-
plained by any preexisting disease, concomitant drug use,
or other chemical substance. Information about the patient
discontinuing use of the drug is not complete or is not
available.
- Unlikely: The adverse reaction occurred during a time period that does not correspond to the drug usage, and cannot be explained by any preexisting disease, concomitant drug use, or other chemical substance.
- Unclassified: More data are essential for a proper assessment or those additional data are under examination.
- Unclassifiable: The information is insufficient or contradictory, which makes it impossible to judge the relationship between the health product and the adverse event. Data cannot be supplemented or verified.
Individuals 18 years and older with a history of cutaneous adverse
drug reactions from PPIs at Siriraj Hospital from January
2005 through May 2010 were included in a study group. After
identifying each study case, the next 15 patients with consecutive
hospital numbers were sampled, and one who had
received PPIs during the study period without adverse reaction
was chosen for the control group. Inpatient and outpatient data
of the case and control subjects were reviewed retrospectively.
The prescription data of each PPI were obtained from the database
at the Information Technology Center at Siriraj Hospital.
Statistical Analysis
Descriptive statistics, eg, mean, median, minimum, maximum,
and percentages, were used to describe demographic data,
cutaneous adverse drug reactions, and clinical characteristics.