Rebamipide enema therapy for left-sided ischemic colitis patients accompanied by ulcers: Open label study

Table 1 Stage classification of gastric ulcer by Sakita-Miwa and its translation into numerical expression[26]

Stages		Manifestation
Active stage	A1 (6p)	The surrounding mucosa is edematously swollen and no regenerating epithelium is seen endoscopically
	A2 (5p)	The surrounding edema has decreased, the ulcer margin is clear, and a slight amount of regenerating epithelium is seen in the ulcer margin. A red halo in the marginal zone and a white slough circle in the ulcer margin are frequently seen. Usually, converging mucosal folds can be followed right up to the ulcer margin
Healing stage	H1 (4p)	The white coating is becoming thin and the regenerating epithelium is extending into the ulcer base. The gradient between the ulcer margin and the ulcer floor is becoming flat. The ulcer crater is still evident and the margin of the ulcer is sharp. The diameter of the mucosal defect is about one-half to two-thirds that of A1
	H2 (3p)	The defect is smaller than in H1 and the regenerating epithelium covers most of the ulcer floor. The area of white coating is about a quarter to one-third that of A1
Scarring stage	S1 (2p)	The regenerating epithelium completely covers the floor of ulcer. The white coating has disappeared. Initially, the regenerating region is markedly red. Upon close observation, many capillaries can be seen. This is called “red scar”
	S2 (1p)	In several months to a few years, the redness is reduced to the color of the surrounding mucosa. This is called “white scar”

Table 2 Clinical features of the ischemic colitis patients: Comparison between the rebamipide and conventional therapy groups

	Conventional group (n = 9)	Rebamipide group (n = 6)	Statistical significance
Age (mean, range, yr)	68 ± 19 (35-87)	69 ± 16 (41-85)	NS
Percentage of females (%)	77.8	66.7	NS
Lesion location: left colon (%)	88.9	100	NS
Performance status 0-1 (%)	77.8	100	NS
WBC count (× 103/&mgr;L)	12.3 ± 4.7	13.5 ± 5.3	NS
CRP (mg/dL)	2.6 ± 4.1	1.7 ± 1.8	NS
K (mEq/L)	3.8 ± 0.4	4.2 ± 0.5	NS
Total cholesterol (mg/dL)	179.3 ± 30.6	191.2 ± 63.0	NS
TG (mg/dL)	93.3 ± 41.0	131.2 ± 74.2	NS
LDH (IU/L)	190.0 ± 42.8	202.8 ± 18.2	NS
CPK (IU/L)	80.7 ± 38.9	118.0 ± 76.6	NS

Values are the mean ± SD. The percentage of females and the lesion location were evaluated by the Fisher’s exact test. Other data were evaluated by Student’s t-test after skewing the values by log transformation. WBC: White blood cell; CRP: C-reactive protein; K: Potassium; TG: Triglyceride; LDH: Lactate dehydrogenase; CPK: Creatinine phosphokinase.

Table 3 Underlying disease: Comparison between the rebamipide and conventional therapy groups n (%)

	Conventional group (n = 9)	Rebamipide group (n = 6)	Statistical significance
Hypertension	6 (66.7)	2 (33.3)	NS
Hyperlipidemia	0	3 (50.0)	NS
Diabetes mellitus	1 (11.1)	1 (16.7)	NS
Atrial fibrillation	1 (11.1)	0	NS
Cerebral infarction	1 (11.1)	0	NS
Chronic constipation	5 (55.6)	1 (16.7)	NS
Medications
Antihypertensive agents	5 (55.6)	1 (16.7)	NS
Others	1 (11.1)	1 (16.7)	NS
History of abdominal surgery	4 (44.4)	3 (50.0)	NS

Values are expressed in percentages. Percentages were evaluated by the Fisher’s exact test.

Table 4 Duration of fasting, duration of hospitalization and reduction in the ulcer score: Comparison between the rebamipide and conventional therapy groups

	Conventional group (n = 9)	Rebamipide group (n = 6)	Statistical significance
Duration of fasting (d)	7.9 ± 4.1	2.7 ± 1.8	P = 0.0121
Duration of hospitalization (d)	17.9 ± 6.8	9.2 ± 1.5	P = 0.0092
Degree of ulcer healing1 (points)	2.8 ± 0.5 (n = 5)	3.5 ± 0.5	P = 0.0797
WBC decrease2 (× 103/&mgr;L)	8.6 ± 5.7	12.0 ± 5.6	P = 0.3360

Values are the mean ± SD.

¹The ulcer lesion was scored according to the Sakita-Miwa classification of the stage of gastric ulcer, then the difference between the baseline score (at the time of diagnosis) and at the time of the follow-up colonoscopy was divided by the number of days between the baseline and the follow-up examination, to correct the results to the value on d 7 (A1: 6 points, A2: 5 points, H1: 4 points, H2: 3 points, S1: 2 points, S2: 1 point).

²Difference in value between that measured at admission and that measured at the time of the follow-up was divided by the number of days between the two examinations to correct the results to the value on d 7.