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Vertebroplasty and kyphoplasty for cervical spine metastases: a systematic review and meta-analysis.International Journal of Spine Surgery 2016Vertebroplasty (VP) and kyphoplasty (KP) are two minimally invasive techniques used to relieve pain and restore stability in metastatic spinal disease. However, most of...
BACKGROUND
Vertebroplasty (VP) and kyphoplasty (KP) are two minimally invasive techniques used to relieve pain and restore stability in metastatic spinal disease. However, most of these procedures are performed in the thoracolumbar spine, and there is limited data on outcomes after VP/KP for cervical metastases. The purpose of this article is to evaluate the safety and efficacy of VP and KP for treating pain in patients with cervical spine metastases.
METHODS
A systematic review of the literature was conducted using the PubMed and Medline databases. Only studies that reported five or more patients treated with VP/KP in the cervical spine were included. Levels of evidence and grades of recommendation were established based on the Oxford Centre for Evidence-Based Medicine guidelines. Data was pooled to perform a meta-analysis for pain relief and complication rates.
RESULTS
Six studies (all level 4 studies) met the inclusion criteria, representing 120 patients undergoing VP/KP at 135 vertebrae; the most common addressed level was C2 in 83 cases. The average volume of injected cement was 2.5 ± 0.5 milliliters at each vertebra. There were 22 asymptomatic cement leaks (16%; 95% CI, 9.8% - 22.2%) most commonly occurring in the paraspinal soft tissue. There were 5 complications (4%; 95% CI, 0.5% - 7.5%): 3 cases of mild odynophagia, 1 case of occipital neuralgia secondary to leak, and 1 case of stroke secondary to cement embolism. Pain relief was achieved in 89% of cases (range: 80 - 100%). The calculated average pain score decreased significantly from 7.6 ± 0.9 before surgery to 1.9 ± 0.8 at last evaluation (p=0.006).
CONCLUSION
Although the calculated complication rate after VP/KP in the cervical spine is low (4%) and the reported pain relief rate is approximately 89%, there is lack of high-quality evidence supporting this. Future randomized controlled trials are needed.
PubMed: 26913227
DOI: 10.14444/3007 -
Injury Dec 2015Long bone infection remains a challenging situation for the orthopaedic surgeon. For most, treatment comprises a thorough debridement of all the infected bone, the... (Review)
Review
BACKGROUND
Long bone infection remains a challenging situation for the orthopaedic surgeon. For most, treatment comprises a thorough debridement of all the infected bone, the filling of the resultant cavity with a bone substitute, and general antibiotics for a certain time. However, the type of bone substitute to insert in the cavity is still debated.
PURPOSE
In this study, we aimed to systematically review the results of studies using bioactive glass for long bone infection in the clinical setting.
MATERIAL AND METHOD
We searched systematically Medline via Pubmed for studies published until August 2015 that report the results of bioactive glass for long bone infection in humans.
RESULTS
Three studies, including a total of 41 patients, met the inclusion criteria. Mean age was 46.5 (16-84). Twenty-nine were male and twelve were female. Period of inclusion went from 2007 to 2013. All the patients had a clinically and radiologically diagnosed osteomyelitis. They all underwent a state of the art surgical procedure to address osteomyelitis. All the patients were implanted with BAG-S53P4 granules (BonAlive Biomaterials Ltd, Turku, Finland) to fill in the resultant cavity. Mean volume inserted was 16.8 milliliters (2-60). After a mean follow-up of 21 months (10-38), three cases of osteomyelitis recurred. In two cases, a new procedure was performed. No complication directly related to the bioactive glass was reported.
DISCUSSION
Despite a limited use for long bone infection in humans, bioactive glass seems to be an interesting option as bone substitute after thorough bone debridement and skin coverage. It associates antibacterial activities, osteoconductive properties and vascular stimulation.
CONCLUSION
From this review, bioactive glass seems to be a useful bone substitute for long bone infection in humans. Few recurrences occurred after its use. In these cases, the volume of bone glass to insert was frequently underestimated and/or the skin coverage not adequate.
