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Microsurgery Nov 2016Reconstruction of the distal radius in children is cumbersome, requiring simultaneous restoration of joint function and axial growth. Vascularized proximal fibular... (Review)
Review
PURPOSE
Reconstruction of the distal radius in children is cumbersome, requiring simultaneous restoration of joint function and axial growth. Vascularized proximal fibular epiphyseal transfers (VFET) have been popularized over non-vascularized transfers and prosthesis. This systematic review aims to evaluate the effectiveness of VFET and its associated complications.
METHODS
Electronic database of PubMed MEDLINE was searched between 1970 and 2014. Studies reporting VFET for distal radius reconstruction in children (<15 years old) with clear reporting of technique (vascular pedicle) and objective outcome measures were included. Outcomes of interest were rate of graft growth, bone union and complications. A one-way Analysis of Variance (ANOVA) test was used to compare growth rates between pedicle types.
RESULTS
Fourteen studies met the inclusion criteria, representing 25 patients. Pedicles used were anterior tibial (44%), peroneal (16%), or bi-pedicled (40%) anastomosed in antegrade (64%) or reverse flow (36%) fashion. Among all pedicle types, best results were achieved using anterior tibial artery with reversed flow, yielding average growth rate of 0.83 cm/year (P = 0.01). Recipient complications included four premature epiphyseal plate closures, a flap loss, and six wrist radial deviations. Donor complications included six common peroneal nerve palsies (five temporary, a permanent), and a talocalcaneal instability. Overall complication rates between pedicle types were comparable (P = 0.062).
CONCLUSION
VFET may be a surgical option capable of restoring joint function and axial growth potential in select patients. The reverse flow technique based on the anterior tibial artery may result in superior outcomes. However, the overall complication rate is high and permanent peroneal nerve palsy may result.
LEVEL OF EVIDENCE
IV © 2015 Wiley Periodicals, Inc. Microsurgery 36:705-711, 2016.
Topics: Bone Transplantation; Child; Epiphyses; Fibula; Free Tissue Flaps; Humans; Postoperative Complications; Radius; Plastic Surgery Procedures
PubMed: 26497641
DOI: 10.1002/micr.22521 -
JBI Database of Systematic Reviews and... Sep 2015Craniosynostosis is a condition characterized by the premature closure of one or more of the cranial vault sutures. It can occur alone or in association with other... (Comparative Study)
Comparative Study Meta-Analysis Review
Morphological, functional and neurological outcomes of craniectomy versus cranial vault remodeling for isolated nonsyndromic synostosis of the sagittal suture: a systematic review.
BACKGROUND
Craniosynostosis is a condition characterized by the premature closure of one or more of the cranial vault sutures. It can occur alone or in association with other congenital defects and may be part of a syndrome. The sagittal suture is most commonly affected, comprising 40-60% of cases. Premature fusion of the sagittal suture can cause scaphocephaly due to compensatory anterior-posterior growth of the skull. This is morphologically considered as a narrow elongated skull with a decreased cephalic index, and is diagnosed clinically and/or radiologically. Both the indications for surgery and the techniques used have varied with time and location. Surgical techniques have evolved, from limited craniectomy to calvarial remodeling. In recent times a return to craniectomy methods has occurred with the more recent introduction of endoscopic methods.
OBJECTIVES
The objectives of this review were to identify and synthesize the best available evidence on the morphological, functional and neurological outcomes of craniectomy compared to cranial vault remodeling.
INCLUSION CRITERIA
This review considered studies of infants with primary isolated sagittal synostosis operated on or before the mean age of 24 months. The intervention of interest was local craniectomy and this was compared to cranial vault remodeling. Morphological (primary), functional and neurological (secondary) outcomes were included. Mortality, complications and aesthetic outcome were included as tertiary outcomes.
METHODS
A comprehensive search was undertaken across major databases. The retrieved studies were assessed by two independent reviewers for methodological validity prior to inclusion. Data was then extracted and, where possible, pooled in statistical meta-analysis. For descriptive studies, where statistical pooling was not possible, the findings are presented in narrative form.
