scholarly journals Gadobutrol in India—A Comprehensive Review of Safety and Efficacy

2017 ◽  
Vol 10 ◽  
pp. 1178623X1773004 ◽  
Author(s):  
Jan Endrikat ◽  
Nicoletta Anzalone
Keyword(s):  
Observational Studies ◽  
Event Rate ◽  
Standard Dose ◽  
Age Groups ◽  
Adverse Event Rate ◽  
Diagnostic Efficacy ◽  
Clinical Phase ◽  
Impaired Liver ◽  
The Central Nervous System ◽  
Magnetic Resonance Imaging Mri

Gadobutrol is a gadolinium (Gd)-based contrast agent for magnetic resonance imaging (MRI). In India, gadobutrol is approved for MRI of the central nervous system (CNS), liver, kidneys, breast and for MR angiography for patients 2 years and older. The standard dose for all age groups is 0.1 mmol/kg body weight. The safety profile has been demonstrated in 42 clinical phase 2 to 4 studies (>6800 patients), 7 observational studies, and by assessing pharmacovigilance data of 29 million applications. Furthermore, studies in children, adults, and elderly and in patients with impaired liver or kidney function did not show any increased adverse event rate. Diagnostic efficacy was demonstrated in numerous studies and various indications, such as diseases of the CNS, peripheral and supra-aortic vessels, kidneys, liver, and breast.

scholarly journals Cholangioscopy-guided lithotripsy vs. conventional therapy for complex bile duct stones: a systematic review and meta-analysis

2020 ◽  
Vol 33 (1) ◽  
Author(s):  
Facundo GALETTI ◽  
Diogo Turiani Hourneaux de MOURA ◽  
Igor Braga RIBEIRO ◽  
Mateus Pereira FUNARI ◽  
Martin CORONEL ◽  
...  
Keyword(s):  
Adverse Event ◽  
Bile Duct ◽  
Conventional Therapy ◽  
Observational Studies ◽  
Event Rate ◽  
Common Bile Duct Stones ◽  
Adverse Event Rate ◽  
Bile Duct Stones ◽  
Procedure Time ◽  
The Mean

ABSTRACT Introduction: Endoscopic removal of common bile duct stones has a high success rate ranging from 85% to 95%. Bile duct stones >15 mm are difficult and frequently require lithotripsy. Peroral cholangioscopy (POC) allows lithotripsy with similar success rates. Aim: To determine the efficacy and safety of cholangioscopy-guided lithotripsy used in the treatment of difficult to remove bile duct stones vs. conventional therapy. Methods: Search was based in Medline, Embase, Cochrane Central, Lilacs/Bireme. Studies enrolling patients referred for the removal of difficult bile duct stones via POC were considered eligible. Two analyses were carried out separately, one included randomized controlled trials (RCTs) and another observational studies. Results: Forty-six studies were selected (3 RTC and 43 observational). In the analysis there was no statistical significant difference between successful endoscopic clearance (RD=-0.02 CI: -0.17, 0.12/I²=0%), mean fluoroscopy time (MD=-0.14 CI -1.60, 1.32/I²=21%) and adverse events rates (RD=-0.06 CI: -0.14, 0.02/I²=0%), by contrast, the mean procedure time favored conventional therapy with statistical significance (MD=27.89 CI: 16.68, 39.10/I²=0%). In observational studies, the successful endoscopic clearance rate was 88.29% (CI95: 86.9%-90.7%), the first session successful endoscopic clearance rate was 72.7 % (CI95: 69.9%-75.3%), the mean procedure time was 47.50±6 min for session and the number of sessions to clear bile duct was 1.5±0.18. The adverse event rate was 8.7% (CI95: 7%-10.9%). Conclusions: For complex common bile duct stones, cholangioscopy-guided lithotripsy has a success rate that is similar to traditional ERCP techniques in terms of therapeutic success, adverse event rate and means fluoroscopy time. Conventional ERCP methods have a shorter mean procedure time.

scholarly journals Beyond Oncological Hyperthermia: Physically Drivable Magnetic Nanobubbles as Novel Multipurpose Theranostic Carriers in the Central Nervous System

Molecules ◽  
2020 ◽  
Vol 25 (9) ◽  
pp. 2104 ◽  
Author(s):  
Eleonora Ficiarà ◽  
Shoeb Anwar Ansari ◽  
Monica Argenziano ◽  
Luigi Cangemi ◽  
Chiara Monge ◽  
...  
Keyword(s):  
Central Nervous System ◽  
Nervous System ◽  
Brain Tumors ◽  
Ad Hoc ◽  
Superparamagnetic Iron Oxide ◽  
Conventional Radiotherapy ◽  
The Central Nervous System ◽  
Magnetic Resonance Imaging Mri ◽  
The Brain

