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.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.
5.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.
6.Application of Kaitianmen acupoint massage in patients with rheumatoid arthritis
Yahui CHENG ; Chunhua YAN ; Fangfang HU ; Xinguo FAN ; Wenling CHU ; Caihong ZHANG ; Chunjie WANG
Chinese Journal of Practical Nursing 2025;41(2):96-102
Objective:To explore the application effect of Kaitianmen point massage on pain, faligue, anxiety and depression in patients with rheumatoid arthritis.Methods:This study was a randomized controlled study, a total of 80 patients with rheumatoid arthritis who were admitted to Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine from May to November 2023 were selected as the research objects. The control group was given routine treatment and nursing, and the experimental group was given Kaitianmen acupoint massage on the basis of routine treatment and nursing. The differences in pain score, fatigue score, anxiety and depression score before and after intervention were compared between the two groups.Results:In the final, there were 37 cases in the experimental group and 36 cases in the control group completed the study. Before intervention, there was no statistically significant difference in pain scores, fatigue scores, anxiety and depression scores between the two groups (all P>0.05). After four weeks of intervention, the pain score of the experimental group was (2.06 ± 0.35), and that of the control group was (3.72 ± 0.59), the difference was statistically significant ( t=14.57, P<0.05). After four weeks of intervention, the fatigue score of the experimental group was (20.11 ± 8.03), and that of the control group was (25.02 ± 8.32), the difference was statistically significant ( t=2.55, P<0.05). After four weeks of intervention, the anxiety score of the experimental group was (48.33 ± 6.13), which was significantly different from (53.99 ± 4.91) of the control group ( t=4.35, P<0.05), and the depression score of the experimental group was (49.99 ± 6.33), compared with the (54.86 ± 4.83) of control group, the difference was statistically significant ( t=3.69, P<0.05). Conclusions:Kaitianmen acupoint massage can relieve limb pain, fatigue, anxiety and depression in patients with rheumatoid arthritis, which is worthy of clinical promotion.
7.A case of hemopneumothorax caused by ruptured pulmonary sequestration during pregnancy
Huayang SUN ; Lihang ZHONG ; Yufang CUI ; Xiaojing ZHANG ; Xietong WANG ; Chunhua ZHANG
Chinese Journal of Perinatal Medicine 2025;28(4):335-338
This article reported a pregnant woman admitted to the hospital due to "25 +2 weeks of amenorrhea and a 1-day history of shortened cervical canal accompanied by vaginal bleeding". The patient with pregestational diabetes mellitus and suboptimal glycemic control required prolonged hospitalization for tocolytic therapy due to shortened cervical length. She developed a cough at 31 weeks and 4 days of gestation, followed by right-sided intercostal pain and hypotension after coughing at 31 weeks and 6 days of gestation. Bedside chest ultrasound showed a small anechoic fluid collection (approximately 1.1 cm in width) in the right pleural cavity. The emergency cesarean section was performed at 31 weeks and 4 days of gestation. However, the intraoperative bleeding and other conditions were inconsistent with the obstetric clinical presentations of blood loss. Subsequent repeated ultrasound and CT examinations confirmed the diagnosis of pulmonary sequestration and right-sided progressive hemopneumothorax. On the same day, an emergency right lower lobectomy was performed, achieving stable postoperative recovery. Both mother and infant had favorable outcomes. Hemopneumothorax complicated by pulmonary sequestration is uncommon, and its occurrence during pregnancy is exceedingly rare. Multidisciplinary consultations, aggressive, rapid, and accurate diagnosis, and combined treatment are critical to ensuring maternal-fetal survival. Hemopneumothorax caused by the rupture of pulmonary sequestration during pregnancy represents a life-threatening condition. Emergency thoracotomy can timely clarify the cause, arrest bleeding, relieve compression, and resect the lesion, thereby reducing mortality and the complications risk.
