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Bioequivalence and Safety Assessment of 2 Formulations of Low-Dose Metformin Hydrochloride under Fasting Conditions in Healthy Chinese Participants: A Randomized Phase 1 Clinical Trial.
Sun, ML, Xu, XW, Liu, C, Tong, YX, Wei, YL, Liu, HJ, Zhang, W, Wang, XH
Clinical pharmacology in drug development. 2024;(3):307-314
Abstract
The incidence of type 2 diabetes is high, and the existing metformin hydrochloride (MH) tablets of 250 mg cannot meet the demands of the Chinese drug market. This study aimed to evaluate the bioequivalence and safety of generic formulations of MH tablets (test formulation [T], 250 mg/tablet) and innovative products (reference formulation [R], 250 mg/tablet) under fasting conditions. This was an open-label, single-dose, 2-period, 2-sequence crossover, single-center, randomized phase I clinical trial. T and R were considered bioequivalent if the adjusted geometric mean ratios (GMRs) and 90% confidence intervals of the area under the curve (AUC) and maximum concentration (Cmax ) were within the range of 0.8-1.25. Thirty-five participants completed the trial. The T/R adjusted GMRs (95.7% for Cmax , 98.7% for AUC0→t , 98.8% for AUC0→∞ ) were within the acceptable bioequivalence range of 80%-125%. No serious adverse events or suspected or unexpected serious adverse reactions occurred during this trial. The study findings confirmed that generic MH is a well-tolerated and bioequivalent alternative to innovative products under fasting conditions in healthy Chinese participants. (www.chinadrugtrials.org.cn; registration no. CTR20190356).
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2.
[Research progress in associations between dental caries and systemic diseases].
Wang, XH, Xu, ZQ, Bian, Z, Meng, LY
Zhonghua kou qiang yi xue za zhi = Zhonghua kouqiang yixue zazhi = Chinese journal of stomatology. 2024;(1):99-104
Abstract
Dental caries is a bacteria-mediated, multifactorial, chronic progressive disease that results in the phasic demineralization and remineralization of dental hard tissues. In recent years, amounts of studies have focused on the association between dental caries and systemic diseases. This paper reviews the researches about associations between caries and systemic diseases. An electronic search was conducted in PubMed and Web of Science for articles published from 2003 to 2022 in the English language. Studies were included in the following ten categories of systemic diseases: cardiovascular diseases, metabolic disorders, respiratory diseases, autoimmune rheumatic diseases, neurologic diseases, gastrointestinal diseases, kidney diseases, skin diseases, iron deficiency anaemia and tumors. This review discusses the relationship between dental caries and systemic diseases, as well as the potentially involved mechanisms, providing new ideas for disease prevention, diagnosis, and treatment strategies for dentists and other clinicians.
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3.
Exploring choices of early nutritional support for patients with sepsis based on changes in intestinal microecology.
Yang, XJ, Wang, XH, Yang, MY, Ren, HY, Chen, H, Zhang, XY, Liu, QF, Yang, G, Yang, Y, Yang, XJ
World journal of gastroenterology. 2023;29(13):2034-2049
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Sepsis is a condition brought about by infection and results in organ dysfunction and gut microbiota imbalance. Nutrition plays a large part in recovery from sepsis, however it is unclear as to the optimal diet for gut microbial balance in individuals with sepsis. This randomised control trial of 30 individuals with sepsis aimed to determine the optimal delivery of nutrition for gut microbial health either through a gastric tube (TEN), through the jugular vein (TPN), or a mixture of the two modes (SPN). The results showed differences in gut microbiota composition between the different modes of nutrition. Enterococcus increased in TEN, Campylobacter decreased in TPN, and Dialister decreased in SPN groups. Fermentation products produced by gut microbiota also changed depending on the mode of nutrition, with the TEN group showing improvements amongst the most fermentation products. Individuals in the TEN group also showed improved immune system function alongside those in the SPN group. It was concluded that based upon improvements to the immune system and gut microbiota, TEN is the most suitable mode for nutrition in individuals with sepsis. This study could be used by healthcare professionals to understand that nutrition methods for individuals with sepsis aren’t equally effective and recovery may be faster if individuals receive nutrition through a gastric tube.