RESULTS
Search and retrieval: Based on critical appraisal, 27 studies were considered to be suitable for this review. These studies were all descriptive in nature. Meta-analysis was only possible for the primary morphological outcome (post-operative cephalic index).Morphological (cephalic index):At one year follow-up, post-operatively remodeling offers an advantage over craniectomy (Z = 4.16, P<0.0001)Morphological:Improvements of the cephalic index to varying degrees were seen in patients receiving either procedure and there is not enough evidence to suggest that either treatment group had greater improvement over the other.Functional and neurological:Although their global scores may be comparable to an age-matched population, patients with sagittal synostosis who have undergone a surgical repair of any type may have discrepancies in specific domains and may be at risk of developing learning disorders. There is insufficient primary research with inter-procedure comparisons of preoperative and postoperative cognitive and neurological outcomes.Tertiary outcomes:There is not enough evidence to comment on mortality or postoperative infection in either treatment group. Patients undergoing cranial vault remodeling have a higher rate of transfusion compared to those undergoing craniectomy; however, it is likely that this difference relates to elective transfusion based on hospital-specific protocols. It remains unknown whether there is an inherently higher need for transfusion in patients undergoing remodeling procedures. Delaying surgery however may increase the risk of raised intracranial pressure (ICP) and its associated complications. Whilst there is no evidence for raised ICP post-craniectomy, a few studies have shown raised ICP in patients post-remodeling. There is not enough evidence to establish a relationship between both procedures and raised ICP. Aesthetic outcome appears to be "better" in patients who undergo remodeling; however, there is little rigorous evidence to support this hypothesis.
CONCLUSIONS
Conclusions were drawn from both the meta-analysis and the narrative results.When comparing the mean change in cephalic index one year after surgery, remodeling was shown to be superior to limited craniectomy in patients with isolated synostosis of the sagittal suture. However both procedures were seen to give improvements at short, medium and longer term time points. Improvements in cephalic index may be sustained, deteriorate or improve over time; based on the current data neither procedure offers a clear long-term advantage over the other. Longer follow-up is required to compare outcomes at different time points.Patients who have surgery (any type) for isolated sagittal synostosis may have deficiencies in different subdomains at later school-age testing, whilst maintaining an age-appropriate global intelligence quotient (IQ) and school performance. There is no evidence to suggest that surgery of either type imparts any benefit in terms of functional or neurological outcomes.There is no evidence to suggest that surgery of either type imparts any benefit in terms of functional or neurological outcomes. While school performance and general IQ may be comparable to age-matched controls, patients with sagittal synostosis who have undergone surgical repair of any type may be at risk of deficiencies in sub-areas of testing and be at risk of learning disorders.There is insufficient evidence regarding mortality, infection, postoperative ICP and aesthetic outcome. While transfusion rates were greater in the remodeling group, this may be due to higher rates of elective transfusion.The inconclusive findings indicate an ongoing need for higher quality primary research comparing the morphological and functional outcomes of craniectomy and cranial vault remodeling in primary sagittal synostosis. Outcomes should be measured in both the short and long term.
Topics: Child, Preschool; Cranial Sutures; Craniosynostoses; Craniotomy; Female; Humans; Infant; Male; Postoperative Complications; Postoperative Period; Plastic Surgery Procedures; Skull; Tomography, X-Ray Computed; Treatment Outcome
PubMed: 26470674
DOI: 10.11124/jbisrir-2015-2470 -
Archives of Disease in Childhood. Fetal... Mar 2016We performed a systematic review and meta-analysis of all the available evidence to assess the efficacy and safety of paracetamol for the treatment of patent ductus... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVES
We performed a systematic review and meta-analysis of all the available evidence to assess the efficacy and safety of paracetamol for the treatment of patent ductus arteriosus (PDA) in neonates, and to explore the effects of clinical variables on the risk of closure.
DATA SOURCE
MEDLINE, Scopus and ISI Web of Knowledge databases, using the following medical subject headings and terms: paracetamol, acetaminophen and patent ductus arteriosus. Electronic and manual screening of conference abstracts from international meetings of relevant organisations. Manual search of the reference lists of all eligible articles.
STUDY SELECTION
Studies comparing paracetamol versus ibuprofen, indomethacin, placebo or no intervention for the treatment of PDA.
DATA EXTRACTION
Data regarding efficacy and safety were collected and analysed.
RESULTS
Sixteen studies were included: 2 randomised controlled trials (RCTs) and 14 uncontrolled studies. Quality of selected studies is poor. A meta-analysis of RCTs does not demonstrate any difference in the risk of ductal closure (Mantel-Haenszel model, RR 1.07, 95% CI 0.87 to 1.33 and RR 1.03, 95% CI 0.92 to 1.16, after 3 and 6 days of treatment, respectively). Proportion meta-analysis of uncontrolled studies demonstrates a pooled ductal closure rate of 49% (95% CI 29% to 69%) and 76% (95% CI 61% to 88%) after 3 and 6 days of treatment with paracetamol, respectively. Safety profiles of paracetamol and ibuprofen are similar.
