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PubMed2003

Are there teratogenic risks associated with antidotes used in the acute management of poisoned pregnant women?

OBJECTIVE: We reviewed evidence suggesting teratogenic risk associated with the use of antidotes in the acute management of poisoned pregnant women. METHODS: Medline, Toxline, and DART/ETIC searches; references of retrieved articles, pertinent databases and textbooks were also searched. RESULTS: There are case reports or case series of women who received antidotes for poisoning during (*) or after (+) the period of organogenesis who showed no fetal adverse effects. Some antidotes, however, have no teratogenic risk: atropine (cohort/surveillance studies)+, calcium (oral supplement: cohort study)+ and pyridoxine (Bendectin studies). Also, ethanol+, methylene blue (intra-amniotic injection but not oral) and penicillamine* can be considered teratogens but their risks in the treatment of poisonings are unknown. There is no epidemiologic study evaluating the risk of the following antidotes during pregnancy: N-acetylcysteine(*+), BAL (dimercaprol)+, black widow spider antivenin+, calcium EDTA+, crotalidae antivenin, crotalidae polyvalent immune FAB, cyanide antidote kit (amyl and sodium nitrate, sodium thiosulfate), deferoxamine(*+), digoxin immune FAB+, DMSA+, flumazenil+, fomepizole, methylene blue (IV), naloxone, physostigmine, pralidoxime+, protamine+; and parenteral pharmacologic doses of calcium+, folinic acid*, glucagon+, hydroxycobalamin, phytonadione (vitamin K), and pyridoxine. CONCLUSIONS: Despite the limited evidence supporting the risk of antidote use during pregnancy, antidotes should be used when there is a clear maternal indication to decrease the morbidity or mortality associated with poisoning. The only exception may be penicillamine, which is a teratogen. Better antidotes exist for most poisonings that penicillamine could potentially treat. At this time, there is no known fetal indication for all antidotes. Reporting the use of an antidote during pregnancy should be encouraged, especially if used during the critical period of organogenesis.

Abnormalities, Drug-Induced↗
PubMed2007

Statins and risk of cancer: a systematic review and metaanalysis.

We conducted a systematic review of the association between HMG-CoA reductase inhibitor (statin) use and cancer risk. We searched MEDLINE, EMBASE, Web of Science, ISI Proceedings and BIOSIS Previews bibliographic databases, electronic trials registers and reference lists for potentially eligible randomized trials and observational studies. Thirty-eight individual studies (26 randomized trials involving 103,573 participants and 12 observational studies with 826,854 participants) were included. Median follow-up was 3.6 and 6.2 years for trials and observational studies, respectively. In metaanalyses of randomized trials, there was no evidence that statin therapy was associated with incidence of all-cancers (26 trials; pooled risk ratio = 1.00; 95% CI 0.95-1.05; I(2) = 0%) or the following site-specific cancers: breast (7 trials; risk ratio = 1.01; 0.79-1.30; I(2) = 43%), prostate (4 trials; risk ratio = 1.00; 0.85-1.17; I(2) = 0%), colorectum (9 trials; risk ratio = 1.02; 0.89-1.16; I(2) = 0%), lung (9 trials; risk ratio = 0.96; 0.84-1.09; I(2) = 0%), genito-urinary (5 trials; risk ratio = 0.95; 0.83-1.09; I(2) = 0%), melanoma (4 trials; risk ratio = 0.86; 0.62-1.20; I(2) = 17%) or gastric (1 trial; risk ratio = 1.00; 0.35-2.85). There was no evidence of differential effects by length of follow-up, statin type (lipophilic vs. lipophobic) or potency. Trial results were generally consistent with observational studies. We conclude that statin use is not associated with short-term cancer risk, but longer-latency effects remain possible.

Humans↗
PubMed1994

Dose-response assessment for developmental toxicity. II. Comparison of generic benchmark dose estimates with no observed adverse effect levels.

