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
Abstract
BACKGROUND

Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder that occurs in pregnant women and can lead to a range of adverse pregnancy outcomes. The condition is typically marked by pruritus (itching) and elevated levels of liver enzymes and bile acids. The standard treatment for ICP has generally been ursodeoxycholic acid and ademetionine 1,4-butanedisulfonate, but the efficacy of this approach remains less than optimal. Recently, polyene phosphatidylcholine has emerged as a promising new therapeutic agent for ICP due to its potential hepatoprotective effects.

AIM

To evaluate the effect of polyene phosphatidylcholine/ursodeoxycholic acid/ ademetionine 1,4-butanedisulfonate on bile acid levels, liver enzyme indices, and pregnancy outcomes in patients with ICP.

METHODS

From June 2020 to June 2021, 600 patients with ICP who were diagnosed and treated at our hospital were recruited and assigned at a ratio of 1:1 via random-number table method to receive either ursodeoxycholic acid/ademetionine 1,4-butanedisulfonate (control group, n = 300) or polyene phosphatidylcholine/ursodeoxycholic acid/ademetionine 1,4-butanedisulfonate (combined group, n = 300). Outcome measures included bile acids levels, liver enzyme indices, and pregnancy outcomes.

RESULTS

Prior to treatment, no significant differences were observed between the two groups (P > 0.05). Post-treatment, patients in both groups had significantly lower pruritus scores, but the triple-drug combination group had lower scores than the dual-drug combination group (P < 0.05). The bile acid levels decreased significantly in both groups, but the decrease was more significant in the triple-drug group (P < 0.05). The triple-drug group also exhibited a greater reduction in the levels of certain liver enzymes and a lower incidence of adverse pregnancy outcomes compared to the dual-drug group (P < 0.05).

CONCLUSION

Polyene phosphatidylcholine/ursodeoxycholic acid/ademetionine 1,4-butanedisulfonate effectively relieves pruritus and reduces bile acid levels and liver enzyme indices in patients with ICP, providing a positive impact on pregnancy outcome and a high safety profile. Further clinical trials are required prior to clinical application.

Keywords: Ademetionine 1,4-butanedisulfonate; Bile acids; Intrahepatic cholestasis of pregnancy; Liver enzyme indices; Polyene phosphatidylcholine; Pregnancy outcome; Ursodeoxycholic acid

Core Tip: Intrahepatic cholestasis of pregnancy (ICP) can have negative effects on pregnancy outcomes, but the standard treatment with ursodeoxycholic acid and ademetionine is not always effective. This study aimed to evaluate the use of polyene phosphatidylcholine in combination with ursodeoxycholic acid and ademetionine for ICP treatment. The study involved 600 patients with ICP who were randomly assigned to receive either the standard dual-drug combination or the triple-drug combination including polyene phosphatidylcholine. The outcomes measured included bile acid levels, liver enzyme indices, and pregnancy outcomes. The results showed that the triple-drug combination was more effective in reducing pruritus scores, bile acid levels, and liver enzyme indices in comparison to the dual-drug combination. Additionally, the triple-drug group had a lower incidence of adverse pregnancy outcomes. Therefore, it can be concluded that the use of polyene phosphatidylcholine/ursodeoxycholic acid/ademetionine 1,4-butanedisulfonate is a safe and effective treatment option for ICP, although further clinical trials are necessary to confirm its clinical application.