BACKGROUND: This study aimed to investigate programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in treating patients with advanced non-small cell lung cancer (NSCLC) in a real-world setting. METHODS: This retrospective, multicenter, observational study enrolled adult patients who received PD-1/PD-L1 antibody-based therapy in China and met the following criteria: (1) had pathologically confirmed, unresectable stage III-IV NSCLC; (2) had a baseline PD-L1 tumor proportion score (TPS); and (3) had confirmed efficacy evaluation results after PD-1/PD-L1 treatment. Logistic regression, Kaplan-Meier analysis, and Cox regression were used to assess the progression-free survival (PFS), overall survival (OS), and immune-related adverse events (irAEs) as appropriate. RESULTS: A total of 409 patients, 65.0% ( n = 266) with a positive PD-L1 TPS (≥1%) and 32.8% ( n = 134) with PD-L1 TPS ≥50%, were included in this study. Cox regression confirmed that patients with a PD-L1 TPS ≥1% had significantly improved PFS (hazard ratio [HR] 0.747, 95% confidence interval [CI] 0.573-0.975, P = 0.032). A total of 160 (39.1%) patients experienced 206 irAEs, and 27 (6.6%) patients experienced 31 grade 3-5 irAEs. The organs most frequently associated with irAEs were the skin (52/409, 12.7%), thyroid (40/409, 9.8%), and lung (34/409, 8.3%). Multivariate logistic regression revealed that a PD-L1 TPS ≥1% (odds ratio [OR] 1.713, 95% CI 1.054-2.784, P = 0.030) was an independent risk factor for irAEs. Other risk factors for irAEs included pretreatment absolute lymphocyte count >2.5 × 10 9 /L (OR 3.772, 95% CI 1.377-10.329, P = 0.010) and pretreatment absolute eosinophil count >0.2 × 10 9 /L (OR 2.006, 95% CI 1.219-3.302, P = 0.006). Moreover, patients who developed irAEs demonstrated improved PFS (13.7 months vs. 8.4 months, P <0.001) and OS (28.0 months vs. 18.0 months, P = 0.007) compared with patients without irAEs. CONCLUSIONS A positive PD-L1 TPS (≥1%) was associated with improved PFS and an increased risk of irAEs in a real-world setting. The onset of irAEs was associated with improved PFS and OS in patients with advanced NSCLC receiving PD-1/PD-L1-based therapy.
Humans ; Carcinoma, Non-Small-Cell Lung/metabolism* ; Male ; Female ; Retrospective Studies ; Middle Aged ; Lung Neoplasms/metabolism* ; Aged ; B7-H1 Antigen/metabolism* ; Programmed Cell Death 1 Receptor/metabolism* ; Adult ; Aged, 80 and over ; Immune Checkpoint Inhibitors/therapeutic use*

