OBJECTIVES: To explore the value of serum cystatin C (CysC) levels in evaluating renal prognosis in IgA nephropathy (IgAN) patients. METHODS: We retrospectively collected the clinical data of IgAN patients diagnosed by renal biopsy at Guangdong Provincial People's Hospital from January, 2014 to December, 2018. Based on baseline serum CysC levels, the patients were divided into high serum CysC (>1.03 mg/L) group and normal serum CysC (≤1.03 mg/L) group. The composite endpoint for poor renal prognosis was defined as ≥50% decline in estimated glomerular filtration rate (eGFR) and/or progression to end-stage renal disease (ESRD). Lasso regression, multivariate Cox regression and Kaplan-Meier survival analysis were used to identify the risk factors and compare renal survival rates between the two groups. Smooth curves fitting and threshold effect analysis were used to explore the relationship between serum CysC levels and the outcomes. A nomogram model was constructed and its predictive performance was evaluated using concordance index, calibration curve, receiver operating characteristic (ROC) curve and the area under curve (AUC). RESULTS: A total of 356 IgAN patients were enrolled, who were followed up for 4.65±0.93 years. The composite endpoint occurred in 74 patients. High serum CysC was identified as an independent risk factor for poor renal prognosis in IgAN (HR=2.142, 95% CI 1.222 to 3.755), and the patients with high serum CysC levels had a lower renal survival rate (Log-rank χ²=47.970, P<0.001). In patients with serum CysC below 2.12 mg/L, a higher CysC level was associated with an increased risk of poor renal prognosis (β=3.487, 95% CI: 2.561-4.413, P<0.001), while above this level, the increase of the risk was not significant (β=0.676, 95% CI: -0.642-1.995, P=0.315). The nomogram model based on serum CysC and 3 other independent risk factors demonstrated good internal validity with a concordance index of 0.873 (95% CI: 0.839-0.907) and an AUC of 0.909 (95% CI: 0.873-0.945). CONCLUSIONS Serum CysC levels are associated with renal prognosis in IgAN patients, and high serum CysC an independent risk factor for poor renal prognosis.
Humans ; Glomerulonephritis, IGA/diagnosis* ; Cystatin C/blood* ; Prognosis ; Risk Factors ; Retrospective Studies ; Glomerular Filtration Rate ; Kidney Failure, Chronic ; Male ; Female ; Adult ; Nomograms ; Middle Aged

Objective:To investigate value of contrast-enhanced ultrasound(CEUS)in predicting ischemic-type biliary lesions(ITBLs)in patients with thickened hilar bile duct wall at early stage after liver transplantation.Methods:A total of 45 patients,who underwent liver transplantation at the Liver Transplantation Center of Beijing Friendship Hospital Affiliated to Capital Medical University from June 25,2020 to December 28,2022,and occurred hilar bile duct wall thickening at early stage after surgery,were prospectively included.CEUS was performed on biliary tract when the thickened hilar bile duct wall was first detected by routine ultrasound,and the enhanced mode of duct wall at each phase was recorded.Subsequently,according to the results of cholangiography,these patients were divided into ITBLs group(15 cases)and non-ITBLS group(30 cases).The enhanced degree of each phase of CEUS of two groups was qualitatively analyzed and compared,and the diagnostic efficacy of CEUS for ITBLs after liver transplantation was evaluated.Results:There were no significant differences in source of liver donor,biliary anastomosis,autoimmune liver disease,hepatic artery occlusion(HAO),rejection,cytomegalovirus infection and cholangitis between the two groups(P>0.05).The compared results of the enhanced mode of CEUS at arterial phase between the two groups indicated that 25 patients(83.3%)were hyper-enhancement,and 5 patients(16.7%)were iso-enhancement,and 0 patient was hypo-enhancement or non-enhancement in non-ITBLS group.The compared results also indicated that 3 patients(20.0%)were hyper-enhancement,and 4 patients(26.7%)were iso-enhancement,and 8 patients(53.3%)were hypo-enhancement or non-enhancement in ITBLs group.The difference of above results between the two groups was statistically significant(x2=22.946,P<0.000).There was no significant difference between the two groups in the enhanced mode at the late phase(P>0.05).The accuracy,sensitivity,specificity,positively predictive value and negatively predictive value of the prompted hypo-enhancement or non-enhancement at arterial phase of CEUS on biliary tract were respectively 84.4%,53.3%,100%,100%and 84.4%in diagnosing ITBLs.For 8 patients who were diagnosed as ITBLs by CEUS,the diagnostic time of CEUS for ITBLs was 1 to 6 months[3.0(1-5)months]ahead of that of cholangiography.Conclusion:CEUS can more accurately predict ITBLs before the biliary tract occurs significant morphological change,which can significantly advance the diagnostic time for ITBLs.

