Safety Profile of the Use of Iodopovidone for Pleurodesis in Patients with Malignant Pleural Effusion.

BACKGROUND: Iodopovidone is an alternative agent used to promote pleurodesis in patients with malignant pleural effusion (MPE). However, safety is a concern, and many authors still reject its use. OBJECTIVES: Our main objective is to describe the occurrence of common and severe adverse events after pleurodesis with two different doses of iodopovidone in patients with MPE. Our secondary objective is to evaluate dose dependency, efficacy, quality of life, and systemic inflammation. METHODS: We conducted a double-blind, randomized clinical trial including patients with recurrent MPE. Patients underwent chest tube insertion and were randomized into two groups according to the doses of iodopovidone: group 1 received 1% iodopovidone, and group 2 received 2% iodopovidone. During follow-up, adverse events, inflammatory markers, quality of life, and imaging exams were systematically evaluated and registered. RESULTS: Sixty patients were analyzed (55 females, 5 males, median age 55.9 years). Overall, 227 adverse events possibly related to pleurodesis were registered, including 47 serious adverse events (in 34 patients). Pleuritic pain and hypertensive peaks were the most frequently observed serious adverse events (11 and 10 episodes, respectively). Grade 3/4 metabolic events such as hyponatremia and an increase in alkaline phosphatase, AST and ALT levels were also common. C-reactive protein (CRP) levels increased substantially and peaked 48 h after pleurodesis. No difference was observed between groups with regard to adverse events, CRP levels, efficacy, or quality of life. CONCLUSIONS: Adverse events after iodopovidone pleurodesis in patients with MPE are common and similar in the two doses studied.

Concurrent and construct validity of the audit in an urban brazilian sample.

AIMS: To assess the concurrent and the construct validity of the Alcohol Use Disorders Identification Test (AUDIT) in an urban Brazilian sample. METHODS: A random sample of 166 clients of a health management organization, participated in this study. They were visited in their households and completed a self-report questionnaire, which included the AUDIT. Later, they answered the alcohol-related disorders (ARDs) Section of the Composite International Diagnostic Interview. The receiver operating curve (ROC) was used to find the best cut-off point for ICD-10 diagnosis of ARDs. Confirmatory factor analysis was run to assess the construct validity. RESULTS: The ROC analysis showed the same cut-off point (7/8) for ICD-10 diagnosis of ARDs found in previous studies carried out in primary care settings, including in Brazil, with a sensitivity of 100% and a specificity of 76%. The confirmatory factor analysis suggested a two-factor structure. The first factor measured consumption and the second factor alcohol-related problems. CONCLUSIONS: The results supported the use of the self-reported version of the AUDIT in epidemiologic studies, and showed a similar cut-off point for detection of ARDs and hazardous drinking.