1.Research on Construction of Medical Insurance Fund Supervision Index System under CHS-DRG Payment
Yang LI ; Zhe WANG ; Linghan SHAN ; Yuan MA ; Wen CHE ; Chao LIANG ; Zijun LIANG ; Lijun CUI ; Liang WANG
Chinese Hospital Management 2025;45(10):65-68
Objective To screen out the indexes of medical insurance fund under China Healthcare Security Diagno-sis Related Groups(CHS-DRG)payment based on Delphi method and improve the efficiency of medical insurance fund supervision.Methods Using the Delphi method,32 experts in the medical insurance field were selected and 2 rounds of expert questionnaires were conducted to design an evaluation scale for the monitoring indicators of medi-cal insurance funds under CHS-DRG payment.The consultation results were evaluated from three aspects of motiva-tion,authority,and coordination.Results A medical insurance fund supervision index system based on three dimen-sions of medical insurance fund use quality,efficiency and safety supervision is constructed,including 3 first-level indicators,7 second-level indicators and 44 third-level indicators.Results The construction ofmedical insurance fund supervision index system under CHS-DRG payment should respect the actual clinical diagnosis and treatment,strengthen the intelligent supervision method,and timely intervene in medical insurance fund management risks.
2.Prediction of PD-1 monoclonal antibody human pharmacokinetic characteristics based on PK in cynomolgus monkeys
Yanjun XU ; Zijun HAN ; Liang WANG ; Fang YANG ; Beilei LOU ; Shaoyu YAN ; Jiman ZHU ; Lihui BAI ; Yong GAO
Chinese Journal of Pharmacology and Toxicology 2025;39(2):109-117
OBJECTIVE To establish a population pharmacokinetic(PopPK)model to predict the PK characteristics of GLS-010 in humans.METHODS Fifty-eight cynomolgus monkeys were used,18 of which were randomly divided into three groups and received a single intravenous infusion of GLS-010 at doses of 2,6,and 18 mg·kg-1,respectively.The rest were randomly assigned to four groups and received multiple intravenous infusions of GLS-010 at doses of 0,5,25,and 100 mg·kg-1,respectively,once a week(quaque week,qw)for five consecutive weeks.Blood samples were collected before and after administration.The concentrations of GLS-010 in the monkey serum were measured using a validated enzyme-linked immunosorbent assay,while those of anti-drug antibodies(ADA)in the cynomolgus monkey serum were determined by ultra-sensitive electrochemiluminescence immunoassay.The PK data on GLS-010 in cynomolgus monkeys was obtained,and the drug-time curves were plotted.A PopPK model was constructed using non-compartmental analysis and evaluated by goodness-of-fit plots and visual predictive checks.The constructed PopPK model was used to predict the PK characteristics in humans,which were finally compared with actual Phase Ⅰ clinical study results for validation.RESULTS The predictive results of the PopPK model were highly consistent with the actual Phase Ⅰ clinical study results.The model was able to predict the human PK characteristics under various dosing regimens,including 1 mg·kg-1 quaque 2 weeks(q2w),4 mg·kg-1(q2w),240 mg(q2w),240 mg(q3w),and 10 mg·kg-1(q2w).The predicted maximum plasma concentrations(Cmax)were 24.8,99.1,85.0,85.0,and 247.8 mg·L-1,respectively,and the AUC0-336h was 4 902.0,20 060.0,17 147.7,22 145.7(AUC0-504h),and 50 817.6 mg·h·L-1,respectively.The safety risks for the corresponding dosing regimens were 47.3,11.6,13.5,10.5,and 4.6,respectively.The predicted receptor occupancy at steady state(ROss)at Cmax,average plasma concentration(Cavg),and minimum plasma concentration(Cmin)were 38.8%,72.7%,69.4%,64.1%and 87.2%,29.1%,63.8%,60.0%,49.8%and 82.1%,21.9%,55.5%,51.3%,36.3%and 76.7%,respectively.CONCLUSION The PopPK model can effectively predict the human PK characteristics under different dosing regimens with high consistency with actual Phase Ⅰ clinical study results,which can serve as an important reference for selection of safe and effective doses for first-in-human research.