CONCLUSIONS
Efficacy and safety of paracetamol appear to be comparable with those of ibuprofen. These results should be interpreted with caution, taking into account the non-optimal quality of the studies analysed and the limited number of neonates treated with paracetamol so far.
Topics: Acetaminophen; Cyclooxygenase Inhibitors; Ductus Arteriosus, Patent; Humans; Ibuprofen; Infant, Newborn; Infant, Premature
PubMed: 26283668
DOI: 10.1136/archdischild-2014-307312 -
The Cochrane Database of Systematic... Mar 2015In preterm newborns, the ductus arteriosus frequently fails to close and the infants require medical or surgical closure of the patent ductus arteriosus (PDA). A PDA can... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In preterm newborns, the ductus arteriosus frequently fails to close and the infants require medical or surgical closure of the patent ductus arteriosus (PDA). A PDA can be treated surgically or medically with one of two prostaglandin inhibitors, indomethacin or ibuprofen. Case reports suggest that paracetamol may be an alternative for the closure of a PDA. Concerns have been raised that in neonatal mice paracetamol may cause adverse effects on the developing brain, and an association between prenatal exposure to paracetamol and later development of autism or autism spectrum disorder has been reported.
OBJECTIVES
To determine the efficacy and safety of intravenous or oral paracetamol compared with placebo or no intervention, intravenous indomethacin, intravenous or oral ibuprofen, or with other cyclo-oxygenase inhibitors for closure of a PDA in preterm or low-birth-weight infants.
SEARCH METHODS
We used the standard search strategy of the Cochrane Neonatal Review Group. This included electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL, Cochrane Library), MEDLINE, EMBASE and CINAHL. We searched abstracts from the meetings of the Pediatric Academic Societies and the Perinatal Society of Australia and New Zealand. We searched clinicaltrials.gov; controlled-trials.com; anzctr.org.au; World Health Organization International Clinical Trials Registry Platform at who.int/ictrp for ongoing trials and the Web of Science for articles quoting identified randomised controlled trials. We searched the first 200 hits on Google Scholar(TM) to identify grey literature. All searches were conducted in December 2013. A repeat search of MEDLINE in August 2014 did not identify any new trials.
SELECTION CRITERIA
We identified two randomised controlled trials (RCTs) that compared oral paracetamol to oral ibuprofen for the treatment of an echocardiographically diagnosed PDA in infants born preterm (≤ 34 weeks postmenstrual age (PMA)).
DATA COLLECTION AND ANALYSIS
We performed data collection and analyses in accordance with the methods of the Cochrane Neonatal Review Group.
MAIN RESULTS
Two unmasked studies of treatment of PDA that enrolled 250 infants were included. The sequence of randomisation and the allocation to treatment groups were concealed in both studies. In one study the cardiologist assessing PDA closure was blinded to group allocation of the infant. In the other study it was not stated if that was the case or not. The quality of the trials, using GRADE, was low for the primary outcome of PDA closure and moderate for all other important outcomes. There was no significant difference between treatment with oral paracetamol versus oral ibuprofen for failure of ductal closure after the first course of drug administration (typical relative risk (RR) 0.90, 95% confidence interval (CI) 0.67 to 1.22; typical risk difference (RD) -0.04, 95% CI -0.16 to 0.08; I(2) = 0 % for RR and 23% for RD).There were no significant differences between the paracetamol and the ibuprofen groups in the secondary outcomes except for 'duration for need of supplemental oxygen' (mean difference -12 days, 95% CI -23 days to -2 days; 1 study, n = 90) and for hyperbilirubinaemia (RR 0.57, 95% CI 0.34 to 0.97; RD -0.15, 95% CI -0.29 to -0.01; number needed to treat to benefit (NNTB) 7, 95% CI 3 to 100 in favour of paracetamol; 1 study, n = 160).
AUTHORS' CONCLUSIONS
Although a limited number of infants with a PDA have been studied in randomised trials of low to moderate quality according to GRADE, oral paracetamol appears to be as effective in closing a PDA as oral ibuprofen. In view of a recent report in mice of adverse effects on the developing brain from paracetamol, and another report of an association between prenatal paracetamol and the development of autism or autism spectrum disorder in childhood, long-term follow-up to at least 18 to 24 months postnatal age must be incorporated in any studies of paracetamol in the newborn population. Such trials are required before any recommendations for the use of paracetamol in the newborn population can be made.
