BACKGROUND: Chronic kidney disease (CKD)-associated anemia (CKD-anemia) is associated with poor survival, and hemoglobin targets are often not achieved with current therapies. Phase 3 trials have demonstrated the treatment efficacy of roxadustat for CKD-anemia. This phase 4 study aims to evaluate the long-term (52-week) safety and effectiveness of roxadustat in a broad real-world patient population with CKD-anemia with and without dialysis in China. METHODS: This Phase 4 multicenter, open-label, prospective study, conducted from 24 November 2020 to 11 November 2022, evaluated the long-term safety and effectiveness of roxadustat for CKD-anemia in China. Patients aged ≥18 years with CKD-anemia with or without dialysis were included. The initial oral dose was 70-120 mg (weight-based followed by dose adjustment) over 52 weeks. The primary endpoint was safety based on adverse events (AEs). The secondary endpoints were hemoglobin changes from baseline and the proportion of patients who achieved mean hemoglobin ≥100 g/L. Effectiveness evaluable populations 1 (EE1) and EE2 included roxadustat-naïve and previously roxadustat-treated patients, respectively. The safety analysis set (SAF) included all patients who received ≥1 occasion. RESULTS: The EE1, EE2, and SAF populations included 1804, 193, and 2021 patients, respectively. In the SAF, the mean age was 50 ± 14 years, and 1087 patients (53.8%) were male. Mean baseline hemoglobin was 96.9 ± 14.0 g/L in EE1 and 100.3 ± 12.9 g/L in EE2. In EE1, the mean (95% confidence interval) hemoglobin changes from baseline over weeks 24-36 and 36-52 were 14.2 (13.5-14.9) g/L and 14.3 (13.5-15.0) g/L, respectively. Over weeks 24-36 and 36-52, 83.3% and 86.1% of patients in EE1 and 82.7% and 84.7% in EE2 achieved mean hemoglobin ≥100 g/L, respectively. In the SAF, 1643 (81.3%) patients experienced treatment-emergent AEs (TEAEs). Overall, 219 (10.8%) patients experienced drug-related TEAEs. Thirty-eight (1.9%) patients died of TEAEs (unrelated to the study drug). Vascular access thrombosis was uncommon. CONCLUSIONS: Roxadustat (52 weeks) increased hemoglobin and maintained the treatment target in Chinese patients with CKD-anemia with acceptable safety, supporting its use in real-world settings. REGISTRATION Chinese Clinical Trial Registry ( www.chictr.org.cn ) ChiCTR2100046322; CDE ( www.chinadrugtrials.org.cn ) CTR20201568.
Humans ; Male ; Female ; Anemia/etiology* ; Middle Aged ; Renal Insufficiency, Chronic/complications* ; Glycine/adverse effects* ; Isoquinolines/adverse effects* ; Aged ; Prospective Studies ; Adult ; Hemoglobins/metabolism* ; Treatment Outcome ; China ; Registries ; East Asian People

OBJECTIVES: To investigate the ethnic origin of Chuanqing people, one of the largest unidentified ethnic groups in Guizhou, China, and analyze its genetic relationships with surrounding populations. METHODS: Based on a self-developed microhaplotype system, we conducted genotyping and analyzed the genetic distribution of microhaplotype loci and their forensic applicability in Chuanqing population in Guizhou Province. Using the microhaplotype data from different intercontinental populations and previously reported data from Han population living in Guizhou Province, we systematically investigated the genetic background of Chuanqing people through population genetic approaches, including genetic distance estimation, principal component analysis, and phylogenetic tree construction. RESULTS: Among the studied population, the number of haplotype per microhaplotype ranged from 6 to 25. The average expected heterozygosity (He), observed heterozygosity (Ho), power of discrimination (PD), and probability of exclusion (PE) were 0.8291, 0.8301, 0.9387, and 0.6593, respectively. The cumulative power of discrimination (CPD) and cumulative probability of exclusion (CPE) for these 33 loci were 1-2.62×10^-41 and 1-7.64×10^-17, respectively. Population genetic analyses revealed that the Chuanqing population had close genetic relationships with the East Asian populations, especially the local Guizhou Han population, Beijing Han population and the Han populations living in southern China. CONCLUSIONS The 33 microhaplotypes exhibit high levels of genetic diversity in the Guizhou Chuanqing population, highlighting their potentials for both forensic identification and parentage testing. The Han populations might have contributed a significant amount of genetic material to the Chuanqing population during the formation and development of the latter.
Humans ; China/ethnology* ; Ethnicity/genetics* ; Forensic Genetics/methods* ; Genetics, Population ; Genotype ; Haplotypes ; Phylogeny ; East Asian People/genetics*