Developmental toxicity risk assessment currently relies on the estimation of reference doses (RfDDTS) of reference concentrations (RfCDTS) based on the use of no observed adverse effect levels (NOAELS) divided by uncertainty factors (UFs). The benchmark dose (BMD) has been proposed as an alternative basis for reference value calculations. A large database of 246 developmental toxicity experiments representing 1825 endpoints related to dead implants or malformed fetuses has been compiled for use in evaluating alternative approaches to developmental toxicity risk assessment. Using this database we have compared two approaches for BMD estimation with each other and with corresponding statistically derived NOAELS. Comparisons have been based on proportion of affected litters (litters with one or more affected offspring, a quantal response variable) and on the proportion of affected offspring within each litter (a continuous response variable). A quantal Weibull model was used to calculate generic BMDs for the quantal response variable (QBMDs) and a continuous power model was used to calculate generic BMDs for the continuous response variable (CBMDs) at three levels of additional risk (10, 5, and 1%). CBMD05s (continuous benchmark doses for 5% risk) and CNOAELs (statistically derived NOAELs based on the continuous response variable) were similar, with over 98% of the data subsets having CBMD05 and CNOAEL values that differed by less than an order of magnitude. In contrast, QNOAELs tended to be greater than corresponding QBMD10s. The observed conservatism of the QBMD values relative to the corresponding CBMD values was attributed to two factors, lower maximum likelihood estimates for the quantal model and wider confidence intervals around the maximum likelihood estimates, compared to the continuous model.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1993

Polymorphic SSR (simple-sequence-repeat) markers for chromosome 20.

Chromosome 20-specific simple-sequence-repeat (SSR) markers were developed from a flow-sorted phage library (LL20NS01), subcloned in Bluescript, and screened with a tetranucleotide repeat, (AAAG)6, to identify potentially polymorphic loci. Of 100 clones sequenced, 39 were selected to construct primers. Of these 39, 22 were polymorphic. Reference to the CEPH linkage database (version 5) permitted genetic mapping of 16 of the new markers to specific regions of chromosome 20. Ten of the SSRs showed heterozygosity indices (above 70%) that would qualify them as potential index markers.

Base Sequence↗
PubMed1997

Cricoid pressure.

PURPOSE: Although cricoid pressure (CP) is a superficially simple and appropriate mechanical method to protect the patient from regurgitation and gastric insufflation, in practice it is a complex manoeuvre which is difficult to perform optimally. The purpose of this review is to examine and evaluate studies on the application of (CP). It deals with anatomical and physiological considerations, techniques employed, safety and efficacy issues and the impact of CP on airway management with special mention of the laryngeal mask airway. SOURCE OF MATERIAL: Three medical databases (48 Hours, Medline, and Reference Manager Update) were searched for citations containing key words, subject headings and text entries on CP to October 1996. PRINCIPLE FINDINGS: There have been no studies proving that CP is beneficial, yet there is evidence that it is often ineffective and that it may increase the risk of failed intubation and regurgitation. After evaluation of all available data, potential guidelines are suggested for optimal use of CP in routine and complex situations. CONCLUSIONS: If CP is to remain standard practice during induction of anaesthesia, it must be shown to be safe and effective. Meanwhile, further understanding of its advantages and limitations, improved training in its use, and guidelines on optimal force and method of application should lead to better patient care.

Cricoid Cartilage↗
PubMed2004

Combination enteral and parenteral nutrition in critically ill patients: harmful or beneficial? A systematic review of the evidence.

OBJECTIVE: A combination of enteral (EN) and parenteral nutrition (PN) is often used as a strategy to optimize nutritional intake in critically ill patients; however, the effects of this intervention on clinically important outcomes have not been widely studied. This paper systematically reviewed studies that compare EN + PN to enteral nutrition (EN) alone in critically ill patients. METHODS: We searched bibliographic databases, personal files, and relevant reference lists to identify randomized controlled trials that compared combination EN + PN to EN alone. RESULTS: Only five studies met the inclusion criteria. In all these studies PN was started at the same time as EN in the experimental group. When the results of these trials were aggregated, EN + PN had no significant effect on mortality. There was no difference between the two groups in rates of infectious complications, length of hospital stay, or ventilator days. CONCLUSIONS: In critically ill patients who are not malnourished and have an intact gastrointestinal tract, starting PN at the same time as EN provides no benefit in clinical outcomes over EN alone. More research is needed to determine the effects of combination EN + PN on clinical outcomes in critically ill patients who are poorly intolerant to EN.

Critical Care↗
PubMed1999

Bone mineral density in sixty adult patients with Marfan syndrome.

