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1.
BMC Cancer ; 22(1): 90, 2022 Jan 21.
Artículo en Inglés | MEDLINE | ID: mdl-35062896

RESUMEN

BACKGROUND: Oral mucositis (OM) associated with cancer treatment not only impairs patients' quality of life but also causes treatment delays or changes. This prospective exploratory study was conducted to evaluate the efficacy of Episil® oral liquid, which is an approved protective formulation for the oral mucosa in patients with OM. The extent of the pain-relieving effect, feeling during use, and adverse events or problems were evaluated. METHODS: In total, 10 Japanese cancer patients with OM receiving chemotherapy, pretreatment therapy for hematopoietic stem cell transplantation, or radiation therapy for head and neck cancer were enrolled. RESULTS: A numerical rating scale (NRS) was used to assess oral pain intensity due to OM. Compared to baseline, the mean NRS began to decrease at 5 min after using Episil® (7.1 ± 1.4 to 4.6 ± 2.87; p = 0.264). A significant decrease was observed in the pain score after using Episil® compared with that before using Episil®, and this effect lasted up to 120 min. The protective effects of Episil® were observed 3-5 min after application. Some patients felt slight soreness or discomfort when applying Episil®. However, this discomfort due to Episil®'s stimulation was within the allowable range and transient. No adverse events were observed in any of the cases. CONCLUSIONS: The results of this prospective study showed that Episil® could be an effective treatment to relieve oral pain in Japanese patients with moderate to severe OM, and this newly approved product might adequately support patients' oral intake. TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR) ( UMIN000031921 ).


Asunto(s)
Antineoplásicos/efectos adversos , Dolor/tratamiento farmacológico , Traumatismos por Radiación/tratamiento farmacológico , Elastómeros de Silicona/administración & dosificación , Estomatitis/tratamiento farmacológico , Adulto , Anciano , Estudios de Factibilidad , Femenino , Neoplasias de Cabeza y Cuello/terapia , Trasplante de Células Madre Hematopoyéticas , Humanos , Masculino , Persona de Mediana Edad , Mucosa Bucal/efectos de los fármacos , Dolor/etiología , Dimensión del Dolor , Estudios Prospectivos , Calidad de Vida , Traumatismos por Radiación/etiología , Estomatitis/etiología , Resultado del Tratamiento
2.
Acta Pharmacol Sin ; 41(1): 119-128, 2020 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-31534201

RESUMEN

Inefficient diabetic ulcer healing and scar formation remain a challenge worldwide, owing to a series of disordered and dynamic biological events that occur during the process of healing. A functional wound dressing that is capable of promoting ordered diabetic wound recovery is eagerly anticipated. In this study, we designed a silicone elastomer with embedded 20(S)-protopanaxadiol-loaded nanostructured lipid carriers (PPD-NS) to achieve ordered recovery in scarless diabetic ulcer healing. The nanostructured lipid carriers were prepared through an emulsion evaporation-solidification method and then incorporated into a network of silicone elastomer to form a unique nanostructured lipid carrier-enriched gel formulation. Interestingly, the PPD-NS showed excellent in vitro anti-inflammatory and proangiogenic activity. Moreover, in diabetic mice with full-thickness skin excision wound, treatment with PPD-NS significantly promoted in vivo scarless wound healing through suppressing inflammatory infiltration in the inflammatory phase, promoting angiogenesis during the proliferation phase, and regulating collagen deposition in the remodeling phase. Hence, this study demonstrates that the developed PPD-NS could facilitate ordered diabetic wound recovery via multifunctional improvement during different wound-healing phases. This novel approach could be promising for scarless diabetic wound healing.


Asunto(s)
Inhibidores de la Angiogénesis/farmacología , Antiinflamatorios no Esteroideos/farmacología , Pie Diabético/tratamiento farmacológico , Neovascularización Patológica/tratamiento farmacológico , Sapogeninas/farmacología , Elastómeros de Silicona/química , Inhibidores de la Angiogénesis/administración & dosificación , Animales , Antiinflamatorios no Esteroideos/administración & dosificación , Movimiento Celular/efectos de los fármacos , Supervivencia Celular/efectos de los fármacos , Células Cultivadas , Pie Diabético/patología , Portadores de Fármacos/química , Liberación de Fármacos , Geles/administración & dosificación , Geles/química , Humanos , Inflamación/tratamiento farmacológico , Inflamación/patología , Lípidos/química , Lipopolisacáridos/antagonistas & inhibidores , Lipopolisacáridos/farmacología , Masculino , Ratones , Nanoestructuras/química , Neovascularización Patológica/patología , Óxido Nítrico/antagonistas & inhibidores , Óxido Nítrico/biosíntesis , Tamaño de la Partícula , Células RAW 264.7 , Sapogeninas/administración & dosificación , Sapogeninas/química , Elastómeros de Silicona/administración & dosificación , Propiedades de Superficie , Cicatrización de Heridas/efectos de los fármacos
3.
Graefes Arch Clin Exp Ophthalmol ; 255(10): 1947-1955, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-28674834

