PMID- 18549663
OWN - NLM
STAT- MEDLINE
DCOM- 20080811
LR  - 20190911
IS  - 1473-4877 (Electronic)
IS  - 0300-7995 (Linking)
VI  - 24
IP  - 7
DP  - 2008 Jul
TI  - Topical bovine thrombin and adverse events: a review of the literature.
PG  - 2071-87
LID - 10.1185/03007990802186417 [doi]
AB  - OBJECTIVE: To review published evidence suggesting a link between topical bovine 
      thrombin (TBT) and important adverse events (AEs). RESEARCH DESIGN AND METHODS: 
      English language articles and abstracts were obtained from MEDLINE using 
      combinations of text and MeSH terms for thrombin, bovine thrombin and their trade 
      names. References from summary articles were also retrieved. Published case 
      reports, review articles, and retrospective, prospective or observational studies 
      involving either immunogenicity or AEs were selected for further assessment. 
      Retrieved articles were evaluated separately as AE case reports, quantitative 
      studies of antibodies, or quantitative studies of AEs. MAIN OUTCOME MEASURES: 
      Presence of case causal information, temporal pattern of case report publication, 
      reproducibility of aggregate data findings, and study design features. RESULTS: 
      The major limitations of reviewed publications were insufficient information 
      regarding TBT and other exposures, and designs in which linkage between 
      laboratory immune phenomena and AEs could not be evaluated. While immunogenicity 
      studies did support an increased risk for post-TBT antibodies, there was no 
      consistent evidence that this led to an increased AE risk or severity. Common 
      evidentiary deficiencies included case reports from high incidence environments, 
      studies of combination or mixture products, biased study designs, lack of 
      patient-level exposure data, inadequate control groups and insufficient sample 
      sizes. The best designed study (a randomized, controlled comparison of TBT to a 
      recombinant bovine product) documented post-TBT antibody production, but no 
      important efficacy or AE differences. An examination of publication dates for 
      case reports showed a peak between 1992 and 1994 followed by a substantial drop. 
      Since 1997 the number of published AE case reports has continued to decline. 
      CONCLUSIONS: TBT increases the risk for antibody elevations in patients. A 
      careful review of published evidence does not show that either TBT itself or any 
      associated elevations in anti-bovine antibodies are risk factors for clinically 
      important AEs.
FAU - Clark, John
AU  - Clark J
AD  - United BioSource Corporation, Medford, MA 02155, USA.
FAU - Crean, Sheila
AU  - Crean S
FAU - Reynolds, Matthew W
AU  - Reynolds MW
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PT  - Review
DEP - 20080611
PL  - England
TA  - Curr Med Res Opin
JT  - Current medical research and opinion
JID - 0351014
RN  - 0 (Hemostatics)
RN  - EC 3.4.21.5 (Thrombin)
SB  - IM
MH  - Administration, Topical
MH  - Animals
MH  - Antibody Formation
MH  - Cattle
MH  - Hemostatics/*administration & dosage/*adverse effects/immunology
MH  - Humans
MH  - Thrombin/*administration & dosage/*adverse effects/immunology
RF  - 47
EDAT- 2008/06/14 09:00
MHDA- 2008/08/12 09:00
CRDT- 2008/06/14 09:00
PHST- 2008/06/14 09:00 [pubmed]
PHST- 2008/08/12 09:00 [medline]
PHST- 2008/06/14 09:00 [entrez]
AID - 4460 [pii]
AID - 10.1185/03007990802186417 [doi]
PST - ppublish
SO  - Curr Med Res Opin. 2008 Jul;24(7):2071-87. doi: 10.1185/03007990802186417. Epub 
      2008 Jun 11.