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CONTEXT: Necrotizing enterocolitis (NEC) is the most frequent gastrointestinal emergency in neonates. The microbiome of the preterm gut may regulate the integrity of the intestinal mucosa. Probiotics may positively contribute to mucosal integrity, potentially reducing the risk of NEC in neonates. OBJECTIVE: To perform an updated systematic review and meta-analysis on the efficacy and safety of probiotics for the prevention of NEC in premature infants. DATA SOURCES: Structured searches were performed in: Medline, Embase, and the Cochrane Central Register of Controlled Trials (all via Ovid, from 2013 to January 2015). Clinical trial registries and electronically available conference materials were also searched. An updated search was conducted June 3, 2016. STUDY SELECTION: Randomized trials including infants less than 37 weeks gestational age or less than 2,500 g on probiotic vs. standard therapy. DATA EXTRACTION: Data extraction of the newly-identified trials with a double check of the previously-identified trials was performed using a standardized data collection tool. RESULTS: Thirteen additional trials (n = 5,033) were found. The incidence of severe NEC (RR 0.53 95% CI [0.42-0.66]) and all-cause mortality (RR 0.79 95% CI [0.68-0.93]) were reduced. No difference was shown in culture-proven sepsis RR 0.88 95% CI [0.77-1.00]. LIMITATIONS: Heterogeneity of organisms and dosing regimens studied prevent a species-specific treatment recommendation from being made. CONCLUSIONS: Preterm infants benefit from probiotics to prevent severe NEC and death.
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Background. The relative efficacy and safety of lacosamide as adjunctive therapy compared to other antiepileptic drugs has not been well established. Objective. To determine if lacosamide provides improved efficacy and safety, reduced length of hospital stay and improved quality of life compared with other anti-epileptic therapies for adults with partial-onset seizures. Data Sources. A systematic review of the medical literature using Medline (1946-Week 4, 2012), EMBASE (1980-Week 3, 2012), Cochrane Central Register of Controlled Trials (Issue 1 of 12, January 2012). Additional studies were identified (through to February 7, 2012) by searching bibliographies, the FDA drug approval files, clinical trial registries and major national and international neurology meeting abstracts. No restrictions on publication status or language were applied. Study Selection. Randomized controlled trials of lacosamide in adults with partial-onset seizures were included. Data Extraction. Study selection, extraction and risk of bias assessment were performed independently by two authors. Authors of studies were contacted for missing data. Data Synthesis. All pooled analyses used the random effects model. Results. Three trials (1311 patients) met inclusion criteria. Lacosamide increased the 50% responder rate compared to placebo (RR 1.68 [95% CI 1.36 to 2.08]; I(2) = 0%). Discontinuation due to adverse events was statistically significantly higher in the lacosamide arm (RR3.13 [95% CI 1.94 to 5.06]; I(2) = 0%). Individual adverse events (ataxia, dizziness, fatigue, and nausea) were also significantly higher in the lacosamide group. Limitations. All dosage arms from the included studies were pooled to make a single pair-wise comparison to placebo. Selective reporting of outcomes was found in all of the included RCTs. Conclusions. Lacosamide as adjunctive therapy in patients with partial-onset seizures increases the 50% responder rate but with significantly more adverse events compared to the placebo.
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PURPOSE: Carcinoid crises are rare life-threatening events involving cardiac instability when carcinoid tumours release vasoactive peptides. Such events can occur in the perioperative setting. Octreotide, a somatostatin analogue, is administered as a bolus dose of 100-500 µg iv or by infusion to treat carcinoid crises. Due to the apparent low risk-to-benefit profile, a much higher dose is sometimes used in urgent situations. The purpose of this study was to assess the evidence for administering doses or hourly infusions of octreotide that exceeded 1,500 µg iv to treat carcinoid crises. We also sought to identify which patients may require large doses and to describe the adverse effects of such doses. SOURCE: We systematically searched Medline, EMBASE, and Cochrane databases and hand-searched reference lists of relevant articles in 2006 and again in 2010 and 2011. All study designs were included in our search. Resolution of crisis symptoms was the primary outcome. PRINCIPAL FINDINGS: Eighteen articles were included. No patient died during a carcinoid crisis. A retrospective chart review of 89 patients with carcinoid heart disease reported octreotide doses of 25-54,000 µg to treat carcinoid crises, although neither crisis symptoms nor outcomes were described. CONCLUSION: In the included case reports, carcinoid crises were managed effectively using octreotide 25-500 µg iv. Previous exposure to octreotide and carcinoid heart disease may warrant the need for higher doses. In addition to the low quality of the articles and the small sample size, inconsistent use of the term "carcinoid crisis" and paucity of reported outcomes were also limitations of this systematic review. These findings highlight the need for further investigation into dose-response relationships of octreotide for the treatment of carcinoid crisis.
