Elektronisk udgave - Sundhedsstyrelsen

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about 1 to 2 units. Reductions were not estimable in the case of PAD,
and seemed very small in the case of EPO. Thirdly, in the case of EPO,
autotransfusion/CS and PAD there were trends towards lower rates
of infection. The number of patients that would have to be treated so
that one patient would avoid postoperative infection (possibly caused
by immunosuppression from receiving allogeneic blood) was in the
range of 40 to 50 patients, while aprotinin and TXA were not found
effective with regard to this outcome (wound infection/complication
and fever noted in the postoperative period) .
Finally, the update found a trend towards lower rates of re-operation
due to bleeding in relation to TXA as well as aprotinin, while
ISPOT-analyses only had this result in the case of aprotinin.
3.4 Results from an additional analysis of adverse effects
The clinical trials included in the ISPOT-analyses have been concerned
primarily with the efficacy of these technologies. Reported side
effects in the studies have been rare – most likely because they were
not looked for (or known to the attending surgeon). On the other
hand, information about the safety of the interventions had mostly
relied on case reports, uncontrolled studies, and, for the pharmacological
agents, extrapolation from non-surgical settings. Therefore,
in addition to the ISPOT-study, a more specific search restricted to
adverse effects was performed for each individual technology (exept
ANH) by Faught et al (7) 14 . For the pharmacological agents, randomized
controlled trials that described the presence or absence of
adverse effects were combined in a meta-analysis whenever possible
(which have to be distinguished from the previous ISPOT-analyses).
In the following, main findings focused on clinical implications are
summarized.
Aprotinin
The most common side effects reported with aprotinin include hypersensitivity
reactions, renal dysfunction and arterial thrombosis.
The risk of an allergic reaction and possible anaphylaxis with aprotinin
is not insignificant, especially in the case of reexposure to aprotinin,
where reactions occur in approximately 2.8% of patients.
Aprotinin should be avoided entirely within 6 months of previous
14 Using MEDLINE and EMBASE databases from 1966-97 for the pharmcological agents (for EPO 1985-97) and from 1993-1997 for PAD
and autotransfusion/CS.