Sixty adult patients (40 women, 20 men) with Marfan syndrome (MFS) according to the Berlin criteria had a full clinical examination and bone mineral density (BMD) measurement by dual-energy X-ray absorptiometry of the hip and nondominant forearm. BMD was expressed as a Z-score and compared with the reference population of the Hologic database. In MFS men, BMD (g/cm(2)) was compared with the BMD of 45 normal tall Caucasian adults. Osteocalcin was measured by radioimmunoassay. In patients with MFS, BMD was compared between patients with and without previous fractures and according to the phenotypic severity of MFS. The mean age of the patients was 32.9 +/- 9.3 years (women 32.5 +/- 9.7, men 33.4 +/- 8.6), mean height was 180.3 +/- 10.3 cm (women 176.3 +/- 9.2, men 188.1 +/- 7.5) and mean body mass index 20.9 +/- 3.6 kg/m(2) (women 20.8 +/- 3.4, men 20.95 +/- 3.97). Hyperlaxity score (Beighton criteria) was 6.9 +/- 1. 1. Six patients (10%) had a previous fracture. Thirty per cent of patients had had at least one previous operation for scoliosis, aortic dilatation or eye problems. BMD values in the 60 patients were as follows: Z-score of the hip, -1.26 +/- 0.93, p<10(-9) (neck, -0.93 +/- 1.09, p<10(-9); trochanter, -1.31 +/- 0.85, p<10(-9); intertrochanter, -1.39 +/- 0.99, p<10(-9); Ward's triangle, -0.93 +/- 1.88, p<10(-9)); Z-score of the radius: -1.6 +/- 1.06, p<10(-9) (1/3 proximal, -1.29 +/- 1.03; mid-radius, -1.94 +/- 1.04; ultradistal, -0.68 +/- 1.1, p<10(-9)). The decrease in BMD was similar in men and women at both the hip and the radius. BMD in MFS patients was significantly decreased at cortical compared with trabecular sites (radius 1/3 proximal vs ultradistal, p<0.0001; total femur vs Ward's triangle, p<0.0005). No difference in BMD was found between MFS patients with or without previous fractures and those with severe or less severe phenotypic expression of MFS. An influence of height and weight in MFS on BMD is suspected. Osteocalcin was not increased in our group of MFS patients. Thus both men and women with MFS have a significant deficit of BMD at the hip and radius. The decrease in BMD is present equally in both sexes and is more pronounced at predominantly cortical sites. In our group of patients we found no increase in fractures and no relation between decreased BMD and phenotypic expression of the syndrome.

Absorptiometry, Photon↗
PubMed2005

Three percent diclofenac in 2.5% hyaluronan gel in the treatment of actinic keratoses: a meta-analysis of the recent studies.

Three percent diclofenac in 2.5% hyaluronan gel (DHA) is approved by the Food and Drug Administration (FDA) in the treatment of actinic keratoses (AK). We conducted a meta-analysis of the few prospective studies that evaluated the effect of DHA on the target lesion number score TLNS0 (indicating complete resolution of all target lesions in the treatment area) and/or the cumulative target lesion number score CLNS0 (indicating resolution of the target and new lesions in the treatment area) with assessment 30 days after the end of treatment. A comprehensive search of the 1966-2005 MEDLINE database and review of the reference lists of relevant articles identified the published randomised trials. Three studies were included, with a total of 364 patients. The placebo was the hyaluronan vehicle gel (HAV). The intention-to-treat analyses show that DHA significantly improve the TLNS0 (OR= 3.72; 95% CI=2.05-6.74) and the CLNS0 (OR=4.09; 95% CI=2.55-6.56) compare to HAV. Overall, 42/106 (39.6% CI: 30.8- 49.1%) had a TLNS0 with mean treatment duration of 75 days +/- 21 [mean+/-standard deviation (SD)], and 70/179 (39.1% CI:32.3-46.4%) patients had a CLNS0 with a mean 78 days+/-16 treatment duration. DHA is effective compared to HAV in the treatment of AK. Further studies should establish subgroup analyses according to sites and severity of the AK lesions in order to determine if more patients could be improved in restricted indications. Biopsies, a longer follow-up evaluation, and comparisons with the other treatments of AK will also be helpful in the future to define the place of this treatment in the management of AK.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed2006

Attributable mortality of candidemia: a systematic review of matched cohort and case-control studies.

