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 establish an ion-pair chromatographic method combined with an electrospray detector(CAD)for the simultaneous determination of glycyrrhizin,glycine and D,L-methionine in compound glycyrrhizin tablets.Methods:An Agilent Poroshell 120 SB-C18 column(2.1 mm ×250 mm,4 μm)was adopted.0.3％non-afluorovaleric acid(A)-acetonitrile(B)was used as the mobile phase with a gradient elution(0-8 min,100％A,8-15 min,82％A,and 15-30 min,40％A).The flow rate was 0.2 mL·min-1.The column temperature was set at 30 ℃.The detector of CAD was applied with collection frequency of 10 Hz,nebulization temperature of 35 ℃,filter:5.Results:The peaks of glycyrrhizin,glycine,and D,L-methionine were well separated by this method,and the recoveries of spiked samples were 100.4％,100.4％,and 100.1％.The results of the three bat-ches of samples were in the range of 95.0％-105.0％.Conclusion:The method is show well convenience,sensi-tivity and accurate for the quality control of compound glycyrrhizin tablets.

Objective:To analyze and explore the selection of secondary intervention strategies for residual issues following congenital aortic valve disease surgery in children, as well as to evaluate their prognostic efficacy.Methods:A retrospective analysis was conducted on the clinical data of 41 children with residual issues after congenital aortic valve disease surgery, who were treated at the Department of Cardiovascular and Thoracic Surgery, Shanghai Children's Medical Center, between January 2013 and August 2024. Among them, 25 were male and 16 were female, with a mean age of(116.8±45.1)months and a mean weight of(40.0±20.2)kg. The mean interval for secondary intervention was(60.0±36.4)months. The residual issues included aortic valve insufficiency(20 cases), aortic valve stenosis(11 cases), and combined aortic valve insufficiency and stenosis(10 cases).Results:Secondary interventions included aortic valve repair(7 cases), mechanical valve replacement(20 cases), Ross procedure(13 cases), and Ozaki procedure(1 case). Additionally, 5 cases with left ventricular outflow tract stenosis underwent concomitant Konno surgery.One case of early postoperative in-hospital death occurred, with a mortality rate of 2.4%, primarily due to acute left heart failure and multiple organ dysfunction. The average follow-up period for surviving children was( 64.6±34.5) months(5-147 months), with no mid- to long-term mortality. Follow-up results showed that In surviving children, the left heart showed significant reduction in size postoperatively, with the LVEDD Z-score decreasing from 1.24±2.23 before surgery to -0.97±1.48( P=0.001). Postoperative LVEF 0.66±0.06 showed no significant difference compared to pre-reintervention 0.68±0.10( P=0.140). In aortic stenosis(AS) patients, the peak transvalvular pressure gradient decreased from(69.5±19.8) mmHg(1 mmHg=0.133 kPa) preoperatively to(25.1±10.9) mmHg postoperatively( P=0.003). In aortic insufficiency(AI) patients, the width of the aortic regurgitation jet decreased from(5.8±1.1) mm preoperatively to(2.7±1.1) mm postoperatively( P=0.012). 97.5% of children maintained mild-to-moderate aortic regurgitation(jet width <4 mm), with only 1 case of moderate regurgitation(jet width 4.4 mm)remaining under close observation.Two children underwent reoperation on the aortic valve, with a tertiary intervention rate of 5.0%. One case underwent redo commissurotomy 21 months after aortic valve repair due to recurrent stenosis, and the other underwent mechanical valve replacement 34 months after the Ozaki procedure due to leaflet calcification and infective endocarditis. Mid-term follow-up revealed good cardiac function recovery in surviving children, with 87.5% achieving NYHA functional class Ⅰ/Ⅱ. Conclusion:Due to the demands of growth and development and the degenerative nature of valve tissue, residual issues are inevitable in the mid- to long-term following congenital aortic valve disease surgery in children, often necessitating secondary intervention. Given the lack of suitable autologous valve tissue, the use of aortic valve replacement has significantly increased in secondary interventions. The Ross procedure, as an ideal secondary intervention, demonstrates satisfactory mid-term follow-up outcomes. For children with high-risk factors for the Ross procedure, mechanical valve replacement also yields favorable prognoses.

This article reports the diagnosis and treatment process of a case of iron deficiency anemia in a patient with Crohn's disease who has a poor response to iron supplementation therapy. It reviews relevant literature reports to enhance clinicians' understanding of iron deficiency anemia in patients with inflammatory bowel disease who have a poor response to iron supplementation therapy, and to provide timely effective treatment and regular follow-up and monitoring for the patient after analyzing the causes of anemia.