Objective: Compare and analyze the results of the domestic Lanyi AH600 glycated hemoglobin analyzer and other different detection systems to understand the comparability of the detection results of different detectors, and establish the best cut point of Lanyi AH600 determination of haemoglobin A1c (HbA1c) in the diagnosis of diabetes. Methods: Multi center cohort study was adopted. The clinical laboratory departments of 18 medical institutions independently collected test samples from their respective hospitals from March to April 2022, and independently completed comparative analysis of the evaluated instrument (Lanyi AH600) and the reference instrument HbA1c. The reference instruments include four different brands of glycosylated hemoglobin meters, including Arkray, Bio-Rad, DOSOH, and Huizhong. Scatter plot was used to calculate the correlation between the results of different detection systems, and the regression equation was calculated. The consistency analysis between the results of different detection systems was evaluated by Bland Altman method. Consistency judgment principles: (1) When the 95% limits of agreement (95% LoA) of the measurement difference was within 0.4% HbA1c and the measurement score was≥80 points, the comparison consistency was good; (2) When the measurement difference of 95% LoA exceeded 0.4% HbA1c, and the measurement score was≥80 points, the comparison consistency was relatively good; (3) The measurement score was less than 80 points, the comparison consistency was poor. The difference between the results of different detection systems was tested by paired sample T test or Wilcoxon paired sign rank sum test; The best cut-off point of diabetes was analyzed by receiver operating characteristic curve (ROC). Results: The correlation coefficient R² of results between Lanyi AH600 and the reference instrument in 16 hospitals is≥0.99; The Bland Altman consistency analysis showed that the difference of 95% LoA in Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180) was -0.486%-0.325%, and the measurement score was 94.6 points (473/500); The difference of 95% LoA in the Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant II) was -0.727%-0.612%, and the measurement score was 89.8 points; The difference of 95% LoA in the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT) was -0.231%-0.461%, and the measurement score was 96.6 points; The difference of 95% LoA in the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT) was -0.469%-0.479%, and the measurement score was 91.9 points. The other 14 hospitals, Lanyi AH600, were compared with 4 reference instrument brands, the difference of 95% LoA was less than 0.4% HbA1c, and the scores were all greater than 95 points. The results of paired sample T test or Wilcoxon paired sign rank sum test showed that there was no statistically significant difference between Lanyi AH600 and the reference instrument Arkray HA8180 (Z=1.665,P=0.096), with no statistical difference. The mean difference between the measured values of the two instruments was 0.004%. The comparison data of Lanyi AH600 and the reference instrument of all other institutions had significant differences (all P<0.001), however, it was necessary to consider whether it was within the clinical acceptable range in combination with the results of the Bland-Altman consistency analysis. The ROC curve of HbA1c detected by Lanyi AH600 in 985 patients with diabetes and 3 423 patients with non-diabetes was analyzed, the area under curve (AUC) was 0.877, the standard error was 0.007, and the 95% confidence interval 95%CI was (0.864, 0.891), which was statistically significant (P<0.001). The maximum value of Youden index was 0.634, and the corresponding HbA1c cut point was 6.235%. The sensitivity and specificity of diabetes diagnosis were 76.2% and 87.2%, respectively. Conclusion: Among the hospitals and instruments currently included in this study, among these four hospitals included Nanjing Maternity and Child Health Care Hospital in Jiangsu Province (reference instrument: Arkray HA8180), Tibetan Traditional Medical Hospital of TAR (reference instrument: Bio-Rad Variant Ⅱ), the People's Hospital of Chongqing Liang Jiang New Area (reference instrument: Huizhong MQ-2000PT), and the Taihe Hospital of traditional Chinese Medicine in Anhui Province (reference instrument: Huizhong MQ-2000PT), the comparison between Lanyi AH600 and the reference instruments showed relatively good consistency, while the other 14 hospitals involved four different brands of reference instruments: Arkray, Bio-Rad, DOSOH, and Huizhong, Lanyi AH600 had good consistency with its comparison. The best cut point of the domestic Lanyi AH600 for detecting HbA1c in the diagnosis of diabetes is 6.235%.
Pregnancy ; Child ; Humans ; Female ; Glycated Hemoglobin ; Cohort Studies ; Diabetes Mellitus/diagnosis* ; Sensitivity and Specificity ; ROC Curve

