Published online Sep 26, 2023. doi: 10.12998/wjcc.v11.i27.6431
Peer-review started: June 14, 2023
First decision: June 21, 2023
Revised: June 25, 2023
Accepted: July 14, 2023
Article in press: July 14, 2023
Published online: September 26, 2023
Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder that can occur in pregnant women and lead to various adverse pregnancy outcomes. The condition is characterized by pruritus, elevated levels of liver enzymes, and bile acids. The standard treatment for ICP involves the use of ursodeoxycholic acid and ademetionine 1,4-butanedisulfonate, but it may not always be effective. Researchers have therefore investigated alternative therapies, with polyene phosphati
The results showed that the triple-drug combination was more effective in improving pruritus scores, reducing bile acid levels and liver enzyme indices, and lowering the incidence of adverse pregnancy outcomes. The research provides a promising alternative therapy for ICP, which may improve pregnancy outcomes and patient quality of life.
This study aimed to evaluate the therapeutic efficacy and safety of a triple-drug combination therapy including polyene phosphatidylcholine, ursodeoxycholic acid, and ademetionine 1,4-butanedisulfonate in treating ICP.
This study employed a randomized controlled trial (RCT) method to evaluate the therapeutic efficacy and safety of a triple-drug combination therapy for the treatment of ICP. The study recruited 600 patients diagnosed with ICP who were randomly assigned to either the control group, receiving standard therapy with ursodeoxycholic acid and ademetionine 1,4-butanedisulfonate, or the combined group, receiving the triple-drug combination therapy including polyene phosphatidylcholine, ursodeoxycholic acid, and ademetionine 1,4-butanedisulfonate. Patients were monitored for changes in symptoms and biochemical markers such as bile acid levels, liver enzyme indices, and pregnancy outcomes before and after treatment. Outcome measures were compared between the two groups to evaluate the effect of the triple-drug combination therapy on improving the treatment of ICP.
The study results showed that the triple-drug combination therapy, including polyene phosphatidylcholine, ursodeoxycholic acid, and ademetionine 1,4-butanedisulfonate, was more effective than the standard therapy with ursodeoxycholic acid and ademetionine 1,4-butanedisulfonate alone, in treating ICP. Patients in both groups had significantly lower pruritus scores after the treatment, but the triple-drug combination group had lower scores than the dual-drug combination group. Bile acid levels decreased significantly in both groups, but the reduction was more significant in the triple-drug group. The triple-drug group also exhibited a greater reduction in certain liver enzymes' levels and a lower incidence of adverse pregnancy outcomes compared to the dual-drug group.
This study demonstrates that the triple-drug combination therapy including polyene phosphatidylcholine, ursodeoxycholic acid, and ademetionine 1,4-butanedisulfonate is more effective in treating ICP compared to the standard therapy with ursodeoxycholic acid and ademetionine 1,4-butanedisulfonate alone. The therapy was found to relieve pruritus and reduce bile acid levels and liver enzyme indices in patients with ICP, leading to better pregnancy outcomes and a high safety profile.
This study provides valuable insights into the treatment of ICP and highlights the potential benefits of using a triple-drug combination therapy including polyene phosphatidylcholine, ursodeoxycholic acid, and ademetionine 1,4-butanedisulfonate. However, further research is needed to evaluate the long-term efficacy and safety of this therapy, as well as to identify the optimal dosage and duration of treatment. Future studies could also explore the underlying mechanisms of how these drugs work together to alleviate the symptoms of ICP and improve pregnancy outcomes. Additionally, since ICP is a rare condition, multicenter trials with larger sample sizes are needed to validate these findings and ensure the generalizability of the results. Finally, it would be beneficial to investigate the impact of lifestyle modifications, such as diet and exercise, on the management of ICP in conjunction with drug therapy. Overall, continued research in this area has the potential to improve the quality of care for pregnant women with ICP and reduce the negative consequences of this condition on maternal and fetal health.