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 analyze and explore the selection of secondary intervention strategies for residual issues following congenital aortic valve disease surgery in children, as well as to evaluate their prognostic efficacy.Methods:A retrospective analysis was conducted on the clinical data of 41 children with residual issues after congenital aortic valve disease surgery, who were treated at the Department of Cardiovascular and Thoracic Surgery, Shanghai Children's Medical Center, between January 2013 and August 2024. Among them, 25 were male and 16 were female, with a mean age of(116.8±45.1)months and a mean weight of(40.0±20.2)kg. The mean interval for secondary intervention was(60.0±36.4)months. The residual issues included aortic valve insufficiency(20 cases), aortic valve stenosis(11 cases), and combined aortic valve insufficiency and stenosis(10 cases).Results:Secondary interventions included aortic valve repair(7 cases), mechanical valve replacement(20 cases), Ross procedure(13 cases), and Ozaki procedure(1 case). Additionally, 5 cases with left ventricular outflow tract stenosis underwent concomitant Konno surgery.One case of early postoperative in-hospital death occurred, with a mortality rate of 2.4%, primarily due to acute left heart failure and multiple organ dysfunction. The average follow-up period for surviving children was( 64.6±34.5) months(5-147 months), with no mid- to long-term mortality. Follow-up results showed that In surviving children, the left heart showed significant reduction in size postoperatively, with the LVEDD Z-score decreasing from 1.24±2.23 before surgery to -0.97±1.48( P=0.001). Postoperative LVEF 0.66±0.06 showed no significant difference compared to pre-reintervention 0.68±0.10( P=0.140). In aortic stenosis(AS) patients, the peak transvalvular pressure gradient decreased from(69.5±19.8) mmHg(1 mmHg=0.133 kPa) preoperatively to(25.1±10.9) mmHg postoperatively( P=0.003). In aortic insufficiency(AI) patients, the width of the aortic regurgitation jet decreased from(5.8±1.1) mm preoperatively to(2.7±1.1) mm postoperatively( P=0.012). 97.5% of children maintained mild-to-moderate aortic regurgitation(jet width <4 mm), with only 1 case of moderate regurgitation(jet width 4.4 mm)remaining under close observation.Two children underwent reoperation on the aortic valve, with a tertiary intervention rate of 5.0%. One case underwent redo commissurotomy 21 months after aortic valve repair due to recurrent stenosis, and the other underwent mechanical valve replacement 34 months after the Ozaki procedure due to leaflet calcification and infective endocarditis. Mid-term follow-up revealed good cardiac function recovery in surviving children, with 87.5% achieving NYHA functional class Ⅰ/Ⅱ. Conclusion:Due to the demands of growth and development and the degenerative nature of valve tissue, residual issues are inevitable in the mid- to long-term following congenital aortic valve disease surgery in children, often necessitating secondary intervention. Given the lack of suitable autologous valve tissue, the use of aortic valve replacement has significantly increased in secondary interventions. The Ross procedure, as an ideal secondary intervention, demonstrates satisfactory mid-term follow-up outcomes. For children with high-risk factors for the Ross procedure, mechanical valve replacement also yields favorable prognoses.

Designation of ideological and political teaching of Medical Immunology courses focuses on"cultivate talent for Party and the State",and adheres to goal of"build morality and cultivate people".From perspective of big ideology and politics,with basic foundation of"major guiding,disciplines supporting and curriculum shaping",principle of"six combinations"is applied to con-struct ideological and political cases of Medical Immunology courses,to create an infiltrating teaching pattern,which simultaneously cultivate talent for the Party and the State,and forms a synergistic effect of professional course learning and ideological and political learning.