Topics: Acetaminophen; Administration, Oral; Ductus Arteriosus, Patent; Humans; Ibuprofen; Indomethacin; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Oxygen Inhalation Therapy; Randomized Controlled Trials as Topic
PubMed: 25758061
DOI: 10.1002/14651858.CD010061.pub2 -
The Cochrane Database of Systematic... Feb 2015Indomethacin is used as standard therapy to close a patent ductus arteriosus (PDA) but is associated with reduced blood flow to several organs. Ibuprofen, another... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Indomethacin is used as standard therapy to close a patent ductus arteriosus (PDA) but is associated with reduced blood flow to several organs. Ibuprofen, another cyclo-oxygenase inhibitor, may be as effective as indomethacin with fewer adverse effects.
OBJECTIVES
To determine the effectiveness and safety of ibuprofen compared with indomethacin, other cyclo-oxygenase inhibitor, placebo or no intervention for closing a patent ductus arteriosus in preterm, low birth weight, or preterm and low birth weight infants.
SEARCH METHODS
We searched The Cochrane Library, MEDLINE, EMBASE, Clincialtrials.gov, Controlled-trials.com, and www.abstracts2view.com/pas in May 2014.
SELECTION CRITERIA
Randomised or quasi-randomised controlled trials of ibuprofen for the treatment of a PDA in newborn infants.
DATA COLLECTION AND ANALYSIS
Data collection and analysis conformed to the methods of the Cochrane Neonatal Review Group.
MAIN RESULTS
We included 33 studies enrolling 2190 infants.Two studies compared intravenous (iv) ibuprofen versus placebo (270 infants). In one study (134 infants) ibuprofen reduced the incidence of failure to close a PDA (risk ratio (RR) 0.71, 95% confidence interval (CI) 0.51 to 0.99; risk difference (RD) -0.18, 95% CI -0.35 to -0.01; number needed to treat for an additional beneficial outcome (NNTB) 6, 95% CI 3 to 100). In one study (136 infants), ibuprofen reduced the composite outcome of infant mortality, infants who dropped out, or infants who required rescue treatment (RR 0.58, 95% CI 0.38 to 0.89; RD -0.22, 95% CI -0.38 to -0.06; NNTB 5, 95% CI 3 to 17). One study (64 infants) compared oral ibuprofen with placebo and noted a significant reduction in failure to close a PDA (RR 0.26, 95% CI 0.11 to 0.62; RD -0.44, 95% CI -0.65 to -0.23; NNTB 2, 95% CI 2 to 4).Twenty-one studies (1102 infants) reported failure rates for PDA closure with ibuprofen (oral or iv) compared with indomethacin (oral or iv). There was no significant difference between the groups (typical RR 1.00, 95% CI 0.84 to 1.20; I(2) = 0%; typical RD 0.00, 95% CI -0.05 to 0.05; I(2) = 0%). The risk of developing necrotising enterocolitis (NEC) was reduced for ibuprofen (16 studies, 948 infants; typical RR 0.64, 95% CI 0.45 to 0.93; typical RD -0.05, 95% CI -0.08 to -0.01; NNTB 20, 95% CI 13 to 100; I(2) = 0% for both RR and RD). The duration of ventilatory support was reduced with ibuprofen (oral or iv) compared with iv or oral indomethacin (six studies, 471 infants; mean difference (MD) -2.4 days, 95% CI -3.7 to -1.0; I(2) = 19%).Eight studies (272 infants) reported on failure rates for PDA closure in a subgroup of the above studies comparing oral ibuprofen with indomethacin (oral or iv). There was no significant difference between the groups (typical RR 0.96, 95% CI 0.73 to 1.27; typical RD -0.01, 95% CI -0.12 to 0.09). The risk of NEC was reduced with oral ibuprofen compared with indomethacin (oral or iv) (seven studies, 249 infants; typical RR 0.41, 95% CI 0.23 to 0.73; typical RD -0.13, 95% CI -0.22 to -0.05; NNTB 8, 95% CI 5 to 20; I(2) = 0% for both RR and RD). There was a decreased risk of failure to close a PDA with oral ibuprofen compared with iv ibuprofen (four studies, 304 infants; typical RR 0.41, 95% CI 0.27 to 0.64; typical RD -0.21, 95% CI -0.31 to -0.12; NNTB 5, 95% CI 3 to 8). Transient renal insufficiency was less common in infants who received ibuprofen compared with indomethacin. High dose versus standard dose of iv ibuprofen, early versus expectant administration of iv ibuprofen, echocardiographically guided iv ibuprofen treatment vs. standard iv ibuprofen treatment and continuous infusion of ibuprofen vs. intermittent boluses of ibuprofen and long-term follow-up were studied in too few trials to draw any conclusions.
