scholarly journals Randomized Trial of Two Dosages of Rabbit Antithymocyte Globulin in Patients with Aplastic Anemia

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3873-3873
Author(s):  
Atsushi Narita ◽  
Xiaofan Zhu ◽  
Hideki Muramatsu ◽  
Xiaojuan Chen ◽  
Ye Guo ◽  
...  

Abstract Introduction: In patients with severe aplastic anemia (SAA) who are not candidates for stem cell transplantation (SCT), immunosuppressive therapy (IST) with antithymocyte globulin (ATG) and cyclosporine A (CyA) is the treatment of choice. A randomized controlled trial demonstrated the inferiority of rabbit ATG compared with horse ATG for first-line treatment of SAA (Scheinberg et al. N Engl J Med 365:430-438, 2011). However, horse ATG remains unavailable in many countries outside the USA. In Asian countries, the recommended dose of rabbit ATG ranges from 2.5 to 3.5 mg/kg/day. Here we report the first prospective randomized multicenter study comparing two dosages of rabbit ATG in patients with SAA (www.umin.ac.jp UMIN000011134). Methods: Patients with SAA who required initial IST in Japan (n = 89), China (n = 85), and Korea (n= 48) were enrolled between May 2012 and October 2017. Randomization was 1:1 in blocks between the two dosages of rabbit ATGs. The IST regimen comprised rabbit ATG (thymoglobulin®, 2.5 or 3.5 mg/kg/day for 5 days), CyA (6 mg/kg/day for minimum 6 months), and methylprednisolone (2 mg/kg/day for 5 days) with subsequent tapering of the dose for 28 days. The dose of CyA was adjusted to maintain whole blood trough concentrations between 150 and 250 ng/mL. The primary endpoint was hematologic response at day 180. Secondary endpoints included frequency of Epstein-Barr virus-associated lymphoproliferative disorder (EBV-LPD), hematologic response at day 360, relapse, and overall survival (OS). Results: In total, 222 patients (age 0.5-71.0 years) were randomized, with 112 patients receiving 2.5 mg/kg and 110 receiving 3.5 mg/kg of rabbit ATG. Patient characteristics were well matched between the two groups. Median follow-up duration for all patients was 742 days from first ATG infusion (range, 16-2165) and 887 days for those surviving till the end of the study (range, 32-1757). After 3 months, in the 2.5mg/kg of rabbit ATG group, 4 (4%) patients achieved a complete response (CR) and 35 (31%) a partial response (PR), for an overall response rate (ORR) of 35%. In the 3.5mg/kg of rabbit ATG group, 1 (1%) patient achieved a CR and 43 (39%) a PR, for an ORR of 40%. After 6 months, in the 2.5mg/kg of rabbit ATG group, 55 patients (49%) achieved an ORR including 7 (6%) who achieved a CR and 48 (43%) PR. In the 3.5mg/kg of rabbit ATG group, 53 patients (48%) achieved a response including CR in 9 patients (8%) and PR in 44 (40%). The response rates did not differ significantly