Objective:To assess the association between temperature and risk of animal injury, and identifying vulnerable populations.Methods:Based on a time-stratified case-crossover design, the number of animal injuries monitored in hospitals of Guangdong Provincial Injury Surveillance System in 2011 and 2015-2016 was included, and the daily meteorological data were derived from the fifth generation of European ReAnalysis-Land, which was produced by the European Centre for Medium-Range Weather Forecasts. Conditional logistic regression combined with a distributed lagged nonlinear model was applied to analyze the association of temperature and animal-specific injuries. We also conducted stratified analysis by region, sex, age, occupation, and location of injury occurrence.Results:There was an almost linear relationship between temperature and the occurrence of animal injury. The excess risk ( ER) of animal injury was 2.65% (95% CI: 2.27%-3.04%) for a 1 ℃ rise in temperature with much higher risk of occurrence ( ER=9.34%, 95% CI: 7.57%-11.13%) for non-mammalian injury than that for mammalian injuries ( ER=2.30%, 95% CI: 1.90%-2.70%). Stratified analysis revealed that the occurrence of animal injury was more susceptible to temperature influences in urban ( ER=2.78%, 95% CI: 2.35%-3.21%), female ( ER=2.71%, 95% CI: 2.16%-3.27%), the elderly aged 60 years and above ( ER=3.05%, 95% CI: 1.65%- 4.47%), farmer ( ER=4.66%, 95% CI: 3.03%-6.32%) and agricultural area ( ER=10.63%, 95% CI: 7.57%-13.79%) than their correspondents. In terms of mammalian injury, dog bites showed the highest risk ( ER=2.71%, 95% CI: 2.12%-3.30%). In terms of non-mammalian,snake injuries were highly influenced by temperature ( ER=16.74%, 95% CI: 11.33%-22.40%). Conclusions:The ambient temperature rises could increase the risk of animal injury with much higher risk for non-mammalian than that for mammalian injuries. Our findings suggest that global warming may increase the risk and disease burden from animal injuries.

Objective:To establish an ion-pair chromatographic method combined with an electrospray detector(CAD)for the simultaneous determination of glycyrrhizin,glycine and D,L-methionine in compound glycyrrhizin tablets.Methods:An Agilent Poroshell 120 SB-C18 column(2.1 mm ×250 mm,4 μm)was adopted.0.3％non-afluorovaleric acid(A)-acetonitrile(B)was used as the mobile phase with a gradient elution(0-8 min,100％A,8-15 min,82％A,and 15-30 min,40％A).The flow rate was 0.2 mL·min-1.The column temperature was set at 30 ℃.The detector of CAD was applied with collection frequency of 10 Hz,nebulization temperature of 35 ℃,filter:5.Results:The peaks of glycyrrhizin,glycine,and D,L-methionine were well separated by this method,and the recoveries of spiked samples were 100.4％,100.4％,and 100.1％.The results of the three bat-ches of samples were in the range of 95.0％-105.0％.Conclusion:The method is show well convenience,sensi-tivity and accurate for the quality control of compound glycyrrhizin tablets.

OBJECTIVE To establish a population pharmacokinetic(PopPK)model to predict the PK characteristics of GLS-010 in humans.METHODS Fifty-eight cynomolgus monkeys were used,18 of which were randomly divided into three groups and received a single intravenous infusion of GLS-010 at doses of 2,6,and 18 mg·kg-1,respectively.The rest were randomly assigned to four groups and received multiple intravenous infusions of GLS-010 at doses of 0,5,25,and 100 mg·kg-1,respectively,once a week(quaque week,qw)for five consecutive weeks.Blood samples were collected before and after administration.The concentrations of GLS-010 in the monkey serum were measured using a validated enzyme-linked immunosorbent assay,while those of anti-drug antibodies(ADA)in the cynomolgus monkey serum were determined by ultra-sensitive electrochemiluminescence immunoassay.The PK data on GLS-010 in cynomolgus monkeys was obtained,and the drug-time curves were plotted.A PopPK model was constructed using non-compartmental analysis and evaluated by goodness-of-fit plots and visual predictive checks.The constructed PopPK model was used to predict the PK characteristics in humans,which were finally compared with actual Phase Ⅰ clinical study results for validation.RESULTS The predictive results of the PopPK model were highly consistent with the actual Phase Ⅰ clinical study results.The model was able to predict the human PK characteristics under various dosing regimens,including 1 mg·kg-1 quaque 2 weeks(q2w),4 mg·kg-1(q2w),240 mg(q2w),240 mg(q3w),and 10 mg·kg-1(q2w).The predicted maximum plasma concentrations(Cmax)were 24.8,99.1,85.0,85.0,and 247.8 mg·L-1,respectively,and the AUC0-336h was 4 902.0,20 060.0,17 147.7,22 145.7(AUC0-504h),and 50 817.6 mg·h·L-1,respectively.The safety risks for the corresponding dosing regimens were 47.3,11.6,13.5,10.5,and 4.6,respectively.The predicted receptor occupancy at steady state(ROss)at Cmax,average plasma concentration(Cavg),and minimum plasma concentration(Cmin)were 38.8％,72.7％,69.4％,64.1％and 87.2％,29.1％,63.8％,60.0％,49.8％and 82.1％,21.9％,55.5％,51.3％,36.3％and 76.7％,respectively.CONCLUSION The PopPK model can effectively predict the human PK characteristics under different dosing regimens with high consistency with actual Phase Ⅰ clinical study results,which can serve as an important reference for selection of safe and effective doses for first-in-human research.