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1.
Arch Orthop Trauma Surg ; 143(8): 4633-4639, 2023 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-36577799

RESUMEN

INTRODUCTION: To evaluate the clinical and radiological results after fixation of the first metatarsal head (MTH) with one or two screws as part of the third-generation minimally invasive Chevron-Akin osteotomy (MICA) for hallux valgus deformities. MATERIALS AND METHODS: Between August 2020 and November 2021, 55 MICA procedures (50 patients, male:female = 7:43), 22 with two (MICA2), 33 with one screw (MICA1) were performed for mild to severe hallux valgus deformities. Exclusion criteria were a concomitant pes adductus (Sgarlato angle > 20°) or hindfoot/midfoot deformities requiring treatment. In 27 cases, additional procedures on the forefoot (small toe corrections or metatarsal osteotomies II-V) were necessary. Pre- and post-operatively, hallux valgus angle (HVA) and intermetatarsal I/II angle (IMA) were measured. Clinically, subjective satisfaction, range of motion (ROM) of the first metatarsophalangeal joint (MTPJ), and pain level (NRS score) were evaluated. The minimum follow-up was 12 months. RESULTS: Displacement of MTH was 70-90% on average, all osteotomies showed full consolidation at latest follow-up. In one case of either group, a slight subsidence of MTH was documented. The radiological and clinical parameters showed no differences between the groups. The pain level improved by an average of three points. The mobility of the MTPJ showed a slight reduction in nine cases after three months (4 MICA2, 5 MICA1) which persisted in three cases. Fifty-two of 55 patients (95%) would opt again for the operation. CONCLUSIONS: Fixation of the first MTH with a single bicortical screw in MICA with moderate lateralization of MTH shows stable anchoring and good clinical results. The routine use of a second metatarsal screw can be omitted.


Asunto(s)
Hallux Valgus , Huesos Metatarsianos , Humanos , Masculino , Femenino , Huesos Metatarsianos/diagnóstico por imagen , Huesos Metatarsianos/cirugía , Hallux Valgus/cirugía , Estudios de Casos y Controles , Resultado del Tratamiento , Tornillos Óseos , Osteotomía/métodos , Dolor
2.
Arch Orthop Trauma Surg ; 142(2): 205-210, 2022 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-33047231

RESUMEN

INTRODUCTION: Chondral and osteochondral lesions of the talus (OLTs) remain a challenging issue with numerous operative treatments proposed to date. The aim of this study was to evaluate 1-year follow-up data in the German Cartilage Registry (KnorpelRegister DGOU). METHODS: Among 401 patients in the database, 114 patients with a complete 1-year Foot and Ankle Outcome (FAOS) score for subscale Pain as the primary variable were included. A total of 12 different surgical treatments were performed. However, 8 techniques were carried out in negligible numbers of patients (n = 1-3), leaving 89 patients treated with the following techniques: arthroscopic antegrade bone marrow stimulation (group A; n = 32), autologous chondrocyte implantation with autologous cancellous bone grafting (group B; n = 9), matrix-augmented bone marrow stimulation (group C; n = 22), and matrix-augmented bone marrow stimulation with autologous cancellous bone grafting (group D; n = 26). Group differences and possible influencing variables such as age and sex were evaluated. Level of significance was set at p < 0.05 for all statistical tests. RESULTS: All four treatment groups showed significant improvement of the FAOS scores at 1 year postoperatively compared with their preoperative scores. No significant differences were found with respect to score changes among the groups. A positive correlation between FAOS subscale Pain improvement and defect size volume and negative correlations between increasing age and FAOS subscales Sports/Rec and QoL were found. Concomitant ankle stabilization led to greater improvement in FAOS subscales Symptoms and ADL than in patients with no stabilization. FAOS subscale Pain showed greater improvement in women than in men. CONCLUSION: All analyzed treatment options were effective for treatment of OLTs. In particular, large defects appeared to benefit from treatment. In the presence of concomitant ankle instability, a stabilizing procedure appeared to have a positive impact on the outcome.


