scholarly journals Evaluation of Clinical Effects and Tolerability of Cefepime in Hospital Settings in Bangladesh

2018 ◽  
Vol 27 (1) ◽  
pp. 17-24
Author(s):  
Mohammad Manirul Islam ◽  
ABM Fazlur Rahman ◽  
Bidhan C Das ◽  
Mohammad Zaid Hossain ◽  
Kumkum Pervin
Keyword(s):  
Treatment Strategy ◽  
Clinical Success ◽  
Outcome Evaluation ◽  
Fourth Generation ◽  
Outcome Analysis ◽  
Clinical Effects ◽  
Serious Adverse Events ◽  
The Mean ◽  
Tract Infections

Background: Cefepime a parenteral fourth generation cephalosporin is active against many Gram-positive and Gram-negative organisms. The study aimed to evaluate the effectiveness and tolerability of cefepime when used alone or in combination with other antibiotics for the treatment of infections in hospital settings in Bangladesh. Methods: This multi-centric, prospective observational study enrolled eligible males and females >18 years who had been prescribe cefepime as a part of treatment strategy regardless of the purpose of hospitalization. No therapeutic intervention was implied rather treatment strategy and dosage of cefepime was on individual physician’s discretion as per routine clinical practice. Percentage of patients who would have clinical success in terms of cure, improvement or failure was evaluated during the end of cefepime therapy. Patient’s overall tolerability to cefepime therapy as excellent, good, satisfactory and poor was considered for safety assessment. The outcome analysis was done in patients’ available follow-up at the end of therapy. Results: A total of 1000 patients were enrolled in this study between March 2013 and September 2014 in different hospital settings of Internal Medicine, Coronary Care Unit, Orthopedic, Intensive Care Unit, Surgery and Nephrology (51.6%, 17.8%, 15.2%, 11.6%, 2.2% & 1.6%). The mean (±SD) age of patients was 50.1 (±14.7) years (range 18-100) and 64.3% were males. Bacteriology or culture sensitivity report was available with 67 patients at baseline and most common microorganisms were E coli (35.8%), Pseudomonas sp. (20.8%), Klebsiella sp. (16.4%), Staphylococcus sp. (11.9%) and Streptococcus sp. (7.4%) and others (7.4). Cefepime was used as medical or surgical prophylaxis in 52.2% of the patients. In 47.8% of patients cefepime was prescribed for treatment of infections including lower respiratory tract infections, trauma / fracture related wound infections, urinary tract infections, treatment of gangrene and septicaemia (39.7%, 31.8%, 10.9%, 9.2% & 8.4%). The dose of cefepime was 500 mg to 2 gm twice or thrice daily with the mean (±SD) duration of 6.1 (±2.1) days (range 2-14). 55 patients were lost to follow-up at the end of therapy and 25 died due to congestive heart failure, renal or hepatic failure and multiple organ failure. On physicians end of therapy overall clinical outcome evaluation, 70.7% of the patients were cured, 24.9% improved and 4.4% had no improvement or worsening in the sign and symptoms. Overall tolerability of cefepime was good in 56.6 %, excellent in 28.7%, satisfactory in 9.8% and poor in 4.9% of patients. No non-serious adverse event was reported in this study. Nonetheless, the 25 death cases would be considered as serious adverse events. Conclusion: Cefepime therapy in different indications was effective in hospitalized patients for cure (67.5 %) or improvement (26.9 %) of sign and symptoms. It was also well tolerated in 85.3% of patients as assessed by the treating physicians J Dhaka Medical College, Vol. 27, No.1, April, 2018, Page 17-24

scholarly journals Flow diverter stents in the treatment of recanalized intracranial aneurysms

2021 ◽  
pp. 159101992199050
Author(s):  
Erol Akgul ◽  
Hasan Bilen Onan ◽  
Irem Islek ◽  
Mehmet Tonge ◽  
Yavuz Durmus ◽  
...  
Keyword(s):  
Intracranial Aneurysms ◽  
Demographic Data ◽  
Previous Treatment ◽  
Flow Diverter ◽  
Serious Adverse Events ◽  
Clinical Complications ◽  
Tertiary Hospitals ◽  
The Mean ◽  
Technical Complication

