The promulgation of the Technical Specifications for Clinical Use of Blood (2025 Edition) signifies that China's clinical blood transfusion management has transitioned from mere technical operations to a new stage centered on patient blood management (PBM). Through an in-depth comparison of the new and old specifications, this paper analyzes the core transformations regarding conceptual reconstruction, legal alignment, technological upgrades, and closed-loop management. The new specifications establish PBM principles, reinforce legal safeguards for informed consent and emergency treatment, and construct a comprehensive, refined quality control system by specifying compatibility testing standards and introducing a post-transfusion evaluation system. Medical institutions should seize this opportunity to update management protocols and information systems, deepen multidisciplinary collaboration, and drive the profound transformation of clinical blood use from focusing solely on safety assurance to placing equal emphasis on science and value.

Purpose: This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy. Materials and Methods: Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received 18F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety. Results: Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of 18F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways. Conclusion This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. 18F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.

Purpose: This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy. Materials and Methods: Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received 18F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety. Results: Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of 18F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways. Conclusion This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. 18F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.

Purpose: This Phase II trial was objected to evaluate the efficacy and safety of adding fulvestrant to neoadjuvant chemotherapy in patients with estrogen receptor (ER)+/human epidermal growth factor receptor 2 (HER2)– locally advanced breast cancer (LABC). Additionally, the study aimed to investigate the association of 16α-18F-fluoro-17β-fluoroestradiol (18F-FES) positron emission tomography (PET)–computed tomography (CT) and metabolites with efficacy. Materials and Methods: Fulvestrant and EC-T regimen were given to ER+/HER2– LABC patients before surgery. At baseline, patients received 18F-FES PET-CT scan, and plasma samples were taken for liquid chromatography–mass spectrometry analysis. The primary endpoint was objective response rate (ORR). Secondary endpoints included total pathologic complete response (tpCR) and safety. Results: Among the 36 patients enrolled, the ORR was 86.1%, the tpCR rate was 8.3%. The incidence of grade ≥ 3 treatment-emergent adverse events was 22%. The decrease in ER value in sensitive patients was larger than that in non-sensitive patients, as was Ki-67 (p < 0.05). The maximum standardized uptake value, mean standardized uptake values, total lesion ER expression of 18F-FES PET-CT in sensitive patients were significantly higher than those in non-sensitive patients (p < 0.05). Moreover, these parameters were significantly correlated with Miller and Payne grade and the change in ER expression before and after treatment (p < 0.05). Thirteen differential expressed metabolites were identified, which were markedly enriched in 19 metabolic pathways. Conclusion This regimen demonstrated acceptable toxicity and encouraging antitumor efficacy. 18F-FES PET-CT might serve as a tool to predict the effectiveness of this therapy. Altered metabolites or metabolic pathways might be associated with treatment response.

The p60 subunit of the chromatin assembly factor-1 complex, that is, chromatin assembly factor-1 subunit B (CHAF1B), is a histone H3/H4 chaperone crucial for the transcriptional regulation of cell differentiation and self-renewal. CHAF1B is overexpressed in several cancers and may represent a potential target for cancer therapy. However, its expression and clinical significance in lung squamous-cell carcinoma (LUSC) remain unclear. In this study, we performed weighted gene correlation network analysis to analyze the Gene Expression Omnibus GSE68793 LUSC dataset and identified CHAF1B as one of the most important driver gene candidates. Immunohistochemical analysis of 126 LUSC tumor samples and 80 adjacent normal lung tissues showed the marked upregulation of CHAF1B in tumor tissues and the negative association of its expression level with patient survival outcomes. Silencing of CHAF1B suppressed LUSC proliferation in vitro and LUSC tumor growth in vivo. Furthermore, bulk RNA sequencing of CHAF1B knockdown cells indicated SET domain containing 7 (SETD7) as a significant CHAF1B target gene. In addition, CHAF1B competitively binds to the SETD7 promoter region and represses its transcription. Altogether, these results imply that CHAF1B plays a vital role in LUSC tumorigenesis and may represent a potential molecular target for this deadly disease.
Humans ; Lung Neoplasms/metabolism* ; Histone-Lysine N-Methyltransferase/metabolism* ; Carcinoma, Squamous Cell/metabolism* ; Gene Expression Regulation, Neoplastic ; Disease Progression ; Cell Proliferation/genetics* ; Cell Line, Tumor ; Chromatin Assembly Factor-1/metabolism* ; Animals ; Mice ; Male ; Female

