1.Clinical Utilization Analysis of Rituximab Biosimilar: A Single-Center Retrospective Study
Yuzhen ZOU ; Ran XIAO ; Shaohong WANG ; Rui DAI ; Xiaoli DU
Medical Journal of Peking Union Medical College Hospital 2025;16(6):1484-1492
To investigate the clinical utilization of Rituximab biosimilar (Rituximab injection) in order to provide references for evaluating its rationality and economic value in clinical application. A retrospective analysis was conducted on medical records of inpatients who received Rituximab injection at Peking Union Medical College Hospital between January 1, 2020, and December 31, 2023. The clinical usage patterns, off-label use, economic benefits compared to the originator drug, and adverse drug reactions (ADRs) were analyzed. A total of 725 patients treated with Rituximab injection were included. The majority of patients were from the Department of Nephrology (80.69%), followed by Rheumatology and Immunology (9.24%), Hematology (8.41%), and Dermatology (0.97%). The drug was used for 27 different diseases, with the top five being membranous nephropathy (62.90%), minimal change disease (7.31%), systemic lupus erythematosus (4.41%), anti-neutrophil cytoplasmic antibody-associated vasculitis (3.72%), and granulomatosis with polyangiitis or microscopic polyangiitis (3.59%). The off-label use rate was as high as 96.28% (698/725). The overall incidence of ADRs was 21.24%. The total consumption of Rituximab injection was 1183.2 g, resulting in calculated cost savings of about ¥7.35 million compared to the originator drug. Rituximab injection is widely used in hematologic malignancies and immune-mediated diseases, with a low overall incidence of ADRs and greater cost-effectiveness compared to the originator drug. The extremely high rate of off-label use is supported by corresponding guidelines or clinical studies.
2.Association of serum KLF5 and actinin-4 levels with prognosis of TACE treatment for hepatocellular carcinoma
Shunle LI ; Rong LI ; Yaya TIAN ; Xiaoli RAN ; Yanpei ZHAO ; Meng XU
Basic & Clinical Medicine 2024;44(9):1284-1289
Objective To explore the relationship between serum Krüppel-like factor 5(KLF5)and actinin-4 with prognosis of hepatocellular carcinoma(HCC)treated with transcatheter arterial chemoembolization(TACE).Methods From March 2015 to March 2020,130 HCC patients admitted into the Second Affiliated Hospital were collected as study subjects and divided into HCC group and 86 patients with liver cirrhosis were collected as control group.After 3 years of postoperative follow-up,HCC patients were sub-divided into survival group(n=38)and mortality group(n=92)based on their survival outcomes.ELISA was applied to detect the level of serum KLF5 and actinin-4 in each group and analyzed the correlation between serum KLF5 and actinin-4 levels.Cox regression was applied to analyze the risk factors affecting the prognostic mortality of HCC patients;Receiver operating char-acteristic curve(ROC)was plotted to evaluate the predictive value of serum KLF5 and actinin-4 levels for the prognostic mortality of HCC patients.Results The serum level of KLF5 and actinin-4 in the mortality group was significantly higher than those in the survival group(P<0.05);There was a positive correlation between serum level of KLF5 and actinin-4 in HCC patients(P<0.001);Low differentiation,staging(CNLC)stage IIIa of China liver cancer staging(CNLC),vascular invasion and elevated level of KLF5 and actinin-4 were risk factors for prognostic mortality in HCC patients(P<0.05);The area under the curve(AUC)of serum KLF5 and acti-nin-4 alone and in combination for predicting mortality in HCC patients was 0.835,0.866,and 0.936,respec-tively,showing a high level of combined predicting function(Zcombination-KLF5=2.792,P=0.005,Zcombi-nation-actinin-4=2.014,P=0.044).Conclusions Serum level of KLF5 and actinin-4 l found in HCC patients has a high predictive value for prognosis.