Asunto(s)
Cartílago Articular , Astrágalo , Trasplante Óseo , Cartílago , Cartílago Articular/cirugía , Femenino , Estudios de Seguimiento , Humanos , Imagen por Resonancia Magnética , Masculino , Calidad de Vida , Sistema de Registros , Astrágalo/cirugía , Trasplante Autólogo , Resultado del Tratamiento
3.
Z Rheumatol ; 79(10): 1046-1049, 2020 Dec.
Artículo en Alemán | MEDLINE | ID: mdl-32816071

RESUMEN

A 46-year-old female patient with a known HIV-2-infection suffered from adult onset Still's disease, which was initially complicated by a macrophage activation syndrome (MAS). The required glucocorticoid treatment induced a psychosis and the patient developed an aversion to glucocorticoids. After failure of treatment with anakinra, an alternative option with the JAK-inhibitor tofacitinib was introduced because of the short half-life and to reduce glucocorticoid exposure. A switch to tofacitinib was only successful after an overlapping treatment with anakinra and tofacitinib for 3 weeks. The patient is currently being treated with monotherapy with tofacitinib as well as NSAID on demand, is in stable remission and can continue working as normal.


Asunto(s)
Infecciones por VIH/complicaciones , Piperidinas/uso terapéutico , Inhibidores de Proteínas Quinasas/uso terapéutico , Pirimidinas/uso terapéutico , Pirroles/uso terapéutico , Enfermedad de Still del Adulto , Adulto , Femenino , VIH-2 , Humanos , Persona de Mediana Edad , Enfermedad de Still del Adulto/complicaciones , Enfermedad de Still del Adulto/tratamiento farmacológico , Resultado del Tratamiento
4.
Orthopade ; 49(11): 962-967, 2020 Nov.
Artículo en Alemán | MEDLINE | ID: mdl-32990760

RESUMEN

Minimally invasive medializing calcaneal osteotomy, the implantation of a tarsi spacer and the tendoscopy of the posterior tibial tendon have been established as treatment options for tibialis posterior insufficiency grade II. The minimally invasive medializing calcaneal osteotomy allows a correction of the hindfoot valgus like an open procedure with a significantly lower risk of wound healing problems. It has gained increasing popularity within recent years. There is also good evidence for arthroereisis, with the use of the sinus tarsi spacer being primarily an addition to calcaneus sliding osteotomy. The possibilities for tendoscopy of the posterior tibial tendon are limited to debridement and synovectomy. Various papers report minimally invasive alternatives to the strayer procedure for a shortened gastrocnemius muscle. The proximal lengthening of the medial head of the gastrocnemius muscle is particularly popular as a soft tissue-sparing, less traumatic procedure. So far, no reports of a minimally invasive cotton osteotomy have been found in the literature.


Asunto(s)
Tendón Calcáneo/cirugía , Calcáneo/cirugía , Pie Plano , Osteotomía/métodos , Disfunción del Tendón Tibial Posterior/cirugía , Adulto , Calcáneo/diagnóstico por imagen , Pie , Talón , Humanos , Resultado del Tratamiento
5.
Orthopade ; 49(6): 531-537, 2020 Jun.
Artículo en Alemán | MEDLINE | ID: mdl-31486913

RESUMEN

In surgical correction of cavovarus deformity bony hindfoot procedures are required in most cases. For treatment planning X­rays in two or more planes are usually used. In conventional X­ray-techniques the hindfoot and ankle joint are presented in a more or less outward rotated position. Moreover, the peritalar complex is not delineated in the most corrected position. Therefore, the frequently used talus-metatarsal-I-angle (Meary angle) cannot be measured correctly. By application of the Coleman block test and additional adjustment of the malrotation in the lateral view, the peritalar complex and ankle joint can be evaluated in the corrected and "hindfoot-centred" position. Also, the frequently seen anterior ankle impingement can be observed precisely. Planning of osteotomies or corrective peritalar fusions is supported thereby. Some treatment examples are presented.


