Combination of palonosetron plus dexamethasone is highly effective in controlling acute and delayed CINV, with palonosetron superior to ondansetron.
Background Bronchopulmonary dysplasia (BPD) is a complex lung pathological lesion secondary to multiple factors, and one of the most common chronic lung diseases with poor prognosis, especially in preterm infants with moderate and severe BPD. However, there is lack of effective therapies for this disease. Stem cell therapy has been shown a promising way for improving lung injury and abnormal alveolarization, and human umbilical cord (hUC) is a good resource for mesenchymal stem cells (MSCs), which have demonstrated in some other diseases. We hypothesis that intravenous allogeneic hUC-MSCs is safe and effective for moderate and severe BPD. Methods/design The MSC-BPD trial is a randomized single-center open-label and dose-escalation phase II trial designed to investigate the safety and efficacy of hUC-MSCs in children with moderate and severe BPD. In this study, 57 patients will be enrolled and randomly divided into two intervention groups and one control group. Patients in the intervention groups will be receive a low dose of hUC-MSCs (n=19, 1 million cells/kg) or a high dose of hUC-MSCs (n=19, 5 million cells/kg) in combination with traditional supportive treatments for BPD. The patients in the control group (n=19) will be treated with traditional supportive treatments alone without receiving hUC-MSCs treatment. The primary outcome measures will be the accumulative duration of oxygen therapy. Follow-up assessments will be performed at 1, 3, 6, 12, 24 months after interventions. Statistical analyses will evaluate the efficacy of the hUC-MScs treatment. Discussion This study will be the first randomized controlled trial to evaluate the safety and efficacy of intravenous hUC-MSCs in children with moderate and severe BPD. Results of the trial will provide a new evidence-based therapy for moderate and severe BPD. Trial Registration ClinicalTrials.gov, NCT03601416. Registered on 26th July 2018.
Background Environmental noise is becoming increasingly recognized as an urgent public health problem, but the quality of current studies needs to be assessed. To evaluate the significance, validity and potential biases of the associations between environmental noise exposure and health outcomes. Methods We conducted an umbrella review of the evidence across meta-analyses of environmental noise exposure and any health outcomes. A systematic search was done until November 2021. PubMed, Cochrane, Scopus, Web of Science, Embase and references of eligible studies were searched. Quality was assessed by AMSTAR and Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Results Of the 31 unique health outcomes identified in 23 systematic reviews and meta-analyses, environmental noise exposure was more likely to result in a series of adverse outcomes. Five percent were moderate in methodology quality, the rest were low to very low and the majority of GRADE evidence was graded as low or even lower. The group with occupational noise exposure had the largest risk increment of speech frequency [relative risk (RR): 6.68; 95% confidence interval (CI): 3.41–13.07] and high-frequency (RR: 4.46; 95% CI: 2.80–7.11) noise-induced hearing loss. High noise exposure from different sources was associated with an increased risk of cardiovascular disease (34%) and its mortality (12%), elevated blood pressure (58–72%), diabetes (23%) and adverse reproductive outcomes (22–43%). In addition, the dose–response relationship revealed that the risk of diabetes, ischemic heart disease (IHD), cardiovascular (CV) mortality, stroke, anxiety and depression increases with increasing noise exposure. Conclusions Adverse associations were found for CV disease and mortality, diabetes, hearing impairment, neurological disorders and adverse reproductive outcomes with environmental noise exposure in humans, especially occupational noise. The studies mostly showed low quality and more high-quality longitudinal study designs are needed for further validation in the future.
Background and Objective Glioblastoma is a cranial malignant tumor with a high recurrence rate after surgery and a poor response to chemoradiotherapy. Bevacizumab has demonstrated efficacy in the treatment of glioblastoma by inhibiting vascular endothelial growth factor, but the efficacy of vascular endothelial growth factor receptor tyrosine kinase inhibitors varies in treating glioblastoma. This single-arm prospective study aimed to explore the efficacy and safety of the vascular endothelial growth factor receptor tyrosine kinase inhibitor apatinib in treating recurrent glioblastoma after chemoradiotherapy. Methods A total of 15 patients with recurrent glioblastoma (2016 World Health Organization grade IV) after chemoradiotherapy were enrolled in this study from September 2017 to September 2019 and treated with apatinib 500 mg once daily. Responses were evaluated according to the Response Assessment in Neuro-Oncology criteria, and adverse events were recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0. Results The overall response rate was 33.3%, and the disease control rate was 66.6%. The median progression-free survival was 2 months, and the median overall survival was 6.5 months. The apatinib dose was adjusted in seven patients because of adverse events (46.6%). The most common adverse events were thrombocytopenia (53.3%), asthenia (40%), and hand-foot syndrome (33.3%). Conclusions Apatinib might be effective in treating recurrent glioblastoma after chemoradiotherapy in terms of the overall response rate, but the efficacy is not durable and the clinical benefit is limited. The adverse effects of apatinib were acceptable. Clinical Trial Registration ChiCTR-ONC-17013098, date of registration: 24 October, 2017.
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