RESUMEN
The Naloxegol Cancer Study (NACASY) was a multinational European study aimed to evaluate the 4-week safety and efficacy of naloxegol in a real-world setting in patients with cancer pain diagnosed with opioid-induced constipation. The primary safety endpoint was the incidence of adverse events leading to study discontinuation. We recruited 170 patients who received at least one dose of naloxegol (i.e., safety population). Out of 170 patients, 20 (11.8%, 95%CI 6.9-16.6) discontinued the study due to adverse events, and, of them, 12 (7.1%, 95%CI 3.2-10.9%) were study discontinuations due to naloxegol-related adverse events. From 76 patients subjects who had completed both 4 weeks of treatment and 28 days of the diary, 55 patients (72.4%, 95% CI 62.3-82.4%) were regarded as responders (i.e., showed ≥3 bowel-movements per week and an increase of ≥1 bowel-movement over baseline) to naloxegol treatment. The Patient Assessment of Constipation-Quality of Life Questionnaire total score and all its subscales improved from baseline to 4 weeks of follow up. Our findings support and provide new evidence about the beneficial effect of naloxegol in terms of improvement of constipation and quality-of-life in patients with cancer-related pain and opioid-induced constipation and show a safety profile consistent with previous pivotal and real-world studies.
Asunto(s)
Traumatismo Múltiple/enfermería , Niño , Maltrato a los Niños/diagnóstico , Preescolar , Escala de Coma de Glasgow , Hemorragia/diagnóstico , Hemorragia/enfermería , Hemorragia/terapia , Humanos , Lactante , Traumatismo Múltiple/diagnóstico , Traumatismo Múltiple/terapia , Diagnóstico de Enfermería , Resucitación/enfermeríaRESUMEN
BACKGROUND: The toxic effects of Datura stramonium most often include visual and auditory hallucinations, confusion and agitation. Severe and even fatal complications (coma, respiratory distress or death in more than 5% of cases) are not rare since the lethal concentration of the drug's toxic substances (i.e., atropine and scopolamine) is close to the level at which delirium occurs. CASES: A 17-year-old man was admitted to our emergency department with agitation, delirium with persecutory ideation and frightening hallucinations of being assaulted by animals. Blood samples taken 12 hours after Datura stramonium ingestion and analyzed with liquid chromatography and mass spectrometry (LC-MS/MS) found 1.7 ng/mL of atropine, close to the lethal level. After restraint and treatment with the antipsychotic drug cyamemazine, the young man returned to normal 36 hours after drug ingestion. A 17-year-old woman was admitted to our emergency department after losing consciousness on a public thoroughfare. At the emergency department, 2 hours after she had ingested Datura stramonium, she was agitated, with delirium, anxiety, and frightening visual and tactile hallucination of green turtles walking on her as well as auditory hallucinations. Blood samples at D0, D1 and D2 after Datura stramonium ingestion, analyzed with LC-MS/MS, found: 1.4, 1.0, and 0.2 ng/mL of scopolamine, respectively. Atropine was massively eliminated in urine on D1 (114 ng/mL). After restraint and cyamemazine treatment, the young woman returned to normal 40 hours after she had first ingested this hallucinogen. DISCUSSION: These cases of intoxication with Datura stramonium are, to our knowledge, the first clinical reports correlated with toxicologic analysis by the reference method (LC-MS/MS) in an emergency setting. Since neither the drug-users nor those accompanying them usually volunteer information about drug use, it is important to consider this specific risk in cases of agitation and confusion in adolescents or young adults.