RESUMEN

PURPOSE: The management of chronic ocular hypotony and complicated proliferative vitreoretinopathy-related retinal detachment represents a challenge. Being non-absorbable and non-biodegradable, a silicone oil implant is expected to restore the volume and the intraocular pressure of the globe, as well as to approximate the detached retina. Further advantages could be a long-term tamponade potential, absence of toxicity, and prevention of silicone oil emulsification or anterior chamber oil-prolapse. The aim of this study was to assess the histological tolerance of the silicone oil implant in a pig model. METHODS: A seamless silicone balloon implant with optional surface modifications was developed. Mini pigs were used as experimental animals, and three variants of silicone implants with different surfaces were tested: uncoated, NCO-sP(EO-stat-PO) coated, and heparin-NCO-sP(EO-stat-PO) coated silicone implants. An extracapsular lens extraction was achieved via a standard phacoemulsification followed by a standard three-port vitrectomy. The implant was then placed in the posterior segment and filled with 5000 centistoke silicone oil. One month later, the pigs were euthanized, the eyes were enucleated, and histological specimens were prepared for microscopy. RESULTS: The analysis of the histology revealed that adverse histological changes in conjunctiva, cornea, iris, and ciliary body could be excluded in all eyes operated on regardless of which variant of implant had been employed. The retina as the implant-contacting ocular tissue showed overall good tolerance, although some inflammatory reaction and fibrous proliferation was evident in some cases. CONCLUSIONS: The silicone oil implant is a promising candidate and has the potential to fulfill clinical requirements to act as a long-term intraocular tamponade agent. The heparin-NCO-sP(EO-stat-PO) coating approach could lead to a novel bioactive surface for intraocular devices with excellent properties to hinder cell adhesion and protein adsorption, although further studies will be necessary to evaluate long-term biocompatibility and long-term resistance to biological attacks.


Asunto(s)
Presión Intraocular/fisiología , Hipotensión Ocular/cirugía , Prótesis e Implantes , Retina/patología , Elastómeros de Silicona/administración & dosificación , Animales , Enfermedad Crónica , Modelos Animales de Enfermedad , Estudios de Seguimiento , Hipotensión Ocular/patología , Hipotensión Ocular/fisiopatología , Diseño de Prótesis , Porcinos , Porcinos Enanos
4.
Aesthetic Plast Surg ; 41(2): 397-412, 2017 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-28127664

RESUMEN

BACKGROUND: Modern rhinoplasty is not just a reduction procedure. An optimal nasal esthetic result occasionally requires augmenting the nasal tip, the dorsum or the lateral wall with autografts or alloplasts. A large number of nasal implant types have been reported in the medical literature. OBJECTIVE: The goal of this article is to demystify the role and indications of nasal implants in rhinoplasty. As well, it offers both the novice and experienced nasal surgeon a basic, simplified and organized approach to the use of soft and firm nasal implants in rhinoplasty. METHODS: This article presents the authors experience with 311 rhinoplasties using both soft and firm alloplastic implants. The indications for both types of alloplasts are discussed, the surgical technique detailed and the outcomes analyzed. RESULTS: A total of 311 nasal implant cases were reviewed. This series revealed a low incidence of postoperative infection (5.57% for soft implants and 0.1% for the firm ones). The revision rate was 2.7% for the soft implants group and 7.1% for the firm implants group. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .


Asunto(s)
Prótesis e Implantes/clasificación , Implantación de Prótesis/métodos , Rinoplastia/métodos , Adolescente , Adulto , Materiales Biocompatibles/administración & dosificación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Nariz/cirugía , Tereftalatos Polietilenos/administración & dosificación , Estudios Retrospectivos , Elastómeros de Silicona/administración & dosificación , Adulto Joven
5.
Exp Eye Res ; 134: 148-54, 2015 May.
Artículo en Inglés | MEDLINE | ID: mdl-25704214

RESUMEN

Accommodation may be restored to presbyopic lenses by refilling the lens capsular bag with a soft polymer. After this accommodative lens refilling prevention of capsular opacification is a requirement, since capsular opacification leads to a decreased clarity of the refilled lens. It has been hypothesized that capsular fibrosis causing the capsular opacification results in increased stiffness of the lens capsular bag, therewith contributing to a decrease in accommodative amplitude of the lens. However, the change in viscoelastic properties of refilled lenses due to capsular fibrosis has never been measured directly. In this study we examined natural lenses from enucleated porcine eyes and refilled lenses directly after refilling and after three months of culturing, when capsular fibrosis had developed, and determined their viscoelastic properties with a low load compression tester. Control refilled lenses were included in which capsular opacification was prevented by treatment with actinomycin D. We related lens stiffening to the degree of capsular opacification, as derived from the microscopic images taken with a confocal laser scanning microscope. Overall, the refilled lenses directly after refilling were softer than refilled lenses after three months of culturing, and refilled lenses treated with actinomycin D were softer compared with untreated refilled lenses. The degree of capsular opacification as assessed by microscopy corresponds to an increase in lens stiffness. This indicates that the viscoelastic properties of the refilled lens are influenced by capsular fibrosis and modulated by treatment of the lens epithelium. In conclusion, this study shows that the development of capsular fibrosis negatively affects the viscoelastic properties of isolated, cultured refilled lenses.


