Objective To reveal the average pass rate of a general hospital's ethic review and common problems.Methods The records generated by the ethics committee of a hospital in 3 consecutive years were reviewed and analysed with ridit of CMH and Bootstrap statistical methods.Results The pass rate for drug clinical trial is 36.09%,medical instruments 18.42%,and subject evaluation 14.29%.Among the problems,those concerning informed consent take up 63.59%,of protocol 14.56%,of CRF 7.77% and of the others 22.820%.The domestic applicants had more problems than those abroad.Besides,the pass rate of drug trials decreased with year from 45.83% in 2006 to 19.44% in 2008,which was statistically significant (P=0.029).In terms of drug clinical trial,the pass rate of revised projects in foreign countries was significantly higher than the domestic ones (P=0.028).ConclusionEthics Committee in a hospital plays a very important role in clinical researches.And informed consent and research protocol are very important in the ethic review.

Objective To evaluate the reasonability and feasibility of evaluation index system for the Capital Research Fund for Medical Development in order to provide some preliminary practical and theo-retical fundamentals for setting up and improving an evaluation index system for the Capital Research Foun-dation for Medical Development. Methods Based on the investigation of thirty three hospital's administra-tors in Beijing,we used statistical methods to evaluate the reliability and validity of the evaluation index sys-tem. Results The first grade and second grade index were approved by more than 87.88% responders;the half-reliability of the evaluation index system was 0.7933 and the Cronbach's alpha coefficient is 0.9103, the factor analysis of the second grade indicators showed that there were four factors extracted, and the accu-mulative variance reached 78.44%. Conclusion The evaluation index system for the Capital Research Fund for Medical Development is reasonable and feasible,and the research result will provide a basis for fur-ther study.

OBJECTIVETo conduct health economic evaluation of the prevention of mother-to-child HIV among pregnant women in Dehong prefecture, Yunnan province, China from 2004 to 2013.

METHODSData on cost were collected mainly from the annual prevention of mother-to-child transmission (PMTCT) reporting system of Dehong prefecture, and supplemented by HIV PMTCT-related resource allocation data from local health bureau. Effectiveness indexes were from local continuous HIV surveillance system and annual reported data. Cost-effectiveness and cost-utility analysis were used to conduct the health economic evaluation.

RESULTSFrom 2004 to 2013, 283980 pregnant women were screened for HIV, 2 059 were detected as positive, and the HIV positive rate was 0.73%. The total cost of the PMTCT program was 14 227 000 RMB after discounting, and the unit cost of positive case finding was 4 200 RMB. A total of 26 cases of adults and 325 infants were avoided HIV infection, and the cost-effectiveness ratio (CER) was 40 500 RMB/case. The total obtained quality adjusted life years (QALY) from the program was 8 911.5, each one of which cost 1 600 RMB/QALY. If the feeding pattern were breast feeding, CER would be 42 800 RMB/case and each one of QALY would cost 2 200 RMB.

CONCLUSIONBased on the cost-effectiveness and cost-utility analysis, the HIV PMTCT of Dehong prefecture had economic value, which indicates that continued investment is needed to strengthen local HIV PMTCT work.

Acquired Immunodeficiency Syndrome ; Adult ; Child ; China ; Cost-Benefit Analysis ; Costs and Cost Analysis ; Female ; HIV Infections ; Health ; Humans ; Infant ; Infectious Disease Transmission, Vertical ; Mothers ; Pregnancy ; Quality-Adjusted Life Years

OBJECTIVETo understand provider initiated HIV testing and counseling (PITC) in a region with high HIV/AIDS epidemic in China, and analyze its effect to early detection of HIV infections.

METHODSBetween January and December, 2013, 37 county level medical institutions were selected as the study sites, among which, 19 were public medical institutions and 18 were private institutions. According to the related regulation, procedures and contents of PITC, the study was implemented among outpatients and inpatients who seek for doctors in these medical institutions and PITC were provided for them. The 'Individual Investigation Form' was used to record the information and high-risky factors, and the respondents were taken venous blood and given HIV screening and confirmation. All available serum samples of newly found HIV/AIDS cases were tested using the BED HIV Incidence Capture Enzyme Immunoassay (BED-CEIA) to differentiate the long-term infections and new infections (early detected infections). Chi-square analysis was used to compare the differences of characteristics of newly infected patients.