Asunto(s)
Radiografía/métodos , Pie Cavo/diagnóstico por imagen , Astrágalo/diagnóstico por imagen , Articulación del Tobillo/fisiopatología , Pie , Humanos , Inestabilidad de la Articulación/complicaciones , Pie Cavo/cirugía , Rayos X
6.
Unfallchirurg ; 121(9): 715-722, 2018 Sep.
Artículo en Alemán | MEDLINE | ID: mdl-29959450

RESUMEN

Fractures of the lateral tubercle of the talus (PLT) are rare. With the increasing popularity of the trend sport snowboarding, the incidence of PLT fractures has increased. The most common classification of PLT fractures is the Hawkins classification. The aim of this review was to raise awareness for the injury and discuss the current evidence. A literature search revealed eight studies, each including at least seven patients. Six out of the eight studies were descriptive, retrospective case series without predefined treatment concepts. These resulted in only moderate treatment outcomes. Due to the low number of patients, the lack of computed tomography (CT) or magnetic resonance imaging (MRI) and inconsistent treatment approaches, these studies do not allow to draw conclusions on a treatment concept for PLT fractures. The other two studies validated existing treatment regimens. Overall, surgical treatment of dislocated fractures and conservative treatment of non-dislocated fractures was carried out with satisfactory results. The outcome of conservative treatment of dislocated factures remains unclear. A reason for the inconsistent treatment results could be the observed concomitant injuries, including dislocation of the tendons of the peroneus muscles (46%), calcaneal chondral injuries (48%) and subluxation of the subtalar joint (7%). Based on the limited evidence available, the authors recommend the application of CT and MRI for PLT fractures to assess concomitant injuries, which are the primary indication for surgery. Dislocated type I and II fractures (>2 mm) should be treated operatively, type III and non-dislocated type I and II fractures can be treated conservatively by immobilization and partial weight-bearing for 6 weeks.


Asunto(s)
Fracturas de Tobillo/diagnóstico , Fracturas de Tobillo/terapia , Traumatismos en Atletas/diagnóstico , Traumatismos en Atletas/terapia , Esquí/lesiones , Astrágalo/lesiones , Fracturas de Tobillo/clasificación , Fracturas de Tobillo/diagnóstico por imagen , Traumatismos en Atletas/diagnóstico por imagen , Humanos
7.
AAPS PharmSciTech ; 19(1): 148-154, 2018 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-28634790

RESUMEN

The objective of this work was the preparation of osmotic tablets using polymer blends of cellulose acetate butyrate (CAB) or ethylcellulose with ammonio methacrylate copolymer (Eudragit® RL). The advantage of these coatings in comparison to the traditionally used cellulose acetate is their solubility in safer organic solvents like ethanol. Polymer films were characterized with respect to their water uptake, dry mass loss, and mechanical properties. The effect of the polymer blend ratio on drug release and on the rupture force of the coating was investigated. In addition, the effect of drug solubility and content, pH and agitation rate of the release medium, and coating level and plasticizer content on the release were studied. With increased Eudragit® RL content in the coating blends, higher medium uptake of the film was observed, resulting in shorter lag times and faster drug release from the osmotic tablets. Replacing ethylcellulose with cellulose acetate butyrate as a coating material led to shorter lag times and faster drug release due to increased film permeability. In addition, CAB-based films had a higher strength and flexibility. The drug release was osmotically controlled and decreased with increasing coating level. It increased with increased drug solubility, plasticizer content, change of buffer species (acetate > phosphate), and decreased coating level. Agitation rate and drug content had no effect on the drug release. A 20% w/w coating level was sufficient for the tablet to tolerate forces of more than five times of the gastric destructive force reported in literature.


Asunto(s)
Celulosa/análogos & derivados , Ácidos Polimetacrílicos/química , Comprimidos/química , Celulosa/química , Liberación de Fármacos , Excipientes/química , Ósmosis , Plastificantes , Solubilidad
8.
Int J Legal Med ; 131(4): 1179-1189, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-28204948

RESUMEN

Luminol has been used for a long time for detecting latent blood traces during police investigations because it is easy to use and does not pose any health risks, while providing trace evidence for DNA analysis. It is often the method of choice for examining clothing. Clothes worn during the offense are often destroyed or washed afterwards by the offenders. The purpose of this study is to show the possibilities of blood and DNA detection on washed clothes by documenting the macroscopic results and their chemiluminescence after washing. The tests comprised different fabrics and laundry detergents including different washing and drying methods. Chemiluminescence was detected on almost all blood-marked samples (95.9%), even after all traces visible to the naked eye have been removed by washing. Evidence of a complete DNA profile or individual alleles could be confirmed in almost all of the test cases (93.3%).