Abstract
BACKGROUND Sepsis exacerbates intestinal microecological disorders leading to poor prognosis. Proper modalities of nutritional support can improve nutrition, immunity, and intestinal microecology. AIM: To identify the optimal modality of early nutritional support for patients with sepsis from the perspective of intestinal microecology. METHODS Thirty patients with sepsis admitted to the intensive care unit of the General Hospital of Ningxia Medical University, China, between 2019 and 2021 with indications for nutritional support, were randomly assigned to one of three different modalities of nutritional support for a total of 5 d: Total enteral nutrition (TEN group), total parenteral nutrition (TPN group), and supplemental parenteral nutrition (SPN group). Blood and stool specimens were collected before and after nutritional support, and changes in gut microbiota, short-chain fatty acids (SCFAs), and immune and nutritional indicators were detected and compared among the three groups. RESULTS In comparison with before nutritional support, the three groups after nutritional support presented: (1) Differences in the gut bacteria (Enterococcus increased in the TEN group, Campylobacter decreased in the TPN group, and Dialister decreased in the SPN group; all P < 0.05); (2) different trends in SCFAs (the TEN group showed improvement except for Caproic acid, the TPN group showed improvement only for acetic and propionic acid, and the SPN group showed a decreasing trend); (3) significant improvement of the nutritional and immunological indicators in the TEN and SPN groups, while only immunoglobulin G improved in the TPN group (all P < 0.05); and (4) a significant correlation was found between the gut bacteria, SCFAs, and nutritional and immunological indicators (all P < 0.05). CONCLUSION TEN is recommended as the preferred mode of early nutritional support in sepsis based on clinical nutritional and immunological indicators, as well as changes in intestinal microecology.
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Effect of dietary fiber on gut barrier function, gut microbiota, short-chain fatty acids, inflammation, and clinical outcomes in critically ill patients: A systematic review and meta-analysis.
Liu, T, Wang, C, Wang, YY, Wang, LL, Ojo, O, Feng, QQ, Jiang, XS, Wang, XH
JPEN. Journal of parenteral and enteral nutrition. 2022;(5):997-1010
Abstract
BACKGROUND Although some studies have explored the relationships between dietary fiber (DF) supplement and gut barrier function, changes of gut microbiota, and clinical outcomes in critically ill patients, the results were not consistent. OBJECTIVE The purpose was to explore the effect of DF on gut barrier function, gut microbiota, short-chain fatty acids (SCFAs), inflammation, and clinical outcomes in critically ill patients. METHODS A search was performed through five databases from inception to July 12, 2021. Data were expressed as mean difference (MD) or odds ratio (OR) with CI. RESULTS Twenty-one studies involving 2084 critically ill patients were included. There was a significant reduction in intestinal permeability, demonstrated by lactulose/rhamnose ratio (MD, -0.04; 95% CI, -0.08 to -0.00; P = 0.03) on day 8, C-reactive protein on day 14 (MD, -36.66; 95% CI, -44.40 to -28.93; P < 0.001) and duration of hospital stay (MD, -3.16; 95% CI, -5.82 to -0.49; P < 0.05) after DF supplement. There were no significant differences in SCFA levels, duration of mechanical ventilation, and mortality between two groups. However, subgroup analysis results indicated significant decreases in duration of hospital stay and risk of mortality were seen in the subgroups with a supplementary fiber dose ≥20 g/day (MD, -5.62 [95% CI, -8.04 to -3.21; P < 0.0001]; OR, 0.18 [95% CI, 0.06-0.57; P = 0.004]), as well as in the medical intensive care unit (MD, -4.77 [95% CI, -7.48 to -2.07; P < 0.01]; OR, 0.13 [95% CI, 0.03-0.65; P < 0.05]). CONCLUSIONS DF may improve gut barrier function, modulate intestinal microbiota, decrease systemic inflammatory response, and advance clinical outcomes in critically ill patients.
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The Effects of COVID-19 Lockdown on Glycaemic Control and Lipid Profile in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis.