AUTHORS' CONCLUSIONS
Ibuprofen is as effective as indomethacin in closing a PDA and currently appears to be the drug of choice. Ibuprofen reduces the risk of NEC and transient renal insufficiency. Oro-gastric administration of ibuprofen appears as effective as iv administration. To make further recommendations, studies are needed to assess the effectiveness of high-dose versus standard-dose ibuprofen, early versus expectant administration of ibuprofen, echocardiographically guided versus standard iv ibuprofen, and continuous infusion versus intermittent boluses of ibuprofen. Studies are lacking evaluating the effect of ibuprofen on longer-term outcomes in infants with PDA.
Topics: Administration, Oral; Cyclooxygenase Inhibitors; Ductus Arteriosus, Patent; Enterocolitis, Necrotizing; Humans; Ibuprofen; Indomethacin; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Injections, Intravenous; Randomized Controlled Trials as Topic; Treatment Failure
PubMed: 25692606
DOI: 10.1002/14651858.CD003481.pub6 -
British Journal of Cancer Jul 2014Erythropoiesis-stimulating agents (ESAs) reduce the need for red blood cell transfusions; however, they increase the risk of thromboembolic events and mortality. The... (Meta-Analysis)
Meta-Analysis Review
Effects of erythropoiesis-stimulating agents on fatigue- and anaemia-related symptoms in cancer patients: systematic review and meta-analyses of published and unpublished data.
BACKGROUND
Erythropoiesis-stimulating agents (ESAs) reduce the need for red blood cell transfusions; however, they increase the risk of thromboembolic events and mortality. The impact of ESAs on quality of life (QoL) is controversial and led to different recommendations of medical societies and authorities in the USA and Europe. We aimed to critically evaluate and quantify the effects of ESAs on QoL in cancer patients.
METHODS
We included data from randomised controlled trials (RCTs) on the effects of ESAs on QoL in cancer patients. Randomised controlled trials were identified by searching electronic data bases and other sources up to January 2011. To reduce publication and outcome reporting biases, we included unreported results from clinical study reports. We conducted meta-analyses on fatigue- and anaemia-related symptoms measured with the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) and FACT-Anaemia (FACT-An) subscales (primary outcomes) or other validated instruments.
RESULTS
We identified 58 eligible RCTs. Clinical study reports were available for 27% (4 out of 15) of the investigator-initiated trials and 95% (41 out of 43) of the industry-initiated trials. We excluded 21 RTCs as we could not use their QoL data for meta-analyses, either because of incomplete reporting (17 RCTs) or because of premature closure of the trial (4 RCTs). We included 37 RCTs with 10581 patients; 21 RCTs were placebo controlled. Chemotherapy was given in 27 of the 37 RCTs. The median baseline haemoglobin (Hb) level was 10.1 g dl(-1); in 8 studies ESAs were stopped at Hb levels below 13 g dl(-1) and in 27 above 13 g dl(-1). For FACT-F, the mean difference (MD) was 2.41 (95% confidence interval (95% CI) 1.39-3.43; P<0.0001; 23 studies, n=6108) in all cancer patients and 2.81 (95% CI 1.73-3.90; P<0.0001; 19 RCTs, n=4697) in patients receiving chemotherapy, which was below the threshold (≥ 3) for a clinically important difference (CID). Erythropoiesis-stimulating agents had a positive effect on anaemia-related symptoms (MD 4.09; 95% CI 2.37-5.80; P=0.001; 14 studies, n=2765) in all cancer patients and 4.50 (95% CI 2.55-6.45; P<0.0001; 11 RCTs, n=2436) in patients receiving chemotherapy, which was above the threshold (≥ 4) for a CID. Of note, this effect persisted when we restricted the analysis to placebo-controlled RCTs in patients receiving chemotherapy. There was some evidence that the MDs for FACT-F were above the threshold for a CID in RCTs including cancer patients receiving chemotherapy with Hb levels below 12 g dl(-1) at baseline and in RCTs stopping ESAs at Hb levels above 13 g dl(-1). However, these findings for FACT-F were not confirmed when we restricted the analysis to placebo-controlled RCTs in patients receiving chemotherapy.
CONCLUSIONS
In cancer patients, particularly those receiving chemotherapy, we found that ESAs provide a small but clinically important improvement in anaemia-related symptoms (FACT-An). For fatigue-related symptoms (FACT-F), the overall effect did not reach the threshold for a CID.
