OBJECTIVE To upgrade the drug traceability code management system for a pediatric hospital under the “payment by code” background， aiming to comprehensively enhance traceability integrity， efficiency， and compliance. METHODS Taking Xiamen Children’s Hospital as the implementation setting， a before-and-after control design was adopted to construct an intelligent drug traceability code management system through systematic upgrades involving the technology platform， core mechanisms， and coordination with medical insurance. Key interventions included： upgrading a traceability code management platform and designing a dynamic code pool； innovating differentiated traceability mechanisms for routine， split-dose， and special drugs； establishing a tiered early-warning and emergency response system； and constructing a data coordination and quality control system. The drug traceability code upload rate served as the primary outcome. Process indicators such as the root causes distribution of failed uploads and the duration of medication returns， and a comprehensive outcome （the number of insurance-flagged abnormal prescriptions） were also analyzed. The data between the baseline period （April 2025） and the observation period （June-August 2025） were compared and evaluated. RESULTS After the upgrade， the overall upload rate of drug traceability codes increased from 9.21% （baseline） to 99.86% （August 2025）. The upload rate of traceability codes in previously unmanaged areas， such as the inpatient pharmacy and pharmacy intravenous admixture services， soared from 0 to nearly 100%. The proportion of non-uploads due to system issues fell from 66.44% （June 2025） to 2.62% （August Additionally， the number of insurance-flagged） abnormal prescriptions dropped sharply from 2 275.00 in the first “payment by code” policy month （July 2025） to 212.00 by the end of the observation period （August 2025）， a 90.70% decrease. CONCLUSIONS The developed management system effectively addresses complex scenario challenges such as high-frequency drug splitting. It significantly enhances traceability code upload performance and ensures a high degree of compliance with medical insurance data requirements. These outcomes contribute to proactive risk mitigation against insurance claim denials and demonstrate a concurrent optimization of pharmacy operations.

Objective: To explore the setting of gray zone of Treponema pallidum (TP) testing by retrospective analysis of blood donors with single reagent reactive anti-TP results, so as to improve blood utilization and supply safety. Methods: Blood samples were collected from 112 blood donors previously deferred due to single reagent reactive TP antibody results between January 2020 and December 2023, and subjected to dual ELISA reagents and TPPA test. The gray zone panel analysis was performed on the two ELISA reagents currently used in our department. The detection rate at each concentration of the gray zone panle was counted, and the corresponding concentrations for C , C , and C and gray zone cut-off were calculated. Results: Among the 50 samples deferred by reagent 1, 19 were confirmed reactive and 31 non-reactive in supplementary testing. Among the 62 samples deferred by reagent 2, 12 were confirmed reactive and 50 non-reactive in supplementary testing. For reagent 1, the detection rate of was 56% for S/CO≥1 and 20% for 0.5≤S/CO<1, retrospectively. For reagent 2, the detection rate was 27% for S/CO≥1 and 12.5% for 0.5≤S/CO<1, retrospectively. The detection rate for S/CO≥1 was higher than those for 0.5≤S/CO<1 for both reagents. All the 112 samples were negative in TPPA test. The C concentration of reagent 1 was 1.51 mIU/mL, and the concentration range of C ±20% was 1.21-1.81 mIU/mL. The C concentration of reagent 2 was 1.45 mIU/mL, and the concentration range of C ±20% was 1.16-1.74 mIU/mL. The C and C concentration of both reagents were within the C ±20% range, suggesting that the gray zone cutoff for both Reagent 1 and Reagent 2 should be set at S/CO=0.8 (80% of the CO value). Conclusion: All anti-TP single reagent reactive samples with S/CO value within the gray zone was tested negative by TPPA. It is necessary to consider the rationality and necessity of establishing the gray zone, so as to ensure blood safety and improve the utilization rate of blood resources.

