1.Changes in renal function in chronic hepatitis B patients treated initially with entecavir versus tenofovir alafenamide fumarate and related influencing factors
Shipeng MA ; Yanqing YU ; Xiaoping WU ; Liang WANG ; Liping LIU ; Yuliang ZHANG ; Xin WAN ; Shanfei GE
Journal of Clinical Hepatology 2025;41(1):44-51
ObjectiveTo investigate the influence of entecavir (ETV) versus tenofovir alafenamide fumarate (TAF) on renal function in previously untreated patients with chronic hepatitis B (CHB). MethodsA retrospective analysis was performed for the clinical data of 167 previously untreated CHB patients who received ETV or TAF treatment for at least 48 weeks at the outpatient service of Department of Infectious Diseases in The First Affiliated Hospital of Nanchang University from September 2019 to November 2023, and according to the antiviral drug used, they were divided into ETV group with 117 patients and TAF group with 50 patients. In order to balance baseline clinical data, propensity score matching (PSM) was used for matching and analysis at a ratio of 2∶1, and the two groups were compared in terms of estimated glomerular filtration rate (eGFR) and the incidence rate of abnormal renal function at week 48. According to eGFR at week 48, the patients were divided into normal renal function group and abnormal renal function group. The independent-samples t test or the Mann-Whitney U test was used for comparison of continuous data between two groups, and the chi-square test or the Fisher’s exact test was used for comparison of categorical data between two groups. The multivariate Logistic regression analysis was used to investigate the influencing factors for abnormal renal function, and the receiver operating characteristic (ROC) curve was used to assess the performance of each indicator in predicting abnormal renal function. The Kaplan-Meier method was used to analyze the cumulative incidence rate of abnormal renal function, and the log-rank test was used for comparison. The analysis of variance with repeated measures was used to compare the dynamic changes of eGFR during antiviral therapy in CHB patients. ResultsAfter PSM matching, there were 100 patients in the ETV group and 50 patients in the TAF group. There were no significant differences in baseline clinical data between the ETV group and the TAF group (all P>0.05), with an eGFR level of 112.29±9.92 mL/min/1.73 m2 in the ETV group and 114.72±12.15 mL/min/1.73 m2 in the TAF group. There was a reduction in eGFR from baseline to week 48 in both groups, and compared with the TAF group at week 48, the ETV group had a significantly lower eGFR (106.42±14.12 mL/min/1.73 m2 vs 112.25±13.44 mL/min/1.73 m2, t=-2.422, P=0.017) and a significantly higher incidence rate of abnormal renal function (17.00% vs 4.00%, χ2=5.092, P=0.024). After the patients were divided into normal renal function group with 131 patients and abnormal renal function group with 19 patients, the univariate analysis showed that there were significant differences between the two groups in age (Z=-2.039, P=0.041), treatment drug (ETV/TAF) (χ2=5.092, P=0.024), and baseline eGFR level (t=4.023, P<0.001), and the multivariate Logistic regression analysis showed that baseline eGFR (odds ratio [OR]=0.896, 95% confidence interval [CI]: 0.841 — 0.955, P<0.001) and treatment drug (OR=5.589, 95%CI: 1.136 — 27.492, P=0.034) were independent influencing factors for abnormal renal function. Baseline eGFR had an area under the ROC curve of 0.781 in predicting abnormal renal function in CHB patients, with a cut-off value of 105.24 mL/min/1.73 m2, a sensitivity of 73.68%, and a specificity of 82.44%. The Kaplan-Meier curve analysis showed that the patients with baseline eGFR≤105.24 mL/min/1.73 m2 had a significantly higher cumulative incidence rate of abnormal renal function than those with baseline eGFR>105.24 mL/min/1.73 m2 (χ2=22.330, P<0.001), and the ETV group had a significantly higher cumulative incidence rate of abnormal renal function than the TAF group (χ2=4.961, P=0.026). With the initiation of antiviral therapy, both the ETV group and the TAF group had a significant reduction in eGFR (F=5.259, P<0.001), but the ETV group only had a significant lower level of eGFR than the TAF group at week 48 (t=-2.422, P=0.017); both the baseline eGFR≤105.24 mL/min/1.73 m2 group and the baseline eGFR>105.24 mL/min/1.73 m2 group had a significant reduction in eGFR (F=5.712, P<0.001), and there was a significant difference in eGFR between the two groups at baseline and weeks 12, 24, 36, and 48 (t=-13.927, -9.780, -8.835, -9.489, and -8.953, all P<0.001). ConclusionFor CHB patients initially treated with ETV or TAF, ETV antiviral therapy has a higher risk of renal injury than TAF therapy at week 48.
