Safety evaluation of Elixir Paregorico in healthy volunteers: a phase I study.

A liquid alcoholic extract of Papaver somniferum named Elixir Paregorico is extensively used for diarrheal diseases in Brazil. Its increased popularity has brought concerns and fears over the safety of this herbal product. Given the lack of investigative clinical studies, in this regard, this study investigated whether Elixir Paregorico administration causes any noticeable toxic effects in healthy volunteers. In all, 28 middle-aged healthy male (n = 14) and female (n = 14) were enrolled. After screening and a washout period, eligible subjects received four oral doses per day of Elixir Paregorico (3 mL diluted in 30 mL of water) over a 10-day period. Altogether, all 28 participants completed the study. The results of hematological and biochemical tests performed pre and post-treatment were within the normal range. In both male and female volunteers, there were no statistical differences (P > 0.05) in the results of clinical and laboratory tests performed at screening, on 5th and 10th day visits, and at final assessment. Although mild adverse events were related, which subsided spontaneously, no serious untoward reactions were reported following Elixir Paregorico administration. To our knowledge, this is the first demonstration that Elixir Paregorico administered four times a day for 10 days is safe and does not cause any noticeable toxic effect in healthy volunteers.

Orgaran (Org 10172) or heparin for preventing venous thrombosis after elective surgery for malignant disease? A double-blind, randomised, multicentre comparison. ANZ-Organon Investigators' Group.

This double-blind, randomised, multicentre trial in 513 patients having elective surgery for intra-abdominal or intrathoracic malignancy compared the efficacy and safety of venous thrombosis (VT) prophylaxis using 750 anti-factor Xa units of Orgaran (a mixture of low molecular weight heparinoids) given subcutaneously (sc) twice-daily with that of twice-daily injections of 5,000 units standard heparin. The main study endpoints were the development of postoperative VT detected by 125I-fibrinogen leg scanning, and the onset of clinically significant venous thromboembolism or bleeding. "Intent to treat" analysis showed a statistically non-significant trend towards less VT during Orgaran prophylaxis (10.4%) than after heparin (14.9%) and there was no difference in bleeding complications between the two study groups. Results remained similar if only patients who completed the intended course of therapy ("compliant patients") were analysed. Other trials have shown that Orgaran prevents VT after hip surgery and stroke. We now show it is also safe and effective in patients having major surgery for cancer.

[Blood culture update]. / Actualités sur l'hémoculture.

BACKGROUND: Blood culture is one of the most important bacteriological examinations with important clinical and therapeutic consequences. Blood cultures should be ordered in all patients with signs suggesting septicemia, endocarditis or severe infection (pneumococcal pneumonia, bacterial meningitis with bloodstream dissemination). Blood culture methods have evolved considerably over the last twenty years. After using manual methods for many years, read by non-standardized visual methods, the development of media with defined compositions and supplemented to allow growth of bacteria difficult to culture has been associated with the development of automatic blood culture devices. AUTOMATIC DEVICES: These devices have undergone rapid improvement. Semi-automatic devices (Bactec NR-660) were rapidly followed by completely automatic techniques, including four devices currently available: since 1989 Bio-Argos (Rio-Rad) and Bact/Alert (Organon-Teknika) and in 1993, Bactec 9240 (Becton-Dickinson) and Vital (BioMérieux). All these devices allow automatic detection of CO2 produced during bacterial growth. Automatic reading systems provide continuous output avoiding the need for invasive methods and thus the risk of contamination in addition to saving time. Potential application to achieve quantitative blood cultures for intensive care units is in the development stage. CONSEQUENCES: The reliability of these devices is well recognized and their contribution to severe bacterial infection is undeniable. There are certain limitations however related to material cost and the non-identification of the pathogen involved. Molecular biology techniques open new perspectives in this field. The evolution of techniques, definitions, and pathogenic approach to septicemia must be revisited as new infectious situations have been identified at the same time as new investigation tools resulting from considerable technological progress. New methods of blood culture have largely contributed to this progress.