Το FDA εγκρίνει τη χρήση του συνεζευγμένου τετραδύναμου αντιμηνιγγιτιδοκοκκικού εμβολίου για βρέφη από 9 μηνών και άνω

The U.S. Food and Drug Administration today approved the use of Menactra in children as young as 9 months for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y and W-135. Menactra already is approved for use in people ages 2 through 55 years.

Meningococcal disease is a life-threatening illness caused by bacteria that infect the bloodstream (sepsis) and the lining that surrounds the brain and spinal cord (meningitis). Neisseria meningitidis is a leading cause of meningitis in young children. Even with appropriate antibiotics and intensive care, between 10 percent and 15 percent of people who develop meningococcal disease die from the infection. Another 10 percent to 20 percent suffer complications such as brain damage or loss of limb or hearing.

Although the rates of meningococcal disease are low in the United States, infants and toddlers are more susceptible to getting this serious illness. Meningococcal disease is particularly dangerous because it progresses rapidly and can cause death within hours. Early symptoms are often difficult to distinguish from influenza and other common illnesses.

“The highest rate of meningococcal disease occurs in children under one year of age. With today’s approval, Menactra can now be used in children as young as 9 months of age to help prevent this potentially life-threatening disease,” said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research.

The safety of Menactra in children as young as 9 months was evaluated in four clinical studies in which over 3,700 participants received the vaccine. The most common adverse events reported in children who received Menactra at 9 months and 12 months of age were injection-site tenderness and irritability. Occurrence of fever was comparable to other vaccines routinely recommended for young children.

Menactra is given as a two-dose series beginning at 9-months, three months apart; and the study results showed the vaccine produces antibodies in the blood that are protective against the disease.

Menactra was originally approved on Jan. 14, 2005, for use in individuals ages 11 years through 55 years and was approved in October 2007 for children as young as 2 years. Menactra is manufactured by Sanofi Pasteur Inc. of Swiftwater, Pa.

Χημειοπροφύλαξη για ουρολοίμωξη σε παιδιά

Long-term antibiotics for preventing recurrent urinary tract infection in children.

Cochrane Database Syst Rev. 2011 Mar 16;3:CD001534.

GJ Williams, A Lee, JC Craig

Abstract

Background

Urinary tract infection (UTI) is common in children. Symptoms include fever, lethargy, anorexia, and vomiting. UTI is caused by Escherichia coli in over 80% of cases and treatment is a course of antibiotics. Due to acute illness caused by UTI and the risk of pyelonephritis-induced permanent kidney damage, many children are given long-term antibiotics aimed at preventing recurrence.

Objectives

To determine the efficacy and harms of long-term antibiotics to prevent recurrent UTI in children.

Search strategy

In November 2010 we searched without language restriction MEDLINE, EMBASE, CENTRAL (in the Cochrane Library), the Cochrane Renal Group's Specialised Register, reference lists of review articles and contacted content experts.

Selection criteria

Randomised comparisons of antibiotics with other antibiotics, placebo or no treatment to prevent recurrent UTI.

Data collection and analysis

Two authors independently assessed and extracted information. A random-effects model was used to estimate risk ratio (RR) and risk difference (RD) for recurrent UTI with 95% confidence intervals (CI).

Main results

Twelve studies (1557 children) were identified with six (five analysed, 1069 children) comparing antibiotics with placebo/no treatment. Duration of antibiotic prophylaxis varied from 10 weeks to 12 months. Compared to placebo/no treatment, when all studies were included, antibiotics did not appear to reduce the risk of symptomatic UTI (RR 0.75, 95% CI 0.36 to 1.53) however when we evaluated the effects of antibiotics in studies with low risk of bias, there was a statistically significant reduction (RR 0.68, 95% CI 0.48 to 0.95).
The effect was similar in children with vesicoureteric reflux (VUR) (RR 0.65, 95% CI 0.39 to 1.07) compared to those without VUR (RR 0.56, 95% CI 0.15 to 2.12). There was no consistency in occurrence of adverse events.
Three studies reported antibiotic resistance, showing a non-significant increased risk for resistance to the antibiotic in the active treatment groups (RR 2.4, 95% CI 0.62 to 9.26).

Five studies (4 analysed, 367 children) compared one antibiotic with another but all compared different combinations or different outcomes and studies were not pooled. Two studies reported microbial resistance, nitrofurantoin having a significantly lower risk of resistance than cotrimoxazole (RR 0.54, 95% CI 0.31 to 0.92).

One study compared alternate with every day cefadroxil treatment.

Authors' conclusions

Long-term antibiotics appear to reduce the risk of repeat symptomatic UTI in susceptible children but the benefit is small and must be considered together with the increased risk of microbial resistance.

Αμυγδαλεκτομή στα παιδιά

The panel offered options to recommend tonsillectomy for
recurrent throat infection with a frequency of

• at least 7 episodes in the past year or
• at least 5 episodes per year for 2 years or
• at least 3 episodes per year for 3 years with documentation in the medical record for each episode of sore throat
  

and 1 or more of the following:

• temperature 38.3°C,
• cervical adenopathy,
• tonsillar exudate, or
• positive test for group A β-hemolytic streptococcus.

The panel made recommendations for

(1) watchful waiting for recurrent throat infection if there have been

• fewer than 7 episodes in the past year or
• fewer than 5 episodes per year in the past 2 years or
• fewer than 3 episodes per year in the past 3 years;

(2) assessing the child with recurrent throat infection who does not meet criteria in statement 2 for modifying factors that may nonetheless favor tonsillectomy, which may include but are not limited to

• multiple antibiotic allergy/intolerance,
• periodic fever, aphthous stomatitis, pharyngitis and adenitis, or
• history of peritonsillar abscess;

(3) asking caregivers of children with sleep-disordered breathing and tonsil hypertrophy about comorbid conditions that might improve after tonsillectomy, including

• growth retardation,
• poor school performance,
• enuresis, and
• behavioral problems;

(4) counseling caregivers about tonsillectomy as a means to improve health in children with abnormal polysomnography who also have tonsil hypertrophy and sleep-disordered breathing;

(5) counseling caregivers that sleep-disordered breathing may persist or recur after tonsillectomy and may require further management;

(6) advocating for pain management after tonsillectomy and educating caregivers about the importance of managing and reassessing pain; and

(7) clinicians who perform tonsillectomy should determine their rate of primary and secondary posttonsillectomy hemorrhage at least annually.



The online version of this article can be found at:

http://oto.sagepub.com/content/144/1_suppl/S1