Objective: QL1604 is a highly selective, humanized monoclonal antibody against programmed death protein 1. We assessed the efficacy and safety of QL1604 plus chemotherapy as first-line treatment in patients with advanced cervical cancer. Methods: This was a multicenter, open-label, single-arm, phase II study. Patients with advanced cervical cancer and not previously treated with systemic chemotherapy were enrolled to receive QL1604 plus paclitaxel and cisplatin/carboplatin on day 1 of each 21-day cycle for up to 6 cycles, followed by QL1604 maintenance treatment. Results: Forty-six patients were enrolled and the median follow-up duration was 16.5 months. An 84.8% of patients had recurrent disease and 13.0% had stage IVB disease. The objective response rate (ORR) per Response Evaluation Criteria in Advanced Solid Tumors (RECIST) v1.1 was 58.7% (27/46). The immune ORR per immune RECIST was 60.9% (28/46).The median duration of response was 9.6 months (95% confidence interval [CI]=5.5–not estimable). The median progression-free survival was 8.1 months (95% CI=5.7–14.0). Fortyfive (97.8%) patients experienced treatment-related adverse events (TRAEs). The most common grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%). Conclusion QL1604 plus paclitaxel-cisplatin/carboplatin showed promising antitumor activity and manageable safety profile as first-line treatment in patients with advanced cervical cancer. Programmed cell death protein 1 inhibitor plus chemotherapy may be a potential treatment option for the patient population who have contraindications or can’t tolerate bevacizumab, which needs to be further verified in phase III confirmatory study.

Objective: QL1604 is a highly selective, humanized monoclonal antibody against programmed death protein 1. We assessed the efficacy and safety of QL1604 plus chemotherapy as first-line treatment in patients with advanced cervical cancer. Methods: This was a multicenter, open-label, single-arm, phase II study. Patients with advanced cervical cancer and not previously treated with systemic chemotherapy were enrolled to receive QL1604 plus paclitaxel and cisplatin/carboplatin on day 1 of each 21-day cycle for up to 6 cycles, followed by QL1604 maintenance treatment. Results: Forty-six patients were enrolled and the median follow-up duration was 16.5 months. An 84.8% of patients had recurrent disease and 13.0% had stage IVB disease. The objective response rate (ORR) per Response Evaluation Criteria in Advanced Solid Tumors (RECIST) v1.1 was 58.7% (27/46). The immune ORR per immune RECIST was 60.9% (28/46).The median duration of response was 9.6 months (95% confidence interval [CI]=5.5–not estimable). The median progression-free survival was 8.1 months (95% CI=5.7–14.0). Fortyfive (97.8%) patients experienced treatment-related adverse events (TRAEs). The most common grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%). Conclusion QL1604 plus paclitaxel-cisplatin/carboplatin showed promising antitumor activity and manageable safety profile as first-line treatment in patients with advanced cervical cancer. Programmed cell death protein 1 inhibitor plus chemotherapy may be a potential treatment option for the patient population who have contraindications or can’t tolerate bevacizumab, which needs to be further verified in phase III confirmatory study.

