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      Experiencia en la prevención de la ptosis palpebral secundaria al tratamiento de arrugas glabelares con OnabotulinumtoxinA Translated title: Experience in prevention of upper eyelid ptosis complication in the treatment of glabellar lines with OnabotulinumtoxinA

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          Abstract

          Resumen Introducción y objetivo. Hoy en día, el uso de toxina botulínica tipo A para el tratamiento de las arrugas glabelares es uno de los procedimientos cosméticos no quirúrgicos más frecuentemente realizados, y la blefaroptosis (ptosis palpebral) es uno de los efectos secundarios adversos que se presenta con más frecuencia en este procedimiento. A través de un estudio retrospectivo presentamos nuestra experiencia y técnica de punción con la que consideramos que hemos reducido de manera significativa la incidencia de la blefaroptosis secundaria al tratamiento de las arrugas glabelares empleando una de las formas de toxina botulínica tipo A disponibles en el mercado. Nuestro objetivo es valorar si el cambio en la técnica de infiltración de los músculos glabelares ha disminuido la incidencia de blefaroptosis en nuestra casuística empleando OnabotulinumtoxinA y manteniendo la misma efectividad terapéutica. Material y método. Analizamos las fichas clínicas de 2 series consecutivas de 247 pacientes cada una, comparando el resultado obtenido tras la infiltración de los músculos glabelares con una punción paralela y con una punción perpendicular a la zona baja del periostio del hueso frontal. Empleamos en ambas series OnabotulinumtoxinA. Resultados. Los procedimientos con punción perpendicular tuvieron una inidencia de blefaroptosis del 1.22% en comparación con la ausencia de ptosis registrada en los procedimientos con punción paralela. Conclusiones. En nuestra experiencia, la infiltración con punción paralela de OnatolulinumtoxinA para el tratamiento de las arrugas glabelares redujo la incidencia de blefaroptosis, sin afectar a la eficacia del tratamiento.

          Translated abstract

          Abstract Background and objective. The use of botulinum toxin type A for treating glabellar lines is nowadays one of the most frequent nonsurgical cosmetic procedures, and upper eyelid ptosis (blepharoptosis) is one of the common minor side effects on this procedure. Through a retrospective study we present our experience and puncture technique which we consider has significantly reduced the incidence of upper eyelid ptosis secondary to the treatment of glabellar lines using one of the commercially available forms of botulinum toxin type A. Our aim is to explore whether the change in the form of infiltration of glabellar muscles has decreased the incidence of ptosis in our case series using OnabotulinumtoxinA, maintaining the same therapeutic effectiveness. Methods. Medical records of 2 consecutive series of 247 patients each where reviewed comparing the results of the treatment of glabellar lines obtained with the infiltration of the glabellar muscles with perpendicular and with parallel puncture of the lower zone of the frontal periosteum. We use OnabotulinumtoxinA in both series. Results. The perpendicular puncture procedure was associated with a ptosis incidence of 1.22%, compared to absence of ptosis with the parallel puncture. Conclusions. In our experience, parallel infiltration of OnabotulinumtoxinA for the treatment of glabellar lines reduced the incidence of ptosis without affecting the effectiveness of treatment.

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          Most cited references23

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          Pharmaceutical, Biological, and Clinical Properties of Botulinum Neurotoxin Type A Products

          Botulinum neurotoxin injections are a valuable treatment modality for many therapeutic indications and have revolutionized the field of aesthetic medicine so that they are the leading cosmetic procedure performed worldwide. Studies show that onabotulinumtoxinA, abobotulinumtoxinA, and incobotulinumtoxinA are comparable in terms of clinical efficacy. Differences between the products relate to the botulinum neurotoxin complexes, specific biological potency, and their immunogenicity. Protein complex size and molecular weight have no effect on biological activity, stability, distribution, or side effect profile. Complexing proteins and inactive toxin (toxoid) content increase the risk of neutralizing antibody formation, which can cause secondary treatment failure, particularly in chronic disorders that require frequent injections and long-term treatment. These attributes could lead to differences in therapeutic outcomes, and, given the widespread aesthetic use of these three neurotoxin products, physicians should be aware of how they differ to ensure their safe and effective use.
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            Botulinum toxin type A injections: adverse events reported to the US Food and Drug Administration in therapeutic and cosmetic cases.