Background We assessed the safety and efficacy of flow diverter stents (FDSs) in the treatment of recanalized or residual intracranial aneurysms treated endovascularly. Materials & Methods Patients whose recanalized or residual aneurysms were treated with FDSs in five tertiary hospitals were reviewed retrospectively. The patients’ demographic data, aneurysm characteristics, types of previous treatment, and clinical complications, or serious adverse events associated with FDSs, as well as the results of neurological and angiographic follow-up assessments, were recorded. Results Eighty-six patients (37 males) with 87 aneurysms were included in this study. Eighty (91.9%) aneurysms were in the anterior and seven (8.1%) in the posterior circulation. The initial treatment methods were the primary coiling or balloon remodeling technique in 69 (79.3%) and stent-assisted coiling in 18 (20.7%) aneurysms. The endovascular procedure was successful in all patients. Complications occurred in four patients, for a total complication rate of 4.6%. A technical complication developed in one patient (1.2%). An in-stent thrombosis treated with tirofiban was seen in two cases. Late in-stent stenosis exceeding 50% was treated with balloon angioplasty in one patient. The mean length of follow-up was 21.0 months. The first angiographic follow-up (3–6 months) revealed the complete occlusion of 74 aneurysms (85.1%). While 76 aneurysms (87.4%) were occluded at the last angiographic follow-up (mean: 26.0 months), 11 aneurysms (12.6%) were still filling. Morbimortality was zero. Conclusion The drawback of endovascular treatment is aneurysmal remnants or recurrences, which is safely and durably amenable to flow diversion.

scholarly journals Autologous Matrix-Induced Chondrogenesis for Treatment of Focal Cartilage Defects in the Knee: A Follow-up Study

2021 ◽  
Vol 9 (2) ◽  
pp. 232596712098187
Author(s):  
Justus Gille ◽  
Ellen Reiss ◽  
Moritz Freitag ◽  
Jan Schagemann ◽  
Matthias Steinwachs ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Demographic Data ◽  
Case Series ◽  
Defect Size ◽  
Lysholm Score ◽  
Outcome Analysis ◽  
Cartilage Defects ◽  
Chondral Defects ◽  
The Mean

Background: Autologous matrix-induced chondrogenesis (AMIC) is a well-established treatment for full-thickness cartilage defects. Purpose: To evaluate the long-term clinical outcomes of AMIC for the treatment of chondral lesions of the knee. Study Design: Case series; Level of evidence, 4. Methods: A multisite prospective registry recorded demographic data and outcomes for patients who underwent repair of chondral defects. In total, 131 patients were included in the study. Lysholm, Knee injury and Osteoarthritis Outcome Score (KOOS), and visual analog scale (VAS) score for pain were used for outcome analysis. Across all patients, the mean ± SD age of patients was 36.6 ± 11.7 years. The mean body weight was 80.0 ± 16.8 kg, mean height was 176.3 ± 7.9 cm, and mean defect size was 3.3 ± 1.8 cm2. Defects were classified as Outerbridge grade III or IV. A repeated-measures analysis of variance was used to compare outcomes across all time points. Results: The median follow-up time for the patients in this cohort was 4.56 ± 2.92 years. Significant improvement ( P < .001) in all scores was observed at 1 to 2 years after AMIC, and improved values were noted up to 7 years postoperatively. Among all patients, the mean preoperative Lysholm score was 46.9 ± 19.6. At the 1-year follow-up, a significantly higher mean Lysholm score was noted, with maintenance of the favorable outcomes at 7-year follow-up. The KOOS also showed a significant improvement of postoperative values compared with preoperative data. The mean VAS had significantly decreased during the 7-year follow-up. Age, sex, and defect size did not have a significant effect on the outcomes. Conclusion: AMIC is an effective method of treating chondral defects of the knee and leads to reliably favorable results up to 7 years postoperatively.

scholarly journals TOLTERODINE IMPROVES QUALITY OF LIFE IN PATIENTS WITH AN OVERACTIVE BLADDER, WITH OR WITHOUT URINARY INCONTINENCE: A PROSPECTIVE MULTICENTER STUDY

2010 ◽  
Vol 22 (1) ◽  
pp. 5
Author(s):  
F. Mantovani ◽  
G. Bozzini ◽  
P. Acquati ◽  
S.S. Di Pierro ◽  
M.G. Spinelli ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Overactive Bladder ◽  
Clinical Effects ◽  
Health Questionnaire ◽  
Prospective Multicenter Study ◽  
Study Materials ◽  
Trial Entry ◽  
The Mean

