Abstract: Objective To investigate the efficacy and safety of adenosine butyldisulfonate combined with ursodeoxycholic acid in the treatment of intrahepatic cholestasis of pregnancy (ICP). Methods 68 pregnant women with ICP who were diagnosed and treated from January 2021 to February 2024 were randomly divided into observation group and control group. On the basis of routine intervention and polyene phosphatidylcholine treatment, the control group was treated with ursodeoxycholic acid capsule, and the observation group was treated with adenosylmethionine butadisulfate for injection. The changes of endothelial cell function, bile metabolism and liver function indicators, as well as pregnancy outcomes and safety were observed. Results After 2 weeks of treatment, serum ET-1 and sFlt-1 levels in the observation group were (11.54±2.06)ng/L and (13.86±2.15)μg/L, which were lower than (15.85±2.43)ng/L and (16.75±2.49)μg/L in the control group, and VEGF levels in the observation group were (72.49±8.16)pg/L, higher than (65.81±7.54)pg/L in the control group, the difference was statistically significant (t=7.814, 7.529, 7.354, all P<0.05). The levels of CG, CBA and TBA in the observation group were (2.38±0.51)mg/L, (9.53±1.84)μmol/L and (11.51±2.06)μmol/L, which were lower than those in the control group (2.89±0.62) mg/L, (12.89±2.26) μmol/L and (14.08±2.53) μmol/L. The difference was statistically significant (t=6.824, 7.826, 8.046, all P<0.05). ALT, γ-GT and TBil levels in the observation group were (70.26±5.46)U/L, (205.54±14.23)U/L and (94.52±8.53)μmol/L. It was lower than that in the control group (79.58±6.73) U/L, (246.70±19.29) U/L, (105.63±11.67) μmol/L, and the difference was statistically significant (t=6.563, 6.429, 6.470, all P<0.05). In the observation group, the incidence rates of FGR, premature delivery, fecal amniotic fluid contamination, neonatal asphyxia, cesarean section, postpartum hemorrhage and puerperal infection were 5.88%, 2.94%, 2.94%, 2.94%, 17.65% and 2.94%. They were lower than those in the control group (11.76%, 8.82%, 5.88%, 8.82%, 38.24%, 5.88%), and the difference was statistically significant (P<0.05). There was no statistical significance in the incidence of adverse drug reactions between the two groups (P>0.05). Conclusion Treating ICP with ADT combined with ursodeoxycholic acid capsule can protect endothelial cell function, improve bile metabolism and liver function, and improve pregnancy outcome, with high drug safety.

Key words: ICP, Adenosine butyldisulfonate, Ursodeoxycholic acid, Endothelial function, Liver function, Pregnancy outcome