Asunto(s)
Manchas de Sangre , Vestuario , Dermatoglifia del ADN , ADN/aislamiento & purificación , Lavandería , Humanos , Luminiscencia , Sustancias Luminiscentes , Luminol
9.
Eur Arch Otorhinolaryngol ; 274(11): 3859-3866, 2017 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-28825129

RESUMEN

Keloids are benign cutaneous lesions, arising from proliferating fibroblasts. Keloids of the ear may occur after trauma, surgery or helix piercings and are difficult to treat, since they tend to form recurrences. Guidelines suggest multimodal therapy; however, recurrence rates remain high and distinct algorithms for the combination of different modalities are missing. To unravel the most effective combination of therapeutic options for keloids of the ear, 38 patients with the diagnosis of an ear keloid were included in our cohort. In a prospective subgroup (B) of this cohort (n = 17), patients either underwent surgery using the "fillet technique" (a meticulous peeling of the keloid skin) and intra-lesional injections of triamcinolone 10 mg/ml every 4-6 weeks for 6 months, or they were additionally treated with a non-customized pressure device which was recommended for at least 16/24 h per day over 6 months. To further compare our results, the remaining 21 patients of our cohort, who were treated at our clinic before, were retrospectively evaluated concerning their recurrence rates. The mean follow-up was 48 months. The mean count of adjuvant steroid injections was two in all patients, four in subgroup B. The recurrence rate was 30% (13/38) in all patients (subgroup B 0/17). Aesthetic results were good to excellent in all non-recurrent cases. No patient treated with fillet technique showed recurrence (p < 0.001). However, we could not confirm a significant effect but a trend of repeated steroid injections for preventing recurrences (p = 0.099). The application of pressure using our non-customized clip also showed a clear trend towards preventing recurrences in cross-table analysis (p = 0.057). Although several studies on different treatment regimens for keloids of the ear exist, the effectiveness of a multimodal treatment regimen needs to be elucidated. Overall, the best results in preventing recurrences were achieved by combining three different treatments. However, the fillet technique was the only modality preventing recurrences of keloids in uni- and multivariate analysis. The application of pressure with a non-customized clip and repeated steroid injections also showed a positive trend but failed level of significance. Based on our data and the literature we recommend, when feasible, the combination of more than one therapeutic regimen, since relapse risk went down from single to dual and triple therapy from 40% (8/20) to 14.3% (2/14) to 0% (0/4), respectively in our cohort. The use of "fillet technique" was especially beneficial.


Asunto(s)
Algoritmos , Terapia Combinada , Oído Externo , Queloide/terapia , Adulto , Antiinflamatorios/uso terapéutico , Protocolos Clínicos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Presión , Estudios Prospectivos , Recurrencia , Estudios Retrospectivos , Triamcinolona/uso terapéutico
10.
Orthopade ; 46(5): 388-394, 2017 May.
Artículo en Alemán | MEDLINE | ID: mdl-28361192

RESUMEN

Clinical and radiological examination of the foot are mandatory before surgical correction of the forefoot. The clinical examination includes leg axis, position of the hind foot, deformity of the first ray as well as skin conditions, pulse status and possible sensitive deficits. A shortening of the gastrocnemius muscle can be identified using the Silfverskiöld test. Discomfort in the midfoot can indicate pathologies of the tarsometatarsal joint and the same applies for osteophyte infiltration around the Lisfranc joint line, whereby the second tarsometatarsal joint often shows more advanced degenerative arthritis than the first tarsometatarsal joint. Callosities under the second and third metatarsal heads correlate with a faulty load transmission of the first ray. A limitation of the range of movement of the first metatarsophalangeal joint is usually associated with degenerative arthritis in X­ray imaging. Under weight bearing, X­rays of the foot in two planes represent the standard imaging examination. In addition to the intermetatarsal angle, the hallux valgus angle and the interphalangeal angle as well as the width of the first metatarsal bone influence the therapy decision. The same applies to degenerative changes or an obvious instability of the first tarsometatarsal joint. In many cases, initial signs of degenerative arthritis can be found in the metatarsophalangeal joint and around the sesamoid bones, although these often do not correlate to clinical symptoms.