Objective: This cross-sectional investigation aimed to determine the incidence, clinical characteristics, prognosis, and related risk factors of olfactory and gustatory dysfunctions related to infection with the SARS-CoV-2 Omicron strain in mainland China. Methods: Data of patients with SARS-CoV-2 from December 28, 2022, to February 21, 2023, were collected through online and offline questionnaires from 45 tertiary hospitals and one center for disease control and prevention in mainland China. The questionnaire included demographic information, previous health history, smoking and alcohol drinking, SARS-CoV-2 vaccination, olfactory and gustatory function before and after infection, other symptoms after infection, as well as the duration and improvement of olfactory and gustatory dysfunction. The self-reported olfactory and gustatory functions of patients were evaluated using the Olfactory VAS scale and Gustatory VAS scale. Results: A total of 35 566 valid questionnaires were obtained, revealing a high incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain (67.75%). Females(χ2=367.013, P<0.001) and young people(χ2=120.210, P<0.001) were more likely to develop these dysfunctions. Gender(OR=1.564, 95%CI: 1.487-1.645), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), oral health status (OR=0.881, 95%CI: 0.839-0.926), smoking history (OR=1.152, 95%CI=1.080-1.229), and drinking history (OR=0.854, 95%CI: 0.785-0.928) were correlated with the occurrence of olfactory and taste dysfunctions related to SARS-CoV-2(above P<0.001). 44.62% (4 391/9 840) of the patients who had not recovered their sense of smell and taste also suffered from nasal congestion, runny nose, and 32.62% (3 210/9 840) suffered from dry mouth and sore throat. The improvement of olfactory and taste functions was correlated with the persistence of accompanying symptoms(χ2=10.873, P=0.001). The average score of olfactory and taste VAS scale was 8.41 and 8.51 respectively before SARS-CoV-2 infection, but decreased to3.69 and 4.29 respectively after SARS-CoV-2 infection, and recovered to 5.83and 6.55 respectively at the time of the survey. The median duration of olfactory and gustatory dysfunctions was 15 days and 12 days, respectively, with 0.5% (121/24 096) of patients experiencing these dysfunctions for more than 28 days. The overall self-reported improvement rate of smell and taste dysfunctions was 59.16% (14 256/24 096). Gender(OR=0.893, 95%CI: 0.839-0.951), SARS-CoV-2 vaccination status (OR=1.334, 95%CI: 1.164-1.530), history of head and facial trauma(OR=1.180, 95%CI: 1.036-1.344, P=0.013), nose (OR=1.104, 95%CI: 1.042-1.171, P=0.001) and oral (OR=1.162, 95%CI: 1.096-1.233) health status, smoking history(OR=0.765, 95%CI: 0.709-0.825), and the persistence of accompanying symptoms (OR=0.359, 95%CI: 0.332-0.388) were correlated with the recovery of olfactory and taste dysfunctions related to SARS-CoV-2 (above P<0.001 except for the indicated values). Conclusion: The incidence of olfactory and taste dysfunctions related to infection with the SARS-CoV-2 Omicron strain is high in mainland China, with females and young people more likely to develop these dysfunctions. Active and effective intervention measures may be required for cases that persist for a long time. The recovery of olfactory and taste functions is influenced by several factors, including gender, SARS-CoV-2 vaccination status, history of head and facial trauma, nasal and oral health status, smoking history, and persistence of accompanying symptoms.
Female ; Humans ; Adolescent ; SARS-CoV-2 ; Smell ; COVID-19/complications* ; Cross-Sectional Studies ; COVID-19 Vaccines ; Incidence ; Olfaction Disorders/etiology* ; Taste Disorders/etiology* ; Prognosis

Objective: To evaluate the efficacy and safety of hybutimibe monotherapy or in combination with atorvastatin in the treatment of primary hypercholesterolemia. Methods: This was a multicenter, randomized, double-blind, double-dummy, parallel-controlled phase Ⅲ clinical trial of patients with untreated primary hypercholesterolemia from 41 centers in China between August 2015 and April 2019. Patients were randomly assigned, at a ratio of 1∶1∶1∶1∶1∶1, to the atorvastatin 10 mg group (group A), hybutimibe 20 mg group (group B), hybutimibe 20 mg plus atorvastatin 10 mg group (group C), hybutimibe 10 mg group (group D), hybutimibe 10 mg plus atorvastatin 10 mg group (group E), and placebo group (group F). After a dietary run-in period for at least 4 weeks, all patients were administered orally once a day according to their groups. The treatment period was 12 weeks after the first dose of the study drug, and efficacy and safety were evaluated at weeks 2, 4, 8, and 12. After the treatment period, patients voluntarily entered the long-term safety evaluation period and continued the assigned treatment (those in group F were randomly assigned to group B or D), with 40 weeks' observation. The primary endpoint was the percent change in low density lipoprotein cholesterol (LDL-C) from baseline at week 12. Secondary endpoints included the percent changes in high density lipoprotein cholesterol (HDL-C), triglyceride (TG), apolipoprotein B (Apo B) at week 12 and changes of the four above-mentioned lipid indicators at weeks 18, 24, 38, and 52. Safety was evaluated during the whole treatment period. Results: Totally, 727 patients were included in the treatment period with a mean age of (55.0±9.3) years old, including 253 males. No statistical differences were observed among the groups in demographics, comorbidities, and baseline blood lipid levels. At week 12, the percent changes in LDL-C were significantly different among groups A to F (all P<0.01). Compared to atorvastatin alone, hybutimibe combined with atorvastatin could further improve LDL-C, TG, and Apo B (all P<0.05). Furthermore, there was no significant difference in percent changes in LDL-C at week 12 between group C and group E (P=0.991 7). During the long-term evaluation period, there were intergroup statistical differences in changes of LDL-C, TG and Apo B at 18, 24, 38, and 52 weeks from baseline among the statins group (group A), hybutimibe group (groups B, D, and F), and combination group (groups C and E) (all P<0.01), with the best effect observed in the combination group. The incidence of adverse events was 64.2% in the statins group, 61.7% in the hybutimibe group, and 71.0% in the combination group during the long-term evaluation period. No treatment-related serious adverse events or adverse events leading to death occurred during the 52-week study period. Conclusions: Hybutimibe combined with atorvastatin showed confirmatory efficacy in patients with untreated primary hypercholesterolemia, which could further enhance the efficacy on the basis of atorvastatin monotherapy, with a good overall safety profile.
Male ; Humans ; Middle Aged ; Atorvastatin/therapeutic use* ; Hydroxymethylglutaryl-CoA Reductase Inhibitors/therapeutic use* ; Hypercholesterolemia/drug therapy* ; Cholesterol, LDL/therapeutic use* ; Anticholesteremic Agents/therapeutic use* ; Treatment Outcome ; Triglycerides ; Apolipoproteins B/therapeutic use* ; Double-Blind Method ; Pyrroles/therapeutic use*

