1.Analysis of the characteristics and influencing factors of mirtazapine steady-state trough concentration and concentration-to-dose ratio
Ze ZHANG ; Mengqiang ZHAO ; Ruiyan YU ; Yiyuan WANG ; Yuanyuan ZHAO ; Jing YU ; Chunhua ZHOU
China Pharmacy 2026;37(6):776-781
OBJECTIVE To analyze the distribution characteristics of mirtazapine steady-state trough concentration and concentration-to-dose ratio ( C / D ), and to investigate the influence of clinical and genetic factors on C / D . METHODS A retrospective study was conducted on hospitalized patients with depression who received mirtazapine treatment and underwent therapeutic drug monitoring at the First Hospital of Hebei Medical University from May 2022 to May 2025. The collected data included patients’ gender, age, body mass index, daily dose, steady-state trough concentration, smoking status, history of liver disease, drug type, concomitant medications, and CYP2D6 metabolic phenotype. The C / D was calculated. Spearman rank correlation was used to analyze the relationship between mirtazapine steady-state trough concentration and daily dose. Univariate analysis and multiple linear regression model were employed to screen the factors potentially influencing the C / D of mirtazapine. RESULTS A total of 226 patients were included. The daily dose of mirtazapine was 25.00 (24.82, 30.00) mg/d, the steady-state trough concentration was 44.46 (20.00, 70.00) ng/mL, and the C / D was 1.83 (1.00, 2.00) (ng·d)/(mL·mg). Steady-state trough concentrations were within the reference range (30-80 ng/mL) in 121 patients (53.54%), below the lower limit in 80 patients (35.40%), and above the upper limit in 25 patients (11.06%). A positive correlation was observed between mirtazapine steady-state trough concentration and daily dose (coefficient of determination was 0.320 8, P <0.001). Gender, smoking status, and CYP2D6 metabolic phenotype were significantly associated with the mirtazapine C / D ( P <0.05). CONCLUSIONS Significant interindividual variability exists in mirtazapine steady-state trough concentrations. Gender, smoking status, and CYP2D6 metabolic phenotype are identified as independent influencing factors for the mirtazapine C / D , with higher C / D ratios observed in females, non-smokers, and intermediate metabolizers.
2.Development and application of hospital drug traceability code management model based on full-cycle perspective
Mei ZHANG ; Chunhua GONG ; Guanghui CHEN ; Jiawei LIN ; Haiwei ZHANG ; Kaifeng QIU
China Pharmacy 2026;37(7):854-858
OBJECTIVE To explore and establish a full-cycle management model for drug traceability codes that aligns with national policy requirements and the practical needs of healthcare institutions, thereby enhancing the refinement of drug management and the level of medication safety. METHODS A tripartite strategy integrating “hardware deployment, system transformation, and process re-engineering” was adopted. This involved the introduction of intelligent identification devices (personal digital assistant, high-definition industrial reader), the modification of the hospital information system interface, and the re-engineering of workflows (drug warehousing, dispensing and distribution, drug withdrawal, uploading to the insurance platform) to achieve comprehensive, informatized collection and association of drug traceability codes throughout all stages. RESULTS A full-cycle management model for drug traceability codes was successfully established, realizing the goals of making drugs “traceable to their source, trackable in their distribution, and accountable in their responsibility”. The patient waiting time for medication dispensing before and after the implementation was [3.08(1.67,5.58)] min and [3.28(1.77,5.98)] min, respectively. Among them, the patient waiting time under the pre-preparation mode was [3.60(2.13,6.35)] min and [3.50(2.03,6.30)] min, respectively; the patient waiting time under the real-time mode was [2.05(0.83,4.03)] min and [2.78(1.18,5.38)] min, respectively; the number of dispensing errors was 3, 0, respectively; the staffing of relevant positions had not been increased. CONCLUSIONS The drug traceability code management model constructed from a full-cycle perspective effectively meets national policy requirements. It provides data support for refined hospital management and offers solid technical and procedural safeguards for ensuring patient medication safety and strengthening medical insurance fund supervision, demonstrating practical value.