3.Imaging and pathological analysis of undifferentiated embryonal sarcoma of the liver in children
Shuochun WU ; Xuefeng SUN ; Mei YANG ; Xiaoli YI ; Ran TAO ; Jizhen ZOU
Chinese Journal of Clinical Oncology 2024;51(1):31-35
Objective:To enhance comprehension of undifferentiated embryonal sarcoma of the liver(UESL)in children by analyzing ultra-sound,CT,and MRI imaging features.Methods:A retrospective analysis was conducted on 11 cases of UESL in children,confirmed through surgery and pathology,at the Children's Hospital,Affiliated Capital Institute of Pediatrics from December 2009 to December 2021.We ana-lyzed the ultrasound,CT,and MRI imaging features of all patients and summarized their characteristics.Results:All 11 cases presented with solitary hepatic masses ranging from 11.5 to 19.8 cm in diameter.Imaging manifestations of UESL correlated with component proportion and distribution within the masses.Lesions displayed clear boundaries in all cases.CT scans revealed mixed low density in 11 cases,with ir-regular floc soft tissue density shadows observed at the edge of cystic density areas or around partitions in a few cases.Ultrasound images of all six cases showed solid space-occupying masses,with varying sizes of anechoic regions within the solid mass.MRI T1WI showed mixed low intensity signal in three cases and strip/large high intensity signal areas in the lesion.T2WI revealed mixed high intensity signal and strip low intensity signal areas in 3 lesions.In the arterial phase,lesions displayed slightly to moderately heterogeneous strip/patch enhancement,primarily marginal enhancement in nine cases and thickened,tortuous arterial shadows in eight cases.In the delayed phase,lesions showed continuous uneven enhancement,with enhancement at the edge and peripheral-to-central filling observed in eight cases.Additionally,the enhancement range continuously increased in eight cases,with the false capsule sign identified in eight cases in the delayed stage.Conclu-sions:Imaging features of UESL in children exhibit distinct characteristics.Understanding these features,in conjunction with clinical findings,may aid in early diagnosis.
4.MR enterography features of intestinal Behcet disease and Crohn disease in pediatric patients
Shuochun WU ; Xuefeng SUN ; Xuemei ZHONG ; Xiaoli YI ; Ran TAO ; Mei YANG
Chinese Journal of Radiology 2024;58(3):307-312
Objective:To explore the MR enterography (MRE) features of intestinal Behcet disease (BD) and Crohn disease (CD) in pediatric patients.Methods:This study was a cross-sectional study. The BD patients and CD patients were retrospectively enrolled from Children′s Hospital Affiliated to Capital Institute of Pediatrics from January 2019 to October 2022. There were 17 children with intestinal BD, including 6 males and 11 females, aged 5-12 (8.4±2.6) years, and 23 children with CD, including 15 males and 8 females, aged 7-15 (10.2±2.7) years. The MRE images were observed, and the evaluation contents included the diseased intestine (terminal ileum, ileum+ascending colon, ileum+ascending colon+transverse colon, whole colon), the form of intestinal wall thickening (uniform/eccentric thickening), MRI signal (fat suppression T 2WI, DWI), the enhancement mode (uniform/layered enhancement), intestinal stenosis, intestinal dilatation, mesentery comb sign, mesentery fatty fibrosis, lymph node enlargement, and the extraintestinal complication (anal fistula, fluid collection). The comparison of MRE signs between groups was performed using the χ2 test or Fisher exact test. Results:All children were completed MRE examination with good intestinal filling, and no adverse reactions. The significant differences were found in the scope of the diseased bowel, the form of intestinal wall thickening, DWI signal, intestinal dilatation, lymph node enlargement, anal fistula and fluid collection between the intestinal BD and CD patients ( P<0.05), while no significant differences were found in the fat suppression T 2WI signal, enhancement mode of the lesion, intestinal stenosis, mesentery comb sign, and mesentery fatty fibrosis ( P>0.05). Conclusion:MRE is safe and effective, and there are certain significantly different MRE features between children with intestinal BD and CD.