Magnetic Oxygen-Loaded Nanobubbles (MOLNBs), manufactured by adding Superparamagnetic Iron Oxide Nanoparticles (SPIONs) on the surface of polymeric nanobubbles, are investigated as theranostic carriers for delivering oxygen and chemotherapy to brain tumors. Physicochemical and cyto-toxicological properties and in vitro internalization by human brain microvascular endothelial cells as well as the motion of MOLNBs in a static magnetic field were investigated. MOLNBs are safe oxygen-loaded vectors able to overcome the brain membranes and drivable through the Central Nervous System (CNS) to deliver their cargoes to specific sites of interest. In addition, MOLNBs are monitorable either via Magnetic Resonance Imaging (MRI) or Ultrasound (US) sonography. MOLNBs can find application in targeting brain tumors since they can enhance conventional radiotherapy and deliver chemotherapy being driven by ad hoc tailored magnetic fields under MRI and/or US monitoring.

scholarly journals A multicenter, hospital-based and non-inferiority study for diagnostic efficacy of automated whole breast ultrasound for breast cancer in China

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yujing Xin ◽  
Xinyuan Zhang ◽  
Yi Yang ◽  
Yi Chen ◽  
Yanan Wang ◽  
...  
Keyword(s):  
Breast Cancer ◽  
False Negative ◽  
Final Analysis ◽  
Age Group ◽  
Surgical Biopsy ◽  
True Negative ◽  
Diagnostic Efficacy ◽  
Negative Results ◽  
Informed Consent Form ◽  
Magnetic Resonance Imaging Mri

AbstractThis study is the first multi-center non-inferiority study that aims to critically evaluate the effectiveness of HHUS/ABUS in China breast cancer detection. This was a multicenter hospital-based study. Five hospitals participated in this study. Women (30–69 years old) with defined criteria were invited for breast examination by HHUS, ABUS or/and mammography. For BI-RADS category 3, an additional magnetic resonance imaging (MRI) test was provided to distinguish the true negative results from false negative results. For women classified as BI-RADS category 4 or 5, either core aspiration biopsy or surgical biopsy was done to confirm the diagnosis. Between February 2016 and March 2017, 2844 women signed the informed consent form, and 1947 of them involved in final analysis (680 were 30 to 39 years old, 1267 were 40 to 69 years old).For all participants, ABUS sensitivity (91.81%) compared with HHUS sensitivity (94.70%) with non-inferior Z tests, P = 0.015. In the 40–69 age group, non-inferior Z tests showed that ABUS sensitivity (93.01%) was non-inferior to MG sensitivity (86.02%) with P < 0.001 and HHUS sensitivity (95.44%) was non-inferior to MG sensitivity (86.02%) with P < 0.001. Sensitivity of ABUS and HHUS are all superior to that of MG with P < 0.001 by superior test.For all participants, ABUS specificity (92.89%) was non-inferior to HHUS specificity (89.36%) with P < 0.001. Superiority test show that specificity of ABUS was superior to that of HHUS with P < 0.001. In the 40–69 age group, ABUS specificity (92.86%) was non-inferior to MG specificity (91.68%) with P < 0.001 and HHUS specificity (89.55%) was non-inferior to MG specificity (91.68%) with P < 0.001. ABUS is not superior to MG with P = 0.114 by superior test. The sensitivity of ABUS/HHUS is superior to that of MG. The specificity of ABUS/HHUS is non-inferior to that of MG. In China, for an experienced US radiologist, both HHUS and ABUS have better diagnostic efficacy than MG in symptomatic individuals.

scholarly journals Uncommon manifestations of a rare disease: a case of autoimmune GFAP astrocytopathy

BMC Neurology ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Hong Di ◽  
Yue Yin ◽  
Ruxuan Chen ◽  
Yun Zhang ◽  
Jun Ni ◽  
...  
Keyword(s):  
Rare Disease ◽  
Hormone Secretion ◽  
White Matter Lesions ◽  
Signs And Symptoms ◽  
Careful Examination ◽  
Case Presentation ◽  
Inappropriate Antidiuretic Hormone Secretion ◽  
Contrast Enhanced ◽  
The Central Nervous System ◽  
Magnetic Resonance Imaging Mri