3.Quality control of Sagina japonica by HPLC fingerprint combined with quantitative analysis of multi-components by single-marker
Junhong LIU ; Xue LI ; Meiqin ZHANG ; Han HU ; Chunmei BAI ; Chunhua LIU ; Yongjun LI
China Pharmacy 2026;37(7):883-888
OBJECTIVE To establish the high-performance liquid chromatography (HPLC) fingerprint of Sagina japonica , and to establish a quantitative analysis of multi-components by single-marker (QAMS) method for simultaneous determination of six componen ts in S. japonica , aiming to provide references for the quality control of this medicinal herb. METHODS HPLC method was used to establish the fingerprints of 12 batches (No. S1-S12) of S . japonica according to Similarity Evaluation System of Chromatographic Fingerprint of Traditional Chinese Medicine . The similarity evaluation and identification of common peaks were conducted, followed by cluster analysis (CA) and principal component analysis (PCA) for 12 batches of samples. Using vicenin-2 as internal reference, the contents of p-hydroxy cinnamic acid, apigenin-6-C-arabinoside-8-C-glucoside, isoorientin, vitexin and 20-hydroxyecdysone were determined by QAMS method. The results were then compared with those obtained by the external standard method. RESULTS The similarities of HPLC fingerprints for 12 batches of S . japonica ranged from 0.828-0.998. A total of 17 common peaks were calibrated, and 6 common peaks were identified. Specifically, peak 5 was identified as vicenin-2, peak 7 as p-hydroxycinnamic acid, peak 10 as apigenin-6-C-arabinoside-8-C-glucoside, peak 11 as isoorientin, peak 13 as vitexin, and peak 15 as 20-hydroxyecdysone. The results of CA showed that S1-S5, S7 and S9-S11 were clustered into one category, S6 was clustered into one category, and S8 and S12 were clustered into one category. The results of PCA revealed that the accumulative contribution rate of the four main components was 89.430%. The content ranges measured by QAMS method for p-hydroxy cinnamic acid, apigenin-6-C-arabinoside-8-C-glucoside, isoorientin, vitexin and 20-hydroxyecdysone were 0.017 4-0.269 4, 0.568 8-4.240 3, 0.503 2-5.040 3, 0.024 0-0.132 0 and 2.551 3-4.881 1 mg/g, respectively. There was no significant difference in the contents of components measured between QAMS method and the external standard method ( P >0.05). CONCLUSIONS The established HPLC fingerprint and QAMS method can be used for quality evaluation and quality control of S . japonica.
4.Timing selection for the treatment of vitreous hemorrhage after panretinal photocoagulation in proliferative diabetic retinopathy
Hongru MA ; Xinyi HOU ; Chenglin FU ; Chunhua DAI ; Jing ZHANG ; Meng XIN ; Shu LIU
International Eye Science 2026;26(9):1578-1584
Panretinal photocoagulation(PRP)is the first-line treatment for severe non-proliferative diabetic retinopathy and proliferative diabetic retinopathy(PDR).Its therapeutic efficacy varies due to multiple patient-specific systemic and ocular factors. Despite standardized PRP, some patients fail to show adequate regression of neovascularization and subsequently develop vitreous hemorrhage(VH). In such cases, pars plana vitrectomy(PPV)effectively clears the hemorrhage, restores transparency of the ocular media, supplement PRP, and delays the progression of PDR, thus becoming a critical intervention. With recent advances in surgical techniques, concepts, and equipment, early PPV intervention for VH following PRP has emerged as a growing research focus. Nevertheless, consensus remains lacking regarding its indications, optimal timing, and surgical protocols. This article systematically reviews relevant domestic and international studies, summarizing the surgical timing, approaches, and prognoses of PPV for VH in PDR patients after PRP, aiming to provide evidence-based reference for clinical decision-making and reduce the risk of PDR-related blindness.
