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.Clinical efficacy and influencing factors of Chaihu anxin capsules in the treatment of mild-to-moderate depression
Yaqing LI ; Yupei HAO ; Shizhao YUAN ; Wentao WANG ; Chunhua ZHOU ; Yancong HAN ; Yuanyuan ZHAO ; Zhuo ZHANG ; Shulian FU ; Jing YU
China Pharmacy 2026;37(18):2402-2407
OBJECTIVE To evaluate the clinical efficacy of Chaihu anxin capsules in the treatment of mild-to-moderate depression, analyze the influencing factors of its efficacy, construct a nomogram prediction model.METHODS Patients with mild-to-moderate depression treated at The First Hospital of Hebei Medical University from May 1, 2023 to March 10, 2025 were retrospectively included and categorized into Chaihu anxin capsules group and milnacipran group according to treatment regimen. Propensity score matching (PSM) was used to balance baseline characteristics, and treatment efficacy was compared after 8 weeks, including 24 Hamilton Depression Scale (HAMD-24) scores and changes, Hamilton Anxiety Scale (HAMA) scores and changes, and treatment response rate after 8 weeks of treatment. Patients receiving Chaihu anxin capsules were further classified as responders or non-responders based on the occurrence of treatment response. Univariate and multivariate Logistic regression analyses were conducted to identify the influencing factors of treatment response, and a nomogram model was constructed to predict the probability of treatment response, its predictive performance was evaluated using receiver operating characteristic (ROC) curves, calibration curves, and decision curve analysis.RESULTS A total of 297 patients were included before PSM, including 196 patients in the Chaihu anxin capsules group and 101 patients in the milnacipran group. After PSM, each group included 44 patients. After PSM, the HAMD-24 scores and HAMA scores at 8 weeks after treatment in the Chaihu anxin capsules group, as well as the HAMD-24 scores in the milnacipran group, were significantly lower than their respective baseline values ( P <0.05); the change in HAMA score in the Chaihu anxin capsules group was significantly greater than that in the milnacipran group ( P =0.04). Multivariable Logistic regression identified age, total bilirubin, and baseline HAMD-24 score as independent predictors of treatment response ( P <0.05). The area under the ROC curve of the constructed nomogram prediction model was 0.72 (95% confidence interval: 0.637-0.799), and the corrected Brier score was 0.143 (95% confidence interval: 0.112-0.176); compared with the “all intervention” and “all non intervention” strategies, applying this nomogram prediction model could achieve higher net benefits within the threshold probability range of 8% to 37%.CONCLUSIONS The efficacy of Chaihu anxin capsules in improving mild-to-moderate depression is comparable to that of milnacipran, and it has certain advantages in improving anxiety symptoms; age, total bilirubin, and baseline HAMD-24 score are independent influencing factors for the treatment response of Chaihu anxin capsules. The nomogram prediction model constructed based on these factors has good discrimination, calibration, and clinical applicability.
3.Comprehensive Clinical Evaluation of Different Preparations of Amphotericin B Based on A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition)
Chaoli CHEN ; Ran FU ; Donghan WANG ; Luyao CHANG ; Yang SONG ; Jing YU ; Chunhua ZHOU
Herald of Medicine 2025;44(11):1835-1842
Objective To conduct a comprehensive evaluation of Amphotericin B Deoxycholate(AmB-D)for injection,Liposomal Amphotericin B(L-AmB)for injection,and Amphotericin B Colloidal Dispersion(ABCD)for injection,and to provide a reference for the selection and rational use of drugs in medical institutions.Methods Based on the quantitative evaluation and selection record form in the A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition),evidence was collected to conduct a comprehensive assessment of the included drugs.Results Comprehensively considering the pharmacological properties,efficacy,safety,economy,and other attributes of different preparations of amphotericin B,the quantitative scoring results were ranked from high to low,with ABCD(CSPC Ouyi Pharmaceutical Co.,Ltd.)scoring 79.10 points,L-AmB(Gilead Sciences)scoring 78.30 points,and L-AmB(Shanghai Shangyao Xinya Pharmaceutical Co.,Ltd.)scoring 72.01 points.AmB-D(Shanghai Shanghai Pharmaceutical Xinya Pharmaceutical Co.,Ltd)scored 63.20 points,and AmB-D(North China Pharmaceutical Co.,Ltd.)scored 59.78 points.Conclusion Both L-AmB and ABCD have better clinical efficacy and higher safety in the treatment of invasive fungal infections,and ABCD has a better price advantage than L-AmB.Based on A Quick Guideline for Drug Evaluation and Selection in Chinese Medical Institutions(the Second Edition),the evaluation results of different preparations of amphotericin B can provide a reference for the selection and rational use of amphotericin B in medical institutions.
