-
The Cochrane Database of Systematic... Jul 2015Atopic dermatitis (AD) (or atopic eczema) is a chronic inflammatory skin condition that affects children and adults and has an important impact on quality of life.... (Review)
Review
BACKGROUND
Atopic dermatitis (AD) (or atopic eczema) is a chronic inflammatory skin condition that affects children and adults and has an important impact on quality of life. Topical corticosteroids (TCS) are the first-line therapy for this condition; however, they can be associated with significant adverse effects when used chronically. Tacrolimus ointment (in its 2 manufactured strengths of 0.1% and 0.03%) might be an alternative treatment. Tacrolimus, together with pimecrolimus, are drugs called topical calcineurin inhibitors (TCIs).
OBJECTIVES
To assess the efficacy and safety of topical tacrolimus for moderate and severe atopic dermatitis compared with other active treatments.
SEARCH METHODS
We searched the following databases up to 3 June 2015: the Cochrane Skin Group Specialised Register, CENTRAL in the Cochrane Library (Issue 5, 2015), MEDLINE (from 1946), EMBASE (from 1974), LILACS (from 1982), and the Global Resource of Eczema Trials (GREAT database). We searched six trials registers and checked the bibliographies of included studies for further references to relevant trials. We contacted specialists in the field for unpublished data.A separate search for adverse effects of topical tacrolimus was undertaken in MEDLINE and EMBASE on 30 July 2013. We also scrutinised the U.S. Food and Drug Administration (FDA) websites for adverse effects information.
SELECTION CRITERIA
All randomised controlled trials (RCTs) of participants with moderate to severe atopic dermatitis (both children and adults) using topical tacrolimus at any dose, course duration, and follow-up time compared with other active treatments.
DATA COLLECTION AND ANALYSIS
Two authors independently screened and examined the full text of selected studies for compliance with eligibility criteria, risk of bias, and data extraction. Our three prespecified primary outcomes were physician's assessment, participant's self-assessment of improvement, and adverse effects. Our secondary outcomes included assessment of improvement of the disease by validated or objective measures, such as SCORAD (SCORing Atopic Dermatitis), the EASI (Eczema Area and Severity Index), and BSA (Body Surface Area) scores.
MAIN RESULTS
We included 20 studies, with 5885 participants. The variability of drug doses, outcomes, and follow-up periods made it difficult to carry out meta-analyses.A single trial showed that tacrolimus 0.1% was better than low-potency TCS by the physician's assessment (risk ratio (RR) 3.09, 95% confidence interval (CI) 2.14 to 4.45, 1 study, n = 371, moderate-quality evidence). It was also marginally better than low-potency TCS on face and neck areas and moderate-potency TCS on the trunk and extremities by the physician's assessment (RR 1.32, 95% CI 1.17 to 1.49, 1 study, n = 972, moderate level of evidence) and for some of the secondary outcomes. Compared with pimecrolimus 1%, people treated with tacrolimus were almost twice as likely to improve by the physician's assessment (RR 1.80, 95% CI 1.34 to 2.42, 2 studies, n = 506, moderate quality of evidence). Compared with the lower concentration of 0.03%, the tacrolimus 0.1% formulation reduced the risk of not having an improvement by 18% as evaluated by the physician's assessment (RR 0.82, 95% CI 0.72 to 0.92, 6 studies, n = 1640, high-quality evidence). Tacrolimus 0.1% compared with moderate-to-potent TCS showed no difference by the physician's assessment, and 2 secondary outcomes (1 study, 377 participants) and a marginal benefit favouring tacrolimus 0.1% was found by the participant's assessment (RR 1.21, 95% CI 1.13 to 1.29, 1 study, n = 974, low quality of evidence) and SCORAD.Based on data from 2 trials, tacrolimus 0.03% was superior to mild TCS for the physician's assessment (RR 2.58, 95% CI 1.96 to 3.38, 2 studies, n = 790, moderate-quality evidence) and the participant's self-assessment (RR 1.64, 95% CI 1.41 to 1.90, 1 study, n = 416, moderate quality of evidence). One trial showed moderate benefit of tacrolimus 0.03% compared with pimecrolimus 1% on the physician's assessment (RR 1.42, 95% CI 1.02 to 1.98, 