[Experience with the use of undenatured type II collagen in patients with stage III knee osteoarthritis: a multicenter, prospective, double-blind, placebo-controlled, randomized trial].
L I Alekseeva, N G Kashevarova, E A Taskina, E A Strebkova, T A Korotkova, E P Sharapova, N M Savushkina, A M Lila, N A Shostak, I I Nesterovich, V A Dedkova, V B Vasilyuk, N V Egorova, M A Leontyeva, S P Yakupova, I B Vinogradova, V N Sorotskaya, L I Shirokova, A V Rudakova
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引用次数: 0
Abstract
Introduction: Current strategies for treating osteoarthritis (OA) are based on a multimodal approach that includes pharmacological and non-pharmacological methods. Undenatured chicken collagen type II (NK2) is considered safe and effective for maintaining joint health and can be used alone and combined with drugs for OA treatment.
Aim: To further evaluate the efficacy of the combination of Artneo containing NK2 in patients with stage III knee OA compared with placebo in a multicenter, prospective, double-blind, placebo-controlled, randomized trial.
Materials and methods: The study included 212 patients from 12 centers in the Russian Federation, of whom 50 had radiological stage III knee OA: 41 (82.0%) females and 9 (18.0%) males aged 44 to 75. Using the interactive web response system (IWRS), the study population was randomized into two groups: Group 1 (Artneo group) included 28 patients receiving the drug 1 capsule once a day for 180 days, Group 2 (placebo group) included 22 patients receiving placebo with drug-matched presentation and the same regimen as in Group 1. The effectiveness of therapy was assessed by the change of pain using the Visual Analog Scale, the WOMAC index, KOOS, the EQ-5D quality of life questionnaire, and the need for non-steroidal anti-inflammatory drugs. All patients had a complete blood count, urinalysis, blood chemistry, and ultrasonic examination of the target knee joint.
Results: A prospective, double-blind, placebo-controlled, randomized trial demonstrated that Artneo containing NK2 was significantly superior to placebo in all studied parameters, improved all clinical manifestations of OA: reduced pain and stiffness, improved joint function and quality of life, and had a good safety profile.
Conclusion: Artneo showed high efficacy and safety in the general population of patients, including those with stage III knee OA.
期刊介绍:
Терапевтический архив
The journal was founded by the prominent Russian therapists M.P. Konchalovsky and G.F. Lang in 1923. Then its editors-in-chief were Professors V.N. Vinogradov and A.G. Gukasyan. Since 1972, E.I. Chazov, Academician of the Russian Academy of Sciences, has been heading the editorial board of the journal.
Over 90 years, there have been more than 1000 issues where the authors and editorial staff have done their best for readers to keep abreast of current advances in medical science and practice and for physicians to master the advanced principles of recognition and treatment of a wide spectrum of visceral diseases.
The papers published in the journal (editorials, original articles, lectures, reviews, etc.) cover both current scientific achievements and practical experience in diagnosing, treating, and preventing visceral diseases. The authors of publications are not only Russian, but also foreign scientists and physicians. All papers are peer-reviewed by highly qualified Russian specialists.
The journal is published monthly. Traditionally, each issue has predominantly certain thematic areas covering individual therapy specializations. Every year, one of the issues is devoted to related problems in practical medicine (allergology and immunology, neurology and psychiatry, obstetrics, oncology, etc.). This all draws the attention of the reading public to the journal.
The journal is indexed in RSCI (Russian Science Citation Index), PubMed/Medline, Index Medicus, Scopus/EMBASE, Web of Science Core Collection (Science Citation Index Expanded), Web of Science (Russian Science Citation Index - RSCI, Current Contents Connect, BIOSIS Previews), Google Scholar, Ulrich''s Periodicals Directory.
The journal is included in the list of periodicals recommended by the Higher Attestation Committee for publishing the papers containing the basic materials of doctoral and candidate dissertations.
By the decision of the Presidium of the Russian Academy of Medical Sciences, the “Therapevticheskiy Arkhiv” was awarded the Botkin medal. It was admitted to the European Association of Sciences Editors (EASE).
The journal was honored with the Golden Press Fund decoration at the 13th International Press Professional Exhibition.