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©2012 Baishideng Publishing Group Co.
World J Gastroenterol. Apr 21, 2012; 18(15): 1773-1780
Published online Apr 21, 2012. doi: 10.3748/wjg.v18.i15.1773
Published online Apr 21, 2012. doi: 10.3748/wjg.v18.i15.1773
Table 1 Simple Clinical Colitis Activity Index[10]
Symptom | Score |
Bowel frequency (d) | |
1-3 | 0 |
4-6 | 1 |
7-9 | 2 |
> 9 | 3 |
Bowel frequency (night) | |
1-3 | 1 |
4-6 | 2 |
Urgency of defecation | |
Hurry | 1 |
Immediately | 2 |
Incontinence | 3 |
Blood in stool | |
Trace | 1 |
Occasionally frank | 2 |
Usually frank | 3 |
General wellbeing | |
Very well | 0 |
Slightly below par | 1 |
Poor | 2 |
Very poor | 3 |
Terrible | 4 |
Extracolonic features | 1 per manifestation |
Table 2 Description of four excluded patients and eight dropouts
Day | SCCAI run in | Reason for discontinuation | SCCAI dropout | Reduction | Increase |
Excluded patients | |||||
10 | 8.9 | 1 | 6.6 | 2.3 | |
45 | 8.0 | 1 | 4.1 | 3.9 | |
100 | 8.2 | 1 | 4.1 | 4.1 | |
116 | 11 | 2 | 3.6 | 7.4 | |
Drop-outs | |||||
9 | 8.9 | 3 | 6.7 | 2.2 | |
54 | 4.6 | 3 | 5.1 | 0.5 | |
73 | 5.9 | 3 | 7.3 | 1.4 | |
100 | 5.6 | 3 | 8.4 | 2.8 | |
102 | 9.0 | 3 | 6.7 | 2.3 | |
127 | 6.6 | 3 | 5.6 | 1.0 | |
140 | 6.7 | 3 | 5.3 | 1.4 | |
141 | 8.3 | 3 | 6.3 | 2.0 |
Table 3 Demographic and baseline clinical characteristics of patients
Characteristic | Profermin, n = 39 |
Sex, male:female | 15/24 |
Age, yr, median and range | 35 (19-50) |
Mean duration of disease, yr, median and range | 7 (1-21) |
Disease location, n (%) | |
Proctitis | 17 (44) |
Left-sided colitis/procto-sigmoiditis | 11 (28) |
Pancolitis | 11 (28) |
Extraintestinal manifestations, n (%) | 17 (43) |
Initial CRP, mg/L, median and range | 15 (< 1-156) |
Initial albumin, g/L, median and range | 41 (23-47) |
Table 4 Concomitant medications
n (%) | |
Mesalamine oral | |
Alone | 21 (54) |
Combined with immunosuppressants | 8 (21) |
Mesalamine enema or suppository | 6 (15) |
Azathioprine or 6-mercaptopurine | 3 (8) |
Corticosteroids oral | 0 (0) |
Corticosteroids enema | 1 (3) |
Antibiotics | 0 (0) |
TNF-α inhibitors | 3 (8) |
None | 3 (8) |
- Citation: Krag A, Israelsen H, Ryberg BV, Andersen KK, Bendtsen F. Safety and efficacy of Profermin® to induce remission in ulcerative colitis. World J Gastroenterol 2012; 18(15): 1773-1780
- URL: https://www.wjgnet.com/1007-9327/full/v18/i15/1773.htm
- DOI: https://dx.doi.org/10.3748/wjg.v18.i15.1773