OBJECTIVE: To investigate the transfusion and infusion warmer manufacturers, combine the use failures to analyze adverse events, and provide support for enterprise risk management and clinical safe use. METHODS: The sentinels from 7 manufacturing enterprises and 11 medical institutions that participated in Shandong Province's key monitoring program during the "14th Five-Year Plan" period were targeted. This was done by understanding the equipment's principles, structures, and quality control. Additionally, real-world data from January 2019 to December 2023 were collected to count adverse events. RESULTS: During production, there are risks in switching power supply stability and solder joint firmness. Fifteen kinds of faults occurred during use, and common faults such as inability to heat, unable to turn on the machine, and bubbles in the infusion tube accounted for more than 80%. CONCLUSION There are many risk points and failures for transfusion and infusion warmers, so enterprises should improve processes and quality control to address risks, and medical institutions should formulate specifications and maintenance plans to provide targeted theoretical basis for supervision.
Blood Transfusion/instrumentation* ; Risk Factors ; Quality Control ; Humans ; Risk Management ; Equipment Failure

Objective:To evaluate the clinical efficacy of endoclip papillaplasty (ECPP) for preventing recurrent choledocholithiasis after endoscopic retrograde cholangiopancreatography (ERCP).Methods:A retrospective analysis was conducted on 1 941 patients who underwent ERCP for choledocholithiasis in Henan Provincial People's Hospital from January 2019 to December 2023. A total of 250 patients who received ECPP were assigned to the ECPP group, while 251 matched controls were selected via 1∶1 year-stratified sampling into the control group. After follow-up, 209 ECPP cases and 190 controls were ultimately included in the analysis. Stone removal success rate, incidence of perioperative complications, and postoperative choledocholithiasis recurrence were compared between the two groups. Univariate and multivariate logistic regression were used to determine the risk factors for choledocholithiasis recurrence after ERCP.Results:Both groups achieved 100.0% stone removal success rate. There was no significant difference in the incidence of intraoperative perforation [0.5% (1/209) VS 1.1% (2/190), χ2=0.01, P=0.934], postoperative hyperamylasemia [21.5% (45/209) VS 17.4% (33/190), χ2=1.10, P=0.295] or post-ERCP pancreatitis [3.8% (8/209) VS 8.1% (9/190), χ2=0.20, P=0.653] between the ECPP group and the control group. The ECPP group showed significantly lower bleeding rate [5.1% (11/209) VS 12.3% (23/190), χ2=5.98, P=0.014] and choledocholithiasis recurrence rate [10.5% (22/209) VS 18.9% (36/190), χ2=5.68, P=0.017] compared with the control group. The multivariate logistic regression identified dilated common bile duct diameter ( OR=1.881, 95% CI: 1.101-3.213, P=0.021) as an independent risk factor for choledocholithiasis recurrence, while being female ( OR=0.482, 95% CI: 0.266-0.875, P=0.016) and ECPP ( OR=0.497, 95% CI:0.278-0.887, P=0.018) were protective factors. Conclusion:ECPP effectively reduces choledocholithiasis recurrence rate and bleeding risk after ERCP. ECPP and being female serve as protective factors for choledocholithiasis recurrence, while dilated bile duct diameter is an independent risk factor.

Objective:To evaluate the clinical efficacy of endoclip papillaplasty (ECPP) for preventing recurrent choledocholithiasis after endoscopic retrograde cholangiopancreatography (ERCP).Methods:A retrospective analysis was conducted on 1 941 patients who underwent ERCP for choledocholithiasis in Henan Provincial People's Hospital from January 2019 to December 2023. A total of 250 patients who received ECPP were assigned to the ECPP group, while 251 matched controls were selected via 1∶1 year-stratified sampling into the control group. After follow-up, 209 ECPP cases and 190 controls were ultimately included in the analysis. Stone removal success rate, incidence of perioperative complications, and postoperative choledocholithiasis recurrence were compared between the two groups. Univariate and multivariate logistic regression were used to determine the risk factors for choledocholithiasis recurrence after ERCP.Results:Both groups achieved 100.0% stone removal success rate. There was no significant difference in the incidence of intraoperative perforation [0.5% (1/209) VS 1.1% (2/190), χ2=0.01, P=0.934], postoperative hyperamylasemia [21.5% (45/209) VS 17.4% (33/190), χ2=1.10, P=0.295] or post-ERCP pancreatitis [3.8% (8/209) VS 8.1% (9/190), χ2=0.20, P=0.653] between the ECPP group and the control group. The ECPP group showed significantly lower bleeding rate [5.1% (11/209) VS 12.3% (23/190), χ2=5.98, P=0.014] and choledocholithiasis recurrence rate [10.5% (22/209) VS 18.9% (36/190), χ2=5.68, P=0.017] compared with the control group. The multivariate logistic regression identified dilated common bile duct diameter ( OR=1.881, 95% CI: 1.101-3.213, P=0.021) as an independent risk factor for choledocholithiasis recurrence, while being female ( OR=0.482, 95% CI: 0.266-0.875, P=0.016) and ECPP ( OR=0.497, 95% CI:0.278-0.887, P=0.018) were protective factors. Conclusion:ECPP effectively reduces choledocholithiasis recurrence rate and bleeding risk after ERCP. ECPP and being female serve as protective factors for choledocholithiasis recurrence, while dilated bile duct diameter is an independent risk factor.

