Development and supervision of food for special medical purpose (FSMP) in China

In China， food for special medical purpose （FSMP） is defined as “formula food specially processed and prepared in order to meet the special nutrient or diet needs for people with food restriction， digestion and absorption disorder， metabolic disorder or specific disease state”. The development of FSMP in China started relatively late. Since the revised “Food Safety Law of the People’s Republic of China” in 2015 officially brought FSMP into the track of legal management， the supervision of FSMP has gradually improved， and the number of products approved for registration has gradually increased. This article briefly introduces the relevant regulations， standards and regulatory requirements of FSMP in China， as well as the basic situation of the products approved for registration， and puts forward some suggestions for the reference of relevant personnel and interested readers

Same-Day Discharge after Laparoscopic Roux-en-Y Gastric Bypass: An Analysis of the Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program Database.

BACKGROUND:Laparoscopic Roux-en-Y gastric bypass (LRYGB) has been performed with successful discharge on postoperative day 1 (POD1). There are limited studies on same-day discharge after LRYGB. The objective of this study was to examine the frequency and outcomes of same-day discharge after LRYGB. STUDY DESIGN:The 2015 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) database was analyzed for adult patients who underwent elective LRYGB cases with same-day vs POD1 discharge. Open and revisional cases were excluded. Multivariate analysis was performed to compare risk-adjusted 30-day mortality, overall morbidity, readmission, and reoperation. RESULTS:There were 354 (0.9%) patients who were discharged on the same day as surgery after LRYGB. After exclusion criteria, 319 patients with same-day discharge and 9,402 patients with POD1 discharge were examined. For same-day vs POD1 discharge groups, mean ages were 45.0 and 44.5 years, respectively, and mean BMIs were 47.3 kg/m2 and 45.9 kg/m2, respectively. The unadjusted mortality rate was significantly higher for same-day compared with POD1 discharge (0.94% vs. 0.05%, respectively; p = 0.0017). Compared with POD1 discharge, same-day discharge had higher overall morbidity (3.76% vs 1.54%; adjusted odds ratio [AOR] 2.41; p = 0.0216), but no statistically significant differences for readmissions (3.45% vs. 3.66%; AOR 0.85; p = 0.9999) or reoperations (1.88% vs. 0.89%; AOR 2.33; p = 0.2428). CONCLUSIONS:Same-day discharge after LRYGB is associated with increased morbidity and mortality compared with POD1 discharge. The practice of same-day discharge after LRYGB should be considered experimental until further studies confirm which patient characteristics will ensure safe same-day discharge

Management and use of food ingredient hyaluronic acid at home and abroad

Hyaluronic acid （HA）， a natural substance widely present in the human body， exhibits diverse physiological regulatory effects and is often found in the structurally stable form known as sodium hyaluronate （SH）. HA finds extensive use in the food industry. Many countries and regions， including Japan， the United States， and the European Union， permit the use of HA in common foods. In contrast， Korea allows HA only in healthy foods and beverages. In China， approval for HA （in the SH form） as a health food ingredient was granted in 2008， and its usage was expanded to general food in December 2020. This study provides an overview of the characteristics of the product， its oral efficacy， regulatory categories， production processes， scope of application， safety limits， and approved functional claims both domestically and internationally. The goal is to explore its applicability and potential market demand. Simultaneously， the status of relevant regulations and approved uses are organized and analyzed to offer a systematic reference for the research and development， regulation， and consumption of HA-related food products. The aim is to promote the rational use and development of HA in the food industry

Development and Validation of Prediction Scores for Early Mortality at Transition to Dialysis.

ObjectiveTo develop and validate a risk prediction model that would help individualize treatment and improve the shared decision-making process between clinicians and patients.Patients and methodsWe developed a risk prediction tool for mortality during the first year of dialysis based on pre-end-stage renal disease characteristics in a cohort of 35,878 US veterans with incident end-stage renal disease who transitioned to dialysis treatment between October 1, 2007, and March 31, 2014 and then externally validated this tool among 4284 patients in the Kaiser Permanente Southern California (KPSC) health care system who transitioned to dialysis treatment between January 1, 2007, and September 30, 2015.ResultsTo ensure model goodness of fit, 2 separate models were selected for patients whose last estimated glomerular filtration rate (eGFR) before dialysis initiation was less than 15 mL/min per 1.73 m2 or 15 mL/min per 1.73 m2 or higher. Model discrimination in the internal validation cohort of veterans resulted in C statistics of 0.71 (95% CI, 0.70-0.72) and 0.66 (95% CI, 0.65-0.67) among patients with eGFR lower than 15 mL/min per 1.73 m2 and 15 mL/min per 1.73 m2 or higher, respectively. In the KPSC external validation cohort, the developed risk score exhibited C statistics of 0.77 (95% CI, 0.74-0.79) in men and 0.74 (95% CI, 0.71-0.76) in women with eGFR lower than 15 mL/min per 1.73 m2 and 0.71 (95% CI, 0.67-0.74) in men and 0.67 (95% CI, 0.62-0.72) in women with eGFR of 15 mL/min per 1.73 m2 or higher.ConclusionA new risk prediction tool for mortality during the first year after transition to dialysis (available at www.DialysisScore.com) was developed in the large national Veterans Affairs cohort and validated with good performance in the racially, ethnically, and gender diverse KPSC cohort. This risk prediction tool will help identify high-risk populations and guide management strategies at the transition to dialysis