AIMS: In order to analyse the effect of tolterodine on the Quality of life (QoL) of patients with overactive bladder (OB) we conducted a prospective multicentre clinical study. MATERIALS AND METHODS: Subjects were questioned at entry and 4, 12 and 24 weeks later about the number of micturitions and incontinent and urgency episodes/day, using a micturition diary. The mean volume voided per micturition and the number of pads used per day was also recorded. The QoL was measured using the Kings Health Questionnaire (KHQ) and the Incontinence Impact Questionnaire (IIQ). A total of 179 patients entered the study: 59 dropped out (4 due to lack of efficacy, 10 due to adverse events, 25 because of lack of interest in the study/other reason and 20 were lost at follow up), leaving 120 patients for analysis. One hundred and eight patients (90%) were female, their mean age was 56.5 years (SD 11.2); 87 had never received treatment for OB/UI (80.6%) and their mean weight was 70.0 Kg (SD 12.7). RESULTS: The mean number of micturitions/day was 9.3 at trial entry and it decreased to 6.8 by the end of the study. The corresponding values for the number of urge episodes, incontinence episodes and number of pads used per day were 3.5, 2.7 and 1.2 and 0.8, 0.9 and 0.4 respectively. The mean volume voided per micturition increased from 146 ml. to 178 ml. All the differences between trial entry and end of study values were statistically significant (p&lt;0.05). Considering the results of the KHQ, the values of all the different areas/domini (?) decreased markedly and in a statistically significant way between the start of treatment and the end of study evaluations. Similar findings emerged when we considered values of the IIQ. The decrease was constant and marked during the first three months and remained constant thereafter. CONCLUSIONS: This study, conducted in a population of subjects with dry and wet OB, shows that tolterodine given for six months lowers the frequency of urgency episodes and incontinence episodes without troublesome adverse effects. These clinical effects are mirrored in the QoL, KHQ and IIQ questionnaire scores, which improved by about 50% over the same period.

scholarly journals Revascularization versus apical barrier technique with mineral trioxide aggregate plug: A systematic review

2018 ◽  
Vol 32 (1) ◽  
pp. 9-16 ◽  
Author(s):  
Luiz Alexandre Chisini ◽  
Guillermo Grazioli ◽  
Alejandro Francia ◽  
Alissa Schmidt San Martin ◽  
Flavio Fernando Demarco ◽  
...  
Keyword(s):  
Clinical Success ◽  
Mineral Trioxide Aggregate ◽  
Clinical Success Rate ◽  
Permanent Teeth ◽  
Radiographic Outcomes ◽  
Bias Risk ◽  
Radiographic Measurements ◽  
High Bias ◽  
The Mean

Aim: To compare the clinical and radiographic outcomes observed in Necrotic Immature Permanent Teeth (NIPT) after revascularization or apexification with MTA-apical plug. Methodology: PubMed/MEDLINE, Web of science and Scopus were the databases used, up to July 30th, 2017, for article research. Independent reviewers read the titles and abstracts of all reports that met inclusion/exclusion criteria: prospective or retrospective clinical studies comparing the revascularization of root canal and apexification. Clinical success of therapies, deposition and thickening of lateral dentinal walls (root width) and the continuation of root development (root length) were investigated. Bias risk of included studies was assessed using the Cochrane risk of bias. Results: From 1642 records, five papers fulfilled all inclusion criteria. Overall, 91 teeth were submitted to revascularization and 64 teeth to apexification with MTA. The mean follow-up was 23.2 months in revascularization and 21.8 in apexification. Clinical success rate was of 87.9% in the revascularization group and 90.6% in the apexification group. An increase on lateral dentinal walls thickening was observed in most revascularization cases (13%) while MTA as apical plug suggest a mild resorption of the root (1.3%). High bias risk was observed on included studies. Conclusions: Apexification with MTA-apical plug provides similar clinical success to revascularization. However, radiographic measurements showed an improvement in thickening of lateral dentinal walls in most of the revascularization cases in addition to a higher dental development. However, these results should be interpreted with caution.

scholarly journals Clinical success of cryoballoon pulmonary vein isolation in patients with atrial fibrillation

