Clinical nephrology最新文献

{"title":"Nomogram analysis of the influencing factors of rapid renal decline in patients with biopsy-proven diabetic nephropathy in type 2 diabetes.","authors":"Yan Ma,&nbsp;Yuqian Ren,&nbsp;Di Hui,&nbsp;Lihua Zhang,&nbsp;Chengfeng Jiao,&nbsp;Honglang Xie","doi":"10.5414/CN111065","DOIUrl":"https://doi.org/10.5414/CN111065","url":null,"abstract":"<p><strong>Background: </strong>HbA1c variability may be related to risk of poor prognoses in chronic kidney disease patients with type 2 diabetes mellitus (T2DM). The aim of this study was to investigate whether HbA1c variability is associated with rapid renal function decline and the related risk factors in type 2 diabetic nephropathy (DN).</p><p><strong>Materials and methods: </strong>An observational analysis was performed on 387 DN patients who were diagnosed by kidney biopsy from January 2006 through January 2016 at the Department of Nephrology, Jinling Hospital Affiliated to Nanjing University. The rapid decliners were defined as an estimated glomerular filtration rate (eGFR) decline slope ≥ 5 mL/min/1.73m²/year. HbA1c variability and 24 baseline clinicopathologic parameters was evaluated using the least absolute shrinkage and selection operator regression (LASSO) and multivariate logistic regression. The nomogram method was applied to score the factors, and a scoring model was constructed.</p><p><strong>Results: </strong>HbA1c variability positively correlated with the rate of renal function decline (r = 0.277; p < 0.001). Higher baseline eGFR, lower serum calcium concentration, glomerular lesions, arteriosclerosis, and interstitial fibrosis and tubular atrophy (IFTA) were selected into the nomogram. The calibration curve for the probability of survival showed good agreement between the prediction by nomogram and actual observation. The C-index for predicting survival was 0.811 (95% confidence interval (CI) 0.680 - 0.785).</p><p><strong>Conclusion: </strong>The proposed nomogram and score provide a useful risk estimate of fast renal function decline in patients with type 2 diabetic nephropathy.</p>","PeriodicalId":10396,"journal":{"name":"Clinical nephrology","volume":"99 6","pages":"274-282"},"PeriodicalIF":1.1,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9530354","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Significant differences between two commonly used bioimpedance methods in hemodialysis patients.","authors":"Ondrej Kade,&nbsp;Jan Malik,&nbsp;Kristyna Cmerdova,&nbsp;Martin Matoulek,&nbsp;Veronika Satrapova,&nbsp;Zuzana Hladinova,&nbsp;Anna Valerianova,&nbsp;Pavla Zurkova","doi":"10.5414/CN110818","DOIUrl":"https://doi.org/10.5414/CN110818","url":null,"abstract":"<p><strong>Introduction: </strong>Bioimpedance methods are currently used abundantly in patients on chronic hemodialysis. In this population, their most important role is to determine the level of fluid volume, respectively its intra- and extracellular components. There are several bioimpedance devices on the market. In this project, we compared two frequently used devices: Body Composition Monitor and InBody S10.</p><p><strong>Materials and methods: </strong>We invited patients on chronic hemodialysis who are being treated in our institution. Inclusion criteria were: clinically stable condition, lack of artificial joints, pacemakers, or other implanted metal objects. The examinations were performed just prior to hemodialysis by both methods 5 minutes apart. Patients were examined in the supine position after 15 minutes at rest to stabilize body fluids. Studied parameters were those that are obtainable by both methods: total body water (TBW) (L), extracellular water (ECW) (L) and intracellular water (ICW) (kg), lean tissue mass (LTM) (L), and fat tissue mass (kg).</p><p><strong>Results: </strong>We included 14 participants (aged 64.4 ± 18.0 years). Statistically and clinically significant differences between data from compared devices were observed for all variables. Inbody S10 overestimated TBW by 2.58 ± 2.73 L and ICW by 4.56 ± 2.27 L in comparison to BCM. The highest difference (27%) was measured for LTM and ICW 22%. LTM, fat, and ECW were higher when measured by BCM (LTM by 8.54 ± 6.43 kg, p < 0.001; fat by 3.41 ± 4.22, p = 0.01; ECW by 2.01 ± 0.89 L, p < 0.001).</p><p><strong>Conclusion: </strong>The differences between tested devices were significant not only statistically, but also clinically. These two devices cannot be used interchangeably for dry weight setting of hemodialysis patients.