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.Effect of Processed Polygonatum cyrtonema in Preventing Depression Induced by Chronic Unpredictable Mild Stress in Female Rats
Xinyu DENG ; Chunhua MA ; Zimeng WANG ; Man TANG ; Xinran LI ; Lurong YU ; Xianyuan HE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):117-124
ObjectiveTo observe the prevention and control effect of processed Polygonatum cyrtonema on depression induced by chronic unpredictable mild stress (CUMS) in female rats. MethodsForty rats were assigned into control, model, and low-, medium-, and high-dose processed P. cyrtonema groups according to the random number table method, with 8 rats in each group. The rat model of depression was established with the CUMS method. The body mass, open field test, forced swimming test, Morris water maze test, levels of neurotransmitters [dopamine (DA), 5-hydroxytryptamine (5-TH), and acetylcholine (ACh)], serum levels of sex hormones [gonadotropin-releasing hormone(GnRH), testosterone (T), and estradiol (E2)] and inflammatory factors [tumor necrosis factor-α (TNF-α), interleukin (IL)-6, and IL-10], and mRNA and protein levels of factors in the brain-derived neurotrophic factor (BDNF)/tyrosine kinase receptor B (TRKB)/cAMP-response element binding protein (CREB) pathway were employed to evaluate the effect of processed P. cyrtonema on the CUMS-induced depression in female rats. ResultsThe body mass, open field test results, and forced swimming test results showed that the rat model of depression was successfully established. The comparison of behaviors, neurotransmitters, sex hormones, inflammatory factors, and neural pathways among groups showed that processed P. cyrtonema had different effects of preventing the development of depression in female rats. SPSS 25 was used for statistical analysis of error and significance. T test was conducted between groups. Each treatment group showed significant therapeutic effect compared with the model group (P<0.05). Processed P. cyrtonema elevated the level of 5-TH (P<0.01) and lowered the levels of DA and ACh (P<0.01) in the brain tissue of female rats. In addition, it reduced the serum levels of GnRH, T, E2, TNF-α, and IL-6 (P<0.05) and up-regulated the mRNA levels of BDNF and TRKB in the rat brain. ConclusionProcessed P. cyrtonema has a non-hyperactive preventive effect on CUMS-induced depression in rats, which provides a theoretical basis for the development of processed P. cyrtonema as a functional food product.
6.Effect of Processed Polygonatum cyrtonema in Preventing Depression Induced by Chronic Unpredictable Mild Stress in Female Rats
Xinyu DENG ; Chunhua MA ; Zimeng WANG ; Man TANG ; Xinran LI ; Lurong YU ; Xianyuan HE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):117-124
ObjectiveTo observe the prevention and control effect of processed Polygonatum cyrtonema on depression induced by chronic unpredictable mild stress (CUMS) in female rats. MethodsForty rats were assigned into control, model, and low-, medium-, and high-dose processed P. cyrtonema groups according to the random number table method, with 8 rats in each group. The rat model of depression was established with the CUMS method. The body mass, open field test, forced swimming test, Morris water maze test, levels of neurotransmitters [dopamine (DA), 5-hydroxytryptamine (5-TH), and acetylcholine (ACh)], serum levels of sex hormones [gonadotropin-releasing hormone(GnRH), testosterone (T), and estradiol (E2)] and inflammatory factors [tumor necrosis factor-α (TNF-α), interleukin (IL)-6, and IL-10], and mRNA and protein levels of factors in the brain-derived neurotrophic factor (BDNF)/tyrosine kinase receptor B (TRKB)/cAMP-response element binding protein (CREB) pathway were employed to evaluate the effect of processed P. cyrtonema on the CUMS-induced depression in female rats. ResultsThe body mass, open field test results, and forced swimming test results showed that the rat model of depression was successfully established. The comparison of behaviors, neurotransmitters, sex hormones, inflammatory factors, and neural pathways among groups showed that processed P. cyrtonema had different effects of preventing the development of depression in female rats. SPSS 25 was used for statistical analysis of error and significance. T test was conducted between groups. Each treatment group showed significant therapeutic effect compared with the model group (P<0.05). Processed P. cyrtonema elevated the level of 5-TH (P<0.01) and lowered the levels of DA and ACh (P<0.01) in the brain tissue of female rats. In addition, it reduced the serum levels of GnRH, T, E2, TNF-α, and IL-6 (P<0.05) and up-regulated the mRNA levels of BDNF and TRKB in the rat brain. ConclusionProcessed P. cyrtonema has a non-hyperactive preventive effect on CUMS-induced depression in rats, which provides a theoretical basis for the development of processed P. cyrtonema as a functional food product.