            Botulinum toxin type A (BTA) (Botox) received Food and Drug Administration (FDA) approval for therapeutic treatment of strabismus and blepharospasm in 1989, cervical dystonia in 2000, and cosmetic treatment of glabellar wrinkles (Botox Cosmetic) in 2002. In 2002 alone there were approximately 1.1 to 1.6 million patients using cosmetic BTA. Our objective was to review adverse event (AE) reporting to the FDA after BTA administration. We reviewed all (therapeutic and cosmetic use) serious (per FDA regulations) AEs reported to the FDA for the 13.5 years since licensure of the product (December 1989-May 2003) and nonserious AEs reported from December 2001 to November 2002. AEs are reported to the FDA through the MedWatch system. We reviewed 1437 AE reports; 406 followed therapeutic use of BTA (217 serious and 189 nonserious) and 1031 followed cosmetic use (36 serious and 995 nonserious). Reported AEs occurred predominantly in female patients, with a median age of 50 years. In the year December 2001 to November 2002, when both serious and nonserious reports were evaluated, the proportion of reports classified as serious was 33-fold higher for therapeutic than for cosmetic cases. The 217 serious AEs reported in therapeutic cases involved a wide spectrum of events and included all 28 reported deaths. Among cosmetic users, no deaths were reported and, of the 36 serious AEs, 30 were included as possible complications in the FDA-approved label. The remaining 6 serious AEs did not display a pattern suggesting a common causal relationship to BTA. Among the 995 cosmetic cases reported to have nonserious AEs, most commonly noted were lack of effect (623, 63%), injection site reaction (190, 19%), and ptosis (111, 11%). Serious AEs were more likely to be reported for therapeutic than for cosmetic use, which may be related to higher doses, complicated underlying diseases, or both. Among cosmetic cases, few serious AEs were reported, and these were predominantly events that were previously recognized in clinical trials of BTA for the labeled use. This study is limited primarily by the incomplete nature of AE reporting by clinicians. Numerous departures from FDA-approved recommendations for drug dose, dilution, handling, site of injection, and storage were noted in these AE reports.
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              Efficacy and safety of 3- and 5-injection patterns (30 and 50 U) of botulinum toxin A (Dysport) for the treatment of wrinkles in the glabella and the central forehead region.

              To investigate the efficacy and safety of 2 injection site patterns (3- and 5-injection patterns [30 and 50 U]) of botulinum toxin A (Dysport; Ipsen Pharma, Ettlingen, Germany), in the treatment of glabellar and central forehead wrinkles.
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                Author and article information

                Journal
                cpil
                Cirugía Plástica Ibero-Latinoamericana
                Cir. plást. iberolatinoam.
                Sociedad Española de Cirugía Plástica, Reparadora y Estética (SECPRE) (Madrid, Madrid, Spain )
                0376-7892
                1989-2055
                September 2020
                : 46
                : 3
                : 361-366
                Affiliations
                [1] Santiago orgname Chile
                [2] Santiago orgname Chile
                Article
                S0376-78922020000400013 S0376-7892(20)04600300013
                10.4321/s0376-78922020000400013
                05382826-620e-4348-8656-322298b486ff

                This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

                History
                : 15 May 2020
                : 20 April 2020
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 23, Pages: 6
                Product

                SciELO Spain

                Categories
                Tratamientos no quirúrgicos

                Blefaroptosis,Arrugas glabelares,Procedimiento cosmético,Músculo elevador párpado superior,Levator palpebrae superioris muscle,Cosmetic technique,Glabellar lines,Blepharoptosis,OnabotulinumtoxinA

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