ObjectiveTo observe the clinical effect of Xiaozhi Hugan capsules in treating patients with non-alcoholic steatohepatitis （NASH） combined with phlegm-dampness and blood stasis syndrome and its effects on serum interleukin-6 （IL-6） and monocyte chemoattractant protein-1 （MCP-1）. MethodsA total of 124 patients with NASH combined with phlegm-dampness and blood stasis syndrome who were admitted to the Department of Spleen， Stomach， and Hepatobiliary Diseases， the First Affiliated Hospital of Henan University of Chinese Medicine from July 2020 to December 2022 were selected. According to the random number table method， patients were randomly divided into an observation group （62 cases） and a control group （62 cases）. The treatment duration was 6 months. The observation group received Xiaozhi Hugan capsules orally， while the control group received polyene phosphatidylcholine capsules. The efficacy indicators included alanine aminotransferase （ALT）， aspartate aminotransferase （AST）， controlled attenuation parameter （CAP）， liver stiffness measurement （LSM）， traditional Chinese medicine （TCM） syndrome scores （discomfort/dull pain/distending pain in liver region， fatigue， etc.）， body mass index （BMI）， waist-to-height ratio （WHtR）， high-density lipoprotein cholesterol （HDL-C）， total cholesterol （TC）， triglycerides （TG）， homeostatic model assessment for insulin resistance （HOMA-IR） ［including fasting blood glucose （FBG） and fasting insulin level （INS）］， free fatty acids （FFA）， IL-6， and MCP-1. Adverse drug reactions were recorded. ResultsAfter treatment， the total effective rate in the observation group was 92.3% （48/52）， while that in the control group was 75.5% （39/49）. The total effective rate in the observation group was higher than that in the control group （χ²=5.339， P<0.05）. After treatment， the TCM syndrome scores in both groups were significantly reduced （P<0.05）， and the post-treatment scores in the observation group were better than those in the control group （P<0.05）. After treatment， the levels of ALT， AST， TC， FFA， fasting insulin （FINS）， HOMA-IR， MCP-1， IL-6， CAP， LSM， BMI， and WHtR were decreased （P<0.05） significantly in both groups， and the observation group showed superior improvement in the above indicators compared to the control group （P<0.05）. The observation group exhibited significant reductions in TG and FBG （P<0.05） and an increase in HDL-C （P<0.05）， while no significant changes were observed in the control group. The observation group was superior to the control group after treatment （P<0.05）. No severe adverse reactions occurred in either group during the treatment. ConclusionXiaozhi Hugan capsules have significant clinical efficacy in treating patients with NASH combined with phlegm-dampness and blood stasis syndrome. It reduces hepatic steatosis， lowers liver stiffness， inhibits the expression of serum inflammatory factors， and alleviates liver inflammation. No obvious adverse reactions occur， suggesting it is suitable for clinical application.

ObjectiveTo observe the clinical effect of Xiaozhi Hugan capsules in treating patients with non-alcoholic steatohepatitis （NASH） combined with phlegm-dampness and blood stasis syndrome and its effects on serum interleukin-6 （IL-6） and monocyte chemoattractant protein-1 （MCP-1）. MethodsA total of 124 patients with NASH combined with phlegm-dampness and blood stasis syndrome who were admitted to the Department of Spleen， Stomach， and Hepatobiliary Diseases， the First Affiliated Hospital of Henan University of Chinese Medicine from July 2020 to December 2022 were selected. According to the random number table method， patients were randomly divided into an observation group （62 cases） and a control group （62 cases）. The treatment duration was 6 months. The observation group received Xiaozhi Hugan capsules orally， while the control group received polyene phosphatidylcholine capsules. The efficacy indicators included alanine aminotransferase （ALT）， aspartate aminotransferase （AST）， controlled attenuation parameter （CAP）， liver stiffness measurement （LSM）， traditional Chinese medicine （TCM） syndrome scores （discomfort/dull pain/distending pain in liver region， fatigue， etc.）