A systematic review of matched cohort and case-control studies was performed to examine the mortality attributable to candidemia. The review included studies that compared mortality of patients with candidemia (cases) to that of matched patients without candidemia (controls). Secondary variables examined were the length and cost of hospital stay. Relevant studies were identified using the PubMed database and by examining the references of the initially selected studies. Two independent reviewers performed the literature search, study selection and data extraction from the identified studies. A total of seven studies were included in the review. The patients included those hospitalized in intensive care units (ICU) and hospital wards and those undergoing transplantation. The mortality attributed to candidemia in the reviewed studies ranged from 5 to 71%. For six of the reviewed studies the difference in mortality between cases and controls was statistically significant. Among those who survived, the length of stay and the cost of hospitalization of patients with candidemia were significantly higher than those of controls. Despite the methodological heterogeneity of the reviewed studies, the data from the available matched cohort and case-control studies suggest that candidemia is associated with considerable mortality that is attributed, at least to some degree, to the infection itself and not only to the presence of another comorbidity.

Adult↗
PubMed2003

Head and neck nodal station images: guidance for three-dimensional radiation therapy treatment planning.

When we use radiation to treat cancer patients, the irradiated volume usually encloses the detectable tumor and any metastatic areas that are thought to be at risk. Usually, in three-dimensional (3D) radiation therapy, we need to define the clinical target volume (CTV), which identifies the areas suspected of containing microscopic metastasis. We can use a set of computed tomographic (CT) images to define these suspected areas, which we relate to nodal station distributions. The traditional method uses special anatomic landmarks for such definition. This lymph node image guidance method uses a set of CT images to show the relevant nodal stations and find the correlation between the suspected areas and the lymphatic pathways. First, we used CT images from head and neck cancer patients. Then, we designed a program to delineate the regional lymphatic areas in order to distinguish the position of all the major lymph nodes in the head and neck region. These lymph nodes were then used to assist the oncologist in developing treatment references. Finally, we established a database management system to determine the relationships between different lesions and lymph nodes, as well as correlations, with metastatic pathways. Defining these relationships on the CT images provided oncologists specific information that could be used to define the CTV more precisely for 3D radiation therapy.

Head and Neck Neoplasms↗
PubMed2004

S-gene sequences and genotype-related restriction sites in hepatitis B virus carriers in Turkey.

BACKGROUND: Although hepatitis B virus (HBV) infections are a major health problem in Turkey, there is little information on the genotype distribution of the virus. In this study, HBV genotypes were determined by DNA sequencing and restriction enzyme analysis of the S gene. MATERIALS AND METHODS: The S genes of hepatitis B virus isolated from 23 chronically infected HBV-DNA-positive Turkish patients were amplified and directly sequenced. Nucleotide sequences were then aligned with reference isolates from the GenBank database and subjected to phylogenetic analysis. HBsAg subtype-specific amino acid substitutions at codons 122, 127, 134, 159, and 160 were analyzed using translated sequences. The amplified products were also subjected to restriction enzyme analysis using endonucleases Mva I, Rsa I, and Hinf I. RESULTS: Phylogenetic analysis showed clustering of all samples with genotype D sequences. The mean intragroup divergence was 0.95% (range 0.00%-4.00%). All isolates were ayw2, as predicted from translated sequences. The results of the restriction enzyme analysis of the samples were consistent with the phylogenetic analysis. CONCLUSION: Our data complement the findings that genotype D viruses are prevalent in the Turkish population. Being rapid and inexpensive, restriction enzyme analysis described in this study should be useful for large-scale epidemiological analysis of HBV infections.

Amino Acid Sequence↗
PubMed1990

To what extent do congestive heart failure patients in sinus rhythm benefit from digoxin therapy? A systematic overview and meta-analysis.