1 study, n = 139, low-quality evidence), but the effects were equivocal when evaluating BSA. In the comparison of tacrolimus 0.03% with moderate-to-potent corticosteroids, no difference was found in most of the outcomes measured (including physician's and participant's assessment and also for the secondary outcomes), but in two studies, a marginal benefit favouring the corticosteroid group was found for the EASI and BSA scores.Burning was more frequent in those using calcineurin inhibitors than those using corticosteroid tacrolimus 0.03% (RR 2.48, 95% CI 1.96 to 3.14, 5 studies, 1883 participants, high-quality evidence), but no difference was found for skin infections. Symptoms observed were mild and transient. The comparison between the two calcineurin inhibitors (pimecrolimus and tacrolimus) showed the same overall incidence of adverse events, but with a small difference in the frequency of local effects.Serious adverse events were rare; occurred in both the tacrolimus and corticosteroid groups; and in most cases, were considered to be unrelated to the treatment. No cases of lymphoma were noted in the included studies nor in the non-comparative studies. Cases were only noted in spontaneous reports, cohorts, and case-control studies. Systemic absorption was rarely detectable, only in low levels, and this decreased with time. Exception is made for diseases with severe barrier defects, such as Netherton's syndrome, lamellar ichthyosis, and a few others, with case reports of a higher absorption. We evaluated clinical trials; case reports; and in vivo, in vitro, and animal studies; and didn't find any evidence that topical tacrolimus could cause skin atrophy.
AUTHORS' CONCLUSIONS
Tacrolimus 0.1% was better than low-potency corticosteroids, pimecrolimus 1%, and tacrolimus 0.03%. Results were equivocal when comparing both dose formulations to moderate-to-potent corticosteroids. Tacrolimus 0.03% was superior to mild corticosteroids and pimecrolimus. Both tacrolimus formulations seemed to be safe, and no evidence was found to support the possible increased risk of malignancies or skin atrophy with their use. The reliability and strength of the evidence was limited by the lack of data; thus, findings of this review should be interpreted with caution. We did not evaluate costs.
Topics: Administration, Topical; Calcineurin Inhibitors; Dermatitis, Atopic; Dermatologic Agents; Humans; Randomized Controlled Trials as Topic; Tacrolimus
PubMed: 26132597
DOI: 10.1002/14651858.CD009864.pub2 -
European Journal of Obstetrics &... Jan 2020This study aimed to synthesize evidence from published studies about the diagnostic accuracy of lamellar body count (LBC) as a predictor of fetal lung maturity. (Review)
Review
OBJECTIVE
This study aimed to synthesize evidence from published studies about the diagnostic accuracy of lamellar body count (LBC) as a predictor of fetal lung maturity.
STUDY DESIGN
We searched Medline (via PubMed), EBSCO, Web of Science, Scopus and the Cochrane Library for relevant published studies assessing the accuracy of LBC as a predictor of fetal lung maturity. Studies were classified according to the counting essays, centrifugation protocols, and the reported optimum cut off values. Data of the true positive, true negative, false positive, and false negative were extracted and analyzed to calculate the overall sensitivity and specificity of the LBC.
RESULTS
Thirty-one studies were included in the final analysis. Fourteen studies reported data for centrifuged amniotic fluid (AF) samples, 13 studies reported data for uncentrifuged samples, and four studies did not have enough information about whether centrifugation was done. LBC showed an area under the curve >80% in diagnosing lung immaturity with variable cut off values. Pooled analysis showed that LBC a 100% specificity to exclude respiratory distress syndrome (RDS) at a cut off value of 15,000 and 100% sensitivity to diagnose RDS at a cut off value of 55,000.
CONCLUSION
Cases with LBC < 15,000 are considered to have lung immaturity while cases with LBC > 45,000 in centrifuged AF samples or >55,000 in uncentrifuged AF samples are likely to have mature lungs. Cases with LBC ranging between these maturity and immaturity limits should be considered for further evaluation by other lung maturity tests.