Background::Although overnight fasting is recommended prior to endoscopic retrograde cholangiopancreatography (ERCP), the benefits and safety of high-carbohydrate fluid diet (CFD) intake 2 h before ERCP remain unclear. This study aimed to analyze whether high-CFD intake 2 h before ERCP can be safe and accelerate patients’ recovery.Methods::This prospective, multicenter, randomized controlled trial involved 15 tertiary ERCP centers. A total of 1330 patients were randomized into CFD group ( n = 665) and fasting group ( n = 665). The CFD group received 400 mL of maltodextrin orally 2 h before ERCP, while the control group abstained from food/water overnight (>6 h) before ERCP. All ERCP procedures were performed using deep sedation with intravenous propofol. The investigators were blinded but not the patients. The primary outcomes included postoperative fatigue and abdominal pain score, and the secondary outcomes included complications and changes in metabolic indicators. The outcomes were analyzed according to a modified intention-to-treat principle. Results::The post-ERCP fatigue scores were significantly lower at 4 h (4.1 ± 2.6 vs. 4.8 ± 2.8, t = 4.23, P <0.001) and 20 h (2.4 ± 2.1 vs. 3.4 ± 2.4, t= 7.94, P <0.001) in the CFD group, with least-squares mean differences of 0.48 (95% confidence interval [CI]: 0.26–0.71, P <0.001) and 0.76 (95% CI: 0.57–0.95, P <0.001), respectively. The 4-h pain scores (2.1 ± 1.7 vs. 2.2 ± 1.7, t = 2.60, P = 0.009, with a least-squares mean difference of 0.21 [95% CI: 0.05–0.37]) and positive urine ketone levels (7.7% [39/509] vs. 15.4% [82/533], χ2 = 15.13, P <0.001) were lower in the CFD group. The CFD group had significantly less cholangitis (2.1% [13/634] vs. 4.0% [26/658], χ2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ2 = 0.59, P = 0.444). Subgroup analysis revealed that CFD reduced the incidence of complications in patients with native papilla (odds ratio [OR]: 0.61, 95% CI: 0.39–0.95, P = 0.028) in the multivariable models. Conclusion::Ingesting 400 mL of CFD 2 h before ERCP is safe, with a reduction in post-ERCP fatigue, abdominal pain, and cholangitis during recovery.Trail Registration::ClinicalTrials.gov, No. NCT03075280.

Objective:To predict the status of microvascular invasion (MVI) in intrahepatic cholangiocarcinoma (ICC) patients preoperatively based on the radiomics analysis of contrast-enhanced CT to provide imaging evidence for early identification of patients at high risk of recurrence.Methods:Clinical data of 40 ICC patients who underwent radical hepatectomy at Nanjing Drum Tower Hospital from January 2021 to May 2024 were retrospectively collected. Patients were divided into the MVI group ( n=8) and the non-MVI group ( n=32) according to the MVI status of the postoperative pathology report. Whether there were differences in each pathological index between the groups and the efficacy of radiomics analysis of contrast-enhanced CT for the preoperative prediction of MVI were analyzed. The regions of interest (ROI) were outlined on the arterial and venous phase images using the 3D Slicer software. Then, radiomics features were extracted from each ROI based on Python. Finally, the LASSO regression and glm function were used to screen radiomics features and establish a prediction model based on the R language. The established predictive model′s diagnostic efficacy, calibration, and net clinical benefit were evaluated using the receiver operating characteristic (ROC) curve, calibration curve, and decision curve analysis (DCA), respectively. Normally distributed measurement data were expressed as mean±standard deviation ( ± s) and compared using the t-test. Count data were expressed as frequency and compared using the chi-square test. Results:Patients in the MVI group had more poorly differentiated tumors and a significantly higher proportion of lymph node metastases ( P<0.05). The established radiomics prediction model included six features, 1 first-order statistical feature and 5 gray texture features. The area under the ROC curve was 0.87, the sensitivity was 75.0%, and the specificity was 90.6%. The calibration curve showed good agreement between the predicted MVI and actual MVI status, and the decision curve demonstrated that the model could provide a large net clinical benefit. Conclusion:Radiomics analysis of contrast-enhanced CT can identify the MVI status of ICC patients preoperatively and aid in clinical decision-making, providing vital evidence for individualized and precise treatment of ICC.