， body mass index （BMI）， waist-to-height ratio （WHtR）， high-density lipoprotein cholesterol （HDL-C）， total cholesterol （TC）， triglycerides （TG）， homeostatic model assessment for insulin resistance （HOMA-IR） ［including fasting blood glucose （FBG） and fasting insulin level （INS）］， free fatty acids （FFA）， IL-6， and MCP-1. Adverse drug reactions were recorded. ResultsAfter treatment， the total effective rate in the observation group was 92.3% （48/52）， while that in the control group was 75.5% （39/49）. The total effective rate in the observation group was higher than that in the control group （χ²=5.339， P<0.05）. After treatment， the TCM syndrome scores in both groups were significantly reduced （P<0.05）， and the post-treatment scores in the observation group were better than those in the control group （P<0.05）. After treatment， the levels of ALT， AST， TC， FFA， fasting insulin （FINS）， HOMA-IR， MCP-1， IL-6， CAP， LSM， BMI， and WHtR were decreased （P<0.05） significantly in both groups， and the observation group showed superior improvement in the above indicators compared to the control group （P<0.05）. The observation group exhibited significant reductions in TG and FBG （P<0.05） and an increase in HDL-C （P<0.05）， while no significant changes were observed in the control group. The observation group was superior to the control group after treatment （P<0.05）. No severe adverse reactions occurred in either group during the treatment. ConclusionXiaozhi Hugan capsules have significant clinical efficacy in treating patients with NASH combined with phlegm-dampness and blood stasis syndrome. It reduces hepatic steatosis， lowers liver stiffness， inhibits the expression of serum inflammatory factors， and alleviates liver inflammation. No obvious adverse reactions occur， suggesting it is suitable for clinical application.

Cancer represents a major worldwide disease burden marked by escalating incidence and mortality. While therapeutic advances persist, developing safer and precisely targeted modalities remains imperative. Nanomedicines emerges as a transformative paradigm leveraging distinctive physicochemical properties to achieve tumor-specific drug delivery, controlled release, and tumor microenvironment modulation. By synergizing passive enhanced permeation and retention effect-driven accumulation and active ligand-mediated targeting, nanoplatforms enhance pharmacokinetics, promote tumor microenvironment enrichment, and improve cellular internalization while mitigating systemic toxicity. Despite revolutionizing cancer therapy through enhanced treatment efficacy and reduced adverse effects, translational challenges persist in manufacturing scalability, longterm biosafety, and cost-efficiency. This review systematically analyzes cutting-edge nanoplatforms, including polymeric, lipidic, biomimetic, albumin-based, peptide engineered, DNA origami, and inorganic nanocarriers, while evaluating their strategic advantages and technical limitations across three therapeutic domains: immunotherapy, chemotherapy, and radiotherapy. By assessing structure-function correlations and clinical translation barriers, this work establishes mechanistic and translational references to advance oncological nanomedicine development.
Humans ; Neoplasms/radiotherapy* ; Immunotherapy/methods* ; Nanoparticles/chemistry* ; Animals ; Nanomedicine/methods* ; Drug Delivery Systems/methods* ; Drug Carriers/chemistry* ; Radiotherapy/methods*

Transarterial radioembolization (TARE) is a widely utilized therapeutic approach for hepatocellular carcinoma (HCC), however, the clinical implementation is constrained by the stringent preparation conditions of radioembolization agents. Herein, we incorporated the superstable homogeneous iodinated formulation technology (SHIFT), simultaneously utilizing an enhanced solvent form in a carbon dioxide supercritical fluid environment, to encapsulate radionuclides (such as ¹³¹I,¹⁷⁷Lu, or ¹⁸F) with lipiodol for the preparation of radiolipiodol. The resulting radiolipiodol exhibited exceptional stability and ultra-high labeling efficiency (≥99%) and displayed notable intratumoral radionuclide retention and in vivo stability more than 2 weeks following locoregional injection in subcutaneous tumors in mice and orthotopic liver tumors in rats and rabbits. Given these encouraging findings, ¹⁸F was authorized as a radiotracer in radiolipiodol for clinical trials in HCC patients, and showed a favorable tumor accumulation, with a tumor-to-liver uptake ratio of ≥50 and minimal radionuclide leakage, confirming the feasibility of SHIFT for TARE applications. In the context of transforming from preclinical to clinical screening, the preparation of radiolipiodol by SHIFT represents an innovative physical strategy for radionuclide encapsulation. Hence, this work offers a reliable and efficient approach for TARE in HCC, showing considerable promise for clinical application (ChiCTR2400087731).