Objective:To analyze the trend of liver cancer morbidity and mortality among residents with household registration in certain District, 2017 to 2019.Methods:The crude morbidity and mortality rate of males and females in the whole population were calculated by using the relevant data from the certain District Cancer Registry and Report System and the Cause of Death Surveillance System. The standardized morbidity and mortality rate were calculated according to the age structure of 2000 National Demographic Census and Segi's world population, respectively. Trend in liver cancer morbidity and mortality were evaluated using percent change (PC), annual percentage change, and case-number-weighted annual percent change. Age-specific rates were used to analyze the epidemic trend of liver cancer with age.Results:The crude morbidity rate of liver cancer in the whole population (male and female) of the certain district from 2017 to 2019 were 18.86/100 000, 26.05/100 000 and 11.90/100 000 respectively, and the crude mortality rates were 21.20/100 000, 29.29/100 000 and 13.38/100 000 respectively. The crude morbidity and mortality rate of liver cancer among male showed a downward trend (PC=-16.77% and -20.15% respectively). The crude morbidity and mortality rate of liver cancer among female showed inconsistent changes; however, the crude morbidity rate showed a downward trend, and the crude mortality rate first increased and then decreased (PC=-19.42% and -0.30% respectively). Liver cancer morbidity and mortality rate in male after the age of 30 were increased with age. The two key points of accelerated growth were around the age of 65 and 75, and the peak of morbidity (130.78/100 000) and mortality (201.96/100 000) were after the age of 80. The morbidity and mortality rate were significantly lower in female than those of male aged 60; however, after the age of 65, the morbidity rate was increased rapidly and gradually approached as that of male. After the age of 80 (the peak morbidity and mortality were 104.40/100,000 and 132.87/100,000, respectively), male were about twice as high as those female aged between 75 and 79.Conclusion:Morbidity and mortality rate of liver cancer in the certain District showed an overall downward trend from 2017 to 2019, but it increased with age, and the disease burden was relatively high among the elderly population. Liver cancer mostly occurred in male, so the prevention and control of liver cancer epidemics in middle-aged and elderly should be actively monitored.

Objective:To investigate the clinicpathological features of basal cell type dysplasia of the esophagus.Methods:The clinicopathological data of 71 cases of basal cell type dysplasia of esophagus were collected at the People′s Liberation Army Joint Logistics Support Force 989 Hospital, from 2009 to 2019, and the histomorphologic characteristics and immunophenotype were evaluated. The relevant literature was reviewed.Results:The ratio of male to female patients was 1.6∶1.0, and the median age was 65 years (range 48-81 years). The tumors were located in the upper segment of the esophagus in four cases (5.6%), the middle segment in 54 cases (76.1%), and the lower segment in 13 cases (18.3%).The median maximal tumor diameter was 12.0 mm (range 3-42 mm). According to Paris Classification, 0-Ⅱb accounted for 42.3% (30/71) of the cases. Under endoscope, the lesions were reddish with abnormal mucosal microvessels. Histologically, the neoplastic cells were small, with a high nuclear-cytoplasmic ratio, similar to basal cells, and uniform in morphology. The structural atypia was characterized by dense and disordered tumor cells, loss of basal cell polarity, and absence of normal squamous differentiation gradient. In 10 cases, the tumors were confined to the lower part of the epithelium. The tumor cells were smaller and more uniform in shape, and extend to the superficial lamina propria. Sixty-one tumors involved at least the entire layer of the upper cortex. There were 31 cases of neoplasms with superficial invasive carcinoma. The types of neoplasms included typical squamous cell carcinoma, basaloid squamous cell carcinoma, small cell neuroendocrine carcinoma, squamous cell carcinoma with sebaceous adenoid carcinoma, and differentiation of glandular/ductal epithelioid carcinoma. Immunohistochemical staining showed that the mutant expression rate of p53 protein was 41.5% (17/41). All 41 cases (100.0%) showed abnormal distribution pattern of Ki-67. According to the initial pathologic diagnosis, there were 18 cases of low grade dysplasia, 12 cases of atypical epithelial cells, and 41 cases of high grade dysplasia and superficially invasive carcinoma.Conclusions:Basal cell type dysplasia has unique morphologic characteristics and represents a tumor subtype in the morphologic lineage of esophageal squamous dysplasia. Tumor cells of basal cell type dysplasia, especially those distributed only in the lower part of the stratified squamous epithelium, may be tumor stem cells at the earliest stage of esophageal carcinogenesis and have multidirectional differentiation potential. When the tumor is confined to the lower part of the stratified squamous epithelium, it does not meet the diagnostic criteria for esophageal squamous dysplasia as defined by the current WHO classification.