2.Construction and effectiveness evaluation of a closed-loop management system for dispensed oral drugs in the inpatient pharmacy based on SWOT analysis
Jia WANG ; Weihong GE ; Ruijuan XU ; Shanshan QIAN ; Xuemin SONG ; Xiangling SHENG ; Bin WU ; Li LI
China Pharmacy 2025;36(4):401-406
OBJECTIVE To improve the efficiency and quality of dispensed oral drug management in the inpatient pharmacy, and ensure the safety of drug use in patients. METHODS SWOT (strength, weakness, opportunity, threat) analysis method was used to analyze the internal strengths and weaknesses, as well as the external opportunities and threats in the construction of a closed-loop management system for dispensed oral drugs in the inpatient pharmacy of our hospital, and propose improvement strategies. RESULTS & CONCLUSIONS A refined, full-process, closed-loop traceability management system for dispensed oral drugs in the inpatient pharmacies was successfully established, which is traceable in origin, trackable in destination, and accountable in responsibility. After the application of this system, the registration rate of dispensed drug information and the correctness rate of registration content both reached 100%. The proportion of overdue drug varieties in the same period of 2024 decreased by 77.78% compared to March 2020, the inventory volume decreased by 29.50% compared to the first quarter of 2020, the per-bed medication volume decreased by 32.14% compared to the first quarter of 2020; the average workload per post in the same period of 2023 increased by 49.09% compared to 2019, the dispensing accuracy rate reached 100%, and the improvement rate of quality control problem increased by 25.25% compared to 2021. This system effectively improves the safety and accuracy of dispensed oral drug management in the inpatient pharmacy.
3.Status of Clinical Practice Guideline Information Platforms
Xueqin ZHANG ; Yun ZHAO ; Jie LIU ; Long GE ; Ying XING ; Simeng REN ; Yifei WANG ; Wenzheng ZHANG ; Di ZHANG ; Shihua WANG ; Yao SUN ; Min WU ; Lin FENG ; Tiancai WEN
Medical Journal of Peking Union Medical College Hospital 2025;16(2):462-471
Clinical practice guidelines represent the best recommendations for patient care. They are developed through systematically reviewing currently available clinical evidence and weighing the relative benefits and risks of various interventions. However, clinical practice guidelines have to go through a long translation cycle from development and revision to clinical promotion and application, facing problems such as scattered distribution, high duplication rate, and low actual utilization. At present, the clinical practice guideline information platform can directly or indirectly solve the problems related to the lengthy revision cycles, decentralized dissemination and limited application of clinical practice guidelines. Therefore, this paper systematically examines different types of clinical practice guideline information platforms and investigates their corresponding challenges and emerging trends in platform design, data integration, and practical implementation, with the aim of clarifying the current status of this field and providing valuable reference for future research on clinical practice guideline information platforms.
4.Development status analysis and suggestions of TCM pharmacists in Chinese public TCM hospitals
Baojuan XUE ; Ning WU ; Yang ZHAO ; Junshu GE ; Yi WANG ; Zheyuan LIU ; Zhaoheng YANG ; Ying SUN
China Pharmacy 2025;36(8):903-907
OBJECTIVE To understand the development status and existing problems of traditional Chinese medicine(TCM) pharmacists in public TCM hospitals in China, aiming to provide suggestions for the competent departments to formulate management policies for TCM pharmacists and promote the healthy development of TCM. METHODS The data on the number and professional titles of TCM pharmacists in public TCM hospitals in China from 2019 to 2023 were collected. Descriptive analysis was employed to analyze the number, distribution and professional titles of TCM pharmacists in public TCM hospitals across the country, and to measure the quantity shortfalls of the number of TCM pharmacists in these hospitals. RESULTS From 2019 to 2023, the number of TCM pharmacists in public TCM hospitals in China grew slowly, with an average annual growth rate of 2.56%. However, the proportion of TCM pharmacists to the total number of pharmacists in public TCM hospitals gradually decreased, with an average annual growth rate of -0.65%. In terms of hospital grades, the number of TCM pharmacists in tertiary public TCM hospitals showed positive growth, while those in secondary and primary public TCM hospitals showed negative growth. In terms of hospital types, the average annual growth rate of TCM pharmacists in TCM hospitals was 2.22%, in integrated Chinese and Western medicine hospitals it was 7.97%, and in ethnic minority medicine hospitals it was 2.74%. The development of TCM pharmacists in different provinces was uneven. The annual growth rate of TCM pharmacists in Guizhou exceeded 10%, while the growth rate in Hunan and Heilongjiang was negative. In 2023, the number of TCM pharmacists per thousand population in public TCM hospitals was 0.03, indicating a relatively low staffing level. The professional titles of TCM pharmacists in public TCM hospitals were mainly primary and E-mail:601907549@qq.com intermediate, with a total of 67.33%. According to the calculation that the proportion of TCM pharmacists to pharmacists was not less than 60%, public TCM hospitals and hospitals of integrated TCM and Western medicine should be reconfigured with TCM pharmacists 6 212 and 1 288 people, respectively. CONCLUSIONS The number of TCM pharmacists in public TCM hospitals is growing slowly, with insufficient staffing levels, relatively low professional titles, and uneven distribution and development across provinces. It is suggested that relevant competent departments strengthen policy guidance, increase the attention given by the state level to TCM pharmacists, strengthen the construction of the talent team for TCM pharmacists, improve the quality and optimize the allocation of TCM pharmacist talents in order to promote the high-quality development of TCM services.
