A Real-World Investigation of MRI Changes in Bone in Patients with Type 1 Gaucher Disease Treated with Velaglucerase Alfa: The EIROS Study.

Background/Objectives: Gaucher disease type 1 (GD1) is characterized by hepatosplenomegaly, thrombocytopenia, and disabling bone manifestations requiring regular MRI monitoring. The EIROS study assessed the real-world impact of velaglucerase alfa on GD1 bone disease, using MRI data collected in French clinical practice. Methods: MRIs collected retrospectively from treatment initiation and prospectively during follow-up (12-months) were analyzed centrally by a blinded expert radiologist to evaluate bone infiltration using the Bone Marrow Burden (BMB) score and a qualitative method (stable, improved or worsened for the spine and femur). Abdominal MRIs were also centrally analyzed to assess hepatosplenomegaly. Bone manifestations, hepatosplenomegaly, and hematologic parameters were analyzed from medical records. Results: MRI data were available for 20 patients: 6 treatment-naive patients and 14 patients who switched to velaglucerase alfa from another GD treatment. Interpretable MRIs for BMB scoring were available for seven patients for the spine and one patient for the femur. Qualitative assessments (n = 18) revealed stability in spine and femur infiltration in 100.0% and 84.6% of treatment-switched patients (n = 13), respectively, and improvements in 80.0% and 60.0% of treatment-naive patients (n = 5), respectively; no worsening of bone infiltration was observed. Liver, spleen, and hematologic parameters improved in treatment-naive patients and remained stable in treatment-switched patients. Conclusions: The qualitative real-world data support findings from clinical trials suggesting the long-term effectiveness of velaglucerase alfa on GD1 bone manifestations. When MRI assessment by radiologists with experience of GD is not possible, a simplified qualitative assessment may be sufficient in clinical practice for monitoring bone disease progression and treatment response.

AUDISTIM® Day/Night Alleviates Tinnitus-Related Handicap in Patients with Chronic Tinnitus: A Double-Blind Randomized Placebo-Controlled Trial.

The aim of this study is to evaluate the efficacy of taking a daily supplement based on active compounds (AUDISTIM® Day Night: A D/N) in alleviating tinnitus-related disability, as suggested by previous real-life studies. This double-blind randomized placebo-controlled study was conducted in adults with mild to severe tinnitus receiving a 3-month supplementation with A D/N (magnesium, vitamins, phytochemicals) or placebo (excipients without active ingredients). Tinnitus-related handicap (THI), psychological stress (MSP-9), and sleep quality (PSQI) were assessed at baseline and during intervention, perceived impression of tinnitus improvement at the end of the follow-up. The full set analysis included 114 patients (59 A D/N, 55 placebo) aged 53.8 ± 11.4 years, 58% women, with fluctuating (45%) or permanent (55%) tinnitus from 9.3 ± 9.4 years. A D/N supplementation led to greater changes in THI (-13.2 ± 16.0 vs. -6.2 ± 14.4, p = 0.0158,Cohen's d =0.44) at 3 months (primary outcome), especially with continuous tinnitus (-15.0 ± 16.3 vs. -4.6 ± 12.8, p = 0.0065), and, to a lesser extent, at 1 month (-9.8 ± 13.1 for A vs. -4.3 ± 12.1, p = 0.0213). PSQI significantly improved over time in both groups, but MSP-9 only with A D/N. In lines with previous observational studies, both clinical (THI score > 7 pts) and statistical (vs. placebo) improvement, more pronounced in permanent tinnitus, demonstrate the effectiveness of the combination of active compounds and support its use in the management of mild to severe tinnitus.

Gastrointestinal Tolerance of Short-Chain Fructo-Oligosaccharides from Sugar Beet: An Observational, Connected, Dose-Ranging Study in Healthy Volunteers.

Dietary fibres are important in the human diet with multiple health benefits. This study aimed to determine the gastrointestinal tolerance of short-chain fructo-oligosaccharides (scFOS), well-known prebiotic fibres, at doses up to 40 g/d. An observational, connected, dose-ranging trial was conducted in 116 healthy volunteers. During the first week, the participants were instructed to consume their usual diet. During the second week, half of the subjects consumed 15 g scFOS per day, and the other half consumed 20 g scFOS per day. For the third week, the scFOS dose was doubled for all subjects. Gastrointestinal symptom severity was reported daily, as well as stool consistency and frequency. The results show that scFOS are well tolerated up to 40 g/d; all reported symptoms remained very mild from a clinical perspective. Stool consistency stayed normal, between 3 and 5 on the Bristol stool scale, confirming that no diarrhoea appeared after scFOS intake. Stool frequency also remained within the normal range. In conclusion, scFOS intake is well tolerated up to 40 g/d in healthy subjects. Thanks to their short chains and unique composition, scFOS prebiotic fibres are much better tolerated than other types of inulin-type fructans with longer chains. The digestive tolerance of fibres should be considered when added to foods and beverages.