OBJECTIVE: To compare the efficacy and safety of intravenous colistin sulfate combined with nebulized inhalation versus intravenous monotherapy for pulmonary infections caused by carbapenem-resistant organism (CRO). METHODS: A multicenter retrospective cohort study was conducted. Clinical data were collected from patients admitted to the intensive care unit (ICU) of 10 tertiary class-A hospitals in Henan Province between July 2021 and May 2023, who received colistin sulfate for CRO pulmonary infections. Data included baseline characteristics, inflammatory markers [white blood cell count (WBC), neutrophil count (NEU), procalcitonin (PCT), C-reactive protein (CRP)], renal function indicators [serum creatinine (SCr), blood urea nitrogen (BUN)], life support measures, anti-infection regimens, clinical efficacy, microbiological clearance rate, and prognostic outcomes. Patients were divided into two groups: intravenous group (colistin sulfate monotherapy via intravenous infusion) and combination group ((intravenous infusion combined with nebulized inhalation of colistin sulfate). Changes in parameters before and after treatment were analyzed. RESULTS: A total of 137 patients with CRO pulmonary infections were enrolled, including 89 in the intravenous group and 48 in the combination group. Baseline characteristics, life support measures, daily colistin dose, and combination regimens (most commonly colistin sulfate plus carbapenems in both groups) showed no significant differences between two groups. The combination group exhibited higher clinical efficacy [77.1% (37/48) vs. 59.6% (52/89)] and microbiological clearance rate [60.4% (29/48) vs. 39.3% (35/89)], both P < 0.05. Pre-treatment inflammatory and renal parameters showed no significant differences between two groups. Post-treatment, the combination group showed significantly lower WBC and CRP [WBC (×10⁹/L): 8.2±0.5 vs. 10.9±0.6, CRP (mg/L): 14.0 (5.7, 26.6) vs. 52.1 (24.4, 109.6), both P < 0.05], whereas NEU, PCT, SCr, and BUN levels showed no significant between two groups. ICU length of stay was shorter in the combination group [days: 16 (10, 25) vs. 21 (14, 29), P < 0.05], although mechanical ventilation duration and total hospitalization showed no significant differences between two groups. CONCLUSIONS Intravenous colistin sulfate combined with nebulized inhalation improved clinical efficacy and microbiological clearance in CRO pulmonary infections with an acceptable safety profile.
