A Phase I/IIa Prospective, Randomized, Open-Label Study on the Safety and Efficacy of Nebulized Liposomal Amphotericin for Invasive Pulmonary Aspergillosis.

Although nebulized liposomal amphotericin B (NLAB) is being used in invasive pulmonary aspergillosis (IPA) prophylaxis, no clinical trial has shown its efficacy as a therapeutic strategy. NAIFI is the inaugural randomized, controlled clinical trial designed to examine the safety and effectiveness of NLAB (dosage: 25 mg in 6 mL, three times per week for 6 weeks) against a placebo, in the auxiliary treatment of IPA. Throughout the three-year clinical trial, thirteen patients (six NLAB, seven placebo) were included, with 61% being onco-hematological with less than 100 neutrophils/µL. There were no significant differences noted in their pre- and post-nebulization results of forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1), and oxygen saturation between the groups. Neither bronchospasm nor serum amphotericin B levels were reported in any patients given NLAB. 18F-Fluorodeoxyglucose positron emission tomography (FDG-PET-TC) was carried out at the baseline and after 6 weeks. A notable decrease in median SUV (standardized uptake value) was observed in NLAB patients after 6 weeks (-3.6 vs. -0.95, p: 0.039, one tail). Furthermore, a reduction in serum substance galactomannan and beta-D-Glucan was identified within NLAB recipients. NLAB is well tolerated and safe for patients with IPA. Encouraging indirect efficacy data have been derived from image monitoring or biomarkers. However, further studies involving more patients are necessary.

STROCSS 2021: Strengthening the reporting of cohort, cross-sectional and case-control studies in surgery.

INTRODUCTION: Strengthening The Reporting Of Cohort Studies in Surgery (STROCSS) guidelines were developed in 2017 in order to improve the reporting quality of observational studies in surgery and updated in 2019. In order to maintain relevance and continue upholding good reporting quality among observational studies in surgery, we aimed to update STROCSS 2019 guidelines. METHODS: A STROCSS 2021 steering group was formed to come up with proposals to update STROCSS 2019 guidelines. An expert panel of researchers assessed these proposals and judged whether they should become part of STROCSS 2021 guidelines or not, through a Delphi consensus exercise. RESULTS: 42 people (89%) completed the DELPHI survey and hence participated in the development of STROCSS 2021 guidelines. All items received a score between 7 and 9 by greater than 70% of the participants, indicating a high level of agreement among the DELPHI group members with the proposed changes to all the items. CONCLUSION: We present updated STROCSS 2021 guidelines to ensure ongoing good reporting quality among observational studies in surgery.

Wound Closure After Port Implantation-A Randomized Controlled Trial Comparing Tissue Adhesive and Intracutaneous Suturing.

BACKGROUND: Wound healing after pectoral port implantation is a major factor determining the success or failure of the procedure. Infection and wound dehiscence can endanger the functionality of the port system and impede chemotherapy. The cosmetic result is important for patient satisfaction as well. METHODS: From August 2015 to July 2017, adult patients with an indication for port implantation were entered into a prospective, randomized and controlled single-center study. The skin incision was closed either with tissue adhesive or with an intracutaneous suture. The primary endpoints were the total score of the scar evaluated by the patient and the investigator on the POSAS scale (Patient and Observer Scar Assessment Scale: 6 [normal skin] to 60 points), blinded assessment of photographic documentation by ten evaluating physicians, and the patient's reported quality of life. The calculation of case numbers was based only on the patients' overall POSAS assessment, which was tested for non-inferiority. The secondary endpoints were other complications (infection, dehiscence) and the duration of wound closure (trial registration number NCT02551510). RESULTS: 156 patients (60 ± 13 years, 64% women) participated in the study. The patient-assessed total POSAS score of tissue adhesive revealed non-inferiority to suturing (adhesive 11.7 ± 5.8 vs. suture 10.1 ± 4.0, p for non-inferiority <0.001). Both the investigators in their POSAS assessments and the blinded physician evaluators in their assessment of photographically documented wounds rated wound closure by suturing better than closure with tissue adhesive. No significant differences were found between groups with respect to quality of life or the frequency of wound infection or dehiscence. CONCLUSION: Closure of the upper cutaneous layer with tissue adhesive is a suitable and safe method of wound closure after port implantation.

Treatment of pityriasis rubra pilaris type I: a systematic review.

