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Objective:To analyze the distribution of glomerular immunofluorescence IgG4 subtypes in primary membranous nephropathy, and to explore the relationship between IgG4 deposit intensity and renal pathology, clinical manifestations and prognosis.Methods:All the patients of biopsy-proven primary membranous nephropathy with IgG staining and at least one IgG subtype staining 1+ or higher on capillary loops from September 2015 to April 2017 were retrospectively enrolled. The distribution of IgG4 deposits were analyzed, and the relationship between IgG4 positive intensity and clinical manifestations, pathological indexes and clinical remission was investigated.Results:A total of 250 cases were enrolled, including 157 males (62.8%) and 93 females (37.2%), and age was (54.4 ± 14.6) years. There were 40 patients in IgG4-negative group, and 210 patients in IgG4-positive group. The IgG4-positive group was divided into subgroups as 114 cases of the mild positive subgroup (1+) and 62 cases of the moderate positive subgroup (2+), and 34 cases of the strong positive subgroup (3+, 4+). The IgG4-positive group had higher 24-hour urine protein and higher positive rate of phospholipase A2 receptor staining than those in the negative group (both P<0.05), while the strong positive subgroup had lower serum albumin and higher IgG1 staining than those in the mild positive subgroup (both P<0.05). There was no difference in the ratio of glomerular sclerosis, tubular atrophy, IgG2, IgG3 or other immunofluorescence between the groups. After a median follow-up of 180(122, 209) days, 32 individuals were lost to follow-up. Among the rest 218 patients, 45 patients (20.6%) got complete remission, 104 patients (47.7%) got partial remission, and 69 patients (31.7%) showed no response. For no response as the outcome event, multivariate Cox regression analysis showed that higher IgG4 staining intensity ( HR=1.371, 95% CI 1.068-1.759, P=0.013), male ( HR=1.818, 95% CI 1.028-3.214, P=0.040), higher 24-hour urine protein level ( HR=1.108, 95% CI 1.003-1.225, P=0.043) were independent risk factors for disease remission. Conclusions:The glomerular IgG4 positivity and intensity are related to the severity of primary membranous nephropathy. The glomerular IgG4 deposit degree may be an effective prognostic marker for the treatment response of primary membranous nephropathy.
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Objective@#To analyze the distribution of glomerular immunofluorescence IgG4 subtypes in primary membranous nephropathy, and to explore the relationship between IgG4 deposit intensity and renal pathology, clinical manifestations and prognosis.@*Methods@#All the patients of biopsy-proven primary membranous nephropathy with IgG staining and at least one IgG subtype staining 1+ or higher on capillary loops from September 2015 to April 2017 were retrospectively enrolled. The distribution of IgG4 deposits were analyzed, and the relationship between IgG4 positive intensity and clinical manifestations, pathological indexes and clinical remission was investigated.@*Results@#A total of 250 cases were enrolled, including 157 males (62.8%) and 93 females (37.2%), and age was (54.4 ± 14.6) years. There were 40 patients in IgG4-negative group, and 210 patients in IgG4-positive group. The IgG4-positive group was divided into subgroups as 114 cases of the mild positive subgroup (1+) and 62 cases of the moderate positive subgroup (2+), and 34 cases of the strong positive subgroup (3+, 4+). The IgG4-positive group had higher 24-hour urine protein and higher positive rate of phospholipase A2 receptor staining than those in the negative group (both P<0.05), while the strong positive subgroup had lower serum albumin and higher IgG1 staining than those in the mild positive subgroup (both P<0.05). There was no difference in the ratio of glomerular sclerosis, tubular atrophy, IgG2, IgG3 or other immunofluorescence between the groups. After a median follow-up of 180(122, 209) days, 32 individuals were lost to follow-up. Among the rest 218 patients, 45 patients (20.6%) got complete remission, 104 patients (47.7%) got partial remission, and 69 patients (31.7%) showed no response. For no response as the outcome event, multivariate Cox regression analysis showed that higher IgG4 staining intensity (HR=1.371, 95%CI 1.068-1.759, P=0.013), male (HR=1.818, 95%CI 1.028-3.214, P=0.040), higher 24-hour urine protein level (HR=1.108, 95%CI 1.003-1.225, P=0.043) were independent risk factors for disease remission.@*Conclusions@#The glomerular IgG4 positivity and intensity are related to the severity of primary membranous nephropathy. The glomerular IgG4 deposit degree may be an effective prognostic marker for the treatment response of primary membranous nephropathy.
