Biomedical subjects

K R Brown

Publications and source records attributed to K R Brown.

56 records · Page 4Linked to original sources

PubMedDate not supplied

Efficacy and safety of imipenem/cilastatin: a review of worldwide clinical experience.

The clinical experience of 1,723 patients treated with imipenem/cilastatin in worldwide clinical trials is reviewed. Dosages of imipenem administered parenterally with cilastatin varied with the severity of the infection and included 250 mg four times a day; 500 mg three or four times a day, and 1 g three of four times a day. Infections of all body systems except the central nervous system due to gram-positive or gram-negative aerobes and anaerobes as well as those due to mixed organisms were treated. Clinical efficacy was demonstrated in 92% of infections. The adverse clinical and laboratory experiences associated with imipenem/cilastatin were similar to those of other beta-lactam agents and included disturbances of gastrointestinal and central nervous system function, allergic reactions, and transient elevations of liver enzyme levels.

Adult↗

PubMedDate not supplied

Problems and benefits of an antibiotic compassionate therapy program.

So-called compassionate therapy can provide life-saving drug(s) for patients but can also introduce liabilities that may discourage such treatment. The procedures required for compassionate use of imipenem/cilastatin and a summary of the results of its use are used as examples. Physicians requesting drugs for compassionate therapy face problems in the timely acquisition of antibiotic from the manufacturer and the completion of the regulatory and patient case report forms. The pharmaceutical company encounters difficulties with the return of documents, the ability to use the treatment data for registration claims, and the assessment of outcome and safety in patients with multiple confounding medical problems. The benefits of compassionate therapy for all participants should favor its continued use. Suggestions for the improvement of compassionate therapy programs include streamlining of case report forms and more disciplined completion of forms by investigators.

Anti-Bacterial Agents↗