The clinical impact of hydro-responsive dressings in dynamic wound healing: Part II.

OBJECTIVE: Over the course of a wound's healing trajectory, whether the wound is acute or hard-to-heal, management is likely to involve the use of several different dressing types. Minimising the complexity of treatment (in terms of dressing usage) would aid clinicians in providing effective wound care but excellent clinical outcomes must remain the primary goal. METHOD: This study was an open-labelled, non-comparative study assessing the clinical effectiveness of a coordinated wound dressing treatment regimen. After an initial phase of using a hydro-responsive wound dressing (HydroClean, HRWD-1, PAUL HARTMANN AG, Germany) to cleanse and debride hard-to-heal wounds, the wounds were subsequently treated with either HydroTac (HRWD-2, PAUL HARTMANN AG, Germany) (to maintain healing progression and re-epithelialisation) or RespoSorb (a superabsorbent dressing, PAUL HARTMANN AG, Germany) (to manage moderate-to-high levels of exudate). The Pressure Ulcer Scale for Healing (PUSH) assessment tool was used to measure the wound status over the course of the treatment period and to assess several wound status parameters (for example, wound area, exudate levels and wound characteristics such as level of re-epithelialisation). RESULTS: The results from this study demonstrated that wounds treated with HRWD-2 showed a positive healing response when using the PUSH score assessment tool with a significant mean reduction (p<0.0001) in the PUSH score of wounds treated with HRWD-2, with >75% of wounds being closed by the end of the study. This result underlines the effectiveness of HRWD-2 in supporting healing progression. CONCLUSION: The results from this study support the coordinated use of HRWDs for the effective management and treatment of a variety of hard-to-heal wounds.

Prevalence of pressure injuries among critically ill patients and factors associated with their occurrence in the intensive care unit: The PRESSURE study.

BACKGROUND: The prevalence of pressure injuries (PIs) in critically ill patients has been extensively studied, but there is uncertainty regarding the risk factors. The main objective of this study was to describe the prevalence of PIs in critically ill patients. Secondary objectives were to describe PI, use of preventive measures for PI, and factors associated with occurrence of PI in the intensive care unit (ICU). MATERIAL AND METHODS: This was a 1-day point-prevalence study performed on a weekday in June 2017 in ICUs in France. On the same day, we noted the presence or absence of PI in all hospitalised patients of the participating ICUs, data on the ICUs, and the characteristics of patients and of PI. RESULTS: Eighty-six participating ICUs allowed the inclusion of 1228 patients. The prevalence of PI on the study day was 18.7% (95% confidence interval: 16.6-21.0). PIs acquired in the ICU were observed in 12.5% (95% confidence interval: 10.6-14.3) of critically ill patients on the study day. The most frequent locations of PI were the sacrum (57.4%), heel (35.2%), and face (8.7%). Severe forms of PI accounted for 40.8% of all PIs. Antiulcer mattresses were used in 91.5% of the patients, and active and/or passive mobilisation was performed for all the patients. Multiple logistic regression analysis identified longer length of stay in the ICU, a higher Simplified Acute Physiology Score, higher body weight, motor neurological disorder, high-dose steroids, and absence of oral nutrition on the study day as factors independently associated with occurrence of PI in the ICU. CONCLUSION: This large point-prevalence study shows that PIs are found in about one of five critically ill patients despite extensive use of devices for preventing PI. Acquisition of PI in the ICU is strongly related to the patient's severity of illness on admission to the ICU and length of stay in the ICU.

The clinical impact of hydroresponsive dressings in dynamic wound healing: Part I.

OBJECTIVE: Management of any wound, either acute or hard-to-heal, might involve the use of multiple and different wound dressings in its treatment. This approach is necessary to overcome the myriad of clinical challenges the wound presents, as well as any underlying comorbidities that might affect the clinical outcomes. This article describes the clinical effectiveness of a coordinated wound dressing treatment regimen. METHOD: This was an open-labelled non-comparative study involving patients with a variety of hard-to-heal and acute wounds of differing levels of severity, but all of which required removal of devitalised tissue to enable wound healing to progress. The first phase used the hydroresponsive wound dressing HydroClean (PAUL HARTMANN AG, Germany). The PUSH score was used as the primary measurement parameter. RESULTS: A total of 86 patients (38 male/48 female), with a mean age of 67.7±21.7 years, took part in the study. The results showed that the hydroresponsive dressing was effective in managing wound exudate production and promoting wound cleansing and debridement, supporting good wound bed preparation. Wound closure was observed in 16/86 (18.6%) wounds at the end of the study (20 weeks). This enabled clinicians to switch to alternative wound dressings to promote subsequent clinical healing outcomes. CONCLUSION: In this study, the hydroresponsive wound dressing was highly effective in preparing a clean wound bed such that the next stage of wound healing could be supported.