5.Research advances in autoimmune pancreatitis with pancreatic exocrine insufficiency
Xiang AO ; Chenxiao LIU ; Xianda ZHANG ; Taojing RAN ; Chunhua ZHOU ; Duowu ZOU
Journal of Clinical Hepatology 2025;41(2):395-400
Autoimmune pancreatitis is a special type of chronic pancreatitis that can lead to abnormal pancreatic exocrine function in patients. Autoimmune pancreatitis comorbid with pancreatic exocrine insufficiency has a complex pathogenesis, and there is limited research on this topic, leading to the lack of understanding of such patients in clinical practice. This article introduces the epidemiology of autoimmune pancreatitis, briefly describes the pathogenesis of pancreatic exocrine insufficiency caused by autoimmune pancreatitis, and summarizes the various detection methods for pancreatic exocrine function, nutritional assessments, lifestyle management, and drug therapy, in order to strengthen the understanding of autoimmune pancreatitis comorbid with pancreatic exocrine insufficiency and improve the clinical diagnosis and treatment of pancreatic exocrine insufficiency.
6.Distribution characteristics of self-reported diseases and occupational injuries among workers in manufacturing enterprises
Lin ZHANG ; Zhi’an LI ; Yishuo GU ; Juan QIAN ; Chunhua LU ; Jianjian QIAO ; Yong QIAN ; Zeyun YANG ; Xiaojun ZHU
Journal of Environmental and Occupational Medicine 2025;42(2):165-170
Background Diseases severely affect the efficiency of workers. Comorbidity refers to the coexistence of two or more chronic diseases or health problems in the same individual. Previous studies have primarily focused on occupational injuries caused by environmental exposures, while the analysis of the epidemiological characteristics of self-reported diseases and occupational injuries among manufacturing workers has been insufficient. Objective To analyze the distribution of self-reported diseases and occupational injuries among manufacturing workers, the strength of correlation between different diseases, and common disease combinations, and to preliminarily explore the relationship between self-reported diseases and occupational injuries. Methods A cross-sectional survey was conducted to investigate the occupational injuries of
7.A randomized,double-blind,placebo-controlled,multicenter clinical study of Shengxuebao Mixture in treating cancer-related anemia
Zhu LIU ; Xiangrong LI ; Xiaojun DAI ; Yanjun WANG ; Xiao LI ; Keqiong WANG ; Tao WU ; Miaowen ZHONG ; Hongjiang YU ; Ji FENG ; Zuowei HU ; Kainan LI ; Shaowei CHEN ; Chunhua LI ; Zhengchuan FU ; Rui ZHANG ; Yongfa CHEN ; Hongyu XU ; Tao REN ; Yibo YAO ; Jianxu JIN ; Pengyin WANG ; Zhijiang HE ; Jian SHEN ; Lei WANG ; Min LI ; Wenming CHANG ; Xinyi CHEN ; Li HOU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(10):1447-1459
Objective We aimed to evaluate the efficacy and safety of Shengxuebao Mixture in the treatment of cancer-related anemia(CRA)presenting with syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood.Methods A randomized,double-blind,placebo-controlled,multicenter clinical trial was conducted.Eligible patients with malignant tumors meeting the inclusion and exclusion criteria were enrolled from 26 hospitals,including Dongzhimen Hospital,Beijing University of Chinese Medicine,Xiaogan Central Hospital,and Yangzhou Hospital of Traditional Chinese Medicine,from June 1,2022,to September 30,2024.Patients were allocated 1:1 to either the experimental group receiving Shengxuebao Mixture or the control group receiving its simulator(placebo)using a block randomization method under double-blind conditions.Both groups received 15 mL orally three times daily for 28 consecutive days.The primary efficacy indicators included the hemoglobin(Hb)improvement rate(RHb)and the traditional Chinese medicine(TCM)syndrome improvement rate(RTCM)at week 4 of treatment.The secondary efficacy indicators encompassed Hb and red blood cell(RBC)count,Karnofsky Performance Status(KPS)score,TCM syndrome score,individual TCM symptom scores,and changes in each of these indicators compared to the baseline period at weeks 2,4,and 