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zoom RSS 早産妊婦への抗生物質投与と脳性麻痺発症に関連性

<<   作成日時 : 2008/09/19 23:37   >>

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 早産妊婦への抗生物質投与と脳性麻痺発症に関連性があるとの報告。
画像 破水がなく抗生物質投与を受けた妊婦の子どもで769人中35人が脳性麻痺だったが、投与されていない場合は735人中12人で差が見られた。
 Oracle study は世界で最も大きな試験であり早産にたいして抗生物質が出生児の状況を改善するかどうかを調査している。
 英国では8人のうち1人が早産であり、乳児死亡の主要な死因となっている。2001年にORACLE は抗生剤エリスロマイシンが、破水した37週未満の早産妊婦に対して分娩を延期し、児の感染と呼吸障害のリスクを軽減するとした。しかし破水していない場合は何の利益も害も無いとしていた。
 7年後の子どもの調査で、抗生物質が機能的な損傷のリスクが増大し、破水しなかった妊婦の子どもの脳性麻痺のリスクを3倍にしたようだという。
 妊娠中や新生児の感染は脳性麻痺をおこす可能性があり、妊娠女性が感染治療に抗生物質を使うことに心配する必要はない。感染の証拠がないのにルーチンに抗生物質を与えることはしないということが重要である。
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Page last updated at 09:49 GMT, Thursday, 18 September 2008 10:49 UK
Antibiotic 'cerebral palsy link'
By Michelle Roberts
Health reporter, BBC News
http://news.bbc.co.uk/2/hi/health/7618221.stm

cerebral palsy
Antibiotics appeared to treble the risk of cerebral palsy

A study has linked a small number of cases of cerebral palsy to antibiotics given to women in premature labour.
The UK study found 35 cases of cerebral palsy in 769 children of women without early broken waters given antibiotics.
This compared with 12 cases among 735 children of women not given the drugs. Advice is being sent to the study's 4,148 mothers and a helpline set up.
Medical experts stressed pregnant women should not feel concerned about taking antibiotics to treat infections.

These findings do not mean that antibiotics are unsafe for use in pregnancy
The Royal College of Obstetricians and Gynaecologists
Q&A: Pregnancy antibiotics and cerebral palsy

The Oracle study was the largest trial in the world into premature labour and was set up to investigate whether giving antibiotics - which might tackle an underlying symptomless infection - to women with signs of premature labour would improve outcomes for babies.
One in eight babies in the UK is born prematurely and prematurity is the leading cause of disability and of infant death in the first month after birth.

Premature labour
In 2001, ORACLE found the antibiotic erythromycin had immediate benefits for women in premature labour (before 37 weeks gestation) whose waters had broken. It delayed onset of labour and reduced the risk of infections and breathing problems in babies.

Pregnant women should not feel concerned about taking antibiotics to treat infections
Chief Medical Officer Sir Liam Donaldson

Erythromycin and the other antibiotic studied - co-amoxiclav - showed no benefit or harm for the women whose waters were still intact, however, and doctors were advised not to routinely prescribe them in such circumstances.
To study the longer-term outcomes, the Medical Research Council-funded scientists followed up the children seven years later.
Unexpectedly, both antibiotics appeared to increase the risk of functional impairment - such as difficulty walking or problems with day to day problem solving - and treble the chance of cerebral palsy in the children of the women whose waters had not broken.