3.Evaluation of short-term outcomes of surgical intervention for severe pulmonary stenosis in infants and young children
Yong ZHANG ; Pengyu WANG ; Liang WANG ; Yiming TAN ; Fangran XIN ; Xu ZHANG ; Chunzhen ZHANG ; Zijun ZHOU ; Lihua LYV ; Minhua FANG
Chinese Journal of Thoracic and Cardiovascular Surgery 2025;41(10):584-588
Objective:To evaluate the short-term efficacy of surgical treatment for severe pulmonary stenosis(PS) in infants and young children, and to clarify the impact of different surgical timings on the efficacy of PS treatment.Methods:A retrospective analysis was conducted on 24 infants and young children who underwent surgical treatment for severe PS at the General Hospital of Northern Theater Command, PLA, from January 1, 2020, to October 1, 2024. Among them, 13 were males and 11 were females. The average weight of the patients was(9.2±3.6) kg, the average gestational age was(39.3±1.7) weeks, and the average age was(15.0±13.5) months. Preoperative clinical symptoms and signs(e.g., cyanosis, shortness of breath), transpulmonary valve pressure gradient(TPVPG), right ventricular systolic pressure(RVSP), and Em/Am were recorded. The patients were divided into two groups based on surgical timing: the infant group(under 1 year old, n=12) and the toddler group(1-3 years old, n=12).Results:There were no deaths among all patients. The postoperative ICU stay was significantly longer in the infant group compared to the toddler group( P<0.05). Compared to preoperative values, surgical treatment significantly improved TPVPG, reduced RVSP, and enhanced right ventricular diastolic function, which stabilized by 3 months postoperatively( P<0.05). Intergroup comparisons revealed that the infant group had significantly lower TPVPG at 6 months postoperatively compared to the toddler group. Additionally, right ventricular diastolic function improved significantly in the infant group postoperatively, while no significant improvement was observed in the toddler group. Younger age and reduced right ventricular diastolic function were identified as major risk factors for prolonged mechanical ventilation(>24 hours). Conclusion:Surgical treatment for PS during infancy and early childhood is safe and effective. Comprehensive preoperative evaluation is crucial, and early surgical intervention is recommended for patients with impaired right ventricular function to improve prognosis.
4.Evaluation of short-term outcomes of surgical intervention for severe pulmonary stenosis in infants and young children
Yong ZHANG ; Pengyu WANG ; Liang WANG ; Yiming TAN ; Fangran XIN ; Xu ZHANG ; Chunzhen ZHANG ; Zijun ZHOU ; Lihua LYV ; Minhua FANG
Chinese Journal of Thoracic and Cardiovascular Surgery 2025;41(10):584-588
Objective:To evaluate the short-term efficacy of surgical treatment for severe pulmonary stenosis(PS) in infants and young children, and to clarify the impact of different surgical timings on the efficacy of PS treatment.Methods:A retrospective analysis was conducted on 24 infants and young children who underwent surgical treatment for severe PS at the General Hospital of Northern Theater Command, PLA, from January 1, 2020, to October 1, 2024. Among them, 13 were males and 11 were females. The average weight of the patients was(9.2±3.6) kg, the average gestational age was(39.3±1.7) weeks, and the average age was(15.0±13.5) months. Preoperative clinical symptoms and signs(e.g., cyanosis, shortness of breath), transpulmonary valve pressure gradient(TPVPG), right ventricular systolic pressure(RVSP), and Em/Am were recorded. The patients were divided into two groups based on surgical timing: the infant group(under 1 year old, n=12) and the toddler group(1-3 years old, n=12).Results:There were no deaths among all patients. The postoperative ICU stay was significantly longer in the infant group compared to the toddler group( P<0.05). Compared to preoperative values, surgical treatment significantly improved TPVPG, reduced RVSP, and enhanced right ventricular diastolic function, which stabilized by 3 months postoperatively( P<0.05). Intergroup comparisons revealed that the infant group had significantly lower TPVPG at 6 months postoperatively compared to the toddler group. Additionally, right ventricular diastolic function improved significantly in the infant group postoperatively, while no significant improvement was observed in the toddler group. Younger age and reduced right ventricular diastolic function were identified as major risk factors for prolonged mechanical ventilation(>24 hours). Conclusion:Surgical treatment for PS during infancy and early childhood is safe and effective. Comprehensive preoperative evaluation is crucial, and early surgical intervention is recommended for patients with impaired right ventricular function to improve prognosis.