5.Enhancing Disciplinary Development Through Journal Columns: Taking the "Clinical Practice Guidelines"Column in Medical Journal of Peking Union Medical College Hospital as an Example
Meihua WU ; Hui LIU ; Qi ZHOU ; Qianling SHI ; Na LI ; Yule LI ; Xiaoqing LIU ; Kehu YANG ; Jinhui TIAN ; Long GE ; Bin MA ; Xiuxia LI ; Xuping SONG ; Xiaohui WANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2025;16(5):1315-1324
To explore the role of the "Clinical Practice Guidelines" column and others in the We collected papers published by the Lanzhou University Evidence-Based Medicine Center team in the "Clinical Practice Guidelines" column and others from 2018 to 2025. These publications were analyzed across multiple dimensions, including authorship and institutional affiliations, citation metrics, and research themes and content. A total of 59 papers were included in the analysis, with authors representing 70 domestie and international research institutions. The cumulative citation count was 639, with the highest single-paper citation frequency reaching 101. The average citation per paper was 10.8, and total downloads exceeded 30 000. The content focused on key themes such as guideline terminology, development methodology, guideline evaluation, and dissemination and implementation. The evolution of research topics progressed from critiques of common misconceptions and hot topies in the field to multidimensional evaluations of thecurrent state of Chinese guidelines, culminating in the fommulation of industry standards for guidelines. These contributions have provided critical references for translating guideline theory into practice in China and have garnered widespread attention and discussion among scholars in the field. The "Clinical Practice Guidelines" column and others in the
6.Simultaneous determination of cyromazine and melamine in poultry eggs and meat with ultra-high performance liquid chromatography-tandem mass spectrometry
ZHANG Xiang ; WU Xiaoqiong ; GE Miaohua ; ZHOU Ying ; OUYANG Nan
Journal of Preventive Medicine 2025;37(7):751-756
Objective:
To establish an ultra-high performance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) method based on solid-phase extraction column purification for simultaneous determination of cyromazine and melamine in poultry eggs and meat.
Methods:
Eggs, quail eggs, and chicken were collected from markets. After homogenization, the sample was extracted with 0.5% formic acid in acetonitrile, subjected to solid-phase extraction using an MCX cartridge, and eluted with 5% ammonia in methanol. The eluate was collected, evaporated to near dryness under nitrogen, and reconstituted in a 10% aqueous methanol solution. Separated using TSK gel Amide-80 column (2.0 mm×150 mm, 5 μm), cyromazine and melamine were simultaneously detected in positive ion multiple reaction monitoring mode via tandem mass spectrometry, with quantification achieved by isotope dilution internal standard methods. Efficiency was enhanced and matrix interference minimized by optimizing conditions such as sample extraction, solid-phase extraction cartridge selection, and instrumental parameters. Calibration curves were constructed, and detection limits, quantification limits, spiked recoveries, and relative standard deviations for (RSD) of cyromazine and melamine were calculated.
Results:
After method optimization, matrix effects for cyromazine and melamine ranged from 0.97 to 1.04, indicating no significant matrix suppression or enhancement. Both cyromazine and melamine exhibited excellent linearity within the concentration range of 1.0-200.0 ng/mL, with correlation coefficients ≥0.999 5. The limits of detection were 0.3 μg/kg for cyromazine and 0.5 μg/kg for melamine, the quantification limits were 1.0 and 1.5 μg/kg, respectively. At spiked levels of 1.0, 20.0, and 150.0 μg/kg, the average recoveries ranged from 78.6% to 103.1%, with RSD between 3.5% and 6.3%. Among 95 samples tested, cyromazine was detected in 6 samples and melamine in 5 samples; neither cyromazine nor melamine was detected in chicken samples.