Asunto(s)
Acomodación Ocular , Opacificación Capsular/fisiopatología , Elasticidad/fisiología , Cristalino/fisiología , Cápsula Posterior del Cristalino/efectos de los fármacos , Elastómeros de Silicona/administración & dosificación , Animales , Opacificación Capsular/etiología , Opacificación Capsular/prevención & control , Capsulorrexis , Dactinomicina/farmacología , Modelos Animales de Enfermedad , Diagnóstico por Imagen de Elasticidad , Fibrosis , Técnicas de Cultivo de Órganos , Cápsula Posterior del Cristalino/patología , Inhibidores de la Síntesis de la Proteína/farmacología , Sus scrofa
6.
Support Care Cancer ; 22(6): 1557-62, 2014 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-24442926

RESUMEN

PURPOSE: CAM2028, a vehicle that forms a bioadhesive lipid barrier when applied to the oral mucosa, was developed as a carrier system for local delivery of benzydamine, an NSAID used for pain relief in oral mucositis. This trial compared the analgesic effect of CAM2028 plus benzydamine (CAM2028-benzydamine) with unmedicated CAM2028 (CAM2028-control) for the treatment of oral mucositis in patients with head-and-neck cancer. METHODS: Thirty-eight study participants were enrolled during their 3rd to 4th week of radiation therapy. Participants were required to have symptomatic oral mucositis (WHO Grade 2 or above) at screening and pain scores of at least 6 on an 11-point Likert scale at screening and on each day before treatment with study medication. After undergoing radiation, patients were administered a single dose of CAM2028-control or CAM2028-benzydamine 2 days apart, in a randomized crossover fashion. Pain was assessed over the following 8 h. RESULTS: With both treatments, patients experienced a mean 40 % decrease in pain intensity at 6 h (the primary study endpoint). Both treatments resulted in significant pain relief within 5 min of application that was evident during the entire 8-h assessment period. There was no difference in pain relief between the two interventions at any time point. Both treatments were safe and well tolerated. CONCLUSIONS: CAM2028-benzydamine and CAM2028-control were both efficacious in reducing pain in patients with oral mucositis related to radiation therapy for head-and-neck cancer. Analgesic effects of both medications were immediate, clinically significant, and persistent for up to 8 h.


Asunto(s)
Bencidamina/administración & dosificación , Neoplasias de Cabeza y Cuello/radioterapia , Dolor/tratamiento farmacológico , Traumatismos por Radiación/tratamiento farmacológico , Elastómeros de Silicona/administración & dosificación , Estomatitis/tratamiento farmacológico , Adulto , Anciano , Bencidamina/efectos adversos , Estudios Cruzados , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Mucosa Bucal/efectos de los fármacos , Mucosa Bucal/efectos de la radiación , Dolor/etiología , Proyectos Piloto , Traumatismos por Radiación/etiología , Traumatismos por Radiación/prevención & control , Elastómeros de Silicona/efectos adversos , Estomatitis/etiología , Estomatitis/prevención & control
7.
J Antimicrob Chemother ; 68(2): 394-403, 2013 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-23109186

RESUMEN

OBJECTIVES: The non-nucleoside reverse transcriptase inhibitor MC1220 has potent in vitro activity against HIV type 1 (HIV-1). A liposome gel formulation of MC1220 has previously been reported to partially protect rhesus macaques against vaginal challenge with a simian HIV (SHIV). Here, we describe the pre-clinical development of an MC1220-releasing silicone elastomer vaginal ring (SEVR), including pharmacokinetic (PK) and efficacy studies in macaques. METHODS: In vitro release studies were conducted on SEVRs loaded with 400 mg of MC1220, using simulated vaginal fluid (SVF, n = 4) and 1 : 1 isopropanol/water (IPA/H(2)O, n = 4) as release media. For PK evaluation, SEVRs were inserted into adult female macaques (n = 6) for 30 days. Following a 1 week washout period, fresh rings were placed in the same animals, which were then challenged vaginally with RT-SHIV162P3 once weekly for 4 weeks. RESULTS: SEVRs released 1.66 and 101 mg of MC1220 into SVF and IPA/H(2)O, respectively, over 30 days, the differential reflecting the low aqueous solubility of the drug. In macaque PK studies, MC1220 was consistently detected in vaginal fluid (peak 845 ng/mL) and plasma (peak 0.91 ng/mL). Kaplan-Meier analysis over 9 weeks showed significantly lower infection rates for animals given MC1220-containing SEVRs than placebo rings (hazard ratio 0.20, P = 0.0037). CONCLUSIONS: An MC1220-releasing SEVR partially protected macaques from vaginal challenge. Such ring devices are a practical method for providing sustained, coitally independent protection against vaginal exposure to HIV-1.


