Objective To systematically evaluate and integrate the experiences of people living with HIV in peer support,and to provide references and suggestions for improving peer support for HIV patients in clinical practice.Methods The computer retrieval was performed in PubMed,CINAHL(EBSCO),Web of Science,ProQuest,CNKI and Wanfang Data from January 1,1996 to September 30,2022,to collect qualitative studies in the experience of people living with HIV participating in peer support.This qualitative systematic review was conducted under the Joanna Briggs Institute guideline.This paper was written according to the enhancing transparency in reporting the synthesis of qualitative research(ENTREQ).Results A total of 7 qualitative studies were included,and 26 findings were extracted,which were summarized into 12 categories and integrated into 4 synthesized findings.Findings included that peer support provides patients with information and help them establish and maintain a healthy lifestyle;patients receive emotional support in peer support;patients receive instrumental support in peer support;the objective requirements and scenarios of peer support.Conclusion AIDS peer support has a positive effect on AIDS prevention and treatment,and it is important to address the practical needs of people living with HIV/AIDS.The practice of HIV peer support needs further theoretical support and scientific guidance.Building an HIV peer support model,providing systematic training and professional guidance to HIV peers is conducive to improving the accuracy of HIV peer support behaviors,the development of HIV peer support activities,and optimizing the effectiveness and sustainability of peer support for people living with HIV/AIDS.

Background::Atopic dermatitis (AD) affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods::This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized (1:1:1) to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score from baseline at week 16. Safety and pharmacodynamics were also studied.Results::At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups (70% [28/40] for high-dose and 65% [26/40] for low-dose) than that in the placebo group (20%[8/40]). The differences in EASI-75 response rate were 50% (high vs. placebo, 95% CI 31%–69%) and 45% (low vs. placebo, 95% CI 26%–64%), with both P values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator’s Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events (TEAEs) was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310. Conclusion::CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration::ClinicalTrials.gov, NCT04805411.

Objective:To explore the association between the intake and changes in various types of food and the changes in blood pressure in patients with mild to moderate hypertension.Methods:Mild to moderate hypertension participants with complete baseline and outcome data were included from DECIDE-Diet study, a multicenter, randomized controlled trial. Dietary records and blood pressure measurements at both 7-day run-in (baseline) and 28-day intervention phases were collected for enrolled participants. Blood pressure change was defined as the difference between blood pressure at the end of trial and the baseline blood pressure. Baseline intake of food was the average daily intake during the run-in period, and the intake increment was defined as the difference between the average intake during the trial period and the average intake during the run-in period. After adjusting for age, sex, study center, intervention groups, baseline body mass index (kg/m 2), antihypertension medication use, and baseline total calorie intake, a linear regression model was used to analyze the associations of the before-after-intervention change in blood pressure with baseline intake and intake increment of foods. Results:A total of 258 patients with mild to moderate hypertension were included, including 133 males, aged (56.5±9.9) years. (1) After adjusting for confounding factors, there was no significant association between baseline intake of food and baseline blood pressure (all P>0.05). The blood pressure change was negatively associated with baseline intakes of tubers, vegetables, and vegetable oils but positively with baseline intake of meats; and was negatively associated with intake increment of whole grains and fish (all P<0.05). (2) The multiple linear regression analysis showed that baseline intake of vegetables ( β=-0.021, P=0.004), vegetable oils ( β=-0.260, P=0.002), and increment in intake of fish ( β=-0.128, P=0.026) were all significantly associated with changes in systolic blood pressure; baseline intake of vegetables ( β=-0.017, P=0.002), vegetable oils ( β=-0.182, P=0.001), dairy products ( β=0.021, P=0.022), and increment in intake of fish ( β=-0.092, P=0.010) were all significantly associated with changes in diastolic blood pressure. Conclusion:Increasing the intake of whole grains, vegetables, vegetable oils, and fish and decreasing the intake of meat may be beneficial for blood pressure control in patients with mild to moderate hypertension.