between the two groups at 3 (P = 0.488) or 6 (P = 0.894) months. Multivariate logistic regression analysis identified disease severity [odds ratio (OR), 2.09; 95% confidence interval (CI), 1.18−3.67; P = 0·011] and interval between diagnosis and treatment (OR, 1.86; 95% CI, 1.07−3.22; P = 0.027) as independent predictors of response to IST at 6 months. Despite relatively short follow-up, relapse and clonal evolution occurred with similar frequencies between the two groups, with 4 relapse (among 55 responders) and 1 clonal evolution in the 2.5 mg/kg group and 4 relapse (among 53 responders) and no evolutions in the 3.5 mg/kg group. One patient in the 3.5 mg/kg group developed EBV-LPD at day 109 after IST. During follow-up, 22 (10%) patients died, all of whom showed no response to IST. The causes of death were infections (n = 13), hemorrhage (n = 4), SCT-related complications (n = 2), clonal evolution (n = 1), and unknown (n = 2). Transplantation free survival (TFS), failure free survival (FFS), and OS at three-year were similar between the two groups [TFS, 73% (95% CI, 63%−81%) vs. 71% (95% CI, 60%−80%); P = 0.991; FFS, 45% (95% CI, 35%−54%) vs. 45% (95% CI, 61%−84%); P = 0.909; OS, 85% (95% CI, 76%−91%) vs. 91% (95% CI, 82%−96%); P = 0.107]. Multivariate logistic regression analysis revealed that lack of response to IST was an independent predictor of OS (OR, 6.95; 95% CI, 1.76%−27.46%; P = 0.006). Conclusions: The current study revealed no differences in the efficacy and safety between 2.5 mg/kg and 3.5 mg/kg dose of rabbit ATG for patients with SAA. However, as the follow-up period was relatively short, longer surveillance is warranted to compare long-term complications and survival rates between the two groups in the follow up study. Disclosures Usuki: Daiichi Sankyo: Research Funding; Sumitomo Dainippon Pharma: Research Funding, Speakers Bureau; Nippon Shinyaku: Speakers Bureau; Ono Pharmaceutical: Speakers Bureau; Novartis: Speakers Bureau; Takeda Pharmaceutical: Speakers Bureau; Chugai Pharmaceutical: Speakers Bureau; SymBio Pharmaceuticals Limited.: Research Funding; Shire Japan: Research Funding; Sanofi K.K.: Research Funding; Pfizer Japan: Research Funding, Speakers Bureau; Janssen Pharmaceutical K.K: Research Funding; Kyowa Hakko Kirin Co., Ltd.: Research Funding; GlaxoSmithKline K.K.: Research Funding; Celgene Corporation: Research Funding, Speakers Bureau; Boehringer-Ingelheim Japan: Research Funding; Otsuka Pharmaceutical Co., Ltd.: Research Funding; Astellas Pharma Inc.: Research Funding; Mochida Pharmaceutical: Speakers Bureau; MSD K.K.: Speakers Bureau. Nakao:Novartis: Honoraria; Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria; Kyowa Hakko Kirin Co., Ltd.: Honoraria. Lee:Alexion Pharmaceuticals, Inc.: Consultancy, Honoraria, Research Funding.