6 of treatment.Safety evaluations were conducted at week 4 of treatment.Results A total of 239 patients were enrolled,with 225 cases included in the Full Analysis Set(FAS)(109 in the experimental group vs.116 control group),163 in the Per Protocol Set(PPS)(77 vs.86),and 225 in the Safety Set(SS)(109 vs.116).Baseline characteristics between groups showed no significant differences.Significant differences were observed between the experimental and control groups in RHb at week 4(FAS:49.51%vs.35.24%,P<0.05;PPS:53.25%vs.36.05%,P<0.05)and RTCM at week 4(FAS:61.54%vs.39.62%,P<0.01;PPS:64.94%vs.40.70%,P<0.01).At weeks 2,4,and 6,the experimental group showed greater improvements in Hb and RBC counts than the control group.Additionally,the TCM syndrome scores were lower in the experimental group than in the control group at these time points.Except for week 2 in PPS,the KPS improvement was better in the experimental group than in the control group(P<0.05).The experimental group also demonstrated a greater reduction in scores for individual TCM symptoms such as spiritlessness and weakness,poor appetite and reduced food intake at weeks 4 and 6 compared to the control group(P<0.05,P<0.01).Furthermore,the reduction in vertigo score was more pronounced in the experimental group at week 6(P<0.01).For the score of pale and lusterless complexion,only in the PPS was the reduction from baseline more significant in the experimental group than in the control group at weeks 4 and 6(P<0.05).No significant differences were observed between the experimental and control groups in the incidence of all adverse events or drug-related adverse reactions.Conclusion Shengxuebao Mixture demonstrates significant efficacy in patients with CRA presenting syndrome of deficiency of liver and kidney combined with syndrome of deficiency of both qi and blood,effectively increasing Hb levels,ameliorating TCM syndromes,alleviating clinical symptoms,and enhancing functional status,with no significant difference in adverse drug reactions compared to the placebo.
8.Epidemiological and clinical characteristics of influenza A/B virus infection in children aged 0-4 in Jining City from 2022 to 2024
Jinghong GUO ; Yan LIU ; Ying ZHANG ; Chunhua HUANG ; Yanan SONG ; Qian DONG
Chinese Journal of Experimental and Clinical Virology 2025;39(1):91-95
Objective:To analyze the epidemiological and clinical characteristics of influenza A/B virus (IAV/IBV) infection in children aged 0-4 years in Jining city from 2022 to 2024.Methods:A retrospective analysis was conducted on the data of 3 106 influenza affected children who visited two monitoring outpost hospitals in Jining city from January 2022 to January 2024. They were separated into two groups based on the type of virus infection: IAV group (n=1 829) and IBV group (n=1 277). Two groups were compared for general information, epidemiological characteristics, and laboratory test indicators.Result:The majority of influenza patients were boys (59.01%) and 1-4 years old (63.01%), with peak body temperature mainly ranging from 37.8 to 38.9 ℃ (59.30%). Coughing (69.00%) and runny nose (66.03%) were the main manifestations. The onset season was concentrated in winter (42.43%) and spring (40.44%), and the exposure target were family members (51.90%), and the proportion of influenza vaccine injections (20.90%) was relatively low. The proportions of visit time≤3 d, peak body temperature≥39.0 ℃, myocardial damage, liver function damage, white blood cell count (WBC) of 4-10×10 9/L, and neutrophil percentage (N)>70% in the IAV group were higher than those in the IBV group ( P<0.05). The proportions of preschool children and WBC>10×10 9/L in the IBV group were higher than those in the IAV group ( P<0.05). Conclusions:Children aged 0-4 years who are infected with IAV in Jining City are more common in terms of high fever, early medical attention, impaired heart and liver function, normal WBC, and abnormal N elevation compared to those infected with IBV. However, children aged 0-4 who are infected with IBV have abnormally high WBC and are more common in daycare.