</p>","PeriodicalId":10396,"journal":{"name":"Clinical nephrology","volume":"99 6","pages":"283-289"},"PeriodicalIF":1.1,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9530851","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Late onset granulomatous interstitial nephritis after booster dose of COVID-19 vaccination: Case report and review of literature.","authors":"Keshav Ghanekar,&nbsp;Hrishikesh Ghanekar,&nbsp;Ramesh Saxena","doi":"10.5414/CN110965","DOIUrl":"https://doi.org/10.5414/CN110965","url":null,"abstract":"<p><p>Billions of doses of COVID-19 vaccine have been administered to combat the coronavirus pandemic. Though the vaccine is generally well tolerated, several cases of new onset or relapsing glomerulonephritis have been reported. In comparison, post-vaccination tubulointerstitial nephritis (TIN) has rarely been reported, mostly after the first or the second dose of the vaccine. Acute interstitial nephritis after booster dose of COVID-19 vaccination has not yet been reported. We report a case of acute granulomatous TIN shortly after the booster dose of Moderna vaccine. Our patient had no clinical evidence of renal injury after the first two doses of vaccine. Renal dysfunction was incidentally observed ~ 1 month after the booster dose of vaccine. The patient responded to steroids with rapid improvement in kidney function. While it is difficult to ascertain the causal relationship between the vaccination and development of TIN, it is important to be vigilant about such delayed side effects of the vaccine.</p>","PeriodicalId":10396,"journal":{"name":"Clinical nephrology","volume":"99 6","pages":"299-306"},"PeriodicalIF":1.1,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10235843","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Relationship of serum albumin at initiation of incident peritoneal dialysis with cardiovascular and overall survival.","authors":"Jane Pitanupong,&nbsp;Arunchai Chang","doi":"10.5414/CN110979","DOIUrl":"https://doi.org/10.5414/CN110979","url":null,"abstract":"<p><strong>Aims: </strong>To investigate whether serum albumin level at peritoneal dialysis (PD) initiation is associated with mortality in end-stage kidney disease (ESKD) patients.</p><p><strong>Materials and methods: </strong>We retrospectively reviewed the records of ESKD patients on continuous ambulatory PD during 2015 - 2021. Patients with initial albumin ≥ 3 mg/dL were placed in the high albumin group and those with albumin < 3 mg/dL in the low albumin group. A Cox proportional hazards model was used to identify variables influencing survival.</p><p><strong>Results: </strong>Among 77 patients, 46 were in the high albumin group and 31 in the low albumin group. The high albumin group had significantly increased cardiovascular (1-, 3-, and 5-year cumulative survival rates of 93 vs. 83%, 81 vs. 64%, and 81 vs. 47%, respectively; log-rank p = 0.016) and overall survival (1-, 3-, and 5-year cumulative survival rates of 84 vs. 77%, 67 vs. 50%, and 60 vs. 29%, respectively; log-rank p = 0.017). Serum albumin < 3 g/dL was an independent predictor of cardiovascular (hazard ratio (HR) 4.401; 95% confidence interval (CI), 1.584 - 12.228; p = 0.004) and overall survival (HR 2.927; 95% CI 1.443 - 5.934, p = 0.003).</p><p><strong>Conclusion: </strong>Low albumin levels at PD initiation are an independent risk factor for decreased cardiovascular and overall survival. Further research is required to know whether increasing albumin levels before PD would decrease mortality.</p>","PeriodicalId":10396,"journal":{"name":"Clinical nephrology","volume":"99 6","pages":"265-273"},"PeriodicalIF":1.1,"publicationDate":"2023-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9530831","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"FGF-23 and sclerostin in serum and bone of CKD patients.","authors":"Florence Lima,&nbsp;Marie-Claude Monier-Faugere,&nbsp;Hanna Mawad,&nbsp;Valentin David,&nbsp;Hartmut H Malluche","doi":"10.5414/CN111111","DOIUrl":"https://doi.org/10.5414/CN111111","url":null,"abstract":"<p><strong>Aims: </strong>Renal osteodystrophy occurs in the early stages of chronic kidney disease (CKD) and progresses during loss of kidney function. Fibroblast growth factor (FGF)-23 and sclerostin, both produced by osteocytes, are increased in blood of patients with CKD. The aim of this study was to analyze the impact of decline in kidney function on FGF-23 and sclerostin protein expression in bone and to study their relationship with their serum levels and bone histomorphometry.