Conclusion
The UPLC-MS/MS method established in this study enables simultaneous detection and accurate quantification of cyromazine and melamine in poultry eggs and meat.
7.Epidemiological characteristics of scrub typhus in Huai'an, Jiangsu Province in 2006 - 2024
Lei XU ; Zhizhen CUI ; Qiang GAO ; Hao JU ; Chuanyu WAN ; Ranfeng HANG ; Shiyao WU ; Ben CAI ; Zheng ZHANG ; Haiyan GE
Journal of Public Health and Preventive Medicine 2025;36(6):39-42
Objective To describe and analyze the epidemiological characteristics of scrub typhus in Huai'an, Jiangsu Province from 2006 to 2024 and explore the long-term incidence trend and distribution of high-risk areas, and to formulate targeted prevention and control strategies. Methods The scrub typhus case report data of Huai'an from 2006 to 2024 in the Chinese Disease Prevention and Control Information System were extracted for descriptive analysis. Results A total of 898 cases of scrub typhus were reported in Huai'an, with an average annual incidence rate of 0.96 per 100 000 from 2006 to 2024. There was a turning point in the incidence trend of scrub typhus in 2011. From 2006 to 2011, the annual percentage change (APC) was 47.09% (95% CI: 7.53 - 859.39), and the upward trend was statistically significant (P < 0.05). From 2012 to 2024, the APC was -2.12% (95% CI: -29.09 - 3.75), and the downward trend was not statistically significant. October and November were the high-incidence months, and the total concentration from 2006 to 2024 was 0.93, indicating that scrub typhus had strict seasonality. The circular distribution method estimated that the peak period of the epidemic was from October 11th to November 25th, and the peak day of incidence was November 3rd. Jinhu County was a high-incidence area. The ratio of male to female cases was 1.03. The age group with the highest reported incidence was 40 to < 80 years old. The occupation with the highest proportion was farmers, accounting for 78.03%. Conclusion From 2006 to 2024, scrub typhus in Huai'an shows a peak every 3 - 4 years. Middle-aged and elderly farmers are the key population at risk, and Jinhu County is a key area. In the future, targeted health education should be carried out to effectively control the prevalence of scrub typhus.
8.Bioequivalence study of sidenafil citrate tablets in Chinese healthy subjects
Xiao-Bin LI ; Lu CHEN ; Xiu-Jun WU ; Yu-Xin GE ; Wen-Chao LU ; Ting XIAO ; He XIE ; Hua-Wei WANG ; Wen-Ping WANG
The Chinese Journal of Clinical Pharmacology 2024;40(3):430-434
Objective To evaluate the bioequivalence of oral sidenafil citrate tablets manufactured(100 mg)test preparations and reference preparations in healthy subjects under fasting and fed conditions.Methods Using a single-dose,randomized,open-lable,two-period,two-way crossover design,36 healthy subjects respectively for fasting and fed study were enrolled,and randomized into two groups to receive a single dose of test 100 mg with 7-day washout period.Plasma concentration of sidenafil and N-demethylsildenafil was determined by liquid chromatography-tandem mass spectrometry(LC-MS/MS)method.The pharmacokinetic parameters were calculated by Analyst 1.6.3(AB Scie)using non-compartmental model,and bioequivalence evaluation was performed for the two preparations.Relevant safety evaluations were performed during the trial.Results The main pharmacokinetic parameters of sidenafil after a single oral dose of sidenafil citrate tablets under fasting condition for test and reference were as follows:Cmax were(494.69±230.94)and(558.78±289.83)ng·mL-1,AUC0-t were(1 336.21±509.78)and(1 410.82±625.99)h·ng·mL-1,AUC0-were(1 366.49±512.16)and(1 441.84±628.04)h·ng·mL-1,respectively.The main pharmacokinetic parameters of sidenafil under fed condition for T and R were as follows:Cmax were(381.89±126.53)and(432.47±175.91)ng·mL-1,AUC0-t were(1 366.34±366.99)and(1 412.76±420.37)h·ng·mL-1,AUC0-were(1 403.28±375.32)and(1 454.13±429.87)h·ng·mL-1,respectively.The results demonstrated the bioequivalence of sidenafil citrate tablets between T and R.The incidence of adverse events in fasting and fed tests were 33.33%and 25.00%,respectively.No serious adverse event was reported.Conclusion The test and reference formulation of sidenafil citrate tablets were equivalent and was safe.