Asunto(s)
Hallux Valgus/diagnóstico , Hallux Valgus/terapia , Dolor/diagnóstico , Dolor/prevención & control , Examen Físico/métodos , Tomografía Computarizada por Rayos X/métodos , Puntos Anatómicos de Referencia/diagnóstico por imagen , Diagnóstico Diferencial , Medicina Basada en la Evidencia , Humanos , Dolor/etiología
11.
Orthopade ; 46(3): 234-241, 2017 Mar.
Artículo en Alemán | MEDLINE | ID: mdl-28004128

RESUMEN

INTRODUCTION: Endoprostheses of the ankle joint show higher revision rates of 3.29 revisions per 100 component years. The aims of this study were the application and modification of the consensus classification of the synovia-like interface membrane (SLIM) for periprosthetic failure of the ankle joint, the etiological clarification of periprosthetic pseudocysts and a detailed measurement of proliferative activity (Ki67) in the region of osteolysis. MATERIAL AND METHOD: Tissue samples from 159 patients were examined according to the criteria of the standardized consensus classification. Of these, 117 cases were derived from periprosthetic membranes of the ankle. The control group included 42 tissue specimens from the hip and knee joints. Particle identification and characterization were carried out using the particle algorithm. An immunohistochemical examination with Ki67 proliferation was performed in all cases of ankle pseudocysts and 19 control cases. RESULTS: The consensus classification of SLIM is transferrable to endoprosthetic failure of the ankle joint. Periprosthetic pseudocysts with the histopathological characteristics of the appropriate SLIM subtype were detectable in 39 cases of ankle joint endoprostheses (33.3%). The mean value of the Ki67 index was 14% and showed an increased proliferation rate in periprosthetic pseudocysts of the ankle (p-value 0.02037). CONCLUSION: In periprosthetic pseudocysts an above average higher detection rate of type 1 SLIM induced by abrasion (51.3%) with an increased Ki67 proliferation fraction (p-value 0.02037) was found, which can be interpreted as local destructive intraosseus synovialitis. This can be the reason for formation of pseudocystic osteolysis caused by high mechanical stress in ankle endoprostheses. A simplified diagnostic classification scoring system of dysfunctional endoprostheses of the ankle is proposed for collation of periprosthetic pseudocysts, ossifications and the Ki67 proliferation fraction.


Asunto(s)
Articulación del Tobillo/patología , Articulación del Tobillo/cirugía , Artroplastia de Reemplazo de Tobillo/efectos adversos , Artroplastia de Reemplazo de Tobillo/instrumentación , Osteólisis/etiología , Osteólisis/patología , Falla de Prótesis/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
13.
Unfallchirurg ; 119(2): 120-4, 2016 Feb.
Artículo en Alemán | MEDLINE | ID: mdl-26838595

RESUMEN

BACKGROUND: Endoscopic surgical techniques are nowadays standard procedures in medicine. The advantages of these minimally invasive techniques compared to open techniques are a smaller access route with reduced tissue damage, reduced scarring and often faster postoperative mobilization. Tendoscopy can be used to treat pathologies of tendons as well as of the surrounding tissues. OBJECTIVES: This article presents the advantages of endoscopic treatment of the Achilles tendon compared to open procedures as well as the chances and limitations of tendoscopy. MATERIAL AND METHODS: Surgical instructions for endoscopy of the Achilles tendon are presented and a review of the literature is given. RESULTS: The literature review showed excellent results for pathologies of the paratenon and Achilles tendinitis. Compared to open surgery there was a significantly lower rate of wound healing problems. All articles reported a high reduction of pain level with an early return to sports activities. Limitations of the procedure are extensive intratendinous pathologies and alterations of tendon insertion sites. CONCLUSION: Tendoscopy of the Achilles tendon is a safe but sometimes challenging minimally invasive technique for the treatment of paratendinopathy.


Asunto(s)
Tendón Calcáneo/lesiones , Endoscopía/métodos , Tendinopatía/cirugía , Traumatismos de los Tendones/patología , Traumatismos de los Tendones/cirugía , Tenotomía/métodos , Tendón Calcáneo/patología , Tendón Calcáneo/cirugía , Endoscopía/instrumentación , Medicina Basada en la Evidencia , Humanos , Tendinopatía/patología , Tenotomía/instrumentación , Resultado del Tratamiento
17.
Artículo en Alemán | MEDLINE | ID: mdl-24297452

