be determined.


Asunto(s)
Resfriado Común/tratamiento farmacológico , Descongestionantes Nasales/administración & dosificación , Administración Intranasal , Adulto , Niño , Humanos , Imidazoles/administración & dosificación , Descongestionantes Nasales/efectos adversos , Oximetazolina/administración & dosificación , Fenilpropanolamina/administración & dosificación , Seudoefedrina/administración & dosificación , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Tiempo
16.
J Obstet Gynaecol Res ; 42(8): 1016-20, 2016 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-27087030

RESUMEN

Agnathia-otocephaly or agnathia-sinotia-microstomy syndrome is the most severe malformation affecting the first branchial arch. It is a rare congenital anomaly characterized by absence of the lower jaw and abnormal ear positioning. Prenatal diagnosis is possible on conventional 2-D ultrasound in the second trimester. Three-dimensional ultrasound enhances detection of abnormal facial phenotype, especially in surface rendering mode. In addition, 3-D volume datasets are used to produce a physical model of the anomaly. We present a case of second trimester ultrasound diagnosis of agnathia-otocephaly associated with limb deformities. A physical model produced using 3-D ultrasound volume datasets facilitated better understanding of this congenital malformation, and improvement of parental counselling and management by the multispecialist team.


Asunto(s)
Anomalías Craneofaciales/diagnóstico por imagen , Exposición Materna , Descongestionantes Nasales/efectos adversos , Oximetazolina/efectos adversos , Ultrasonografía Prenatal/métodos , Adulto , Región Branquial/anomalías , Región Branquial/diagnóstico por imagen , Femenino , Peroné/anomalías , Peroné/diagnóstico por imagen , Dedos/anomalías , Dedos/diagnóstico por imagen , Humanos , Interpretación de Imagen Asistida por Computador , Imagenología Tridimensional/métodos , Embarazo , Primer Trimestre del Embarazo/efectos de los fármacos , Segundo Trimestre del Embarazo , Cúbito/anomalías , Cúbito/diagnóstico por imagen
17.
Indian J Chest Dis Allied Sci ; 58(3): 191-193, 2016 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-30152655

RESUMEN

Lipoid pneumonia is a rare form of pneumonia caused by inhalation or aspiration of fat containing substances. It can present acutely or more commonly presents as an insidious onset chronic respiratory illness. It requires a high degree of suspicion with great emphasis on history. It can mimic tuberculosis, malignancy or interstitial lung disease. We report the case of a 31-year-old male with a history of sniffing hydrogenated oil, presenting with a non-resolving pneumonia.


Asunto(s)
Ghee/efectos adversos , Enfermedades Pulmonares Intersticiales/diagnóstico , Neoplasias Pulmonares/diagnóstico , Descongestionantes Nasales/efectos adversos , Neumonía Lipoidea , Tuberculosis Pulmonar/diagnóstico , Administración Intranasal/efectos adversos , Adulto , Animales , Biopsia/métodos , Búfalos , Disnea/etiología , Disnea/fisiopatología , Humanos , Pulmón/patología , Masculino , Descongestionantes Nasales/administración & dosificación , Manejo de Atención al Paciente/métodos , Neumonía Lipoidea/diagnóstico , Neumonía Lipoidea/etiología , Neumonía Lipoidea/fisiopatología , Neumonía Lipoidea/terapia , Ruidos Respiratorios/etiología , Ruidos Respiratorios/fisiopatología , Tomografía Computarizada por Rayos X/métodos , Resultado del Tratamiento
18.
Prescrire Int ; 25(172): 153, 2016 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-27486644

RESUMEN

In addition to the risk of cardiovascular events and neurological disorders, sympathomimetic decongestants have teratogenic potential, albeit weak, when taken during the first trimester of pregnancy, probably through disruption of the vascular system of the embryo and the pregnant woman. In the second and third trimesters of pregnancy, the fetus is exposed to the same adverse effects as the mother.


