FDA“治疗等效性评价供企业用指导原则”（草案）介绍

美国食品药品管理局（FDA）于2022年7月发布了"治疗等效性评价供企业用指导原则"（草案）。该指导原则阐明了FDA治疗等效性的标准以及治疗等效性编码系统，目的是准确评价仿制药与参比制剂的治疗等效性并通过治疗等效性代码，在"橙皮书"中迅速检索到治疗等效的仿制药。而中国目前尚无类似的指导原则，详细介绍FDA该指导原则主要内容，期望对中国加强仿制药的治疗等效性评价和加速完善和实施符合国情的治疗等效性编码系统有所帮助。     

Evaluating a Food Pantry–Based Intervention to Improve Food Security,Dietary Intake,and Quality in Midwestern Food Pantries

BackgroundVoices for Food was a longitudinal community, food pantry–based intervention informed by the social ecological model, and designed to improve food security, dietary intake, and quality among clients, which was carried out in 24 rural food pantries across 6 Midwestern states.ObjectiveOur objective was to evaluate changes in adult food security, dietary intake, and quality from baseline (2014) to follow-up (2016), and to assess the role of adult food security on dietary outcomes.DesignA multistate, longitudinal, quasi-experimental intervention with matched treatment and comparison design was used to evaluate treatment vs comparison group changes over time and changes in both groups over time.Participants/settingAdult food pantry clients (n = 617) completed a demographic food security survey, and up to three 24-hour dietary recalls at baseline (n = 590) and follow-up (n = 160).InterventionCommunity coaching served as the experimental component, which only “treatment” communities received, and a food council guide and food pantry toolkit were provided to both “treatment” and matched “comparison” communities.Main outcome measuresChange in adult food security status, mean usual intakes of nutrients and food groups, and Healthy Eating Index-2010 scores were the main outcome measures.Statistical analyses performedLinear mixed models estimated changes in outcomes by intervention group and by adult food security status over time.ResultsImprovements in adult food security score (–0.7 ± 0.3; P = .01), Healthy Eating Index-2010 total score (4.2 ± 1.1; P < .0001), and empty calories component score (3.4 ± 0.5; P <.0001) from baseline to follow-up were observed in treatment and comparison groups, but no statistically significant changes were found for adult food security status, dietary quality, and usual intakes of nutrients and food groups between the 2 groups over time. The intervention effect on dietary quality and usual intake changes over time by adult food security status were also not observed.ConclusionsFood pantry clients in treatment and comparison groups had higher food security and dietary quality at the follow-up evaluation of the Voices for Food intervention trial compared with baseline, despite the lack of difference among the groups as a result of the experimental coaching component.     

Out of the boxes,out of the silos: The need of interdisciplinary collaboration to reduce poor-quality medical products in the supply chain

In this paper, we argue that understanding and addressing the problem of poor-quality medical products requires a more interdisciplinary approach than has been evident to date. While prospective studies based on rigorous standardized methodologies are the gold standard for measuring the prevalence of poor-quality medical products and understanding their distribution nationally and internationally, they should be complemented by social science research to unpack the complex set of social, economic, and governance factors that underlie these patterns. In the following sections, we discuss specific examples of prospective quality surveys and of social science studies, highlighting the value of cross-sector partnerships in driving high-quality, policy-relevant research in this area.     

Biomolecular alterations in the early life stages of four food fish following acute exposure of Triclosan

We investigated the effect of acute concentrations of triclosan (TCS; 96 h exposure and 10d post exposure) on the free amino acid, primary (SDS-PAGE) and secondary (FT-IR) structure of proteins in the embryos/larvae of Cyprinus carpio, Ctenopharyngodon idella, Labeo rohita and Cirrhinus mrigala. A concentration dependent increase in free amino acids, upregulation of polypeptides (100 and 70 kDa in C. carpio, C. idella and L. rohita, 55, 45, 36 kda in C. idella and L. rohita and 22 kDa in all the fish) and a decline in percent area of all the selected peaks of the FT-IR spectra was observed after exposure and recovery period. The decline in percent area was greatest for L. rohita at peak 1080 – 1088 cm⁻¹ (−75.99%) after exposure and at peak 2854 – 2855 cm⁻¹ (−53.59%) after recovery. Curve fitting analysis revealed a decrease in α-helices and increase in β-sheets in all fish after exposure and recovery period. The results suggest that TCS elicits alterations in biomolecules of fish embryos.     