Topics: Anti-Bacterial Agents; Bone Substitutes; Combined Modality Therapy; Debridement; Female; Glass; Humans; Osteomyelitis; Wound Healing
PubMed: 26747915
DOI: 10.1016/S0020-1383(15)30048-6 -
The Cochrane Database of Systematic... Oct 2015Several agents are used to clear secretions from the airways of people with cystic fibrosis. Inhaled dry powder mannitol is now available in Australia and some countries... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Several agents are used to clear secretions from the airways of people with cystic fibrosis. Inhaled dry powder mannitol is now available in Australia and some countries in Europe. The exact mechanism of action of mannitol is unknown, but it increases mucociliary clearance. Phase III trials of inhaled dry powder mannitol for the treatment of cystic fibrosis have been completed. The dry powder formulation of mannitol may be more convenient and easier to use compared with established agents which require delivery via a nebuliser.
OBJECTIVES
To assess whether inhaled dry powder mannitol is well tolerated, whether it improves the quality of life and respiratory function in people with cystic fibrosis and which adverse events are associated with the treatment.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group Trials Register which comprises references identified from comprehensive electronic databases, handsearching relevant journals and abstracts from conferences.Date of last search: 16 April 2015.
SELECTION CRITERIA
All randomised controlled studies comparing mannitol with placebo, active inhaled comparators (for example, hypertonic saline or dornase alfa) or with no treatment.
DATA COLLECTION AND ANALYSIS
Authors independently assessed studies for inclusion, carried out data extraction and assessed the risk of bias in included studies.
MAIN RESULTS
The searches identified nine separate studies (45 publications), of which four studies (36 publications) were included with a total of 667 participants, one study (only available as an abstract) is awaiting assessment and two studies are ongoing. Duration of treatment in the included studies ranged from two weeks to six months with open-label treatment for an additional six months in two of the studies. Three studies compared mannitol with control (a very low dose of mannitol or non-respirable mannitol); two of these were parallel studies with a similar design and data could be pooled, where data for a particular outcome and time point were available; also, one short-term cross-over study supplied additional results. The fourth study compared mannitol to dornase alfa alone and to mannitol plus dornase alfa. There was generally a low risk of bias in relation to randomisation and blinding; evidence from the parallel studies was judged to be of low to moderate quality and from the cross-over studies was judged to be of low to very low quality. While the published papers did not provide all the data required for our analysis, additional unpublished data were provided by the drug's manufacturer and the author of one of the studies. There was an initial test to see if participants tolerated mannitol, with only those who could tolerate the drug being randomised to the studies; therefore the study results are not applicable to the cystic fibrosis population as a whole.For the comparison of mannitol and control, we found no consistent differences in health-related quality of life in any of the domains, except for burden of treatment, which was less for mannitol up to four months in the two pooled studies of a similar design; this difference was not maintained at six months. Up to and including six months, lung function in terms of forced expiratory volume at one second (millilitres) and per cent predicted were significantly improved in all three studies comparing mannitol to control. Beneficial results were observed in these studies in adults and in both concomitant dornase alfa users and non users. A significant reduction was shown in the incidence of pulmonary exacerbations in favour of mannitol at six months; however, the estimate of this effect was imprecise so it is unclear whether the effect is clinically meaningful. Cough, haemoptysis, bronchospasm, pharyngolaryngeal pain and post-tussive vomiting were the most commonly reported side effects on both treatments. Mannitol was not associated with any increase in isolation of bacteria over a six-month period.In the 12-week cross-over study (28 participants), no significant differences were found in the recorded domains of health-related quality of life or measures of lung function between mannitol versus dornase alfa alone and versus mannitol plus dornase alfa. There seemed to be a higher rate of pulmonary exacerbations in the mannitol plus dornase alfa arm compared with dornase alfa alone; although not statistically significant, this was the most common reason for stopping treatment in this arm. Cough was the most common side effect in the mannitol alone arm but there was no occurrence of cough in the dornase alfa alone arm and the most commonly reported reason of withdrawal from the mannitol plus dornase alfa arm was pulmonary exacerbations. Mannitol (with or without dornase alfa) was not associated with any increase in isolation of bacteria over the 12-week period.