RESULTSBetween January and December, 2013, a total of 37 medical institutions provided PITC. 55 164 person times were received HIV screening, among which 658 were HIV positive, and 598 were confirmed to be HIV positive. The 598 cases were all provided transferring service. The differences of age, marital status, education levels, transmission routes and testing institutions had statistical significance to early detection (χ(2) equals to 23.54, 10.50, 17.96, 21.22 and 4.80; P equals to < 0.001, 0.005, < 0.001, < 0.001 and 0.029, respectively). And the early detection proportions among patients aged from 20 to 29 and from 50 to 84 were 47.1% (114/242) and 42.1% (24/57), respectively; the proportions among single and married patients were 37.8% (56/148) and 38.9% (143/368), respectively; the proportion among patients with high school education levels were 42.6% (26/61); the proportion among patients transmitted by fixed heterosexual sexual partners was 46.0% (86/187); the proportion among private hospitals was 40.3% (58/144).

CONCLUSIONA certain proportion of HIV infections were early detected by PITC in this region. The HIV early detection proportions among specific age group and population with spouse/fixed sexual partners were relatively high.

Acquired Immunodeficiency Syndrome ; diagnosis ; epidemiology ; Adult ; Aged ; Aged, 80 and over ; China ; Counseling ; Early Diagnosis ; Epidemics ; HIV Infections ; diagnosis ; epidemiology ; Humans ; Marital Status ; Mass Screening ; Middle Aged ; Outpatients ; Surveys and Questionnaires ; Young Adult

Objective:To explore the changing trends and influencing factors of AIDS-related and non-AIDS-related deaths after receiving antiretroviral therapy (ART) among HIV-positive individuals in Dehong Dai Jingpo autonomous prefecture (Dehong) from 2010 to 2019.Methods:Based on the Chinese National treatment database, HIV patients who initiated ART from 2010 to 2019 were included in the analysis. The cumulative incidence function was used to estimate the cumulative incidence of AIDS-related death and non-AIDS-related death, respectively. The Fine-Grey model was used to compare the differences between AIDS-related and non-AIDS-related deaths and analyze its influencing factors.Results:A total of 7 068 HIV-positive individuals were included, of which 388 were AIDS-related deaths and 570 were non-AIDS-related deaths. The cumulative mortality rate at years 1, 2, 3, 4, 5, 7 and 9 after receiving ART were 2.27%, 3.46%, 4.47%, 5.03%, 5.84%, 6.61%, 7.40% for AIDS-related deaths, and 1.63%, 3.11%, 4.68%, 6.02%, 7.42%, 10.49%, 12.75% for non-AIDS-related deaths, respectively. In the Fine-Grey model, older age at ART initiation, male, unmarried, injection drug use as the transmission route, lower baseline BMI, lower baseline CD4 + T cell counts, baseline FIB-4 score >3.25, and baseline anemia were risk factors for AIDS-related death. In contrast, age at ART initiation ≥45 years, male, Dai, and Jingpo minority ethnicities, unmarried, injection drug use as the transmission route, lower baseline BMI, baseline FIB-4 score >3.25, baseline eGFR <60 ml·min -1·1.73 m -2, and baseline anemia were risk factors for non-AIDS-related deaths. Conclusions:The cumulative mortality rate was low among HIV-positive individuals after receiving ART in Dehong during 2010-2019. The mortality of non-AIDS-related deaths was higher than that of AIDS-related deaths. There were also differences in the factors influencing AIDS-related and non-AIDS-related deaths and interventions should be intensified to target the influencing factors for non-AIDS-related deaths.

