Prospective Study
Copyright ©The Author(s) 2023. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Clin Cases. Sep 26, 2023; 11(27): 6431-6439
Published online Sep 26, 2023. doi: 10.12998/wjcc.v11.i27.6431
Effect of polyene phosphatidylcholine/ursodeoxycholic acid/ademetionine on pregnancy outcomes in intrahepatic cholestasis
Xiao-Rui Dong, Qian-Qian Chen, Meng-Ling Xue, Ling Wang, Qin Wu, Teng-Fei Luo
Xiao-Rui Dong, Qian-Qian Chen, Meng-Ling Xue, Ling Wang, Qin Wu, Department of Obstetrics, Women’s Hospital School of Medicine Zhejiang University, Hangzhou 310000, Zhejiang Province, China
Teng-Fei Luo, Department of Obstetrics and Gynecology, Hangzhou Women's Hospital, Hangzhou 310016, Zhejiang Province, China
Author contributions: Dong XR and Chen QQ proposed the concept of this study; Xue ML and Wang L have contributed to data collection; Dong XR, Wu Q, and Luo TF contributed to formal analysis; Dong XR and Wu Q contributed to the investigation; Luo TF, Chen QQ, and Xue ML have contributed to these methods; Dong XR, Xue ML, Chen QQ, and Luo TF supervised the study; Wu Q validated this study; Dong XR and Wang L contributed to the visualization of this study; Dong XR and Luo TF wrote the first draft of the manuscript; Dong XR, Chen QQ, Xue ML, Wang L, Wu Q, Luo TF reviewed and edited the manuscript.
Institutional review board statement: This study has been approved by the Ethics Committee of the Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine.
Clinical trial registration statement: This study is registered at Clinical Hospital Center trial registry (https://www.researchregistry.com). The registration identification number is researchregistry8967.
Informed consent statement: This study has obtained informed consent from patients.
Conflict-of-interest statement: The authors declare no conflicts of interest.
Data sharing statement: All data generated or analyzed during this study are included in this published article.
CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Teng-Fei Luo, MD, Attending Doctor, Department of Obstetrics and Gynecology, Hangzhou Women's Hospital, No. 369 Kunpeng Road, Hangzhou 310016, Zhejiang Province, China. qiangzhuoxinliang@126.com
Received: June 14, 2023
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
Processing time: 98 Days and 8.4 Hours
ARTICLE HIGHLIGHTS
Research background

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 phosphatidylcholine emerging as a promising option due to its potential hepatoprotective effects.

Research motivation

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.

Research objectives

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.

Research methods

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.

Research results

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.

Research conclusions

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.

Research perspectives

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.