Pityriasis rubra pilaris (PRP) is an uncommon papulosquamous inflammatory disease of the skin, which may progress to erythroderma. The diagnosis is based on both clinical and histopathological findings. There are numerous treatment options in the literature, but often reported as unsuccessful. To summarize the therapy of type I PRP in a systematic manner. We performed a systematic search following the PRISMA Guidelines based on PubMed, Web of Science, and Medline databases using the term 'pityriasis rubra pilaris treatment' (in German and English) on human subjects, published between 1997 and 2017, documenting therapy for PRP type I. A total of 449 records were identified; 148 full-text articles were assessed for eligibility and 105 articles were included in the qualitative synthesis. We identified mainly individual case reports, a few retrospective studies, and small case series. No randomized controlled trials were found. Treatment options included topical and systemic agents, and physical modalities. Based on our review, we suggest a continuous topical treatment and, when appropriate, in combination with phototherapy. As first-line therapy, we recommend a retinoid, and as second-line, a combination of retinoid and methotrexate (considering the patient's condition and side effects), azathioprine, or cyclosporine A. Biologicals can be used as third-line therapy. In case of treatment failure, biologicals can be combined with a retinoid, methotrexate, or cyclosporine A. Randomized controlled clinical trials are needed in order to provide an evidence-based high-quality standardized treatment for patients with PRP type I.

Treatment of Cutaneous Pseudolymphoma: A Systematic Review.

Cutaneous pseudolymphoma (CPL) is a reactive polyclonal T- or B-cell lymphoproliferative process. CPL may appear as localized or disseminated skin lesions. While most cases of CPL are idiopathic, they may also occur as a response to, for example, contact dermatitis, arthropod reactions, and bacterial infections. CPL can be classified based on its clinical features, but all variants have similar histopathological patterns of either predominantly B-cell infiltrates, T-cell infiltrates, or mixed T/B-cell infiltrates. The prognosis of CPL is good, but the underlying disease process should be taken into account. If an antigenic stimulus is identified, it should be removed. In patients with idiopathic CPL, a close follow-up control strategy should be adopted. The aim of this systematic review is to summarize all reported treatments for CPL. The review was based on articles from the PubMed database, using the query "skin pseudolymphoma treatment", English and German, about "human" subjects, and published between 1990 and 2015 documenting adequate treatment and/or aetiology. Mainly individual case reports and small case series were found. Treatment options include topical and intralesional agents, systemic agents, and physical modalities. The final part of the review proposes a treatment algorithm for CPL according to each aetiology, based on the literature of the last 25 years. Future research should focus on randomized controlled trials and studies on long-term outcomes, which were not identified in the current review.

Treatment of Scleroedema Adultorum Buschke: A Systematic Review.

Scleroedema adultorum Buschke is a rare skin disease, which can be divided into 3 subtypes: classic type, occurring after respiratory infections; a type lacking association with infections; and a type associated with diabetes. Scleroedema adultorum Buschke is characterized by thickening and tightening of the skin, which typically starts at the neck. In half of patients, spontaneous remission may occur. The aim of this systematic review is to summarize all reported treatments for scleroedema adultorum Buschke, based on articles from PubMed database, using the query "scleroedema adultorum Buschke treatment", English and German, published between 1970 and 2016 and documenting adequate treatments. The results are based mainly on individual case reports, small case series, and retrospective studies often reporting unsuccessful results. Treatment options include topical as well as systemic treatments, and physical modalities. There is a need for randomized controlled trials and studies on long-term outcomes after treatment.

Diagnostische Präzision der komponentenbasierten vs. der extraktbasierten In-vitro-Diagnostik von Insektengift-Allergien: Auswirkungen auf das klinische Management.