9.Bioequivalence study of buspirone hydrochloride tablets in Chinese healthy subjects
Ping LU ; Rui WANG ; Hui-Hui WU ; Hai-Yan LIU ; Ge-Fei HE ; Shun-Zhi ZHANG ; Wei WU
The Chinese Journal of Clinical Pharmacology 2024;40(5):723-727
Objective To study the pharmacokinetic characteristics of buspirone hydrochloride tablets in healthy adult populations under conditions of fasting and postprandial administration.Methods A single-center,randomized,three-cycle partially repeated crossover trial design was adopted,and 36 subjects were enrolled on fasting/postprandial,one tablet of the test preparation was taken in one cycle,one tablet of reference preparation(5 mg of buspirone tablets)was taken once in each of 2 cycles,the drug concentration of buspirone in plasma was determined by liquid chromatography-tandem mass spectrometry,and the pharmacokinetic parameters were calculated by WinNonlin software.Results Main pharmacokinetics of buspirone after oral administration of test and reference preparations in fasting group,the Cmax was(285.72±286.08)and(308.94±341.03)pg·mL-1;AUC0-t were(577.09±491.10)and(618.62±642.56)pg·mL-1·h;AUC0-∞ were(586.85±510.04)and(655.92±687.95)pg·mL-1·h;tmax was 0.75(0.33-4.00)and 0.75(0.33-1.75)h.Main pharmacokinetics of buspirone after oral administration of test and reference preparations in the postprandial group,the Cmax were(676.36±603.64)and(760.33±610.27)pg·mL-1;AUC0-t were(1 755.58±1 001.69)and(1 743.00±1 073.33)pg·h·mL-1;AUC0-∞ were(1 839.97±1 044.60)and(1 818.00±1 106.95)pg·mL-1·h;tmax was 1.25(0.25-4.50)and 1.00(0.25-3.50)h.The 90%confidence intervals of the AUC0-t and AUC0-∞ geometric mean ratios of the test preparation and the reference preparation in the fasting test and the postprandial test all fell between 80.00%and 125.00%,and the 95%upper confidence limit of of Cmax was ≤0 and geometric mean ratios point estimates fall between 80.00%and 125.00%.Conclusion Two kinds of buspirone hydrochloride are bioequivalent in Chinese healthy adult subject.
10.Influencing Factors of Inter-arm Systolic Blood Pressure Differences in Hypertensive Population Aged 40 Years and Younger
Qihuan CAO ; Yinan SU ; Ying ZHU ; Wenli DONG ; Yuxi WANG ; Jing GE ; Shouling WU
Chinese Circulation Journal 2024;39(2):164-170
Objectives:To explore the influencing factors of inter-arm systolic blood pressure difference(sIAD)in young hypertensive population. Methods:A total of 12 895 young Kailuan employees aged≤40 years,who participated in the physical examination from 2010 to 2020,were enrolled in this study.All of them underwent blood pressure measurements of four limbs in supine position.Young hypertensive group(n=3 584)and young non-hypertensive group(n=3 584)were 1∶1 matched by sex and age(±1 year),and participants were further divided into sIAD<10 mmHg(1 mmHg=0.133 kPa)and sIAD≥10 mmHg subgroups.A stepwise multivariate logistic regression model was established to analyze the determinants of sIAD≥10 mmHg. Results:The detection rate of sIAD≥10 mmHg was significantly higher in the young hypertensive group than in the young non-hypertensive group(31.72%vs.27.76%,P<0.001).Stepwise multivariate logistic regression analysis showed that in young hypertensive population,ankle-brachial index(ABI)<0.9,male,obesity,overweight,elevated low density lipoprotein cholesterol(LDL-C)level,and systolic blood pressure were positively associated with sIAD≥10 mmHg,while college education or above,physical exercise were negatively correlated with sIAD≥10 mmHg(all P<0.05).In the young non-hypertensive population,ABI<0.9,systolic blood pressure were positively correlated with sIAD≥10 mmHg,while age was negatively associated with sIAD≥10 mmHg(all P<0.05). Conclusions:The detection rate of sIAD≥10 mmHg is higher in young hypertensive population than in young non-hypertensive population.Decreased ABI,male sex,obesity,overweight,increased LDL-C level,systolic blood pressure,college education and above,and physical exercise are the influencing factors of sIAD≥10 mmHg in young hypertensive population.


Result Analysis
Print
Save
E-mail