Asunto(s)
Antivirales/administración & dosificación , Dispositivos Anticonceptivos Femeninos , Portadores de Fármacos , Pirimidinonas/administración & dosificación , Elastómeros de Silicona/administración & dosificación , Síndrome de Inmunodeficiencia Adquirida del Simio/prevención & control , Virus de la Inmunodeficiencia de los Simios/patogenicidad , Animales , Antivirales/farmacocinética , Líquidos Corporales/química , Femenino , Fluorobencenos , Humanos , Macaca mulatta , Plasma/química , Pirimidinonas/farmacocinética , Resultado del Tratamiento , Vagina/química
8.
J Antimicrob Chemother ; 67(8): 2005-12, 2012 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-22556381

RESUMEN

OBJECTIVES: Systemic aciclovir and its prodrug valaciclovir are effective in treating and reducing recurrences of genital herpes simplex virus (HSV) and reducing transmission. Local aciclovir delivery, if it can achieve and maintain comparable intracellular genital tract levels, may be equally effective in the treatment and suppression of genital HSV. Intravaginal ring (IVR) delivery of aciclovir may provide pre-exposure prophylaxis against HSV acquisition. METHODS: Tolerability and pharmacokinetics were evaluated in six HIV-negative women with recurrent genital HSV who switched their daily oral valaciclovir suppression to an aciclovir IVR for 7 days (n = 3) or 14 days (n = 3). Blood and cervicovaginal lavage (CVL) were collected after oral and IVR dosing to measure aciclovir concentrations and genital swabs were obtained to quantify HSV shedding by PCR. RESULTS: The rings were well tolerated. Median plasma aciclovir concentrations were 110.2 ng/mL (IQR, 85.9-233.5) 12-18 h after oral valaciclovir. Little or no drug was detected in plasma following IVR dosing. Median (IQR) CVL aciclovir levels were 127.3 ng/mL (21-660.8) 2 h after oral valaciclovir, 154.4 ng/mL (60.7-327.5) 12-18 h after oral valaciclovir and 438 ng/mL (178.5-618.5) after 7 days and 393 ng/mL (31.6-1615) after 14 days of aciclovir ring use. Median CVL aciclovir levels 2 h after oral dosing were similar to levels observed 7 (P = 0.99) and 14 (P = 0.75) days after ring use. HSV DNA was not detected in genital swabs and there was no significant change in inflammatory mediators. CONCLUSIONS: This first-in-human study demonstrated that an IVR could safely deliver mucosal levels of aciclovir similar to oral valaciclovir without systemic absorption. More intensive site-specific pharmacokinetic studies are needed to determine whether higher local concentrations are needed to achieve optimal drug distribution within the genital tract.


Asunto(s)
Aciclovir/farmacocinética , Antivirales/farmacocinética , Dispositivos Anticonceptivos Femeninos/efectos adversos , Portadores de Fármacos/administración & dosificación , Herpes Genital/tratamiento farmacológico , Herpes Genital/prevención & control , Elastómeros de Silicona/administración & dosificación , Aciclovir/administración & dosificación , Aciclovir/efectos adversos , Adulto , Antivirales/administración & dosificación , Antivirales/efectos adversos , Portadores de Fármacos/efectos adversos , Femenino , Humanos , Persona de Mediana Edad , Membrana Mucosa/química , Plasma/química , Elastómeros de Silicona/efectos adversos , Vagina/química
9.
Eur J Vasc Endovasc Surg ; 43(6): 675-80, 2012 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-22436262

RESUMEN

OBJECTIVES: Customized aortic repair (CAR) is a new concept for endovascular aortic aneurysm repair in which a non-polymerised elastomer is injected to fill the aneurysm sac around a balloon catheter. Amongst other variables, the thrombogenicity of the elastomer should be tested, before further clinical experiments can take place. The aim of this human ex vivo study was to measure the thrombogenicity of the elastomer and to compare it to expanded polytetrafluoroethylene (ePTFE). DESIGN AND MATERIALS: In a validated ex vivo model, non-anticoagulated blood was drawn from the antecubital veins of 10 healthy donors with a 19-gauge needle. It was drawn through elastomer tubes and through ePTFE Gore-Tex vascular grafts, both 60 cm long and with an inner diameter of 3 mm. METHODS: Fibrinopeptide A (FPA) and P-selectin expression was measured in blood samples, collected at the end of the grafts. After the experiments, the deposition of platelets and fibrin onto the grafts was visualised by scanning electron microscopy. RESULTS: For these graft types, a progressive increase in FPA production was observed in time. No significant difference was observed between the elastomer and ePTFE grafts (p > 0.05). No increase in P-selectin expression, and thereby no platelet activation, was observed in the perfusate of either grafts (p > 0.05). By scanning electron microscopy, numerous platelet aggregates were observed on the ePTFE grafts, whereas just a few adhered platelets and no aggregates were observed in the elastomer grafts. CONCLUSIONS: The elastomer in its current formulation has a low thrombogenicity, comparable to ePTFE, making it an ideal substance for endovascular aneurysm sac filling. Further research should clarify the feasibility of CAR in vivo.


