RESUMO
Background Malnourishment has been linked with increased morbidity and mortality among critically ill patients. The current study aimed to assess the factors contributing to the interruption of enteral nutrition so that preventive measures can be formulated to avoid the malnourishment of critically ill patients. Methodology A prospective, observational study was conducted at the Department of Intensive Care Unit, Shifa International Hospital, Islamabad, between November 2020 and May 2021. All patients admitted in the intensive care unit (ICU) during the study period aged between 18 and 80 years, who remained admitted in the medical ICU for at least 72 hours were included in the study. Those who had ileostomy or colostomy were excluded from the study. Diagnostic categories were defined as surgical and medical. Data on clinical parameters including admitting diagnosis and airway-related issues were recorded in a predefined proforma. Results The mean duration of enteral nutrition interruption in males was 13.96 ± 13.12 days while that of females, 12.48 ± 12.43 days. Non-invasive ventilation dependency was significantly associated with an interruption in enteral nutrition (p=0.002). The mean duration of interruption of enteral nutrition was not correlated with airway issues (p=0.569). However, the mean duration of interruption of enteral nutrition was significantly lower in patients who underwent spontaneous breathing trials with T-piece (p = 0.032). Those who were advised nil per oral before surgery had a significantly longer duration of enteral nutrition interruption (p < 0.0001) with a mean length of 30.18 ± 5.83 days. The duration of enteral nutrition interruption was significantly longer in patients who had tracheostomy than those who did not have a tracheostomy (26.3 ± 6.34 vs. 9.54 ± 11.61 days) (p < 0.0001). Conclusion The present study revealed that at least three-forth of the patients admitted in ICUs had documented orders to the interruption of enteral nutrition. The most significant causes that correlated with interruptions to enteral nutrition were non-invasive ventilation dependency, tracheostomy, spontaneous breathing trials with T-piece, and orders of nil per oral before surgery.
RESUMO
Belumosudil (BLM) is a ROCK inhibitor that has been firstly developed by Surface Logix, later acquired by Kadmon Pharmaceuticals for the treatment of chronic graft-versus-host disease (cGVHD), Psoriasis Vulgaris (PV), idiopathic pulmonary fibrosis (IPF), hepatic impairment (HI), diffuse cutaneous systemic sclerosis (dcSSc). BLM received a breakthrough therapy designation and priority review from the FDA, which reviewed the NDA under the real-time oncology review (RTOR) pilot programme and approved it six weeks ahead of the PDUFA deadline of August 30, 2021. On July 16th, 2021, The USFDA authorized BLM under the brand name REZUROCKTM for the treatment of cGVHD in adults and pediatric patients aged ≥ 12 years after the failure of at least two prior lines of systemic therapy. It has been granted orphan drug status by the FDA on August 9, 2020, for the treatment of systemic sclerosis. The European Union (EU) granted Quality Regulatory Clinical Ireland Limited, Ireland, orphan drug status for BLM (KD025) for the treatment of cGVHD on October 17, 2019. BLM is under regulatory assessment by Therapeutic Good Administration (TGA) Australia, Health Canada, MHRA (UK), and The Swiss Agency for Therapeutic Products (Swissmedic), Switzerland for cGVHD. A clinical trial is ongoing in the United States for cutaneous systemic sclerosis. This review article summarizes the milestones in the development of BLM chemistry, Chemical synthesis and development, mechanism of action, pharmacokinetics (PK), pharmacodynamics (PD), adverse effects, regulatory status, and ongoing clinical trials (CT) of BLM.
