Selective opioid agonist Taphalgin® as a component of postoperative analgesia in various surgical areas: “NIKITA” observational multicenter study

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  • Authors: Karelov A.E.1, Ovezov A.M.2, Zabolotskikh I.B.3,4,5, Khoronenko V.E.6, Abuzarova G.R.6, Musaeva T.S.3, Klypa T.V.7, Rodoman G.V.8,9, Alexandrov M.I.8, Bozhkova S.A.10, Boyarkov A.V.11, Potapov A.L.12, Shaimardanov I.V.13, Yemelyanov D.V.14, Ilyin S.A.15, Neduruyev E.V.16, Shevchenko N.P.17, Solovyov G.S.18, Sorokin A.S.19, Gamzeleva O.Y.20, Kraevskaya Y.N.20
  • Affiliations:
    1. I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia
    2. M.F. Vladimirsky Moscow Regional Research Clinical Institute
    3. Kuban State Medical University, Ministry of Health of Russia
    4. Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology
    5. Krasnodar Regional Clinical Hospital No. 2
    6. P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of Russia
    7. Federal Scientific and Clinical Center of the Federal Medical and Biological Agency of Russia
    8. City Clinical Hospital No. 24, Moscow Healthcare Department
    9. Pirogov Russian National Research Medical University, Ministry of Health of Russia
    10. R.R. Vreden National Medical Research Center of Traumatology and Orthopedics, Ministry of Health of Russia
    11. Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department
    12. A.F. Tsyb Medical Radiological Research Center – branch of the National Medical Research Center of Radiology, Ministry of Health of Russia
    13. Republican Clinical Oncological Dispensary named after Prof. M. Z. Sigal
    14. Nizhny Novgorod Regional Clinical Oncological Dispensary
    15. Clinical Hospital of Medsi Group of Companies
    16. Kursk Oncological Scientific and Clinical Center named after G.E. Ostroverkhov, Ministry of Health of the Kursk Region
    17. Clinical Oncological Dispensary No. 1
    18. 1472 Naval Clinical Hospital, Ministry of Defense of Russia
    19. Plekhanov Russian University of Economics
    20. PharmFirma “Sotex”
  • Issue: Vol 14, No 2 (2024)
  • Pages: 36-47
  • Section: DIAGNOSIS AND TREATMENT OF HEAD AND NECK TUMORS
  • Published: 03.08.2024
  • URL: https://ogsh.abvpress.ru/jour/article/view/979
  • DOI: https://doi.org/10.17650/2222-1468-2024-14-2-36-47
  • ID: 979

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Abstract

Introduction. The role of peptides in antinociceptive system regulation has became a subject of interest for scientists worldwide. The first registered peptide analgesic tyrosyl-D-arginyl-phenylalanyl-glycinamide acetate which currently can be used in clinical practice was developed in Russia under the name Taphalgin® (PharmFirma “Sotex”, Russia). The effectiveness and safety of this pharmaceutical in postoperative pain management was evaluated in the all-Russia multicenter prospective observation program NICITA (Non-interventional Clinical Trial of Taphalgin ®).

Aim. To analyze the effectiveness and safety of Taphalgin® in postoperative pain management in various surgical fields.

Materials and methods. The observational program NICITA included 887 patients including patients with malignant tumors of various locations from 15 study centers in different Russian cities. All patients underwent surgical interventions in various anatomical areas under general, regional and combination anesthesia. The principal scheme of postoperative pain management was based on the multimodal approach which included peptide opioid agonist alongside acetaminophen, cyclooxygenase inhibitors in combination with regional anesthesia or without it. The study also included patients who underwent small-volume surgeries, and pain was managed through Taphalgin® monotherapy with subsequent switch to cyclooxygenase inhibitors. The primary endpoint of the NICITA observational program was response to therapy after the first Taphalgin® administration. Decreased pain syndrome per the numerical rating scale 15–60 min after subcutaneous injection and maintenance of analgesic effect 3 h later were considered treatment response. The secondary endpoints included mean time to analgesia start after administration of the 1st single drug dose (in min), duration of effect, types and frequency of adverse reactions including serious in the central nervous system, pulmonary system, gastrointestinal tract developed during the observational program, as well as patient and research physician satisfaction with pain management. To evaluate the significance of pain intensity change at rest and in motion in time, analysis of variance with repeat measurements was used; for pairwise comparison of two time periods, Student’s t-test for dependent samples was used. The differences were considered significant at p = 0.05.

Results. Statistically significant decrease in pain intensity in the total patient group was observed 15 minutes after Taphalgin® administration; it reached its minimum 40 min after the injection (р <0.05). The percentage of patients responding to analgesic therapy with Taphalgin® was 96.5 %. During administration of the drug, insignificant decrease (10–15 mmHg) in arterial blood pressure (1.7 % of cases) and vertigo (1 % of cases) were observed. In some patients, several adverse reactions were observed. Satisfaction with analgesic effect of Taphalgin® was relatively high both in patients and research physicians.

Conclusion. Taphalgin® has pronounced analgesic effect and is effective for pain management after surgical interventions of various volumes and injury level. The use of this drug is associated with low rate of adverse reactions and absence of pulmonary depression characterizing opioid agonists. Therefore, Taphalgin® can be recommended for clinical use for postoperative pain management after various types of surgical interventions.