OBJECTIVE: To explore the effect of Xuebijing injection on inflammation in sepsis by regulating intestinal microbiota and its metabolites. METHODS: A total of 45 male Sprague-Dawley (SD) rats were randomly divided into Sham operation group (Sham group), cecal ligation and perforation (CLP) induced sepsis group (CLP group), and Xuebijing intervention group (XBJ group, 4 mL/kg Xuebijing injection was injected intraperitoneally at 1 hour after CLP), with 15 rats in each group. The survival of rats was observed at 24 hours after operation and sacrificed. Feces were collected for 16S rRNA gene sequencing and liquid chromatography-mass spectrometry (LC-MS) analysis. RESULTS: At 24 hours after operation, all rats in the Sham group survived, the mortality of rats in the XBJ group was lower than that in the CLP group [47% (7/15) vs. 60% (9/15), P > 0.05]. Compared with the Sham group, the diversity of gut microbiota in the CLP group decreased, the dominant flora changed, and the abundance of inflammation-related flora increased. Xuebijing improved the changes in gut microbiota caused by sepsis, and α diversity showed an increasing trend (Ace index: 406.0±22.5 vs. 363.2±38.2, Chao1 index: 409.7±21.8 vs. 362.4±42.5, both P > 0.05). Restrictive constrained principal coordinate analysis (cPCoA) showed a high similarity in gut microbiota among the same group of rats. The CLP group was dominated by Bacteroidetes, while the Sham and XBJ groups were dominated by Firmicutes. In addition, compared with the CLP group, Xuebijing treatment increased the abundance of beneficial bacteria in septic rats, such as Verrucomicrobia, Akkermansia and Lactobacillus. LC-MS and orthogonal partial least squares discriminant analysis (OPLS-DA) showed that there were 12 main differential metabolites among the three groups, and there were certain correlations between these metabolites, which were related to amino acid and lipid metabolism. Correlation analysis showed a significant correlation between changes in metabolites and microbial communities. CONCLUSIONS Xuebijing can improve the survival rate of septic rats, regulate the composition of intestinal flora and related metabolites, which provides a new pathophysiological mechanism for Xuebijing in the treatment of sepsis.
Rats ; Male ; Animals ; Rats, Sprague-Dawley ; Gastrointestinal Microbiome ; RNA, Ribosomal, 16S ; Sepsis/metabolism* ; Inflammation

To analyze the incidence and distribution of oral mucosal diseases in Hunan Province and provide reference for prevention and treatment.
 Methods: The clinical data for all patients, who were treated in Xiangya Hospital of Central South University from April 2013 to March 2017, were collected. After screening, weighing and classifying, sex and age distribution for the disease was analyzed.
 Results: The female with the age between 40 to 49 were in the majority among 21 972 patients. The ratio between men to women was 1:1.05. According to the classification of diseases, the most common diseases were as follows: recurrent aphthous ulcer (27.17%), burning mouth syndrome (15.72%), oral submucous fibrosis (14.75%), oral lichen planus (10.38%), oral leukoplakia (4.21%), traumatic ulceration (4.14%), chronic cheilitis (3.47%), oral fungal infection (3.26%), and atrophic glossitis (2.74%). Recurrent oral ulcer (28.65%), burning mouth syndrome (23.70%) and oral lichen planus (13.31%) were the most common 3 kinds of oral mucosal diseases during females in Hunan. Oral submucous fibrosis was the most common oral mucosal disease among males in Hunan (28.56%).
 Conclusion: Recurrent oral ulcer, burning mouth syndrome and oral lichen planus are very popular in women in Hunan Province, and oral submucous fibrosis is the most common disease in male in this region. It shows a high trend of incidence in the surrounding provinces.
Adult ; Age Distribution ; Burning Mouth Syndrome ; epidemiology ; China ; epidemiology ; Female ; Fibrosis ; Humans ; Incidence ; Leukoplakia, Oral ; epidemiology ; Lichen Planus, Oral ; epidemiology ; Male ; Middle Aged ; Mouth Diseases ; epidemiology ; therapy ; Mouth Mucosa ; pathology ; Oral Submucous Fibrosis ; Oral Ulcer ; epidemiology ; Sex Distribution ; Stomatitis, Aphthous ; epidemiology