AUTHORS' CONCLUSIONS
There is evidence to show that treatment with mannitol over a six-month period is associated with an improvement in some measures of lung function in people with cystic fibrosis compared to control. There is no evidence that quality of life is improved for participants taking mannitol compared to control; a decrease in burden of treatment was observed up to four months on mannitol compared to control but this difference was not maintained to six months. Randomised information regarding the burden of adding mannitol to an existing treatment is limited. There is no randomised evidence of improvement in lung function or quality of life comparing mannitol to dornase alfa alone and to mannitol plus dornase alfa.Mannitol as a single or concomitant treatment to dornase alfa may be of benefit to people with cystic fibrosis, but further research is required in order to establish who may benefit most and whether this benefit is sustained in the longer term.The clinical implications from this review suggest that mannitol could be considered as a treatment in cystic fibrosis; however, studies comparing its efficacy against other (established) mucolytic therapies need to be undertaken before it can be considered for mainstream practice.
Topics: Administration, Inhalation; Adult; Cystic Fibrosis; Deoxyribonuclease I; Humans; Mannitol; Mucociliary Clearance; Powders; Randomized Controlled Trials as Topic; Recombinant Proteins
PubMed: 26451533
DOI: 10.1002/14651858.CD008649.pub2 -
Transfusion Medicine Reviews Oct 2015Despite multimodal approaches to treatment, postpartum hemorrhage (PPH) is a life-threatening condition whose incidence continues to rise. In developing areas, such as... (Meta-Analysis)
Meta-Analysis Review
Despite multimodal approaches to treatment, postpartum hemorrhage (PPH) is a life-threatening condition whose incidence continues to rise. In developing areas, such as sub-Saharan Africa, PPH is the leading cause of maternal mortality. Tranexamic acid (TXA) is a possible prophylactic treatment for the prevention of PPH. We performed a systematic review and meta-analysis of randomized trials comparing prophylactic TXA vs placebo or no treatment in term parturients to quantify the effects of prophylactic TXA administration on peripartum bleeding outcomes. The meta-analysis was performed using a random-effects model. The outcomes assessed were (i) incidence of PPH, (ii) mean blood loss (in milliliters) within 24hours, (iii) incidence of red blood cell transfusion within 24hours, (iv) use of additional uterotonics, (v) minor side effects (ie, nausea, vomiting, headache, etc), (vi) major venous thromboembolism, (vii) length of hospital stay, and (viii) mortality. Eighteen trials (3846 subjects) were included in the quantitative analysis, with 1935 patients receiving TXA. The studies were of poor to moderate quality. Prophylactic TXA administration was associated with a decreased incidence of PPH after delivery (odds ratio [OR], 0.32; 95% confidence interval [CI], 0.17-0.59; P = .0006), a reduction in mean blood loss by 149.1mL (95% CI, 112.9-185.2; P < .00001), and a reduction in red blood cell transfusions (OR, 0.28; 95% CI, 0.15-0.49; P < .00001) while also being associated with a reduction in the use of additional uterotonics (OR, 0.45; 95% CI, 0.30-0.66; P < .00001). Minor side effects were more common in those who received TXA (OR, 2.51; 95% CI, 1.69-3.74; P < .00001). There appeared to be no increased risk of venous thromboembolism and no difference in length of hospital stay associated with TXA use. Although prophylactic TXA administration may be associated with improved peripartum bleeding, existing evidence is insufficient for any definitive recommendations secondary to the poor to moderate quality of the literature. A large well-designed, methodologically sound, randomized controlled trial is needed to better delineate the true effect size and address potential safety concerns.
Topics: Adult; Antifibrinolytic Agents; Chemoprevention; Female; Humans; Postpartum Hemorrhage; Pregnancy; Randomized Controlled Trials as Topic; Tranexamic Acid; Treatment Outcome
PubMed: 26282735
DOI: 10.1016/j.tmrv.2015.07.002 -
PloS One 2015Neck dissection is the most definitive and effective treatment for head and neck cancer. This systematic review aims to compare the efficacy and surgical outcomes of... (Comparative Study)
Comparative Study Meta-Analysis
OBJECTIVE
Neck dissection is the most definitive and effective treatment for head and neck cancer. This systematic review aims to compare the efficacy and surgical outcomes of neck dissection between the harmonic scalpel and conventional surgical techniques and conduct a quantitative meta-analysis of the randomized trials.
METHODS
Randomized controlled trials (RCTs) were identified from the major electronic databases (MEDLINE, EMBASE and Cochrane Library) using the keywords ''harmonic scalpel'' and ''neck dissection,'' and a quantitative meta-analysis was conducted. The operative time and intraoperative bleeding were the primary outcome measures, and other parameters assessed included the drainage fluid volume and length of hospital stay.
