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Effectiveness and safety of Moluodan in the treatment of precancerous lesions of gastric cancer: A randomized clinical trial.
Zou, TH, Gao, QY, Liu, S, Li, YQ, Meng, XJ, Zhang, GX, Tian, ZB, Zou, XP, He, S, Hou, XH, et al
Journal of digestive diseases. 2024;(1):27-35
Abstract
OBJECTIVE To investigate the clinical potential and safety of Moluodan to reverse gastric precancerous lesions. METHODS Patients aged 18-70 years diagnosed with moderate-to-severe atrophy and/or moderate-to-severe intestinal metaplasia, with or without low-grade dysplasia, and negative for Helicobacter pylori were recruited in this randomized, double-blind, parallel-controlled trial. The primary outcome was the improvement of global histological diagnosis at 1-year follow-up endoscopy using the operative link for gastritis assessment, the operative link for gastric intestinal metaplasia assessment, and the disappearance rate of dysplasia. RESULTS Between November 3, 2017 and January 27, 2021, 166 subjects were randomly assigned to the Moluodan group, 168 to the folic acid group, 84 to the combination group, and 84 to the high-dose Moluodan group. The improvement in global histological diagnosis was achieved in 60 (39.5%) subjects receiving Moluodan, 59 (37.8%) receiving folic acid, 26 (32.1%) receiving the combined drugs, and 36 (47.4%) receiving high-dose Moluodan. Moluodan was non-inferior to folic acid (95% confidence interval: -9.2 to 12.5; P = 0.02). High-dose Moluodan had a trend for better protective efficacy, though there was no statistical significance. The disappearance rate of dysplasia was 82.8% in the Moluodan group, which was superior to folic acid (53.9%; P = 0.006). No drug-related serious adverse events were observed. CONCLUSIONS One pack of Moluodan three times daily for 1 year was safe and effective in reversing gastric precancerous lesions, especially dysplasia. Doubling its dose showed a better efficacy trend.
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Development and Evaluation of a Nomogram for Predicting the Outcome of Immune Reconstitution Among HIV/AIDS Patients Receiving Antiretroviral Therapy in China.
Wang, Y, Liu, S, Zhang, W, Zheng, L, Li, E, Zhu, M, Yan, D, Shi, J, Bao, J, Yu, J
Advanced biology. 2024;(2):e2300378
Abstract
This study aims to develop and evaluate a model to predict the immune reconstitution among HIV/AIDS patients after antiretroviral therapy (ART). A total of 502 HIV/AIDS patients are randomized to the training cohort and evaluation cohort. Least absolute shrinkage and selection operator (LASSO) regression and multivariate logistic regression analysis are performed to identify the indicators and establish the nomogram for predicting the immune reconstitution. Decision curve analysis (DCA) and clinical impact curve (CIC) are used to evaluate the clinical effectiveness of the nomogram. Predictive factors included white blood cells (WBC), baseline CD4+ T-cell counts (baseline CD4), ratio of effector regulatory T cells to resting regulatory T cells (eTreg/rTreg) and low-density lipoprotein cholesterol (LDL-C) and are incorporated into the nomogram. The area under the curve (AUC) is 0.812 (95% CI, 0.767∼0.851) and 0.794 (95%CI, 0.719∼0.857) in the training cohort and evaluation cohort, respectively. The calibration curve shows a high consistency between the predicted and actual observations. Moreover, DCA and CIC indicate that the nomogram has a superior net benefit in predicting poor immune reconstitution. A simple-to-use nomogram containing four routinely collected variables is developed and internally evaluated and can be used to predict the poor immune reconstitution in HIV/AIDS patients after ART.
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The efficacy and safety of fexuprazan in treating erosive esophagitis: a phase III, randomized, double-blind, multicenter study.