2019 ◽  
Vol 7 (4S) ◽  
pp. 6-14
Author(s):  
T. Y. Chichkova ◽  
S. E. Mamchur ◽  
E. A. Khomenko
Keyword(s):  
Atrial Fibrillation ◽  
Pulmonary Vein ◽  
Pulmonary Vein Isolation ◽  
Direct Current ◽  
Clinical Success ◽  
Persistent Atrial Fibrillation ◽  
Cryoballoon Ablation ◽  
Clinical Effects ◽  
Rf Ablation

Aim. To estimate the clinical success of cryoballoon pulmonary vein isolation (PVI).Methods.230 patients (males: 49.6%, mean age 57 (53; 62) with symptomatic paroxysmal and persistent atrial fibrillation (AF) resistant to antiarrhythmic therapy were included in a single-center prospective study. The patients were randomized into 2 groups to undergo either cryoballoon ablation (n = 122) or radiofrequency (RF) (n = 108) ablation. Both groups were comparable in baseline parameters. The follow-up period was 12 months. Clinical outcomes were estimated with the use of a three-stage scale. The rates of cardiovascular rehospitalizations, direct-current cardioversions and repeated ablations during were estimated within the follow-up. The quality of life (QoL) in the cryoablation group was measured using the AFEQT scale.Results.77% (n = 94) of patients in the cryoballoon ablation group and 71.3% (n = 77) of patients in the RF group (р = 0.71) demonstrated reported the optimal clinical effects. Both groups, cryo ablation and RF ablation, had similar rates of cardiovascular hospitalizations (23.8 vs 28.7%, OR 0.8, 95% CI 0.4–1.4; р = 0.39), direct-current cardioversions (12.3 vs 17.6%, OR 0.7, 95% CI 0.3–1.4; р = 0.26) and repeated ablations (9.8–11.1%, OR 0.9, 95% CI 0.4–2.0; р = 0.75). The patients treated with cryoballoon as opposed to RF ablation had significantly more successful usage of “pill-in-pocket” strategy – 14.8 vs 6.5% (OR 2.5, 95% CI 1.01–6.2; р = 0.04). Significant improvements of the QoL parameters with strong size effect have been found in the cryoablation group, i.e. global score (GS) increased by 8.9±6.9 (95% CI 6.6–10.1; dCohen 1.2; р<0.001), symptoms (S) – by 8.3±7.9 (95% CI 4.2–8.8; dCohen 1.5; р<0.001), daily activities (DA) – by 10.0±6.9 (95% CI = 6.4–10.6; dCohen 0.9; р<0.001), treatment concerns (TC) – by 5.5±6.0 (95% CI 6.3–9.2; dCohen 1.2; р<0.001) and treatment satisfaction (TS) – by 5.5±6.0 (95% CI 5.4–9.8; dCohen 0.9; р<0.001).Conclusion.The both catheter-based technologies had comparable clinical success. Cryoablation was characterized by improvement in all QoL parameters based on the AFEQT score.

scholarly journals Elective Percutaneous Coronary Interventions (PCI) in 100 Cases in a Centre Without On-site Cardiac Surgery Support

2013 ◽  
Vol 24 (1) ◽  
pp. 8-11
Author(s):  
Md Nurul Afsar Badrul ◽  
Kamal Ahmed ◽  
Sufia Rahman
Keyword(s):  
Success Rate ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Hospital Death ◽  
Percutaneous Coronary Interventions ◽  
Vessel Disease ◽  
Coronary Interventions ◽  
Percutaneous Coronary ◽  
The Mean