PubMed: 32021970
DOI: 10.1016/j.eurox.2019.100059 -
European Clinical Respiratory Journal 2015Fabry disease is an X-linked disorder caused by a deficiency of the lysosomal enzyme α-galactosidase A, resulting in accumulation of glycosphingolipids in multiple... (Review)
Review
BACKGROUND
Fabry disease is an X-linked disorder caused by a deficiency of the lysosomal enzyme α-galactosidase A, resulting in accumulation of glycosphingolipids in multiple organs, primarily heart, kidneys, skin, CNS, and lungs.
MATERIALS AND METHOD
A systematic literature search was performed using the PubMed database, leading to a total number of 154 hits. Due to language restriction, this number was reduced to 135; 53 papers did not concern Fabry disease, 19 were either animal studies or gene therapy studies, and 36 papers did not have lung involvement in Fabry disease as a topic. The remaining 27 articles were relevant for this review.
RESULTS
The current literature concerning lung manifestations describes various respiratory symptoms such as dyspnoea or shortness of breath, wheezing, and dry cough. These symptoms are often related to cardiac involvement in Fabry disease as respiratory examinations are seldom performed. Pulmonary function tests primarily show obstructive airway limitation, but a few articles also report of patients with restrictive limitation and a mixture of both. No significant association has been found between smoking and the development of symptoms or spirometry abnormalities in patients with Fabry disease. Electron microscopy of lung biopsy and induced sputum show lamellar inclusion bodies (Zebra bodies) in the cytoplasm of cells in the airway wall. X-ray and CT scan have shown patchy ground-glass pulmonary infiltrations, fibrosis, and air trapping. Fibrosis diagnosed by high-resolution CT has not been significantly correlated with lung spirometry.
CONCLUSION
Consistent findings have not been shown in the current literature. Pulmonary function tests and registration of symptoms showed various results; however, there is a trend towards obstructive airway limitation in patients with Fabry disease. Further studies are needed to evaluate pathogenesis, progression, and the effects of treatment.
PubMed: 26557248
DOI: 10.3402/ecrj.v2.26721 -
Neonatology 2023We evaluate the accuracy of postnatal biochemical and lung function tests performed within 3 h from birth for predicting surfactant need in preterm infants ≤34 weeks'...
INTRODUCTION
We evaluate the accuracy of postnatal biochemical and lung function tests performed within 3 h from birth for predicting surfactant need in preterm infants ≤34 weeks' gestation receiving noninvasive respiratory support for respiratory distress syndrome (RDS).
METHODS
We systematically searched MEDLINE, Embase, The Cochrane Library, PROSPERO, and clinicaltrials.gov databases for studies published from 2000 to November 10, 2021, cross-referencing relevant literature and contacting experts. We included diagnostic accuracy studies and systematic reviews of biochemical or lung function tests identifying the need for surfactant in preterm neonates ≤34 weeks' with RDS not intubated at birth. The authors individually assessed the risk of bias following a tailored QUADAS-2 tool.
RESULTS
Eight studies, including 810 infants, met the inclusion criteria. Four tests were included: the click test, the stable microbubble test, the lamellar body count on gastric aspirates, and the forced oscillation technique. The reference standards were transparent criteria for distinguishing the infants according to oxygen requirement, which reflected the current criteria for surfactant therapy. The risk of bias was judged high because of the population selection and exclusion of participants from the analysis. There were no serious concerns regarding blinding and applicability. The individual study sensitivity and specificity range from 0.60 to 1 and from 0.51 to 0.91, respectively. It was not appropriate to combine the accuracy estimates in a meta-analysis because of the heterogeneity of the study characteristics.
CONCLUSIONS
Current evidence is insufficient to recommend biochemical and lung function tests for tailoring surfactant therapy.
Topics: Humans; Infant, Newborn; Infant, Premature; Pulmonary Surfactants; Respiratory Distress Syndrome, Newborn; Respiratory Function Tests; Surface-Active Agents
PubMed: 36516800
DOI: 10.1159/000527670