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.

Purpose To quantitatively evaluate myocardial three-dimensional strains using cardiac magnetic resonance feature tracking,investigate whether ferroptosis contributes to myocardial injury in experimental autoimmune myocarditis(EAM),and explore the relationship between strains and ferroptosis biomarkers.Materials and Methods EAM was induced in Lewis rats via subcutaneous injections with porcine cardiac myosin emulsified in same amount of complete Freund's adjuvant.Both EAM(n=15)and control(n=15)rats underwent 7T cardiac magnetic resonance and were euthanatized at day 21.Cardiac magnetic resonance assessments included left ventricular function and strains.The cardiac damage and ferroptosis-related markers were measured with histopathology,serology,Western blot and polymerase chain reaction.Results The left ventricular ejection fraction declined in the rats post-immunization with porcine cardiac myosin at day 21(t=7.86,P<0.001).Global,basal,middle and apical strains encompassing radial strain,circumferential strain and longitudinal strain were significantly lower in the EAM group compared to the control group(t=2.61-10.45,P<0.05).Cardiac and inflammatory biomarkers,including lactate dehydrogenase,cardiac troponin I and interferon γ indicated myocardial injury in EAM group compared to the control group(t=16.54,21.20,16.06,all P<0.001).Prussian blue staining revealed iron overload in EAM group.Compared to the control group,malondialdehyde and reactive oxygen significantly increased in EAM group(t=15.75,3.47,both P<0.01),and superoxide dismutase were significantly decreased(t=14.21,P<0.001).Western blot and histopathology showed that the protein expression of ferritin heavy chain was significantly higher in the EAM group compared to the control group(t=5.15,P<0.01).The solute carrier family 7 member 11/glutathione/glutathione peroxidase 4 axis was down regulated at serum,mRNA and protein expression levels in EAM group(t=7.73-30.14,all P<0.001).Global circumferential and longitudinal strains were significantly associated with ferroptosis biomarkers(r=-0.854-0.829,all P<0.05).Conclusion Cardiac magnetic resonance feature tracking has the potential to quantitatively evaluate myocardial damage of EAM which involves ferroptosis.The strains are related with ferroptosis biomarkers.

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.

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.

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.

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.

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.

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.

Objective To establish a standardized diagnostic and treatment pathway for chronic renal failure(CRF)based on a nephrology cluster,providing a reference for the traditional Chinese medicine(TCM)diagnosis and treatment of CRF.Methods A TCM diagnostic and treatment proto-col for CRF was developed through cluster construction.A preliminary framework for the standardized diagnostic and treatment pathway of CRF was constructed through literature research.Three rounds of Delphi expert consultation were conducted among 26 experts.The experts'enthusiasm,authority,co-ordination of opinions,importance ratings,and coefficient of variation were analyzed to ultimately form the standardized diagnostic and treatment pathway for CRF.Results The active coefficients(Caj)for the first,second,and third rounds of expert consultation were 1.000,0.923,and 1.000,respectively.The expert authority coefficients(Cr)were 0.895,0.910,and 0.923,respectively.The overall Kendall's W coefficients were 0.233,0.248,and 0.293(P＜0.001).The final stand-ardized diagnostic and treatment pathway for CRF included 4 primary indicators,19 secondary indica-tors,and 77 tertiary indicators,with mean importance ratings ranging from 4.42 to 4.87 and coeffi-cients of variation ranging from 0.072 to 0.126.Conclusion The standardized diagnostic and treat-ment pathway for CRF established based on a nephrology cluster is highly scientific and reliable,with clear guidance and ease in implementation,providing good guidance for the TCM diagnosis and treat-ment of CRF.

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.