Asunto(s)
Aneurisma de la Aorta/terapia , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Dimetilpolisiloxanos/administración & dosificación , Procedimientos Endovasculares/instrumentación , Politetrafluoroetileno , Elastómeros de Silicona/administración & dosificación , Trombosis/prevención & control , Adulto , Aneurisma de la Aorta/sangre , Aneurisma de la Aorta/cirugía , Implantación de Prótesis Vascular/efectos adversos , Dimetilpolisiloxanos/efectos adversos , Procedimientos Endovasculares/efectos adversos , Fibrina/metabolismo , Fibrinopéptido A/metabolismo , Humanos , Inyecciones , Masculino , Microscopía Electrónica de Rastreo , Selectina-P/sangre , Adhesividad Plaquetaria , Diseño de Prótesis , Elastómeros de Silicona/efectos adversos , Trombosis/sangre , Trombosis/etiología , Trombosis/patología , Factores de Tiempo , Adulto Joven
10.
Retina ; 32(6): 1121-8, 2012 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-22027863

RESUMEN

PURPOSE: To determine the effectiveness of macular buckling in eyes with myopic foveoschisis and describe two methods of macular buckling: hard silicone implant and Ando plombe. METHODS: Sixteen eyes of 16 consecutive patients with myopic foveoschisis who underwent surgery with the macular buckling procedure were studied. Pars plana vitrectomy combined with macular buckling with hard silicone implant was used in 6 eyes, whereas the other 10 eyes underwent pars plana vitrectomy and macular buckling with the Ando macular plombe. RESULTS: Macular buckling, with both hard silicone implant and macular plombe resulted in reduction of retinal thickness in all patients. Best-corrected visual acuity improved in 14 of 16 eyes (87.5%), whereas it remained stable or decreased in 2 eyes (12.5%). Mean preoperative best-corrected visual acuity was 20/125 (mean logarithm of the minimal angle of resolution 0.8), whereas mean postoperative best-corrected visual acuity improved to 20/50 (mean logarithm of the minimal angle of resolution 0.39). Both methods showed a similar rate of complications, the most frequent being the development of localized areas of retinal pigment epithelium atrophy. CONCLUSION: Combined pars plana vitrectomy and macular buckling is an effective approach to treat myopic foveoschisis with both anatomical and visual improvement. Despite a similar complication rate with both buckling techniques, macular buckling with the Ando plombe was found to be technically easier with shorter surgical times.


Asunto(s)
Miopía/cirugía , Retinosquisis/cirugía , Curvatura de la Esclerótica/métodos , Anciano , Femenino , Humanos , Masculino , Persona de Mediana Edad , Miopía/etiología , Enfermedades de la Retina/complicaciones , Retinosquisis/etiología , Elastómeros de Silicona/administración & dosificación , Agudeza Visual , Vitrectomía/métodos
11.
Artículo en Inglés | MEDLINE | ID: mdl-22262288

RESUMEN

PURPOSE: To evaluate the long-term efficacy of silicone intubation in adults with presumed functional nasolacrimal duct obstruction. METHODS: This retrospective cohort study reviewed adults with unilateral or bilateral epiphora and presumed functional nasolacrimal duct obstruction treated with silicone intubation and followed for signs of treatment failure (defined as persistent epiphora or need for a secondary procedure). Median time to event (failure) after silicone intubation was calculated using Kaplan-Meier survival analysis. Analysis was conducted at the level of the individual eye, with clustering by person taken in account. Cox proportional hazards models were used and adjusted for within-subject variance using a robust sandwich estimator. RESULTS: Forty-four eyes from 30 patients with isolated functional nasolacrimal duct obstruction underwent silicone intubation for epiphora. Mean time to stent removal in 40 of 44 eyes was 4.0 (±4.1) months. Mean duration from the time of stent placement to last follow-up was 2.6 (±2.0) years. Overall success after silicone intubation for resolution of symptoms was 77%. Kaplan-Meier survival analysis for time to event after silicone intubation yielded a median time of 5.7 years. Extrapolated data demonstrated a 96% success rate at 2 years and 85% success rate at 3 years and predicted approximately 50% of patients to have relief of epiphora between 5 and 6 years after silicone intubation. CONCLUSIONS: In this study, silicone intubation has good long-term success for relief of epiphora in patients with presumed functional nasolacrimal duct obstruction. This study provides important clinical information to guide management of epiphora in adults with functional nasolacrimal duct obstruction.


Asunto(s)
Intubación/métodos , Enfermedades del Aparato Lagrimal/terapia , Obstrucción del Conducto Lagrimal/terapia , Conducto Nasolagrimal , Elastómeros de Silicona/administración & dosificación , Adulto , Anciano , Anciano de 80 o más Años , Métodos Epidemiológicos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Stents , Insuficiencia del Tratamiento , Adulto Joven
12.
Eur J Vasc Endovasc Surg ; 40(1): 65-70, 2010 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-20382549

RESUMEN

OBJECTIVE: This study aimed to test a percutaneous technique for aneurysm-sac filling by means of in situ polymerisation in an in vivo model. DESIGN: Aortic Customize is a new endovascular treatment concept for aortic aneurysms: a non-cross-linked liquid elastomer is injected to fill the aneurysm sac around a balloon-catheter. With this method, a compliant elastomer mould with a patent lumen is created. MATERIAL: The formulation used in the experiments consisted of a two-component addition-cure liquid-silicone formulation, based on vinyl-terminated polydimethylsiloxane (PDMS). METHODS: The concept of aneurysm-sac filling was tested in vivo in porcine experiments (n = 3). RESULTS: In vivo porcine experiments with the sac-filling application showed successful exclusion of the created aneurysms with patent lumens and absence of endoleaks. The aneurysms were excluded successfully in the in vivo model, injecting elastomer through a 7-French catheter, filling up the entire aneurysm sac. CONCLUSIONS: These in vivo experiments demonstrate that the principle of aneurysm-sac filling by means of in situ curing is feasible, excluding the aneurysm and creating a new lumen. Further long-term animal experiments must be done prior to consideration of clinical application.