Zhuang, Q, Liao, A, He, Q, Liu, C, Zheng, C, Li, X, Liu, Y, Wang, B, Liu, S, Zhang, Y, et al
Journal of gastroenterology and hepatology. 2024;(4):658-666
Abstract
BACKGROUND AND AIM Fexuprazan is a novel potassium-competitive acid blocker (P-CAB). This study aimed to explore the noninferior efficacy and safety of fexuprazan to esomeprazole in treating erosive esophagitis (EE). METHODS This was a phase III, randomized, double-blind multicenter study. Patients with endoscopically confirmed EE were randomized to receive fexuprazan 40 mg or esomeprazole 40 mg once a daily for 4-8 weeks. The healing rates of EE, symptom response, GERD-health-related quality life (GERD-HRQL), and treatment-emergent adverse events (TEAEs) were compared between fexuprazan group and esomeprazole group. RESULTS A total of 332 subjects were included in full analysis set (FAS) and 311 in per-protocol set (PPS). The healing rates of fexuprazan and esomeprazole groups at 8 weeks were 88.5% (146/165) and 89.0% (145/163), respectively, in FAS and 97.3% (145/149) and 97.9% (143/146), respectively, in PPS. Noninferiority of fexuprazan compared with esomeprazole according to EE healing rates at 8 weeks was demonstrated in both FAS and PPS analysis. No significant difference was found between groups in EE healing rates at 4 weeks, symptom responses, and changes of GERD-HRQL. The incidence of drug-related AEs was 19.4% (32/165) in fexuprazan arm and 19.6% (32/163) in esomeprazole arm. CONCLUSION This study demonstrated noninferior efficacy of fexuprazan to esomeprazole in treating EE. The incidence of TEAEs was similar between fexuprazan and esomeprazole. Trial registration number NCT05813561.
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A model for predicting postoperative persistent acute kidney injury (AKI) in AKI after cardiac surgery patients with normal baseline renal function.
Chen, Y, Mo, Z, Chu, H, Hu, P, Fan, W, Wu, Y, Song, L, Zhang, L, Li, Z, Liu, S, et al
Clinical cardiology. 2024;(1):e24168
Abstract
BACKGROUND Persistent acute kidney injury (AKI) after cardiac surgery is not uncommon and linked to poor outcomes. HYPOTHESIS The purpose was to develop a model for predicting postoperative persistent AKI in patients with normal baseline renal function who experienced AKI after cardiac surgery. METHODS Data from 5368 patients with normal renal function at baseline who experienced AKI after cardiopulmonary bypass cardiac surgery in our hospital were retrospectively evaluated. Among them, 3768 patients were randomly assigned to develop the model, while the remaining patients were used to validate the model. The new model was developed using logistic regression with variables selected using least absolute shrinkage and selection operator regression. RESULTS The incidence of persistent AKI was 50.6% in the development group. Nine variables were selected for the model, including age, hypertension, diabetes, coronary heart disease, cardiopulmonary bypass time, AKI stage at initial diagnosis after cardiac surgery, postoperative serum magnesium level of <0.8 mmol/L, postoperative duration of mechanical ventilation, and postoperative intra-aortic balloon pump use. The model's performance was good in the validation group. The area under the receiver operating characteristic curve was 0.761 (95% confidence interval: 0.737-0.784). Observations and predictions from the model agreed well in the calibration plot. The model was also clinically useful based on decision curve analysis. CONCLUSIONS It is feasible by using the model to identify persistent AKI after cardiac surgery in patients with normal baseline renal function who experienced postoperative AKI, which may aid in patient stratification and individualized precision treatment strategy.
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Effects of Time-Restricted Eating on Nonalcoholic Fatty Liver Disease: The TREATY-FLD Randomized Clinical Trial.
