Objective:To analyze the screening results of the Urban Cancer Early Diagnosis and Treatment Project in Qinghai Province from 2019 to 2024.Methods:A summary and statistical analysis were conducted on six years of screening data from the Urban Cancer Early Dia-gnosis and Treatment Program in Qinghai Province,with the high-risk rate,screening rate,and detection rate calculated separately for each type of cancer.Results:From 2019 to 2024,56,882 high-risk individuals were identified.The high-risk rates for lung,colorectal,breast,up-per gastrointestinal,and liver cancer were 22.02%,21.57%,14.23%,13.52%,and 6.10%,respectively.Overall,13,592 individuals com-pleted clinical screening,with detection rates of 0.32%for lung cancer,0.41%for liver cancer,0.08%for precancerous gastric lesions,3.63%for precancerous colorectal lesions,0.08%for esophageal cancer,0.16%for gastric cancer,and 0.14%for colorectal cancer.Conclusions:The implementation of the Urban Cancer Early Diagnosis and Treatment Program in Qinghai Province aids in the early detection of cancer,improves early diagnosis and survival rates,and reduces mortality.Nevertheless,due to low public awareness and limited participation,en-hancements in program management and public outreach are required.

Objective To evaluate the safety and efficacy of valve-in-valve transcatheter mitral valve replacement(ViV-TMVR)in patients with bioprosthetic valve degeneration who are at high surgical risk.Methods This study is a multi-center,retrospective cohort analysis of 20 consecutive patients who underwent transseptal ViV-TMVR using the Edwards SAPIEN 3 transcatheter heart valve(THV).The primary endpoints include technical success and procedural success,both defined according to the Mitral Valve Academic Research Consortium(MVARC)criteria,as well as mortality and functional change assessed based on New York Heart Association(NYHA)classification at 30-days and six months post-procedure.Clinical follow-up assessments are conducted at 30-days and six months.Results From February 2021 to October 2022,a total of 20 patients with symptoms of bioprosthetic valve degeneration were enrolled across nine sites in China.The patients had a mean age of(73.5±5.5)years,with 85.0％being females and 70.0％classified as NYHA class Ⅲ/Ⅳ.The study achieved a 100.0％technical success rate and a 90.0％procedural success rate finally.All patients remained alive during the 30-day follow-up period.However,six months post-intervention,two patients(10.0％)were re-hospitalized due to heart failure,and sadly,one of them(5.0％)died.None of the patients reported any adverse events related to ViV-TMVR during the follow-up period.Notably,there was a significant improvement in NYHA class compared to baseline(P=0.0004)at six-month follow-ups.Conclusions The transseptal ViV-TMVR technique proved to be highly successful and was associated with significant improvement in NYHA class function.These findings strongly suggest that it serves as a safe and efficient treatment alternative for high-risk patients suffering from bioprosthetic valve degeneration.

Objectives:To investigate the predictive value of the hemoglobin to serum creatinine ratio(Hb/SCr)for all-cause mortality within 3 years after percutaneous coronary intervention(PCI)in patients with ST-segment elevation myocardial infarction(STEMI).Methods:A total of 687 STEMI patients who successfully underwent the first PCI at the Department of Cardiology,Gansu Provincial People's Hospital,from June 2016 to June 2020 were retrospectively enrolled.Patients were divided into survival and non-survival groups according to their vital status at 3 years post-PCI.Cox regression analysis was performed to identify predictive factors of all-cause mortality.Receiver operating characteristic(ROC)curves were constructed to evaluate the predictive value of Hb/SCr for all-cause mortality,and Kaplan-Meier survival curves were used to compare cumulative survival rates between subgroups stratified by Hb/SCr levels.Results:The median follow-up duration was 37(25,50)months.Among the 663 patients(96.51%)with complete follow-up data,41 cases(6.18%)experiencing all-cause death.Multivariable Cox regression analysis revealed that age(HR=1.086,95%CI:1.037-1.137,P=0.000),body mass index(HR=1.195,95%CI:1.128-1.266,P=0.000),fasting blood glucose(HR=1.069,95%CI:1.007-1.135,P=0.030),fibrinogen(HR=1.418,95%CI:1.120-1.795,P=0.004),TIMI flow grade 1(HR=4.968,95%CI:1.194-20.667,P=0.028),TIMI flow grade 2(HR=3.861,95%CI:1.336-11.156,P=0.013),and Hb/SCr(HR=0.858,95%CI:0.766-0.961,P=0.008)were the independent predictors of all-cause mortality.ROC curve analysis demonstrated that the area under the curve(AUC)of Hb/SCr was 0.721(95%CI:0.645-0.798)for predicting all-cause mortality,with a sensitivity of 65.9%and specificity of 71.2%,at the optimal cut-offvalue of 16.627.Kaplan-Meier analysis showed that patients with Hb/SCr<16.627 had significantly lower survival rates than those with Hb/SCr≥16.627(log-rank P=0.000).Conclusions:Hb/SCr is an independent predictor of 3-year all-cause mortality in STEMI patients after PCI and this indicator could be used as risk stratification parameter and patients with lower Hb/SCr might benefit comprehensive post-PCI management to improve their outcome.