9.Identification of Molecular Subtypes of Breast Cancer Using Machine Learning Models Based on Multimodal MRI
Mengying XU ; Pan ZHANG ; Chunhua LI ; Jian LI ; Zihan HONG ; Bing CHEN
Chinese Journal of Medical Imaging 2025;33(10):1043-1048,1055
Purpose To explore the value of machine learning models based on synthetic MRI,dynamic contrast-enhanced MRI(DCE-MRI)and diffusion weighted imaging(DWI)parameters in identifying molecular subtypes of breast cancer.Materials and Methods A retrospective analysis was conducted on the data of 292 patients who underwent synthetic MRI,DCE-MRI and DWI examinations from September 2020 to September 2024 in Ningxia Medical University General Hospital before surgery and were pathologically confirmed to have breast cancer postoperatively.Patients were randomly divided into training and test sets using a ratio of 7:3.Multiple parameters were obtained from the synthetic MRI,DCE-MRI and DWI images.Variance analysis were used to screen the characteristic parameters among molecular subtype groups.Five machine learning models were established based on the selected characteristic parameters,and receiver operating characteristic curves were plotted to calculate the area under the curve among the molecular subtype groups.Results The support vector machine model exhibited the highest overall performance,with an area under the curve of 0.972,accuracy of 82.5%,specificity of 94.76%and sensitivity of 82.14%in the test set.This model's area under the curve values for differentiating luminal A,luminal B,human epidermal growth factor receptor-2 overexpression,and triple-negative groups in the training set were 0.979,0.925,0.971 and 0.982,respectively;in the test set,the area under the curve values were 0.973,0.873,0.956 and 0.955,respectively.Conclusion Machine learning models based on multimodal MRI parameters can assist clinicians in preoperatively determining the molecular subtypes of breast cancer and the support vector machine model shows relatively high comprehensive performance.
10.Analysis of prostate cancer screening results and exploration of screening model for elderly males in Songjiang Rural Areas of Shanghai City based on PSA preliminary screening under the community linkage mode
Daocheng FANG ; Lingfeng WU ; Lixin CHEN ; Chunhua TANG ; Yong WANG ; Hui LI ; Hui WANG ; Kui ZHANG ; Shuangquan SUN ; Qiang GAO ; Mingyuan DONG ; Chao WANG ; Yi YANG ; Zhiwei YANG ; Jing LIU ; Wendi DU ; Zhenbing SHI ; Shumei BI ; Hui WEN
Chinese Journal of Preventive Medicine 2025;59(2):230-234
This study aims to analyze the screening results and epidemiological characteristics of prostate cancer (PCa) among elderly males in the rural areas of Songjiang, Shanghai City, through the implementation of a preliminary prostate-specific antigen (PSA) screening based on a community-linkage model, and to explore an effective screening approach. A retrospective observational study design was employed to collect data from residents who underwent PSA screening at Songjiang Hospital affiliated to Shanghai Jiao Tong University School of Medicine, in collaboration with multiple community health service centers in Songjiang District, Shanghai City, between June 2022 and June 2024, through free clinics and annual health examinations. Prostate biopsy was recommended for individuals with total PSA (tPSA) levels >10 ng/ml and those with 4 ng/ml≤tPSA≤10 ng/ml and abnormal free-to-total PSA (f/tPSA) ratios. Clinical characteristics of detected PCa patients were analyzed. Follow-up was conducted through phone calls and home visits by family doctors, coupled with enhanced health education. The results indicated that a total of 17 198 residents participated in the screening, among which 2 234 (12.99%) had tPSA levels between 4 ng/ml and 10 ng/ml, and 257 (1.49%) had tPSA levels >10 ng/ml. Ultimately, 417 residents underwent prostate biopsy, with 171 being diagnosed with PCa, yielding a positive biopsy rate of 41.00% and a PCa detection rate of 0.99%. The predominant pathological subtype among PCa patients was adenocarcinoma (168 cases, 98.24%). Of the 146 PCa patients who received treatment, the majority were classified as intermediate or high-risk (124 cases, 84.93%). Furthermore, with the optimization of the screening model, there was a significant increase in the proportion of subsequent outpatient visits. In conclusion, the community-linkage-based PSA screening model demonstrated high effectiveness in screening for PCa among elderly males in the rural areas of Songjiang, Shanghai City. Epidemiological findings revealed that PCa patients in this region are primarily composed of intermediate and high-risk groups, highlighting the need for intensified early screening and health education.

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