About the authors

A. E. Karelov

I.I. Mechnikov North-Western State Medical University, Ministry of Health of Russia

Author for correspondence.
Email: a.karelov@mail.ru
ORCID iD: 0000-0003-4401-1599

Alexey Evgenievich Karelov

41 Kirochnaya St., Saint Petersburg 191015

Russian Federation

A. M. Ovezov

M.F. Vladimirsky Moscow Regional Research Clinical Institute

Email: fake@neicon.ru
ORCID iD: 0000-0001-7629-6280

Bld. 1, 61/2 Shchepkina St., Moscow 129110

Russian Federation

I. B. Zabolotskikh

Kuban State Medical University, Ministry of Health of Russia; Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology; Krasnodar Regional Clinical Hospital No. 2

Email: fake@neicon.ru
ORCID iD: 0000-0002-3623-2546

4 Mitrofana Sedina St., Krasnodar 350063; 777 Lytkino, Solnechnogorsk, Moscow Region 141534; 6/2 Krasnykh Partizan St., Krasnodar 350012

Russian Federation

V. E. Khoronenko

P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of Russia

Email: fake@neicon.ru
ORCID iD: 0000-0001-8845-9913

3 2nd Botkinsky Proezd, Moscow 125284

Russian Federation

G. R.  Abuzarova

P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of Russia

Email: fake@neicon.ru

3 2nd Botkinsky Proezd, Moscow 125284

Russian Federation

T. S. Musaeva

Kuban State Medical University, Ministry of Health of Russia

Email: fake@neicon.ru
ORCID iD: 0000-0001-9285-852X

4 Mitrofana Sedina St., Krasnodar 350063

Russian Federation

T. V. Klypa

Federal Scientific and Clinical Center of the Federal Medical and Biological Agency of Russia

Email: fake@neicon.ru
ORCID iD: 0000-0002-2732-967X

28 Orekhovy bul’var, Moscow 115682

Russian Federation

G. V. Rodoman

City Clinical Hospital No. 24, Moscow Healthcare Department; Pirogov Russian National Research Medical University, Ministry of Health of Russia

Email: fake@neicon.ru
ORCID iD: 0000-0001-6692-1425

10 Pistsovaya St., Moscow 127015; 1 Ostrovityanova St., Moscow 117513

Russian Federation

M. I. Alexandrov

City Clinical Hospital No. 24, Moscow Healthcare Department

Email: fake@neicon.ru
ORCID iD: 0000-0002-3242-4444

10 Pistsovaya St., Moscow 127015

Russian Federation

S.  A. Bozhkova

R.R. Vreden National Medical Research Center of Traumatology and Orthopedics, Ministry of Health of Russia

Email: fake@neicon.ru
ORCID iD: 0000-0002-2083-2424

8 Akademika Baykova St., Saint Petersburg 195427

Russian Federation

A. V. Boyarkov

Moscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare Department

Email: fake@neicon.ru
ORCID iD: 0000-0002-5406-2106

8 Sosenskiy Stan, Kommunarka, Moscow 142770

Russian Federation

A. L. Potapov

A.F. Tsyb Medical Radiological Research Center – branch of the National Medical Research Center of Radiology, Ministry of Health of Russia

Email: fake@neicon.ru
ORCID iD: 0000-0003-3752-3107

4 Koroleva St., Obninsk 249036

Russian Federation

I.  V. Shaimardanov

Republican Clinical Oncological Dispensary named after Prof. M. Z. Sigal

Email: fake@neicon.ru
ORCID iD: 0000-0002-0156-4516

29 Sibirskiy Trakt, Kazan 420029

Russian Federation

D. V. Yemelyanov

Nizhny Novgorod Regional Clinical Oncological Dispensary

Email: fake@neicon.ru
ORCID iD: 0009-0003-6968-8851

11/1 Delovaya St., Nizhny Novgorod 603126

Russian Federation

S. A. Ilyin

Clinical Hospital of Medsi Group of Companies

Email: fake@neicon.ru
ORCID iD: 0009-0002-8071-2982

Bld. 1, 2 Otradnoye,Moscow Region, Krasnogorsk 143442

Russian Federation

E. V. Neduruyev

Kursk Oncological Scientific and Clinical Center named after G.E. Ostroverkhov, Ministry of Health of the Kursk Region

Email: fake@neicon.ru
ORCID iD: 0009-0002-4972-0327

1 Eliseeva St., Kislino, Kursk District, Kursk Region 305524

Russian Federation

N.  P. Shevchenko

Clinical Oncological Dispensary No. 1

Email: fake@neicon.ru
ORCID iD: 0009-0004-8572-1049

146 Dmitrova St., Krasnodar 350040

Russian Federation

G. S. Solovyov

1472 Naval Clinical Hospital, Ministry of Defense of Russia

Email: fake@neicon.ru
ORCID iD: 0000-0001-7246-1111

1 Hospital Descent, Sevastopol 299001

Russian Federation

A. S. Sorokin

Plekhanov Russian University of Economics

Email: fake@neicon.ru
ORCID iD: 0000-0002-9328-7017

36 Stremyanny Lane, Moscow 117997

Russian Federation

O. Yu. Gamzeleva

PharmFirma “Sotex”

Email: fake@neicon.ru
ORCID iD: 0000-0003-3171-2847

Bld. 7, Block 4, 22 Kashirskoe Shosse, Moscow 115201

Russian Federation

Yu. N. Kraevskaya

PharmFirma “Sotex”

Email: fake@neicon.ru
ORCID iD: 0009-0006-2266-1688

Bld. 7, Block 4, 22 Kashirskoe Shosse, Moscow 115201

Russian Federation

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