Conectar
by Sadahiro Hijikata, Norihiko Inoue, Kiyohide Fushimi, Tetsuo Sasano
Takotsubo cardiomyopathy is characterized by temporary ballooning of the left ventricle and may lead to thrombosis, necessitating anticoagulation therapy in high-risk patients. However, no previous studies have compared anticoagulation therapies for this population. We aimed to compare the clinical outcomes of patients treated with direct oral anticoagulants (DOACs) and those treated with heparin. This retrospective study included patients with Takotsubo cardiomyopathy receiving DOACs or heparin within the first 2 days of admission between April 2012 and March 2021, identified from a nationwide in-hospital database in Japan. The primary outcome was in-hospital mortality. The secondary outcomes were ischemic and bleeding events, hospitalization costs, and length of hospital stay. After adjustment with propensity score-based inverse probability weighting, the risks of outcomes were estimated using Poisson regression models. Among 4,813 patients, 530 received DOACs and 4,283 received heparin. The DOAC group was older than the heparin group (mean [standard deviation] 78.1 [9.4] vs. 74.4 [11.2] years). After covariate adjustment, in-hospital mortality (4.0% vs. 3.8%; p = 0.87), ischemic events (1.1% vs. 2.8%; p = 0.067), and bleeding events (0.2% vs. 0.3%; p = 0.67) did not significantly differ between the DOAC and heparin groups. In contrast, the DOAC group had shorter hospital stays (median, 11 days vs. 13 days; pby Masatsugu Ishii, Osamu Itano, Hideki Iwamoto, Yuko Takami, Naomi Okada, Tetsuya Inoue, Satoshi Itano
We identified an effective chemotherapy regimen in patients refractory to standard chemotherapy. We included patients with unresectable colorectal liver metastases who underwent hepatic artery infusion chemotherapy and systemic chemotherapy between January 2015 and December 2022. This study was a retrospective analysis conducted at a single center. The patients received either biweekly oxaliplatin and 5-fluorouracil through hepatic artery infusion chemotherapy as well as bevacizumab and leucovorin injected intravenously (HAIC-FOLFOX-B) or biweekly irinotecan and 5-fluorouracil by hepatic artery infusion chemotherapy and bevacizumab and leucovorin injected intravenously (HAIC-FOLFIRI-B). Of the 42 patients, 20 underwent HAIC-FOLFOX-B while 22 underwent HAIC-FOLFIRI-B treatment with response rates of 25% and 4.5%, respectively. The median overall survival and progression-free survival were 12.9 and 4.7 months and 17.4 and 7.7 months in patients undergoing HAIC-FOLFOX-B and HAIC-FOLFIRI-B, respectively. The overall incidence of grade 3/4 toxicity was 23.8%. However, no treatment-related deaths occurred. Functional catheter-associated problems occurred in 9.5% of the patients. Hepatic arterial occlusion occurred in three patients (7.1%); catheter-associated infection occurred in one (2.4%) patient. However, these occurrences were not life-threatening complications. HAIC-FOLFOX-B and HAIC-FOLFIRI-B might improve survival in patients with unresectable colorectal liver metastases and in those who underwent both systemic oxaliplatin-based and irinotecan-based chemotherapies and were refractory to them. HAIC FOLFOX-B and FOLFIRI-B regimens might be effective therapeutic options in patients with unresectable colorectal liver metastases refractory to standard systemic chemotherapy.Neonatal haemochromatosis, considered to be a gestational alloimmune liver disease (NH-GALD), is a rare but serious disease that results in fulminant hepatic failure. The recurrence rate of NH-GALD in a subsequent infant of a mother with an affected infant is 70%–90%. Recently, antenatal maternal high-dose intravenous immunoglobulin (IVIG) therapy has been reported as being effective for preventing recurrence of NH-GALD in a subsequent infant. However, no clinical trial has been conducted to date.
This is a multicentre open-label, single-arm study of antenatal maternal high-dose IVIG therapy in pregnant women with a history of documented NH in a previous offspring. The objective of this study is to evaluate the efficacy and safety of antenatal maternal high-dose IVIG therapy in preventing or reducing the severity of alloimmune injury to the fetal liver.
The clinical trial is being performed in accordance with the Declaration of Helsinki. The trial protocol was approved by the Clinical Research Review Board at four hospitals. Before enrolment, written informed consent would be obtained from eligible pregnant women. The results are expected to be published in a scientific journal.
28 October 2024, V.8.0.
jRCT1091220353.
Accidental hypothermia (AH) can occur in mild-to-severe cases; however, its management is crucial in severe cases as it can cause ventricular fibrillation and lead to death. Among various rewarming therapies for AH, endovascular catheter rewarming has been the focus of recent studies as a minimally invasive alternative to invasive internal rewarming, such as extracorporeal membrane oxygenation (ECMO). However, no study has demonstrated the efficacy and safety of endovascular catheter rewarming therapy. This study aimed to validate the efficacy and safety of endovascular catheter rewarming for patients with AH.
The intensive care with endovascular catheter rewarming in accidental severe hypothermia (ICE-CRASH II) study is a multicentre, randomised study of patients with AH. This study will include patients with AH (age ≥65 years, core temperature
This study was approved by the Hokkaido University Certified Review Board (approval number: 024-00013). Written informed consent will be obtained from all the participants or their legally acceptable representatives. The results will be disseminated through publications and presentations.
Japan Registry of Clinical Trials (jRCT1012240051).
Atopic dermatitis (AD) is a chronic inflammatory skin condition that impairs the quality of life of affected paediatric patients and their families. Dupilumab, an antagonist of the shared alpha chain subunit of the cytokines interleukin-4 and interleukin-13, has revolutionised the management of moderate-to-severe AD by effectively targeting type 2 inflammation. However, live attenuated vaccines, including live attenuated influenza vaccines (LAIVs), are contraindicated during dupilumab therapy owing to limited safety data. This restriction poses challenges to immunisation strategies, particularly in paediatric populations. This study aims to evaluate the safety and efficacy of LAIV in paediatric patients with AD undergoing dupilumab therapy.
This multicentre, prospective, single-arm, open-label trial will enrol 50 paediatric patients aged 2–18 years with AD undergoing dupilumab treatment. The participants will receive intranasal LAIV, followed by a 25-week observation period after vaccination. The primary outcome is the proportion of participants with a four-fold or greater increase in haemagglutination inhibition titres against influenza strains A(H1N1), A(H3N2) and B at 4 weeks post vaccination. The secondary outcomes include the incidence of influenza and systemic or local adverse events, such as injection site reactions, fever and other influenza-like symptoms observed within 4 weeks of vaccination. Exploratory endpoints include the evaluation of immunosuppressive markers such as neutrophil counts, lymphocyte subsets and serum immunoglobulin G levels. Safety analyses will assess the frequency of each adverse event, whereas efficacy analyses will focus on immunogenicity and influenza incidence during the 25-week follow-up period. This study aims to provide critical safety and immunogenicity data to guide immunisation strategies in biologically treated paediatric patients with AD.
This study complies with the principles of the Declaration of Helsinki and received ethics approval from the Institutional Review Board of Chiba University Hospital as a specified clinical trial. Informed consent and assent will be obtained as appropriate based on the participants’ ages. These findings will be disseminated through peer-reviewed journals and scientific conferences to inform clinical vaccination strategies for biologically treated populations.
jRCTs031240442.
FreshRSS 