Objective:To investigate the incidence of anemia and risk factors in HIV/AIDS patients with access to antiretroviral therapy (ART) during 2004-2018 in Dehong Jingpo and Dai Autonomous Prefecture (Dehong).Methods:A retrospective cohort study was conducted in HIV/AIDS patients receiving ART in Dehong during 2004-2018 based on the data extracted from the National HIV/AIDS antiretroviral therapy database. Cox proportional risk model was used to analyze the factors associated with the incidences of anemia and moderate or severe anemia in the HIV/AIDS patients. And the piecewise linear mixed-effects model was used to depict the trajectory of hemoglobin changes over time after initiating ART according to baseline level.Results:A total of 8 044 HIV/AIDS patients were included, in whom 6 337 (78.8%) were without anemia at baseline survey and had a median follow up time of 4.43 ( P 25, P 75: 1.50, 6.71) years. The median follow up time for 1 291 new anemia cases and 293 new moderate or severe anemia cases was 0.16 ( P 25, P 75: 0.07, 1.99) years and 0.48 ( P 25, P 75:0.09, 2.97) years, respectively. The incidence rate of anemia and moderate or severe anemia was 4.40 per 100 person-years and 0.41 per 100 person-years respectively. In multivariable Cox regression analysis, older age, being female, being in Dai and Jingpo ethnic group, baseline BMI <18.5 kg/m 2, baseline CD4 +T lymphocyte cell counts (CD4) <200 cells/μl, and zidovudine (AZT) -based initial treatment regimen were factors significantly and positively associated with incidence of anemia after treatment. Factors as being female, being in Dai ethnic group, baseline BMI <18.5 kg/m 2, mild baseline anemia, and AZT-based initial treatment regimen were significantly and positively associated with incidence of moderate or severe anemia after treatment. Conclusion:The risk for anemia was higher in HIV/AIDS patients with specific characteristics, such as age ≥60 years , being female, being in Dai and Jingpo ethnic groups, lower BMI, CD4 <200 cells/μl, and treatment of AZT, after initiation of ART in Dehong during 2004-2018. Additional efforts are needed to strengthen the screening, prevention and treatment of anemia in this population.

Objective:To understand the incidence of diabetes and influencing factors, the trend of FPG change and risk for mortality in HIV-infected individuals after antiretroviral therapy (ART) in Dehong Dai and Jingpo Autonomous Prefecture (Dehong).Methods:The HIV/AIDS treatment database was collected from China Information System for Disease Control and Prevention. This retrospective cohort study was conducted in HIV-infected individuals with access to ART in Dehong during 2004-2020.The Cox proportional hazard regression model was used to analyze the incidence density of diabetes, the influencing factors and risk for mortality in HIV-infected individuals with access to ART, mixed linear effects model was used to analyze the trend of FPG change and predict FPG in those with different glucose metabolic status at baseline survey. Statistical analysis was performed using software SAS 9.4.Results:A total of 8 763 HIV-infected individuals were included, in whom 8 432 (96.2%) had no diabetes, 331 had diabetes. The incidence density of diabetes was 2.31/1 000 person years. Multivariate Cox proportional hazard regression analysis revealed that 30- 59 years old, BMI ≥24.0 kg/m 2, Efavirenz (EFV) based initial treatment regimen and impaired fasting glucose (IFG) at baseline survey were significantly and positively associated with incidence of diabetes. Mixed effect model revealed that FPG was positively correlated with the duration of ART, age and baseline FPG. Suffering from diabetes was a risk factor for mortality in HIV-infected individuals both at baseline survey and during follow-up. Conclusions:The risk for diabetes increased in HIV-infected individuals who were 30-59 years old, baseline BMI ≥24.0 kg/m 2, received EFV based initial treatment, and IFG in HIV-infected individuals after antiretroviral therapy in Dehong, 2004-2020. It is important to pay close attention to their blood glucose, and patients with high blood glucose should receive treatment as early as possible.

Objective: To study the prevalence and correlates of diabetes among HIV/AIDS who were on antiretroviral therapy (ART) in Dehong Dai and Jingpo autonomous prefectures (Dehong), Yunnan province. Methods: The database of HIV/AIDS receiving ART in Dehong was downloaded by using the basic information system of AIDS prevention and control in China. In this cross-sectional study, HIV/AIDS patients who were currently on ART and aged 18 years or above, were consecutively recruited, between July 2017 and June 2018, in Dehong. All the subjects underwent hemoglobin A1c (HbA1c) testing. Patient with diabetes was defined as meeting any of these indicators (HbA1c ≥6.5%, baseline FPG ≥7.0 mmol/L, FPG ≥7.0 mmol/L in the most recent visit). Both univariate and multivariate logistic regression analysis were carried on to evaluate the correlates of diabetes among the HIV/AIDS patients. Results: In total of 4 376 HIV/AIDS patients were included for analysis, with the average age as (43.7±10.1) years, proportion of males as 53.8% (2 356/4 376) and the HCV positive rate as 24.1% (1 055/4 376). The mean years was (8.9±3.8) years after the HIV diagnosis was made, and the mean duration on treatment was (6.8±2.9) years. The prevalence of diabetes was 11.4% (500/4 376). Through multivariate logistic regression analysis, data showed that the risk factors of diabetes of HIV/AIDS on ART were: aged 40 years or above, being male, HCV positive, baseline body mass index ≥24.0 kg/m², elevated TG ≥1.70 mmol/L in the most recent visit and baseline antiretroviral regimens under Efavirenz (EFV). Conclusions Prevalence rate of diabetes appeared higher in HIV/AIDS patients who were on ART in Dehong. Prevention and control measures should be targeted on HIV/AIDS patients who were with risk factors of diabetes as being elderly, male, HCV positive, overweight and higher TG. Further esearch is needed to evaluate the association between the use of EFV and diabetes.

