Sk. Bowalekar et al., SAFETY AND EFFICACY OF INTRAVENOUS PEFLOXACIN IN SURGICAL PATIENTS - PROPHYLACTIC AND THERAPEUTIC USE, Advances in therapy, 13(3), 1996, pp. 149-153
Citations number
6
Categorie Soggetti
Medicine, Research & Experimental","Pharmacology & Pharmacy
This report of the first phase IV computerized study on pefloxacin inf
usion in Indian patients includes completed, comprehensive patient rec
ord sheets (N = 2171) compiled by 290 doctors in various surgical spec
ialties. Ready-to-use pefloxacin (RTUP) was given prophylactically to
1347 patients undergoing clean, clean contaminated, or contaminated su
rgical procedures. Some patients received one 400-mg dose of RTUP befo
re surgery and some received one 400-mg dose before surgery and one 12
hours after surgery. Total dose in 24 hours was 800 mg (maximum). In
770 patients with postoperative infections, RTUP was administered twic
e daily for 6 days. Fever, pain, swelling, and exudates were assessed
on days 1 through 7 and 10 days after therapy. All side effects were n
oted. Proportions were expressed as percentages in computerized data e
ntry and statistical analyses (95% confidence interval). The 2171 pati
ents were categorized as having undergone: gastrointestinal (893), ort
hopedic (497), urologic (223), gynecologic (112), minor surgery (280),
or other (166) procedures. RTUP was uniformly effective and 84% of pa
tients treated for infection and 91% of patients treated prophylactica
lly responded favorably. Overall response rates showed that fever disa
ppeared in 3.5 to 5.3 days, swelling in 3.6 to 5.1 days, pain in 3.4 t
o 4.7 days, and exudate in 5.3 to 6.7 days. A total of 44 patients (2%
) reported side effects, 18 of whom (40%) had nausea and vomiting. Oth
er side effects were diarrhea (5/44), gastric upset (7/44), abdominal
pain (6/44), dizziness (4/44), and chills (4/44). No patient discontin
ued therapy because of an adverse reaction. Study results of this firs
t computerized phase IV evaluation of RTUP indicate that it is safe an
d effective in Indian patients.