Objective: QL1604 is a highly selective, humanized monoclonal antibody against programmed death protein 1. We assessed the efficacy and safety of QL1604 plus chemotherapy as first-line treatment in patients with advanced cervical cancer. Methods: This was a multicenter, open-label, single-arm, phase II study. Patients with advanced cervical cancer and not previously treated with systemic chemotherapy were enrolled to receive QL1604 plus paclitaxel and cisplatin/carboplatin on day 1 of each 21-day cycle for up to 6 cycles, followed by QL1604 maintenance treatment. Results: Forty-six patients were enrolled and the median follow-up duration was 16.5 months. An 84.8% of patients had recurrent disease and 13.0% had stage IVB disease. The objective response rate (ORR) per Response Evaluation Criteria in Advanced Solid Tumors (RECIST) v1.1 was 58.7% (27/46). The immune ORR per immune RECIST was 60.9% (28/46).The median duration of response was 9.6 months (95% confidence interval [CI]=5.5–not estimable). The median progression-free survival was 8.1 months (95% CI=5.7–14.0). Fortyfive (97.8%) patients experienced treatment-related adverse events (TRAEs). The most common grade≥3 TRAEs (>30%) were neutrophil count decrease (50.0%), anemia (32.6%), and white blood cell count decrease (30.4%). Conclusion QL1604 plus paclitaxel-cisplatin/carboplatin showed promising antitumor activity and manageable safety profile as first-line treatment in patients with advanced cervical cancer. Programmed cell death protein 1 inhibitor plus chemotherapy may be a potential treatment option for the patient population who have contraindications or can’t tolerate bevacizumab, which needs to be further verified in phase III confirmatory study.

With the gradual improvement of medical informatization and the vigorous development of medical and health big data，the exploration and practice of real -world research are becoming more and more mature ，and real -world data have become an important source of evidence for post marketing re -evaluation of drugs . As an important high -quality real -world medical data ， electronic medical record data is an indispensable data source for post marketing re -evaluation of drugs . Most of the existing guidelines and norms of real -world research are designed from the perspective of prospective research ，and do not propose specific measures and methods in the implementation of retrospective research ，especially for the operation suggestions on the technical level of using conventionally collected electronic medical record data . In combination with the operational process framework formulated by the existing guidelines and norms ，this paper creatively adds the operating procedures for dataE- validation，data integration ，data verification ，and throughout quality control ，data management and storage of retrospectiveelectronic medical record data ，and describes the data analysis methods and key points involved in carrying out multi -center retrospective real -world research using electronic medical record data ，taking the post marketing safety research of drugs as an example. Finally，the full process operation procedure applicable to the use of multi -center retrospective electronic medical record data is established .

Objective:To observe and analyze the correlation between macular microvascular parameters and urinary albumin to creatinine ratio (UACR) in patients with type 2 diabetes mellitus (T2DM).Methods:A cross-sectional study. From October 2017 to April 2018, 100 eyes of 100 patients (T2DM) and 27 eyes of 27 healthy controls (the control group) were enrolled in Xuzhou First People’s Hospital. All subjects underwent anterior segment examination via slit-lamp biomicroscopy, dilated fundus examination, 7-field fundus photographs, OCT angiography (OCTA), the fasting glucose test, glycosylated hemoglobin (HbA1c), urinary albumin, urinary creatinine and UACR levels determination. Height and weight measurement were taken for calculating body mass index (BMI). Diabetic retinopathy was ruled out by fundoscopic examinations and 7-field fundus photographs in T2DM patients. According to the UACR, patients in the T2DM group were subdivided into A1 group (UACR< 30 mg/g), A2 group (UACR 30-300 mg/g), and A3 group (UACR>300 mg/g), with 38 cases and 38 eyes respectively , 40 cases with 40 eyes, 22 cases with 22 eyes. A 6 mm×6 mm scanning area centered on the macular fovea were scanned for right eye using a frequency domain OCTA instrument, which were divided into three concentric circles centered on the macular fovea by the software automatically. The foveal zone was defined as a circular area measuring 1 mm in diameter, the parafoveal zone was described as a middle circle area measuring 1-3 mm in diameter, and the perifoveal zone was an outer circle area measuring 3-6 mm in diameter. The vessel density of superficial capillary plexus (SCP) and deep capillary plexus (DCP), foveal avascular area (FAZ) and perimeter (PERIM), non-circularity index (AI) were measured. The correlation between the macular vessel density, FAZ and UACR was analyzed by Spearman correlation analysis.Results:A1 group, A2 group, A3 group, and normal control group. The macular area SCP and DCP ( F=13.722, 5.644), foveal area ( F=4.607, 4.719), parafoveal area ( H=23.142, F=2.904), the blood flow density of the area around the fovea ( F=12.292, H=10.946), the difference was statistically significant ( P<0.05); with the increase of UACR, the blood flow density of each area of SCP and DCP showed a downward trend. The results of correlation analysis showed that the blood flow density of the whole SCP, parafoveal area, and surrounding area of T2DM patients was negatively correlated with UACR ( r=-0.376, -0.240, -0.364,-0.347, P<0.05). There were no correlation among fasting plasma glucose, HbAlc and UACR ( r=0.179, 0.085, P>0.05). There were no correlation among blood flow density in BMI, SCP foveal area, DCP and UACR (| r|<0.3, P>0.05). Conclusion:The whole, parafovea and perifovea vessel density values of SCP in T2DM eyes without DR are negatively correlated with UACR.