RESULTS
Seven trials that met the inclusion criteria included 406 neck dissection cases (201 in the harmonic scalpel group). Compared with conventional surgical techniques, the HS group had an operative time that was significantly reduced by 29.3 minutes [mean difference: -29.29; 95% CI = (-44.26, -14.32); P=0.0001], a reduction in intraoperative bleeding by 141.1 milliliters [mean difference: -141.13; 95% CI = (-314.99, 32.73); P=0.11], and a reduction in drainage fluid volume by 64.9 milliliters [mean difference: -64.86; 95% CI = (-110.40, -19.32); P=0.005] , but it is not significant after removal of studies driving heterogeneity. There was no significant difference in the length of the hospital stay [mean difference: -0.21; 95% CI = (-0.48, 0.07); P=0.14].
CONCLUSION
This systematic review showed that using the harmonic scalpel for neck dissection significantly reduces the operative time and drainage fluid volume and that it is not associated with an increased length of hospital stay or perioperative complications. Therefore, the harmonic scalpel method is safe and effective for neck dissection. However, the statistical heterogeneity was high. Further studies are required to substantiate our findings.
Topics: Blood Loss, Surgical; Drainage; Hemostasis, Surgical; Humans; Length of Stay; Neck Dissection; Operative Time; Publication Bias; Randomized Controlled Trials as Topic; Surgical Instruments
PubMed: 26161897
DOI: 10.1371/journal.pone.0132476 -
The Cochrane Database of Systematic... Apr 2015Hemophilia A and B are inherited coagulation disorders characterized by a reduced or absent level of factor VIII or factor IX respectively. The severe form is... (Review)
Review
BACKGROUND
Hemophilia A and B are inherited coagulation disorders characterized by a reduced or absent level of factor VIII or factor IX respectively. The severe form is characterized by a factor level less than 0.01 international units (IU) per milliliter. The development of inhibitors in hemophilia is the main complication of treatment, because the presence of these antibodies, reduces or even nullifies the efficacy of replacement therapy, making it very difficult to control the bleeding. People with inhibitors continue to have significantly higher risks of morbidity and mortality, with considerable treatment costs. Given the wide 'off-label' use of rituximab for treating people with hemophilia and inhibitors, its efficacy and safety need to be evaluated.
OBJECTIVES
To assess the efficacy and safety of rituximab for treating inhibitors in people with inherited severe hemophilia A or B.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Coagulopathies Trials Register, complied from electronic database searches and handsearching of journals and conference abstract books. We searched the reference lists of relevant articles and reviews and also searched for ongoing or unpublished studies.Date of last search: 27 January 2015.
SELECTION CRITERIA
Randomized controlled trials and controlled clinical trials investigating the efficacy and safety of rituximab for treating inhibitors in people with hemophilia.
DATA COLLECTION AND ANALYSIS
No randomized controlled trials matching the selection criteria were eligible for inclusion.
MAIN RESULTS
No randomized controlled trials on rituximab for treating inhibitors in people with hemophilia were identified.
AUTHORS' CONCLUSIONS
We were unable to identify any relevant trials on the efficacy and safety of rituximab for treating inhibitors in people with hemophilia. The research evidence available is from case reports and case series. Randomized controlled trials are needed to evaluate the efficacy and safety of rituximab for this condition. However, prior to the publication of any possible future randomized controlled trials, meta-analysis of case reports and case series may provide some evidence.
Topics: Antibodies, Monoclonal, Murine-Derived; Factor IX; Factor VIII; Hemophilia A; Hemophilia B; Humans; Immunologic Factors; Rituximab
PubMed: 25841099
DOI: 10.1002/14651858.CD010810.pub2 -
The Cochrane Database of Systematic... Nov 2014Slow-release fluoride devices have been investigated as a potentially cost-effective method of reducing dental caries in people with high risk of disease. (Review)
Review
BACKGROUND
Slow-release fluoride devices have been investigated as a potentially cost-effective method of reducing dental caries in people with high risk of disease.
OBJECTIVES
To evaluate the effectiveness and safety of different types of slow-release fluoride devices on preventing, arresting, or reversing the progression of carious lesions on all surface types of primary (deciduous) and permanent teeth.