RESUMEN

The aim of this study was to assess the health status of the occlusal surface on the first molars of Westphalian students, of whom 41.0% were immigrants. The prevalence and retention of fissure sealants (FS) and caries experience was scored for 161 students aged 8 and 10 years. Logistic regression analysis was used to predict the influence of sex, ethnicity, and retention of FS on the occlusal caries risk of the first molars. There was no difference in caries prevalence and experience in 8-year-old German students and immigrants (5.6%/10.5%; 0.07 DMFT/0.21 DMFT), both parameters were significantly higher in 10-year-old immigrants than in German students (25.5%/9.5%; 0.55 DMFT/0.11 DMFT). The prevalence and number of molars with FS was not different between German students and immigrants at 8 years (39.1%, 1.28 FS; 33.8%, 0.94 FS) and at 10 years of age (47.4%, 1.68 FS; 39.4%, 1.17 FS). The occlusal caries risk of first molars without FS was significantly higher in 8-year-old immigrants than in German students (OR 4.62). FS should be used more frequently in daily dental practice. To improve the quality of FS, stricter implementation of guideline-based standards is required.


Asunto(s)
Caries Dental/etnología , Caries Dental/prevención & control , Emigrantes e Inmigrantes/estadística & datos numéricos , Selladores de Fosas y Fisuras/uso terapéutico , Estudiantes/estadística & datos numéricos , Niño , Caries Dental/diagnóstico , Encuestas de Salud Bucal , Femenino , Alemania/epidemiología , Humanos , Masculino , Diente Molar , Salud Bucal , Prevalencia , Distribución por Sexo
18.
Orthopadie (Heidelb) ; 53(1): 39-46, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-38078936

RESUMEN

INTRODUCTION: Minimally invasive calcaneal osteotomy (MICO) is already an established surgical procedure for correcting hindfoot deformities using a lateral approach. So far, no description of a medial approach for MICO has been published. MATERIAL AND METHODS: Between August 2022 and March 2023, 32 consecutive patients (MICO with medial approach, MMICO: n = 15; MICO with lateral approach, LMICO: n = 17) underwent MICO as part of complex reconstructive surgery of the foot and ankle with concomitant procedures. The amount of correction in the axial view of the calcaneus and consolidation rates were evaluated radiographically. Subjective satisfaction, stiffness of the subtalar joint, and pain level (numeric rating scale, NRS) at the level of the heel were assessed clinically. The last follow-up was at 6 months. RESULTS: All osteotomies consolidated within 6 months after surgery. Displacement of the tuber was 9 mm on average in either group. Relevant subtalar joint stiffness was detected in 5 MMICO and 6 LMICO patients. No relevant differences between the groups were detected for wound healing problems, nerve damage, heel pain or patient satisfaction. CONCLUSION: In this study lateral and medial approaches for MICO were performed. Similar degrees of correction and low complication rates were found in both groups. The medial approach for MICO is safe and can be beneficial regarding patient positioning and arrangement of the C­arm.


Asunto(s)
Pie Plano , Humanos , Estudios de Casos y Controles , Pie Plano/cirugía , Estudios de Factibilidad , Osteotomía/efectos adversos , Dolor
19.
medRxiv ; 2024 Mar 29.
Artículo en Inglés | MEDLINE | ID: mdl-38585784

