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[The results of phase III multicenter open randomized controlled study REM-Chol-III-16 in patients with intrahepatic cholestasis syndrome caused by chronic diffuse liver diseases].

Author: AntonovaE A, BelikovaT N, KovalenkoA L, MorozovV G, PopovaV B, RafalskiyV V, Stel'makhV V, UspenskiyY P

Clinical Trial, Phase IIIA Phase III trial is a trial that further rigorously verifies the efficacy and safety of a new drug or treatment, whose efficacy and safety have been confirmed in a Phase II trial, in a large number of patients, and evaluates whether it is superior to existing treatments.
English AbstractA summary of a research paper/publication written in English for a wider audience.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Overview

Remaxol, a solution for infusion, demonstrated similar efficacy to parenteral S-adenosyl-L-methionine (Heptral) in treating patients with intrahepatic cholestasis syndrome associated with chronic diffuse liver diseases. Both treatments showed positive trends in liver function parameters and pruritus severity, with no significant between-group differences in adverse event frequency.
Paper Details　
Original Abstract of the Article :
AIM: To assess the safety and efficacy of Remaxol, solution for infusion, compared with parenteral form of S-adenosyl-L-methionine, in the treatment of patients with intrahepatic cholestasis syndrome accompanying chronic diffuse liver diseases of various etiology. MATERIALS AND METHODS: In a multic...See full text at original site
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引用元：
https://doi.org/10.26442/00403660.2021.12.201266

データ提供：米国国立医学図書館（NLM）

Remaxol: A Potential Treatment for Intrahepatic Cholestasis Syndrome

This research investigates the efficacy and safety of [Remaxol] in treating [intrahepatic cholestasis syndrome], a condition often associated with [chronic diffuse liver diseases]. The study, a [multicenter open-label comparative study], compared Remaxol with [S-adenosyl-L-methionine (Heptral)] in [317 patients]. The results indicate that [Remaxol demonstrates similar efficacy to Heptral] in treating intrahepatic cholestasis syndrome. The study found that [the proportion of responders] was [similar in both groups], and the non-inferiority hypothesis was proven. The study also highlights the [safety of Remaxol], with no significant between-group differences in the frequency of adverse events.

Remaxol: A Viable Treatment Option for Intrahepatic Cholestasis Syndrome

The study's findings suggest that [Remaxol is a safe and effective treatment option] for intrahepatic cholestasis syndrome. The results demonstrate that Remaxol is [non-inferior to Heptral] in terms of efficacy, offering patients a viable alternative treatment option. This research highlights the importance of conducting comprehensive clinical trials to assess the effectiveness and safety of new treatments.

Understanding the Challenges of Liver Disease

Liver disease can be a complex and challenging health issue. This research explores the potential of Remaxol as a treatment option for intrahepatic cholestasis syndrome, a condition often associated with chronic liver disease. Remember, just as the desert landscape can be harsh and unforgiving, managing liver disease requires a careful and comprehensive approach.

Dr.Camel's Conclusion

The study's findings suggest that Remaxol is a safe and effective treatment option for intrahepatic cholestasis syndrome. The research underscores the importance of conducting comprehensive clinical trials to assess the effectiveness and safety of new treatments. Remember, just as the desert holds hidden oases of life, the field of medicine is constantly seeking new solutions to improve patient health.

Date :
  1. Date Completed 2022-10-31
  2. Date Revised 2022-10-31
Further Info :

Pubmed ID

36286675

DOI: Digital Object Identifier

10.26442/00403660.2021.12.201266

SNS
PICO Info
in preparation
Languages

Russian

Positive IndicatorAn AI analysis index that serves as a benchmark for how positive the results of the study are. Note that it is a benchmark and requires careful interpretation and consideration of different perspectives.

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