Objective Through organizing a proficiency evaluation activity for animal illuminance testing laboratories,to assess the accuracy of testing data from participating laboratories,and to propose suggestions for testing methods.Methods In September 2024,China National Institute for Food and Drug Control(NIFDC)organised reference laboratories to conduct on-site testing through open registration.A total of 35 laboratories participated,completed on-site testing,and submitted their reports.The samples to be tested were two adjacent guinea pig breeding rooms in the NIFDC laboratory animal facility.In order to reduce the impact of room voltage fluctuations on animal illumination,chip on board(COB)light sources powered by regulated power supply were used,and brightness was adjusted by regulating voltage output.Split-level test sample pairs were used to set animal illuminance in both rooms,and the reference laboratories conducted testing according to Laboratory animals——Environment and housing facilities(GB 14925-2023).Each reference laboratory was assigned a 3-digit random code,conducted 2 tests for each breeding room,and submitted an on-site test report,original records,and illuminance meter verification or calibration certificate.WPS Spreadsheet 12.1 was used to summarize data,Grubbs' test(α=0.01)was used to check the data and remove outliers,and SPSS 26.0 software was used for data processing and graph drawing.The median value from each reference laboratory was used as the specified value,the robust standard deviation was used as the uncertainty,the robust z-score method(both intra-laboratory and inter-laboratory z-scores)was used to evaluate the test results from each laboratory,and the factors affecting results were analyzed from aspects of personnel,equipment,and operational environment.Results Under the detection level of α=0.01,no outliers were identified.The specified values for Room 1 and Room 2 were 17.80 lx and 19.00 Ix,respectively.The results obtained from 34 laboratories were evaluated as"satisfactory",while the results from one laboratory were"unsatisfactory".Through analysis of illuminance meter calibration certificates from various laboratories,it was found that some reference laboratories had insufficient calibration points and coverage,which caused test results to fail to accurately reflect the actual illuminance of the facility.Conclusion The present study reveals that factors such as personnel,equipment,and operation environment have different impacts on animal illuminance measurements.The present study concentrates exclusively on animal illuminance in guinea pig breeding rooms,where the testing environment is relatively dim.Future research should focus on the development of more efficient methods for selecting measurement sites,with the combination of illuminance meters equipped with wireless probes and storage functions to enhance testing efficiency.

Objective Through organizing a proficiency evaluation activity for animal illuminance testing laboratories,to assess the accuracy of testing data from participating laboratories,and to propose suggestions for testing methods.Methods In September 2024,China National Institute for Food and Drug Control(NIFDC)organised reference laboratories to conduct on-site testing through open registration.A total of 35 laboratories participated,completed on-site testing,and submitted their reports.The samples to be tested were two adjacent guinea pig breeding rooms in the NIFDC laboratory animal facility.In order to reduce the impact of room voltage fluctuations on animal illumination,chip on board(COB)light sources powered by regulated power supply were used,and brightness was adjusted by regulating voltage output.Split-level test sample pairs were used to set animal illuminance in both rooms,and the reference laboratories conducted testing according to Laboratory animals——Environment and housing facilities(GB 14925-2023).Each reference laboratory was assigned a 3-digit random code,conducted 2 tests for each breeding room,and submitted an on-site test report,original records,and illuminance meter verification or calibration certificate.WPS Spreadsheet 12.1 was used to summarize data,Grubbs' test(α=0.01)was used to check the data and remove outliers,and SPSS 26.0 software was used for data processing and graph drawing.The median value from each reference laboratory was used as the specified value,the robust standard deviation was used as the uncertainty,the robust z-score method(both intra-laboratory and inter-laboratory z-scores)was used to evaluate the test results from each laboratory,and the factors affecting results were analyzed from aspects of personnel,equipment,and operational environment.Results Under the detection level of α=0.01,no outliers were identified.The specified values for Room 1 and Room 2 were 17.80 lx and 19.00 Ix,respectively.The results obtained from 34 laboratories were evaluated as"satisfactory",while the results from one laboratory were"unsatisfactory".Through analysis of illuminance meter calibration certificates from various laboratories,it was found that some reference laboratories had insufficient calibration points and coverage,which caused test results to fail to accurately reflect the actual illuminance of the facility.Conclusion The present study reveals that factors such as personnel,equipment,and operation environment have different impacts on animal illuminance measurements.The present study concentrates exclusively on animal illuminance in guinea pig breeding rooms,where the testing environment is relatively dim.Future research should focus on the development of more efficient methods for selecting measurement sites,with the combination of illuminance meters equipped with wireless probes and storage functions to enhance testing efficiency.