FROM THE TODAY PROGRAMME

More from Today programme
Of the 769 children born to mothers without early broken waters and given both antibiotics, 35 had cerebral palsy, compared with 12 out of 735 whose mothers did not receive antibiotics in the same circumstances.
The reasons behind this link are unclear, particularly as there was no increased risk of cerebral palsy in women whose waters had broken.
Hostile environment
The researchers believe cerebral palsy is unlikely to be a direct effect of the antibiotic but rather due to factors involved in prolonging a pregnancy that might otherwise have delivered early.
Researcher Professor Peter Brocklehurst of Oxford University said: "We have a suspicion that infection is implicated in premature labour.
"Antibiotics may merely suppress levels of infection to stop preterm labour, but the baby remains in a hostile environment."
The challenges a mother faces bringing up a child with cerebral palsy
Infections during pregnancy or infancy are known to cause cerebral palsy.
In a letter to doctors and midwives advising them about the findings, Chief Medical Officer Sir Liam Donaldson says: "Pregnant women should not feel concerned about taking antibiotics to treat infections.
"It is important to note that these women had no evidence of infection and would not routinely be given antibiotics."
Where there is obvious infection, antibiotics can be life-saving for both mother and baby, the CMO says.
The Royal College of Obstetricians and Gynaecologists said: "These findings do not mean that antibiotics are unsafe for use in pregnancy. Pregnant women showing signs of infection should be treated promptly with antibiotics."
Cerebral palsy can cause physical impairments and mobility problems.
It results from the failure of a part of the brain to develop before birth or in early childhood or brain damage and affects one in 400 births.
A helpline is available for study participants on 0800 085 2411 between 0930 and 1630 BST. NHS Direct has information available for other members of the public.
A spokeswoman from the special care baby charity Bliss said: "This highlights the importance of fully understanding both the immediate and long-term impact of the care and treatment that both mother and baby receive at this crucial time."

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The Lancet: ORACLE studies
http://www.thelancet.com/online/focus/oracle

New data to inform clinical practice around preterm labour
Pregnant woman
Long-term follow-up data on the effects of antibiotics in pregnant women experiencing premature labour and the developmental effects on their children were published by The Lancet on Sept 18, 2008.
The original ORACLE trial published in 2001 investigated the effect of two antibiotics given around preterm labour. The ORACLE follow-up findings have important implications for the clinical management of pregnant women experiencing preterm birth, and were presented at a press conference on Sept 16, 2008.

ORACLE I: 2008
Childhood outcomes after prescription of antibiotics to pregnant women with preterm rupture of the membranes: 7-year follow-up of the ORACLE I trial
S Kenyon, K Pike, DR Jones, P Brocklehurst, N Marlow, A Salt, DJ Taylor - (DOI: 10.1016/S0140-6736(08)61202-7)
Summary | Full Text
ORACLE II: 2008
Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial
S Kenyon, K Pike, DR Jones, P Brocklehurst, N Marlow, A Salt, DJ Taylor - (DOI: 10.1016/S0140-6736(08)61203-9)
Summary | Full Text
A Comment also published on Sept 18, 2008, assesses the two ORACLE papers:
Antibiotics in preterm labour―the ORACLE speaks
AR Bedford Russell, PJ Steer - (DOI: 10.1016/S0140-6736(08)61248-9)
Full Text

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The Lancet Early Online Publication, 18 September 2008
The Lancet DOI:10.1016/S0140-6736(08)61202-7

Articles
Childhood outcomes after prescription of antibiotics to pregnant women with preterm rupture of the membranes: 7-year follow-up of the ORACLE I trial

Background
The ORACLE I trial compared the use of erythromycin and/or amoxicillin--clavulanate (co-amoxiclav) with that of placebo for women with preterm rupture of the membranes without overt signs of clinical infection, by use of a factorial randomised design. The aim of the present study―the ORACLE Children Study I―was to determine the long-term effects on children of these interventions.

Methods

We assessed children at age 7 years born to the 4148 women who had completed the ORACLE I trial and who were eligible for follow-up with a structured parental questionnaire to assess the child's health status. Functional impairment was defined as the presence of any level of functional impairment (severe, moderate, or mild) derived from the mark III Multi-Attribute Health Status classification system. Educational outcomes were assessed with national curriculum test results for children resident in England.

Findings

Outcome was determined for 3298 (75%) eligible children. There was no difference in the proportion of children with any functional impairment after prescription of erythromycin, with or without co-amoxiclav, compared with those born to mothers who received no erythromycin (594 [38?3%] of 1551 children vs 655 [40?4%] of 1620; odds ratio 0?91, 95% CI 0?79--1?05) or after prescription of co-amoxiclav, with or without erythromycin, compared with those born to mothers who received no co-amoxiclav (645 [40?6%] of 1587 vs 604 [38?1%] of 1584; 1?11, 0?96--1?28). Neither antibiotic had a significant effect on the overall level of behavioural difficulties experienced, on specific medical conditions, or on the proportions of children achieving each level in reading, writing, or mathematics at key stage one.