Humans ; Colistin/therapeutic use* ; Retrospective Studies ; Administration, Inhalation ; Anti-Bacterial Agents/therapeutic use* ; Carbapenems/pharmacology* ; Male ; Female ; Middle Aged ; Gram-Negative Bacteria/drug effects* ; Aged ; Treatment Outcome ; Respiratory Tract Infections/drug therapy*

BACKGROUND:Haploidentical hematopoietic stem cell transplantation is associated with a higher rate of graft rejection and therefore often requires a higher CD34+ cell dose,but the findings reported in existing studies regarding the relationship between CD34+ cell dose and study endpoints after allogeneic hematopoietic stem cell transplantation are controversial. OBJECTIVE:To investigate the effect of CD34+ cell dose on clinical outcomes of haploidentical hematopoietic stem cell transplantation for malignant hematological diseases. METHODS:135 patients who underwent haploidentical hematopoietic stem cell transplantation at Hematopoietic Stem Cell Transplantation Center,Department of Hematology,First Affiliated Hospital of Zhengzhou University between January 2019 and December 2021 were included.Combining the results of previous studies and our center's experience,the cohort was divided into two groups using a CD34+ cell count of 5.0×106/kg as the cut-off point.Clinical outcomes related to graft implantation,relapse incidence,non-relapse mortality,overall survival and progression-free survival were evaluated in both groups. RESULTS AND CONCLUSION:(1)CD34+ cell dose correlated with platelet engraftment,with platelets implanted earlier in the high-dose group than in the low-dose group(14 days vs.16 days,P=0.013).(2)There was no significant difference in 3-year overall survival between the two groups(67.5%vs.53.8%,P=0.257);nor was there a significant difference in progression-free survival between the two groups(65.6%vs.44.2%,P=0.106),but stratified analysis based on disease risk index revealed an association with elevated 3-year progression-free survival in the high-dose group among low-risk patients(72.0%vs.49.3%,P=0.036).(3)The cumulative 3-year relapse incidence was smaller in the high-dose group than in the low-dose group(16.0%vs.33.5%,P=0.05).(4)The rate of non-relapse mortality within 100 days was greater in the high-dose group than in the low-dose group,but there was no significant difference(17.3%vs.6.7%,P=0.070);stratified analysis revealed that non-relapse mortality within 100 days was significantly higher in the high-dose group than in the low-dose group(20.0%vs.3.3%,P=0.046).(5)In conclusion,CD34+ cell doses>5.0×106/kg promote early platelet implantation,improve 3-year progression-free survival in low-risk patients at transplantation and reduce the cumulative relapse incidence.However,in high-risk patients,high-dose CD34+ cells result in increased non-relapse mortality within 100 days after transplantation,which is considered to be possibly associated with an increased occurrence of severe acute graft versus host disease in the early post-transplantation period.Therefore,it is considered that graft versus host disease monitoring should be enhanced in patients who transfused high-dose CD34+ cells.

Objective·To analyze the development trend and current situation of high-level clinical research at Shanghai Jiao Tong University School of Medicine(SJTUSM)from 2015 to 2023,and to summarize the strategies for improving clinical research capability of SJTUSM,aiming to provide reference and inspiration for medical universities to promote high-level clinical research.Methods·Papers published by first authors from SJTUSM or its affiliated hospitals during this period were retrieved in the Web of Science core collection database.General descriptive methods were used to quantify the number of clinical research papers,registered clinical trials,clinical research talent teams,and the current status of clinical research cooperation.Bibliometric methods were used to visualize the international collaboration and topic distribution of retrieved clinical research papers.The differences in the number of clinical research publications,Q1 publications,publications in top clinical medical journals,and full-time researchers between the periods of 2015?2018 and 2019?2023 were compared and analyzed.Results·From 2015 to 2023,a total of 9 468 clinical research papers were published by SJTUSM or its affiliated hospitals as the first author's institution,showing an increasing trend year by year.During this period,the number of Q1 publications of SJTUSM's clinical research,publications in top clinical medical journals,clinical studies registered on the United States Clinical Trial Registry website,clinical studies registered on the Chinese Clinical Trial Registry website,clinical guidelines and expert consensus publications,full-time research team members,and newly added national-level talents all showed an overall upward trend.Tumors,cardiovascular and cerebrovascular diseases,major chronic diseases,and mental illnesses were the main research hotspots.A total of 1 308 papers(13.82%)were international collaborative papers.Developed countries/regions such as the United States(733 papers),Australia(137 papers),and the United Kingdom(99 papers)were closely cooperating with SJTUSM.From 2019 to 2023,there was a significant increase in the number of clinical research papers,Q1 publications,publications in top clinical medical journals,and newly added full-time research team members in affiliated hospitals compared to the period from 2015 to 2018(all P<0.05).Conclusion·SJTUSM has strengthened top-level design,conducted in-depth major diseases,and constructed a systematic,integrated and closed-loop model for enhancing clinical research level along the"platform-talent-methodology"pathway,resulting in a number of high-quality clinical research outcomes.