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).

Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

Objective:To study the application effect of the Hazard Analysis and Critical Control Point(HACCP)system in risk assessment and dynamic management of operational safety of medical equipment in surgery rooms.Methods:Based on the HACCP principle,hazard analysis and risk assessment were conducted on the operational safety of equipment in surgery room,and the critical control points were determined,and measures of monitor and management were formulated to conduct whole-process dynamic management for equipment in surgery room.A total of 120 medical equipment in use in the surgery room of Shaanxi Provincial Cancer Hospital from January 2022 to January 2024 were selected.According to random number table method,they were divided into conventional management mode group(60 equipment that received conventional management mode)and dynamic management mode group(60 equipment that received the mode of risk assessment and dynamic management based on HACCP system for operational safety of medical equipment in surgery rooms)to receive different managements.The effect,operational quality,the score of management standardization,and management level for equipment in managing and controlling risk of safety of equipment were compared between two management modes.Results:The average pressure-related injury,electrical injury,extravasation of body fluid,and incidence of unqualified cleaning and disinfection of equipment in the dynamic management mode group were respectively(3.01±1.01)%,(2.65±0.78)%,(1.65±0.64)%and(1.15±0.16)%,all of which were lower than those in the conventional management mode group,and the differences were statistically significant(t=16.311,13.434,12.018,12.629,P<0.05).The average utilization rate,cost-benefit amplification and social benefit amplification of the equipment in the dynamic management mode group were respectively(95.36±2.87)%,(7.98±1.32)%and(10.68±2.36)%,all of which were higher than those in the conventional management mode group,and the average operating rate in the dynamic management mode group was(9.87±1.54)%,which was lower than that in the conventional management mode group,and the differences of the above indicators were significant(t=7.657,15.567,10.354,12.466,P<0.05).The scores of the standard degrees of use and operation,disinfection and sterilization,operation and maintenance,and repairing fault of equipment in the dynamic management mode group were higher than those in the conventional management mode group,and the differences of the above data between two groups were statistically significant(t=16.289,11.415,13.396,9.420,P<0.05),respectively.The rate of standard placement,the rate of reasonable recording and integrity rate of equipment in the dynamic management mode group were higher than those in the conventional management mode group,and the failure rate was lower than that of the conventional management mode group,and the differences of the above indicators between the two groups were statistically significant(x2=6.708,7.070,8.491,13.333,P<0.05).Conclusion:The risk assessment and dynamic management based on HACCP system for operational safety of medical equipment in surgery room can improve the management effect for equipment in surgery room,and reduce the operational risk of equipment,and realize the whole-process management and control for medical equipment in surgery room.

Objective:To study the application effect of the Hazard Analysis and Critical Control Point(HACCP)system in risk assessment and dynamic management of operational safety of medical equipment in surgery rooms.Methods:Based on the HACCP principle,hazard analysis and risk assessment were conducted on the operational safety of equipment in surgery room,and the critical control points were determined,and measures of monitor and management were formulated to conduct whole-process dynamic management for equipment in surgery room.A total of 120 medical equipment in use in the surgery room of Shaanxi Provincial Cancer Hospital from January 2022 to January 2024 were selected.According to random number table method,they were divided into conventional management mode group(60 equipment that received conventional management mode)and dynamic management mode group(60 equipment that received the mode of risk assessment and dynamic management based on HACCP system for operational safety of medical equipment in surgery rooms)to receive different managements.The effect,operational quality,the score of management standardization,and management level for equipment in managing and controlling risk of safety of equipment were compared between two management modes.Results:The average pressure-related injury,electrical injury,extravasation of body fluid,and incidence of unqualified cleaning and disinfection of equipment in the dynamic management mode group were respectively(3.01±1.01)%,(2.65±0.78)%,(1.65±0.64)%and(1.15±0.16)%,all of which were lower than those in the conventional management mode group,and the differences were statistically significant(t=16.311,13.434,12.018,12.629,P<0.05).The average utilization rate,cost-benefit amplification and social benefit amplification of the equipment in the dynamic management mode group were respectively(95.36±2.87)%,(7.98±1.32)%and(10.68±2.36)%,all of which were higher than those in the conventional management mode group,and the average operating rate in the dynamic management mode group was(9.87±1.54)%,which was lower than that in the conventional management mode group,and the differences of the above indicators were significant(t=7.657,15.567,10.354,12.466,P<0.05).The scores of the standard degrees of use and operation,disinfection and sterilization,operation and maintenance,and repairing fault of equipment in the dynamic management mode group were higher than those in the conventional management mode group,and the differences of the above data between two groups were statistically significant(t=16.289,11.415,13.396,9.420,P<0.05),respectively.The rate of standard placement,the rate of reasonable recording and integrity rate of equipment in the dynamic management mode group were higher than those in the conventional management mode group,and the failure rate was lower than that of the conventional management mode group,and the differences of the above indicators between the two groups were statistically significant(x2=6.708,7.070,8.491,13.333,P<0.05).Conclusion:The risk assessment and dynamic management based on HACCP system for operational safety of medical equipment in surgery room can improve the management effect for equipment in surgery room,and reduce the operational risk of equipment,and realize the whole-process management and control for medical equipment in surgery room.

