RESUMEN
PURPOSE: To evaluate the evidence on the value of preparative fluid fasting for patients undergoing elective computed tomography (CT) with intravenous administration of contrast material and to survey leading institutions in a number of countries on their current policies in this regard. MATERIALS AND METHODS: This study qualified for exempt status by the institutional review board. First, 20 keyword combinations were entered into Medline to ascertain the correlation between fluid ingestion preceding contrast material-enhanced CT and development of aspiration pneumonia. The numbers of patients were summed up to estimate incidence of aspiration pneumonia attributable to ingestion of clear inert fluid before contrast-enhanced CT examination. Second, a multinational survey was conducted about the length of preparative fasting protocols, if any, for fluids and solids that they recommend to patients before elective non-gastrointestinal contrast-enhanced CT. RESULTS: Aspiration was not noted in any of 2001 patients (13 studies in the literature) who underwent contrast-enhanced CT after fluid ingestion. Data were available from 69 (86.3%) of 80 institutions queried (17 Korean, 14 U.S., 11 French, 10 Australian, 10 German, and seven Egyptian hospitals). Two-thirds (14 of 21 [66.7%]) of the French and German hospitals had a no-restriction policy for both fluids and solids, while Australian hospitals had a policy liberal about fluids (no restrictions in eight of 10 [80%]) only. Policies on fluids were variable in Korea, the United States, and Egypt (restrictions of 0-8 hours, 0-4 hours, and 0-6 hours, respectively), as were policies on solids in Korea, the United States, Australia, and Egypt (restrictions of 0-8 hours, 0-6 hours, 0 to 4-6 hours, and 0 hours to overnight, respectively). The length of fasting was longer for solids than for fluids in 20 hospitals. CONCLUSION: There is little evidence that ingestion of clear inert fluid prior to contrast-enhanced CT is a cause of aspiration pneumonia; the length of fasting is variable in any country, being much longer in some hospitals than in others.
Asunto(s)
Medios de Contraste/administración & dosificación , Ayuno , Neumonía por Aspiración/epidemiología , Neumonía por Aspiración/prevención & control , Tomografía Computarizada por Rayos X , Humanos , Incidencia , Política OrganizacionalRESUMEN
The human papillomavirus (HPV)-16/18 AS04-adjuvanted cervical cancer vaccine has been demonstrated to be highly efficacious and immunogenic with a favorable safety profile. This study assessed the immunogenicity and safety of the HPV-16/18 AS04-adjuvanted vaccine in healthy Korean girls aged 10-14 yr. This multi-center, observer-blind trial randomly assigned 321 healthy girls to receive three doses (0, 1, 6-month schedule) of HPV-16/18 AS04-adjuvanted vaccine or hepatitis A vaccine. Immunogenicity against vaccine antigens was assessed one month post-Dose 3. Solicited and unsolicited adverse events (AEs) and serious AEs (SAEs) were recorded. In the according-to-protocol analysis, all initially seronegative subjects vaccinated with the HPV-16/18 AS04-adjuvanted vaccine had seroconverted at Month 7, with a peak geometric mean titer (GMT) that was 600-fold higher than the natural infection titer of 29.8 EU/mL for HPV-16 and a peak GMT that was 400-fold higher than the natural infection titer of 22.6 EU/mL for HPV-18. The vaccine was well tolerated with no increase in reactogenicity with subsequent doses and no reports of vaccine-related SAEs. In conclusion, the HPV-16/18 AS04-adjuvanted vaccine is shown to be highly immunogenic and generally well-tolerated in Korean girls aged 10-14 yr.