A 15-year-old female was referred to the hospital with intermittent fever, where multiple systemic abnormalities were found, such as splenomegaly, secondary hypersplenism, retinitis pigmentosa, and ectodermal dysplasia. Medical history revealed that she had suffered recurrent respiratory infections, blurred vision at night, and dysplasia of teeth and nail beds since childhood. Then she was suspected to be experiencing ROSAH syndrome, a rare disease newly recognized in recent years, which was finally confirmed by gene sequencing results. During a course of treatment with tumor necrosis factor inhibitors, recurrent fever with elevated inflammatory markers reappeared, and the child developed headaches. To guide the comprehensive treatment and improve the patient's quality of life, the multidisciplinary team in Peking Union Medical College Hospital discussed together and directed the following treatment.

Objective:To explore the predictability cytokines in aqueous humor affecting optical coherence tomography angiography (OCTA) parameters after anti-vascular endothelial growth factor (VEGF) treatment in patients with polypoidal choroidal vasculopathy (PCV).Methods:A cross-sectional study was carried out.Twenty eyes of 20 patients with PCV were included in Xuzhou First People's Hospital from July 2017 to July 2020.All PCV eyes were treated by intravitreal injection of conbercept (IVC) following 3+ PRN regimen.One hundred μl of aqueous humor was collected before treatment and before the third injection, respectively.Thirteen kinds of cytokines in the aqueous humor were detected with Luminex bead-based multiplex array.The aqueous humor of 16 eyes of 16 cataract patients with age and gender matched were collected in the same way during phacoemulsification surgery as control.The values of center macular thickness (CMT), subretinal fluid height (SRFH), pigment epithelial detachment height (PEDH) and pigment epithelial detachment diameter (PEDD) of the eyes in the PCV group were examined with OCTA system.The target cytokines in aqueous humor affecting OCTA parameter change values (the difference between before and after treatment) was analyzed.This study protocol was approved by an Medical Ethic Committee of Xuzhou First People's Hospital (No.xyyll[2020]27) and complied with Declaration of Helsinki.Written informed consent was obtained from each patient prior to any medical invention.Results:The concentration of interleukin-8 (IL-8), Leptin, hepatocyte growth factor (HGF), fibroblast growth factor-2 (FGF-2), angiopoietin-2 (Ang-2), endothelin-1 and vascular endothelial growth factor-A (VEGF-A) were significantly higher in aqueous humor of the PCV group before treatment than those in the cataract group (all at P<0.05). After treatment, the concentration of VEGF-A in aqueous humor of the PCV group was significantly lower than that before treatment ( P<0.001). The values of CMT, SRFH, PEDH and PEDD were significantly reduced in comparison with before treatment, showing statistical significances (all at P<0.05). The concentration of VEGF-A in aqueous humor was positively correlated and endothelin-1 in aqueous humor was negatively correlated with the change value of CMT ( r=0.592, -0.485, both at P<0.05). The concentration of IL-8 and HGF were positively correlated with SRFH change value ( r=0.492, 0.466, both at P<0.05). VEGF-A and IL-8 concentraions of aqueous humor before treatment were the risk factor of the change value of CMT and SRFH.Every 1pg/ml increase of baseline VEGF-A, the CMT change value reduced 0.836 μm ( P=0.006), and every 1pg/ml increase of baseline IL-8, the SRFH change value reduced 12.522 μm ( P=0.028). Conclusions:The concentrations of VEGF-A and IL-8 in aqueous humor might predict the CMT and SRFH improvement in PCV eyes after anti-VEGF therapy.