Abstract Background Manifestations of intractable hyponatremia and hypokalemia in autoimmune glial fibrillary acidic protein (GFAP) astrocytopathy have been rarely reported. Case presentation A 75-year-old male patient presented as the case of syndrome of inappropriate antidiuretic hormone secretion (SIADH) and intractable hypokalemia, showed fever, fatigue, and mental disorders. Signs and symptoms of meningoencephalitis, ataxia, and cognitive abnormalities. Magnetic resonance imaging (MRI) revealed multiple white matter lesions of the central nervous system. He had GFAP-IgG in the cerebrospinal fluid (CSF). After treatment with corticosteroids, his symptoms were alleviated gradually, and the level of electrolytes was normal. However, head contrast-enhanced MRI + susceptibility-weighted imaging (SWI) showed a wide afflicted region, and the serum GFAP-IgG turned positive. Considering the relapse of the disease, ha was treated with immunoglobulin and mycophenolate mofetil (MMF) to stabilize his condition. Conclusion This case showed a rare disease with uncommon manifestations, suggesting that careful examination and timely diagnosis are essential for disease management and satisfactory prognosis.

scholarly journals Disease-modifying therapy prescription patterns in people with multiple sclerosis by age

2021 ◽  
Vol 14 ◽  
pp. 175628642110064
Author(s):  
Yinan Zhang ◽  
Amber Salter ◽  
Shan Jin ◽  
William J. Culpepper ◽  
Gary R. Cutter ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Disease Activity ◽  
Age Groups ◽  
The Elderly ◽  
Department Of Veterans Affairs ◽  
Real World Data ◽  
Research Committee ◽  
The North ◽  
Disease Modifying ◽  
Magnetic Resonance Imaging Mri

Background: Disease-modifying therapies (DMTs) for multiple sclerosis (MS) are approved for their ability to reduce disease activity, namely clinical relapses and signal changes on magnetic resonance imaging (MRI). Disease activity appears age dependent. Thus, the greatest benefit would be expected in younger people with MS (PwMS) whereas benefits in the elderly are uncertain. Methods: Real-world data were obtained from PwMS from the North American Research Committee on Multiple Sclerosis (NARCOMS) registry and the US Department of Veterans Affairs Multiple Sclerosis Surveillance Registry (MSSR). Results: 6948 PwMS were surveyed from NARCOMS, and the MSSR had 1719 participants. In younger adult PwMS 40-years old or less, 183 (61.4%) in NARCOMS and 179 (70.5%) in the MSSR were prescribed DMTs. Among PwMS over age 60, 1575 (40.1%) in NARCOMS and 239 (36.3%) in the MSSR were prescribed DMTs. More PwMS in the age group of 31–40 ( p = 0.035) and 41–50 ( p = 0.001) in the MSSR were using DMTs compared with PwMS of the same age groups in NARCOMS. Conclusion: These findings suggest that DMTs are under-utilized in the younger population and continue to be commonly prescribed in the elderly. Broader access may explain the higher prescription rate of DMTs in US veterans.

scholarly journals Multifocal glioblastoma multiform with “encephalitis-like presentation” : a case report

2021 ◽  
Vol 52 (1) ◽  
Author(s):  
Issam Sa’adeh ◽  
Mohamed Jamal Saadh
Keyword(s):  
Vasogenic Edema ◽  
Neurological Deficits ◽  
Herpes Simplex Virus 1 ◽  
Glioblastoma Multiform ◽  
Atypical Clinical Presentation ◽  
Mri Scans ◽  
The Central Nervous System ◽  
Magnetic Resonance Imaging Mri ◽  
Simplex Virus ◽  
Multifocal Glioblastoma

Abstract Background Glioblastoma multiform is the most common and aggressive type of primary malignant tumor that affects the central nervous system in adults. It clinically presents with seizures, headache, and/or progressive focal neurological deficits. Radiologically, glioblastoma multiform appears as a single distinguishable, large heterogeneous lesion affecting the cerebrum with characteristic central necrosis, marginal enhancement, and surrounding vasogenic edema. This article describes a patient that exhibited an atypical clinical presentation of multifocal glioblastoma multiform with misleading early radiological features that simulated herpetic encephalitis. Results A 66-year-old female that presented with left-sided hemiparesis and left partial motor seizures underwent multi-slice computed tomography (MSCT) and magnetic resonance imaging (MRI) scans. A cerebrospinal fluid (CSF) polymerase chain reaction (PCR) test was also performed to screen for herpes simplex virus 1 (HSV-1). Conclusions The early stages of glioblastoma may manifest as symptoms typical to encephalitis, which can delay diagnosis and treatment. Therefore, early diagnosis and identification of atypical glioblastoma multiform presentations, as reported in this article, are essential.

