Antibiotikaprofylax vid kirurgiska ingrepp - SBU

Table 4.12.4 continued
Author
Year
Reference
Country
Study
design
Population
characteristics
Intervention
Method
Number individuals
Control
Number
individuals
Results
Withdrawal
Drop outs
Study quality
and relevance
Comments
Tobias-
Machado
2003
[29]
Brazil
Controlled
trial
Transrectal core prostate
biopsy. No risk factors
(catheter, pos urine culture,
diabetes, valvular
disease). No ab 1 week
prior to procedure.
n=257
I1: Single dose ciprofloxacin
500 mg po 2 h prior to
biopsy (n=64)
I2: Ciprofloxacin 500 mg
po x 2 for 3 days (n=46)
C1: Chloramphenicol
500 mg
po x 2 for 3 days
(n=71)
C2: Norfloxacin
400 mg po x 2
for 3 days (n=76)
Minor infectious complications
I1: 2/64 (3.1%)
I2: 1/46 (2.1%)
C1: 12/71 (16.9%)
C2: 8/76 (10.5%)
Major infectious complication
Prostatitis with septis
I1: 0
I2: 0
C1: 1/71 (1.4%)
C2: 0
I1, I2 vs C1, C2 sign
I1 vs I2 ns
Not
indicated
Moderate
Minor infectious
complications =
UTI, self-limited
fever, prostatitis,
epididymitis
Yamamoto
2008
[30]
Japan
RCT
Transrectal core prostate
biopsy. Sterile urine and
no risk factors identified
before biopsy
I: Tosufloxacin 300 mg
x 2 for 2 days. First dose 2 h
before biopsy (n=124)
C: Levofloxacin
200 mg x 2 for
2 days, same
regimen (n=119)
Prostatitis/cystitis
I: 6/124 (4.8%)
C: 6/119 (5.0%)
ns
Not
reported
Moderate
Rather high rates
for low-risk patients
Hospitalisation
I: 3/124 (2.4%)
C: 3/119 (2.5%)
ns
ab = Antibiotics; ABP = Antibiotic prophylaxis; C = Control group; cfu = Colony forming
units; h = Hour; I = Intervention group; im = Intramuscular; ITT = Intention-to-treat;
iv = Intravenous; n = Number of patients; NNT = Number needed to treat; ns= Non
significant; po = Per os; PP = Per protocol; RCT = Randomised controlled trial; RF =
Rheumatoid factors; RR = Relative risk; sign = Significant; TMP/SMX = Trimethoprim/
Sulfamethoxazole; TPB = Transrectal prostatic biopsy; UTI = Urinary tract infection;
VHD = Valvular heart disease
462 antibiotikaprofylax vid kirurgiska ingrepp KAPITEL 4 • den systematiska litteraturöversikten
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