SEARCH METHODS
We searched the following electronic databases: the Cochrane Oral Health Group Trials Register (to 13 August 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (2014, Issue 7), MEDLINE via Ovid (1946 to 13 August 2014), and EMBASE via Ovid (1980 to 13 August 2014). We searched the US National Institutes of Health Trials Register and the World Health Organization (WHO) International Clinical Trials Registry Platform. We placed no restrictions on the language or date of publication when searching the electronic databases.We first published the review in 2006. The update in 2013 found 302 abstracts, but none of these met the inclusion criteria of the review.
SELECTION CRITERIA
Parallel randomised controlled trials (RCTs) comparing slow-release fluoride devices with an alternative fluoride treatment, placebo, or no intervention in all age groups. The main outcomes measures sought were changes in numbers of decayed, missing, and filled teeth or surfaces (DMFT/DMFS in permanent teeth or dmft/dmfs in primary teeth), and progression of carious lesions through enamel and into dentine.
DATA COLLECTION AND ANALYSIS
We conducted data collection and analysis using standard Cochrane review methods. At least two review authors independently performed all the key steps in the review such as screening of abstracts, application of inclusion criteria, data extraction, and risk of bias assessment. We resolved discrepancies through discussions or arbitration by a third or fourth review author.
MAIN RESULTS
We found no evidence comparing slow-release fluoride devices against other types of fluoride therapy.We found only one double-blind RCT involving 174 children comparing a slow-release fluoride device (glass beads with fluoride were attached to buccal surfaces of right maxillary first permanent molar teeth) against control (glass beads without fluoride were attached to buccal surfaces of right maxillary first permanent molar teeth). This study was assessed to be at high risk of bias. The study recruited children from seven schools in an area of deprivation that had low levels of fluoride in the water. The mean age at the beginning of the study was 8.8 years and at the termination was 10.9 years. DMFT in permanent teeth or dmft in primary teeth was greater than one at the start of the study and greater than one million colony-forming units of Streptococcus mutans per millilitre of saliva.Although 132 children were still included in the trial at the two-year completion point, examination and statistical analysis was performed on only the 63 children (31 in intervention group, 32 in control group) who had retained the beads (retention rate was 47.7% at two years). Among these 63 children, caries increment was reported to be statistically significantly lower in the intervention group than in the control group (DMFT: mean difference -0.72, 95% confidence interval (CI) -1.23 to -0.21; DMFS: mean difference -1.52, 95% CI -2.68 to -0.36 (very low quality evidence)). Although this difference was clinically significant, it only holds true for those children who maintain the fluoride beads; over 50% of children did not retain the beads.Harms were not reported within the trial report. Evidence for other outcomes sought in this review (progression to of caries lesion, dental pain, healthcare utilisation data) were also not reported.
AUTHORS' CONCLUSIONS
There is insufficeint evidence to determine the caries-inhibiting effect of slow-release fluoride glass beads. The body of evidence available is of very low quality and there is a potential overestimation of benefit to the average child. The applicability of the findings to the wider population is unclear; the study had included children from a deprived area that had low levels of fluoride in drinking water, and were considered at high risk of carries. In addition, the evidence was only obtained from children who still had the bead attached at two years (48% of all available children); children who had lost their slow-release fluoride devices earlier might not have benefited as much from the devices.
Topics: Cariostatic Agents; Child; DMF Index; Delayed-Action Preparations; Dental Caries; Fluorides; Glass; Humans; Randomized Controlled Trials as Topic
PubMed: 25432017
DOI: 10.1002/14651858.CD005101.pub3 -
The Cochrane Database of Systematic... Jun 2013Functional endoscopic sinus surgery (FESS) is a minimally invasive technique that is used to treat chronic sinusitis. Small bleeding areas can reduce operative... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Functional endoscopic sinus surgery (FESS) is a minimally invasive technique that is used to treat chronic sinusitis. Small bleeding areas can reduce operative visibility and result in destruction of surrounding structures. Deliberate hypotension (lowering the mean arterial blood pressure to between 50 and 65 mm Hg in normotensive patients) using a range of pharmacological agents during general anaesthesia reduces blood loss in many operations.
OBJECTIVES
We aimed to compare the use of the intravenous anaesthetic agent propofol versus other techniques for deliberate hypotension during FESS with regard to blood loss and operative conditions.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2012, Issue 1), MEDLINE (1950 to April 2012), EMBASE (1980 to April 2012), LILACS (1982 to April 2012) and ISI Web of Science (1946 to April 2012). We also searched the reference lists of relevant articles and conference proceedings and contacted the authors of included trials.