Ojo, O, Wang, XH, Ojo, OO, Orjih, E, Pavithran, N, Adegboye, ARA, Feng, QQ, McCrone, P
International journal of environmental research and public health. 2022;(3)
Abstract
UNLABELLED The impact of the COVID-19 lockdown on glycaemic control and other metabolic parameters in patients with type 2 diabetes is still evolving. AIM: This systematic review and meta-analysis aims to examine the effects of COVID-19 lockdown on glycaemic control and lipid profile in patients with type 2 diabetes. METHODS The PRISMA framework was the method used to conduct the systematic review and meta-analysis, and the search strategy was based on the population, intervention, control and outcome (PICO) model. The Health Sciences Research databases was accessed via EBSCO-host, and EMBASE were searched for relevant articles. Searches were conducted from inception of the databases until 17 September 2021. RESULTS The results identified three distinct areas: glycaemic control, lipid parameters and body mass index. It was found that COVID-19 lockdown led to a significant (p < 0.01) increase in the levels of glycated haemoglobin (%) compared with pre-COVID group (gp) with a mean difference of 0.34 (95% CI: 0.30, 0.38). Eleven studies contributed to the data for glycated haemoglobin analysis with a total of 16,895 participants (post-COVID-19 lockdown gp, n = 8417; pre-COVID gp, n = 8478). The meta-analysis of fasting plasma glucose (mg/dL) also showed a significant (p < 0.05) increase in levels of post-COVID-19 lockdown gp compared with pre-COVID gp, with a mean difference of 7.19 (95% CI: 5.28, 9.10). Six studies contributed to fasting plasma glucose analysis involving a total of 2327 participants (post-COVID-19 lockdown, n = 1159; pre-COVID gp, n = 1168). The body mass index (BMI) (kg/m2) analysis also demonstrated that post-COVID-19 lockdown gp had a significantly (p < 0.05) higher BMI than the pre-COVID gp with a mean difference of 1.13 (95% CI: 0.99; 1.28), involving six studies and a total of 2363 participants (post-COVID-19 lockdown gp, n = 1186; pre-COVID gp, n = 1177). There were significantly (p < 0.05) lower levels of total cholesterol (mmol/L), triglyceride (mmol/L) and LDL cholesterol (mmol/L), and higher levels of HDL cholesterol (mg/dL) in the post-COVID-19 lockdown gp compared with pre-COVID gp, although these results were not consistent following sensitivity analysis. CONCLUSION The findings of the systematic review and meta-analysis have demonstrated that COVID-19 lockdown resulted in a significant increase (p < 0.05) in the levels of glycated haemoglobin, fasting glucose and body mass index in patients with type 2 diabetes. In contrast, the effect of the lockdown on lipid parameters, including total cholesterol, triglycerides, LDL and HDL cholesterol was not consistent.
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The Role of High-Content Complex Dietary Fiber in Medical Nutrition Therapy for Gestational Diabetes Mellitus.
Wang, HK, Cheng, DC, Yang, YM, Wang, XH, Chen, Y, Zhang, L, Xiu, L, Xu, XM
Frontiers in pharmacology. 2021;:684898
Abstract
Objectives: A controlled open clinical study was conducted to evaluate the role of Ricnoat, a high-content complex dietary fiber powder produced by Zhuhai Aimed Biotechnology Co. Ltd., in medical nutrition therapy (MNT) to treat gestational diabetes mellitus (GDM). The study aimed to investigate glycemic control, lipid control, weight control, and pregnancy outcomes (neonatal weight) in patients with GDM, as well as evaluate the clinical safety of Ricnoat. Methods: A total of 120 patients with GDM who were admitted to three hospitals in Shanghai between January 2019 and January 2020 were enrolled. Ricnoat was used for intervention for patients in the experimental group. Using a χ2 test and t-test, respectively, comparisons were conducted between the measurement data and countable data of the demographics and baseline disease characteristics of the experimental group and control group. Results: Fasting blood glucose, 2-h postprandial blood glucose, glycated hemoglobin, total cholesterol, triglycerides, low-density lipoprotein, maternal gestational weight gain, neonatal weight, serum creatinine, glutamate transaminase, and aspartate aminotransferase were lower in the experimental group than in the control group, whereas high-density lipoprotein was higher in the experimental group than in the control group. Ricnoat intervention resulted in satiety higher than the expected 80% and more common occurrence of type 4 (smooth and soft, like salami or a snake) and type 5 (a soft mass with clear edges) stools. Conclusion: Ricnoat intervention had a significant effect on glycemic control, lipid control, weight control, and pregnancy outcomes (neonatal weight) in patients with GDM by enhancing maternal satiety and improving the stool features of pregnant women. It was also found to be safe for application during pregnancy.