Objective:To investigate the clinicopathological features and significance of spindle cell type squamous dysplasia of the esophagus.Methods:The clinicopathological data of 37 cases of spindle cell type squamous dysplasia of esophagus were collected retrospectively at People′s Liberation Army Joint Logistics Support Force 989 Hospital (formerly 152 Hospital), Pingdingshan, China, from 2009 to 2019. The histological and immunohistochemical characteristics were analyzed, with a literature review.Results:The median age of the 37 patients was 65 years (range 47-81 years), while the ratio of men to women was 1.5∶1.0. There were 4 cases in the upper esophagus, 31 in the middle esophagus and 2 in the lower esophagus. The median diameter of the lesions was 14 mm (range 3-40 mm). According to the Paris classification, 11 cases were 0-Ⅱa, 14 cases were 0-Ⅱb, 3 cases were 0-Ⅱb and 0-Ⅱa, and 9 cases were 0-Ⅱc. Under endoscope, the lesional mucosa was reddish. The micro-vessels were dilated, with various shapes and density. Histologically, tumor cells and nuclei were spindle shaped or elongated spindle shaped, with considerable homogeneity, dark nuclei and delicate or slightly thickened chromatin. The mitosis was conspicuous, and atypic mitoses were seen; the cytoplasm was acidophilic, and the intercellular bridge was obvious. The cells were dense and often lost polarity, but still arranged in parallel, mostly perpendicular to the basement membrane. Spindle cells often involved the whole layer of epithelium, with no gradient maturation and differentiation of normal squamous epithelium. The tumor was well demarcated. The spindle cells often invaded lamina propria. There were 15 cases with focal high-grade dysplasia and superficial invasive squamous cell carcinoma. Immunohistochemical staining showed that the mutation rate of p53 was 41.4% (12/29), the median of Ki-67 labeling index was 40% (range 20%-80%), and the abnormal distribution pattern of Ki-67 was 29 (100%). According to the initial pathological diagnosis, there were 6 cases of low-grade dysplasia, 4 cases of atypical epithelial cells and 27 cases of high-grade dysplasia and superficial invasive squamous cell carcinoma.Conclusions:Spindle tumor cells have moderate to severe atypia, and some tumors show invasive pattern. P53 mutation and Ki-67 abnormal distribution pattern indicate that they are high-grade dysplasia of esophageal squamous epithelium. The unique characteristics of spindle tumor cells suggest that they may represent a spindle cell subtype in the morphological spectrum of esophageal squamous dysplasia. When the knowledge of the lesion is insufficient, it can be easily misdiagnosed or missed.

Objective To explore the relationship between red blood cell volume distribution width (RDW) and degree of liver fibrosis in patients with chronic hepatitis B (CHB). Methods One hundred and sixty-four patients with CHB were consecutively selected. According to the fibrosis index based on the 4 factors (FIB-4) index, the patients were divided into 3 groups: low-FIB group (FIB-4 <1.45, 116 cases), mid-FIB group (FIB-4 1.45-3.25, 31 cases) and high-FIB group (FIB-4 > 3.25, 17 cases), and the clinical data and laboratory indexes (including RDW) were compared. The patients were divided into Ⅰ group (RDW<0.113, 43 cases), Ⅱ groups (RDW 0.113-0.119, 40 cases), Ⅲ group (RDW 0.120-0.127, 43 cases) andⅣgroup (RDW>0.127, 38 cases) according to the RDW, and the FIB-4 were compared. The correlation between RDW and FIB-4 was analyzed by Spearman correlation test. Results The RDW and aspartate aminotransferase (AST) in low-FIB group, mid-FIB group and high- FIB group were gradually increased: 0.117 ± 0.011, 0.122 ± 0.010, 0.134 ± 0.018 and (18.9 ± 7.3), (28.2 ± 10.4), (44.1 ± 13.3) U/L, but the platelet was gradually decreased:(211.3 ± 48.8), (159.3 ± 40.0) and (150.4 ± 31.2) ×109/L, and there were statistical differences (P<0.05). The FIB-4 inⅠgroup,Ⅱgroup,Ⅲgroup andⅣgroup was gradually increased:1.07 ± 0.74, 1.11 ± 0.56, 1.35 ± 0.70 and 2.03 ± 1.06, and there was statistical difference (P<0.05). Spearman correlation test result showed that FIB-4 and RDW was positively correlated (r=0.447, P<0.01). Conclusions The level of RDW is closely related with the degree of liver fibrosis in patients with CHB. RDW has a potential value in assessing the progress of liver fibrosis.

