Efficacy and safety of Nafamostat mesylate in patients with end-stage renal failure

Table 1 General characteristics of the two groups

Group	Number of patients	Sex		Cause of disease		Age
		Male	Female	Chronic nephritis, nephrotic syndrome, renal tubulointerstitial disease	Others
Observation group	33	17 (51.51)	16 (48.48)	24 (72.72)	9 (27.27)	66.98 ± 6.45
Control group	32	18 (56.25)	14 (43.75)	22 (68.75)	10 (31.25)	67.13 ± 6.13
χ2/t	-	0.146		0.124		0.096
P value	-	0.701		0.724		0.923

Data are presented as mean ± SD or n (%).

Table 2 Response rates in the two groups

Group	Number of patients	Significant	Effective	Ineffective	Total efficacy rate
Observation group	33	22 (66.66)	9 (27.27)	2 (6.06)	31 (93.93)
Control group	32	7 (21.87)	15 (46.87)	10 (31.25)	22 (68.75)
χ2	-	-	-	-	6.847
P value	-	-	-	-	0.008

Data are presented as n (%).

Table 3 Coagulation status in the two groups

Group	Number of patients	Grade 0	Grade I	Grade II	Grade III
Observation group	33	20 (60.60)	5 (15.15)	6 (18.18)	2 (6.06)
Control group	32	5 (15.62)	2 (6.06)	14 (43.75)	11 (34.37)
χ2	-	13.887	1.339	0.498	8.140
P value	-	< 0.001	0.247	0.025	0.004

Data are presented as n (%).

Table 4 Coagulation indices in the two groups

Group	PT (s)		APTT (s)		TT (s)		INR (s)		FIB (g/L)
	Pre-treatment	Post-treatment	Pre-treatment	Post-treatment	Pre-treatment	Post-treatment	Pre-treatment	Post-treatment	Pre-treatment	Post-treatment
Observation group (n = 33)	16.25 ± 0.26	12.35 ± 0.56b	40.12 ± 0.13	36.65 ± 0.23b	21.48 ± 0.89	17.56 ± 0.48b	2.31 ± 0.13	0.94 ± 0.05b	6.17 ± 0.19	5.26 ± 0.11b
Control group (n = 32)	16.29 ± 0.33	15.48 ± 0.48b	40.17 ± 0.19	39.48 ± 0.24b	21.15 ± 0.78	20.03 ± 0.26b	2.32 ± 0.19	2.01 ± 0.12b	6.13 ± 0.56	3.26 ± 0.56b
t	0.543	24.160	1.241	48.544	1.587	25.680	0.248	47.181	0.388	20.124
P value	0.588	< 0.001	0.219	< 0.001	0.117	< 0.001	0.804	< 0.001	0.699	< 0.001

^bP < 0.001 in comparison with the pre-treatment value. Data are presented as mean ± SD. PT: Prothrombin time; APTT: Activated partial thromboplastin time; TT: Thrombin time; INR: International normalized ratio; FIB: Fibrinogen.

Table 5 Hemoglobin level and platelet count in the two treatment groups

Group	Number of patients	PLT count (× 109/L)		HGB level (g/L)
		Pre-treatment	Post-treatment	Pre-treatment	Post-treatment
Observation group	33	41.23 ± 2.08	41.45 ± 2.56	96.58 ± 1.23	96.88 ± 1.11
Control group	32	41.45 ± 1.98	41.88 ± 2.43	96.45 ± 1.08	96.78 ± 1.37
t	-	0.436	0.694	0.452	0.323
P value	-	0.664	0.490	0.652	0.747

Data are presented as mean ± SD. PLT: Platelet; HGB: Hemoglobin.

Table 6 Adverse reactions after treatment in the two groups

Group	Number of patients	Autogenous hemorrhage	Rash	Fever	Untoward effect
Observation group	33	1 (3.03)	0 (0.00)	0 (0.00)	1 (3.03)
Control group	32	6 (18.75)	0 (0.00)	1 (3.12)	7 (21.87)
χ2	-	-	-	-	5.345
P value	-	-	-	-	0.027

Data are presented as n (%).