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7.
Sinomenine in Cardio-Cerebrovascular Diseases: Potential Therapeutic Effects and Pharmacological Evidences.
Zhang, MW, Wang, XH, Shi, J, Yu, JG
Frontiers in cardiovascular medicine. 2021;:749113
Abstract
Cardio-cerebrovascular diseases, as a major cause of health loss all over the world, contribute to an important part of the global burden of disease. A large number of traditional Chinese medicines have been proved effective both clinically and in pharmacological investigations, with the acceleration of the modernization of Chinese medicine. Sinomenine is the main active constituent of sinomenium acutum and has been generally used in therapies of rheumatoid arthritis and neuralgia. Varieties of pharmacological effects of sinomenine in cardio-cerebrovascular system have been discovered recently, suggesting an inspiring application prospect of sinomenine in cardio-cerebrovascular diseases. Sinomenine may retard the progression of atherosclerosis by attenuating endothelial inflammation, regulating immune cells function, and inhibiting the proliferation of vascular smooth muscle cells. Sinomenine also alleviates chronic cardiac allograft rejection relying on its anti-inflammatory and anti-hyperplastic activities and suppresses autoimmune myocarditis by immunosuppression. Prevention of myocardial or cerebral ischemia-reperfusion injury by sinomenine is associated with its modulation of cardiomyocyte death, inflammation, calcium overload, and oxidative stress. The regulatory effects on vasodilation and electrophysiology make sinomenine a promising drug to treat hypertension and arrhythmia. Here, in this review, we will illustrate the pharmacological activities of sinomenine in cardio-cerebrovascular system and elaborate the underlying mechanisms, as well as give an overview of the potential therapeutic roles of sinomenine in cardio-cerebrovascular diseases, trying to provide clues and bases for its clinical usage.
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The Role of Dietary Fiber Supplementation in Regulating Uremic Toxins in Patients With Chronic Kidney Disease: A Meta-Analysis of Randomized Controlled Trials.
Yang, HL, Feng, P, Xu, Y, Hou, YY, Ojo, O, Wang, XH
Journal of renal nutrition : the official journal of the Council on Renal Nutrition of the National Kidney Foundation. 2021;(5):438-447
Abstract
OBJECTIVES The results of previously published meta-analyses showed that dietary fiber could reduce the levels of p-cresyl sulfate, blood urea nitrogen, and creatinine in patients with chronic kidney disease (CKD). However, these results were based on some trials with pre-post design and randomized controlled trials of low quality. Additionally, it has been suggested that the dosage and duration of fiber supplementation and patients' characteristics potentially influence the effect of dietary fiber in reducing uremic toxins, but it would appear that no research has provided reliable evidence. DESIGN AND METHODS We searched PubMed, Web of Science, and Cochrane Library. Data were pooled by the generic inverse variance method using random effects models and expressed as standardized mean difference (SMD) with 95% confidence interval (CI). Heterogeneity was quantified by I2. Publication bias was evaluated by Egger's test. RESULTS Ten randomized controlled trials involving 292 patients with CKD were identified. Dietary fiber supplementation can significantly reduce the levels of indoxyl sulfate (SMD = -0.55, 95% CI = -1.04, -0.07, P = .03), p-cresyl sulfate (SMD = -0.47, 95% CI = -0.82, -0.13, P < .01), blood urea nitrogen (SMD = -0.31, 95% CI = -0.58, -0.03, P = .03), and uric acid (SMD = -0.60, 95% CI = -1.02, -0.18, P < .01), but not on reducing creatinine (SMD = -0.31, 95% CI = -0.73, 0.11, P = .14). In subgroup analyses, the reduction of indoxyl sulfate was more obvious among patients on dialysis than patients not on dialysis (P for interaction = .03); the reduction of creatinine was more obvious among patients without diabetes than those with diabetes (P for interaction <.01). CONCLUSIONS This meta-analysis indicates that dietary fiber supplementation can significantly reduce the levels of uremic toxins in patients with CKD, with evidence for a more obvious effect of patients on dialysis and without diabetes. These findings inform recommendations for using dietary fiber to reducing the uremic toxin among CKD patients in clinical practice.