SELECTION CRITERIA
We sought all randomized controlled trials (RCTs) conducted to compare propofol with other techniques. Our primary outcome was total blood loss (TBL). Other outcomes included surgical field quality, operation time, mortality within 24 hour, complications and failure to reach target blood pressure.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted details of trial methodology and outcome data from reports of all trials considered eligible for inclusion. All analyses were made on an intention-to-treat basis where possible. When I(2) was < 40% and the P value from the Chi(2) test was > 0.10, we pooled data by using the fixed-effect model. Otherwise we pooled data by using the random-effects model.
MAIN RESULTS
We included four studies with 278 participants in the review. Deliberate hypotension with propofol did not decrease TBL (millilitres) when compared with inhalation anaesthetics in either children or adults. Propofol improved the quality of the surgical field by less than one category on a scale from 0 (no bleeding) to 5 (severe bleeding) (mean difference (MD) 0.64 better with propofol, 95% confidence interval (CI) 0.37 to 0.91 better), but no difference in operation time was reported. Failure to lower blood pressure to target was less common in the propofol group (relative risk of failure with propofol (RR) 0.24, 95% CI 0.09 to 0.66).
AUTHORS' CONCLUSIONS
Using propofol to achieve deliberate hypotension may improve the surgical field, but the effect is small. Deliberate hypotension with propofol did not decrease TBL and operation time. RCTs with good quality methodology and large sample size are required to investigate the effectiveness of deliberate hypotension with propofol for FESS.
Topics: Adult; Anesthetics, Intravenous; Blood Loss, Surgical; Child; Endoscopy; Humans; Hypotension, Controlled; Operative Time; Paranasal Sinuses; Propofol; Randomized Controlled Trials as Topic
PubMed: 23740693
DOI: 10.1002/14651858.CD006623.pub2 -
American Journal of Orthodontics and... Apr 2013The objective of this systematic review was to assess the short- and long-term release of components of orthodontic adhesives and polycarbonate brackets in the oral... (Review)
Review
INTRODUCTION
The objective of this systematic review was to assess the short- and long-term release of components of orthodontic adhesives and polycarbonate brackets in the oral environment.
METHODS
Electronic database searches of published and unpublished literature were performed. The following electronic databases with no language and publication date restrictions were searched: MEDLINE (via Ovid and PubMed), EMBASE (via Ovid), Cochrane Oral Health Group's Trials Register, and CENTRAL. Unpublished literature was searched on ClinicalTrials.gov, the National Research Register, and Pro-Quest Dissertation Abstracts and Thesis database. The reference lists of all eligible studies were checked for additional studies. Two review authors performed data extraction independently and in duplicate using data collection forms. Disagreements were resolved by discussion or the involvement of an arbiter.
RESULTS
No randomized controlled trial was identified. In the absence of randomized controlled trials, observational studies were included. Eleven studies met the inclusion criteria. All were observational studies conducted in vivo or in vitro. The bisphenol-A release from orthodontic bonding resins was found to be between 0.85 and 20.88 ng per milliliter in vivo, and from traces to 65.67 ppm in vitro. Polycarbonate brackets released amounts of 22.24 μg per gram in ethanol solution and 697 μg per gram after 40 months in water. Bis-GMA and TEGDMA leaching in vitro reached levels of 64 and 174 mg per 10 μL, respectively. Because of the heterogeneity in methodologies and reporting, only qualitative synthesis was performed.
CONCLUSIONS
The available evidence on this topic derived from observational in-vivo and in-vitro studies that represent a moderate level of evidence. The variety of setups and the different units allied to the diversity of reporting among studies did not allow calculation of pooled estimates.
Topics: Benzhydryl Compounds; Bisphenol A-Glycidyl Methacrylate; Estrogens, Non-Steroidal; Humans; Orthodontic Brackets; Phenols; Polycarboxylate Cement; Polyethylene Glycols; Polymethacrylic Acids; Resin Cements
PubMed: 23540625
DOI: 10.1016/j.ajodo.2012.11.015 -
The Cochrane Database of Systematic... Oct 2012There is a risk that people who have invasive urodynamic studies (cystometry) will develop urinary tract infections or bacteria in the urine or blood. However, the use... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
There is a risk that people who have invasive urodynamic studies (cystometry) will develop urinary tract infections or bacteria in the urine or blood. However, the use of prophylactic antibiotics before or immediately after invasive cystometry or urodynamic studies is not without risks of adverse effects and emergence of resistant microbes.