5.Prediction of PD-1 monoclonal antibody human pharmacokinetic characteristics based on PK in cynomolgus monkeys
Yanjun XU ; Zijun HAN ; Liang WANG ; Fang YANG ; Beilei LOU ; Shaoyu YAN ; Jiman ZHU ; Lihui BAI ; Yong GAO
Chinese Journal of Pharmacology and Toxicology 2025;39(2):109-117
OBJECTIVE To establish a population pharmacokinetic(PopPK)model to predict the PK characteristics of GLS-010 in humans.METHODS Fifty-eight cynomolgus monkeys were used,18 of which were randomly divided into three groups and received a single intravenous infusion of GLS-010 at doses of 2,6,and 18 mg·kg-1,respectively.The rest were randomly assigned to four groups and received multiple intravenous infusions of GLS-010 at doses of 0,5,25,and 100 mg·kg-1,respectively,once a week(quaque week,qw)for five consecutive weeks.Blood samples were collected before and after administration.The concentrations of GLS-010 in the monkey serum were measured using a validated enzyme-linked immunosorbent assay,while those of anti-drug antibodies(ADA)in the cynomolgus monkey serum were determined by ultra-sensitive electrochemiluminescence immunoassay.The PK data on GLS-010 in cynomolgus monkeys was obtained,and the drug-time curves were plotted.A PopPK model was constructed using non-compartmental analysis and evaluated by goodness-of-fit plots and visual predictive checks.The constructed PopPK model was used to predict the PK characteristics in humans,which were finally compared with actual Phase Ⅰ clinical study results for validation.RESULTS The predictive results of the PopPK model were highly consistent with the actual Phase Ⅰ clinical study results.The model was able to predict the human PK characteristics under various dosing regimens,including 1 mg·kg-1 quaque 2 weeks(q2w),4 mg·kg-1(q2w),240 mg(q2w),240 mg(q3w),and 10 mg·kg-1(q2w).The predicted maximum plasma concentrations(Cmax)were 24.8,99.1,85.0,85.0,and 247.8 mg·L-1,respectively,and the AUC0-336h was 4 902.0,20 060.0,17 147.7,22 145.7(AUC0-504h),and 50 817.6 mg·h·L-1,respectively.The safety risks for the corresponding dosing regimens were 47.3,11.6,13.5,10.5,and 4.6,respectively.The predicted receptor occupancy at steady state(ROss)at Cmax,average plasma concentration(Cavg),and minimum plasma concentration(Cmin)were 38.8%,72.7%,69.4%,64.1%and 87.2%,29.1%,63.8%,60.0%,49.8%and 82.1%,21.9%,55.5%,51.3%,36.3%and 76.7%,respectively.CONCLUSION The PopPK model can effectively predict the human PK characteristics under different dosing regimens with high consistency with actual Phase Ⅰ clinical study results,which can serve as an important reference for selection of safe and effective doses for first-in-human research.
6.Research on Construction of Medical Insurance Fund Supervision Index System under CHS-DRG Payment
Yang LI ; Zhe WANG ; Linghan SHAN ; Yuan MA ; Wen CHE ; Chao LIANG ; Zijun LIANG ; Lijun CUI ; Liang WANG
Chinese Hospital Management 2025;45(10):65-68
Objective To screen out the indexes of medical insurance fund under China Healthcare Security Diagno-sis Related Groups(CHS-DRG)payment based on Delphi method and improve the efficiency of medical insurance fund supervision.Methods Using the Delphi method,32 experts in the medical insurance field were selected and 2 rounds of expert questionnaires were conducted to design an evaluation scale for the monitoring indicators of medi-cal insurance funds under CHS-DRG payment.The consultation results were evaluated from three aspects of motiva-tion,authority,and coordination.Results A medical insurance fund supervision index system based on three dimen-sions of medical insurance fund use quality,efficiency and safety supervision is constructed,including 3 first-level indicators,7 second-level indicators and 44 third-level indicators.Results The construction ofmedical insurance fund supervision index system under CHS-DRG payment should respect the actual clinical diagnosis and treatment,strengthen the intelligent supervision method,and timely intervene in medical insurance fund management risks.
7.Evaluation of intervention effect of health education on overweight and obesity among middle school students in Guangzhou
LIANG Jianping, LIANG Yuelang, GUO Jiajia, GONG Zijun, CHENG Qi, LIU Li, YAO Zhenjiang
Chinese Journal of School Health 2023;44(4):498-501
Objective:
To explore the effect of the comprehensive intervention on overweight and obesity among middle school students at the population level (health education lecture and official account push) and individual level (personalized dietary guidance), so as to provide a reference for preventing and controlling their overweight and obesity.
