Selective opioid agonist Taphalgin® as a component of postoperative analgesia in various surgical areas: “NIKITA” observational multicenter study
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...
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2024-08-01
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| Series: | Опухоли головы и шеи |
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| author | A. E. Karelov A. M. Ovezov I. B. Zabolotskikh V. E. Khoronenko G. R. Abuzarova T. S. Musaeva T. V. Klypa G. V. Rodoman M. I. Alexandrov S. A. Bozhkova A. V. Boyarkov A. L. Potapov I. V. Shaimardanov D. V. Yemelyanov S. A. Ilyin E. V. Neduruyev N. P. Shevchenko G. S. Solovyov A. S. Sorokin O. Yu. Gamzeleva Yu. N. Kraevskaya |
| author_facet | A. E. Karelov A. M. Ovezov I. B. Zabolotskikh V. E. Khoronenko G. R. Abuzarova T. S. Musaeva T. V. Klypa G. V. Rodoman M. I. Alexandrov S. A. Bozhkova A. V. Boyarkov A. L. Potapov I. V. Shaimardanov D. V. Yemelyanov S. A. Ilyin E. V. Neduruyev N. P. Shevchenko G. S. Solovyov A. S. Sorokin O. Yu. Gamzeleva Yu. N. Kraevskaya |
| author_sort | A. E. Karelov |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-5aada4efd56c48888b2cd6c50229dd88 |
| institution | Kabale University |
| issn | 2222-1468 2411-4634 |
| language | Russian |
| publishDate | 2024-08-01 |
| publisher | ABV-press |
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| series | Опухоли головы и шеи |
| spelling | doaj-art-5aada4efd56c48888b2cd6c50229dd882025-08-20T04:00:07ZrusABV-pressОпухоли головы и шеи2222-14682411-46342024-08-01142364710.17650/2222-1468-2024-14-2-36-47594Selective opioid agonist Taphalgin® as a component of postoperative analgesia in various surgical areas: “NIKITA” observational multicenter studyA. E. Karelov0A. M. Ovezov1I. B. Zabolotskikh2V. E. Khoronenko3G. R. Abuzarova4T. S. Musaeva5T. V. Klypa6G. V. Rodoman7M. I. Alexandrov8S. A. Bozhkova9A. V. Boyarkov10A. L. Potapov11I. V. Shaimardanov12D. V. Yemelyanov13S. A. Ilyin14E. V. Neduruyev15N. P. Shevchenko16G. S. Solovyov17A. S. Sorokin18O. Yu. Gamzeleva19Yu. N. Kraevskaya20I.I. Mechnikov North-Western State Medical University, Ministry of Health of RussiaM.F. Vladimirsky Moscow Regional Research Clinical InstituteKuban State Medical University, Ministry of Health of Russia; Federal Research and Clinical Center of Intensive Care Medicine and Rehabilitology; Krasnodar Regional Clinical Hospital No. 2P.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of RussiaP.A. Hertzen Moscow Oncology Research Institute – branch of the National Medical Research Radiological Center, Ministry of Health of RussiaKuban State Medical University, Ministry of Health of RussiaFederal Scientific and Clinical Center of the Federal Medical and Biological Agency of RussiaCity Clinical Hospital No. 24, Moscow Healthcare Department; Pirogov Russian National Research Medical University, Ministry of Health of RussiaCity Clinical Hospital No. 24, Moscow Healthcare DepartmentR.R. Vreden National Medical Research Center of Traumatology and Orthopedics, Ministry of Health of RussiaMoscow Multidisciplinary Clinical Center “Kommunarka”, Moscow Healthcare DepartmentA.F. Tsyb Medical Radiological Research Center – branch of the National Medical Research Center of Radiology, Ministry of Health of RussiaRepublican Clinical Oncological Dispensary named after Prof. M. Z. SigalNizhny Novgorod Regional Clinical Oncological DispensaryClinical Hospital of Medsi Group of CompaniesKursk Oncological Scientific and Clinical Center named after G.E. Ostroverkhov, Ministry of Health of the Kursk RegionClinical Oncological Dispensary No. 11472 Naval Clinical Hospital, Ministry of Defense of RussiaPlekhanov Russian University of EconomicsPharmFirma “Sotex”PharmFirma “Sotex”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.https://ogsh.abvpress.ru/jour/article/view/979postoperative analgesiapeptide analgesictaphalgin® |
| spellingShingle | A. E. Karelov A. M. Ovezov I. B. Zabolotskikh V. E. Khoronenko G. R. Abuzarova T. S. Musaeva T. V. Klypa G. V. Rodoman M. I. Alexandrov S. A. Bozhkova A. V. Boyarkov A. L. Potapov I. V. Shaimardanov D. V. Yemelyanov S. A. Ilyin E. V. Neduruyev N. P. Shevchenko G. S. Solovyov A. S. Sorokin O. Yu. Gamzeleva Yu. N. Kraevskaya Selective opioid agonist Taphalgin® as a component of postoperative analgesia in various surgical areas: “NIKITA” observational multicenter study Опухоли головы и шеи postoperative analgesia peptide analgesic taphalgin® |
| title | Selective opioid agonist Taphalgin® as a component of postoperative analgesia in various surgical areas: “NIKITA” observational multicenter study |
| title_full | Selective opioid agonist Taphalgin® as a component of postoperative analgesia in various surgical areas: “NIKITA” observational multicenter study |
| title_fullStr | Selective opioid agonist Taphalgin® as a component of postoperative analgesia in various surgical areas: “NIKITA” observational multicenter study |
| title_full_unstemmed | Selective opioid agonist Taphalgin® as a component of postoperative analgesia in various surgical areas: “NIKITA” observational multicenter study |
| title_short | Selective opioid agonist Taphalgin® as a component of postoperative analgesia in various surgical areas: “NIKITA” observational multicenter study |
| title_sort | selective opioid agonist taphalgin r as a component of postoperative analgesia in various surgical areas nikita observational multicenter study |
| topic | postoperative analgesia peptide analgesic taphalgin® |
| url | https://ogsh.abvpress.ru/jour/article/view/979 |
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