This study aimed to investigate the prevalence and molecular characteristics of Listeria monocytogenes in cooked products in Zigong City, China. The overall occurrence of the L. monocytogenes in the ready-to-eat (RTE) shops and mutton restaurants surveyed was 16.2% (141/873). An occurrence of 13.5% was observed in RTE pork, 6.5% in RTE vegetables, and more than 24.0% in either cooked mutton or cooked haggis. Serotype 1/2b (45.4%), 1/2a (33.3%), and 1/2c (14.2%) were the predominant types. By comparing the clonal complexes (CCs) based on multilocus sequence typing (MLST) of the L. monocytogenes from cooked foods in Zigong City and 33 listeriosis cases from different districts of China, CC87, CC9, CC8, and CC3 were showed to be prevalent in cooked products and CC87 and CC3 were the first two frequent types in the 33 clinic-source strains. All CC87 stains harbored the newly reported Listeria pathogenicity island 4 (LIPI-4) gene fragment ptsA, and all CC3 strains possessed the Listeria pathogenicity island 3 (LIPI-3) gene fragment llsX. These may increase the occurrence of the strains belonging to CC87 and CC3 in listeriosis cases in China and also underline the risk of infection owing to the consumption of the cooked products from Zigong. ST619 (serotype 1/2b) harbored both llsX and ptsA, indicating a potential hypervirulent sequence type in Zigong.
China ; epidemiology ; Cooking ; Fast Foods ; microbiology ; Food Contamination ; Food Microbiology ; Humans ; Listeria monocytogenes ; genetics ; pathogenicity ; Listeriosis ; epidemiology ; microbiology ; Meat ; microbiology ; Multilocus Sequence Typing ; Prevalence ; Seasons

Objective To investigate the risk factors of bladder spasm after transurethral resection of the prostate (TURP) and the intervention effect of cluster nursing. Methods From January 2011 to December 2012, the clinical data of 120 cases of TURP patients were analyzed for the risk factors of bladder spasm after TURP. According to the results of the analysis, cluster nursing plan was constructed. The 150 TURP patients from January 2013 to December 2014 were selected as the control group and given routine nursing care. The 150 TURP patients from January 2015 to December 2016 were recruited as the observation group and given cluster nursing. The postoperative bladder spasm, catheter blockage and patients satisfaction were compared between the two groups. Results The results of the multivariate regression analysis indicated that the score of Self-rating Anxiety Scale, air bag water injection, unstable bladder or low compliance bladder, and postoperative constipation were independent factors of bladder spasm after TURP (OR=1.427, 0.092, 13.263, 27.437; P<0.01). After the implementation of cluster nursing, the postoperative bladder spasm rate was 6.0%, and the catheter blockage rate was 5.3%, which were both lower than those of the control group (28.4%,29.3%), and the differences were statistically significant (χ2=25.726, 30.149; P<0.01). The patient postoperative satisfaction of the observation group was (95.21±4.63), which was higher than that of the control group (85.76±4.23), and the difference was statistically significant (t=14.469, P<0.01). Conclusions Cluster nursing can reduce the rate of bladder spasm and catheter blockage after TURP, and increase patients' satisfaction after surgery.

AIM To study the chemical constituents from Phyllodium pulchellum (L.) Desv..METHODS The ethyl acetate and n-butanol fractions of P.pulchellum 95％ ethanol extract were isolated and purified by Sephadex LH-20,silica,ODS and pre-HPLC column,then the structures of isolated compounds were identified by physicochemical properties and spectral data.RESULTS Eleven compounds were isolated and identified as phydroxybenzoic acid (1),protocatechuic acid (2),protocaechuic acid methyl ester (3),protocatechuic acid ethyl ester (4),ethyl gallate (5),p-coumaric acid (6),caffeic acid ester (7),loliolide (8),uridine (9),arbutin (10),daucosterol (11).CONCLUSION Compounds 4-11 are isolated from genus Phyllodium for the first time,compounds 2 and 3 are first obtained from this plant.

