Standard methods for drug quality evaluation include high-performance liquid chromatography (HPLC) and spectroscopy. It is imperative that a falsified medicine be identified as quickly as possible so that regulatory agencies and enforcement officials can take immediate action, assuming that drug quality is a priority issue and these agencies are adequately funded to take the necessary action. The scarcity and high cost of some medicines and unregulated markets are also major contributors to the problem. Also, weak drug regulatory and enforcement agencies enable the counterfeiters to proliferate. Although these countries are relatively poor, the prevalence of the disease contributes to a high volume of sales, thereby making these areas lucrative locations for the counterfeit trade. Low-income countries with high malaria burden are easy targets for falsified (term used to distinguish from the term counterfeit medicines that invokes intellectual property issues) drug manufacturers. 4 As a result of the expanding market in Africa, falsified (counterfeit) AMLF (Coartem) has already been reported in many west and central African countries. The first fixed-dose ACT, meeting the WHO prequalification criteria for efficacy, safety, and quality is the brand Coartem ™, an AMLF drug manufactured by Novartis (Basel, Switzerland). 3 An ACT being very widely purchased and distributed by international and national organizations globally combines lumefantrine (long half-life drug) with artemether (artemisinin derivative) into a fixed-dose tablet (AMLF).
This formulation, termed artemisinin combination therapy (ACT) is recommended by the World Health Organization (WHO) as first-line treatment in most malaria-endemic countries. Therefore, this class of antimalarial is combined with a partner drug, such as lumefantrine, amodiaquine, piperaquine, or mefloquine, possessing a longer half-life. Although the artemisinins are the most rapidly acting of all antimalarial drugs, 2 potential resistance has led to the abandonment of oral artemisinin monotherapy.
1 Malaria can be cured with effective antimalarial drugs but due to the growth of Plasmodium falciparum resistance, traditional antimalarials such as chloroquine and sulfadoxine/pyrimethamine are no longer recommended. In 2012, an estimated 627,000 deaths were attributed to malaria with the disease occurring mostly in African children. Minimally invasive approach does not decrease the incidence of new-onset AF.Low-income countries bear the highest proportion of deaths caused by human immunodeficiency virus/acquired immune deficiency syndrome (HIV/AIDS), tuberculosis, and malaria. New-onset AF is associated with severe post-operative complications and longer hospital stay. Transthoracic approach is an independent risk factor for the development of new-onset AF after esophagectomy. Multiple logistic regression analysis showed transthoracic approach (OR = 3.71, CI = 1.23-11.17, p = 0.02) and thyroid disorder (OR = 6.29, CI = 1.54-25.65, p = 0.01), and severe post-op complications (OR = 3.34, CI = 1.20-9.28, p = 0.02) were significantly associated with the development of new-onset AF. 14 days, p < 0.001) with severe post-operative complications (Clavien score ≥ III) (69 vs. 87.74%, p = 0.02) and stayed longer in hospital (19 vs. 61.3, p = 0.021), with medical comorbidities (thyroid disorder, hyperlipidemia, and coronary artery disease p < 0.05) and lower diffusion capacity on Pulmonary function test (80.16 vs. Median onset of AF was post-op day 3 (0-32). Forty-five (23.4%) patients with esophagectomy developed new-onset AF. Overall 30-day or in-hospital mortality was 3.6% (7/192). Gastric conduit was used in 185 patients and colonic conduit in seven patients. Esophagectomies were performed with Ivor Lewis Mckeown approach in 78 patients, Ivor Lewis approach in 56 patients (31 MIE, 10 Open, 15 Hybrid) and Transhiatal approach in 58 patients (16 MIE and 42 Open). Of 192 esophagectomies, 160 had malignancy (138 adenocarcinoma and 22 squamous cell carcinoma) and 106 (66.25%) received neo-adjuvant therapy. Appropriate statistical analysis is performed utilizing Sigmaplot(®) version 12.3.įrom 2003 to 2013, 245 esophagectomies were performed at our institution, of these, 192 (147 males, mean age of 62 ± 11.12 years) were included in the final analysis and 53 were excluded. Data variables collected include pre-operative, intra-operative, and post-operative factors.
The objective of this study is to identify the surgical risk factors associated with new-onset atrial fibrillation after esophagectomy.Īfter Institutional Review Board approval, a prospectively maintained database was retrospectively queried to identify patients who underwent esophagectomy between 20. Atrial fibrillation (AF) has been associated with higher morbidity after esophagectomy.
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