Organ and effective doses in infants undergoing upper gastrointestinal (UGI) fluoroscopic examination

To provide more detailed data on organ and effective doses in digital upper gastrointestinal (UGI) fluoroscopy studies of newborns and infants, the present study was conducted employing the time-sequence videotape-analysis technique used in a companion study of newborn and infant voiding cystourethrograms (VCUG). This technique was originally pioneered [O. H. Suleiman, J. Anderson, B. Jones, G. U. Rao, and M. Rosenstein, Radiology 178, 653-658 (1991)] for adult UGI examinations. Individual video frames were analyzed to include combinations of field size, field center, x-ray projection, image intensifier, and magnification mode. Additionally, the peak tube potential and the mA or mAs values for each segment/subsegment or digital photospot were recorded for both the fluoroscopic and radiographic modes of operation. The data from videotape analysis were then used in conjunction with a patient-scalable newborn tomographic computational phantom to report both organ and effective dose values via Monte Carlo radiation transport. The study includes dose estimates for five simulated UGI examinations representative of patients ranging from three to six months of age. Effective dose values for UGI examinations ranged from 1.17 to 6.47 mSv, with a mean of 3.14 mSv and a large standard deviation of 2.15 mSv. The colon, lungs, stomach, liver, and esophagus absorbed doses in sum were found to constitute between 63 and 75% of the effective dose in these UGI studies. Representing 23-30% of the effective dose, the lungs were found to be the most significant organ in the effective dose calculation. Approximately 80-95% of the effective dose is contributed by the dynamic fluoroscopy segments with larger percentages found in longer studies. The mean effective dose for newborn UGI examinations was not found to be statistically different from that seen in newborn VCUG examinations.     

A review of clinical safety data for sumatriptan nasal powder administered by a breath powered exhalation delivery system in the acute treatment of migraine

Introduction: AVP-825 (sumatriptan nasal powder) is an FDA-approved intranasal medication delivery system containing low-dose sumatriptan powder for acute treatment of migraine with or without aura in adults. AVP-825 utilizes unique nasal anatomy features to avoid limitations of other intranasal delivery methods.

Areas covered: Literature search terms: ‘AVP-825’, ‘sumatriptan nasal powder’, ‘intranasal sumatriptan’, ‘sumatriptan safety’, ‘sumatriptan acute migraine’. Pharmacokinetic, Phase 2/3 studies, reviews (AVP-825) and metanalyses/reviews (sumatriptan) were evaluated.

Expert opinion: AVP-825 provides a more efficient sumatriptan delivery method versus other formulations. Pharmacokinetics showed that a single dose of AVP-825 (22 mg) delivers 15-16 mg sumatriptan and produces significantly lower exposure than oral or injectable formulations, which may translate into a better safety/tolerability profile. AVP-825 was well tolerated in controlled trials, with the most common adverse events localized at the administration-site (abnormal taste, nasal discomfort); these were mostly mild, leading to only one discontinuation. Compared to 100 mg oral sumatriptan, AVP-825 had a significantly lower rate of atypical sensations across multiple attacks. AVP-825 has the advantage of early efficacy onset associated with faster absorption at a lower delivered dose than liquid nasal spray or oral formulations. AVP-825 provided earlier efficacy (within 30 min) vs. 100 mg oral sumatriptan and similar sustained efficacy. AVP-825 offers the benefits of a non-oral, low-dose, tolerable acute migraine medication.     

Health Halo Effects from Product Titles and Nutrient Content Claims in the Context of “Protein” Bars

Research on front-of-package (FOP) labeling demonstrates that nutrient content claims (e.g., “low fat”) can lead consumers to perceive foods as healthier in general—effects that have been interpreted using halo effect theories of impression formation. Extending this work, the present study investigates whether these effects may depend on whether nutrient information comes in the form of a nutrient content claim (“good source of protein”) or embedded within the product title itself (“protein” bar)—an important question given the popularity of energy/nutrition bars and ongoing policy debates over food-labeling regulation. Results from a between-subjects experiment (n = 274) revealed that although both conditions increased perceived protein content for a nutritional bar, only the product title condition increased overall perceptions of product healthfulness—an effect mediated by increased perceptions of additional non-claimed “healthy” nutrients (fiber, iron). Finally, although the presence of a traffic light warning label increased perceived sugar and calorie content, it did not counteract the effect of the product title on perceived healthfulness. We conclude with a discussion focused on implications for policy and health halo effects in the context of food labeling.     