Wei, X, Lin, B, Huang, Y, Yang, S, Huang, C, Shi, L, Liu, D, Zhang, P, Lin, J, Xu, B, et al
JAMA network open. 2023;(3):e233513
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Abstract
IMPORTANCE The efficacy and safety of time-restricted eating (TRE) on nonalcoholic fatty liver disease (NAFLD) remain uncertain. OBJECTIVE To compare the effects of TRE vs daily calorie restriction (DCR) on intrahepatic triglyceride (IHTG) content and metabolic risk factors among patients with obesity and NAFLD. DESIGN, SETTING, AND PARTICIPANTS This 12-month randomized clinical trial including participants with obesity and NAFLD was conducted at the Nanfang Hospital in Guangzhou, China, between April 9, 2019, and August 28, 2021. INTERVENTIONS Participants with obesity and NAFLD were randomly assigned to TRE (eating only between 8:00 am and 4:00 pm) or DCR (habitual meal timing). All participants were instructed to maintain a diet of 1500 to 1800 kcal/d for men and 1200 to 1500 kcal/d for women for 12 months. MAIN OUTCOMES AND MEASURES The primary outcome was change in IHTG content measured by magnetic resonance imaging; secondary outcomes were changes in body weight, waist circumference, body fat, and metabolic risk factors. Intention-to-treat analysis was used. RESULTS A total of 88 eligible patients with obesity and NAFLD (mean [SD] age, 32.0 [9.5] years; 49 men [56%]; and mean [SD] body mass index, 32.2 [3.3]) were randomly assigned to the TRE (n = 45) or DCR (n = 43) group. The IHTG content was reduced by 8.3% (95% CI, -10.0% to -6.6%) in the TRE group and 8.1% (95% CI, -9.8% to -6.4%) in the DCR group at the 6-month assessment. The IHTG content was reduced by 6.9% (95% CI, -8.8% to -5.1%) in the TRE group and 7.9% (95% CI, -9.7% to -6.2%) in the DCR group at the 12-month assessment. Changes in IHTG content were comparable between the 2 groups at 6 months (percentage point difference: -0.2; 95% CI, -2.7 to 2.2; P = .86) and 12 months (percentage point difference: 1.0; 95% CI, -1.6 to 3.5; P = .45). In addition, liver stiffness, body weight, and metabolic risk factors were significantly and comparably reduced in both groups. CONCLUSIONS AND RELEVANCE Among adults with obesity and NAFLD, TRE did not produce additional benefits for reducing IHTG content, body fat, and metabolic risk factors compared with DCR. These findings support the importance of caloric intake restriction when adhering to a regimen of TRE for the management of NAFLD. TRIAL REGISTRATION ClinicalTrials.gov Identifiers: NCT03786523 and NCT04988230.
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Effect of Laser Panretinal Photocoagulation Combined with Lucentis on Long-Term Visual Acuity of Patients with Retinal Arterial Macroaneurysm.
Liu, S, Wang, Y
Alternative therapies in health and medicine. 2023;(8):412-417
Abstract
OBJECTIVE To analyze the efficacy of laser panretinal photocoagulation in combination with Lucentis treatment on patients with retinal arterial macroaneurysm and investigate more effective novel therapy options to treat retinal arterial macroaneurysm. METHOD This study was conducted in the Pediatric department of Chongqing Aier Hospital between October 2016 and October 2020, and a total of 62 inpatients were enrolled for the study. Patients were randomly organized into two groups, an 'observation group' with patients receiving combinational treatment of laser panretinal photocoagulation and Lucentis, and a 'control group' with patients treated by only laser panretinal photocoagulation, were allotted. Though a comparative statistical analysis, the clinical outcomes and adverse effects on both groups, including their best corrected visual acuity, central macular thickness, intraocular pressure, and required number of laser treatments before and after treatments, were investigated. Also prognosis associated factors for patient's visual function, were analyzed. RESULTS The clinical efficacy of the combinational treatment of laser panretinal photocoagulation and Lucentis was better than single laser panretinal photocoagulation treatment, accompanied by decreased incidence of adverse reactions (P < .05). For a combinational treatment, the observation group showed improved best corrected visual acuity and reduced central macular thickness and intraocular pressure, including fewer laser treatments (P < .05). Also, a better prognostic quality of life score; (measured as physical function, mental state, visual function, and social activity ability of patients), was observed for a combinational treatment than that of laser panretinal photocoagulation treatment (P < .05). CONCLUSION Laser panretinal photocoagulation combined with lucentis can deliver with reduced incidence of adverse effects compared to laser panretinal photocoagulation treatment and hence can more effectively contribute to retinal rehabilitation of patients with retinal arterial macroaneurysm.
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Effect of increased gonadotropin dosing on maternal and neonatal outcomes in predicted poor responders undergoing IVF: follow-up of a randomized trial.