Background::A phase II trial on recombinant human tenecteplase tissue-type plasminogen activator (rhTNK-tPA) has previously shown its preliminary efficacy in ST elevation myocardial infarction (STEMI) patients. This study was designed as a pivotal postmarketing trial to compare its efficacy and safety with rrecombinant human tissue-type plasminogen activator alteplase (rt-PA) in Chinese patients with STEMI.Methods::In this multicenter, randomized, open-label, non-inferiority trial, patients with acute STEMI were randomly assigned (1:1) to receive an intravenous bolus of 16 mg rhTNK-tPA or an intravenous bolus of 8 mg rt-PA followed by an infusion of 42 mg in 90 min. The primary endpoint was recanalization defined by thrombolysis in myocardial infarction (TIMI) flow grade 2 or 3. The secondary endpoint was clinically justified recanalization. Other endpoints included 30-day major adverse cardiovascular and cerebrovascular events (MACCEs) and safety endpoints.Results::From July 2016 to September 2019, 767 eligible patients were randomly assigned to receive rhTNK-tPA ( n = 384) or rt-PA ( n = 383). Among them, 369 patients had coronary angiography data on TIMI flow, and 711 patients had data on clinically justified recanalization. Both used a –15% difference as the non-inferiority efficacy margin. In comparison to rt-PA, both the proportion of patients with TIMI grade 2 or 3 flow (78.3% [148/189] vs. 81.7% [147/180]; differences: –3.4%; 95% confidence interval [CI]: –11.5%, 4.8%) and clinically justified recanalization (85.4% [305/357] vs. 85.9% [304/354]; difference: –0.5%; 95% CI: –5.6%, 4.7%) in the rhTNK-tPA group were non-inferior. The occurrence of 30-day MACCEs (10.2% [39/384] vs. 11.0% [42/383]; hazard ratio: 0.96; 95% CI: 0.61, 1.50) did not differ significantly between groups. No safety outcomes significantly differed between groups. Conclusion::rhTNK-tPA was non-inferior to rt-PA in the effect of improving recanalization of the infarct-related artery, a validated surrogate of clinical outcomes, among Chinese patients with acute STEMI.Trial registration::www.ClinicalTrials.gov (No. NCT02835534).

Objective:To explore the relationship between lipid metabolism molecules in plasma and carotid atherosclerotic plaques,traditional cardiovascular risk factors and possible dietary related factors.Methods:Firstly,among 1 312 community people from those who participated in a 10-year follow-up study of subclinical atherosclerosis cohort in Shijingshan District,Beijing,85 individuals with 2 or more carotid soft plaques or mixed plaques and 89 healthy individuals without plaques were selected according to the inclusive and the exclusive criteria(＜70 years,not having clinical cardiovascular disease and other diseases,etc.).Secondly,10 cases and 10 controls were randomly selected in the above 85 and 89 individuals respectively.Carotid plaques were detected using GE Vivid i Ultrasound Machine with 8L de-tector.Lipid metabolism molecules were detected by high performance liquid chromatography-mass spec-trometry.The detection indexes included 113 lipid metabolism molecules.Traditional cardiovascular risk factors were collected by unified standard questionnaires,and dietary related factors were collected by main dietary frequency and weight scale.The difference of lipid metabolism molecules between the case group and the control group was analyzed by Wilcoxin rank test.In the control group,the Spearman cor-relation method was used to analyze the correlation between statistically significant lipid metabolism molecules and traditional cardiovascular risk factors and dietary factors.Results:Among the 113 lipid metabolism molecules,53 lipid metabolism molecules were detected.C24∶0 sphingomyelin(SM),C22∶0/C24∶0 ceramide molecules,C18∶0 phosphoethanolamine(PE)molecules,and C18∶0/C18∶2(Cis)phosphatidylcholine(PC)were significantly higher in the carotid atherosclerotic plaque group than in the control group.The correlation analysis showed that C24∶0 SM was significantly positively correlated with low density lipoprotein cholesterol(LDL-C,r=0.636,P＜0.05),C18∶2(Cis)PC(DLPC)was sig-nificantly positively correlated with systolic pressure(r=0.733,P＜0.05),C18∶0 PE was significantly positively correlated with high sensitivity C-response protein(r=0.782,P＜0.01),C22∶0,C24∶0 ce-ramide and C18∶0 PE were negatively correlated with vegetable intake(r=-0.679,P＜0.05;r=-0.711,P＜0.05;r=-0.808,P＜0.01),C24∶0 ceramide was also negatively correlated with beans food intake(r=-0.736,P＜0.05)in the control group.Conclusion:The increase of plasma C24∶0 SM,C22∶0,C24∶0 ceramide,C18∶0PE,C18∶2(Cis)PC(DLPC),C18∶0PC(DSPC)may be new risk factors for human atherosclerotic plaques.These molecules may be related to blood lipid,blood pres-sure or inflammatory level and the intake of vegetables and soy products,but the nature of the association needs to be verified in a larger sample population.