2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
Sara Fernandes ◽  
Beatriz Donato ◽  
Adriana Paixão Fernandes ◽  
Luís Falcão ◽  
Mário Raimundo ◽  
...  

Abstract Background and Aims Anemia is a well-know complication of Chronic Kidney Disease (CKD) and it seems to contribute for deterioration of kidney function. Experimental data suggest that anemia produces hypoxia of tubular cells which leads to tubulointerstitial damage resulting on CKD progression. Other mechanism described is that red blood cells have antioxidant properties that prevent the damage of tubulointerstitial cells and glomerulosclerosis from oxidative stress. There aren’t many observational studies that evaluated the association between anemia and progression of CKD. Therefore, our aim was to evaluate the association of anemia and CKD progression and its association outcomes in an outpatient ND-CKD population. Method We conduct a retrospective, patient-level, cohort analysis of all adult ND-CKD patients evaluated in an outpatient nephrology clinic over a 6 years period. The follow up time was at least 12 months. Anemia was defined according to the WHO definition (hemoglobin [hb] < 13.0 g/dL in men and 12.0 g/dL in women). Progression of CKD was defined by one of the following criteria: decline in eGFR (CKD-EPI) superior to 5 ml/min/1.73 m2/year; duplication of serum creatinine or the need renal replacement therapy. Demographics and clinical data were also accessed. Results Out of 3008 patients referred to the nephrology clinic, 49.9% had anemia (mean age 71.9±15.9 years; 50.4% male; 92% white; mean follow-up time of 2.3±1.2 years). The mean Hb was 11.8 ±1.9 g/dL. Important cardiovascular comorbidities in patients with anemia were arterial hypertension (86.7%), obesity (65.5%), Diabetes Mellitus (DM) (52%) and dyslipidemia (46%). In univariate analysis, mortality was associated with anemia (36.9 vs 13.0%, p<0.001), obesity (30.1 vs 21.8%, p<0.001) and DM (30.1 vs 21.1%, p<0.001). Of the patients with anemia, 738 met the criteria for CKD progression. In univariate analysis, CKD progression was associated with anemia (49.6 vs 43.9%, p=0.002), male gender (49.5 vs 43.6% p= 0.001); DM (49.6 vs 44.8 % p=0.009) and hypertension (47.9 vs 42.3% p=0.0018). In multivariate logistic regression analysis, anemia emerged was an independent predictor of CKD progression (OR 1.435, CI 95% 1.21-1.71, p<0,001). Comparing hb values intervals (hb ≤10g/dl; hb10-12 g/dL; hb ≥12 g/dL), in the multivariate logistic regression analysis, hb ≤10g/dl was not associated with CKD progression and hb value between 10-12 g/dL was associated (OR 1,486, CI 95% 1.23-1.80, p<0,001), when compared with the group with hb ≥12g/dL. In multivariate logistic regression analysis, the independent predictors of mortality were: older age (OR per 1 year increase: 1.048, 95% CI 95% 1.04-1.06, p<0.001); arterial hypertension (OR 0.699 CI 95% 0.51-0.96, p=0.0029); obesity (OR 0.741, CI 95% 0.60-0.91, p=0.004) and hb value (OR per 1 g/dL decrease: 1.301, CI 95% 1.23-1.38, p<0.001). Cardiovascular events were correlated with Hb levels between 10-12 g/dL (univariate analysis: OR 2.021, CI 95% 1.27-3.22, P=0.003), but not with the group with hb≤10 g/dL (univariate analysis: OR 1.837, CI 95% 0.96-3.51, P=0.066), having the group with hb ≥12g/dL was reference. Anemia was strongly associated with hospitalizations (multivariate logistic regression analysis: OR per 1 g/dL of Hb decrease: 1.256 CI 95% 1.12-1.32 p<0.001), and this strong association was also observed on the groups with hb hb≤10 g/dL (multivariate logistic regression analysis: OR 3.591 CI 95% 32.67-4.84 p<0.001) and between 10-12 g/dL (multivariate logistic regression analysis: OR 1.678 CI 95% 1.40-2.02, p<0.001) Conclusion Our study suggests that anemia, at first consultation, increases the risk for rapid CKD progression and global mortality. This study could guide us on the development of futures studies in order to prove if anemia correction can slow the progression of CKD.


2019 ◽  
Vol 30 (5) ◽  
pp. 655-663 ◽  
Author(s):  
Wei Shi ◽  
Shan Wang ◽  
Huifang Zhang ◽  
Guoqin Wang ◽  
Yi Guo ◽  
...  