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Objective To study the renal prognosis with the type and proportion of crescentic in adult Henoch Schonlein purpura nephritis (HSPN).Methods A total of 275 HSPN cases diagnosed in the First Affiliated Hospital of Zhejiang University were retrospectively analyzed.According to the pathological results,they were divided into four groups:99 patients in none crescent group (NC),35 patients in segmental crescents group (SC),122 patients with circumferential crescent ＜25％ (C1),and 19 patients with circumferential crescent≥25％ (C2).Renal prognostic events were defined as estimated glomerular filtration rate (eGFR) decreased by 30％ over baseline within 2 years,doubling of serum creatinine or end-stage renal disease during follow-up.Kaplan-Meier survival analysis was used to compare the renal survival rate of each group.Univariate and multivariate Cox regression model was used to recognize the risk factor of poor renal outcome.Results There was no significant difference in age,extra renal organ performance and mean arterial pressure among groups.Among NC group,SC group,C1 group and C2 group,difference in serum creatinine (P=0.001),eGFR (P=0.003) and proteinuria levels (P ＜ 0.001) were statistically significant.There was no significant difference in the ratio of global sclerosis,mesangial hypercellularity and interstitial inflammation/fibrosis among the groups.The patients were followed up for 86(58,116) months.The renal survival rates of NC group,SC group,C1 group and C2 group were 96％,100％,83.6％ and 68.4％ respectively.Kaplan-meier survival analysis showed significant differences (Log Rank=23.24,P＜ 0.001).Cox multivariate regression analysis indicated that presence of circumferential crescent (HR=3.59,95％CI 1.34-9.62,P=0.008) and low eGFR (HR=0.979,95％ CI 0.968-0.989,P ＜ 0.001) were independent prognostic factors.Conclusion The presence of circumferential crescent and low eGFR level are independent risk factors for poor renal prognosis in HSPN patients.
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OBJECTIVE:To discuss the countermeasure on the quality improvement of the drug clinical trials in our hospital based on the discovery of key links of the quality of clinical trials. METHODS:Quality results of 14 drug clinical trials in 10 ma-jors from the drug clinical trial institute in our hospital in 2014 were investigated. Referring to the grading and classifying methods of the inspection problems in European Medicines Agency,the key links of occurring problems were analyzed,and the effects of interventions for key links were evaluated. RESULTS:In 2014,totally 125 important and general problems were found,in which, the numbers of problems occurred in case report form filling,informed consent of subjects,enrolling and screening of subjects,in-vestigational products management accounted for 79.20%. The above 4 links were the key links affecting quality of drug clinical tri-als. According to strengthening the training about relevant knowledge of the researchers,improving system and standard operation procedures management,enhancing link quality control,introducing project clinical research coordinator,developing centralized drug management and other interventions,the total numbers of found important and general problems in 2015 and 2016 were 68 and 59,respectively. Compared with 2014,the differences were statistically significant(P0.05). There were no severe problems during 2014-2016. After interventions,numbers of occurring prob-lems in majors with less complex drug clinical trial had obviously declined in 2016. Compared with 2014,the differences were sta-tistically significant (P0.05). CONCLUSIONS:Controlling the key links in drug clinical trial process can obviously reduce the occurrence of general problems while has little effect on the occurrence of im-portant problems. It is different for different majors in undertaking drug clinical trial projects,so as the links and degree of occur-ring problems. It should be distinguished in quality control checking.
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Objective To explore the etiologies of fever of unknown origin(FUO)and methods for confirming di-agnosis in patients at a hospital,and provide reference for clinical diagnosis and treatment of FUO.Methods Pa-tients with FUO admitted to a hospital between January 2008 and July 2014 were performed clinical diagnosis with methods of serology,bacteriology,molecular biology,bone marrow aspiration,tissue biopsy,and diagnostic thera-py,the etiologies and final diagnosis of 224 patients were analyzed retrospectively.Results Of 224 FUO cases,189 (84.38%)eventually got confirmed diagnosis,35 (15.62%)were not confirmed.The percentage of infectious dis-eases,connective tissue diseases,malignant tumor,and other diseases were 50.45%,18.75%,9.82%,and 5.36%respectively.Among infectious diseases,the major pathogens were bacteria,followed by virus.The major connec-tive tissue diseases were systemic lupus erythematosus and polyarteritis nodosa;the main malignant tumor was he-matological tumor,lymphoma was the main form.Among 189 patients with confirmed diagnosis,30.16% and 24.34% were performed pathogenic and pathologic detection respectively,and 20.11% were performed the other (compre-hensive)methods.Conclusion Infectious diseases,connective tissue diseases,and tumor are major etiologies of FUO.