Liu, X, Wang, D, Wen, W, Wang, T, Tian, L, Li, N, Sun, T, Wang, T, Zhou, H, Qu, P, et al
European journal of obstetrics, gynecology, and reproductive biology. 2023;:123-129
Abstract
OBJECTIVE To evaluate, in women scheduled for IVF with predicted poor ovarian response, the effect of increased dosing of gonadotropin on maternal and neonatal outcomes compared with standard dosing. STUDY DESIGN We performed a follow-up study of an open-labelled randomized controlled trial comparing increased (225 or 300 IU/d) versus standard (150 IU/d) dose gonadotrophins on cumulative live birth rates. We randomized 661 women with a predicted poor ovarian response (based on their antral follicle count) scheduled for their first IVF/ICSI cycle. Here, we report on maternal and neonatal outcomes between increased and standard dosing groups. RESULTS There was a trend of increased risk of gestational diabetes mellitus in the increased gonadotrophin dose group compared with the standard group in both cumulative live birth pregnancies (14.8% vs. 7.8%, relative risk (RR) 1.90, 95% confidence interval (CI) 0.96-3.74, P = 0.06) and live birth pregnancies in the first transfer (15.2% vs. 7.7%, RR 1.98, 95 %CI 0.93-4.19, P = 0.08), without reaching statistical significance. The occurrence of gestational diabetes mellitus was significantly higher in the increased gonadotrophin dose group (24/149, 16.1% vs. 8/128, 6.3%; risk ratio (RR) 2.58, 95 %CI 1.19 to 5.54, P = 0.02) in singleton pregnancies. In women with first embryo transfer cycle, maternal hypothyroidism occurred also more frequent in the increased gonadotrophin dose group than the standard group (16.0% vs. 6.8%, RR 2.34, 95 %CI:1.07-5.11, P = 0.03). CONCLUSIONS In women with predicted poor ovarian response, increased dosing of gonadotropin may result in an increased risk of gestational diabetes mellitus and maternal hypothyroidism.
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Icosapent ethyl therapy for very high triglyceride levels: a 12-week, multi-center, placebo-controlled, randomized, double-blinded, phase III clinical trial in China.
Wang, Z, Zhang, X, Qu, Y, Zhang, S, Chen, Y, Chen, X, Qi, X, Liu, P, Liu, S, Jiang, S, et al
Lipids in health and disease. 2023;(1):71
Abstract
OBJECTIVES Eicosapentaenoic acid in its ethyl ester form is the single active component of icosapent ethyl (IPE). This study was a phase III, multi-center trial assessing the safety and efficiency of IPE for treating very high triglyceride (TG) in a Chinese cohort. METHODS Patients having TG levels (5.6-22.6 mmol/L) were enrolled and randomly assigned to receive a treatment of oral intake of 4 g or 2 g/day of IPE, or placebo. Before and after 12 weeks of treatment, TG levels were assessed and the median was calculated to determine the change between the baseline and week 12. In addition to examining TG levels, the impact of such treatments on other lipid changes was also investigated. The official Drug Clinical Trial Information Management Platform has registered this study (CTR20170362). RESULTS Random assignments were performed on 373 patients (mean age 48.9 years; 75.1% male). IPE (4 g/day) lowered TG levels by an average of 28.4% from baseline and by an average of 19.9% after correction for placebo (95% CI: 29.8%-10.0%, P < 0.001). In addition, plasma concentration of non-high-density lipoprotein cholesterol (non-HDL-C), very low-density lipoprotein (VLDL) cholesterol, and VLDL-TG remarkedly reduced after IPE (4 g/day) treatment by a median of 14.6%, 27.9%, and 25.2%, respectively compared with participants in placebo group. Compared to the placebo, neither 4 nor 2 g of IPE daily elevated LDL-C levels with statistical significance. IPE was well tolerated by all the treatment groups. CONCLUSIONS IPE at 4 g/day dramatically lowered other atherogenic lipids without a noticeable increase in LDL-C, thereby decreasing TG levels in an exceptionally high-TG Chinese population.
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Associations between life-course household wealth mobility and adolescent physical growth, cognitive development and emotional and behavioral problems: A birth cohort in rural western China.