A novel rapid and selective enzymatic debridement agent for burn wound management: A multi-center RCT

Objectives

Excisional debridement followed by autografting is the standard of care (SOC) for deep burns, but is associated with serious potential complications. Conservative, non-surgical and current enzymatic debridement methods are inefficiently slow. We determined whether a non-surgical option of rapid enzymatic debridement with the debriding enzyme NexoBrid™ (NXB) would reduce need for surgery while achieving similar esthetic and functional outcomes as SOC.

Methods

We conducted a multi-center, open-label, randomized, controlled clinical trial including patients aged 4-55 years with deep partial and full thickness burns covering 5-30% of their total body surface area (TBSA). Patients were randomly assigned to burn debridement with NXB (applied for 4 h) or SOC, which included surgical excisional or non-surgical debridement.

Results

NXB significantly reduced the time from injury to complete débridement (2.2 vs. 8.7 days, P < 0.0001), need for surgery (24.5% vs. 70.0%, P < 0.0001), the area of burns excised (13.1% vs. 56.7%, P < 0.0001) and the need for autografting (17.9% vs. 34.1%, P = 0.01). Scar quality and quality of life scores were similar in both study groups as were the rates of adverse events.

Conclusions

Enzymatic débridement with NXB resulted in reduced need for and extent of surgery compared with SOC while achieving comparable long-term results in patients with deep burns.

Trial registration

: Clinical Trials.gov NCT00324311.     

Comparison of Intravenous versus Topical Tranexamic Acid in Total Knee Arthroplasty: A Prospective Randomized Study

The purpose of this study was to compare the efficacy of topical Tranexamic Acid (TXA) versus Intravenous (IV) Tranexamic Acid for reduction of blood loss following primary total knee arthroplasty (TKA). This prospective randomized study involved 89 patients comparing topical administration of 2.0 g TXA, versus IV administration of 10 mg/kg. There were no differences between the two groups with regard to patient demographics or perioperative function. The primary outcome measure, perioperative change in hemoglobin level, showed a decrease of 3.06 ± 1.02 in the IV group and 3.42 ± 1.07 in the topical group (P = 0.108). There were no statistical differences between the groups in preoperative hemoglobin level, lowest postoperative hemoglobin level, or total drain output. One patient in the topical group required blood transfusion (P = 0.342). Based on our study, topical Tranexamic Acid has similar efficacy to IV Tranexamic Acid for TKA patients.     

Fasting and exercise increase plasma cannabinoid levels in THC pre-treated rats: an examination of behavioural consequences

Rationale

Δ⁹-Tetrahydrocannabinol (THC), the main psychoactive constituent of cannabis, accumulates in fat tissue where it can remain for prolonged periods. Under conditions of increased fat utilisation, blood cannabinoid concentrations can increase. However, it is unclear whether this has behavioural consequences.

Objectives

Here, we examined whether rats pre-treated with multiple or single doses of THC followed by a washout would show elevated plasma cannabinoids and altered behaviour following fasting or exercise manipulations designed to increase fat utilisation.

Methods

Behavioural impairment was measured as an inhibition of spontaneous locomotor activity or a failure to successfully complete a treadmill exercise session. Fat utilisation was indexed by plasma free fatty acid (FFA) levels with plasma concentrations of THC and its terminal metabolite (-)-11-nor-9-carboxy-?⁹-tetrahydrocannabinol (THC-COOH) also measured.

