scholarly journals Efetividade do metronidazol tópico e/ou sistêmico no controle do mau odor de tumores malignos fétidos: revisão sistemática

2021 ◽  
Vol 62 (1) ◽  
pp. 121-128
Author(s):  
Juliana Massote Caldeira Brant ◽  
Laryssa Hillary Teodora da Silva
Keyword(s):  
Systematic Review ◽  
Malignant Tumors ◽  
Phase Iii ◽  
Double Blind ◽  
Effective Interventions ◽  
Topical Metronidazole ◽  
Collection Period ◽  
Phase Iii Studies ◽  
Distressing Condition ◽  
Systemic Metronidazole

Introduction: Fetid tumors are a devastating complication of cancer and cause much discomfort and patient isolation. They usually develop themselves in the last six months of life and they are very difficult to be successfully treated. The aim of this systematic review was to analyze the evidence on the effectiveness of topical and/or systemic metronidazole for the treatment of bad odor in malignant tumor wounds. Results: Sixty-two articles were initially found, and of these, only 4 articles met the inclusion criteria. Two of them were clinical trials, being 1 double-blind, randomized and 1 non-controlled phase III studies. One study was retrospective with a 10-years data collection period and 1 was a cohort prospective study. Of these, 3 analyzed the efficacy of treating malignant tumors with a bad odor using topical metronidazole and only 1 compared the use of topical and systemic metronidazole. Discussion: A factor that contributes to the bad odor not being properly controlled is the lack of standardized protocols. Over the years, studies have tried to find affordable and effective interventions to reduce serious recurrences of bad odor in necrotic wounds. Conclusion: Both topical and systemic routes have been shown to be effective in controlling bad odor. The results of this systematic review highlight the lack of research in this area with little evidence to guide clinical practice in the treatment of these injuries. Further studies are needed to establish more effective protocols to control this distressing condition, experienced by some cancer patients.

056 Perampanel and secondarily generalised seizures in a pooled analysis of phase III studies and their open-label extension: effect of enzyme-inducing antiepileptic drugs

2018 ◽  
Vol 89 (6) ◽  
pp. A23.2-A23
Author(s):  
David Ko ◽  
Betsy Williams ◽  
Anna Patten ◽  
Antonio Laurenza
Keyword(s):  
Antiepileptic Drugs ◽  
Phase Iii ◽  
Adjunctive Treatment ◽  
Seizure Freedom ◽  
Partial Seizures ◽  
Open Label ◽  
Double Blind ◽  
Link Type ◽  
Open Label Extension ◽  
Phase Iii Studies

IntroductionPerampanel is approved for adjunctive treatment of partial seizures, with or without secondarily generalised seizures (SGS), and primary generalised tonic-clonic seizures in epilepsy patients aged ≥12 years. Approval of perampanel for partial seizures was based on three randomised, double-blind, placebo-controlled, Phase III Studies 304 (NCT00699972), 305 (NCT00699582) and 306 (NCT00700310); patients completing these could enter open-label extension (OLEx) Study 307 (NCT00735397). Here, we report efficacy of perampanel as adjunctive treatment of SGS by co-administration of enzyme-inducing antiepileptic drugs (EIAEDs) versus non-EIAEDs in both the Phase III and OLEx studies.MethodsIn the double-blind studies, patients (≥12 years) with partial seizures, with or without SGS, receiving 1–3 AEDs at Baseline were randomised to placebo or 2–12 mg/day perampanel for 19 weeks. In the OLEx, patients received ≤12 mg/day perampanel for ≤272 weeks. Efficacy assessments included median percent change in SGS frequency/28 days, SGS 50% and 75% responder and seizure-freedom rates.ResultsFor patients with SGS at pre-perampanel Baseline, 564 were in the double-blind studies and 388 received perampanel for ≥1 year in the OLEx. In the double-blind studies, perampanel co-administered with an EIAED (carbamazepine, eslicarbazepine, oxcarbazepine, phenytoin) had reduced efficacy compared with non-EIAEDs due to increased clearance; this was particularly evident at higher doses, although these differences were still greater than placebo. In the OLEx, concomitant administration of both non-EIAEDs and EIAEDs was associated with sustained efficacy, with slightly better efficacy during the first, second and third years of perampanel exposure for non-EIAEDs compared with EIAEDs.ConclusionPerampanel demonstrated good and sustained long-term efficacy against SGS. With the recent FDA approval of perampanel for monotherapy use for partial seizures, non-EIAED data may be more relevant for consideration if perampanel is used as a single agent (no other AED) while real-world data and experience are accumulated.Study supportEisai Inc.

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