Objective To evaluate the safety and efficacy of valve-in-valve transcatheter mitral valve replacement(ViV-TMVR)in patients with bioprosthetic valve degeneration who are at high surgical risk.Methods This study is a multi-center,retrospective cohort analysis of 20 consecutive patients who underwent transseptal ViV-TMVR using the Edwards SAPIEN 3 transcatheter heart valve(THV).The primary endpoints include technical success and procedural success,both defined according to the Mitral Valve Academic Research Consortium(MVARC)criteria,as well as mortality and functional change assessed based on New York Heart Association(NYHA)classification at 30-days and six months post-procedure.Clinical follow-up assessments are conducted at 30-days and six months.Results From February 2021 to October 2022,a total of 20 patients with symptoms of bioprosthetic valve degeneration were enrolled across nine sites in China.The patients had a mean age of(73.5±5.5)years,with 85.0％being females and 70.0％classified as NYHA class Ⅲ/Ⅳ.The study achieved a 100.0％technical success rate and a 90.0％procedural success rate finally.All patients remained alive during the 30-day follow-up period.However,six months post-intervention,two patients(10.0％)were re-hospitalized due to heart failure,and sadly,one of them(5.0％)died.None of the patients reported any adverse events related to ViV-TMVR during the follow-up period.Notably,there was a significant improvement in NYHA class compared to baseline(P=0.0004)at six-month follow-ups.Conclusions The transseptal ViV-TMVR technique proved to be highly successful and was associated with significant improvement in NYHA class function.These findings strongly suggest that it serves as a safe and efficient treatment alternative for high-risk patients suffering from bioprosthetic valve degeneration.

Objectives:To investigate the predictive value of the hemoglobin to serum creatinine ratio(Hb/SCr)for all-cause mortality within 3 years after percutaneous coronary intervention(PCI)in patients with ST-segment elevation myocardial infarction(STEMI).Methods:A total of 687 STEMI patients who successfully underwent the first PCI at the Department of Cardiology,Gansu Provincial People's Hospital,from June 2016 to June 2020 were retrospectively enrolled.Patients were divided into survival and non-survival groups according to their vital status at 3 years post-PCI.Cox regression analysis was performed to identify predictive factors of all-cause mortality.Receiver operating characteristic(ROC)curves were constructed to evaluate the predictive value of Hb/SCr for all-cause mortality,and Kaplan-Meier survival curves were used to compare cumulative survival rates between subgroups stratified by Hb/SCr levels.Results:The median follow-up duration was 37(25,50)months.Among the 663 patients(96.51%)with complete follow-up data,41 cases(6.18%)experiencing all-cause death.Multivariable Cox regression analysis revealed that age(HR=1.086,95%CI:1.037-1.137,P=0.000),body mass index(HR=1.195,95%CI:1.128-1.266,P=0.000),fasting blood glucose(HR=1.069,95%CI:1.007-1.135,P=0.030),fibrinogen(HR=1.418,95%CI:1.120-1.795,P=0.004),TIMI flow grade 1(HR=4.968,95%CI:1.194-20.667,P=0.028),TIMI flow grade 2(HR=3.861,95%CI:1.336-11.156,P=0.013),and Hb/SCr(HR=0.858,95%CI:0.766-0.961,P=0.008)were the independent predictors of all-cause mortality.ROC curve analysis demonstrated that the area under the curve(AUC)of Hb/SCr was 0.721(95%CI:0.645-0.798)for predicting all-cause mortality,with a sensitivity of 65.9%and specificity of 71.2%,at the optimal cut-offvalue of 16.627.Kaplan-Meier analysis showed that patients with Hb/SCr<16.627 had significantly lower survival rates than those with Hb/SCr≥16.627(log-rank P=0.000).Conclusions:Hb/SCr is an independent predictor of 3-year all-cause mortality in STEMI patients after PCI and this indicator could be used as risk stratification parameter and patients with lower Hb/SCr might benefit comprehensive post-PCI management to improve their outcome.