Objective To analyze the 14 indicators of on-site evaluation at 18 hospitals under Beijing hospital authority in 2016 , and to provide technical support and reference for further optimization of medical quality and service .Methods According to the "Beijing Municipal Administration of Hospital 2016 On-site Evaluation Indicators", the results were analyzed using the fuzzy combined method of TOPSIS and rank sum ratio , and the ranking of the indicators was sorted .Results TOPSIS method and rank sum ratio weighted fuzzy joint analysis showed that the top three indicators from high to low were medical technology management , patient identification and verification system , clinical care service management;and the last three indicators were hospital-acquired infection monitoring , medical malpractice reporting and management , critical value report and disposal .Conclusions Hospitals are recommended to strengthen their exchange , popularize the concept of continuous improvement , the use of management tools to solve practical problems , and further improve the hospital medical quality and service quality .

Objective To explore the problems and solving countermeasures in application of nursing vertical management,and provide references for nursing post management reform.Methods Through purposive sampling method,nursing administers,clinical nurses,heads of clinical departments and performance directors from five hospitals were interviewed by semi-structured interview method.Data were analyzed using 7-step Colaizzi's phenomenological analysis method.Results Four themes were formed about the problems in application of nursing vertical management,including:affecting department management and doctor-nurse collaboration,insufficient scientificity and fairness of performance evaluation,significant issues regarding post setting of senior nurses,competence and sense of belonging of temporarily deployed nurses.Four themes were formed about the solving countermeasures in application of nursing vertical management,including:improving participation of clinical departments in nursing management,making performance system to public and asking advices of nurses,providing career development for senior nurses,and conducting standardized training and establishing reserve nurses tank.Conclusion The main problems in application of nursing vertical management consisted of affecting department management and doctor-nurse collaboration,insufficient scientificity and fairness of performance evaluation,post setting of senior nurses,and competence and sense of belonging of temporarily deployed nurses.We suggested to better apply nursing vertical management by improving participation of clinical department in nursing management,making performance system to public and asking advices of nurses,providing career development for senior nurses,and conducting standardized training and establishing reserve nurses tank.

Objective To study the causes of emergency department (ED) overcrowding and access block in Beijing.Methods This was a multi-center cross sectional study.The studied cohort of patients included all ED visiting patients from 18 municipal teaching hospital EDs in Beijing from 2012 to 2013.Patient' s characteristics and medical care settings were analyzed.Results The urgent care cases accounted for only 4.6 ％ (71 224/1 554 387) of the emergency annual visits in 2012 and 5.5 ％ (88 190/1 615 571) in 2013.The total number of observation patients in EDs was 185 277 and 211 900 in 2012 and 2013 respectively,with an increase of 14.4 ％ (P ＜ 0.01).The total ED-admission inpatients only accounted for 2.97％ and 2.89 ％ of total annual visits in 2012 and 2013 respectively.The average time of ED-admission took 37.1 hours and 36.2 hours in 2012 and 2013 respectively.The average time of ED stay for observation was 4.9 days and 5.4 days in 2012 and 2013 respectively.Upper respiratory tract infection was the leading illness in annual visits.The leading cause of ED stay for observation was bedridden with pneumonia.Conclusions The ED settings in Beijing are different from other countries.The EDs actually assume the task of the clinic and ED service for 24 hours thereby made EDs terribly overcrowded.The main causes are large number of non-emergency patients visiting the ED and patients in the ED are difficulty to be hospitalized.Patients with end-stage disease and multiple organ failure stayed in the ED due to nursing home shortage.