5.A study on the application of blunt separation method in midline catheter intubation in elderly patients with coagulation dysfunction
Xiufen JIA ; Yuping LIU ; Shuhong LONG ; Jin WANG ; Ran MENG ; Xiaoli JIANG
Chinese Journal of Nursing 2024;59(4):395-400
Objective To explore the efficacy of blunt separation method in midline catheter intubation in elderly patients with coagulation dysfunction.Methods A total of 80 elderly patients with coagulation dysfunction were selected in the convenience sampling method from October 2022 to April 2023 in our hospital,and they were randomly divided into an experimental(blunt)group and a control(routine)group,with 40 patients in each group.The differences in the degree of bleeding and exudation at the puncture site,the pain score and the incidence of complications(including bleeding and exudation,phlebitis,symptomatic catheter-related thrombus,catheter blockage,catheter pulling-off)were compared between 2 groups.Results In the experimental group,the degree of bleeding and exudation at the puncture point immediately after the operation,degree of bleeding and exudation at the puncture point 24 hours after the operation,pain score 1 day after the catheterization,pain score 3 days after the catheterization,incidence of bleeding and exudation,total incidence of complications and maintenance times were significantly lower than these in the control group(P<0.05).In terms of the pain score immediately after the operation,pain score 5 days after the operation,incidence of phlebitis,incidence of symptomatic catheter-related thrombosis,incidence of catheter blockage,incidence of catheter pulling-off,incidence of catheter related skin injury,incidence of unplanned extubation,success rate of one-time sheath delivery and the indwelling time,the differences between the experimental group and control group were not significant(P<0.05).Conclusion The application of blunt separation method in midline catheter indwelling can significantly reduce the incidence and degree of bleeding at the puncture point,decrease the maintenance times and relieve the pain in elderly patients with coagulation dysfunction.
6.The application value of imaging in the diagnosis and treatment of external auditory canal cholesteatoma in children
Shuochun WU ; Xuefeng SUN ; Yingxia LU ; Chang LIU ; Xiaoli YI ; Ran TAO
Chinese Archives of Otolaryngology-Head and Neck Surgery 2024;31(2):97-100
OBJECTIVE To investigate the HRCT and MRI characteristic of external auditory canal cholesteatoma(EACC)in children.METHODS A total of 40 patients(45 lesions)with EACC confirmed by pathology were retrospectively analyzed with HRCT and MRI characteristics and clinical therapeutic value.Imaging findings of 40 patients(45 lesions)with EACC were retrospectively analyzed.RESULTS Soft tissues were found in all the external auditory canal(EAC).Of the forty-five soft tissues,7 manifested as inhomogeneous strip soft tissues and 38 as lesions solid soft tissues;30 located in medial part of the EAC and covered the tympanic membrane,while the other 15 presented as tympanic membrane perforation and involved the tympanic cavity.The MRI of the 3 ears showed high signal on T2/T1 iso-intensity,high signal on DWI,and low signal on ADC.Normal whole bony EAC was observed in 17 cases and enlarged medial EAC in 28 cases.Seven cases only involved in the superior wall,but 38 cases displayed as multiple bone wall involved,of which 6 involved in circumferential walls.Thirty-three cases displayed atactic ear bone margin,11 displayed blunted or disappeared drum shield plate.Destroy of long crus of incus and manubrium mallei occurred in 15 cases,of short crus of incus in 8 cases,of stapes in 2 cases,and mastoiditis in 5 cases.According to the pneumatization degree of mastoid air cell,37 cases were classified into pneumatic type,7 cases into mixed type,and the last one into diploic type.CONCLUSION The children EACC tends to be limited and rarely involved in middle ear and mastoid process.No patient with peri-ear infection was found.Application of HRCT and MRI help accurate location and determination of cholesteatoma.According to the extent of the lesion,selecting the appropriate surgical method is an effective method to remove cholesteatoma,improve hearing and reduce recurrence.