Objective:To analyze the screening results of the Urban Cancer Early Diagnosis and Treatment Project in Qinghai Province from 2019 to 2024.Methods:A summary and statistical analysis were conducted on six years of screening data from the Urban Cancer Early Dia-gnosis and Treatment Program in Qinghai Province,with the high-risk rate,screening rate,and detection rate calculated separately for each type of cancer.Results:From 2019 to 2024,56,882 high-risk individuals were identified.The high-risk rates for lung,colorectal,breast,up-per gastrointestinal,and liver cancer were 22.02%,21.57%,14.23%,13.52%,and 6.10%,respectively.Overall,13,592 individuals com-pleted clinical screening,with detection rates of 0.32%for lung cancer,0.41%for liver cancer,0.08%for precancerous gastric lesions,3.63%for precancerous colorectal lesions,0.08%for esophageal cancer,0.16%for gastric cancer,and 0.14%for colorectal cancer.Conclusions:The implementation of the Urban Cancer Early Diagnosis and Treatment Program in Qinghai Province aids in the early detection of cancer,improves early diagnosis and survival rates,and reduces mortality.Nevertheless,due to low public awareness and limited participation,en-hancements in program management and public outreach are required.

OBJECTIVE To sort out the evaluation mechanism and methodology of published cases of comprehensive clinical evaluation of drugs in China,and provide a reference for promoting standardized comprehensive clinical evaluation of drugs and strengthening policy transformation in China.METHODS Clinical comprehensive evaluation cases of drugs published in China from CNKI,Wanfang Data,PubMed and Web of Science were systematically searched,and the retrieval time was from the inception to December 31st,2023.The summary and analysis were performed from the aspects of theme selection,indicator system construction,evaluation methods,comprehensive decision-making,quality control,etc.RESULTS A total of 143 pieces of literature were ultimately included from 2014 to 2023.The number of publications has shown a rapid upward trend since 2019.The subjects of the evaluation cases were mainly pediatric drugs,Chinese patent medicines,cardiovascular drugs and anti-tumor drugs.The evaluation dimensions were between 3-8,all involving safety and effectiveness dimensions.Most cases adopted rapid evaluation methods based on literature review and expert interviews/questionnaire surveys with less emphasis on real-world research.Most cases did not involve comprehensive decision-making,quality control,or policy transformation.CONCLUSIONS The clinical comprehensive evaluation of drugs in China has made rapid progress under the guidance of national policies.However,there are still issues and challenges such as incomplete evaluation methods and standards,few cases of evaluation results being converted into decision-making,and a lack of quality control mechanisms.It is suggested that standardized evaluation paths and quality control mechanisms should be explored;when the evidence-based basis is insufficient,real-world research should be conducted as much as possible,so as to accelerate the policy transformation of evaluation results.

Objective:To evaluate the 10-year protective effect and immunogenicity of quadrivalent human papillomavirus (HPV) vaccine in Chinese women aged 20 to 45 years.Methods:From October 2019 to April 2020, a long-term follow-up study was conducted on the subjects of the Phase III clinical trial of the quadrivalent HPV vaccine (NCT00834106). Participants underwent a questionnaire survey, venous blood sampling, gynecological examination, cervical exfoliated cell pathology examination, and serum neutralizing antibody titers for HPV-6, 11, 16, and 18 were measured using a pseudovirus neutralization assay. The results of the cytological examination and the positive rate and titers of serum antibodies of different cervical exfoliated cells were compared.Results:A total of 889 subjects were followed up, including 240 in the control group, 453 in the vaccination group and 196 in the post-trial vaccination group. The age of the control group was (40±7) years old, which was higher than that of the supplementary vaccination group and the vaccination group [(38±4) and (38±6) years old, respectively] ( P<0.05). There were no statistically significant differences in condom use and sexual frequency among all groups (all P values>0.05). The abnormal proportion of cervical exfoliation cytopathology in the vaccination group was 3.7% (17/453), which was significantly lower than that in the control group [9.6% (23/240)] and post-trial vaccination group [5.6% (11/196)] ( P<0.05). There were two cases of cervical intraepithelial neoplasia (CIN) grade 1 in the vaccination group, two cases of CIN grade 1 and three cases of CIN grade 2 and above in the control group, and no CIN grade 1 and above cases in the post-trial vaccination group. The positive rate of HPV-18 antibody was 35.5% (161/453) in the vaccination group and 76.0% (149/196) in the post-trial vaccination group, which was significantly lower than that of other types ( P<0.05). The neutralizing antibody GMT ratio between the vaccination group and the control group ranged from 2.62 to 25.33 (9.05 to 83.08). Conclusion:Protective neutralizing antibodies are sustained in Chinese women aged 20 to 45 years after ten years of vaccination with quadrivalent HPV vaccine.