OBJECTIVELaminoplasty has been used in recent years as an alternative approach to laminectomy for preventing spinal deformity after resection of intramedullary spinal cord tumors (IMSCTs). However, controversies exist with regard to its real role in maintaining postoperative spinal alignment. The purpose of this study was to examine the incidence of progressive spinal deformity in patients who underwent laminoplasty for resection of IMSCT and identify risk factors for progressive spinal deformity.METHODSData from IMSCT patients who had undergone laminoplasty at Beijing Tsinghua Changgung Hospital between January 2014 and December 2016 were retrospectively reviewed. Univariate tests and multivariate logistic regression analysis were used to assess the statistical relationship between postoperative spinal deformity and radiographic, clinical, and surgical variables.RESULTSOne hundred five patients (mean age 37.0 ± 14.5 years) met the criteria for inclusion in the study. Gross-total resection (> 95%) was obtained in 79 cases (75.2%). Twenty-seven (25.7%) of the 105 patients were found to have spinal deformity preoperatively, and 10 (9.5%) new cases of postoperative progressive deformity were detected. The mean duration of follow-up was 27.6 months (SD 14.5 months, median 26.3 months, range 6.2–40.7 months). At last follow-up, the median functional scores of the patients who did develop progressive spinal deformity were worse than those of the patients who did not (modified McCormick Scale: 3 vs 2, and p = 0.04). In the univariate analysis, age (p = 0.01), preoperative spinal deformity (p < 0.01), extent of tumor involvement (p < 0.01), extent of abnormal tumor signal (p = 0.02), and extent of laminoplasty (p < 0.01) were identified as factors associated with postoperative progressive spinal deformity. However, in subsequent multivariate logistic regression analysis, only age ≤ 25 years and preoperative spinal deformity emerged as independent risk factors (p < 0.05), increasing the odds of postoperative progressive deformity by 4.1- and 12.4-fold, respectively (p < 0.05).CONCLUSIONSProgressive spinal deformity was identified in 25.7% patients who had undergone laminoplasty for IMSCT resection and was related to decreased functional status. Younger age (≤ 25 years) and preoperative spinal deformity increased the risk of postoperative progressive spinal deformity. The risk of postoperative deformity warrants serious reconsideration of providing concurrent fusion during IMSCT resection or close follow-up after laminoplasty.


2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 420-420 ◽  
Author(s):  
Rahul K. Bansal ◽  
Anil Kapoor ◽  
Antonio Finelli ◽  
Ricardo A. Rendon ◽  
Ronald Brian Moore ◽  
...  

420 Background: Partial nephrectomy (PN) is the standard of care for small renal masses (SRMs) whenever feasible. The occurrence of a positive surgical margin (PSM) on a pathological specimen is not uncommon and an ideal management is unknown. We conducted this study to examine the rate of PSM, predictors of PSM and their oncological outcomes after PN for renal cell carcinoma (RCC), using the Canadian Kidney Cancer information system (CKCis) database. Methods: We accessed the prospectively maintained CKCis database for 1066 patients who underwent PN for RCC in major academic centers all across Canada. Demographics, clinical, pathological and follow-up data were noted for patients with PSM and negative surgical margins (NSM). Multivariate logistic regression analysis was performed to assess predictors of PSM. Results: Out of 1066 patients, 59 (5.5%) had PSM, 928 (87%) had NSM and records of 79 (7.4%) patients were not available. Mean patient age was 61 years and 59 years in the PSM and NSM group respectively, and in each group 63% of the patients were males. Mean tumor size was 3.6cm (range 1.1 – 9.5) and 3.3cm (range 0.5 – 16.2) in PSM and NSM group respectively. PSM group had 5 (8%) grade 1, 28 (47%) grade 2, 16 (27%) grade 3 and 5 (8%) grade 4 tumors as compared to 127 (14%), 458 (50%), 207 (23%) and 27 (3%) respectively in NSM group. Four (6.7%) patients from the PSM group and 49 (5.3%) patients from the NSM group had local and/or systemic progression of disease. There were two cancer specific deaths in NSM group and none in PSM group. Fifty two (88%) and 861 (93%) patients were alive at mean follow-up of 18.5 (range 0 – 91.7) and 28.9 months (range 0 – 315.5) in PSM and NSM group respectively. For the multivariate logistic regression analysis; Fuhrman grade 4 predicted presence of PSM whereas age, operative technique, tumor size, tumor stage did not. Conclusions: Results from the CKCis database suggest that PSM after PN are common but does not result in adverse oncological outcomes. Presence of Fuhrman grade 4 may be associated with PSM on final pathological specimen.


Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2823-2823
Author(s):  
Jorge J. Castillo ◽  
Joshua Gustine ◽  
Maria Demos ◽  
Andrew Keezer ◽  
Kirsten Meid ◽  
...  

