Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384～0.069)and PPS(-0.139,95%CI-0.390～0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.

[Objective]To investigate the prevalence rate of chronic non-communicable diseases(NCDs)and the association with quality of life in middle-aged and elderly patients with HIV/AIDS.[Methods]This cross-sectional study surveyed 432 patients with HIV/AIDS(aged≥45 years)in the Infectious Disease Center in Guangzhou Eighth People's Hospital of Guangzhou Medical University,and 366 participants were included in the analysis after quality control.A questionnaire and the EuroQol 5-Dimensional 3-level version(EQ-5D-3L)were used to investigate NCDs and quality of life and Tobit regression model was used to estimate the association between chronic diseases and quality of life.[Results]Among the 366 participants,29(7.9%)had cardiovascular disease,45(12.3%)had hypertension,122(33.3%)had hyperglycemia,151(41.3%)had hyperlipidemia,7(1.9%)had cancer,17(4.6%)had chronic kidney disease,38(10.4%)had chronic liver disease,21(5.7%)had musculoskeletal disorders,and 253(69.1%)suffered from at least one type of chronic diseases.The median(lower and upper quartiles)of EQ-5D utility index was 1.000(0.964～1.000).Multivariate Tobit regression results of the total population showed that cancer[ba=-0.08,95%CI(-0.15,-0.01),P=0.036],chronic kidney disease[ba=-0.07,95%CI(-0.12,-0.02),P=0.006],musculoskeletal disease[ba=-0.09,95%CI(-0.13,-0.05),P<0.001],and≥3 types of chronic diseases[ba=-0.05,95%CI(-0.08,-0.01),P=0.013]were negatively correlated with EQ-5D utility index.The stratified analysis results of different CD4+T cell levels showed that hypertension[ba=-0.07,95%CI(-0.12,-0.02),P=0.007],chronic kidney disease[ba=-0.10,95%CI(-0.18,-0.03),P=0.006],musculoskeletal disease[ba=-0.15,95%CI(-0.22,-0.07),P<0.001]and≥3 types of chronic diseases[ba=-0.09,95%CI(-0.09,-0.01),P<0.001]were negatively correlated with EQ-5D utility index in the group with CD4≤500(cells/μL),whereas cancer[ba=-0.11,95%CI(-0.20,-0.01),P=0.031]was negatively correlated with EQ-5D utility index in the group with CD4＞500(cells/μL).[Conclusions]The prevalence rate of chronic non-communicable diseases in middle-aged and elderly patients with HIV/AIDS is relatively high.The classification of NCDs such as cancer or chronic kidney disease or other chronic diseases and the numbers of NCDs categories are negatively correlated with quality of life.However,this association varies among patients with HIV/AIDS of different CD4+T cell levels.It is suggested that we should try to prevent and identify NCDs at an early stage,strengthen linkages and integration of health services for AIDS and chronic NCDs,and jointly manage and control AIDS with chronic diseases to improve the quality of life among people living with HIV/AIDS.

Objective:To investigate the efficacy of low-methoxyl pectin (LMP) combined with early enteral nutrition (EEN) in patients with severe acute pancreatitis (SAP) complicated by acute kidney injury (AKI).Methods:A prospective study was conducted, enrolling 85 patients with SAP complicated by AKI admitted to the First Hospital of Qinhuangdao from January 2022 to December 2023. These patients were randomized into an LMP group ( n=42) and a control group ( n=43) using a random number table. The control group received traditional EEN, while the LMP group received traditional EEN combined with LMP. Nutritional indicators [total protein (TP), albumin (Alb), and prealbumin (PA)], inflammatory markers [C-reactive protein (CRP), interleukin (IL)-1, IL-6, IL-8, and tumor necrosis factor-α (TNF-α)], renal function indicators [creatinine (Cr), estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), uric acid (UA)], AKI stage, and fecal intestinal flora were compared between these two groups before and 7 days after intervention. Results:After 7 days of intervention, the TP, Alb, and PA levels significantly increased in both groups (all P<0.05); the increases in TP and PA were more significant in the LMP group (both P<0.05), whereas the increase in Alb did not differ significantly between groups ( P>0.05). The levels of CRP, IL-1, IL-6, IL-8, and TNF-α decreased significantly in both groups (all P<0.05),with more significant reductions in the LMP group (all P<0.001). The levels of Cr, eGFR, BUN, and UA improved significantly in both groups (all P<0.05),with more significant improvements in the LMP group (all P<0.05). The incidence of a higher AKI stage in the LMP group was significantly lower than that in the control group( P<0.05), and the incidence of a lower AKI stage was significantly higher than that in the control group ( P<0.001). The fecal counts of Bifidobacterium and Lactobacillus increased significantly while the fecal counts of Enterococcus and Enterobacter decreased significantly in both group (all P<0.001); notably, these changes in bacterial counts were significantly more pronounced in the LMP group ( P<0.001). Conclusions:EEN combined with LMP can significantly enhance nutritional status, reduce inflammatory response, and improve renal function in patients with SAP complicated by AKI.