Background:To compare the efficacy and safety of monthly administrations of gonadotropin releasing hormone (GnRH) agonists LY01005 and Zoladex ? in Chinese patients with premenopausal breast cancer. Methods:From October 2020 to November 2021, 188 premenopausal breast cancer patients were enrolled in 34 hospitals and randomized 1:1 to receive either LY01005 or Zoladex ? every 28 days for a total of three injections. All patients concomitantly received oral tamoxifen (TAM). The primary efficacy endpoint was cumulative probability of maintaining menopausal level [oestradiol (E2) ≤30 pg/ml] from day 29 to day 85. The second efficacy endpoint included changes in E2, luteinizing hormone (LH), and follicle-stimulating hormone (FSH) compared with the baseline. Pharmacokinetics (PK), pharmacodynamics (PD), and safety were analyzed. The study also evaluated the pharmacokinetic and pharmacodynamic characteristics of LY01005. Results:A total of 188 patients were randomised and 187 patients received either LY01005 or Zoladex ?. Cumulative probabilities of maintaining menopausal level (E2≤30 pg/ml) from day 29 to day 85 were 93.1% for LY01005 and 86.3% for Zoladex ?. The between-group difference was 6.8% (95% CI: -2.3%, 15.9%) and primary efficacy in the LY01005 group was not inferior to that in the Zoladex ? group. Changes in E2, LH, and FSH levels compared with the baseline were equivalent between the two groups (E2: 89.34% to 90.23% vs. 82.11% to 85.02%; LH: 88.89% to 95.52% vs. 89.70% to 97.02%; FSH: 75.36% to 80.85% vs.73.07% to 80.24%, respectively). After three consecutive doses of LY01005, the LH and FSH levels of the subjects showed a transient increase after the first dose, reached a peak on the second day and then started to decrease. The LH and FSH reached a lower level and remained at or below that level until the 85th day. Both treatments were well-tolerated. Conclusion:LY01005 is as effective as Zoladex ? in suppressing E2 to menopausal levels in Chinese patients with premenopausal breast cancer, with a similar safety profile.