7.Impact of changes in cognitive load of anesthesia residents on the effectiveness of high-fidelity scenario simulation teaching
Haoyu PEI ; Yi HU ; Li WANG ; Juan DAI ; Qi SUN ; Xing ZHU ; Xiaoli RAN ; Qiuping WU ; Qingxiang MAO
Chinese Journal of Medical Education Research 2024;23(4):548-555
Objective:To investigate the influence of changes in the cognitive load of anesthesia residents on the teaching effectiveness of high-fidelity scenario simulation.Methods:Eighty-seven anesthesia residents in a grade-A tertiary hospital from February to November 2022 were divided into groups A, B, and C according to the random number method. Three cases were selected from the anesthesia crisis resource teaching case library for high-fidelity simulation training for the three groups, respectively, using the crossover design to control the order of the cases. Each round of training consisted of pre-training instruction, simulation teaching, and post-training summarization and analysis. After three rounds of simulation teaching, cognitive load, anxiety status, test scores, and non-technical skills were evaluated for all the study participants. SPSS 20.0 was used to perform analysis of variance with repeated measures and Pearson's correlation analysis.Results:All the three groups showed significantly higher cognitive load and anxiety scores during the first-round simulation training than during the second-round and third-round simulation trianing. The test scores were significantly lower in the first round [(87.07±5.66), (88.38±5.41), (89.07±6.17)] than in the second round [(95.69±2.29), (96.10±2.08), (96.07±2.60)] and the third round [(96.34±1.45), (96.38±1.50), (96.17±1.73); all P<0.05]. The non-technical skill scores were also significantly lower in the first round [(37.24±7.58), (38.69±7.27), (39.24±8.74)] than in the second round [(46.17±5.55), (47.07±5.59), (47.59±6.74)] and the third round [(47.17±5.21), (48.48±5.38), (48.24±6.83); all P<0.05]. For simulations with the same cases, the trainees showed significantly higher cognitive load and anxiety scores and significantly lower test scores and non-technical skill scores in the first round than in the second and third rounds ( P<0.05). Conclusions:Anesthesia residents have higher levels of cognitive load and anxiety in the first scenario simulation training, which can reduce learning outcomes, and repeated simulation training can reduce trainees' cognitive load and anxiety.
8.CT Enterography in Differentiating Active Staging of Pediatric Crohn Disease
Shuochun WU ; Xuemei ZHONG ; Xiaoli YI ; Ran TAO ; Mei YANG ; Xuefeng SUN
Chinese Journal of Medical Imaging 2024;32(6):591-596
Purpose To explore the application value of computed tomography enterography(CTE)in differentiating active staging of pediatric Crohn disease.Materials and Methods The clinical data of 83 pediatric Crohn disease children performed by CTE examination and conducted with pediatric Crohn disease activity index(PCDAI)from January 2019 to October 2022 were selected.According to their different PCDAI scores,the patients were divided into four groups,which were remission stage(11 cases),mild activity period(47 cases),moderate activity period(14 cases)and severe activity period(11 cases),and the parameters of CTE were analyzed.Then the results associated with CTE and the stages of pediatric Crohn disease activity were analyzed.Results The CTE images of different clinical PCDAI activity stages were manifested in the scope of the diseased intestine(χ2=49.934),the enhancement mode of diseased intestinal wall(χ2=56.561),the degree of intestinal cavity stenosis(χ2=31.932),the degree of intestinal wall thickened(χ2=46.535),lymph node enlargement(χ2=17.330);in which there was a significantly difference(P<0.05),respectively.With the aggravation of PCDAI activity stages,the extent of diseased intestinal canal(more than 50 mm,31 cases,37.3%),the layered reinforcement of diseased intestinal wall(27 cases,32.5%),the luminal stenosis(less than 5 mm,19 cases,22.9%),the thickening of intestinal wall(more than 5.0 mm,54 cases,65.1%)were more common.The proportion of occurrence in the enlargement of lymph nodes(more than 7 mm,16 cases,19.3%)was high,with significant statistical significance(P<0.05).Spearman correlation analysis showed that there was a significant positive correlation between pediatric Crohn disease clinical activity stage(all P<0.01)and the extent of the lesion intestinal canal(r=0.500),the enhancement mode of the lesion intestinal wall(r=0.574),the luminal stenosis(r=0.316),the thickening of intestinal wall(r=0.533).Conclusion With the extent of diseased intestinal canal,the degree of the luminal stenosis,the enhancement mode of diseased intestinal wall and intestinal wall thickened increase,and the clinical stage gradually increase.The above four parameters use as characteristic indicators to reflect the activity stage of pediatric Crohn disease.