Objective:To observe the expression of wnt1 in patients with oral submucous fibrosis(OSF) before and after treatment.Methods:40 patients with OSF were treated with triamcinolone acetonide combined with salvia miltiorrhiza,Before and after 4 weeks treatment,pain score of VAS and mouth opening(MO) were examined.wnt1 protein in saliva and gingival crevicular fluid(GCF) was examined by ELISA,wnt1 mRNA expression in buccal mucosa tissue was examined by real-time fluorescent quantitative PCR.20 healthy subjects were served as the controls.Results:The expression of wnt1 in OSF group[buccal tissue RT-PCR (36.89 ± 10.40) × 10-5,saliva ELISA (61.61 ± 4.45) ng/L,GCF ELISA (56.20 ± 3.65) ng/L] were significantly higher than that of control group [buccal tissue RT-PCR (4.63 ± 1.53) × 10-5,saliva ELISA (40.26 ± 3.00) ng/L,GCF ELISA (53.45 ± 1.74) ng/L)] (P ＜ 0.01).In OSF group,after treatment VAS was decreased(P ＜0.01),MO increased(P ＜0.01)),Buccal mucosa wnt1 mRNA level was positively correlated with wnt1 protein in saliva and GCF,negativity with MO (P ＜ 0.05),saliva wnt1 was positively correlated with VAS and GCF wnt1,negitively with MO(P ＜ 0.05).Conclusion:Wnt1 might take part in the occurrence and development of OSF.The detection of wnt1 in saliva and GCF might be a noninvasive method for the evaluation of OSF treatment.

Objective To investigate the protection and mechanism of procyanidins (PC) against H2O2 induced oxidative damage of human trabecular meshwork cells (HTMC) in order to provide an experimental foundation for glaucoma clinical treatment.Methods HTMC were cultured and then divided randomly into 5 groups.As untreated group:Normal cultured HTMC;Control group:Normal cultured HTMC + H2O2 (500 μmol · L-1 for 1 hour);Treated group:Normal cultured HTMC + H2O2 (500 μmol ·L-1 for 1 hour) + PC (PC fmal concentrations were 0.02 g · L-1,0.05 g · L-1,0.10 g· L-1).Real-time fluorescence quantitative polymerase chain reaction (PCR) was used to investigate the expression of mitochondrial complex Ⅰ mRNA.Results Compared with untreated group (1.000 0 ± 0.000 0),the differences of mitochondrial complexⅠ mRNA expression in 0.02 g · L-1 PC (0.401 3 ±0.010 3),0.05 g · L-1 PC (0.791 5 ± 0.008 5) groups were statistically significant (all P ＜ 0.01),but the 0.10 g ·L-1 PC group (1.043 0 ± 0.062 2) had no significant differences (P ＞ 0.05).The differences between PC treated groups and control group were statistically significant (P ＜0.01),which showed HTMC treated with PC could increase the expression of mitochondrial complex Ⅰ mRNA.The differences in each PC treated groups were statistically significant (P ＜ 0.01),which showed the expression of mitochondrial complex Ⅰ mRNA were increased along with the concentration of PC gradually increased.Conclusion Exogenetic PC can increase the expression of mitochondrial complex Ⅰ mRNA in the oxidative damaged HTMC,and in a certain range of concentration,the protective effects of PC have the positive relationship of dose-effect,which suggest that PC may be a good candidate for further study of the clinical treatment of glaucoma.

Objective To study butylphthalide on acute cerebral infarction with leukoaraiosis patients cognitive function. Methods 80 patients with acute cerebral infarction combined with leukoaraiosis in Yuncheng Central Hospital from June 2014 to June 2015 were selected, all patients had cognitive dysfunction, and randomly divided into study group and control group with 40 cases in each group. The two groups were given conventional treatment of cerebral infarction, the study group was given the butylphthalide soft capsules two tablets, three times once day orally for three months, we used MMSE and MoCA scale to assess the cognitive status of the patients in the two groups at four, eight, and 12 weeks after treatment. The changes of liver function during treatment were analyzed. Results In the treatment, the two groups of patients with MMSE were improved, in four weeks of treatment, the MMSE scores of the study group was higher than the control group, but there was no significant difference between the two groups, eight weeks and 12 weeks, the MMSE scores of the study group was significantly higher than the control group, and the difference between the two groups was statistically significant (P<0.05), the MOCA score of patients in the study group gradually become normal, and significantly higher than the control group, after treatment for four weeks, eight weeks and 12 weeks the difference was statistically significant (P<0.05), the study group patients first had abnormal liver function in the treatment, recovered after stopping the medication. Conclusion Butylphthalide can improve the cognitive function of patients with acute cerebral infarction combined with leukoaraiosis, the increase of transaminase caused by treatment has no significant effect on clinical medication, which is worthy of further popularization and application.