Interpretation

The prescription of antibiotics for women with preterm rupture of the membranes seems to have little effect on the health of children at 7 years of age.

Funding

UK Medical Research Council.
Affiliations

a. Reproductive Sciences Section, Cancer Studies and Molecular Medicine, University of Leicester, Leicester, UK
b. Health Sciences Department, University of Leicester, Leicester, UK
c. National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK
d. Academic Division of Child Health, University of Nottingham, Nottingham, UK
e. Great Ormond Street Hospital for Children and Institute of Child Health, University College London, London, UK

Corresponding Author InformationCorrespondence to: Sara Kenyon, Reproductive Sciences Section, Cancer Studies and Molecular Medicine, University of Leicester, 22--28 Princess Road West, Leicester LE1 6TP, UK

-------------------------------------------------
The Lancet Early Online Publication, 18 September 2008
The Lancet DOI:10.1016/S0140-6736(08)61203-9

Articles
Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial

Background
The ORACLE II trial compared the use of erythromycin and/or amoxicillin--clavulanate (co-amoxiclav) with that of placebo for women in spontaneous preterm labour and intact membranes, without overt signs of clinical infection, by use of a factorial randomised design. The aim of the present study―the ORACLE Children Study II―was to determine the long-term effects on children after exposure to antibiotics in this clinical situation.

Methods

We assessed children at age 7 years born to the 4221 women who had completed the ORACLE II study and who were eligible for follow-up with a structured parental questionnaire to assess the child's health status. Functional impairment was defined as the presence of any level of functional impairment (severe, moderate, or mild) derived from the mark III Multi-Attribute Health Status classification system. Educational outcomes were assessed with national curriculum test results for children resident in England.

Findings

Outcome was determined for 3196 (71%) eligible children. Overall, a greater proportion of children whose mothers had been prescribed erythromycin, with or without co-amoxiclav, had any functional impairment than did those whose mothers had received no erythromycin (658 [42?3%] of 1554 children vs 574 [38?3%] of 1498; odds ratio 1?18, 95% CI 1?02--1?37). Co-amoxiclav (with or without erythromycin) had no effect on the proportion of children with any functional impairment, compared with receipt of no co-amoxiclav (624 [40?7%] of 1523 vs 608 [40?0%] of 1520; 1?03, 0?89--1?19). No effects were seen with either antibiotic on the number of deaths, other medical conditions, behavioural patterns, or educational attainment. However, more children whose mothers had received erythromycin or co-amoxiclav developed cerebral palsy than did those born to mothers who received no erythromycin or no co-amoxiclav, respectively (erythromycin: 53 [3?3%] of 1611 vs 27 [1?7%] of 1562, 1?93, 1?21--3?09; co-amoxiclav: 50 [3?2%] of 1587 vs 30 [1?9%] of 1586, 1?69, 1?07--2?67). The number needed to harm with erythromycin was 64 (95% CI 37--209) and with co-amoxiclav 79 (42--591).

Interpretation

The prescription of erythromycin for women in spontaneous preterm labour with intact membranes was associated with an increase in functional impairment among their children at 7 years of age. The risk of cerebral palsy was increased by either antibiotic, although the overall risk of this condition was low.

Funding

UK Medical Research Council.
Affiliations

a. Reproductive Sciences Section, Cancer Studies and Molecular Medicine, University of Leicester, Leicester, UK
b. Health Sciences Department, University of Leicester, Leicester, UK
c. National Perinatal Epidemiology Unit, University of Oxford, Oxford, UK
d. Academic Division of Child Health, University of Nottingham, Nottingham, UK
e. Great Ormond Street Hospital for Children and Institute of Child Health, University College London, London, UK

Corresponding Author InformationCorrespondence to: Sara Kenyon, Reproductive Sciences Section, Cancer Studies and Molecular Medicine, University of Leicester, 22--28 Princess Road West, Leicester LE1 6TP, UK

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