8.Interpreting the Key Differences between CHS-DRG 2.0 and 1.1 from a Clinical Management Perspective
Xinbing LÜ ; Chunhua PAN ; Xifeng SHEN ; Baoyan ZHANG ; Xiang LONG ; Xiaokun GENG ; Yingfeng WU
Chinese Health Economics 2025;44(4):50-55
Objective:Interpret the key differences between the China Health-care Security Diagnosis Related Groups(CHS-DRG)2.0 and CHS-DRG 1.1,and provide reference for optimizing management strategies in medical institutions.Methods:Text analysis was used to import the CHS-DRG 2.0 and 1.1 grouping scheme dictionary data into the SQL database in a structured table format using SQL Server 2014.The key differences between the two schemes in grouping structure,grouping rules,grouping results,and other aspects were identified.Results:CHS-DRG 2.0 version added 26 groups,deleted 3 groups,and refined 10 groups into 20 groups for 14 clinical specialties at the ADRG level compared to CHS-DRG 1.1.Some group codes,names,and grouping rules were adjusted;Adjusted some grouping conditions and grouping results at the DRG level.Conclusion:CHS-DRG 2.0 version has improved grouping efficiency compared to CHS-DRG 1.1,solved some clinical bottleneck problems,and standardized the role of clinical diagnosis in grouping from the perspective of resource consumption.However,it has not completely solved the grouping problems of multi disease co treatment,multi disease treatment,and combined surgery.The adjustment of DRG weights and rates,the follow-up of related supporting policy reforms,and the negative effects of DRG will still pose challenges for medical institutions.
9.CT and MRI manifestations of gastritis cystica profunda
Qian YANG ; Jing YUAN ; Ruili MAO ; Zhiying XUE ; Peng ZHONG ; Weiguo ZHANG ; Chunhua LIU
Chinese Journal of Medical Imaging Technology 2025;41(2):277-280
Objective To observe CT and MRI manifestations of gastritis cystica profunda(GCP).Methods Seventeen patients with GCP confirmed by operation or biopsy pathology were enrolled,and lesions'CT and MRI manifestations were observed.Results Among 17 cases,16 cases(16/17,94.12%)were found with single lesion and 1(1/17,5.88%)with diffuse multiple lesions.The lesion located in the fundus of stomach in 5 cases(5/17,29.41%),in the body of stomach in 4 cases(4/17,23.53%),in the cardia and antrum of stomach each in 3 cases(3/17,17.65%)and in the pylorus in 1 case(1/17,5.88%),while 1 case(1/17,5.88%)was found with diffused multiple lesions within stomach.Non-enhance CT showed local thickening of gastric wall in 10 cases(10/17,58.82%),all were isodensities,and the mucosa uniformly enhanced in contrast enhance CT(CECT).Predominately cystic lesion in 5 cases(5/17,29.41%)presented as submucosal cystic protrusions,and grew into the stomach cavity with circular or oblong low density in non-enhanced CT,while sandwich enhancement of mucosa was observed in CECT.Among these 5 cases(5/17,29.41%),MRI showed lesion confined to the submucosa with low signal on T1WI and high signal on T2WI,while diffusion weighted imaging showed unrestricted diffusion,and the enhancement pattern was consistent with that of CT in 2 cases.In other 2 cases(2/17,11.77%)with cystic-solid lesion,non-enhanced CT showed soft tissue density,while CECT showed lump-like stratified enhancement.Conclusion CT and MRI manifestations of GCP had certain characteristics.
10.Analysis of the therapeutic effect of precise disconnection of pargastric varices guided by endoscopic ultrasound for the treatment of esophagogastric variceal bleeding(20 cases)
Fulong ZHANG ; Jing XU ; Xiao LI ; Yan SHI ; Zongyuan ZHAN ; Yongzhen HU ; Chunhua ZHOU ; Qun ZHU ; Hai WANG ; Chaojun HUANG ; Hongyan YUAN ; Yuhong JIANG ; Yuandong ZHU
China Journal of Endoscopy 2025;31(8):85-90
Objective To explore the therapeutic effect of precise disconnection of pargastric varices guided by endoscopic ultrasound in the treatment of esophagogastric variceal bleeding.Method A retrospective analysis was conducted on 20 patients with cirrhosis esophagogastric variceal bleeding treated with endoscopic ultrasound-guided precise disconnection of pargastric varices from January 1,2024 to December 31,2024.The efficacy was analyzed.Result All 20 patients successfully completed the precise disconnection of pargastric varices under the guidance of endoscopic ultrasound.The injection of tissue gel combined with the placement of spring coils(14 cases)and the injection of tissue gel alone(4 cases)successfully blocked the pargastric varices.All patients did not experience perforation,esophageal and cardia stenosis,massive bleeding,septicemia,or ectopic embolization.One patient who received tissue gel alone had slight bleeding from the pargastric varices after surgery and improved after 3 days of treatment to reduce portal vein pressure.Another one patient who received tissue gel alone had a low-grade fever and normal body temperature after 3 days of anti-infection treatment.Conclusion Precise disconnection of pargastric varices under the guidance of endoscopic ultrasound has a good therapeutic effect on esophagogastric variceal bleeding,with fewer complications such as ectopic embolization,massive bleeding,infection,and perforation.However,close follow-up observation is still needed to address the issue of pargastric varices.

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