Since its introduction in 1977, Percutaneous Coronary  Interventions (PCI) is an important tool in the treatment of  coronary artery disease (CAD). It is a retrospective analysis  of data of 100 cases (132 vessels). The mean age was 50.9  years (range 30-70) with 90 (90%) male and 10 (10%) female.  Indication of PCI includes acute and old MI, Chronic stable  angina and unstable angina were 48 (48%), 33 (33%) and  19(19%) respectively. Procedure done in total 132 vessels  among 100 patients. most of the cases were single vessels  disease (SVD) {68 (68%} followed by double vessel disease  (DVD) {30(30%)} , triple vessel disease (TVD) {02 (02%)}  and chronic total occlusion (CTO) {02 (02%)}.Cobalt  chromium was commonly used stent (117 (88.6%) followed by  drug illuting stent (DES) 12 (9.1%) and bare metal stent  (BMS) 3 (2.3%). Among the site of the stent insertion left  anterior descending (LAD) 62 (47%), right coronary lesion  (RCA) 37 (28), left circumplex artery (LCX) 33  (25%).Maximum stent length was 35 mm, minimum 10mm.  Maximum stent diameter was 3.5 mm whereas minimum  diameter 2.5 mm. The mean pretreatment reference diameter  was 2.55 ± 0.20 mm and post treatment diameter 2.70 ± 0.45  mm. Angiographic, procedural and clinical success rate were  100%, 98% and 98% respectively. Major adverse  cardiovascular event (MACE) {periprocedural MI} occurred  in 2 (02 %) cases. Minor cardiovascular complications  revealed vascular haematoma 2 (02%), bleeding from access  site in 1 (01%), transient ventricular fibrillation (VF) in 3  (03%) cases. There was no hospital death, emergency CABG  before discharge from hospital. Angiographic, procedural and  clinical success rate were excellent with a little MACE and  event free survival within 30 days follow up. So, PCI is a safe  and effective method of myocardial revascularization  irrespective of lesion morphology and type of stents used at  immediate and 30 days follow up. DOI: http://dx.doi.org/10.3329/medtoday.v24i1.14106 Medicine TODAY Vol.24(1) 2012 pp.8-11

scholarly journals Efficacy and safety of EUS-guided gastroenterostomy for benign and malignant gastric outlet obstruction: a systematic review and meta-analysis

2019 ◽  
Vol 07 (11) ◽  
pp. E1474-E1482 ◽  
Author(s):  
Thomas R. McCarty ◽  
Rajat Garg ◽  
Christopher C. Thompson ◽  
Tarun Rustagi
Keyword(s):  
Gastric Outlet Obstruction ◽  
Clinical Success ◽  
Meta Analysis ◽  
Outlet Obstruction ◽  
Clinical Success Rate ◽  
Cochrane Library ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Malignant Gastric Outlet Obstruction

Abstract Background and study aims Endoscopic ultrasound-guided gastroenterostomy (EUS-GE) is a novel endoscopic procedure designed to facilitate sustained luminal patency in patients with gastric outlet obstruction. The primary aim of this study was to evaluate the efficacy and safety of EUS-GE for treatment of gastric outlet obstruction. Methods Searches of PubMed, EMBASE, Web of Science, and Cochrane Library databases were performed through April 2019. Patients with benign and malignant gastric outlet obstruction were included. Measured outcomes included: immediate technical and clinical success as well as rate of serious adverse events (AEs). Heterogeneity was assessed with Cochran Q test and I 2 statistics. Publication bias was ascertained by funnel plot and Egger regression testing. Results A total of five studies (n = 199 patients; 45.73 % male) were included in this study. Four retrospective studies and one prospective study were analyzed. Mean age of patients that underwent the EUS-GE procedure was 64.52 ± 1.37 years with a pooled mean follow-up period of 4.32 ± 1.65 months. In 21 % of patients (n = 43), gastric outlet obstruction was due to benign causes. Immediate technical success was 92.90 % (95 % CI; 88.26 – 95.79; I2 = 0.00 %) and reported in all studies. The clinical success rate of EUS-GE was 90.11 % (95 % CI; 84.64 – 93.44; I2 = 0.00 %). Serious AEs occurred in 5.61 % (95 % CI; 2.87 – 10.67; I2 = 1.67 %) of cases and were related to peritonitis, perforation, bleeding, and abdominal pain. Re-intervention rate was 11.43 % (95 % CI; 7.29 – 17.46; I2 = 17.38 %). Conclusions EUS-GE appears to provide an effective and safe minimally invasive alternative for treatment of benign and malignant gastric outlet obstruction.

A European multicentric experience using the CardioSEAL® and Starflex double umbrella devices to close interatrial communications holes within the oval fossa

2000 ◽  
Vol 10 (5) ◽  
pp. 519-526 ◽  
Author(s):  
M. Carminati ◽  
S. Giusti ◽  
G. Hausdorf ◽  
S. Qureshi ◽  
M. Tynan ◽  
...  
Keyword(s):  
General Anesthesia ◽  
Surgical Repair ◽  
Clinical Success ◽  
The Other ◽  
Thromboembolic Events ◽  
Clinical Complications ◽  
The Mean ◽  
One Year ◽  
Flap Valve