Methods:
Three junior high schools and three senior high schools were randomly selected in Guangzhou in 2018 by convenience sampling. Through physical examination, 1 457 overweight and obese students aged from 12 to 18 years old were screened. Intervention was administered through "Student Personalized Dietary Guidance" manual, health tweets on the official accounts, and health education lectures from September 2018 to December 2019. The Chi square test was used to compare the difference in overweight and obesity constituent ratio between the two groups before and after the intervention. And intervention effect was evaluated by analyzing the number needed to treated(NTT).
Results:
The proportion of overweight before the intervention was 66.71% (972/1 457), and decreased to 59.92% (873/1 457) after the intervention; the proportion of obesity before the intervention was 33.29% (485/1 457), which decreased to 26.63% (388/1 457) after the intervention. Among obese students, the smallest NNT was seen in the girl group aged 12-13 years (NNT=2.6, 95% CI =1.9-4.1), while the largest NNT in the boy group aged 14-18 years (NNT=5.9, 95% CI =4.7-8.1). The NNT of the girls aged 12-13 years was the smallest (NNT=2.7, 95% CI =2.2-3.5), and the NNT of the boys aged 14-18 years was the largest (NNT=7.4, 95% CI =6.0-9.7).
Conclusion
Health education at population level (health education lectures, official account push) with individual level (personalized dietary guidance) can effectively intervene overweight and obesity among middle school students in Guangzhou.
8.Association between maternal pre pregnancy and pre delivery overweight with overweight and obesity of middle school students:a case control study
LIANG Jianping,GONG Zijun,LIANG Yuelang,GUO Jiajia,YANG Jiewen,LIU Li,YAO Zhenjiang
Chinese Journal of School Health 2022;43(2):268-273
Objective:
To explore the association between maternal pre pregnancy and pre delivery overweight with overweight and obesity among offspring during adolescence in Guangzhou, and to provide evidence for child obesity prevention.
Methods:
Based on the routine physical examination of primary and secondary school students in Guangzhou, random sampling was used to 6 middle schools and questionnaire survey was conducted among 3 384 students and their parents. Students with overweight and obesity were included in the case group, and the other students were included in the control group. Propensity Score Matching (PSM) was adopted to reduce selection bias. Logistic regression model and χ 2 test were used to analyze the data before and after PSM.
Results:
The result of univariate analysis showed that there were statistically significant differences between overweight/obese group and the control group by gender, schooling stage (middle and high schools), picky eater, family history of obesity, family monthly income, delivery mode, high birthweight, and gestational weight gain before PSM( χ 2=42.38, 10.64, 14.47, 26.85, 10.58, 13.59 , 15.53, 20.64, P <0.05). After PSM, results showed that there were no statistically significant differences between overweight/obese group and the control group in middle and high schools, and mother delivery mode( P >0.05). Logistic regression analysis showed that the risk of overweight and obesity of maternal pre pregnancy on adolescent offspring was 1.54 times higher than control group (95% CI =1.01-2.36) before PSM, and the overweight and obesity of maternal predelivery also increased the risk of overweight and obesity of adolescent offspring( OR=2.35, 95%CI =1.67-3.31). After PSM, maternal overweight and obesity pre pregnancy ( OR=2.17, 95%CI =1.41-3.34) and maternal overweight and obesity pre delivery( OR=2.99, 95%CI =2.08-4.31) significantly increased the risk of overweight and obesity in adolescent offspring.
Conclusion
Maternal overweight and obesity pre pregnancy and pre delivery are associated with increased risk of overweight and obesity in adolescent offspring.
