ABSTRACT
BACKGROUND: Diabetes mellitus represents an independent risk factor for contrast-induced acute kidney injury. We report the results of a prespecified substudy of patients with diabetes mellitus included in the Acetylcysteine for Contrast-Induced Nephropathy Trial (ACT), the largest randomized study evaluating the effects of acetylcysteine for the prevention of contrast-induced acute kidney injury conducted to date. METHODS AND RESULTS: From the 2308 patients included in the ACT, 1395 had diabetes mellitus and were considered for the present analysis. The study drugs (acetylcysteine 1200 mg or matching placebo) were administered orally twice daily for 2 doses before and 2 doses after the procedure. The allocation was concealed (central Web-based randomization). Participants, healthcare staff, data collectors, and outcome assessors were blinded. All analysis followed the intention-to-treat principle. The incidence of contrast-induced acute kidney injury (primary end point) was 13.8% in the acetylcysteine group and 14.7% in the control group (relative risk 0.93; 95% confidence interval, 0.69-1.26; P=0.64). A combined end point of death or need for dialysis at 30 days was also similar in both the groups (2.2% and 2.1%, respectively; hazard ratio, 1.07; 95% confidence interval, 0.52-2.19; P=0.86). CONCLUSIONS: In this subanalysis, acetylcysteine did not reduce the risk of contrast-induced acute kidney injury or other clinically relevant outcomes in patients with diabetes mellitus undergoing coronary and peripheral vascular angiography. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00736866.
Subject(s)
Acetylcysteine/administration & dosage , Acute Kidney Injury/prevention & control , Contrast Media/adverse effects , Coronary Artery Disease/diagnostic imaging , Diabetic Angiopathies/diagnostic imaging , Peripheral Vascular Diseases/diagnostic imaging , Acute Kidney Injury/etiology , Acute Kidney Injury/mortality , Aged , Coronary Angiography/adverse effects , Coronary Artery Disease/mortality , Diabetic Angiopathies/mortality , Female , Free Radical Scavengers/administration & dosage , Glomerular Filtration Rate , Humans , Incidence , Male , Middle Aged , Peripheral Vascular Diseases/mortality , Placebos , Risk Factors , Treatment FailureABSTRACT
The authors report the occurrence of a fatal case in patient with cutaneous leishmaniasis in the municipality of Caxias, MA. Male patient, 22 years old, road sweeper, presented with an ulcer in left leg, diagnosed as cutaneous leishmaniasis and treated with sodium stibogluconate BP88 (Sb+5) (Shandong Xinhua) at a dose of 10mg/Sb+5/kg/day/20 days. After dose three he presented arthralgia, myalgia, nausea and weakness. During the therapy there was an aggravation of the symptoms with abdominal pain and irradiation into the thorax. After dose seven he presented a picture of associated dyspnea and thoracic pain of mild intensity. At dose nine there was further worsening of the picture, nevertheless the therapy was continued up to dose 11, when the patient's state deteriorated to such an extent that he was hospitalized in the intensive care unit. Exams: erythrocytes, 4.4 million; hemoglobin, 10.6%; hematocrits, 35%; white blood cells 26,400, basophiles and myelocytes (0); segmented leukocytes, 59%; lymphocytes 30%; monocytes 2%; platelets (normal); glucose, 42mg%; urea, 73mg%; creatinine, 2.4mg%; and ECG (blockade of right branch). The patient died from cardiorespiratory insufficiency. The current report underscores the need to clarify health workers regarding the use of Sb+5 and also to remind the Health Ministry to verify the quality and origin when acquiring new products.
Subject(s)
Antimony Sodium Gluconate/adverse effects , Antiprotozoal Agents/adverse effects , Leishmaniasis, Cutaneous/drug therapy , Adult , Fatal Outcome , Humans , MaleABSTRACT
Os autores relatam a ocorrência de óbito em paciente portador da forma cutânea da LTA no município de Caxias-MA. Trata-se de paciente do sexo masculino, 22 anos, gari, portador de lesäo ulcerada no membro inferior (perna esquerda), diagnosticado, após encontro do parasita (Leishmania) na lesäo, tratado com stibogluconato de sódio BP88® (Shandong Xinhua) na dose de 10mg/Sb+5/kg/dia/20 dias. Após a 3ª dose apresentou dores articulares, naúseas, mal estar geral. Com a continuaçäo da medicaçäo houve agravamento do quadro com dor epigástrica e no hipocôndrio direito irradiando-se para o hemitórax homolateral. Após a 7ª dose apresentou dispnéia associado à dor torácica de leve intensidade. Na 9ª dose houve piora do quadro, mesmo assim continuou a usar o medicamento até a 11ª dose quando seu estado agravou-se. Foi internado, necessitando de tratamento intensivo. Nos exames realizados apresentou: 4,4 milhöes de eritócitos, 10,6 por cento de hemoglobina, 35 por cento de hematócrito, 26.400 de leucócitos, basófilos e mielócitos (0), 59 por cento de segmentados, 30 por cento de linfócitos, 2 por cento de monócitos, plaquetas (normais), glicose 42mg por cento, uréia 73mg por cento, creatinina (2,4mg por cento), eletrocardiograma (bloqueio de ramo direito). Veio a falecer tendo como causa do óbito, insuficiência cárdio respiratória. O relato atual mostra a necessidade de esclarecimento das equipes de saúde quanto ao uso dos Sb+5 e também lembrar o Ministério da Saúde quando da aquisiçäo de novos produtos, preocupar-se com a qualidade e procedência do mesmo