AbstractIn this review, we describe the experience from 13 European centres using the CardioSEAL and Starflex double umbrella devices to close interatrial communications within the oval fossa (so-called ‘stcundum’ defects). Between October 1996 and April 1999, the procedure was attempted in 334 patients with a mean age of 12 years and a mean weight of 44kg. The mean measured stretched diameter of the defect was 15 mm. In the overall group, the defect was solitary in 245 patients (73%), multiple in 21 (6%), associated with an aneurysm of the flap valve in 15 (5%), was represented by patency of the oval foramen in 44 (13%), and was a fenestration in a Fontan repair in 9 (3%). In all patients, the devices were inserted under general anesthesia, using fluoroscopic and transesophageal echocardiographic control. Implantation was achieved in 325 (97,3%). The device embolized within either a few minutes or a few hours in 13 patients (4%). Of these, uncomplicated surgical repair was undertaken in 10, while the device was retrieved in 3 using catheters and a second device was successfully implanted. Residual shunting was detected immediately after the procedure in 41% of the patients, with the incidence decreasing to 31% at discharge, 24% at 1 month, 21% at 6 months, and 20.5% at one year. During the period of follow-up, elective surgical repair became necessary in two patients, due to malposition of the device in one, and late embolization in the other. Fractures of arms were seen in 6.1%, most commonly with the largest devices. All those with fractured arms of the device were asymptomatic, and no clinical complications related to the fractures were observed. There were no arrythmias, endocarditis, valvar distortion, thromboembolic events, or other complications. After one year of follow-up, clinical success, defined as complete closure of the defect or presence of only a trivial leak, had been obtained in 92.5% of the patients. We conclude, therefore, that these devices produce excellent results when used to close defects of small to moderate size. Results are less than optimal, or else complications ensure, when attempts are made to close very large defects.

Chronic Idiopathic Neutropenia In Adults: Clinical Features In a 4-Year Prospective Study

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1026-1026
Author(s):  
Bruno Fattizzo ◽  
Tommaso Radice ◽  
Francesca Guidotti ◽  
Anna Zaninoni ◽  
Alberto Ciani ◽  
...  
Keyword(s):  
Bone Marrow ◽  
Prospective Study ◽  
Nk Cells ◽  
Oral Antibiotic ◽  
Upper Respiratory Tract ◽  
Chronic Idiopathic Neutropenia ◽  
Immune Phenotyping ◽  
The Mean ◽  
Tract Infections