9.Optimization of transduction conditions of recombinant adeno-associated virus into NK92 cells
Xiaoli SHEN ; Qungang ZHOU ; Ran ZHENG ; Xiangjun SHEN ; Xiang QIU ; Taiming LI
Journal of China Pharmaceutical University 2023;54(1):115-121
To improve the transduction efficiency of recombinant adeno-associated virus (rAAV) in NK92 cells, the number of cells, concentration of IL-2 in the medium, and serotype and dosage of rAAV were explored to optimize cell state and viral transfection conditions.Then, zinc chloride (ZnCl2), chloroquine, polyvinyl alcohol (PVA) and genistein with different concentration were added separately during transfection to further improve the viral transduction efficiency.The results showed that, at cell number of 5 × 105, the expression efficiency of enhanced green fluorescent protein (EGFP) was relatively high.When the IL-2 concentration was 1 000 IU/mL, NK92 cells were most suitable for virus transfection. The transduction efficiency of different serotypes of rAAV in NK92 cells was rAAV6, rAAV2 and rAAV9 in descending order.Pretreatment of NK92 cells with genistein could significantly increase the viral transduction efficiency, while the addition of other reagents had no significant effect.Through the optimization of the above conditions, the transduction efficiency of rAAV to NK92 cells could be significantly improved, which provided evidence for functional genetic modification of NK92 cells by rAAV.
10.MRI-based investigation of characteristics and outcome of knee bone marrow edema in children with juvenile idiopathic arthritis
Yang YANG ; Ran TAO ; Xiaoli YI ; Xinning WANG ; Xinyu YUAN
Chinese Journal of Radiology 2022;56(6):650-655
Objective:To investigate the prevalence, distribution, and prognosis of knee joint bone marrow edema (BME) in children with juvenile idiopathic arthritis (JIA).Methods:From January 2017 to December 2019, 128 JIA children in the Children′s Hospital, Capital Institute of Pediatrics were analyzed retrospectively, and 136 knees were included totally. BME was evaluated and counted from eight regions according to the juvenile arthritis MRI scoring system (JAMRIS). Chi-square test, independent sample t test or Mann-Whitney U test were used to compare the clinical characteristics between BME group (36 cases) and non-BME group (92 cases). The prognosis of BME were observed. Results:BME was found in 37 of 136 knee joints (27.2%). The ages of the children in BME group and non-BME were (8±4) and (6±4) years old, and the disease duration were 9 (3, 22) and 4 (2, 18) months, respectively, both with statistically significant differences (age: t=-2.63, P=0.010; duration: Z=-5.78, P=0.013). In 23 joints (62.2%,23/37), BME occurred at multiple locations simultaneously in the knee. Locations with BME, according to the frequency of involvement from most to least, were the lateral tibial plateau with 17, the lateral weight-bearing femur with 16, the medial tibial plateau and the medial femoral condyle both with 15, the medial weight-bearing femur with 12, the lateral femoral condyle with 8, the lateral patella with 7, and the medial patella with 5. The MRI score of most of medial femoral conclyle was 1(7/15). Of the 15 BME joints with the MRI follow-up data with interval (7±3) months, BME disappeared in 10 joints, improved in 3 joints and progressed in 2 joints within 12 months after the treatments. Conclusions:There is a low incidence of BME in JIA affected knee joint. Older children and the children with long disease duration have a higher risk for BME, and more likely involved the weight-bearing surfaces of the joint. The overall prognosis is satisfactory after the standard treatments.

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