[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.


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).


CONCLUSIONS
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.
Lorenz
R
R
II. Medizinische Klinik und Poliklinik der Technischen, Universität München, Klinikum rechts der Isar.
Born
P
P
Classen
M
M
D000208:Acute Disease; D000636:Aminosalicylic Acids / Q000627:therapeutic use; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000627:therapeutic use; D003093:Colitis, Ulcerative / Q000097:blood / Q000628:therapy*; D003131:Combined Modality Therapy; D005176:Factor XIII / Q000627:therapeutic use*; D006801:Humans; D019804:Mesalamine; D011239:Prednisolone / Q000627:therapeutic use; D011446:Prospective Studies
D000636:Aminosalicylic Acids; D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine; D005176:Factor XIII; D011239:Prednisolone
Substitution von Faktor-XIII-Konzentrat bei therapieresistenter Colitis ulcerosa. Eine prospektive Pilotstudie.