Neuro-immune crosstalk and food allergy: Focus on enteric neurons and mucosal mast cells

The nervous system and the immune system individually play important roles in regulating the processes necessary to maintain physiological homeostasis, respond to acute stress and protect against external threats. These two regulating systems for maintaining the living body had often been assumed to function independently. Allergies develop as a result of an overreaction of the immune system to substances that are relatively harmless to the body, such as food, pollen and dust mites. Therefore, it has been generally supposed that the development and pathogenesis of allergies can be explained through an immunological interpretation. Recently, however, neuro-immune crosstalk has attracted increasing attention. Consequently, it is becoming clear that there is close morphological proximity and physiological and pathophysiological interactions between neurons and immune cells in various peripheral tissues. Thus, researchers are now beginning to appreciate that neuro-immune interactions may play a role in tissue homeostasis and the pathophysiology of immune-mediated disease, but very little information is available on the molecular basis of these interactions. Mast cells are a part of the innate immune system implicated in allergic reactions and the regulation of host–pathogen interactions. Mast cells are ubiquitous in the body, and these cells are often found in close proximity to nerve fibers in various tissues, including the lamina propria of the intestine. Mast cells and neurons are thought to communicate bidirectionally to modulate neurophysiological effects and mast cell functions, which suggests that neuro-immune interactions may be involved in the pathology of allergic diseases.     

Ovine Iliac Vein Model for Endovascular Thrombectomy of Acute Deep Venous Thrombosis

An ovine iliac vein thrombosis model was devised to test a wall-contacting rotational thrombectomy device. Thrombosis was successfully induced in 9 sheep with an average clot length of 31 mm ± 12 and >60% vessel occlusion on angiography. The thrombus was subsequently removed, maintaining normal intraoperative pulmonary arterial pressure (5.9 mm Hg ± 3.6) and complete distal reperfusion after thrombectomy. Additionally, the sheep were without signs of vascular trauma or embolic complications on gross necropsy and histopathologic analysis. The findings from this study support the use of an ovine iliac deep vein thrombosis model for testing of a lower extremity thrombectomy device.     

Gut microbiome alterations in patients with wheat-dependent exercise-induced anaphylaxis

The intestinal microbiota plays a critical role in food allergy development. However, little is known regarding the structure and composition of the intestinal microbiota in patients with wheat-dependent exercise-induced anaphylaxis (WDEIA). We examined the gut microbiota alterations in patients with WDEIA and the microbiota’s association with WDEIA. Fecal samples were collected from 25 patients with WDEIA and 25 healthy controls. Environmental exposure factors were obtained, serum total IgE, IgE specific to wheat, gluten, and ω-5 gliadin were measured. Fecal samples were profiled using 16S rRNA gene sequencing. The relative abundances of the bacterial genera Blautia (P < 0.05), Erysipelatoclostridium (P < 0.01), Akkermansia (P < 0.05) and Lachnospiraceae_NK4A136_group (P < 0.05) were significantly increased, while those of Lactobacillus (P = 0.001) and Dialister (P < 0.05) were significantly decreased in subjects with WDEIA. The microbial diversity did not differ between WDEIA patients and healthy controls. IgE specific to ω-5 gliadin was positively associated with the Oscillospira (r = 0.48, P < 0.05) and negatively associated with Leuconostoc (r = −0.49, P < 0.05). Total IgE levels were significantly negatively correlated with Bifidobacterium (P < 0.05). The gut microbiome compositions in WDEIA patients differed from those of healthy controls. We identified a potential association between the gut microbiome and WDEIA development. Our findings may suggest new methods for preventing and treating WDEIA.