Results

Rats given daily THC (10 mg/kg) for 5 days followed by a 4-day washout showed elevated plasma THC-COOH when fasted for 24 h relative to non-fasted controls. Fasted rats showed lower locomotor activity than controls suggesting a behavioural effect of fat-released THC. However, rats fasted for 20 h after a single 5-mg/kg THC injection did not show locomotor suppression, despite modestly elevated plasma THC-COOH. Rats pre-treated with THC (5 mg/kg) and exercised 20 h later also showed elevated plasma THC-COOH but did not differ from controls in their likelihood of completing 30 min of treadmill exercise.

Conclusions

These results confirm that fasting and exercise can increase plasma cannabinoid levels. Behavioural consequences are more clearly observed with pre-treatment regimes involving repeated rather than single THC dosing.     

Understanding Prolonged Cessation from Heroin Use: Findings from a Community-Based Sample

Background: There is abundant literature describing heroin initiation, co-morbidities, and treatment. Few studies focus on cessation, examining the factors that motivate and facilitate it.

Methods: The CHANGE study utilized mixed methods to investigate heroin cessation among low-income New York City participants. This paper describes findings from qualitative interviews with 20 former and 11 current heroin users. Interviews focused on background and current activities, supports, drug history, cessation attempts, and motivators and facilitators to cessation. Results: Participants found motivation for cessation in improved quality of life, relationships, and fear of illness, incarceration and/or death. Sustained cessation required some combination of treatment, strategic avoidance of triggers, and engagement in alternative activities, including support groups, exercise, and faith-based practice. Several reported that progress toward goals served as motivators that increased confidence and facilitated cessation. Ultimatums were key motivators for some participants. Beyond that, they could not articulate factors that distinguished successful from unsuccessful cessation attempts, although data suggest that those who were successful could describe more individualized and concrete—rather than general—motivators and strategies. Conclusions: Our findings indicate that cessation may be facilitated by multifaceted and individualized strategies, suggesting a need for personal and comprehensive approaches to treatment.     

Imaging features of immune-mediated genitourinary disease

Purpose

Imaging features of immune-mediated genitourinary diseases often overlap, and the same disease may manifest in different ways, so understanding imaging findings in the context of the patient’s entire clinical picture is important in providing the correct diagnosis.

Methods

In this article, diseases mediated by the immune system which affect the genitourinary system are reviewed. Examples of immune-mediated genitourinary disease including IgG4-related disease, post-transplant lymphoproliferative disorder, immunodeficiency-associated lymphoproliferative disorder due to immunosuppressive and immunomodulatory medications, lymphoma, leukemia, myeloma, amyloidosis, and histiocytosis.

Results

Clinical and imaging features will be presented which may help narrow the differential diagnosis for each disease.

Conclusion

Recognition of immune-related genitourinary disease is important for appropriate medical management as they may mimic other diseases both by imaging and clinical presentation.

     

Targeting CGRP for the Prevention of Migraine and Cluster Headache: A Narrative Review

Calcitonin-gene-related peptide (CGRP), a neuropeptide broadly distributed in neuronal and non-neuronal regions throughout the body, plays a fundamental role in migraine and cluster headache (CH) pathophysiology. CGRP functional blockade alleviates neurogenic inflammation and reduces pain pathway sensitization. Two types of CGRP function-blocking modalities, monoclonal antibodies (MAbs), and small molecules (gepants), have been designed to target the CGRP ligands and CGRP receptors. In this narrative review, we summarized the latest clinical trials on gepants and CGRP function-blocking MAbs for migraine and CH prevention. At the time of writing, newer gepants are currently under Federal Drug Administration (FDA) review for migraine management, but there is no study yet on the usage of gepants for CH. Erenumab, fremanezumab, and galcanezumab have been approved by the FDA for migraine prevention while eptinezumab is under FDA review. CGRP MAbs are as effective as and more tolerable than conventional migraine preventives. For CH prevention, galcanezumab has shown some promising findings and was recently approved for use in episodic cluster prevention. CGRP function-blocking therapy not only demonstrates high efficacy and superior safety profile, but also improves headache frequency and quality of life. Convenient monthly dosing for the MAbs can further improve medication adherence, hence better headache control. With CGRP function-blocking therapy showing efficacy even in individuals who failed other preventives, it has become an exciting new therapeutic option in the field of migraine and CH.