Αρχειοθήκη ιστολογίου

Αλέξανδρος Γ. Σφακιανάκης
ΩτοΡινοΛαρυγγολόγος
Αναπαύσεως 5
Άγιος Νικόλαος Κρήτη 72100
2841026182
6032607174

Κυριακή 3 Απριλίου 2022

Allergische Reaktionen auf Bioimplantate

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Zusammenfassung

Hintergrund

Bioimplantate werden im HNO-Bereich vielfältig eingesetzt, am häufigsten in der rekonstruktiven Gesichtschirurgie, bei Cochleaimplantaten (CI), knochenverankerten Hörgeräten, PORP/TORP-Prothesen („partial ossicular replacement prosthesis", „total ossicular replacement prosthesis"), aber auch u. a. bei Paukendrainagen, Larynxkanülen, Stimmprothesen nach Laryngektomie und auch bei „HNO-nahen" Eingriffen als dentale Implantate in der Zahnmedizin.

Methoden

In einer Literatursuche wurde die Immunologie allergischer Reaktionen auf Bioimplantate analysiert und die vorhandene Evidenz ermittelt durch Recherchen in den Datenbanken Medline, PubMed sowie den nationalen und internationalen Studien- und Leitlinienregistern und der Cochrane Library. Es wurden Humanstudien berücksichtigt, die im Zeitraum bis einschließlich 12/2021 publiziert wurden.

Ergebnis

Basierend auf der internationalen Literatur und bisheriger Erfahrungen wird eine Übersicht über Allergien auf Bioimplantate in der HNO-Heilkunde gegeben.

Schlussfolgerungen

HNO-Ärzte sollten bei Einbringen allogener Materialien immer auch an die Möglichkeit allergischer Reaktionen denken – insbesondere auch, aber nicht nur – bei Bioimplantaten.

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Spezielle Tumorentitäten im Kopf-Hals-Bereich

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Zusammenfassung

Hintergrund

In den letzten Jahren zeigt sich auch bei den speziellen Tumorentitäten im Kopf-Hals-Bereich eine zunehmende Studiendynamik. Bei den onkologischen Tagungen der American Society of Clinical Oncology (ASCO) und European Society for Medical Oncology (ESMO) 2021 wurden einige Studien vorgestellt, welche Änderungen im klinischen Alltag von Nasopharynxkarzinom, Speicheldrüsenkarzinom und Schilddrüsenkarzinom erwarten lassen.

Ziel der Arbeit

Zukünftige Therapieneuerungen spezieller HNO-Tumorentitäten wurden nach Sichtung der auf den Tagungen ASCO 2021 und ESMO 2021 präsentierten klinischen Studien abgeschätzt.

Material und Methoden

Es erfolgte eine systematische Analyse der präsentierten klinischen Phase-II- und -III-Studien zur Behandlung von Nasopharynx‑, Speicheldrüsen- und Schilddrüsenkarzinomen. Unter Berücksichtigung der aktuellen Therapiestandards wurden die Ergebnisse bezüglich ihrer potenziell klinischen Bedeutung eingeordnet.

Ergebnisse und Diskussion

In der kurativen Therapie von fortgeschrittenen Nasopharynxkarzinomen ist eine adjuvante Therapie mit Capecitabin nach primärer Radiochemotherapie als neuer Standard zu diskutieren. In der palliativen Therapie von Nasopharynxkarzinomen ist eine zunehmende Rolle von Immuntherapien zu prognostizieren. Rezidivierte/metastasierte Speicheldrüsenkarzinome werden bei Vorliegen molekularer angreifbarer Zielläsionen mit zielgerichteten Substanzen teilweise sehr effektiv behandelt. Immuntherapien spielen aktuell eine untergeordnete Rolle, scheinen sie nur bei wenigen Patienten mit Speicheldrüsenkarzinomen effektiv zu sein, die sich aktuell durch prädiktive Marker nicht verlässlich identifizieren lassen. Patienten mit radioiodrefraktären differenzierten Schilddrüsenkarzinom profitieren nach Versagen einer VEGFR-TKI-Therapie („vascular endothelial growth factor receptor", Tyrosinkinaseinhibitor) von einer Therapie mit dem Multi-TKI Cabozantinib.

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Navigating the Regulatory Pathway for Medical Devices—a Conversation with the FDA, Clinicians, Researchers, and Industry Experts

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Abstract

Successful translation of new and innovative medical products from concept to clinical use is a complex endeavor that requires understanding and overcoming a variety of challenges. In particular, regulatory pathways and processes are often unfamiliar to academic researchers and start-ups, and even larger companies. Growing evidence suggests that the successful translation of ideas to products requires collaboration and cooperation between clinicians, researchers, industry, and regulators. A multi-stakeholder group developed this review to enhance regulatory knowledge and thereby improve translational success for medical devices. Communication between and among stakeholders is identified as a critical factor. Current regulatory programs and processes to facilitate communication and translation of innovative devices are described and discussed. Case studies are used to highlight the importance of flexibility when considering evidence requirements. We provide a revi ew of emerging strategies, opportunities, and best practices to increase the regulatory knowledge base and facilitate medical device translation by all stakeholders.

