-
Clinical Microbiology and Infection :... Jun 2018To evaluate the evidence for use of different formulations of amphotericin B (AmB), minimum effective dose for each formulation and its comparative efficacy against... (Comparative Study)
Comparative Study Meta-Analysis Review
OBJECTIVES
To evaluate the evidence for use of different formulations of amphotericin B (AmB), minimum effective dose for each formulation and its comparative efficacy against other drugs in achieving definitive cure of visceral leishmaniasis.
METHODS
This systematic review and meta-analysis included following data sources: PubMed, Embase, Scopus, Web of Science and CINAHL. Controlled prospective clinical trials (randomized or nonrandomized, including dose-ranging studies) conducted between 1996 and 2017 with at least one treatment group receiving AmB were included (published data only). The primary outcome was definitive cure at 6 months. Adverse events and mortality were assessed as secondary outcomes. The PROSPERO registration number for this review is CRD42017067488.
RESULTS
Thirty-one studies (26 from India) that enrolled 6903 patients into 84 study groups met the selection criteria. In India, liposomal AmB was not inferior to AmB deoxycholate (relative risk 1.00, 95% confidence interval (CI) 0.96-1.03, two randomized controlled trials (RCTs), 514 participants, high-quality evidence), and a single dose of the earlier formulation as low as 3.75 mg/kg achieved a cure rate of over 89% (95% CI 70.6-97.2). AmB deoxycholate was as effective as miltefosine (relative risk 0.99, 95% CI 0.95-1.03, two trials, 523 participants, high-quality evidence) and may be better than paromomycin (relative risk 1.04, 95% CI 1.02-1.07, one trial, 667 participants, low-quality evidence) in achieving definitive cure.
CONCLUSIONS
AmB is an efficacious drug in the Indian subcontinent. Further evidence is needed from prospective clinical trials in other endemic geographical regions.
Topics: Amphotericin B; Antiprotozoal Agents; Clinical Trials as Topic; Deoxycholic Acid; Drug Combinations; Drug Compounding; Evidence-Based Medicine; Female; Humans; Leishmaniasis, Visceral; Male; Paromomycin; Phosphorylcholine; Survival Analysis; Treatment Outcome
PubMed: 29138100
DOI: 10.1016/j.cmi.2017.11.008 -
The Cochrane Database of Systematic... May 2014Fungating wounds arise from primary, secondary or recurrent malignant disease and are associated with advanced cancer. A small proportion of patients may achieve healing... (Review)
Review
BACKGROUND
Fungating wounds arise from primary, secondary or recurrent malignant disease and are associated with advanced cancer. A small proportion of patients may achieve healing following surgical excision, but treatment is usually palliative. Fungating wound management usually aims to slow disease progression and optimise quality of life by alleviating physical symptoms, such as copious exudate, malodour, pain and the risk of haemorrhage, through selection of appropriate dressings and topical agents.
OBJECTIVES
To review the evidence of the effects of dressings and topical agents on quality of life, and symptoms that impact on quality of life, in people with fungating malignant wounds.
SEARCH METHODS
For this third update we searched the Wounds Group Specialised Register in August 2013; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library); Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL.
SELECTION CRITERIA
Eligible studies comprised randomised controlled trials (RCTs) or, in their absence, controlled clinical trials (CCTs) with a concurrent control group.
DATA COLLECTION AND ANALYSIS
Data extraction and risk of bias assessment was undertaken by one review author and checked for accuracy by a second.
MAIN RESULTS
Four trials involving 164 people were included. One RCT in women with superficial breast lesions compared 6% miltefosine solution with placebo and found that miltefosine delayed tumour progression. The study reported that the time to treatment failure was significantly longer in the miltefosine group (median 56 days) than in the placebo group (median 21 days) (p value 0.007, log-rank test). A second trial compared topical metronidazole with placebo but the results up to the point of cross-over were not statistically significant. A third trial compared the effect of foam dressings containing silver to foam dressings without silver and found that more patients experienced decreased malodour in the foam with silver group than in the foam alone group (p value=0.049). The fourth trial compared the effect of manuka honey-coated dressings with nanocrystalline silver-coated dressings and found no statistically significant difference with regard to exudate, malodour and wound pain. All trials, however, had methodological limitations.
AUTHORS' CONCLUSIONS
There is weak evidence from one small trial that 6% miltefosine solution applied topically to people with superficial fungating breast lesions (smaller than 1cm) who have received either previous radiotherapy, surgery, hormonal therapy or chemotherapy for their breast cancer, may slow disease progression. There is also weak evidence to suggest that foam dressings containing silver may be effective in reducing malodour. There is insufficient evidence in this review to give a clear direction for practice with regard to improving quality of life or managing wound symptoms associated with fungating wounds. More research is needed.
