[Substitution of factor XIII concentrate in treatment refractory ulcerative colitis. A prospective pilot study].

BACKGROUND

Severe acute inflammation in ulcerative colitis is often associated with major intestinal blood loss. Studies on hemostasis present a deficiency of F XIII which is important for clot formation and wound healing.

PATIENTS AND METHODS

A total of ten patients had been treated with 5-aminosalicylic-acid and corticosteroids consequently for three weeks. Thereafter a clinical improvement did not occur, the colitis activity index (CAI) and the endoscopic score (ES) remained elevated (9.9 +/- 1.5 points and 8.9 +/- 2.3 points, respectively). Because of this therapy-resistant active stage of disease in an open and prospective pilot trial F XIII concentrate (1,250 IU, Fibrogammin HS, Behringwerke, Germany) was additionally administered intravenously for ten days.

RESULTS

The additional substitution therapy resulted in a significant improvement of complaints, the stool frequency decreased from 9 +/- 4.1 to 2.4 +/- 1.5 (p < 0.001). Both, the clinical activity index (2.8 +/- 1.6; p < 0.0001, vs day 0) and the endoscopic score (4.4 +/- 2.2; p < 0.005, vs day 0) declined significantly during the F XIII substitution. The F XIII activity was markedly reduced initially (46.1 +/- 17.4%) and showed a significant increase after the substitution (171 +/- 41.7%; p < 0.001).

CONCLUSION

The results may suggest that substitution therapy with F XIII concentrate can be beneficial in patients with therapy-resistant active stage of ulcerative colitis and proven F XIII deficiency. To verify this preliminary results, controlled clinical trials will have to be performed.