Graphical abstract

Clinicians, regulators, industry, and researchers require regulatory knowledge and collaboration for successful translation of innovative medical devices

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In Vivo Murine Models of Cardiotoxicity Due to Anticancer Drugs: Challenges and Opportunities for Clinical Translation

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Abstract

Modern therapeutic approaches have led to an improvement in the chances of surviving a diagnosis of cancer. However, this may come with side effects, with patients experiencing adverse cardiovascular events or exacerbation of underlying cardiovascular disease related to their cancer treatment. Rodent models of chemotherapy-induced cardiotoxicity are useful to define pathophysiological mechanisms of cardiac damage and to identify potential therapeutic targets. The key mechanisms involved in cardiotoxicity induced by specific different antineoplastic agents are summarized in this state-of-the-art review, as well as the rodent models of cardiotoxicity by different classes of anticancer drugs, along with the strategies tested for primary and secondary cardioprotection. Current approaches for early detection of cardiotoxicity in preclinical studies with a focus on the application of advanced imaging modalities and biomarker strategies are also discussed.

Graphical abstract

Potential applications of cardiotoxicity modelling in rodents are illustrated in relation to the advancements of promising research topics of cardiotoxicity. Created with BioRender.com.

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Endoscopic Adenoidectomy Replacing the Outdated Curette Adenoidectomy: Comparison of the Two Methods at a Tertiary Care Centre

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Abstract

To compare intraoperative and postoperative parameters of the two techniques of adenoidectomy, endoscope and microdebrider powered adenoidectomy and conventional adenoidectomy. Study Design Prospective study. Setting: Academic tertiary referral centre. In our study, cases of adenoid hypertrophy were randomly selected from the outpatient department of department of ORL & HNS. Out of these patients, 30 underwent Endoscopic adenoidectomy (EA) (Group A) and 30 underwent Conventional adenoidectomy (CA) (Group B). All of the patients were assessed pre-operatively, intra-operatively and post-operatively to compare the various parameters. The most common complaint in both the groups was mouth breathing with snoring. Intra-operative bleeding was 29.15 ml in group EA and 15.2 ml in group CA. Operative time for CA was shorter at 21.8 min as compared to 32.1 min for group EA. Residual adenoids and injury to adjacent structures were more common in group CA. Hospital stay was 3.2 days for EA patients and 3.43 days for CA patients. Resolution of symptoms was near comparable in both groups. Operative time and intra-operative bleeding are both significantly reduced with the CA as opposed to EA. However, injury to adjacent structures and residual adenoids occur significantly less in group EA. After weighing the risks and benefits, we can conclude that EA is comparatively better than CA.

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The Effect of Topical Tranexamic Acid in Endoscopic Sinus Surgery: A Triple Blind Randomized Clinical Trial

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Annals of Otology, Rhinology &Laryngology, Ahead of Print.
Objective:Our aim is to evaluate the effect of topical tranexamic acid (TA) on bleeding and surgical quality field in the functional endoscopic sinus surgery (FESS).Methods:A total of 74 patients who underwent FESS due to chronic rhinosinusitis were included. The patients were randomized into 2 groups. TA group (n = 37) received a topical cotton pledget soaked with TA and placebo (PL) group (n = 37) received a pledget soaked with saline solution.Results:A significant effect was noted for the TA group versus the PL group in the grade 1 of the Boezaart scale at 35 minutes (4 for TA group and no case for PL group). This effect was absent for higher grades. We did not notice a significant effect between the 2 groups at 5 minutes. Blood loss was 359 ml in the TA group versus 441 ml in the PL group. No significant change was observed between the 2 groups concerning the blood parameters. No side effects were reported.Conclusion:Despite its safety when administrated locally and its low cost, TA provides limited effect on quality of surgical field after 35 minutes of the start of FESS in the patients with chronic rhinosinusitis. This effect was absent at the start of the intervention and when analyzing the blood loss and hematologic parameters.
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Benign paroxysmal positional vertigo

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Benign paroxysmal positional vertigo (BPPV) is characterized by positional vertigo (brief attacks of rotatory vertigo triggered by head position changes in the direction of gravity) and is the most common peripheral cause of vertigo. There are two types of BPPV pathophysiology: canalolithiasis and cupulolithiasis. In canalolithiasis, otoconial debris is detached from the otolithic membrane and floats freely within the endolymph of the canal. In cupulolithiasis, the otoconial debris released from the otolithic membrane settles on the cupula of the semicircular canal and the specific gravity of the cupula is increased.
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Cervical Necrotizing Fasciitis and Free Tissue Transfer

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Annals of Otology, Rhinology &Laryngology, Ahead of Print.
Objectives:Aggressive surgical debridement is required in cervical necrotizing fasciitis, and in severe defects, subsequent free tissue transfer might be necessary. However, there is concern that the inflammatory environment of the infection site may threaten free flap viability, particularly with concerns for thrombosis of feeding vessels and compromised tissue integration. Cases in the head and neck area are rare, so there are limited data regarding outcomes of free tissue transfer in these patients.Methods:A retrospective chart review assessed patients with cervical necrotizing fasciitis treated at an academic tertiary hospital between 2015 and 2021. Twenty-five patients were identified, and eight required free tissue transfer after adequate surgical debridement. Treatment, hospital course, and demographic data were collected on these eight patients.Results:All flaps had full survival at follow up (median fol low up 3 months, range 1-39 months) without concerns for vascular compromise.Conclusion:These data suggest that in patients with large soft tissue defects due to cervical necrotizing fasciitis, free tissue transfer may be a safe treatment modality.
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