Objective:To comparatively analyze for the fundus characteristics of acquired immune deficiency syndrome (AIDS) with cytomegalovirus retinitis (CMVR) between first-visit and non-first-visit in ophthalmology.Methods:A retrospective study was performed for 22 patients (41 eyes) diagnosed as CMVR with AIDS by ophthalmology in the Affiliated Municipal Hospital of Xuzhou Medical University from July 2004 to September 2017. The patients were divided into two groups: one with the first-visit in ophthalmology (FVO) and the other with the first-visit in non-ophthalmology (FVNO). All patients underwent visual acuity, intraocular pressure, slit lamp microscope and indirect ophthalmoscope examinations. Thirty-nine eyes of 21 patients with clear refractive media were examined by color fundus photography, of which 5 patients were examined by FFA. Five patients examined by OCT and B-mode ultrasound. The CMVR were characterized as fulminant type or indolent type. All the 22 patients (41 eyes) except 2 patients (4 eyes) accepted highly active antiroviral therapy, and all patients were treated with ganciclovir intravenously. Nine patients (12 eyes) received intravitreal injection of ganciclovir, 7 patients (10 eyes) underwent vitrectomy because of retinal detachment, 6 patients (7 eyes) gave up surgery because of extensive retinal detachment, and the other 12 eyes did not undergo any eye surgery. All patients were followed for 6-58 months (average 23±39 months). The incidences and fundus characteristics of the patients with fulminant or indolent CMVR were compared and analyzed. Between the two groups, the difference of visual acuity and CD4 +T cell count at the first vist and the last follow-up were analyzed by a t-test, and the macular involvement and spread of the two groups were compared by a chi-square test. Results:Fulminant CMVR showed dense yellow-white necrotic lesions along the great vessels with or without satellite lesions, while indolent CMVR showed sparse yellow-white granular lesions with a little bleeding. The concomitant signs included frost-like dendritic vascular sheath, retinal artery occlusion and optic disc edema. Fourteen eyes of 7 patients in FVO group were fulminant, including 2 patients (2 eyes) with retinal artery occlusion and 1 patient (two eyes) with optic disc edema. In FVNO group, there were 27 eyes of 15 patients, including 21 eyes of 13 cases identified as fulminant type and 6 eyes of 4 patients as indolent type. In the fulminant type, there were 4 patients (6 eyes) with frost-like dendritic vascular sheath, 10 patients (12 eyes) with retinal artery occlusion and 4 patients (4 eyes) with optic disc edema. There was no significant difference in initial visual acuity ( t=-1.534, P=0.133), but there was a significant difference in visual acuity at the last follow-up ( t=-3.420, P=0.001). There was no significant difference in CD4 + T cells between the two groups at the first visit ( t=-0.902, P=0.378). The proportions of macular involvement and 3-4 quadrant involvement in FVO group were significantly higher than those in FVNO group ( χ 2=7.552, 7.865; P=0.006, 0.005). Conclusion:For AIDS patients with CMVR, the first-visit in ophthalmology showed more dense necrotic lesions involving macular and a wider range of lesions than the first-visit in non-ophthalmology.