7.Study on the influential factors of blood concentration for duloxetine based on therapeutic drug monitoring
Yang LUN ; Liguang DUAN ; Feiyue AN ; Ran FU ; Jing YU ; Chaoli CHEN ; Mengqiang ZHAO ; Shi SU ; Yang SONG ; Jiaqi WANG ; Yuhang YAN ; Chunhua ZHOU
China Pharmacy 2025;36(6):727-731
OBJECTIVE To explore the main factors influencing the blood concentration of duloxetine, and provide a scientific basis for the individualized use of duloxetine. METHODS Retrospective analysis was conducted on 434 inpatients with depressive disorders at the First Hospital of Hebei Medical University, who were treated with duloxetine and underwent blood concentration monitoring between January 2022 and April 2024. The study examined the impact of various factors, including gender, age, body mass index (BMI), gene phenotypes, combined medication, drug type (original/generic), and genotyping results of gene single nucleotide polymorphism loci, on blood concentration and the concentration-to-dose (C/D) after dose adjustment. RESULTS The blood concentration of duloxetine was 76.65 (45.57, 130.31) ng/mL, and C/D was 0.96 (0.63, 1.60) ng·d/(mL·mg). The blood concentration of duloxetine was positively correlated with the daily dose of administration (R2=0.253 7, P<0.001). Blood concentration of duloxetine in 38.94% of patients exceeded the recommended range specified in the guidelines. Gender, age, BMI, combined use of CYP2D6 enzyme inhibitors, and CYP2D6 and CYP1A2 phenotypes had significant effects on C/D of duloxetine (P<0.05). CONCLUSIONS The patient’s age, gender, BMI, combined medication, and genetic phenotypes are closely related to the blood concentration of duloxetine.
8.Percutaneous coronary intervention vs . medical therapy in patients on dialysis with coronary artery disease in China.
Enmin XIE ; Yaxin WU ; Zixiang YE ; Yong HE ; Hesong ZENG ; Jianfang LUO ; Mulei CHEN ; Wenyue PANG ; Yanmin XU ; Chuanyu GAO ; Xiaogang GUO ; Lin CAI ; Qingwei JI ; Yining YANG ; Di WU ; Yiqiang YUAN ; Jing WAN ; Yuliang MA ; Jun ZHANG ; Zhimin DU ; Qing YANG ; Jinsong CHENG ; Chunhua DING ; Xiang MA ; Chunlin YIN ; Zeyuan FAN ; Qiang TANG ; Yue LI ; Lihua SUN ; Chengzhi LU ; Jufang CHI ; Zhuhua YAO ; Yanxiang GAO ; Changan YU ; Jingyi REN ; Jingang ZHENG
Chinese Medical Journal 2025;138(3):301-310
BACKGROUND:
The available evidence regarding the benefits of percutaneous coronary intervention (PCI) on patients receiving dialysis with coronary artery disease (CAD) is limited and inconsistent. This study aimed to evaluate the association between PCI and clinical outcomes as compared with medical therapy alone in patients undergoing dialysis with CAD in China.
METHODS:
This multicenter, retrospective study was conducted in 30 tertiary medical centers across 12 provinces in China from January 2015 to June 2021 to include patients on dialysis with CAD. The primary outcome was major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke. Secondary outcomes included all-cause death, the individual components of MACE, and Bleeding Academic Research Consortium criteria types 2, 3, or 5 bleeding. Multivariable Cox proportional hazard models were used to assess the association between PCI and outcomes. Inverse probability of treatment weighting (IPTW) and propensity score matching (PSM) were performed to account for potential between-group differences.