Objective To investigate the effects of ATP-binding cassette subfamily B transporter 6 subfamily B(ABCB6)on cognitive dysfunction in Alzheimer's disease(AD)rats and its possible potential regulatory molecular mechanisms.Methods Amyloid β-protein(Aβ)was injected to construct the AD mouse model in vivo.Water maze test and Y maze test were used to evaluate the learning and memory ability and space exploration ability of rats.An in vitro AD cell model was constructed by HT22 cells and Aβ.The binding relationship between YTH domain containing 1(YTHDC1)and ABCB6 was analyzed by RNA immuniprecipitation(RIP).Quantitative real time polymerase chain reaction(qRT-PCR)was used to detect overexpression and knockdown transfection efficiency.Western blot analysis was performed to detect the expression levels of YTHDC1 and ABCB6 proteins,as well as ferroptosis related proteins[Solute Carrier Family 7 Member 11(SLC7A11),Glutathione peroxidase 4(GPX4)].Cell viability was detected with CCK-8.Malondialdehyde(MDA),Glutathione(GSH),Reactive oxygen species(ROS)levels and Fe2+content were analyzed by the assay kit.Results The ABCB6 mRNA(3.51±0.17 vs 1.02±0.01,3.45±0.21 vs 1.02±0.01)and protein(3.25±0.14 vs 1.01±0.01,3.14±0.16 vs 1.01±0.01)levels in the hippocampus of AD mice and Aβ-induced HT22 cells were up-regulated,and the differences were statistically significant(t=-46.238,-20.349;-50.468,-23.013,all P<0.001).Knocking down ABCB6 decreased the time and distance of AD mice reaching the platform,and increased the ratio of spontaneous exchange rate to the number of times of entered the new arm(t=27.007,11.264,24.414,19.901,all P<0.001).Knockdown ABCB6 promoted HT22 cell proliferation,decreased levels of MDA and Fe2+,increased GSH levels,reduced ROS generation,and promoted expression of SLC7A11 and GPX4 proteins(t=2.883～26.122,all P<0.05).YTHDC1 protein promoted its stability by binding to ABCB6 mRNA and up-regulated the expression of ABCB6 protein.Knockdown of YTHDC1 decreased ABCB6 protein level(t=18.504,P<0.001),promoted the proliferation of HT22 cells,increased GSH content,SLC7A11 and GPX4 protein levels,decreased MDA and Fe2+content,and inhibited ROS production(t=4.404～14.486,all P<0.05).Knocking down YTHDC1 could improve the learning and memory ability and spatial exploration ability of AD mice.Over-expression of ABCB6 reversed the effects of YTHDC1 knockdown on ferroptosis in HT22 cells and cognitive dysfunction in AD mice.Conclusion YTHDC1 may induce ferroptosis of neuronal cells by mediating the up-regulation of ABCB6,thus promoting cognitive dysfunction in AD mice.

Objective:To establish a provincial-level supervision and inspection protocol for Investigator-Initiated Trials (IIT) based on the need for high-quality development of clinical research in China.Methods:Through literature analysis combined with personal work experience, this study proposed a system of clinical research supervision and management in Beijing based on the ″Administrative Measures for the Conduct of Investigator-Initiated Trials by Health Care and Medical Institutions (Trial)″ issued by the National Health Commission.Results:This article detailed the formation and training of supervisory inspectors, the principles and methods for selecting projects for supervisory inspection, the content of supervisory inspection, workflow, the classification and severity assessment of identified issues, as well as guidelines for the classification and handling of inspected projects.Conclusions:This protocol provides valuable experience for ensuring the implementation of high-quality IIT, but its implementation is still in the pilot exploration stage, and its impacts will be evaluated in the next implementation practices.

