The efficacy and safety of intra-articular application of a combination of sodium hyaluronate and chondroitin sulfate for osteoarthritis of the knee: a multicenter prospective study

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  • Authors: Alekseeva L.I.1, Kashevarova N.G.1, Taskina E.A.1, Sharapova E.P.1, Anikin S.G.1, Strebkova E.A.1, Raskina T.A.2, Zonova E.V.3, Otteva E.N.4, Rodionova S.S.5, Torgashin A.N.5, Buklemishev U.V.5, Shmidt E.I.6, Shesternya P.A.7, Naumov A.V.8, Zagorodniy N.V.5, Lila A.M.1
  • Affiliations:
    1. Nasonova Research Institute of Rheumatology
    2. Kemerovo State Medical University
    3. Novosibirsk State Medical University
    4. Institute of Advanced Training for Health Professionals
    5. Priorov National Medical Research Center for Traumatology and Orthopedics
    6. Pirogov Municipal Clinical Hospital №1
    7. Voyino-Yasenetsky Krasnoyarsk State Medical University
    8. Pirogov Russian National Research Medical University
  • Issue: Vol 92, No 5 (2020)
  • Pages: 46-54
  • Section: Original articles
  • URL: https://ter-arkhiv.ru/0040-3660/article/view/34585
  • DOI: https://doi.org/10.26442/00403660.2020.05.000631
  • Cite item

Abstract


in 3 mL on patients with knee osteoarthritis (OA) in a multicenter prospective study.

Materials and methods. 79 outpatients (predominantly females – 81.0%) from 5 RF constituent territories with primary tibiofemoral Kellgren–Lawrence score grade II or III knee OA, ≤40 mm pain intensity during walking on visual analogue scale (VAS), requiring NSAIDs intake (for at least 30 days during 3 months prior to enrollment) were included into the study after signing the informed consent form. Mean age was 60.3±8.7 years, mean BMI – 29.2±4.7 kg/m2, disease duration – 6 (3–10) years. Grade II OA was documented in 68.4% of patients, Grade III – in 31.6%. The study lasted for 6 months. Efficacy and safety evaluations were made based on VAS pain assessment, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) – [WOMAC pain (0–500), WOMAC function (0–1700), WOMAC stiffness (0–200)], VAS patients’ health status, EQ-5D-based assessment of patients’ quality of life, global physician’s and patient’s efficacy assessment, and daily NSAIDs requirements.

Results. Obtained results demonstrate statistically significant VAS pain reduction during walking already in 1 week after intra-articular injection of the combination [respectively, 62 (55–72) and 41 (32–51) mm, р<0.0001]. Moreover, pain continued to subside during all 3 months of follow up [in 1 month – 28 (20–42), in 3 month – 22 (14–37) mm]. A significant pan reduction achieved at Mo 3 persisted until Mo 6 – 20 (14–42) mm, without documented pain increase. Similar trends were observed with total WOMAC score [1125 (899–1540) – at baseline, and 552 (309–837) mm – by the end of the study, p<0.0001], and all WOMAC sub-scores [268 (189–312) – baseline WOMAC pain, 91 (48–171) mm – by the end of the study p<0.0001; stiffness – 101 (59–130) and 40 (20–61) mm, p<0.0001; function – 802 (647–1095) and 402 (191–638) mm, p<0.0001, respectively]. Median time to the onset of therapeutic effect was 7 (5–18) days. Statistically significant improvement of patients’ quality of life by EQ-5D and general health status was observed during all follow up period [respectively, 0.52 (-0.02–0.59) and 0.69 (0.59–0.80), р<0.0001; 48 (30–60) and 72 (60–80) mm, р<0.0001]. One injection of the drug resulted in dose reduction or discontinuation of NSAIDs therapy: at baseline 76 patients (96.2%) were taking NSAIDs, in one week 31 (39.2%) patients discontinued NSAIDs, in 1 month – 72.2%, in 3 months – 73.4%, and by the end of the study at Mo 6 – 54.4% were not taking NSAIDs. These data were consistent with physician’s and patient’s global assessment of the efficacy of treatment, who stated “significant improvement” and “improvement” in the majority of cases, with only few “no effect” or “worsening” cases documented in analyzed population. Adverse events, such as worsening of pain and/or swelling of the joint, were documented in 8 patients (10.1%); they resolved spontaneously or following NSAIDs intake.