Topics: Anemia; Erythropoiesis; Fatigue; Hematinics; Humans; Neoplasms; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 24743705
DOI: 10.1038/bjc.2014.171 -
The Cochrane Database of Systematic... Sep 2013In some people with asthma, expiratory airflow limitation, premature closure of small airways, activity of inspiratory muscles at the end of expiration and reduced... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In some people with asthma, expiratory airflow limitation, premature closure of small airways, activity of inspiratory muscles at the end of expiration and reduced pulmonary compliance may lead to lung hyperinflation. With the increase in lung volume, chest wall geometry is modified, shortening the inspiratory muscles and leaving them at a sub-optimal position in their length-tension relationship. Thus, the capacity of these muscles to generate tension is reduced. An increase in cross-sectional area of the inspiratory muscles caused by hypertrophy could offset the functional weakening induced by hyperinflation. Previous studies have shown that inspiratory muscle training promotes diaphragm hypertrophy in healthy people and patients with chronic heart failure, and increases the proportion of type I fibres and the size of type II fibres of the external intercostal muscles in patients with chronic obstructive pulmonary disease. However, its effects on clinical outcomes in patients with asthma are unclear.
OBJECTIVES
To evaluate the efficacy of inspiratory muscle training with either an external resistive device or threshold loading in people with asthma.
SEARCH METHODS
We searched the Cochrane Airways Group Specialised Register of trials, Cochrane Central Register of Controlled Trials (CENTRAL), ClinicalTrials.gov and reference lists of included studies. The latest search was performed in November 2012.
SELECTION CRITERIA
We included randomised controlled trials that involved the use of an external inspiratory muscle training device versus a control (sham or no inspiratory training device) in people with stable asthma.
DATA COLLECTION AND ANALYSIS
We used standard methodological procedures expected by The Cochrane Collaboration.
MAIN RESULTS
We included five studies involving 113 adults. Participants in four studies had mild to moderate asthma and the fifth study included participants independent of their asthma severity. There were substantial differences between the studies, including the training protocol, duration of training sessions (10 to 30 minutes) and duration of the intervention (3 to 25 weeks). Three clinical trials were produced by the same research group. Risk of bias in the included studies was difficult to ascertain accurately due to poor reporting of methods.The included studies showed a statistically significant increase in inspiratory muscle strength, measured by maximal inspiratory pressure (PImax) (mean difference (MD) 13.34 cmH2O, 95% CI 4.70 to 21.98, 4 studies, 84 participants, low quality evidence). Our other primary outcome, exacerbations requiring a course of oral or inhaled corticosteroids or emergency department visits, was not reported. For the secondary outcomes, results from one trial showed no statistically significant difference between the inspiratory muscle training group and the control group for maximal expiratory pressure, peak expiratory flow rate, forced expiratory volume in one second, forced vital capacity, sensation of dyspnoea and use of beta2-agonist. There were no studies describing inspiratory muscle endurance, hospital admissions or days off work or school.
AUTHORS' CONCLUSIONS
There is no conclusive evidence in this review to support or refute inspiratory muscle training for asthma. The evidence was limited by the small number of trials with few participants together with the risk of bias. More well conducted randomised controlled trials are needed. Future trials should investigate the following outcomes: lung function, exacerbation rate, asthma symptoms, hospital admissions, use of medications and days off work or school. Inspiratory muscle training should also be assessed in people with more severe asthma and conducted in children with asthma.
Topics: Adult; Asthma; Breathing Exercises; Humans; Muscle Strength; Randomized Controlled Trials as Topic; Respiratory Muscles; Respiratory Therapy
PubMed: 24014205
DOI: 10.1002/14651858.CD003792.pub2 -
The Cochrane Database of Systematic... Apr 2013Indomethacin is used as standard therapy to close a patent ductus arteriosus (PDA) but is associated with reduced blood flow to several organs. Ibuprofen, another... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Indomethacin is used as standard therapy to close a patent ductus arteriosus (PDA) but is associated with reduced blood flow to several organs. Ibuprofen, another cyclo-oxygenase inhibitor, may be as effective as indomethacin with fewer side effects.
OBJECTIVES
To determine the efficacy and safety of ibuprofen for closing a PDA in preterm and/or low birth weight infants. Seperate comparisons are presented for 1. ibuprofen (iv) compared with placebo; 2. ibuprofen (oral) compared with placebo; 3. ibuprofen (oral or iv) compared with other cyclo-oxygenase inhibitors (given iv or orally); 4. ibuprofen (oral) versus indomethacin (given iv or orally); 5. ibuprofen (oral) versus iv ibuprofen; 6. high dose versus standard dose of iv ibuprofen; 7. early versus expectant administration of iv ibuprofen.