Introduction: The Bruton tyrosine kinase inhibitor ibrutinib is the only FDA approved therapy for the treatment of symptomatic Waldenstrom macroglobulinemia (WM), and has been associated with high response rates and durable progression-free survival (PFS). Factors associated with depth of response and PFS duration are not well established. We performed a retrospective study aimed at identifying predictive and prognostic factors in WM patients treated with ibrutinib. Methods: We included consecutive patients with a diagnosis of WM treated with ibrutinib monotherapy evaluated at the Dana-Farber Cancer Institute since January 2012 through March 2019. Patients with Bing-Neel syndrome (WM involving the central nervous system) were excluded. Baseline clinical and laboratory characteristics were gathered. MYD88 and CXCR4 mutations were assessed using polymerase chain reaction assays and Sanger sequencing. Responses at 6 months were assessed using criteria from IWWM3. PFS was defined as the time from ibrutinib initiation until last follow-up, death or progression. Univariate and multivariate logistic regression models were fitted for partial response (PR) and very good partial response (VGPR) at 6 months, and Cox proportional-hazard regression models were fitted for PFS. Results: A total of 252 patients were included in our analysis. Selected baseline characteristics include: age ≥65 years (60%), hemoglobin <11.5 g/dl (68%), platelet count <100 K/uL (12%), albumin <3.5 g/dl (39%), b2-microglobulin ≥3 mg/l (70%), serum IgM level ≥7,000 mg/dl (6%), bone marrow involvement ≥60% (54%), previously untreated for WM (33%), time to ibrutinib <3 years (46%). MYD88 L265P and CXCR4 mutations were detected in 98% and 38% of patients, respectively. At 6 months, 71% of patients obtained PR, and 17% VGPR. Multivariate logistic regression analyses showed higher odds of PR at 6 months for hemoglobin <11.5 g/dl (78% vs. 56%; OR 2.8, 95% CI 1.1-6.9; p=0.03) and serum albumin <3.5 g/dl (90% vs. 66%; OR 3.2, 95% CI 1.0-10; p=0.045), while CXCR4 mutations associated with lower odds (44% vs. 82%; OR 0.15, 95% CI 0.06-0.37; p<0.001). Multivariate logistic regression analyses showed higher odds of VGPR at 6 months for b2-microglobulin ≥3 mg/l (21% vs. 3%; OR 3.3, 95% CI 1.1-10; p=0.04) and lower odds for serum IgM level ≥4,000 mg/dl (9% vs. 23%; OR 0.3, 95% CI 0.1-0.8; p=0.02). The median follow-up was 30 months, and the median PFS has not yet been reached. The 5-year PFS rate was 60% (95% CI 48-69%). In the multivariate Cox regression analysis, worse outcomes were seen with CXCR4 mutations (5-year PFS: 45% vs. 71%; HR 2.8, 95% CI 1.4-5.8; p=0.004) and serum albumin <3.5 g/dl (5-year PFS: 36% vs. 68%; HR 2.7, 95% CI 1.3-5.5; p=0.007). A novel PFS risk score was designed using CXCR4 mutational status and serum albumin (Figure), which divided patients into 3 distinct groups: low risk (no risk factors: 43%; 5-year PFS 81%), intermediate risk (1 risk factor: 46%; 5-year PFS 51%) and high risk (2 risk factors: 11%; median PFS 25 months). The PFS difference between groups was statistically significant (p<0.001). The PFS risk score showed consistent results when evaluating previously treated and untreated patients, as well as patients on and off clinical trials. Conclusion: Serum albumin and CXCR4 mutations emerge as important factors predictive of PR at 6 months and also prognostic of PFS in WM patients treated with ibrutinib. A novel PFS stratification tool that separates patients into 3 risk groups was established and would need further validation. Figure Disclosures Castillo: Abbvie: Research Funding; Janssen: Consultancy, Research Funding; Pharmacyclics: Consultancy, Research Funding; Beigene: Consultancy, Research Funding; TG Therapeutics: Research Funding. Hunter:Janssen: Consultancy. Treon:Pharmacyclics: Research Funding; BMS: Research Funding; Janssen: Consultancy.