Asunto(s)
Aneurisma de la Aorta Abdominal/terapia , Implantación de Prótesis Vascular/instrumentación , Implantación de Prótesis Vascular/métodos , Prótesis Vascular , Cateterismo , Dimetilpolisiloxanos/administración & dosificación , Elastómeros de Silicona/administración & dosificación , Animales , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Aortografía , Modelos Animales de Enfermedad , Estudios de Factibilidad , Inyecciones Intralesiones , Diseño de Prótesis , Porcinos
13.
Klin Oczna ; 112(4-6): 108-10, 2010.
Artículo en Polaco | MEDLINE | ID: mdl-20825062

RESUMEN

PURPOSE: To report the safety and efficacy of Ahmed glaucoma valve implantation in the management of secondary glaucoma in children and adolescents. MATERIAL AND METHODS: 6 patients with secondary glaucoma underwent Ahmed valve implantation. 1 patient had aphakic glaucoma, 3 patients had traumatic glaucoma, 1 patient had aniridia and 1 patient had ectropion uveae. IOP values range from 35 to 51 mmHg (mean 41.3 mmHg), with maximal medical treatment by this time. Mean follow-up was 2.17 years. RESULTS: Mean pooperative IOP ranged from 2 to 8 mmHg (mean 6 mmHg), during the first week. 6 months later IOP increased to 15.2 (6-21) mmHg. The mean IOP at last follow-up was 15 mmHg and overall success rate was 83.3%. We observed one hypotony, one tube exposure and one Tenon's cyst formation. CONCLUSIONS: The Ahmed valve is effective treatment for secondary glaucoma in children. It can be useful to avoid enucleation of the eye with traumatic glaucoma.


Asunto(s)
Implantes de Drenaje de Glaucoma , Glaucoma/cirugía , Implantación de Prótesis/métodos , Elastómeros de Silicona/administración & dosificación , Adolescente , Niño , Femenino , Estudios de Seguimiento , Glaucoma/fisiopatología , Humanos , Presión Intraocular , Masculino , Polonia , Diseño de Prótesis , Resultado del Tratamiento , Agudeza Visual
14.
Gynecol Oncol ; 112(1): 90-4, 2009 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-18952271

RESUMEN

OBJECTIVE(S): The aim of the present study is to prospectively investigate the efficacy and complications of macroplastique transurethral implantation in cervical cancer patients affected by stress urinary incontinence (SUI) after radical hysterectomy (RH). METHODS: Patients affected by de novo SUI post type 3 RH were considered for eligibility in this study. Preoperative and postoperative assessment included a standardized urogynecological history, urogynecological and neurological physical examination, evaluation of severity of SUI symptoms, a 3-day voiding diary, urine culture and urodynamic assessment. All patients underwent transurethral implantation using Macroplastique Implantation System (MIS). Patient follow-up was performed 6 and 12 months after surgery. RESULTS: A total of 24 consecutive patients were enrolled. At the 12 month follow up SUI cure rate was 42% (10 of 24 patients), the improvement rate was 42% (10 of 24) and the failure rate was 16% (4 of 24). The overall success rate was 84% (10 patients cured and 10 improved). No intraoperative or postoperative early complications were found. The 4 patients in whom treatment was not a success had preoperative urethral hypermobility. Subjective patient perception of SUI symptom severity showed significant improvement (mean severity of urinary loss perception 6.6+/-1.8 vs 2.3+/-3.3, p<0.05). The frequency of incontinence on the 3-day voiding diary was significantly reduced at the follow up (14.5+/-5.8 vs 4.3+/-7.9 episodes per 3 days, p<0.05). CONCLUSION(S): Bulking agents urethral injection could be a valid option having no surgical complications. This therapeutic strategy is able to treat SUI and improve well being of cervical cancer patients after radical surgery.