Objective:To explore the feasibility of a classification prediction model for gamma pass rates (GPRs) under different intensity-modulated radiation therapy techniques for pelvic tumors using a radiomics-based machine learning approach, and compare the classification performance of four integrated tree models.Methods:With a retrospective collection of 409 plans using different IMRT techniques, the three-dimensional dose validation results were adopted based on modality measurements, with a GPR criterion of 3%/2 mm and 10% dose threshold. Then prediction were built models by extracting radiomics features based on dose documentation. Four machine learning algorithms were used, namely random forest (RF), adaptive boosting (AdaBoost), extreme gradient boosting (XGBoost), and light gradient boosting machine (LightGBM). Their classification performance was evaluated by calculating sensitivity, specificity, F1 score, and AUC value. Results:The RF, AdaBoost, XGBoost, and LightGBM models had sensitivities of 0.96, 0.82, 0.93, and 0.89, specificities of 0.38, 0.54, 0.62, and 0.62, F1 scores of 0.86, 0.81, 0.88, and 0.86, and AUC values of 0.81, 0.77, 0.85, and 0.83, respectively. XGBoost model showed the highest sensitivity, specificity, F1 score, and AUC value, outperforming the other three models. Conclusions:To build a GPR classification prediction model using a radiomics-based machine learning approach is feasible for plans using different intensity-modulated radiotherapy techniques for pelvic tumors, providing a basis for future multi-institutional collaborative research on GPR prediction.

BACKGROUND: Biological agents, such as tumor necrosis factor inhibitors (TNFi), have been widely used in rheumatoid arthritis (RA) patients and greatly improved goal achievement. The aim of this study was to investigate whether conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) combination was better in reducing relapse than methotrexate (MTX) monotherapy, and more cost-effective than continuing TNFi plus MTX in RA patients who achieved low disease activity (LDA) with TNFi and MTX therapy. METHODS: RA patients who failed to csDMARDs received an induction therapy of MTX plus TNFi for maximally 12 weeks. Those achieving LDA in 12 weeks were randomly assigned at a 1:1:1 ratio into three groups: (A) adding hydroxychloroquine and sulfasalazine for the first 12 weeks and then discontinuing TNFi for the following 48 weeks; (B) maintaining TNFi and MTX for 60 weeks; and (C) maintaining TNFi and MTX for the first 12 weeks and then discontinuing TNFi for the following 48 weeks. The primary outcome was relapse. RESULTS: A total of 117 patients were enrolled for induction therapy and 67 patients who achieved LDA within 12 weeks were randomized, with 24, 21, and 22 patients in groups A, B, and C, respectively. The relapse rates of groups A and B during the entire 60 weeks were comparable [10/22 (45.5%) vs. 7/20 (35.0%), χ2 = 0.475, P = 0.491], however, significantly lower than that of group C [10/22 (45.5%) vs. 17/20 (85.0%), χ2 = 5.517, P = 0.019; 7/20 (35.0%) vs. 17/20 (85.0%), χ2 = 11.035, P = 0.004, respectively]. Taking RMB 100,000 Yuan as the threshold of willingness to pay, compared to MTX monotherapy (group C), both TNFi maintenance and triple csDMARDs therapies were cost-effective, but triple csDMARDs therapy was better. CONCLUSION: For RA patients who have achieved LDA with TNFi and MTX, csDMARDs triple therapy was a cost-effective option in favor of reducing relapse. TRIAL REGISTRATION ClinicalTrials.gov, NCT02320630.
Humans ; Cost-Benefit Analysis ; Drug Therapy, Combination ; Treatment Outcome ; Arthritis, Rheumatoid/drug therapy* ; Antirheumatic Agents/therapeutic use* ; Methotrexate/therapeutic use* ; Recurrence

DECIDE-Diet trial was taken as a case to introduce the methods of blinding and blinding assessment for feeding trials, report the details of blinding, conduct a blinding survey and calculate Jame's BI and Bang's BI. Jame's BI was 0.683 (95% CI: 0.593~0.772). The Bang's BI for the intervention group was 0.340 (95% CI: 0.199~0.481), and for the control group was 0.086 (95% CI: -0.060~0.231). The blinding of the DECIDE)-Diet was generally successful, but the intervention group may infer their group to a certain extent. Feeding trials should report the details of blinding and consider blinding assessment.