SEARCH METHODS
We searched The Cochrane Library, MEDLINE, EMBASE, Clincialtrials.gov, Controlled-trials.com, www.abstracts2view.com/pas, and personal files in July 2012.
SELECTION CRITERIA
Randomised or quasi-randomised controlled trials of ibuprofen for the treatment of a PDA in newborn infants.
DATA COLLECTION AND ANALYSIS
Data collection and analysis conformed to the methods of the Cochrane Neonatal Review Group.
MAIN RESULTS
Twenty-seven studies are included in this review. One study (n = 136) compared iv ibuprofen versus placebo. Ibuprofen reduced the composite outcome of infant deaths, infants who dropped out or required rescue treatment; risk ratio (RR) 0.58 (95% confidence interval (CI) 0.38 to 0.89); risk difference (RD) -0.22 (95% CI -0.38 to -06); number needed to benefit (NNTB) 5 (95% CI 3 to 17). One study (n = 64) compared oral ibuprofen with placebo. There was a significant reduction in the failure rate to close a PDA; RR 0.26 (95% CI 0.11 to 0.62); RD -0.44 (95% CI -0.65 to -0.23); NNTB 2 (95% CI 2 to 4). Failure rates for PDA closure with ibuprofen (oral or iv) compared with indomethacin (oral or iv) was reported in 20 studies (n = 1019 infants). There was no significant difference between the groups; typical RR 0.98 (95% CI 0.80 to 1.20) I(2) = 0%; typical RD -0.01 (95% CI -0.06 to 0.05); I(2) = 0%. The risk of developing necrotising enterocolitis (NEC) was reduced for ibuprofen (15 studies (n = 865); typical RR 0.68 (95% CI 0.47 to 0.99); typical RD -0.04 (95% CI -0.08 to -0.00; (P = 0.04); NNTB 25 (95% CI 13, infinity); I(2) = 0%). The duration of ventilatory support was reduced with ibuprofen (oral or iv) compared with iv or oral indomethacin (six studies, n = 471) mean difference (MD) -2.35 days (95% CI -3.71 to -0.99); I(2) = 19%. Failure rates for PDA closure with oral ibuprofen compared with indomethacin (oral or iv) were reported in seven studies (n = 189 infants). There was no significant difference between the groups; typical RR 0.82 (95% CI 0.52 to 1.29); typical RD -0.06 (95% CI -0.18 to 0.06). The risk of NEC was reduced with oral ibuprofen compared with indomethacin (oral or iv) six studies (n = 166); typical RR 0.44 (95% CI 0.23 to 0.82); RD -0.15 (95% CI -0.25 to -0.04); NNTB 7 (95% CI 4 to 25). There was no heterogeneity for this outcome. There was a decreased risk of failure to close a PDA with oral ibuprofen compared with iv ibuprofen, three studies (n = 236) typical RR 0.37 (95% CI 0.23 to 0.61); typical RD -0.24 (95% CI -0.35 to -0.13); NNTB 4 (95% CI 3 to 8). There was less evidence of transient renal insufficiency in infants who received ibuprofen compared with indomethacin. High dose versus standard dose of iv ibuprofen and early versus expectant administration of iv ibuprofen have only been studied in two trials.
AUTHORS' CONCLUSIONS
Ibuprofen is as effective as indomethacin in closing a PDA and reduces the risk of NEC and transient renal insufficiency. Given the reduction in NEC ibuprofen currently appears to be the drug of choice. Oro-gastric administration of ibuprofen appears at least as effective as iv administration. Too few patients have been enrolled in studies assessing the effectiveness of a high dose of ibuprofen versus the standard dose and early versus expectant administration of ibuprofen to make recommendations. Studies are needed to evaluate the effect of ibuprofen compared with indomethacin treatment on longer-term outcomes in infants with PDA.
Topics: Cyclooxygenase Inhibitors; Ductus Arteriosus, Patent; Enterocolitis, Necrotizing; Humans; Ibuprofen; Indomethacin; Infant, Low Birth Weight; Infant, Newborn; Infant, Premature; Randomized Controlled Trials as Topic
PubMed: 23633310
DOI: 10.1002/14651858.CD003481.pub5 -
The Cochrane Database of Systematic... Mar 2013A patent ductus arteriosus (PDA) with significant left to right shunt increases morbidity and mortality in preterm infants. Early closure of the ductus arteriosus may be... (Review)
Review
BACKGROUND
A patent ductus arteriosus (PDA) with significant left to right shunt increases morbidity and mortality in preterm infants. Early closure of the ductus arteriosus may be achieved pharmacologically or by surgery. The preferred initial treatment of a symptomatic PDA, surgical ligation or treatment with indomethacin, is not clear.