Topics: Anti-Infective Agents, Local; Antineoplastic Agents; Biological Dressings; Disease Progression; Female; Humans; Male; Metronidazole; Odorants; Ointments; Phosphorylcholine; Randomized Controlled Trials as Topic; Silver Compounds; Skin Neoplasms; Skin Ulcer; Wounds and Injuries
PubMed: 24832784
DOI: 10.1002/14651858.CD003948.pub3 -
The Cochrane Database of Systematic... Nov 2012Clinical trials have confirmed that surfactant therapy is effective in improving the immediate need for respiratory support and the clinical outcome of premature... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Clinical trials have confirmed that surfactant therapy is effective in improving the immediate need for respiratory support and the clinical outcome of premature newborns. Trials have studied a wide variety of surfactant preparations used either to prevent (prophylactic or delivery room administration) or treat (selective or rescue administration) respiratory distress syndrome (RDS). Using either treatment strategy, significant reductions in the incidence of pneumothorax, as well as significant improvement in survival, have been noted. It is unclear whether there are any advantages to treating infants with respiratory insufficiency earlier in the course of RDS.
OBJECTIVES
To compare the effects of early versus delayed selective surfactant therapy for newborns intubated for respiratory distress within the first two hours of life. Planned subgroup analyses included separate comparisons for studies utilizing natural surfactant extract and synthetic surfactant.
SEARCH METHODS
We searched the Oxford Database of Perinatal Trials, MEDLINE (MeSH terms: pulmonary surfactant; text word: early; limits: age, newborn: publication type, clinical trial), PubMed, abstracts, conference and symposia proceedings, expert informants, and journal handsearching in the English language. For the updated search in April 2012 we searched the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, 2012, Issue 1) and PubMed (January 1997 to April 2012).
SELECTION CRITERIA
Randomized and quasi-randomized controlled clinical trials comparing early selective surfactant administration (surfactant administration via the endotracheal tube in infants intubated for respiratory distress, not specifically for surfactant dosage) within the first two hours of life versus delayed selective surfactant administration to infants with established RDS were considered for review.
DATA COLLECTION AND ANALYSIS
Data regarding clinical outcomes were excerpted from the reports of the clinical trials by the review authors. Subgroup analyses were performed based on type of surfactant preparation, gestational age, and exposure to prenatal steroids. Data analysis was performed in accordance with the standards of the Cochrane Neonatal Review Group.
MAIN RESULTS
Six randomized controlled trials met selection criteria. Two of the trials utilized synthetic surfactant (Exosurf Neonatal) and four utilized animal-derived surfactant preparations.The meta-analyses demonstrate significant reductions in the risk of neonatal mortality (typical risk ratio (RR) 0.84; 95% confidence interval (CI) 0.74 to 0.95; typical risk difference (RD) -0.04; 95% CI -0.06 to -0.01; 6 studies; 3577 infants), chronic lung disease (typical RR 0.69; 95% CI 0.55 to 0.86; typical RD -0.04; 95% CI -0.06 to -0.01; 3 studies; 3041 infants), and chronic lung disease or death at 36 weeks (typical RR 0.83; 95% CI 0.75 to 0.91; typical RD -0.06; 95% CI -0.09 to -0.03; 3 studies; 3050 infants) associated with early treatment of intubated infants with RDS.Intubated infants randomized to early selective surfactant administration also demonstrated a decreased risk of acute lung injury including a decreased risk of pneumothorax (typical RR 0.69; 95% CI 0.59 to 0.82; typical RD -0.05; 95% CI -0.08 to -0.03; 5 studies; 3545 infants), pulmonary interstitial emphysema (typical RR 0.60; 95% CI 0.41 to 0.89; typical RD -0.06; 95% CI -0.10 to -0.02; 3 studies; 780 infants), and overall air leak syndromes (typical RR 0.61; 95% CI 0.48 to 0.78; typical RD -0.18; 95% CI -0.26 to -0.09; 2 studies; 463 infants).A trend toward risk reduction for bronchopulmonary dysplasia (BPD) or death at 28 days was also evident (typical RR 0.94; 95% CI 0.88 to 1.00; typical RD -0.04; 95% CI -0.07 to -0.00; 3 studies; 3039 infants). No differences in other complications of RDS or prematurity were noted.Only two studies reported on infants under 30 weeks' gestation. Decreased risk of neonatal mortality and chronic lung disease or death at 36 weeks' postmenstrual age was noted.
AUTHORS' CONCLUSIONS
Early selective surfactant administration given to infants with RDS requiring assisted ventilation leads to a decreased risk of acute pulmonary injury (decreased risk of pneumothorax and pulmonary interstitial emphysema) and a decreased risk of neonatal mortality and chronic lung disease compared to delaying treatment of such infants until they develop worsening RDS.
Topics: Acute Disease; Acute Lung Injury; Chronic Disease; Drug Combinations; Fatty Alcohols; Humans; Infant, Newborn; Lung Diseases; Phosphorylcholine; Polyethylene Glycols; Pulmonary Surfactants; Randomized Controlled Trials as Topic; Respiratory Distress Syndrome, Newborn; Time Factors
PubMed: 23152207
DOI: 10.1002/14651858.CD001456.pub2