</p><p><strong>Materials and methods: </strong>108 patients aged 25 - 81 years (mean ± SD: 56 ± 13 years) underwent anterior iliac crest biopsies after double-tetracycline labeling. Eleven patients were CKD-2, 16 were CKD-3, 9 were CKD-4 - 5, and 64 CKD-5D. Patients were on hemodialysis for 49 ± 117 months. 18 age-matched patients without CKD were included as controls. Immunostaining was performed on undecalcified bone sections to quantify FGF-23 and sclerostin expression. Bone sections were also evaluated by histomorphometry for bone turnover, mineralization, and volume.</p><p><strong>Results: </strong>FGF-23 expression in bone correlated positively with CKD stages (p < 0.001) increasing from 5.3- to 7.1-fold starting at CKD-2. No difference in FGF-23 expression was seen between trabecular and cortical bone. Sclerostin expression in bone correlated positively with CKD stages (p < 0.001) with an increase from 3.8- to 5.1-fold starting at CKD-2. This increase was progressive and significantly greater in cortical than cancellous bone. FGF-23 and sclerostin in blood and bone were strongly associated with bone turnover parameters. Expression of FGF-23 in cortical bone correlated positively with activation frequency (Ac.f) and bone formation rate (BFR/BS) (p < 0.05), while sclerostin correlated negatively with Ac.f, BFR/BS, and osteoblast and osteoclast numbers (p < 0.05). FGF-23 trabecular and cortical expressions correlated positively with cortical thickness (p < 0.001). Sclerostin bone expression correlated negatively with parameters of trabecular thickness and osteoid surface (p < 0.05).</p><p><strong>Conclusion: </strong>These data show a progressive increase in FGF-23 and sclerostin in blood and bone associated with decrease in kidney function. The observed relationships between bone turnover and sclerostin or FGF-23 should be considered when treatment modalities are developed for management of turnover abnormalities in CKD patients.</p>","PeriodicalId":10396,"journal":{"name":"Clinical nephrology","volume":"99 5","pages":"209-218"},"PeriodicalIF":1.1,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10286735/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10082148","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of Kidney transplantation on cyst growth in autosomal dominant polycystic kidney disease.","authors":"Jorge E Gaytan-Arocha,&nbsp;Aaron Pérez-Segovia,&nbsp;Estefania Reul-Linares,&nbsp;Elisa Naomi Hernández-Paredes,&nbsp;Mónica Chapa-Ibargüengoitia,&nbsp;Ricardo Correa-Rotter,&nbsp;Luis E Morales-Buenrostro,&nbsp;Juan C Ramirez-Sandoval","doi":"10.5414/CN111036","DOIUrl":"https://doi.org/10.5414/CN111036","url":null,"abstract":"<p><strong>Background: </strong>In patients with autosomal dominant polycystic kidney disease (ADPKD), there is limited evidence of the rate of cyst progression after kidney transplantation.</p><p><strong>Aims: </strong>To compare the height-adjusted total kidney volume (Ht-TKV) before and after transplantation in kidney transplant recipients (KTR) with -ADPKD.</p><p><strong>Materials and methods: </strong>Retrospective cohort study. The estimate of Ht-TKV was calculated by the ellipsoid volume equation using measurements from CT or yearly MRI scans before and after transplantation.</p><p><strong>Results: </strong>We included 30 patients with -ADPKD who underwent kidney transplantation (age 49 ± 10.1 years, 11 (37%) females, dialysis vintage 3 (1 - 6) years, and 4 (13%) underwent unilateral nephrectomy during the peritransplant period). The median follow-up time was 5 years (range 2 - 16 years). Transplantation was associated with a significant decrease in Ht-TKV after transplantation in 27 (90%) KTR. Median Ht-TKV decreased from 1,708 (IQR 1,100 - 2,350) mL/m to 710 (IQR 420 - 1,380) mL/m after 6 years of follow-up (p < 0.001), with a mean Ht-TKV change rate per year after transplantation of -1.4, -11.8, -9.7, -12.7, -7.0, and -9.4% after 1, 2, 3, 4, 5, and 6 years, respectively. Even in 2 (7%) KTR without regression, the annual growth was < 1.5% per year after transplantation.</p><p><strong>Conclusion: </strong>Kidney transplantation reduced Ht-TKV after the first 2 years of transplantation, and this decline was continuous for more than 6 years of follow-up.