scholarly journals Microalbuminuria is associated with high adverse event rate following cardiac surgery

2011 ◽  
Vol 39 (6) ◽  
pp. 932-938 ◽  
Author(s):  
Martin Majlund Mikkelsen ◽  
Niels Holmark Andersen ◽  
Thomas Decker Christensen ◽  
Troels Krarup Hansen ◽  
Hans Eiskjaer ◽  
...  
Keyword(s):  
Adverse Event ◽  
Cardiac Surgery ◽  
Event Rate ◽  
Adverse Event Rate ◽  
High Adverse Event

Missed acute myocardial infarction in the emergency department–standardizing measurement of misdiagnosis-related harms using the SPADE method

Diagnosis ◽  
2020 ◽  
Vol 0 (0) ◽  
Author(s):  
Adam L. Sharp ◽  
Aileen Baecker ◽  
Najlla Nassery ◽  
Stacy Park ◽  
Ahmed Hassoon ◽  
...  
Keyword(s):  
Emergency Department ◽  
Adverse Event ◽  
Chest Pain ◽  
Administrative Data ◽  
Diagnostic Performance ◽  
Event Rate ◽  
Public Health Problem ◽  
Diagnostic Error ◽  
Adverse Event Rate ◽  
Disease Pair

AbstractObjectivesDiagnostic error is a serious public health problem. Measuring diagnostic performance remains elusive. We sought to measure misdiagnosis-related harms following missed acute myocardial infarctions (AMI) in the emergency department (ED) using the symptom-disease pair analysis of diagnostic error (SPADE) method.MethodsRetrospective administrative data analysis (2009–2017) from a single, integrated health system using International Classification of Diseases (ICD) coded discharge diagnoses. We looked back 30 days from AMI hospitalizations for antecedent ED treat-and-release visits to identify symptoms linked to probable missed AMI (observed > expected). We then looked forward from these ED discharge diagnoses to identify symptom-disease pair misdiagnosis-related harms (AMI hospitalizations within 30-days, representing diagnostic adverse events).ResultsA total of 44,473 AMI hospitalizations were associated with 2,874 treat-and-release ED visits in the prior 30 days. The top plausibly-related ED discharge diagnoses were “chest pain” and “dyspnea” with excess treat-and-release visit rates of 9.8% (95% CI 8.5–11.2%) and 3.4% (95% CI 2.7–4.2%), respectively. These represented 574 probable missed AMIs resulting in hospitalization (adverse event rate per AMI 1.3%, 95% CI 1.2–1.4%). Looking forward, 325,088 chest pain or dyspnea ED discharges were followed by 508 AMI hospitalizations (adverse event rate per symptom discharge 0.2%, 95% CI 0.1–0.2%).ConclusionsThe SPADE method precisely quantifies misdiagnosis-related harms from missed AMIs using administrative data. This approach could facilitate future assessment of diagnostic performance across health systems. These results correspond to ∼10,000 potentially-preventable harms annually in the US. However, relatively low error and adverse event rates may pose challenges to reducing harms for this ED symptom-disease pair.

Robot-Assisted Stereotactic Shunting as a Novel Treatment for Pontine Glioependymal Cysts

2021 ◽  
Author(s):  
Simon Schieferdecker ◽  
Stefan Hunsche ◽  
Faycal El Majdoub ◽  
Mohammad Maarouf
Keyword(s):  
Abducens Nerve ◽  
Ependymal Cells ◽  
Robot Assisted ◽  
Quick Recovery ◽  
Glioependymal Cyst ◽  
Novel Treatment ◽  
First Case ◽  
Mri Scans ◽  
The Central Nervous System ◽  
Magnetic Resonance Imaging Mri

AbstractIn this case report, the authors describe the first case of a glioependymal cyst of the brainstem managed by robot-assisted, stereotactic, cysto-ventricular shunting. Glioependymal cysts are rare congenital cystic lesions that are thought to form by displacement of ependymal cells during the embryonal period. Glioependymal cysts have been reported in a variety of different locations within the central nervous system. However, glioependymal cysts of the brainstem have only been described once before. Here, we report the case of a 53-year-old man who was referred to our department due to hemiparesis, hemihypesthesia, and hemidysesthesia, as well as facial and abducens nerve palsy. A large pontine glioependymal cyst was confirmed via magnetic resonance imaging (MRI) scans. The cyst was subsequently decompressed by connecting the cyst with the fourth ventricle via robot-assisted stereotactic shunt placement. In the postoperative course, the patient made a quick recovery and did not report any permanent neurologic deficits.

Sign in / Sign up

Export Citation Format

Share Document