9.Etiology and drug sensitivity of bacterial keratitis in recent 40 years in China: a Meta-analysis
Jiamin LIU ; Kai CAO ; Zijun ZHANG ; Leying WANG ; Zhenyu WEI ; Qingfeng LIANG
Chinese Journal of Experimental Ophthalmology 2022;40(2):157-164
Objective:To evaluate the distribution and drug sensitivity of pathogenic bacteria in patients with bacterial keratitis in recent 40 years in China.Methods:A Meta-analysis was conducted.Five databases including PubMed, ScienceDirect, Embase, CNKI and Wanfang Data Knowledge Service Platform were searched.The research was limited to the hospital-based cross-sectional studies published in Chinese and English between 1980 and 2020, without limitations of subject.Two researchers followed the inclusion and exclusion criteria to complete literature retrieval, data extraction and methodological quality evaluation.The literature quality was assessed with reference to a methodological scoring system for rates. Q test and I2 test were used to quantify the degree of heterogeneity of the included literature.According to the heterogeneity, the fixed effects model or random-effects model was used to calculate the combined rates indicators to perform the Meta-analysis. Results:Twenty-seven original studies were incorporated, including 50 046 cases of bacterial keratitis.A random-effects model for the Meta-analysis showed that the positive rate of bacterial culture in bacterial keratitis was 28% (95% CI: 0.24-0.32). Among the culture-positive bacteria, the percentages of gram-positive cocci and gram-negative bacilli were 57% (95% CI: 0.52-0.62) and 32% (95% CI: 0.28-0.37), respectively.The percentages of gram-positive bacilli and gram-negative cocci were 8% (95% CI: 0.06-0.10) and 1% (95% CI: 0.01-0.02), respectively.In the recent 40 years, the proportion of gram-positive cocci isolated from corneas in China was on the rise, and the proportion of gram-negative bacilli was on the decline.Among them, coagulase-negative Staphylococcus accounted for 23% (95% CI: 0.17-0.30), followed by Pseudomonas aeruginosa 18% (95% CI: 0.14-0.23), Streptococcus pneumoniae 8% (95% CI: 0.06-0.12), Staphylococcus aureus 6% (95% CI: 0.04-0.08), Corynebacterium 4% (95% CI: 0.03-0.07), and Escherichia coli 4% (95% CI: 0.02-0.06). The results of the drug sensitivity test showed that gram-positive cocci were highly sensitive to vancomycin, moxifloxacin, levofloxacin and ofloxacin. Pseudomonas aeruginosa was most sensitive to tobramycin, and Escherichia coli was most sensitive to ofloxacin. Conclusions:This Meta-analysis indicates that the proportion of gram-positive cocci isolated from corneas in China has been on the rise, while the proportion of gram-negative bacilli was on the decline during the recent 40 years.Coagulase-negative Staphylococcus and Pseudomonas aeruginosa have become the most common pathogens of bacterial keratitis in China.The sensitivity of various bacteria to commonly used antibiotics shows a downward trend.The sensitive antibiotics should be selected correctly according to the drug sensitivity results.
10.Clinical features of patients with syndrome of intracranial hypotension complicated by bilateral chronic subdural hematoma
Jinnan ZHANG ; Tao ZENG ; Mingsheng WANG ; Zijun XU ; Liang GAO
Chinese Journal of Neuromedicine 2022;21(12):1238-1244
Objective:To explore the clinical features of patients with syndrome of intracranial hypotension (SIH) complicated by bilateral chronic subdural hematoma (CSDH).Methods:A case-control study was conducted; 16 patients with SIH complicated with bilateral CSDH (SIH group) and 32 patients with bilateral CSDH (non-SIH group) admitted to Department of Neurology and Neurosurgery, Shanghai Tenth People's Hospital Affiliated to Tongji University from January 2016 to October 2020 were selected. The differences of demographic characteristics, initial symptoms, medical history and CT image features between the two groups were compared.Results:(1) In 16 patients from the SIH group, 13 (81.3%) complained of typical postural headache symptoms, 3 (18.6%) showed fake subarachnoid hemorrhage on CT, 80.0% (12/15) showed dural diffuse enhancement on MRI, and 33.3% (5/15) showed signs of brain droop. Spinal MRI showed 27.3% patients (3/11) had signs of intracranial cerebrospinal fluid leakage. Of the 10 patients underwent bilateral trepanation and drainage, 6 experienced postoperative deterioration (4 received multiple additional surgeries including decompressive craniectomy, and 1 severe patient died in hospital after giving up treatment due to malignant tumor). (2) SIH group had significantly younger age, and significantly lower percentages of patients with limb weakness symptoms, hypertension, head trauma histories and increased hematoma pressure during trepanation and drainage, significantly lower age-adjusted comorbidities index, significantly decreased total and differential thickness of bilateral hematoma on CT, significantly shorter disease course, and statistically higher proportion of patients with postural headache and hematoma uniform density than non-SIH group ( P<0.05). Conclusion:According to age, initial symptoms and CT features, bilateral CSDH patients caused by SIH can be identified to a certain extent, and cranial and spinal MRI is recommended for definitive diagnosis of SIH.


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