RESULTS:
Of the 1146 patients on dialysis with significant CAD, 821 (71.6%) underwent PCI. After a median follow-up of 23.0 months, PCI was associated with a 43.0% significantly lower risk for MACE (33.9% [ n = 278] vs . 43.7% [ n = 142]; adjusted hazards ratio 0.57, 95% confidence interval 0.45-0.71), along with a slightly increased risk for bleeding outcomes that did not reach statistical significance (11.1% vs . 8.3%; adjusted hazards ratio 1.31, 95% confidence interval, 0.82-2.11). Furthermore, PCI was associated with a significant reduction in all-cause and cardiovascular mortalities. Subgroup analysis did not modify the association of PCI with patient outcomes. These primary findings were consistent across IPTW, PSM, and competing risk analyses.
CONCLUSION
This study indicated that PCI in patients on dialysis with CAD was significantly associated with lower MACE and mortality when comparing with those with medical therapy alone, albeit with a slightly increased risk for bleeding events that did not reach statistical significance.
Humans
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Percutaneous Coronary Intervention/methods*
;
Male
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Female
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Coronary Artery Disease/drug therapy*
;
Retrospective Studies
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Renal Dialysis/methods*
;
Middle Aged
;
Aged
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China
;
Proportional Hazards Models
;
Treatment Outcome
9.Role of vascular endothelial growth factor B and fibroblast growth factor in maintenance of skeletal muscle mass
Yanpu Zhao ; Xiaoyu Yang ; Huikang Yu ; Xueling Yang ; Chunhua Yang ; Geng Tian
Acta Universitatis Medicinalis Anhui 2025;60(2):293-299
Objective :
To verify the role of vascular endothelial growth factor B(VEGFB) in maintenance of skeletal muscle mass under chow-fed and high-fat diet, and to investigate the role of crosstalk between VEGFB and fibroblast growth factor(FGF) signaling pathways in the process.
Methods :
Four experimental groups were designed: VEGFB+/+chow-fed diet group, VEGFB-/-chow-fed diet group, VEGFB+/+high-fat diet group, VEGFB-/-high-fat diet group. Skeletal muscles from 24 weeks mice were isolated and weighed. Gene expression association analysis and qPCR experiments were conducted to assess FGFs expression levels.
Results :
Under both dietary conditions, VEGFB ablation resulted in reduced muscle mass. Under chow-fed diet condition, 8 FGFs level reduced including 6 paracrine FGFs in the skeletal muscle from VEGFB-/-mice. Under high-fat diet condition, 11 FGFs level decreased including 8 paracrine FGFs in VEGFB-/-mice.
Conclusion
VEGFB may participate in regulating skeletal muscle mass through FGF networks in the skeletal muscles.
10."One-day"intensive training on perioperative cardiac ultrasound for anesthesiologists
Bing BAI ; Xu LI ; Chunhua YU ; Le SHEN
Basic & Clinical Medicine 2025;45(9):1248-1252
Objective To explore the teaching effect of a"one-day"training model for basic application of periop-erative echocardiography for refresher anesthesiologists based on AR glasses and simulators.Methods The cardiac ultrasound teaching team of the Department of Anesthesiology at Peking Union Medical College Hospital designed a"one-day"teaching course for 60 trainees with no prior experience,based on AR glasses and simulators,covering basic applications of transthoracic echocardiography(TTE)and transesophageal echocardiography(TEE).We col-lected the scores of theoretical and practical assessments before and after the training and conducted a survey on trainee satisfaction and changes in clinical behavior post-training.Statistical analysis was performed using SPSS 23.0 software.Results The theoretical knowledge scores before and after the training were 52.35±12.33 and 81.20±22.78,respectively(P<0.05);the practical assessment scores were 30.33±10.65 and 73.96±23.15,respectively(P<0.05).Overall satisfaction rate was 96.66%(58/60).Conclusions The"one-day"teaching model for basic application of perioperative cardiac ultrasound based on AR glasses and simulators,as an introductory training model,can help beginners quickly master the core content at the entry level and lay a solid foundation for subsequent clinical application.


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