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loradatine 10 mg/tabletgiven once a day for 14 days To estalish the safety of either regimen, CBC,
or astemizole 10 rag/tablet also given once daily for blood sugar, BUN, creatinine, total protein, alkaline
14 days. phosphatase, SGCOT, SGPT, total bilirubin, and
urinalysis were done prior to and on the last day
Evaluation Criteria of treatment. Side effects were noted on the
symptom diary card and classified accordingly:
Patients daily filled out symptom diary cards to
note the severity of symptoms according to the fol- Mild: Experience was considered
lowing scoring system: trivial and did not cause the
patient any real problem.
O None: No symptom evident
1 - Mild: Trivial; definitely present, Moderate: Experience was a problem to the
but not bothersome patient, but did not interfere
significantly with daily activi-
2 - Moderate: Bothersome, but not ties or the clinical status of
disabling or intolerable the patient.
3 Severe: Disabling and/or intolerable Severe: Experience caused significant
interference with normal daily
On the 3rd, 7th and 14th days of treatment, activities or the clinical status of
overall condition of rhinitis was evaluated by both the patient.
the physician and patient using the following scheme:
O None: Virtually no symptoms are evi- The patient was deemed discharged from the
dent study upon completion of the 14-day drug treatment,
with the development of adverse reactions that
1 Mild: Symptoms do not interfere with prompted discontinuation of the assigned regimen, or
daily activities and/or sleep with persistence of symptoms on the 4th day of
treatment (failure of treatment).
2 Moderate: Some interference with daily
activities and/or sleep
Data Analysis
3 - Severe: Significant/major interference
with daily activities and/or sleep Baseline characteristics and outcome measures of
those who received loratadine and those who received
Therapeutic response was also assessed by both astemizole were compared using Mann-Whitney U
the physician and subject according to the following test or t-test for quantitative variables and chi-square
evaluation scale: or Fisher's exact tests for qualitative variables.
Differences in responses between groups and through
1 - Excellent: Virtually all symptoms have time were evaluated using Friedman's 2-way ANOVA
been eliminated or McEmnar's test.
2 - Good: Most symptoms are improved,
but some symptoms RESULTS
are still listed as mild
Seventy allergic rhinitis patients participated in
3 - Fair: Some response, but most this study. Patient "#32, allocated to receive loratadine,
symptoms are still present was excluded because of abnormally high baseline
level of serum alkaline phosphatase. Another 10 were
4 - Failure: Worse than pre-treatment excluded because of failure to comply with the assigned
baseline Failure: regimen.
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