Background Several scientific societies have endorsed non-anesthesiologist sedation (NAS) during gastrointestinal endoscopy, considering it a safe procedure when administered by adequately trained personnel. This study aimed to evaluate the occurrence of adverse events after implementation of the European Society of Gastrointestinal Endoscopy (ESGE) and European Society of Gastroenterology and Endoscopy Nurses and Associates (ESGENA) sedation training program.
Methods From January 2017 to August 2018, data from all consecutive endoscopic procedures in adults (≥ 18 years) performed at our endoscopy unit were collected using an electronic reporting system.
Results All staff (physicians and nurses) completed the ESGE-ESGENA sedation course. In total, 12 132 patients underwent endoscopic procedures, 10 755 (88.6 %) of which were performed in a non-anesthesiological setting. Of these, about 20 % used moderate sedation with midazolam + fentanyl and 80 % used deep sedation with additional propofol. No sentinel, 5 (0.05 %) moderate risk, and 18 (0.17 %) minor risk adverse events occurred, all during moderate or deep sedation, and all managed by endoscopy staff without the need for anesthesiologist assistance.
Conclusions After completing the ESGE-ESGENA sedation training program, the rate of adverse events was very low in our institution. The findings support implementation of the program in all digestive endoscopy units and inclusion in the curriculum for physicians and nurses to ensure safe endoscopic procedures.
Numerous of studies have established the efficacy of parenteral methotrexate in the management of steroid-dependent and steroid-resistant Crohn's disease, either for inducing or maintaining remission. However, its efficacy in ulcerative colitis has not been properly investigated. Additionally, methotrexate has been shown to reduce the effect of immunization with anti-TNF agents when combined. The drug has potential advantages over thiopurines such as its weekly administration, a possible shorter time of action, low cost, decreased risk for malignancy and overall a comparable safety profile.
The introduction of biological agents has revolutionized the management of many life-threatening and debilitating immune-mediated diseases. Because of the high cost of biological drugs and their patent expiration, the market has opened to biosimilar agents, copy versions of the originators, which can lead to reduced health care expenditure and increase treatment access worldwide. CT-P13 is the first biosimilar of infliximab (IFX) and has been approved for the same indications as its originator drug. It obtained regulatory approval by the European Medicines Agency in September 2013 and by the US Food and Drug Administration in April 2016. The Phase I and Phase III clinical trials conducted in ankylosing spondylitis and rheumatoid arthritis have demonstrated pharmacokinetic and efficacy equivalence with comparable safety and immunogenicity to IFX. For these reasons, the use of CT-P13 has been extrapolated also to inflammatory bowel disease. There have been some initial concerns regarding the use of CT-P13 in inflammatory bowel disease patients, because of the lack of randomized controlled trials. However, emerging real-world data have further confirmed the comparability between CT-P13 and its reference product in terms of efficacy, safety, and immunogenicity, in patients naïve to the anti-tumor necrosis factor alpha agents and after switching from IFX, and will be summarized in this review.
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