2020 ◽  
Vol 5 (1) ◽  
pp. e000354 ◽  
Author(s):  
Koichi Wakimasu ◽  
Koji Kitazawa ◽  
Kanae Kayukawa ◽  
Isao Yokota ◽  
Tsutomu Inatomi ◽  
...  

ObjectiveTo assess graft survival and endothelial cell density (ECD) over a 5-year follow-up period after Descemet’s stripping automated endothelial keratoplasty (DSAEK).Methods and analysisThis retrospective study involved 130 eyes of 130 consecutive patients with Fuchs endothelial corneal dystrophy (FECD), non-FECD bullous keratopathy (BK) (non-FECD) or BK post-trabeculectomy or tube-shunt surgery (glaucoma with bleb) who underwent DSAEK between August 2007 and January 2012 and were followed for more than 5 years postoperatively. Patients with previous keratoplasty, graft suture failure, primary graft failure, postoperative endophthalmitis and ocular infection were excluded. Graft survival and ECD was then examined in all patients who underwent DSAEK and completed the postoperative follow-up period. The association between clinical factors and 5-year graft survival after DSAEK was analysed with multivariate logistic regression analysis.ResultsThe overall graft survival rate at 5 years postoperatively was 85%, yet significantly poorer in the glaucoma with bleb eyes (47%) than in the FECD (100%) or non-FECD (90%) eyes (p<0.01, log-rank test). In the FECD, non-FECD and glaucoma with bleb eyes, the mean ECD at 5 years postoperatively was 1054 cells/mm2, 1137 cells/mm2 and 756 cells/mm2, respectively. Multivariate logistic regression analysis showed history of trabeculectomy or tube-shunt surgery and postoperative allograft rejection to be negative factors for graft survival at 5 years after DSAEK (OR 0.01, 95% CI 0.00 to 0.10 and OR 0.02, 95% CI 0.00 to 0.33, respectively).ConclusionOur findings show that at 5 years postoperatively, the surgical outcome after DSAEK was poorer in eyes after trabeculectomy or tube-shunt surgery.Trial registration numberUMIN000024891.


2021 ◽  
Author(s):  
Yanfang Zhao ◽  
Wenjia Su ◽  
Qingyuan Zhang ◽  
Guohua Liang Liang ◽  
Xiaoyu Shan ◽  
...  

Abstract Purpose In clinical practice, the risk factors for pegylated liposomal doxorubicin-related hand-foot syndrome remain unclear. The purpose of this study was to determine the risk factors associated with hand-foot syndrome in patients with lymphoma using pegylated liposomal doxorubicin.Methods This retrospective descriptive analysis included patients with lymphoma who received PLD treatment (≥ 2 cycles of chemotherapy) at our cancer centre and had complete follow-up data from January 2016 to February 2020. Clinical, laboratory data, as well as the occurrence of hand-foot syndrome (incidence, location, severity, impact on follow-up chemotherapy) were obtained. The primary end point was the incidence of hand-foot syndrome, which was classified according to the "Common Terminology Criteria for Adverse Events" (Version 4.0). A multivariate logistic regression analysis was used to identify risk factors for hand-foot syndrome in patients with lymphoma using doxorubicin liposomes. Findings A total of 167 patients met the inclusion criteria. 58 developed HFS, of which 45 occurred after the second course of chemotherapy. The multivariate logistic regression analysis revealed that a dose increase of pegylated liposomal doxorubicin and hepatobiliary dysfunction were significantly associated with an increased risk for hand-foot syndrome(dose intensity, OR= 6.479; 95% CI, 1.431-29.331 [P =0.015]; history of gallstones, OR = 14.144, 95% CI, 1.512-132.346 [P =0.020]; alanine aminotransferase, OR = 1.194, 95% CI, 1.056-1.350 [P =0.005]; alanine aminotransferase, OR = 1.162, 95% CI, 1.010-1.336 [P =0.035]; and glutamine transpeptidase, OR = 1.092, 95% CI, 1.016-1.174 [P =0.018]).Implications These findings contribute to the risk assessment of patients with lymphoma before using pegylated liposomal doxorubicin. For patients with the above risk factors, preventive measures should be taken in advance to reduce the incidence of HFS.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. e23020-e23020
Author(s):  
Yu-Mei Shi ◽  
Guochun Zhang ◽  
Chong-Yang Ren ◽  
Ling-Zhu Wen ◽  
Wen-zhen Zhu ◽  
...  