Objective::This study aimed to investigate the feasibility, efficacy, and safety of using a miniature mobile integrated cabin-theatre equipped with angiography and surgical operating room capabilities, and to explore its therapeutic scope, effectiveness, and operational mode.Methods::A miniature mobile integrated operating cabin-theatre was deployed across 15 hospitals in 15 cities or counties in China from April 2012 to November 2024. The interventions and outcomes of interventional and minimally invasive surgical procedures were prospectively observed and evaluated; perioperative complications were documented, and the stability, adaptability, and mobility of the integrated system were assessed.Results::A total of 133 procedures were successfully performed, 130 of which were interventional and 3 minimally invasive. The angiography machine showed good imaging performance without any equipment failures, loosening, or damage, with normal chamber unfolding. One patient experienced a fever the day after laparoscopy, while none of the other patients exhibited perioperative complications such as infection, surgical site bleeding/hematoma, or reperfusion arrhythmia. The instrument was easily manipulated, aligning with the needs of clinical intervention and surgery, and was perceived by patients as being a comfortable environment, with no psychological or other obvious discomfort.Conclusions::The miniature mobile integrated cabin-theatre, comprising an angiography machine and an operating room, allows interventional or minimally invasive surgical procedures to be performed smoothly and safely. It can also provide rapid and efficient on-site treatment of acute and critical illnesses across multiple body systems, including the cardiovascular, cerebrovascular, and gastrointestinal systems.

Objective:To investigate the efficacy of low-methoxyl pectin (LMP) combined with early enteral nutrition (EEN) in patients with severe acute pancreatitis (SAP) complicated by acute kidney injury (AKI).Methods:A prospective study was conducted, enrolling 85 patients with SAP complicated by AKI admitted to the First Hospital of Qinhuangdao from January 2022 to December 2023. These patients were randomized into an LMP group ( n=42) and a control group ( n=43) using a random number table. The control group received traditional EEN, while the LMP group received traditional EEN combined with LMP. Nutritional indicators [total protein (TP), albumin (Alb), and prealbumin (PA)], inflammatory markers [C-reactive protein (CRP), interleukin (IL)-1, IL-6, IL-8, and tumor necrosis factor-α (TNF-α)], renal function indicators [creatinine (Cr), estimated glomerular filtration rate (eGFR), blood urea nitrogen (BUN), uric acid (UA)], AKI stage, and fecal intestinal flora were compared between these two groups before and 7 days after intervention. Results:After 7 days of intervention, the TP, Alb, and PA levels significantly increased in both groups (all P<0.05); the increases in TP and PA were more significant in the LMP group (both P<0.05), whereas the increase in Alb did not differ significantly between groups ( P>0.05). The levels of CRP, IL-1, IL-6, IL-8, and TNF-α decreased significantly in both groups (all P<0.05),with more significant reductions in the LMP group (all P<0.001). The levels of Cr, eGFR, BUN, and UA improved significantly in both groups (all P<0.05),with more significant improvements in the LMP group (all P<0.05). The incidence of a higher AKI stage in the LMP group was significantly lower than that in the control group( P<0.05), and the incidence of a lower AKI stage was significantly higher than that in the control group ( P<0.001). The fecal counts of Bifidobacterium and Lactobacillus increased significantly while the fecal counts of Enterococcus and Enterobacter decreased significantly in both group (all P<0.001); notably, these changes in bacterial counts were significantly more pronounced in the LMP group ( P<0.001). Conclusions:EEN combined with LMP can significantly enhance nutritional status, reduce inflammatory response, and improve renal function in patients with SAP complicated by AKI.

Objective::This study aimed to investigate the feasibility, efficacy, and safety of using a miniature mobile integrated cabin-theatre equipped with angiography and surgical operating room capabilities, and to explore its therapeutic scope, effectiveness, and operational mode.Methods::A miniature mobile integrated operating cabin-theatre was deployed across 15 hospitals in 15 cities or counties in China from April 2012 to November 2024. The interventions and outcomes of interventional and minimally invasive surgical procedures were prospectively observed and evaluated; perioperative complications were documented, and the stability, adaptability, and mobility of the integrated system were assessed.Results::A total of 133 procedures were successfully performed, 130 of which were interventional and 3 minimally invasive. The angiography machine showed good imaging performance without any equipment failures, loosening, or damage, with normal chamber unfolding. One patient experienced a fever the day after laparoscopy, while none of the other patients exhibited perioperative complications such as infection, surgical site bleeding/hematoma, or reperfusion arrhythmia. The instrument was easily manipulated, aligning with the needs of clinical intervention and surgery, and was perceived by patients as being a comfortable environment, with no psychological or other obvious discomfort.Conclusions::The miniature mobile integrated cabin-theatre, comprising an angiography machine and an operating room, allows interventional or minimally invasive surgical procedures to be performed smoothly and safely. It can also provide rapid and efficient on-site treatment of acute and critical illnesses across multiple body systems, including the cardiovascular, cerebrovascular, and gastrointestinal systems.