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9.
Mitochondrial Quality Control in Sarcopenia: Updated Overview of Mechanisms and Interventions.
Liu, D, Fan, YB, Tao, XH, Pan, WL, Wu, YX, Wang, XH, He, YQ, Xiao, WF, Li, YS
Aging and disease. 2021;(8):2016-2030
Abstract
Sarcopenia is a common geriatric disorder characterized by decreased muscle strength, low muscle mass and poor physical performance. This aging-related skeletal muscle deterioration leads to adverse outcomes and severely impairs the quality of life of patients. The accumulation of dysfunctional mitochondria with aging is an important factor in the occurrence and progression of sarcopenia. Mitochondrial quality control (MQC) fundamentally ensures the normal mitochondrial functions and is comprised of four main parts: proteostasis, biogenesis, dynamics and autophagy. Therefore, any pathophysiologic factors compromising the quality control of homeostasis in the skeletal muscle may lead to sarcopenia. However, the specific theoretical aspects of these processes have not been fully elucidated. Current therapeutic interventions using nutritional and pharmaceutical treatments show a modest therapeutic efficacy; however, only physical exercise is recommended as the first-line therapy for sarcopenia, which can ameliorate skeletal muscle deficiency by maintaining the homeostatic MQC. In this review, we summarized the known mechanisms that contribute to the pathogenesis of sarcopenia by impairing normal mitochondrial functions and described potential interventions that mitigate sarcopenia through improving MQC.
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10.
The Effects of Almonds on Gut Microbiota, Glycometabolism, and Inflammatory Markers in Patients with Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomised Controlled Trials.
Ojo, O, Wang, XH, Ojo, OO, Adegboye, ARA
Nutrients. 2021;(10)
Abstract
UNLABELLED The use of nutritional interventions for managing diabetes is one of the effective strategies aimed at reducing the global prevalence of the condition, which is on the rise. Almonds are the most consumed tree nut and they are known to be rich sources of protein, monounsaturated fatty acids, essential minerals, and dietary fibre. Therefore, the aim of this review was to evaluate the effects of almonds on gut microbiota, glycometabolism, and inflammatory parameters in patients with type 2 diabetes. METHODS This systematic review and meta-analysis was carried out according to the preferred reporting items for systematic review and meta-analysis (PRISMA). EBSCOhost, which encompasses the Health Sciences Research Databases; Google Scholar; EMBASE; and the reference lists of articles were searched based on population, intervention, control, outcome, and study (PICOS) framework. Searches were carried out from database inception until 1 August 2021 based on medical subject headings (MesH) and synonyms. The meta-analysis was carried out with the Review Manager (RevMan) 5.3 software. RESULTS Nine randomised studies were included in the systematic review and eight were used for the meta-analysis. The results would suggest that almond-based diets have significant effects in promoting the growth of short-chain fatty acid (SCFA)-producing gut microbiota. Furthermore, the meta-analysis showed that almond-based diets were effective in significantly lowering (p < 0.05) glycated haemoglobin (HbA1c) levels and body mass index (BMI) in patients with type 2 diabetes. However, it was also found that the effects of almonds were not significant (p > 0.05) in relation to fasting blood glucose, 2 h postprandial blood glucose, inflammatory markers (C-reactive protein and Tumour necrosis factor α, TNF-α), glucagon-like peptide-1 (GLP-1), homeostatic model assessment of insulin resistance (HOMA-IR), and fasting insulin. The biological mechanisms responsible for the outcomes observed in this review in relation to reduction in HbA1c and BMI may be based on the nutrient composition of almonds and the biological effects, including the high fibre content and the low glycaemic index profile. CONCLUSION The findings of this systematic review and meta-analysis have shown that almond-based diets may be effective in promoting short-chain fatty acid-producing bacteria and lowering glycated haemoglobin and body mass index in patients with type 2 diabetes compared with control. However, the effects of almonds were not significant (p > 0.05) with respect to fasting blood glucose, 2 h postprandial blood glucose, inflammatory markers (C-reactive protein and TNF-α), GLP-1, HOMA-IR, and fasting insulin.