Objective To observe the effect of buccal needle therapy on perioperative analgesia in patients undergoing laparoscopic radical colon cancer surgery.Methods Sixty patients underwent dective laparoscopic radical of colon cancer surgery were selected,32 males and 28 females,aged 45-74 years,BMI 18.5-25.0 kg/m2 and ASA physical status Ⅱ or Ⅲ.The patients were divided into two groups using the randomized numerical table method:buccal needle group and control group,30 patients in each group.Before the induction of anesthesia,the buccal needle group was given buccal needle therapy once,and buc-cal needle therapy was performed once a day at 9 a.m.in the postoperative period,leaving the needle in place for 30 minutes each time,for 3 consecutive days of treatment,and the control group was not treated with buccal needle therapy.The amount of intraoperative propofol,remifentanil,sufentanil used in the 48 hours postoperative period and recorded.VAS pain scores were recorded at 1 hour,4,24,and 48 hours postoperatively.Venous blood was collected at the time of admission to the hand room and at 1 day,2,and 3 days postoperatively,respectively,and the concentrations of plasma C-reactive protein(CRP),interleu-kin-6(IL-6),and tumor necrosis factor-alpha(TNF-α)were measured.The occurrence of adverse reactions within 48 hours after operation was recorded.Results Compared with the control group,intraop-erative propofol,remifentanil,the amount of sufentanil used and the number of analgesic pump presses with-in 48 hours after operation in the buccal needle group were significantly reduced in the buccal needle group(P＜0.05),VAS pain scores were significantly lower at 1 hour,4,24,and 48 hours postoperatively(P＜0.05),CRP,IL-6,and TNF-α concentrations were significantly lower at 1 day,2,and 3 days postopera-tively(P＜0.05),and nausea and vomiting,incidence of laryngospasm and laryngeal discomfort were sig-nificantly reduced(P＜0.05).Conclusion The perioperative use of buccal needle therapy in patients un-dergoing laparoscopic radical colon cancer surgery can effectively reduce pain,inhibit inflammatory respon-ses,and decrease the incidence of postoperative adverse reactions.

Objective To explore the effects of different doses of valproate on serum thyroxine(TSH),prolactin(PRL)and dopamine(DA)in patients with bipolar disorder(BPD)level of influence.Methods A total of 90 patients with BPD who received treatment in hospital from May 2020 to May 2022 were selected as the study objects.They were randomly divided into groups A,B and C,with 30 cases in all.Groups A,B and C were orally administered 10 mg/kg,15 mg/kg and 20 mg/kg sodium valproate every day,respectively.The clinical efficacy,scores of mental diseases before and after treatment,indexes related to blood drug concentration,serum levels before and after treatment,indexes related to liver function and incidence of adverse reactions were compared among the three groups.Results There was no significant difference in the total effective rate among the three groups after treatment(P>0.05).After treatment,the scores of the three groups were significantly improved compared with before treatment(P<0.05).There was significant difference in the time to reach the stable state serum concentration(P<0.05).There were no significant differences in TSH,PRL and DA levels among the three groups after treatment compared with before treatment(P>0.05).ALT and AST levels in the three groups after treatment were increased compared with those before treatment(P<0.05),and there were statistically significant differences in ALT and AST levels among the three groups after treatment(P<0.05).There was significant difference in the incidence of adverse reactions among the three groups(P<0.05).Conclusion Sodium valproate can effectively treat BPD patients and relieve the degree of mania or depression,but has no significant effect on the level of TSH,PRL and DA.Among them,small dose of sodium valproate can guarantee the thera-peutic effect and have less impact on liver function,and less adverse reactions,high safety,worthy of clinical promotion.