Objective To evaluate the efficacy and safety of enteric-coated metformin hydrochloride capsules(Junlida?)in patients with T2DM and poor glycemic control under lifestyle interventions.Methods In this study,419 patients with T2DM were recruited from 15 research centers from July 2020 to March 2022,and randomly divided into observation(Obs)group(n=209)and control group(Con,n=210)using a multicenter,randomized,double-blind,non-inferiority trial design.Patients in the Obs group were treated with enteric-coated Metformin hydrochloride capsules(Junlida?),and patients in the Con group were treated with Metformin hydrochloride tablets(Glucophage?).The optimal effective dose of 2 g/d was achieved within 4 weeks,and the reasonable dose was maintained until the end of treatment.The treatment period was 24 weeks.HbA1c and its compliance rate,FPG,and body weight were compared between the two groups in full analysis set(FAS)and protocol set(PPS).Safety and adverse events(AE)were evaluated in safety set(SS).Results A total of 414 participants were randomized(207 cases in Obs group and 207 cases in Con group).414 cases in FAS population(207 cases in Obs group and 207 cases in Con group),and 328 cases in PPS population(164 cases in Obs group and 164 cases in Con group),and 414 cases in SS population(207 cases in Obs group and 207 cases in Con group).After treatment,HbA1c,FPG and body weight were lower in both groups(P<0.05)in FAS and PPS.HbA1c compliance rate was not significantly different between the two groups in FAS and PPS(P>0.05).The results of non-inferiority test showed that the lower limit was>-0.4%in both FAS(-0.154,95%CI-0.384～0.069)and PPS(-0.139,95%CI-0.390～0.112),and the Obs group reached non-inferiority end point.The achievement rate,compliance rate,safety index and incidence of AE were not significantly different between the two groups(P>0.05).Conclusions Junlida? demonstrated non-inferiority to Glucophage? in glycemic control and can be safely and effectively used in patients with diabetes.

Objective To evaluate the stability,safety and immune enhancement and anti-tumor effects of Wilms'tumor gene 1(WT1)peptide combined with AddaVaxTM emulsion vaccine for acute myeloid leukemia.Methods The stability of WT1 peptide in the adjuvant vaccine was evaluated using MALDI-TOF-MS time-of-flight mass spectrometry.Female C57BL/6 mice were randomly divided into PBS group,WT1 peptide group,and WT1 peptide+AddaVaxTMemulsion adjuvant vaccine group.The immunization was performed at a dose of 50 μg/mouse for antigen and 50 μg/mouse for adjuvant,with intramuscular injection on days 0,14,and 28.HE staining was used to assess the toxicity of intramuscular vaccination on mouse organ tissues.Cytokine levels were detected by ELISA,and the number of IFN-γ-secreting splenocytes was measured by ELISpot.Flow cytometry was employed to detect the maturation of bone marrow-derived dendritic cells(BMDCs)promoted by the vaccine in vitro and the promotion for lymphocyte activation,and H-2Db WT1 tetramer was utilized to detect the proportion of specific CD8+T cells.After establishing a mouse leukemia tumor model using the C1498-mWT1 stable cell line,the anti-tumor effects of the vaccine for prevention and treatment were evaluated.Results The WT1 peptide stably existed in the vaccine without causing significant organ tissue changes in mice after intramuscular injection.Compared to the mice immunized with WT1 aqueous solution,the mice after intramuscular injection of the WT1 peptide emulsion adjuvant vaccine showed stronger immune responses of Th1 cells,including IFN-γ and TNF-α,as well as Th17 cells of IL-17A(P＜0.05),and the mice had not only promoted number of IFN-γ secreting splenocytes(P＜0.01)but also enhanced maturation of BMDCs,as indicated by an increase in the proportions of CD40+/CD11c+and CD86+CD80+/CD11c+ cells(P＜0.05).Additionally,there were increases in both the proportion of CD4+/CD3+T and CD69+/CD8+T cells(P＜0.05)and the proportion of specific CD8+T cells(P＜0.05).In the anti-tumor effect study using the C1498-mWT1 mouse model,the median survival time of the WT1+AddaVaxTM group was extended by 6 d compared to the WT1 aqueous solution group.At day 50,the survival rate of mice in the WT1+AddaVaxTM group was still 28.5％,while all mice in the other groups had died(P＜0.05).Conclusion The vaccine with the WT1 peptide and AddaVaxTM emulsion adjuvant exhibits good immunological and anti-tumor effects.