Abstract Chronic idiopathic neutropenia (CIN) is a rare acquired hematological condition, defined by an absolute neutrophil count (ANCs) lower than 1.8 x103/µL in white and 1.5 x103/µL in black people for more than 3 months, either in the absence or in the presence of anti-neutrophils antibodies (autoimmune forms). CIN is usually diagnosed after the exclusion of congenital and secondary forms. The former are usually marked by frequent and severe infections, that occur early in life, and by and increased risk of evolution to acute myeloid leukemia or myelodisplastic syndromes. In this prospective study we followed up 56 patients with CIN (21 males and 35 females, median age 55 years, range 25-86 years) for a median time of 48 months from January 2009 (10 patients had a previous follow-up of 8 years and 2 of 10 years), focusing on 1) severity of neutropenia, 2) ANCs variations (by general estimating equations GEE models), 3) positivity for anti-neutrophil antibodies (by direct and indirect granulocyte immunofluorescence test), 4) bone marrow features, 5) incidence of infectious episodes, and 6) evolution to definite clonal hematologic diseases (hairy cell leukemia HCL, chronic expansion of NK cells and myelodisplastic syndrome MDS). The mean ANCs were stably under the normal range (1.5-6.5 x103/µL) at all the time points considered; by GEE analysis, a great inter-subject variability was observed during the follow-up (p=0.012), whereas no significant intra-subject variations were found. Considering the severity of neutropenia, 21 patients (47%) showed neutrophils lower than 1x103/µL at enrollment (median 0.49 x103/µL, range 0.1-0.969 x103/µL), and 8 cases <0.5 x103/µL. The mean ANCs observed during the follow up were significantly lower in males than in females (p=0.023) and in cases with mild splenomegaly, although not significantly (11 cases, 20%, mean maximal diameter 11,4 cm by ultrasonography), independently from gender (multivariate analysis). Anti-neutrophil antibodies were detected in 19/56 patients (34%), and mean ANCs values over the follow up were significantly lower in positive versus negative cases (p=0.027). Lymphocyte values greater than the upper normal value of our series (3.4 x103/µL) were observed in 5/56 patients (9%). By peripheral blood immunophenotyping (N=23), 13 (56.5%) patients displayed absolute NK+ cells greater than 0.2 x103/mL (normal NK cut-off value), but all under below 2 x103/µL. Bone marrow evaluation was performed in 27 patients: median cellularity was 35% (range 13-75), and 10/27 (37%) displayed a value lower than 25% (threshold for hypocellularity in aplastic anemia); 19/27 (70%) showed some dysplastic cells, even if less than 10% dysplastic cells and without coexistent MDS-related karyotype; cytogenetic was normal in 24 cases (89%), while 3 males, all older than 60 years, displayed a 45, X0 karyotype (7, 6 and 3 metaphases respectively. Finally, 10 patients (18%) showed monocytosis, and 6 (10%) a MGUS. An infection needing oral antibiotic or antiviral therapy occurred in 13 patients (25%) (2 pneumonias, 7 upper respiratory tract, 3 Herpes Zoster Virus and 1 urinary tract infections), without relationship with the patient’s mean ANCs value, the nadir of ANC value, nor with the presence of anti-neutrophil antibodies. During the follow-up, because of suspected progression/evolution, 14 patients were re-evaluated by bone marrow biopsy or peripheral immune-phenotyping: 4 cases were diagnosed with chronic NK expansion, 4 with HCL, and 2 with MDS, one refractory cytopenia with unilineage dysplasia (RCUD) and one with multilineage dysplasia (RCMD). No association was found between evolution and ANCs, both as values at enrolment and mean counts over the follow up, nor with gender, presence of anti-neutrophils antibodies, monocytosis, splenomegaly, electrophoresis abnormalities and infections. All 4 patients, who developed an NK-expansion, showed peripheral lymphocytes >3.4 x103/µL at enrolment (>5x103/µL in only 1 case), and 3 cases displayed increased NK cells at peripheral immune-phenotyping (p= 0.018). In conclusion, CIN in adults is a benign disease, with an infectious rate not superior to that of the general population and a great variability in ANCs values. During this prospective observation, 10 CIN patients evolved, reaching the criteria for clonal hematological diseases, suggesting that this condition deserves clinical follow up. Disclosures: No relevant conflicts of interest to declare.

scholarly journals ACROSTUDY: the first 5 years

2009 ◽  
Vol 161 (suppl_1) ◽  
pp. S19-S24 ◽  
Author(s):  
Peter J Trainer
Keyword(s):  
Tumour Size ◽  
Safety Data ◽  
Liver Function Tests ◽  
Dose Titration ◽  
Serious Adverse Events ◽  
Once Daily ◽  
Injection Site Reactions ◽  
The Mean ◽  
Magnetic Resonance Imaging Mri

ACROSTUDY is an observational registry intended to collect safety and efficacy data on pegvisomant therapy. A total of 792 patients have been enrolled, of whom 83% had commenced pegvisomant prior to recruitment. The mean follow-up is 1.66 years with the mean duration of pegvisomant therapy 3.31 years representing 2625 patient years of treatment. About 90% of patients were on once daily pegvisomant, and 67% were on monotherapy. Disappointingly, IGF1 was normalised in <70% of patients; furthermore, in 80% of patients with an elevated IGF1, the daily dose of pegvisomant was 20 mg or less. A total of 56 serious adverse events (AEs) were reported, of which 13 were related to pegvisomant. A total of 276 AEs were reported, of which 56 were considered related to pegvisomant. The AEs most frequently attributed to pegvisomant were disturbed liver function tests and injection site reactions. Magnetic resonance imaging (MRI) was available in 684 patients. A total of 411 patients had at least one MRI on pegvisomant compared with a baseline. In 31 patients, a decrease in tumour size has been reported, of whom 20 had previously received radiotherapy. An increase in tumour size has been reported and confirmed in 22 patients. In 11 patients, there was contradictory data on tumour size, while, in six patients, central review of the films failed to confirm increase in tumour size. In conclusion, the safety data are generally reassuring, while the IGF1 normalisation rate is disappointing, which probably reflects a failure of dose titration. Further effort is needed to understand the reasons for the failure of dose titration.

Sign in / Sign up

Export Citation Format

Share Document