GCTOF-MS Combined LC-QTRAP-MS/MS Reveals Metabolic Difference Between Osteoarthritis and Osteoporotic Osteoarthritis and the Intervention Effect of Erxian Decoction

PurposeOP and OA are chronic bone diseases with high incidence in the middle-aged and elderly populations. The latest research shows that the pathological environment of OP may be involved in the aggravation of the pathological process of OA, and the pathological state of OP plays an important role in the aggravation of OA pathology. EXD is a traditional Chinese medicine decoction that has been used to treat osteoporosis. Therefore, we further study whether OA will be aggravated in the OP environment and whether EXD can alleviate OA by intervening in the OP environment. The purpose of this study was to analyze the effect of OP on OA metabolites by using metabolomic methods and to explore the intervention mechanism of EXD on osteoporotic OA.MethodThirty-two SD rats were randomly divided into normal group, OA group, OP-OA group, and EXD group. EXD was administered by gavage. Histopathological evaluation of cartilage tissue was performed using Saffron fast green and HE staining. Western blot and qRT-PCR were used to detect the expression levels of chondrogenesis genes SOX9, COL2A1, and COMP in cartilage tissue. GC-TOFMS and LC-QTRAP-MS/MS metabolomics methods were used to analyze the changes of metabolites in serum samples of rats in each group.ResultThe slice results showed that the cartilage damage in the OP-OA group was more serious than that in the OA group, which was significantly relieved after EXD intervention, indicating that the cartilage damage in the OP-OA group was more severe than that in the OA group and further reduced the protein and gene expressions of cartilage markers SOX9, COL2A1, and COMP. Thirty-seven substances were identified, and gentiopicroside, emodin, quercetin, and diosmetin were analyzed as possible active components of EXD. EXD treatment significantly reduced cartilage damage and reversed the expression of these markers. Metabolomics showed that EXD attenuated cartilage destruction by modulating the expression of cystine, chenodeoxycholate, and D-Turanose, involving glycolysis/gluconeogenesis, pantothenate, and CoA biosynthesis metabolic pathways.ConclusionThe OP environment may promote the progression of OA through metabolic factors. The benign intervention of EXD in osteoporotic OA involves cystine, chenodeoxycholate, and D-Turanose, and their associated glycolysis/gluconeogenesis, pantothenate, and CoA biosynthesis metabolic pathways. Therefore, we have a deep understanding of the metabolic-related intervention of EXD in osteoporotic OA and are eager to better understand the mechanism of multi-targeted intervention of EXD in bone metabolic lesions

<i>Trans</i>-vaccenic acid reprograms CD8⁺ T cells and anti-tumour immunity

Diet-derived nutrients are inextricably linked to human physiology by providing energy and biosynthetic building blocks and by functioning as regulatory molecules. However, the mechanisms by which circulating nutrients in the human body influence specific physiological processes remain largely unknown. Here we use a blood nutrient compound library-based screening approach to demonstrate that dietary trans-vaccenic acid (TVA) directly promotes effector CD8+ T cell function and anti-tumour immunity in vivo. TVA is the predominant form of trans-fatty acids enriched in human milk, but the human body cannot produce TVA endogenously. Circulating TVA in humans is mainly from ruminant-derived foods including beef, lamb and dairy products such as milk and butter, but only around 19% or 12% of dietary TVA is converted to rumenic acid by humans or mice, respectively. Mechanistically, TVA inactivates the cell-surface receptor GPR43, an immunomodulatory G protein-coupled receptor activated by its short-chain fatty acid ligands. TVA thus antagonizes the short-chain fatty acid agonists of GPR43, leading to activation of the cAMP–PKA–CREB axis for enhanced CD8+ T cell function. These findings reveal that diet-derived TVA represents a mechanism for host-extrinsic reprogramming of CD8+ T cells as opposed to the intrahost gut microbiota-derived short-chain fatty acids. TVA thus has translational potential for the treatment of tumours