Ulinastatin in the treatment of severe acute pancreatitis: A single-center randomized controlled trial

Table 1 Comparison of baseline data

	UTI group (n = 91)	Placebo group (n = 90)	P value
Age (year, mean ± SD)	52.7 ± 3.8	53.5 ± 4.1	0.175
Gender, n (%)			0.705
Male	67 (73.63)	64 (71.11)
Female	24 (26.37)	26 (28.88)
BMI (kg/cm2, mean ± SD)	22.6 ± 2.1	23.1 ± 2.5	0.147
Cause of disease, n (%)			0.582
Biliary	61 (67.03)	57 (63.33)
Hyperlipidemic	18 (19.78)	19 (21.11)
Alcoholic	12 (13.09)	14 (15.56)
Smoking history, n (%)			0.483
Yes	53 (58.24)	57 (63.33)
No	38 (41.76)	33 (36.67)
Drinking history, n (%)			0.371
Yes	58 (58.24)	63 (70.00)
No	33 (41.76)	27 (30.00)
Living environment, n (%)			0.604
Town	59 (64.84)	55 (61.11)
Countryside	32 (35.16)	35 (38.89)
Past medical history, n (%)
Hypertension	31 (34.07)	29 (32.22)	0.792
Hyperlipidemia	35 (38.46)	37 (41.11)	0.716
Diabetes	28 (30.77)	29 (32.22)	0.833
Cholelithiasis	17 (18.68)	16 (17.78)	0.875
Previous pancreatitis, n (%)	9 (9.89)	10 (11.11)	0.789
APACHE-II score on admission (mean ± SEM)	12.6 ± 0.8	12.2 ± 0.8	0.724
Ranson score on admission (mean ± SEM)	3.3 ± 0.3	3.2 ± 0.4	0.842
Necrotizing pancreatitis	23 (25.27)	20 (22.22)	0.727
Time from the onset to diagnosis (hours)	15.2 ± 6.5	14.6 ± 7.1	0.950
Endoscopic bile duct drainage	37 (40.66)	42 (46.67)	0.455

UTI: Ulinastatin: BMI: Body mass index; APACHE: Acute Physiology and Chronic Health Evaluation.

Table 2 Comparison of 7-day mortality and clinical efficacy, n (%)

	UTI group (n = 91)	Placebo group (n = 90)	P value
7-d mortality	7 (7.69)	19 (21.11)	0.010
Efficacy			0.001
Cured	55 (60.44)	34 (37.78)
Effective	28 (30.77)	35 (38.89)
Ineffective	8 (8.79)	21 (23.33)
Total effectiveness	83 (91.21)	69 (76.67)	0.008

UTI: Ulinastatin.

Table 3 Comparison of the secondary end-points

	Before treatment			After treatment
	UTI group (n = 91)	Placebo group (n = 90)	P value	UTI group (n = 91)	Placebo group (n = 90)	P value
Inflammatory cytokine, mean ± SD
TNF-α (pg/mL)	77.28 ± 19.43	76.91 ± 18.27	0.895	29.67 ± 11.19	43.17 ± 12.08	< 0.001
IL-6 (pg/mL)	89.37 ± 16.28	87.91 ± 16.74	0.553	50.18 ± 12.24	66.35 ± 14.26	< 0.001
Coagulation function, mean ± SD
PT (s)	21.05 ± 3.44	20.62 ± 3.19	0.385	12.16 ± 2.84	16.71 ± 3.15	< 0.001
APTT (s)	39.22 ± 4.26	40.15 ± 4.39	0.150	32.26 ± 3.73	37.25 ± 4.02	< 0.001
D-D (mg/L)	4.26 ± 1.12	4.33 ± 1.27	0.694	1.75 ± 0.59	2.94 ± 0.79	< 0.001
FIB (g/L)	1.07 ± 0.23	1.12 ± 0.26	0.172	3.46 ± 0.60	3.28 ± 0.55	0.037
Infection index levels, mean ± SD
CRP (mg/L)	31.29 ± 4.16	30.98 ± 4.07	0.613	5.19 ± 0.97	8.34 ± 1.33	< 0.001
PCT (ng/L)	2.05 ± 0.21	2.10± 0.19	0.095	0.75 ± 0.23	0.82 ± 0.38	0.135
WBC (× 109/L)	18.05 ± 9.11	17.56 ± 8.97	0.716	12.74 ± 6.41	15.19 ± 7.29	0.017
Liver function index levels, mean ± SD
ALT (U/L)	32.20 ± 3.74	33.15 ± 3.68	0.087	48.19 ± 4.27	53.11 ± 4.53	< 0.001
AST (U/L)	34.17 ± 2.83	34.42 ± 2.99	0.564	49.67 ± 3.88	50.27 ± 4.19	0.230
Renal function index levels, mean ± SD
Scr	81.26 ± 9.91	79.64 ± 9.12	0.254	84.22 ± 10.16	105.42 ± 11.20	< 0.001
BUN	5.37 ± 1.94	5.19 ± 1.73	0.511	8.06 ± 2.99	10.19 ± 3.28	< 0.001

TNF-α: Tumor necrosis factor-α; IL-6: Interleukin-6; APTT: Activated partial thromboplastin time; PT: Prothrombin time; FIB: Fibrinogen; CRP: C-reactive protein; PCT: Procalcitonin; WBC: White blood cell; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase; BUN: Blood urea nitrogen; UTI: Ulinastatin.

Table 4 Comparison of safety evaluation, and postoperative hospital stays and costs, n (%)

	UTI (n = 91)	Placebo (n = 90)	P value
Granulocytopenia	8 (8.79)	4 (4.44)	0.240
Abnormal liver enzymes	31 (34.07)	25 (27.77)	0.360
Diarrhea	27 (29.67)	18 (20.00)	0.132
Vomiting	19 (20.88)	11 (12.22)	0.117
Allergies	22 (24.18)	9 (10.00)	0.029
Hospitalization stays, day, mean ± SD	17.8 ± 4.2	19.6 ± 5.3	0.012
Hospitalization costs, CNY, mean ± SD	3.94 ± 0.82	3.82 ± 0.99	0.376

UTI: Ulinastatin.