</p>","PeriodicalId":10396,"journal":{"name":"Clinical nephrology","volume":"99 5","pages":"228-236"},"PeriodicalIF":1.1,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9352407","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Creatinine-based equations to estimate glomerular filtration rate should be used with caution in patients with neurogenic bladder.","authors":"Yingchun Ma,&nbsp;Tianyu Xiang,&nbsp;Peng Wang,&nbsp;Limin Liao","doi":"10.5414/CN111011","DOIUrl":"https://doi.org/10.5414/CN111011","url":null,"abstract":"<p><strong>Background: </strong>Patients with neurogenic bladder (NGB) are at an increased risk of developing chronic kidney disease (CKD). However, data related to the real performance of the serum creatinine (Cr)-based estimated glomerular filtration rate (eGFR) equation in patients with NGB are limited. This study is to evaluate the performance of new Cr-based Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation without race and the GFR estimation equation for Chinese CKD patients for the estimation of GFR in Chinese patients with NGB.</p><p><strong>Materials and methods: </strong>GFR was determined simultaneously by three methods: a) GFR measured by renal dynamic imaging with ^99mTc-DTPA (G-GFR), which was used as the reference GFR; b) GFR estimated by the new Cr-based Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation without race (EPI-GFR); and c) GFR estimated by the equation for Chinese CKD patients (C-GFR). Pearson correlation and linear regression were used to compare eGFR and G-GFR. Differences, absolute differences, precision, and accuracy were compared to identify which equation showed better performance in evaluating GFR in patients with NGB.</p><p><strong>Results: </strong>A total of 171 patients with NGB, including 121 men and 50 women from 20 provinces, 4 autonomous regions, and 3 municipalities in China, were enrolled in the final analysis, and the average age was 31.3 ± 11.9 years. Both C-GFR and EPI-GFR were moderately correlated with G-GFR and overestimated G-GFR. The difference between EPI-GFR and G-GFR was similar to that between C-GFR and G-GFR (median of 9.97 vs. 9.95 mL/min/1.73m² for difference, Wilcoxon signed ranks test, Z = -1.704, p = 0.088), but the absolute difference between EPI-GFR and G-GFR was significantly lower than that between C-GFR and G-GFR (median of 22.3 vs. 25.1 mL/min/1.73m² for absolute difference, Wilcoxon signed ranks test, Z = -4.806, p < 0.001). Both EPI-GFR and C-GFR displayed similar results of 15, 30, and 50% accuracies (χ²-test, p > 0.05), and there were no significant differences between EPI-GFR and C-GFR in misclassification percentages at different G-GFR levels (χ²-test, p > 0.05).</p><p><strong>Conclusion: </strong>Our study indicated that for patients with NGB in China, Cr-based eGFR equations, which include the new CKD-EPI equation without race and the Chinese GFR estimation equation, showed suboptimal performance, and limited their application in GFR estimation. Further studies are needed to investigate whether incorporating additional biomarkers, such as cystatin C, could improve their performance of GFR estimating equations in patients with NGB.</p>","PeriodicalId":10396,"journal":{"name":"Clinical nephrology","volume":"99 5","pages":"219-227"},"PeriodicalIF":1.1,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9340531","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Kidney cysts in patients with <i>HOGA1</i> variants.","authors":"Dipal M Patel,&nbsp;Nicolas Page,&nbsp;Neera K Dahl","doi":"10.5414/CN110939","DOIUrl":"https://doi.org/10.5414/CN110939","url":null,"abstract":"<p><p>In an era of increased accessibility to genetic testing, nephrologists may be able to better understand pathophysiologic mechanisms by which their patients develop specific conditions. In this study, we describe clinical and genetic findings of two patients with kidney cysts, who were found to have variants in <i>HOGA1</i>, a mitochondrial 4-hydroxy-2-oxoglutarate aldolase enzyme associated with primary hyperoxaluria type 3 and the development of oxalate-containing kidney stones. We describe possible mechanisms by which mutations in this enzyme could result in the kidney cyst formation seen in our two patients. We propose that patients with mutations in <i>HOGA1</i> are predisposed to crystal or stone deposition, tubule dilation, and inflammasome activation, which can result in kidney cyst formation.