Conclusion. These results suggest that intra-articular injections of hyaluronic acid plus chondroitin sulfate in patients with knee OA are efficient and safe. A single injection of the drug resulted in statistically significant reduction of pain and stiffness, reduction in NSAIDs intake, as well as improvement in patients’ quality of life and function.


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About the authors

L. I. Alekseeva

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru

Russian Federation, Moscow

д.м.н., рук. отд. метаболических заболеваний костей и суставов

 

N. G. Kashevarova

Nasonova Research Institute of Rheumatology

Author for correspondence.
Email: nat-kash@yandex.ru
ORCID iD: 0000-0001-8732-2720

Russian Federation, Moscow

к.м.н., науч. сотр. отд. метаболических заболеваний костей и суставов

 

E. A. Taskina

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
ORCID iD: 0000-0001-8218-3223

Russian Federation, Moscow

к.м.н., ст. науч. сотр. отд. метаболических заболеваний костей и суставов

 

E. P. Sharapova

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
ORCID iD: 0000-0003-4242-8278

Russian Federation, Moscow

к.м.н., науч. сотр. отд. метаболических заболеваний костей и суставов

S. G. Anikin

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
ORCID iD: 0000-0001-5643-3196

Russian Federation, Moscow

к.м.н., ст. науч. сотр. отд. метаболических заболеваний костей и суставов

E. A. Strebkova

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
ORCID iD: 0000-0001-8130-5081

Russian Federation, Moscow

к.м.н., ст. науч. сотр. отд. метаболических заболеваний костей и суставов

 

T. A. Raskina

Kemerovo State Medical University

Email: nat-kash@yandex.ru
ORCID iD: 0000-0002-5804-4298

Russian Federation, Kemerovo

д.м.н., проф., зав. каф. пропедевтики внутренних болезней

E. V. Zonova

Novosibirsk State Medical University

Email: nat-kash@yandex.ru
ORCID iD: 0000-0002-0228-9085

Russian Federation, Novosibirsk

д.м.н., проф. каф. терапии, гематологии и трансфузиологии фак-та повышения квалификации и профессиональной переподготовки врачей

E. N. Otteva

Institute of Advanced Training for Health Professionals

Email: nat-kash@yandex.ru

Russian Federation, Khabarovsk

д.м.н., проф. каф. терапии и профилактической медицины

S. S. Rodionova

Priorov National Medical Research Center for Traumatology and Orthopedics

Email: nat-kash@yandex.ru
ORCID iD: 0000-0002-2726-8758

Russian Federation, Moscow

д.м.н., рук. научно-клинического центра остеопороза

A. N. Torgashin

Priorov National Medical Research Center for Traumatology and Orthopedics

Email: nat-kash@yandex.ru
ORCID iD: 0000-0002-2789-6172

Russian Federation, Moscow

к.м.н., ст. науч. сотр.

U. V. Buklemishev

Priorov National Medical Research Center for Traumatology and Orthopedics

Email: nat-kash@yandex.ru
ORCID iD: 0000-0002-0039-2118

Russian Federation, Moscow

врач

E. I. Shmidt

Pirogov Municipal Clinical Hospital №1

Email: nat-kash@yandex.ru
ORCID iD: 0000-0001-8814-9704

Russian Federation, Moscow

к.м.н., зав. ревматологическим отд-нием

P. A. Shesternya

Voyino-Yasenetsky Krasnoyarsk State Medical University

Email: nat-kash@yandex.ru
ORCID iD: 0000-0001-8652-1410

Russian Federation, Krasnoyarsk

д.м.н., проф

A. V. Naumov

Pirogov Russian National Research Medical University

Email: nat-kash@yandex.ru
ORCID iD: 0000-0002-6253-621X

Russian Federation, Moscow

д.м.н., проф., зав. лаб. костно-мышечных заболеваний

N. V. Zagorodniy

Priorov National Medical Research Center for Traumatology and Orthopedics

Email: nat-kash@yandex.ru

Russian Federation, Moscow

д.м.н., проф., дир.

A. M. Lila

Nasonova Research Institute of Rheumatology

Email: nat-kash@yandex.ru
ORCID iD: 0000-0002-6068-3080

Russian Federation, Moscow

д.м.н., проф. дир.

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