Asunto(s)
Histerectomía/efectos adversos , Elastómeros de Silicona/administración & dosificación , Incontinencia Urinaria de Esfuerzo/etiología , Incontinencia Urinaria de Esfuerzo/cirugía , Neoplasias del Cuello Uterino/cirugía , Adulto , Materiales Biocompatibles/administración & dosificación , Femenino , Humanos , Persona de Mediana Edad , Estudios Prospectivos , Prótesis e Implantes
15.
Colorectal Dis ; 11(1): 73-6, 2009 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-18462216

RESUMEN

INTRODUCTION: The aim of this study was to evaluate the functional efficacy of intersphincteric injected silicone biomaterial (PTQ) in patients with faecal incontinence. METHOD: Prospective study of 33 consecutively included patients (male-female ratio: 9:24); median age 53 years (range: 21-75 years) with faecal incontinence of varied aetiology. The PTQ was injected under general anaesthesia with antibiotic cover. All patients had anorectal manometry, endoanal ultrasonography and responded to faecal incontinence severity questionnaire (Wexner score) and SF-36 short-form health survey questionnaire before and 3 months postoperatively. At time of final follow-up, the continence status and quality of life questionnaire were reassessed. RESULTS: The mean follow-up was 12.9 months (range: 3-22 months). The Wexner Continence Score was significantly reduced short term from 12.7 to 11.0 (P = 0.03) and long term to 10.4 (P = 0.02). The long-term effect on liquid stool incontinence continued to improve significantly (P < 0.01). Six patients (18%) reported major improvement in Wexner Continence Score at the time of final follow-up. Anorectal manometry was not affected except for the maximum tolerable rectal volume, which was significantly reduced (P < 0.05). The SF-36 short-form questionnaire showed no significant improvement in quality of life after treatment with PTQ. CONCLUSIONS: Treatment with intersphincteric injection of PTQ implants can provide an improvement in anal continence in patients with faecal incontinence of varied aetiology. However, the improvement is mainly limited to soiling and minor leakage. A majority of patients still have severe incontinence, both short- and long-term.


Asunto(s)
Canal Anal , Materiales Biocompatibles/administración & dosificación , Incontinencia Fecal/terapia , Elastómeros de Silicona/administración & dosificación , Adulto , Anciano , Femenino , Humanos , Inyecciones , Masculino , Persona de Mediana Edad , Prótesis e Implantes , Calidad de Vida , Resultado del Tratamiento , Adulto Joven
16.
J Comput Assist Tomogr ; 33(2): 233-7, 2009.
Artículo en Inglés | MEDLINE | ID: mdl-19346851

RESUMEN

OBJECTIVE: To assess patient outcome and imaging findings of patients with pulmonary embolism of fluid silicone. METHODS: Medical records and imaging examinations of 10 patients with respiratory distress after illicit injection of fluid silicone were reviewed. Population consisted of 8 male (6 male-to-female transsexuals) and 2 female subjects. RESULTS: Average age was 29 years. Most common injection sites were gluteal and trochanteric. Respiratory symptoms developed between 15 minutes and 2 days after silicone injection. Five referred fever, 6 developed adult respiratory distress syndrome, and 2 subsequently died. Alveolar hemorrhage was demonstrated on pathological examination in 6, with silicone vacuoles in the lung parenchyma in 3. Computed tomography demonstrated peripheral ground glass opacities with interlobular septal thickening in all and peripheral airspace disease in 7. CONCLUSIONS: Illicit injection of large volumes of fluid silicone for cosmetic purposes is associated with pulmonary embolism and acute alveolar hemorrhage and is associated with a significant mortality.


Asunto(s)
Nalgas , Técnicas Cosméticas/efectos adversos , Cuerpos Extraños/etiología , Prótesis e Implantes/efectos adversos , Embolia Pulmonar/diagnóstico por imagen , Embolia Pulmonar/etiología , Elastómeros de Silicona/efectos adversos , Adulto , Brazo , Biopsia , Implantes de Mama/efectos adversos , Femenino , Cadera , Humanos , Inyecciones Subcutáneas , Embolia Pulmonar/patología , Elastómeros de Silicona/administración & dosificación , Muslo , Tórax , Tomografía Computarizada por Rayos X , Adulto Joven
17.
Aesthetic Plast Surg ; 33(3): 274-82, 2009 May.
Artículo en Inglés | MEDLINE | ID: mdl-19280248

RESUMEN

Driven by the rising popularity of minimally invasive techniques, the demand for cosmetic procedures is increasing. Cosmetic body-shaping procedures can be categorized into those that remove tissue and those that add volume. This review focuses on the latter of these categories, particularly on the use of resorbable hyaluronic acid gels specifically developed for minimally invasive volume enhancement. Pilot studies of hyaluronic acid involving its injection to contour various body deformities and its recent use in female breast augmentation are discussed. Injectable hyaluronic acid is effective and well tolerated. It represents an attractive treatment option for volume restoration or augmentation by providing predictable long-lasting results after minimally invasive administration. Alternative treatment options for volume enhancement also are summarized including fat transfer, silicone implants, and the use of injectable nonresorbable products such as silicone, polyalkylimide, and polyacrylamide gels. As patients continue to opt for nonsurgical procedures that offer predictable results, the development of minimally invasive products such as hyaluronic acid is increasingly important.