RESUMEN

Background: SARS-CoV-2 vaccination has reduced hospitalization and mortality for nursing home residents (NHRs). However, emerging variants coupled with waning immunity, immunosenescence, and variability of vaccine efficacy undermine vaccine effectiveness. We therefore need to update our understanding of the immunogenicity of the most recent XBB.1.5 monovalent vaccine to variant strains among NHRs. Methods: The current study focuses on a subset of participants from a longitudinal study of consented NHRs and HCWs who have received serial blood draws to assess immunogenicity with each SARS-CoV-2 mRNA vaccine dose. We report data on participants who received the XBB.1.5 monovalent vaccine after FDA approval in Fall 2023. NHRs were classified based on whether they had an interval SARS-CoV-2 infection between their first bivalent vaccine dose and their XBB.1.5 monovalent vaccination. Results: The sample included 61 NHRs [median age 76 (IQR 68-86), 51% female] and 28 HCWs [median age 45 (IQR 31-58), 46% female). Following XBB.1.5 monovalent vaccination, there was a robust geometric mean fold rise (GMFR) in XBB.1.5-specific neutralizing antibody titers of 17.3 (95% confidence interval [CI] 9.3, 32.4) and 11.3 (95% CI 5, 25.4) in NHRs with and without interval infection, respectively. The GMFR in HCWs was 13.6 (95% CI 8.4,22). Similarly, we noted a robust GMFR in JN.1-specific neutralizing antibody titers of 14.9 (95% CI 7.9, 28) and 6.5 (95% CI 3.3, 13.1) among NHRs with and without interval infection, and a GMFR of 11.4 (95% CI 6.2, 20.9) in HCWs. NHRs with interval SARS-CoV-2 infection had higher neutralizing antibody titers across all analyzed strains following XBB.1.5 monovalent vaccination, compared to NHRs without interval infection. Conclusion: The XBB.1.5 monovalent vaccine significantly elevates Omicron-specific neutralizing antibody titers to XBB.1.5 and JN.1 strains in both NHRs and HCWs. This response was more pronounced in individuals known to be infected with SARS-CoV-2 since bivalent vaccination. Impact Statement: All authors certify that this work entitled " Broad immunogenicity to prior strains and JN.1 variant elicited by XBB.1.5 vaccination in nursing home residents " is novel. It shows that the XBB.1.5 monovalent vaccine significantly elevates Omicron-specific neutralizing antibody titers in both nursing home residents and healthcare workers to XBB and BA.28.6/JN.1 strains. This work is important since JN.1 increased from less than 0.1% to 94% of COVID-19 cases from October 2023 to February 2024 in the US. This information is timely given the CDC's latest recommendation that adults age 65 and older receive a Spring 2024 XBB booster. Since the XBB.1.5 monovalent vaccine produces compelling immunogenicity to the most prevalent circulating JN.1 strain in nursing home residents, our findings add important support and rationale to encourage vaccine uptake. Key Points: Emerging SARS-CoV-2 variants together with waning immunity, immunosenescence, and variable vaccine efficacy reduce SARS-CoV-2 vaccine effectiveness in nursing home residents.XBB.1.5 monovalent vaccination elicited robust response in both XBB.1.5 and JN.1 neutralizing antibodies in nursing home residents and healthcare workers, although the absolute titers to JN.1 were less than titers to XBB.1.5Why does this paper matter? Among nursing home residents, the XBB.1.5 monovalent SARS-CoV-2 vaccine produces compelling immunogenicity to the JN.1 strain, which represents 94% of all COVID-19 cases in the U.S. as of February 2024.

20.
Eur J Clin Pharmacol ; 69(10): 1757-60, 2013 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-23743779

RESUMEN

OBJECTIVE: To analyse users' experience of TOPS, an internet-based system that helps UK clinical research units to prevent healthy volunteers from participating in more than one non-therapeutic trial simultaneously, or starting a second trial too soon after the first. METHODS: We sent to all units that currently use TOPS an anonymous questionnaire comprising 18 questions about the effectiveness and ease of use of the system. RESULTS: Of 35 units that currently use TOPS, 31 (85.7 %) returned questionnaires. Most users find TOPS easy to use, had increased their detection rate of over-volunteering, and had rejected subjects as a result of using TOPS. A GP reply alone is not enough to prevent over-volunteering. Ethics committees, the MHRA and sponsors know about TOPS and support its use. CONCLUSIONS: The results confirm that TOPS does prevent healthy subjects from over-volunteering. Consequently, the Health Research Authority has agreed to take over the management of TOPS. Ethics committee approval of a phase 1 trial and MHRA accreditation of the unit will henceforth be conditional on consistent and proper use of TOPS. That should enhance its effectiveness and improve the safety of volunteers in non-therapeutic trials in the UK.


Asunto(s)
Ensayos Clínicos como Asunto/normas , Voluntarios Sanos , Internet , Experimentación Humana no Terapéutica/normas , Ensayos Clínicos como Asunto/ética , Ensayos Clínicos como Asunto/legislación & jurisprudencia , Ensayos Clínicos como Asunto/estadística & datos numéricos , Revisión Ética , Comités de Ética , Regulación Gubernamental , Voluntarios Sanos/estadística & datos numéricos , Humanos , Experimentación Humana no Terapéutica/ética , Experimentación Humana no Terapéutica/legislación & jurisprudencia , Experimentación Humana no Terapéutica/estadística & datos numéricos , Encuestas y Cuestionarios , Reino Unido
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