OBJECTIVES
To compare the effect of surgical ligation of PDA versus medical treatment with cyclooxygenase inhibitors (indomethacin, ibuprofen or mefenamic acid), each used as the initial treatment, on neonatal mortality in preterm infants with a symptomatic PDA.
SEARCH METHODS
For this update we searched The Cochrane Library 2012, Issue 2, MEDLINE, EMBASE, CINAHL, Clinicaltrials.gov, Controlled-trials.com, Proceedings of the Annual Meetings of the Pediatric Academic Societies (2000 to 2011) (Abstracts2View(TM)) and Web of Science on 8 February 2012.
SELECTION CRITERIA
Randomised or quasi-randomised trials in preterm or low birth weight neonates with symptomatic PDA and comparing surgical ligation with medical treatment with cyclooxygenase inhibitors, each used as the initial treatment for closure of PDA.
DATA COLLECTION AND ANALYSIS
The authors independently assessed methodological quality and extracted data for the included trial. We used RevMan 5.1 for analyses of the data.
MAIN RESULTS
One study reporting on 154 neonates was found eligible. No significant difference between surgical closure and indomethacin treatment was found for in-hospital mortality, chronic lung disease, necrotising enterocolitis, sepsis, creatinine level or intraventricular haemorrhage. There was a significant increase in the surgical group in the incidence of pneumothorax (risk ratio (RR) 2.68; 95% confidence interval (CI) 1.45 to 4.93; risk difference (RD) 0.25; 95% CI 0.11 to 0.38; number needed to treat to harm (NNTH) 4 (95% CI 3 to 9)) and retinopathy of prematurity stage III and IV (RR 3.80; 95% CI 1.12 to 12.93; RD 0.11; 95% CI 0.02 to 0.20; NNTH 9 (95% CI 5 to 50)) compared to the indomethacin group. There was a statistically significant decrease in failure of ductal closure rate in the surgical group as compared to the indomethacin group (RR 0.04; 95% CI 0.01 to 0.27; RD -0.32; 95% CI -0.43 to -0.21, number needed to treat to benefit (NNTB) 3 (95% CI 2 to 4)). No new trials were identified for inclusion in the 2012 update.
AUTHORS' CONCLUSIONS
There are insufficient data to conclude whether surgical ligation or medical treatment with indomethacin is preferred as the initial treatment for symptomatic PDA in preterm infants.
Topics: Cyclooxygenase Inhibitors; Ductus Arteriosus, Patent; Humans; Indomethacin; Infant, Newborn; Infant, Premature; Infant, Very Low Birth Weight; Ligation; Pneumothorax; Postoperative Complications; Randomized Controlled Trials as Topic
PubMed: 23543527
DOI: 10.1002/14651858.CD003951.pub3 -
The Bone & Joint Journal Jan 2013Fractures of the femoral neck in children are rare, high-energy injuries with high complication rates. Their treatment has become more interventional but evidence of the... (Review)
Review
Fractures of the femoral neck in children are rare, high-energy injuries with high complication rates. Their treatment has become more interventional but evidence of the efficacy of such measures is limited. We performed a systematic review of studies examining different types of treatment and their outcomes, including avascular necrosis (AVN), nonunion, coxa vara, premature physeal closure (PPC), and Ratliff's clinical criteria. A total of 30 studies were included, comprising 935 patients. Operative treatment and open reduction were associated with higher rates of AVN. Delbet types I and II fractures were most likely to undergo open reduction and internal fixation. Coxa vara was reduced in the operative group, whereas nonunion and PPC were not related to surgical intervention. Nonunion and coxa vara were unaffected by the method of reduction. Capsular decompression had no effect on AVN. Although surgery allows a more anatomical union, it is uncertain whether operative treatment or the type of reduction affects the rate of AVN, nonunion or PPC, because more severe fractures were operated upon more frequently. A delay in treatment beyond 24 hours was associated with a higher incidence of AVN.
Topics: Adolescent; Child; Femoral Neck Fractures; Fracture Fixation; Fracture Healing; Fractures, Ununited; Humans; Osteonecrosis; Postoperative Complications; Risk Factors; Treatment Outcome
PubMed: 23307688
DOI: 10.1302/0301-620X.95B1.30161