ObjectiveTo determine the characteristics and influencing factors of hepatitis C virus （HCV） co-infection among HIV concordant couples in Dehong Prefecture. MethodsUsing the data of newly reported HIV concordant couples in Dehong Prefecture from 2016 to 2019， we collected the demographic characteristics， exposure history， and HCV infection to determine the characteristics of HCV co-infection among HIV concordant couples. ResultsAmong the 160 HIV concordant couples included in the study， 46 （28.8%） males and 14 （8.8%） females were co-infected with HCV. The prevalence of HIV-HCV co-infection was higher among the male spouses who were diagnosed less than 40， Jingpo ethnic， Burmese， illiteracy， farmers， and intravenous drug users. In contrast， the prevalence of HIV-HCV co-infection was higher among the female spouses who were diagnosed less than 40， Jingpo ethnic， and Burmese. Logistic regression analysis among male spouses showed that the Jingpo ethnic and intravenous drug users had higher risk of HCV co-infection. ConclusionHIV concordant couples in Dehong Prefecture have high prevalence of HIV-HCV co-infection. Effective intervention strategies should be developed based on ethnic-specific factors and exposure characteristics among male and female spouses of HIV concordant couples.

Objective: To investigate the efficacy and safety of the new investigational drug pegylated interferon α-2b (Peg-IFN-α-2b) (Y shape, 40 kD) injection (180 µg/week) combined with ribavirin in the treatment of patients with genotype 1/6 chronic hepatitis C (CHC), with standard-dose Peg-IFN-α-2a combined with ribavirin as a positive control. Methods: A multicenter, randomized, open-label, and positive-controlled phase III clinical trial was performed. Eligible patients with genotype 1/6 CHC were screened out and randomly divided into Peg-IFN-α-2b(Y shape, 40kD) group and Peg-IFN-α-2a group at a ratio of 2:1. The patients in both groups were given oral ribavirin for 48 weeks in addition and then followed up for 24 weeks after drug withdrawal. Abbott Real Time HCV Genotype II was used to determine HCV genotype, and Cobas TaqMan quantitative real-time PCR was used to measure HCV RNA level at 0, 4, 12, 24, 48, and 72 weeks. Adverse events were recorded in detail. The primary efficacy endpoint was sustained virological response (SVR), and a non-inferiority test was also performed. Results: A total of 561 patients with genotype 1/6 CHC were enrolled, among whom 529 received treatment; 90.9% of these patients had genotype 1 CHC. The data of the full analysis set showed that SVR rate was 69.80% (95% CI 65.00%-74.60%) in the trial group and 74.16% (95% CI 67.73%-80.59%) in the control group (P = 0.297 0). The data of the per protocol set (PPS) showed that SVR rate was 80.63% (95% CI 76.04%-85.23%) in the trial group and 81.33% (95% CI 75.10%-87.57%) in the control group (P = 0.849 8), and the 95% CI of rate difference conformed to the non-inferiority standard. The analysis of the PPS population showed that of all subjects, 47.9% achieved rapid virologic response, with a positive predictive value of 93.8%. The incidence rate of adverse events was 96.30% in the trial group and 94.94% in the control group, and the incidence rate of serious adverse events was 5.13% in the trail group and 5.06% in the control group. Conclusion In the regimen of Peg-IFN-α combined with ribavirin for the treatment of genotype 1/6 CHC, the new investigational drug Peg-IFN-α-2b(Y shape, 40 kD) has comparable clinical effect and safety to the control drug Peg-IFN-α-2a.