Objective:To investigate the risk factors of low-level viremia (LLV) among human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS) patients after combined anti-retroviral therapy (ART), and to provide evidence for reducing the risk of LLV.Methods:It was a cross-sectional observation study that enrolled HIV/AIDS patients with LLV (plasma HIV-1 RNA was 50 to 1 000 copies/mL) receiving ART over one year (LLV group) from January 2019 to December 2020 in Guangzhou Eighth People′s Hospital, Guangzhou Medical University. Contemporaneous patients with ART over one year and successful viral suppression (plasma HIV-1 RNA<50 copies/mL) were randomly selected as the control group (suppression group) with a ratio of 1∶2.5, and the risk factors for LLV were analyzed by unconditional logistic regression.Results:A total of 128 and 297 patients were enrolled in LLV group and the suppression group, respectively.ART durations were 3.62(1.83, 4.89) years and 4.91(2.90, 5.88) years, respectively. Multivariate logistic regression analysis showed that the risk factors associated with LLV included the age of initial ART treatment above 50 years old (odds ratio ( OR)=1.82, 95% confidence interval ( CI) 1.01 to 3.26, P=0.046), the baseline HIV-1 RNA over 1×10 5 copies/mL ( OR=2.18, 95% CI 1.30 to 3.68, P=0.003), using the simplified initial ART regimen ( OR=1.82, 95% CI 1.02 to 3.26, P=0.044), missing medication more than three times per year ( OR=2.49, 95% CI 1.55 to 4.01, P<0.001) and changing regimen during ART ( OR=1.90, 95% CI 1.14 to 3.14, P=0.013), while the duration of ART longer than five years could reduce the risk of LLV ( OR=0.37, 95% CI 0.22 to 0.64, P<0.001). In patients with simplified initial ART regimen, the baseline CD4 + T lymphocyte count of whom with LLV was lower than that of whom with viral suppression, and the difference was statistically significant (94.00 (24.00, 281.00)/μL vs 375.00 (310.00, 435.00)/μL, Z=-2.60, P<0.001). Conclusions:The occurrence of LLV is related to the age of initial ART treatment, the baseline HIV-1 RNA, the initial ART regimen, the medication adherence and the change of ART regimen during ART. Strategies may be beneficial to reducing the risk of LLV for HIV/AIDS patients, such as initiating ART as soon as possible, using simplified regimen as initial regimen with caution in patients with low baseline CD4 + T lymphocyte counts, strengthening compliance education, avoiding unnecessary ART regimen changes.

Objective:To observe the differences in biochemical indexes and AIDS-related complications at baseline in HIV-infected patients with different levels of immune reconstitution to antiretroviral therapy (ART).Methods:The subjects were treat-na?ve adult HIV-infected patients who were followed up for more than 24 months in the Guangzhou Eighth People's Hospital affiliated infection clinic at Guangzhou Medical University from January 2010 to December 2017. CD4 + T lymphocyte count at baseline at <200, 200-350, and >350 cells/μl levels were divided into poor, partial, and good immune reconstitution groups. The Kruskal-Wallis H and chi-square tests were used to analyze the differences in baseline sociodemographic characteristics, biochemical indexes, and AIDS-related complications among different groups. The SPSS 20.0 software was used for statistical analysis. Results:Among the 3 900 HIV-infected individuals, 385 cases (9.9%), 1 206 cases (30.9%), and 2 309 cases (59.2%) were grouped into poor, partial and good immune reconstitution groups, respectively. The baseline biochemical indexes of leukocyte, platelet, hemoglobin, TG, TC, FPG, AST, ALT and total bilirubin in the poor immune reconstitution group were significantly different from those in the good immune reconstitution group (all P<0.05). The proportion of AIDS-related complications at baseline in the poor immune reconstitution group, such as tuberculosis, pneumocystis yeli pneumonia, disseminated mycosis, esophageal candidiasis, extrapulmonary tuberculosis, dermatitis, oral candidiasis, oral mucous leukoplakia, continuous diarrhea for more than 1 month and continuous or intermittent fever for more than 1 month, was significantly higher than that in the good immune reconstitution group (all P<0.05). Conclusions:The biochemical indexes and AIDS-related complications in HIV-infected patients with different levels of immune reconstitution were significantly different at baseline. Attention should be paid to monitoring abnormal biomedical indicators and AIDS-related complications at baseline.