</p>","PeriodicalId":10396,"journal":{"name":"Clinical nephrology","volume":"99 5","pages":"260-264"},"PeriodicalIF":1.1,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9355603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Clinical features and prognosis of autosomal dominant polycystic kidney disease with cerebrovascular complications.","authors":"Zhe Li,&nbsp;Song Luo,&nbsp;Yang Wang,&nbsp;Yuchao Zhou,&nbsp;Shutian Xu,&nbsp;Ke Zuo,&nbsp;Shijun Li","doi":"10.5414/CN110959","DOIUrl":"https://doi.org/10.5414/CN110959","url":null,"abstract":"<p><strong>Objectives: </strong>This retrospective study was used to evaluate the clinical and imaging characteristics and the prognosis of autosomal dominant polycystic kidney disease (ADPKD) with cerebrovascular complications.</p><p><strong>Materials and methods: </strong>We retrospectively analyzed 30 patients with ADPKD complicated with intracerebral hemorrhage (ICH), subarachnoid hemorrhage (SAH), unruptured intracranial aneurysms (UIAs), or Moyamoya disease (MMD) who were admitted to Jinling Hospital from January 2001 to January 2022. We analyzed the clinical manifestations and imaging characteristics of ADPKD patients with cerebrovascular complications and followed up on their long-term outcomes.</p><p><strong>Results: </strong>30 patients, 17 men and 13 women, with an average age of 47.5 (40.0, 54.0) years were included in this study, including 12 cases of ICH, 12 cases of SAH, 5 cases of UIA, and 1 case of MMD. The 8 patients who died during follow-up had a lower Glasgow Coma Scale (GCS) on admission (p = 0.024) and a significantly higher serum creatinine (p = 0.004) and blood urea nitrogen (p = 0.006) than the 22 patients with long-term survival.</p><p><strong>Conclusion: </strong>Intracranial aneurysms, SAH, and ICH are the most common cerebrovascular diseases in ADPKD. Patients with low GCS score or worse renal function have a poor prognosis, which can lead to disability and even death.</p>","PeriodicalId":10396,"journal":{"name":"Clinical nephrology","volume":"99 5","pages":"237-246"},"PeriodicalIF":1.1,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9347415","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Three-year safety observation of subcutaneous administration of epoetin-zeta in patients with chronic renal anemia: Results from PASCO II study.","authors":"Stavros Patsialas,&nbsp;Heather Fowler,&nbsp;Ruffy Guilatco,&nbsp;Stephanie Salts,&nbsp;Feng Richard Xia,&nbsp;Sonja Gomez Perez,&nbsp;Andreas Iwanowitsch,&nbsp;Matthias Kohnle","doi":"10.5414/CN110825","DOIUrl":"https://doi.org/10.5414/CN110825","url":null,"abstract":"<p><p>Epoetin has been used to treat patients with renal anemia since 1988. -Anti-erythropoietin antibody-mediated pure red cell aplasia (PRCA) has been associated with epoetin usage, and a PRCA incidence of 4.5 per 10,000 patient-years was observed for epoetin-α (Eprex) in 2002. The PASCO II study (post-authorization safety cohort observation of Retacrit and Silapo (epoetin-ζ) administered subcutaneously for the treatment of renal anemia) followed 6,346 patients (4,501 Retacrit (group R); 1,845 Silapo (group S)) for up to 3 years of subcutaneous treatment with the biosimilar epoetin-ζ. One PRCA in 1 (0.02%) patient in group R who tested positive for neutralizing antibodies was reported. Overall, 527 adverse events of special interest (AESI) including PRCA occurred in 418 (6.60%) patients, lack of efficacy occurred in 34 (0.54%), and thromboembolic events in 389 (6.14%) patients. 41 adverse drug reactions other than AESIs were reported in 28 (0.44%) patients. The exposure-adjusted incident rate of PRCA was 0.84 per 10,000 patient-years. This real-world study showed that among patients with renal anemia receiving subcutaneous administration of the biosimilar product epoetin-ζ, the incidence rate of PRCA was substantially below the risk observed in 2002 for Eprex and that there was no immunogenicity concern or other new safety concern.</p>","PeriodicalId":10396,"journal":{"name":"Clinical nephrology","volume":"99 5","pages":"247-255"},"PeriodicalIF":1.1,"publicationDate":"2023-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10112001/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9381804","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}