Tian, J, Zhu, Y, Liu, S, Wang, L, Qi, Q, Deng, Q, Andegiorgish, AK, Elhoumed, M, Cheng, Y, Shen, C, et al
Frontiers in public health. 2023;:1061251
Abstract
BACKGROUND Parental household wealth has been shown to be associated with offspring health conditions, while inconsistent associations were reported among generally healthy population especially in low- and middle- income countries (LMICs). Whether the household wealth upward mobility in LMICs would confer benefits to child health remains unknown. METHODS We conducted a prospective birth cohort of children born to mothers who participated in a randomized trial of antenatal micronutrient supplementation in rural western China. Household wealth were repeatedly assessed at pregnancy, mid-childhood and early adolescence using principal component analysis for household assets and dwelling characteristics. We used conditional gains and group-based trajectory modeling to assess the quantitative changes between two single-time points and relative mobility of household wealth over life-course, respectively. We performed generalized linear regressions to examine the associations of household wealth mobility indicators with adolescent height- (HAZ) and body mass index-for-age and sex z score (BAZ), scores of full-scale intelligent quotient (FSIQ) and emotional and behavioral problems. RESULTS A total of 1,188 adolescents were followed, among them 59.9% were male with a mean (SD) age of 11.7 (0.9) years old. Per SD conditional increase of household wealth z score from pregnancy to mid-childhood was associated with 0.11 (95% CI 0.04, 0.17) SD higher HAZ and 1.41 (95% CI 0.68, 2.13) points higher FSIQ at early adolescence. Adolescents from the household wealth Upward trajectory had a 0.25 (95% CI 0.03, 0.47) SD higher HAZ and 4.98 (95% CI 2.59, 7.38) points higher FSIQ than those in the Consistently low subgroup. CONCLUSION Household wealth upward mobility particularly during early life has benefits on adolescent HAZ and cognitive development, which argues for government policies to implement social welfare programs to mitigate or reduce the consequences of early-life deprivations. Given the importance of household wealth in child health, it is recommended that socioeconomic circumstances should be routinely documented in the healthcare record in LMICs.
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Conditioning therapy with N-acetyl-L-cysteine, decitabine and modified BUCY regimen for myeloid malignancies patients prior to allogeneic hematopoietic stem cell transplantation.
Tang, Y, Zhang, Z, Liu, S, Yao, Y, Pan, T, Qi, J, Kang, H, Liu, Y, Cai, C, Zhou, M, et al
American journal of hematology. 2023;(6):881-889
Abstract
Conditioning therapy is an essential procedure prior to hematopoietic stem cell transplant (HSCT), imposing a great impact on the outcomes of recipients. We performed a prospective randomized controlled trial to assess the outcome of HSCT recipients with myeloid malignancies after receiving the conditioning therapy consisting of modified BUCY (mBUCY), N-acetyl-L-cysteine (NAC), and decitabine. Enrolled patients were randomly allocated to either Arm A (decitabine, day -12 to -10; NAC, day -9 to +30; mBUCY, day -9 to -2), or Arm B (mBUCY regimen followed by stem cells infusion). Seventy-six patients in Arm A and 78 patients in Arm B were finally evaluated. The results showed platelet recovery accelerate in Arm A, with more patients achieving a platelet count of ≥50 × 109 /L than Arm B at day +30 and +60 (p = .004 and .043, respectively). The cumulative incidence of relapse is 11.8% (95% CI 0.06-0.22) in Arm A, and 24.4% (95% CI 0.16-0.35) in Arm B (p = .048). The estimated 3-year overall survival rate was 86.4% (±4.4%) and 79.9% (±4.7%) in 2 arms, respectively (p = .155). EFS at 3 years was 79.2% (±4.9%) in Arm A and 60.0% (±5.9%) in Arm B (p = .007). Intracellular reactive oxygen species (ROS) level was found to be reversely correlated with platelet recovery, and fewer patients in Arm A displayed excessive ROS within hematopoietic progenitor cells compared to Arm B. In conclusion, the addition of decitabine and NAC to mBUCY is a feasible and promising conditioning therapy for myeloid malignancies patients.