Asunto(s)
Feto/efectos de los fármacos , Descongestionantes Nasales/efectos adversos , Simpatomiméticos/efectos adversos , Femenino , Humanos , Embarazo
19.
J Pediatr ; 167(1): 196-8.e1-2, 2015 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-25888349

RESUMEN

We compared the use of cough and cold medications in 2 multicenter studies of young children hospitalized with bronchiolitis before and after the 2008 Food and Drug Administration cough and cold medications advisory. Although cough and cold medication use decreased after the advisory, nearly 20% of children age 12-23.9 months with severe bronchiolitis received cough and cold medications.


Asunto(s)
Bronquiolitis/tratamiento farmacológico , Resfriado Común/tratamiento farmacológico , Tos/tratamiento farmacológico , Medicamentos sin Prescripción/administración & dosificación , Medicamentos sin Prescripción/efectos adversos , Factores de Edad , Antitusígenos/administración & dosificación , Antitusígenos/efectos adversos , Expectorantes/administración & dosificación , Expectorantes/efectos adversos , Femenino , Humanos , Lactante , Masculino , Madres , Descongestionantes Nasales/administración & dosificación , Descongestionantes Nasales/efectos adversos , Estudios Prospectivos , Retirada de Medicamento por Seguridad , Índice de Severidad de la Enfermedad , Fumar/epidemiología , Estados Unidos , United States Food and Drug Administration
20.
Cerebrovasc Dis ; 39(1): 31-8, 2015.
Artículo en Inglés | MEDLINE | ID: mdl-25547150

RESUMEN

BACKGROUND: Reversible vasoconstriction (RV) may cause ischaemic stroke (IS) in the absence of any other defined stroke aetiology. The three objectives of our study were to evaluate the frequency of RV in a prospective series of young IS patients, to describe the detailed clinical-radiological features in the patients with RV and IS, and to compare these characteristics with those of reversible cerebral vasoconstriction syndrome (RCVS). METHODS: We identified between October 2005 and December 2010, 159 consecutive young patients (<45 years) hospitalized for an acute IS confirmed by cerebral magnetic resonance imaging. An extensive diagnostic work-up was performed including toxicological urinary screening for cannabis, cocaine and amphetamines, and the usual biological, cardiac and vascular investigations for an IS in the young. We specifically studied patients with IS and RV, which was defined as multifocal intracranial arterial stenoses confirmed by intracranial arterial imaging that resolved within 3-6 months. RESULTS: Out of 159 patients with IS, 21 (13%, 12 males, 9 females; mean age 32 years) had multifocal cerebral arterial stenoses that were fully reversible at 3-6 months, and no other cause for stroke. IS were located on posterior territory in 71% of cases, and vasoconstriction predominated on posterior cerebral and superior cerebellar arteries. Precipitating factors of IS and RV were the use of cannabis resin (n = 14), nasal decongestants (n = 2) and triptan (n = 1). Most cases (74%) had unusual severe headache, but none had thunderclap headache. None of 21 cases had reversible posterior leukoencephalopathy, cortical subarachnoid or intracerebral haemorrhage. CONCLUSION: RV was the sole identified cause of IS in 13% of our cohort. These young patients with IS and RV may have a variant of RCVS, related to an increased susceptibility to vasoactive agents in some individuals. RV in our patients differs from the classical characteristics of RCVS by the absence of thunderclap headache, reversible brain oedema and subarachnoid or intracranial haemorrhage. Intracranial arteries should be looked for, by appropriate vascular imaging, in young patients with IS at the acute stage and during the follow-up period.


Asunto(s)
Isquemia Encefálica/fisiopatología , Arterias Cerebrales/fisiopatología , Constricción Patológica/fisiopatología , Accidente Cerebrovascular/patología , Vasoespasmo Intracraneal/fisiopatología , Adulto , Isquemia Encefálica/etiología , Estudios de Cohortes , Constricción Patológica/etiología , Femenino , Cefalea/etiología , Humanos , Imagen por Resonancia Magnética , Masculino , Fumar Marihuana/efectos adversos , Descongestionantes Nasales/efectos adversos , Estudios Prospectivos , Accidente Cerebrovascular/etiología , Triptaminas/efectos adversos , Vasoconstricción , Vasoespasmo Intracraneal/complicaciones
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