Natural killer T(NKT) cells are a heterogeneous group T cells that share properties of both natural killer cells and T cells,play an important role in tumor immunity.Related researches have confirmed that actived NKT cells can inhabit tumor progress,but activated NKT cells commonly become anergic for some unknown reasons after a short time.This article reviews researches on the possible mechanisms and solutions to NKT cells anergy.

Objective:To study the relation between promyelocytic leukemia protein (PML) and gastric and colorectal cancers , and explore the relation between PML and epidermal growth factor receptor (EGFR) and vascular endothelial growth factor (VEGF) .Methods:The expression situations of PML ,EGFR ,and VEGF in gastric and colorectal cancer were detected by immunohistochemistry ,and their relations with tumor invasions ,lymph node metastases ,TNM stages and patients’ survival were analyzed .Results:PML was positively expressed in normal tissue adjacent to gastrointestinal cancer .The rate of PML deficiency was 33 .8% (54/160) in gastric cancer tissue ,while it was 38 .1% (64/168) in colorectal cancer tissue .PML deficiency in gastric cancer tissue was positively correlated with gastric wall invasion (P<0 .001) ,lymph node metastases (P=0 .018) and TNM stage (P<0 .001) ,and the survival period of patients with positive PML was longer than that of patients with negative PML (52 months vs 39 months , P<0 .001) .Age ,PML deficiency and TNM stage were the independent risk factors of gastric cancer prognosis .PML deficiency in colorectal cancer tissue was positively correlated with TNM stage (P=0 .012) ,and the survival period of patients with positive PML was longer than that of patients with negative PML (53 months vs 44 months , P= 0 .001) .The positive expression of EGFR was positively correlated with colorectal wall invasion (P<0 .001) ,lymph node metastases (P<0 .001) and TNM stage (P<0 .001) .PML deficiency ,TNM stage and EGFR expression were the independent risk factors of colorectal cancer prognosis .PML expression was negatively correlated with EGFR and VEGF expression (P<0 .05) .Conclusions:PML deficiency may promote the progression of gastric and colorectal cancer by up‐regulating the expression of EGFR and VEGF .PML deficiency is correlated with prognosis of gastric and colorectal cancer patients .

Objective To design a new cancer vaccine by using alpha-galactosylceramide (α-Galcer,α-GC) loaded tumor cells in combination with TLR 9 ligand and to evaluate its therapeutic effects on colon canc-er in mice.Methods MC38 cells were transfected with lentivirus (GFP-CD1d) to prepare CD1d-MC38 cells. The expression of CD1d molecules in CD1d-MC38 cells was detected by fluorescence microscopy , RT-PCR and flow cytometry.The sorted CD1d-MC38 cells were loaded with α-Galcer to prepare CD1d-MC38/α-GC complex. Flow cytometry was performed to evaluate the efficiency of combination .A mouse model of colon cancer was es-tablished to investigate the therapeutic effects of α-Galcer loaded tumor cells in combination with TLR 9 ligand ( CD1d-MC38/α-GC+CpG1826) on colon cancer in mice by analyzing tumor growth and mice survival time .Im-munohistochemical staining was used to detect CD 4+T and CD8+T infiltrating lymphocytes in tumor tissues .Re-sults The MC38 cancer cells that expressed CD 1d and GFP were successfully constructed , among which 98.10%±2.53%were positive for CD1d.Moreover, the CD1d-MC38 cells could combine with α-Galcer effec-tively in a dose and time dependent manner .Compared with PBS treated group ,α-GC treated group and TLR9 ligand treated group , the experimental vaccine strategy was sufficient to inhibit the growth of established tumors and prolong survival of tumor-bearing mice (P<0.01).Immunohistochemistry analysis revealed that levels of CD4+T cells and CD8+T cells in experiment group were significantly higher than those in groups treated with PBS,α-GC and TLR9 ligand (P<0.01).Conclusion CD1d-MC38/α-GC in combination with CpG1826 could efficiently inhibit the growth of established tumors and prolong survival of tumor-bearing mice .Immunohisto-chemistry analysis revealed that CD 4+T cells and CD8+T cells played important roles in anti-tumor immunity.