Background and purpose:For patients with human epidermal growth factor receptor 2(HER2)-positive metastatic breast cancer,trastuzumab treatment can prolong the overall survival and significantly improve the prognosis of patients.However,the reference original research trastuzumab(Herceptin?)is more expensive.Biosimilars have comparable efficacy and safety profiles while increasing patient access to treatment.This clinical trial aimed to evaluate the efficacy,pharmacokinetics,safety and immunogenicity of the trastuzumab biosimilar AK-HER2 compared to trastuzumab(Herceptin?)in patients with HER2-positive metastatic breast cancer.Methods:This multi-center,randomised,double-blind phase Ⅲ clinical trial was conducted in 43 subcenters in China.This study complied with the research protocol,the ethical principles stated in the Declaration of Helsinki and the quality management standards for drug clinical trials.It was approved by the hospital's medical ethics committee.The clinical trial registration agency is the State Food and Drug Administration(clinical trial approval number:2015L04224;clinical trial registration number:CTR20170516).Written informed consent was obtained from subjects before enrollment.Enrolled patients were randomly assigned to the AK-HER2 group and the control group,respectively receiving AK-HER2 or trastuzumab(initial loading dose 8 mg/kg,maintenance dose 6 mg/kg,every 3 weeks as a treatment cycle,total treatment time is 16 cycles)in combination with docetaxel(75 mg/m2,treatment duration is at least 9 cycles).The primary endpoint of this clinical trial was the objective response rate(ORR9)between the AK-HER2 group and the control group in the 9th cycle.Secondary efficacy endpoints included ORR16,disease control rate(DCR),clinical benefit rate(CBR),progression-free survival(PFS)and 1-year survival rate.In this study,100 subjects(AK-HER2 group to control group=1:1)were randomly selected for blood sample collection after the 6th cycle of medication,The collection time points were 45 minutes after infusion(the end of administration),4,8,24,72,120,168,336,and 504 hours after the end of administration.After collection,blood samples were analyzed by PK parameter set(PKPS).Other evaluation parameters included safety and immunogenicity assessment.Results:A total of 550 patients with HER2-positive metastatic breast cancer were enrolled in this clinical trial between Sep.2017 and Mar.2021.In the AK-HER2 group(n=237),129 subjects in the experimental group achieved complete response(CR)or partial response(PR),and the ORR9 was 54.4%.There were 134 subjects in the control group(n=241)who achieved CR or PR,and the ORR9 was 55.6%.The ORR9 ratio between the AK-HER2 group and the control group was 97.9%[90%confidence interval(CI):85.4%-112.2%,P=0.784],which was not statistically significant.In all secondary efficacy endpoints,no statistically significant differences were observed between the two groups.We conducted a mean ratio analysis of pharmacokinetics(PK)parameters between the AK-HER2 group and the control group,and the results suggested that the pharmacokinetic characteristics of the two drugs are similar.The incidence of treatment emergent adverse event(TEAE)leading to drug reduction or suspension during trastuzumab treatment was 3.6%(10 cases)in the AK-HER2 group and 8.1%(22 cases)in the control group.There was statistically significant difference between the two groups(P=0.027).The incidence rate was significantly lower in the AK-HER2 group than in the control group,and there was no statistically significant difference among the other groups.The differences in the positive rates of anti-drug antibodies(ADA)and neutralizing antibodies(NAB)between groups were of no statistical significance(P=0.385 and P=0.752).Conclusion:In patients with HER2-positive metastatic breast cancer,AK-HER2 was comparable to the trastuzumab(Herceptin?)in terms of drug efficacy,pharmacokinetics,safety and immunogenicity.

Objective:To explore the mechanism of anti anxiety (AD) effect of Shenqi Schisandra chinensis using network pharmacology and molecular docking technology.Methods:The main active ingredients of S-Q-W-W-Z (Shenqi Schisandra chinensis) were screened through the TCMSP database. The corresponding targets of the active ingredients were obtained through the TCMSP database and SymMap database. The drug active ingredient target relationship network was visualized using Cytoscape. Utilize TTD, OMIM, NCBI, Drugbank, and GeneCards databases to directly identify potential targets for anxiety. We constructed interaction diagrams of potential targets based on the String database, and used Cytoscape tool to obtain key target proteins. Gene ontology (GO) enrichment analysis and Tokyo Encyclopedia of Genomes (KEGG) signaling pathway analysis were used to identify key targets and signaling pathways for anti anxiety effects of Schisandra chinensis. AutodockTools software was used to perform molecular docking on key active ingredients and key target proteins, and their binding energies were calculated. The molecular docking results were visualized using PyMol software.Results:The 63 effective ingredients in Shen-Qi-Wu-Wei-Zi (Shenqi Schisandra chinensis) can act on anxiety disorder through 69 targets. Among them, quercetin, luteolin, and stigmasterol are the main active ingredients, and serine threonine protein kinase 1 (AKT1) protein and interleukin-6 (IL-6) protein are key target proteins. Molecular docking technology has verified the good binding ability between these key active ingredients and key target proteins. Shenqi Schisandra mainly exerted therapeutic effects on anxiety disorders by regulating Toll like receptor signaling pathways, tumor necrosis factor (TNF) signaling pathways, cancer pathways, and other pathways.Conclusions:The Shenqi Schisandra may exert anti anxiety effects by regulating related targets such as AKT1 and IL-6, regulating inflammatory reactions, cell apoptosis, and other processes.