HINTERGRUND: Die Bestimmung von spezifischen IgE-Antikörpern spielt eine zentrale Bedeutung bei der Diagnostik von Bienen- und Wespengiftallergien. In den letzten Jahren wurden die komponentenbasierte Diagnostik (CRD) eingeführt, die die Bestimmung spezifischer IgE-Antikörper gegen die Allergene Api m 1, Ves v 1, Ves v 5 und Pol d 5 sowie kreuzreaktive Kohlenhydratdeterminanten (CCDs) erlaubt. Hierdurch soll vor allem bei Probanden mit Doppelsensibilisierungen die klinische Relevanz der einzelnen Sensibilisierungen besser beurteilt werden können. PROBANDEN UND METHODIK: Die spezifischen IgE-Antikörper-Bestimmungen an 143 Probanden mit Bienen- und/oder Wespengiftallergie erfolgten mit den extraktbasierten ImmunoCAP®-Allergenen i1 und i3 sowie den ImmunoCAP®-Allergenkomponenten i208-211 und o214 (Api m 1, Ves v 1, Ves v 5, Pol d 5, CCD). Bei Doppelsensibilisierten wurde zusätzlich ein Inhibitionstest durchgeführt. An einem Teilkollektiv der Studienpopulation erfolgten sIgE-Bestimmungen gegen Api m 1, Api m 4, Pol d 5 und Ves v 5 mittels Allergiechip (ISAC®, n  =  44). ERGEBNISSE: Die Sensitivität von Ves v 5 bei isolierten Wespengiftallergikern betrug 78,5 %, gemeinsam mit Ves v 1 stieg diese auf 92,3 %. Die Sensitivität von Api m 1 bei isolierten Bienengiftallergikern betrug 25 %. Die komponentenbasierte Diagnostik und Inhibitionstests bei Doppelsensibilisierten lieferten divergente Ergebnisse. Die CRD mittels ISAC®-Allergiechip erbrachte deutliche Unterschiede vor allem im Hinblick auf die Diagnostik von Api m 1 und CCDs. SCHLUSSFOLGERUNGEN: Die CRD bereichert das diagnostische Spektrum, sofern sie nicht allein sondern zusätzlich zu den etablierten Verfahren eingesetzt wird. Sie sollte neben Ves v 5 stets die Bestimmung der IgE-Antikörper gegen Ves v 1 umfassen.

Diagnostic precision of component-resolved vs. extract-based in vitro diagnosis of hymenoptera venom allergy: effects on clinical management.

BACKGROUND: The measurement of specific IgE (sIgE) antibodies plays a key role in the diagnosis of honeybee and wasp venom allergy. In recent years, component-resolved diagnosis (CRD) has been introduced, which allows for the measurement of sIgE antibodies against Api m 1, Ves v 1, Ves v 5, and Pol d 5, as well as cross-reactive carbohydrate determinants (CCDs). These tests are intended to help determine the clinical relevance of any given sensitization, especially in patients with dual sensitization. PATIENTS AND METHODS: Specific IgE antibody levels were measured in 143 patients with bee and/or wasp venom allergy using the extract-based ImmunoCAP® allergens i1 and i3 as well as the ImmunoCAP® allergen components i208-211 and O214 (Api m 1, Ves v 1, Ves v 5, Pol d 5, CCDs). In patients with dual sensitization, inhibition testing was also performed. In a subgroup of the study population, sIgE to Api m 1, Api m 4, Pol d 5, and Ves v 5 were determined using the ISAC® allergy microarray (n = 44). RESULTS: The sensitivity of Ves v 5 in patients with isolated wasp venom allergy was 78.5 %; in combination with Ves v 1, that figure increased to 92.3 %. The sensitivity of Api m 1 in individuals with isolated bee venom allergy was 25 %. CRD and inhibition testing in individuals with dual sensitization showed divergent results. CRD using the ISAC® allergy microarray showed marked differences, especially with regard to Api m 1 and CCDs. CONCLUSION: Component-resolved tests are a valuable addition to the diagnostic spectrum as long as they are used in combination with established procedures. Apart from Ves v 5, measuring IgE antibodies to Ves v 1 should always be included in the diagnostic workup.

Treatment of Porokeratosis: A Systematic Review.

BACKGROUND: Porokeratosis (PK) is a rare skin disease of unknown etiology. It consists of a keratinization disorder, which may appear in several clinical forms and can undergo malignant transformation. The histopathological hallmark of PK is the cornoid lamella. While many topical, systemic, and surgical treatment modalities for PK have been described, no randomized controlled trials have been performed yet. Because of a lack of treatment standards for PK, European and international guidelines cannot be created. OBJECTIVE: The aim of this systematic review is to outline options for treating PK. METHODS: We performed a systematic literature search in an electronic database for published literature. A total of 88 articles fulfilling our inclusion criteria were found. RESULTS: There were no randomized controlled trials on the treatment of PK, but mainly case reports and case series. Porokeratosis of Mibelli showed the best outcomes after treatment with imiquimod cream and linear PK responded well to topical or systemic retinoids. Topical vitamin D acid derivatives may be the best therapeutic option for disseminated PK. Surgical interventions and cryotherapy may be preferred in areas where the use of topical agents is difficult or contraindicated. CONCLUSION: To offer patients with PK an evidence-based high-quality standardized therapy, randomized controlled trials are needed.