e23020 Background: CTCs has been confirmed to associate with a poor outcome of breast cancer at primary diagnosis. To date, CTC has not been studied with sufficient details in the follow-up of non-MBC pts, especially in Chinese population. We investigated the associations of CTC with clinicopathological features and metabolic factors to gain insight into potential interactions between physiology and disease burden. Methods: We recruited 264 cases of postoperative pts with non-MBC in Guangdong General Hospital from Jan 2009 to Dec 2015. For each enrolled pts 7.5mL blood samples were drawn for CTC enumeration using the CellSearch system. CTC results were correlated with clinicopathological features, obesity related indicators and HBsAg. A multivariate logistic regression analysis was performed to further determine the independent predictors of CTC. The study defined CTC positive as CTC ≥1. Results: In 10.6 % of all pts (n = 28) a median of 1 (range, 1–108) CTC was detected. A pT1 tumor was present in 47% of pts, 11.4 % had G1 grading and 64.4 % were node-negative. The positive rate of CTCs in pts with IDC and ILC was lower than that in pts with other pathological types (9% and 11.1% vs 28.6% P=0.02). A similar trend that approached significance was noted for age (p=0.062), histological grade( p=0.087), invasion of the nipple areola (p=0.06). CTCs was positively correlated with blood glucose (p=0.015), and negatively correlated with high density lipoprotein (p=0.049). In addition, glycated hemoglobin was positively associated with CTC in correlations that neared significance (p=0.059). The result of multivariate logistic regression analysis is shown in the Table. No associations were observed in triglycerides, free fatty acid, total cholesterol, low-density lipoprotein and HBsAg. Conclusions: This study suggested pathological type and blood glucose were independent predictors of CTC, supporting the notion that high fasting glucose level in BC pts may have severe disease burden, leading to a higher frequency of CTC. [Table: see text]


2013 ◽  
Vol 119 (6) ◽  
pp. 1530-1536 ◽  
Author(s):  
Victor W. Sung ◽  
Ray L. Watts ◽  
Christian J. Schrandt ◽  
Stephanie Guthrie ◽  
Deli Wang ◽  
...  

Object While many centers place bilateral deep brain stimulation (DBS) systems simultaneously, unilateral subthalamic nucleus (STN) DBS followed by a staged contralateral procedure has emerged as a treatment option for many patients. However, little is known about whether the preoperative phenotype predicts when staged placement of a DBS electrode in the opposite STN will be required. The authors aimed to determine whether preoperative clinical phenotype predicts early staged placement of a second STN DBS electrode in patients who undergo unilateral STN DBS for Parkinson disease (PD). Methods Eighty-two consecutive patients with advanced PD underwent unilateral STN DBS contralateral to the most affected hemibody and had at least 2 years of follow-up. Multivariate logistic regression analysis determined preoperative characteristics that predicted staged placement of a second electrode in the opposite STN. Preoperative measurements included aspects of the Unified Parkinson's Disease Rating Scale (UPDRS), motor asymmetry index, and body weight. Results At 2-year follow-up, 28 (34%) of the 82 patients had undergone staged placement of a contralateral electrode while the remainder chose to continue with unilateral stimulation. Statistically significant improvements in UPDRS total and Part 3 scores were retained at the end of the 2-year follow-up period in both subsets of patients. Multivariate logistic regression analysis showed that the most important predictors for early staged placement of a second subthalamic stimulator were low asymmetry index (OR 13.4, 95% CI 2.8–64.9), high tremor subscore (OR 7.2, CI 1.5–35.0), and low body weight (OR 5.5, 95% CI 1.4–22.3). Conclusions This single-center study provides evidence that elements of the preoperative PD phenotype predict whether patients will require early staged bilateral STN DBS. These data may aid in the management of patients with advanced PD who undergo STN DBS.