【Objective】To explore the effects of liver dysfunction in the third trimester of pregnancy on maternal outcomes and identify the factors affecting the maternal prognosis.【Methods】We collected the clinical data of 1 113 women with liver dysfunction in the third trimester of pregnancy （case group） and 1 113 normal pregnancies （control group） from the Third Affiliated Hospital of Sun Yat-sen University between January 2015 and December 2018. We compared the rates of cesarean section，premature delivery，placental abruption，postpartum hemorrhage and maternal mortality in the two groups，conducted the univariate and multivariate analysis for the case group and determined the prognostic risk factors by using Logistic regression. Receiver operating characteristic（ROC）curve analysis was applied to estimate the value of each independent risk factor for predicting liver dysfunction-related maternal mortality. 【Results】The rates of cesarean section，premature delivery，placental abruption，postpartum hemorrhage in the case group were higher than those in the control group（P < 0.05），and the odds ratios（ORs）were 3.59 ，7.81 ，10.68 and 2.93 ，respectively. The maternal mortality in the case group（1.2%）was higher than that in the control group（0.0%）（P < 0.05）. Logistic analysis revealed that high total bilirubin（TBIL），low prothrombin activity（PTA）and low fasting plasma glucose（FPG）were independent risk factors for liver dysfunction- related maternal mortality. The ROC curve analysis indicated that when TBIL was 235.4 μmol/L，the Youden′ s index in maximum was 0.331 with sensitivity of 0.818 and specificity of 0.513. When PTA was 20.5% ，the Youden′ s index in maximum was 0.366 with sensitivity of 0.821 and specificity of 0.545. When FPG was 3.11 mmol/L，the Youden′s index in maximum was 0.405 with sensitivity of 0.769 and specificity of 0.636.【Conclusion】Liver dysfunction in the third trimester of pregnancy has adverse effects on maternal outcomes. TBIL ，PTA and FPG are the factors affecting the maternal prognosis and may have certain predictive value for maternal death.

Objective    To evaluate the feasibility and clinical value of robot-assisted lobectomy through anterior approach. Methods    We retrospectively analyzed the clinical data of 180 patients who underwent robot-assisted lobectomy through anterior approach in our hospital between April 2017 and February 2018. There were 97 males and 83 females, aged 59.5 (32.0-83.0) years. The clinical effects were analyzed. Results    One patient was transferred to thoracotomy due to tumor invasion of adjacent blood vessels and injury to the blood vessels, and there was no perioperative death. There were 8.5 (1.0-35.0) dissected lymph nodes for each patient. The median operation time was 120 (50-360) min, including robot Docking time 5 (1-23) min and robot operation time 65 (7-270) min. The median blood loss was 50 (5-1 500) mL, 132 (73.3%) patients had malignant tumors and median drainage time was 5 (2-30) d. The mean postoperative pain score was 3.4±0.7 points and the postoperative hospital time was 8 (2-32) d. At the median follow-up of 24 months, 11 patients developed recurrence and metastasis, and 3 died. Conclusion    Robot-assisted lobectomy through anterior approach is a safe and convenient operation method, which is worthy of clinical application.