OBJECTIVES
To assess the effectiveness and safety of administering prophylactic antibiotics in reducing the risk of urinary tract infections after urodynamic studies. The hypothesis was that administering prophylactic antibiotics reduces urinary tract infections after urodynamic studies.
SEARCH METHODS
We searched the Cochrane Incontinence Group Specialised Trial Register, MEDLINE (January 1966 to January 2009), CINAHL (January 1982 to January 2009), EMBASE (January 1966 to January 2009), PubMed (1 January 1980 to January 2009), LILACS (up to January 2009), TRIP database (up to January 2009), and the UK NHS Evidence Health Information Resources (searched 10 December 2009). We searched the reference lists of relevant articles, the primary trials and the proceedings of the International Urogynaecological Association International Continence Society and the American Urological Association for the years 1999 to 2009 to identify articles not captured by electronic searches. There were no language restrictions.
SELECTION CRITERIA
All randomized controlled trials and quasi-randomized trials comparing the use of prophylactic antibiotics versus a placebo or no treatment in patients having urodynamic studies were selected. Two authors (PL and RF) independently performed the selection of trials for inclusion and any disagreements were resolved by discussion.
DATA COLLECTION AND ANALYSIS
All assessments of the quality of trials and data extraction were performed independently by two authors of the review (PL and RF) using forms designed according to Cochrane guidelines. We attempted to contact authors of the included trials for any missing data. Data were extracted on characteristics of the study participants including details of previously administered treatments, interventions used, the methods used to measure infection and adverse events.Statistical analyses were performed according to Cochrane Collaboration guidelines. Data from intention-to-treat analyses were used where available. For the dichotomous data, results for each study were expressed as a risk ratio (RR) with 95% confidence interval (CI) and combined for meta-analysis using the Mantel-Haenszel method.The primary outcome was urinary tract infection. Heterogeneity was assessed by the P value and I(2) statistic.
MAIN RESULTS
Nine randomized controlled trials involving the prophylactic use of antibiotics in patients having urodynamic studies were identified and these included 973 patients in total; one study was an abstract. Two further trials were excluded from the review. The methods of the included trials were poorly described.The primary outcome in all trials was the rate of developing significant bacteriuria, defined as the presence of more than 100,000 bacteria per millilitre of a mid-stream urine sample on culture and sensitivity testing. The other outcomes included pyrexia, haematuria, dysuria and adverse reactions to antibiotics.The administration of prophylactic antibiotics when compared to a placebo reduced the risk of significant bacteriuria (4% with antibiotics versus 12% without, risk ratio (RR) 0.35, 95% CI 0.22 to 0.56) in both men and women. The administration of prophylactic antibiotics also reduced the risk of haematuria (RR 0.46, 95% CI 0.23 to 0.91). However, there was no statistically significant difference in the primary outcome, risk of symptomatic urinary tract infection (40/201, 20% versus 59/214, 28%; RR 0.73, 95% CI 0.52 to 1.03); or in the risk of fever (RR 5.16, 95% CI 0.94 to 28.16) or dysuria (RR 0.83, 95% CI 0.5 to 1.36). Only two of 135 people had an adverse reaction to the antibiotics. The number of patients needed to treat with antibiotics to prevent bacteriuria was 12.3. Amongst women, the number needed to treat to prevent bacteriuria was 13.4; while amongst men it was 9.1 (number needed to treat = 1/ absolute risk reduction).
AUTHORS' CONCLUSIONS
Prophylactic antibiotics did reduce the risk of bacteriuria after urodynamic studies but there was not enough evidence to suggest that this effect reduced symptomatic urinary tract infections. There was no statistically significant difference in the risk of fever, dysuria or adverse reactions. Potential benefits have to be weighed against clinical and financial implications, and the risk of adverse effects.
Topics: Antibiotic Prophylaxis; Bacteriuria; Female; Humans; Male; Randomized Controlled Trials as Topic; Risk; Urinary Catheterization; Urinary Tract Infections; Urodynamics
PubMed: 23076941
DOI: 10.1002/14651858.CD008224.pub2