Asunto(s)
Técnicas Cosméticas , Ácido Hialurónico/administración & dosificación , Mamoplastia , Resinas Acrílicas/uso terapéutico , Tejido Adiposo/trasplante , Colágeno/uso terapéutico , Humanos , Hidrogeles/uso terapéutico , Mamoplastia/métodos , Polimetil Metacrilato/uso terapéutico , Rejuvenecimiento , Elastómeros de Silicona/administración & dosificación , Colgajos Quirúrgicos , Trasplante Autólogo
18.
J Cataract Refract Surg ; 34(2): 302-9, 2008 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-18242458

RESUMEN

PURPOSE: To describe a capsular bag refilling procedure using an accommodating intraocular lens (IOL). SETTING: Jinshikai Medical Foundation Nishi Eye Hospital, Osaka, Japan. METHODS: A disk-shaped anterior foldable silicone accommodating IOL that serves as an optical device and as a mechanical device to prevent leakage of the injected silicone polymers was developed. The IOL optic is 6.0 mm and the overall diameter, 9.0 mm. After a 3.5 to 4.0 mm continuous curvilinear capsulorhexis (PCCC) is created, phacoemulsification and aspiration are performed in the usual manner. Then, a posteriorly placed accommodating IOL with sharp edges is implanted in the capsular bag to prevent posterior capsule opacification (PCO) and leakage of the injected silicone polymer. A PCCC is an option at this point. Then, an anterior accommodating IOL is piggybacked over the existing IOL and silicone polymers are injected between the 2 IOLs. RESULTS: Experiments in numerous pig cadaver eyes and in 10 rabbit eyes showed minimal to no silicone leakage. In cases in which a PCCC was not created, 2 eyes had no PCO and 3 showed slight to moderate PCO. None of the 5 eyes with a PCCC had no PCO 5 to 8 weeks after surgery within the PCCC. CONCLUSION: The procedure in rabbit eyes overcame 2 problems of lens-refilling techniques: leakage of the injectable silicone polymer and capsule opacification.


Asunto(s)
Cápsula del Cristalino/cirugía , Implantación de Lentes Intraoculares/métodos , Lentes Intraoculares , Elastómeros de Silicona , Acomodación Ocular , Animales , Capsulorrexis , Catarata/prevención & control , Facoemulsificación , Complicaciones Posoperatorias/prevención & control , Conejos , Elastómeros de Silicona/administración & dosificación , Dehiscencia de la Herida Operatoria/prevención & control , Porcinos
19.
J Am Acad Dermatol ; 59(4): 659-76, 2008 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-18662839

RESUMEN

Acne is a prevalent condition in society and often results in secondary damage in the form of scarring. Of course, prevention is the optimal method to avoid having to correct the physically or emotionally troublesome scars. However, even with the best efforts, scars will certainly arise. This article attempts to give a broad overview of multiple management options, whether medically, surgically, or procedurally based. The hope is that a general knowledge of the current available alternatives will be of value to the physician when confronted with the difficult task of developing a treatment plan for acne-scarred individuals, even in challenging cases.


Asunto(s)
Acné Vulgar/complicaciones , Cicatriz/etiología , Cicatriz/terapia , Adolescente , Adulto , Cicatriz/prevención & control , Criocirugía , Dermabrasión , Femenino , Humanos , Masculino , Persona de Mediana Edad , Fototerapia , Procedimientos de Cirugía Plástica , Retinoides/administración & dosificación , Elastómeros de Silicona/administración & dosificación , Ácido Tricloroacético/administración & dosificación
20.
PLoS One ; 13(3): e0193448, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29570703

RESUMEN

OBJECTIVE: To investigate the usefulness of addition type liquid silicone rubber (ATLSR) as injectable implant after evisceration to maintain the eyeball volume in an animal experiment. METHODS: Twelve adult New Zealand white rabbits were included. One eye of each rabbit was randomly selected for evisceration with the fellow eye as control. ATLSR was injected to fill the eyeball socket after evisceration. In vivo observation and photographs were performed up to 24 weeks post-op. Two rabbits were sacrificed respectively at post-operative week 1, 2, 4, 8, 12 and 24. After enucleation, the vertical, horizontal and sagittal diameters of the experimental eyeballs were measured and compared with the control eyes. Histopathological studies were performed to evaluate signs of inflammation. RESULTS: Cornea remained clear throughout the observation period despite mild epithelial edema and neovascularization. Compared to the control eyes, the experimental eyes were significantly smaller in vertical diameter (17.00±1.17 vs. 17.54±1.11 mm, P<0.001), but larger in sagittal diameter (16.85±1.48 vs. 16.40±1.38 mm, P = 0.008), and had no significant difference in horizontal diameter (17.49±1.53 vs. 17.64±1.21 mm, P = 0.34). Postoperative inflammation was observed at one week after surgery, which peaked at 2-3 weeks, then regressed gradually. At week 12 and week 24, most of the inflammatory cells disappeared with some residual plasma cells and eosinophils. CONCLUSION: Injectable addition type silicon rubber may be a good choice for ocular implantation after evisceration, maintaining eyeball volume and cosmetically satisfactory when compared to the fellow eye. Spontaneous regression of inflammation implied good biocompatibility for at least 24 weeks.


Asunto(s)
Evisceración del Ojo , Ojo Artificial , Ojo/efectos de los fármacos , Ojo/patología , Elastómeros de Silicona/farmacología , Animales , Inyecciones , Tamaño de los Órganos/efectos de los fármacos , Periodo Posoperatorio , Conejos , Elastómeros de Silicona/administración & dosificación
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