Objective To use diagnosis related group (DRGs ) for the first time in overall evaluation of inpatient service performance evaluation of major diagnostic category (MDC)for all the Beijing municipal hospitals,and recommend how to strengthen Beijing municipal hospitals system in diagnosis and treatment ability of main diseases and improve inpateint service performance.Methods BJ-DRGs burster software was used to analyze the first page information of the medical records of cases discharged from all the Beijing municipal hospitals between 2012 and 2014 to determine the weight of each DRG,and based on such weight the related indicators of such hospitals and central hospitals in 2012, 2013,2014 were compared and analyzed.Results Improvements were found in such indices as diagnosis and treatment difficulty of 50% MDC,time efficiency of 81.8% MDC,cost efficiency of 77.3% MDC, and general capacity of 54.5% MDC for all Beijing municipal hospitals.In addition,the municipal hospitals were found superior to the central hospitals in such indices as cost efficiency of 68.2% MDC, and time efficiency of 59.1% MDC.On the other hand however,they were found inferior to the central hospitals in such indices as diagnosis and treatment difficulty of 72.7% MDC,and the comprehensive ability index of the two systems were found equivalent.Another finding was that there was no obvious improvement of the coverage of disease types at major tertiary hospitals in Beijing for the past three years.Municipal hospitals of greater contribution of MDC weight were highly consistent with the hospitals assigned with national key projects of disciplinary developments. Conclusion The comprehensive evaluation results of inpatient service performance of main diseases at Beijing’s municipal hospitals based on DRGs system,showed that the Beijing’s hospital authority had played an important role in improving inpatient service performance especially in reducing the burden of patients,improving the service efficiency through increasing government investment,optimizing service organization and implementation of performance management.But it also suggested that measures such as collectivize construction and management should be taken to improve municipal hospitals’linical specialty ability, improve the MDC diagnosis and treatment difficulty,and resume their functions of tertiary hospitals.

Objective To explore methods of quickly identifying loopholes in medical quality management and to improve medical quality by means of analyzing low-risk death cases.Methods Two rounds of analysis of 1 14 low-risk death cases of hospitals in Beijing in 2012 in terms of data quality and medical procedures,in an effort to identify problems and to verify the feasibility and accuracy of the method through interaction with other data.Results Totally 585 760 inpatients were discharged in 2012 from 21 hospitals,of whom 1 5 1 1 93 being low-risk cases.Such cases included 1 14 low-risk death cases, accounting for 0.01 9% of the total discharged,and 0.075% of low-risk discharged cases.Analysis of these medical records found 50 cases of problematic diagnosis (43.86%),45 cases of possible defects in diagnosis and treatment (39.47%),39 cases of missing items of secondary diagnosis (34.21%),and 28 cases of missing items of surgery/operation (24.56%). Some of the abovementioned cases had overlapping mistakes.Conclusion Analysis of low-risk death cases can help focus among massive data of medical records,problems of diagnostic and therapeutic insufficiency,pinpointing common problems in medical service and improving medical quality and fine management of hospitals.

Public hospitals reform is a key roadblock for the ongoing health reform.By means of such experiments as Three openings and three mechanisms,Beijing is practicing a separation of hospital regulation and management and separation of clinic and pharmacy,while building the mechanism of financial subscription for pricing,that of medical insurance adjustment,and that of hospital corporate governance.These measures aim at building a new management structure,operation mechanism and medical service model focusing on quality of care,efficiency and satisfaction.Separation of clinic and pharmacy has lowered drug proportion,average outpatient expense and out of-pocket payment of patients,as well as producing higher patient satisfaction,quality of care and hospital income.Other benefits include better management efficiency indirectly caused by separation of clinic and pharmacy,higher acceptance of the corporate governance,and service model innovation to better serve the people.