2017 ◽  
Vol 229 (04) ◽  
pp. 223-228 ◽  
Author(s):  
Alicia Montaner ◽  
Raquel Pinillos ◽  
Zenaida Galve ◽  
Hector Boix ◽  
Carmen de la cuesta ◽  
...  

Abstract Aim To investigate whether increased brain natriuretic propeptide (NT-proBNP) levels at 48 to 72 h of life are associated with the development of bronchopulmonary dysplasia (BPD) or death in premature neonates. Methods A retrospective study was performed in neonates born before 32 weeks’ gestation or with birth weight below 1500 grams, in whom NT-proBNP determination and echocardiography were performed at 48 to 72 h of life. Associations between NT-proBNP levels and the combined outcome BPD or death were analyzed using multivariate logistic regression analysis. Results 117 neonates with mean gestational age 27.8±2.1 weeks and birth weight 949.7±267.5 grams were included. Forty (34.2%) had an outcome of BPD or death. The risk of this combined outcome was found to be 3.95-fold higher (OR 3.95; 95% CI 1.1–14.6) in neonates with NT-proBNP levels above 17800 pg/mL. Conclusion Increased NT-proBNP levels may be associated with a significant decrease in BPD-free survival in very immature newborns.


2019 ◽  
Author(s):  
Pangbo Wang ◽  
Kang Ma ◽  
Tunan Chen ◽  
Xingsen Xue ◽  
Dada Ma ◽  
...  

Abstract Background: Progressive spinal deformity has become a well-recognized complication of intracanal tumors resection. However, the factors affecting post-operative spinal stability remain to be further research. Here, we described the current largest series of risk factors analysis for progressive spinal deformity following resection of intracanal tumors. Methods: We retrospectively analyzed the medical records of the patients with resection of intracanal tumors between January 2009 and December 2018. All patients who underwent resection of intracanal tumors performed regular postoperative follow-up were identified and included in the study. Clinical, radiological, surgical, histopathological, and follow-up data were collected. The incidence of postoperative progressive kyphosis or scoliosis was calculated. The statistical relationship between postoperative progressive spinal deformity and radiographic, clinical, and surgical variables was assessed by using univariate tests and multivariate logistic regression analysis. Results: Two hundred seventy-two patients (mean age 42.56 ± 16.18 years) with median preoperative modified McCormick score of 3 met the inclusion criteria. Among them, 7(2.6%)patients were found to have spinal deformity preoperatively, and the extent of spinal deformity in these 7 patients deteriorated after surgery. 36 (13.2%) were new cases of postoperative progressive deformity. The mean duration of follow-up was 21.8 months (median 14 months, range 6–114 months). In subsequent multivariate logistic regression analysis, age≤18 years (p=0.027), vertebral levels of tumor involvement (p = 0.019) and preoperative spinal deformity(p=0.008) was the independent risk factors (p < 0.05), increasing the odds of postoperative progressive spinal deformity by 3.94- , 0.69- and 27.11-fold, respectively. Conclusions: The incidence of postoperative progressive spinal deformity was 15.8%, mostly in these patients who had younger age (≤18 years), tumors involved in multiple segments and preoperative spinal deformity. The risk factors of postoperative progressive spinal deformity warrants serious reconsideration that when performing resection of spinal cord tumors in these patients with such risk factors, the surgeons should consider conducting follow-ups more closely, and when patients suffering from severe symptoms or gradually increased spinal deformity, surgical spinal fusion may be a more suitable choice to reduce the risk of reoperation and improve the prognosis of patients.


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