Effect of polyene phosphatidylcholine/ursodeoxycholic acid/ademetionine on pregnancy outcomes in intrahepatic cholestasis

Table 1 Baseline patient profiles (mean ± SD)

Groups	Age (yr)		Body mass index (kg/m2)		Gestational weeks (wk)		Gravidity
	Range	mean	Range	mean	Range	mean	Range	mean
Control (n = 300)	20–40	25.98 ± 4.21	22.5–24.3	23.21 ± 0.33	30–37	33.41 ± 3.08	1–3	1.19 ± 0.11
Combined (n = 300)	20–40	26.15 ± 3.67	22.7–24.6	23.41 ± 0.25	30–37	33.08 ± 3.17	1–3	1.16 ± 0.15
t value	-	0.255	-	0.808	-	0.625	-	1.349
P value	-	0.799	-	0.420	-	0.533	-	0.180

Table 2 Pruritus scores before and after the treatment (mean ± SD)

Groups	Before the treatment (points)	After the treatment (points)
Control (n = 300)	3.51 ± 0.48	2.71 ± 0.82
Combined (n = 300)	3.47 ± 0.50a	1.23 ± 0.34a
t value	0.484	13.949
P value	0.630	< 0.001

^aP < 0.05 between before and after treatment in one group, indicates a statistically significant difference.

Table 3 Bile acid levels before and after the treatment (mean ± SD)

Groups	Before the treatment (µmol/L)	After the treatment (µmol/L)
Control (n = 300)	45.37 ± 15.16	25.81 ± 5.79
Combined (n = 300)	45.98 ± 16.11a	12.17 ± 2.68a
t value	0.231	17.887
P value	0.818	< 0.001

^aP < 0.05 between before and after treatment in one group, indicates a statistically significant difference.

Table 4 Liver enzyme indices and liver function before and after the treatment (mean ± SD)

Groups	ALT (U/L)		AST (U/L)
	Before the treatment	After the treatment	Before the treatment	After the treatment
Control (n = 300)	86.15 ± 4.45	46.96 ± 3.08a	80.84 ± 5.05	34.68 ± 2.94a
Combined (n = 300)	86.48 ± 4.92	31.01 ± 2.15a	81.02 ± 4.98	29.05 ± 2.03a
t value	0.416	35.527	0.212	13.184
P value	0.678	< 0.001	0.832	< 0.001
	TB (µmol/L)		CG (µg/L)
Control (n = 300)	27.56 ± 6.37	17.68 ± 5.98a	2718.00 ± 280.17	887.21 ± 88.74a
Combined (n = 300)	27.48 ± 6.18	11.43 ± 3.37a	2754.00 ± 253.48	729.81 ± 65.46a
t value	0.075	7.618	0.797	11.942
P value	0.940	< 0.001	0.427	< 0.001

^aP < 0.05 between before and after treatment in one group, indicates a statistically significant difference.

ALT: Aalanine aminotransferas; AST: Aspartate aminotransferase.

Table 5 Pregnancy outcomes, n (%)

Groups	Preterm delivery	Cesarean delivery	Fetal distress	Amniotic fluid contamination
Control (n = 300)	53 (17.67)	172 (57.33)	61 (20.33)	77 (25.67)
Combined (n = 300)	12 (4.00)	98 (32.67)	8 (2.67)	9 (3.00)
χ2	7.056	34.830	11.315	16.190
P value	0.008	< 0.001	0.001	< 0.001