PURPOSE: To reappraise the effectiveness of digoxin for the treatment of congestive heart failure (CHF) in patients with sinus rhythm in light of data from recently published randomized controlled trials and to quantitatively assess its usefulness. STUDY IDENTIFICATION: Computerized searches of the MEDLINE database were performed, and the reference list of each retrieved article was reviewed. STUDY SELECTION: Review of more than 360 citations and the reference lists of 19 review articles and 61 potentially relevant articles revealed seven double-blind randomized controlled trials that were included in this overview. DATA EXTRACTION: Study quality was assessed and descriptive information concerning the study populations, the specific interventions, and clinically relevant outcome measurements was extracted. RESULTS OF DATA SYNTHESIS: The common odds ratio for CHF deterioration while receiving digoxin versus placebo was 0.28, with a 95% confidence interval of 0.16 to 0.49. Predictors of digoxin benefit included presence of a third heart sound and the severity and duration of CHF. CONCLUSION: Data from seven trials of high methodologic quality suggest that, on average, one out of nine patients with CHF and sinus rhythm derive a clinically important benefit from digoxin (with a 95% confidence interval of 1/33 to 1/5).

Digoxin↗
PubMed1989

Control of expression of the human glutathione S-transferase pi gene differs from its rat orthologue.

We have examined regulation of the glutathione S-transferase pi gene by transient expression assay, and find that a fragment from 8 to 99 bp upstream of the cap site promotes transcription, but there is no evidence for any enhancer activity in a further 6 kb of flanking sequence. Analysis of this sequence by reference to a primate sequence database and Southern blotting revealed that as much as 5 kb of this flanking DNA were composed of repetitive insertion elements including an Alu and a LINE 1 repeat. The promoter fragment has been sequenced (Cowell et al (1988) Biochem. J. 255, 79-83) and contains a consensus AP1 binding site; in some cases, these have been associated with transcriptional induction by phorbol esters and ras oncogenes. We measured the steady state levels of glutathione S-transferase pi mRNA in human cell lines which were known to express ras oncogenes and compared them to human cell lines which have not been identified with ras activation. There was no correlation between expression of activated ras and expression of glutathione S-transferase pi mRNA. Treatment of HeLa cells, HepG2 cells and a small cell lung carcinoma line, GLC 8, with the phorbol ester 12-O-tetradecanoylphorbol 13-acetate failed to alter the steady state levels of endogenous glutathione S-transferase pi mRNA. The differences between these results and those of similar studies on rat glutathione S-transferase subunit 7, a structural orthologue of glutathione S-transferase pi, are discussed.

Animals↗
PubMed2006

Selective serotonin reuptake inhibitors and risk of upper GI bleeding: confusion or confounding?

BACKGROUND: Selective serotonin reuptake inhibitors (SSRIs) represent a relatively new class of antidepressants. Several studies have reported bleeding disorders associated with the use of SSRIs, which are considered the result of a decrease in platelet serotonin leading to a defect in platelet aggregation. To what extent the use of SSRIs increases the risk of gastrointestinal bleeding is unclear. METHODS: A comprehensive literature search for studies addressing SSRI use and upper gastrointestinal tract bleeding (UGIB) was conducted using Medline, EMBASE, and Cochrane databases with a recursive manual reference search up to May 2005. Any observational and interventional studies were systematically reviewed, and critical appraisal was conducted on available studies. RESULTS: Published clinical evidence on the relationship between SSRI use and gastrointestinal bleeding is limited to observational studies without any clinical trials. Three cohort studies and one case-control study met inclusion criteria. These studies combined different affinity SSRIs in the class and had differing control groups with conflicting conclusions. Both a cohort study and a case-control study investigating the concurrent use of nonsteroidal anti-inflammatory drugs (NSAIDs) or low-dose aspirin found that combined use with an SSRI increased the risk of UGIB. CONCLUSIONS: Only a few epidemiology studies have investigated the association between SSRIs and UGIB. They provide weak evidence to support the hypothesis of a link between SSRIs and UGIB at a population level. Available evidence shows that concurrent use of NSAIDs or aspirin with SSRIs greatly increases the risk of UGIB. The preventive strategy should be considered in those SSRI users at high risk, especially the elderly or those with a history of UGIB and taking nonselective NSAIDs or aspirin.

Antidepressive Agents↗
PubMed2005

Core data elements tracking elder sexual abuse.

