To assess the risk of maternal, fetal, and neonatal outcomes associated with the administration of an MF59 adjuvanted A/H1N1 vaccine during pregnancy.Historical cohort study.Singleton pregnancies of the resident population of the Lombardy region of Italy.All deliveries between 1 October 2009 and 30 September 2010. Data on exposure to A/H1N1 pandemic vaccine, pregnancy, and birth outcomes were retrieved from regional databases. Vaccinated and non-vaccinated women were compared in a propensity score matched analysis to estimate risks of adverse outcomes.Main maternal outcomes included type of delivery, admission to intensive care unit, eclampsia, and gestational diabetes; fetal and neonatal outcomes included perinatal deaths, small for gestational age births, and congenital malformations.Among the 86,171 eligible pregnancies, 6246 women were vaccinated (3615 (57.9%) in the third trimester and 2557 (40.9%) in the second trimester). No difference was observed in terms of spontaneous deliveries (adjusted odds ratio 1.02, 95% confidence interval 0.96 to 1.08) or admissions to intensive care units (0.95, 0.47 to 1.88), whereas a limited increase in the prevalence of gestational diabetes (1.26, 1.04 to 1.53) and eclampsia (1.19, 1.04 to 1.39) was seen in vaccinated women. Rates of fetal and neonatal outcomes were similar in vaccinated and non-vaccinated women. A slight increase in congenital malformations, although not statistically significant, was present in the exposed cohort (1.14, 0.99 to 1.31).Our findings add relevant information about the safety of the MF59 adjuvanted A/H1N1 vaccine in pregnancy. Residual confounding may partly explain the increased risk of some maternal outcomes. Meta-analysis of published studies should be conducted to further clarify the risk of infrequent outcomes, such as specific congenital malformations.
One of the most frequent complications of endoscopic sphincterotomy (ES) is bleeding. When post-ES bleeding does not respond to the use of typical endoscopic therapy, the only alternative is angiography or surgery. A 82-year-old female was admitted for jaundice. A RMN-cholangiography revealed multiple stones in the common bile duct (CBD). She underwent endoscopic retrograde cholangiopancreatography (ERCP). The papilla major was located between two large periampullary diverticula. During the ES, a severe bleeding was observed from the upper part of the biliary cut. Several methods of hemostasis (injection of adrenaline, thermal methods and balloon tamponate) were performed without efficacy. A partially covered metallic stent was placed across the biliary orifice, in order to compress mechanically the bleeding site archiving the hemostasis.
The objective of this study was to describe the use of neuroleptics among children and adolescents in the province of Rome. Subjects 5 to 19 years of age who received neuroleptic prescriptions within the National Health Service between 1986 and 1991 were identified. Prevalence and incidence of use were estimated. The yearly prevalence of use during the study period ranged from 1.3 to 1.7 per 1000 inhabitants. The incidence during 1989 was 1.1 per 1000, with a marked increase with age. Haloperidol was the drug most frequently prescribed; 59.2% of the subjects received only one prescription during the year. Among subjects with more than one prescription, 42.3% received neuroleptics in combination. The observed pattern of use suggests that in current practice neuroleptics are also used for the treatment of nonpsychotic conditions. The analysis of data derived from a prescription monitoring system may provide an important contribution to the description of neuroleptic use among children and adolescents.
Since 1994, the hypothesis of a potential causal relationship between vaccination against hepatitis B and multiple sclerosis (and other demyelinating diseases) was brought to the attention of the French health authority, and to public debate. In Italy, since 1991, vaccination against hepatitis B has been mandatory for newborns and 12-year-old children, and also recommended for high-risk groups.To re-evaluate the risk/benefit profile of the Italian strategy of hepatitis B vaccination.The study population is a hypothetical cohort of 100,000 newborns.We present a simulation of the hepatitis B cases that could be prevented with the vaccination and of the potential excess of multiple sclerosis cases which would occur, assuming different odds ratios of multiple sclerosis among vaccinees, and by effecting the vaccination at different ages.In the cohort, we would expect 1,099 hepatitis B cases, that would be prevented with vaccination. Assuming that the highest odds ratio of 1.7 reported is true, the excess of "life-time" multiple sclerosis incidence would be 0.3% for 12-year-old subjects, and 2.9% for adults.On the basis of these data, our opinion is that the hepatitis B vaccination strategy presently adopted in Italy for newborns, teen-agers and high risk groups should not be modified.
The objective of this report is to describe the mortality rates in the first two years of life during the period 1990-
2001 in Italy. The analysis is based on death certificates which are centrally collected by the ISTAT (Istituto
Nazionale di Statistica, the Italian National Institute of Statistics), and on the national registries of newborns and of
the resident population. Infant mortality decreased by 41% during the study period: from 81 deaths per 10,000
newborns in 1990-1992, to 48 per 10,000 in 1999-2001. Around 75% of all deaths occurring during the first year of
life take place within the first month, and these deaths are mainly associated (71%) to perinatal conditions. A similar
decrease in infant mortality was observed in all Italian areas, although Southern regions persist on experiencing
higher rates (1.7 greater than North-Eastern regions). During the second year of life mortality has decreased by 33%,
reaching 3 deaths per 10,000 infants in 1999-2001. SIDS events represent around 6% of the post-neonatal mortality.
In 1999-2001 a rate of around 0.6 deaths per 10,000 newborns was observed. If all unexpected or ill defined deaths
are considered the corresponding rate increases to 1.9 deaths per 10,000 newborns.