Sexual abuse in the older adult population is an understudied vector of violent crimes with significant physical and psychological consequences for victims and families. Research requires a theoretical framework that delineates core elements using a standardized instrument. To develop a conceptual framework and identify core data elements specific to the older adult population, clinical, administrative, and criminal experts were consulted using a nominal group method to revise an existing sexual assault instrument. The revised instrument could be used to establish a national database of elder sexual abuse. The database could become a standard reference to guide the detection, assessment, and prosecution of elder sexual abuse crimes as well as build a base from which policy makers could plan and evaluate interventions that targeted risk factors.

Age Factors↗
PubMed2005

Accuracy of B-type natriuretic peptide levels in the diagnosis of left ventricular dysfunction and heart failure: a systematic review.

OBJECTIVES: To evaluate the accuracy of B-type natriuretic peptide levels (BNP) in the diagnosis of heart failure and left ventricular dysfunction. DATA SOURCES: Electronic search in Medline, Embase, Cochrane Library and Medion database, and hand search of reference lists. REVIEW METHODS: We have included published studies on the accuracy of BNP which had both sufficient information to construct the 2x2 diagnostic cross table and an appropriate spectrum of patients. RESULTS: Fifty five studies (16,730 patients) were analyzed. The main determinants of diagnostic accuracy were the reference standard analyzed (clinical heart failure versus left ventricular dysfunction), and the methodological quality of the study. BNP levels were highly accurate for the diagnosis of clinical heart failure (diagnostic OR=41; 95% CI 23-74). The negative likelihood ratios were homogeneous, and useful for excluding the existence of heart failure (pooled negative likelihood ratio=0.11; 95% CI 0.08-0.16). The studies focused on the identification of left ventricular dysfunction were heterogeneous, with indications of publication bias, and showed less overall diagnostic accuracy than studies focused on heart failure. CONCLUSIONS: BNP levels are useful for ruling out heart failure. The accuracy of BNP for identifying patients with systolic dysfunction is more limited.

Cardiac Output, Low↗
PubMed2004

Standardless screening of chemical warfare agents based on gas chromatographic data.

A method for calculation of the retention time of a compound in a temperature-programmed mode of GC analyses is proposed. The method is based on a detailed consideration of thermodynamics of chromatographic process and account of the actual state of a capillary column. The suggested approach permits estimation of probability of a poisonous agent in tests by means of information stored in the database, eliminating a need for reference standard of such an agent.

Algorithms↗
PubMed2004

Does enteral nutrition compared to parenteral nutrition result in better outcomes in critically ill adult patients? A systematic review of the literature.

OBJECTIVE: Nutritional support is part of the standard of care for the critically ill adult patient. In the average patient in the intensive care unit who has no contraindications to enteral nutrition (EN) or parenteral nutrition (PN), the choice of route for nutritional support may be influenced by several factors. Because EN and PN are associated with risks and benefits, we systematically reviewed and critically appraised the literature to compare EN with PN the critically ill patient. METHODS: We searched computerized bibliographic databases, personal files, and relevant reference lists to identify potentially eligible studies. Only randomized clinical trials that compared EN with PN in critically ill patients with respect to clinically important outcomes were included in this review. In an independent fashion, relevant data on the methodology and outcomes of primary studies were abstracted in duplicate. The studies were subsequently aggregated statistically. RESULTS: There were 13 studies that met the inclusion criteria and, hence, were included in our meta-analysis. The use of EN as opposed to PN was associated with a significant decrease in infectious complications (relative risk = 0.64, 95% confidence interval = 0.47 to 0.87, P = 0.004) but not with any difference in mortality rate (relative risk = 1.08, 95% confidence interval = 0.70 to 1.65, P = 0.7). There was no difference in the number of days on a ventilator or length of stay in the hospital between groups receiving EN or PN (Standardized Mean Difference [SMD] = 0.07, 95% confidence interval = -0.2 to 0.33, P = 0.6). PN was associated with a higher incidence of hyperglycemia. Data that compared days on a ventilator and the development of diarrhea in patients who received EN versus PN were inconclusive. In the EN and PN groups, complications with enteral and parenteral access were seen. Four studies documented cost savings with EN as opposed to PN. CONCLUSION: The use of EN as opposed to PN results in an important decrease in the incidence of infectious complications in the critically ill and may be less costly. EN should be the first choice for nutritional support in the critically ill.

Costs and Cost Analysis↗