Back pain. Results of a non-interventional study of using Ambenium® parenteral in routine clinical practice

Autor: Dmitry S. Kurilchenko, Maya A. Kazakova, Yulia G. Kupryashkina, Maria V. Feoktistova, ergey M. Kryzhanovskiy, Elena I. Chukanova
Jazyk: English<br />Russian
Rok vydání: 2024
Předmět:
Zdroj: Клинический разбор в общей медицине, Vol 5, Iss 5, Pp 21-26 (2024)
Druh dokumentu: article
ISSN: 2713-2552
DOI: 10.47407/kr2024.5.5.00401
Popis: Aim: to estimate efficacy, tolerability, and safety of Ambenium® parenteral [phenylbutazone sodium 400 mg and lidocaine hydrochloride 4 mg] used for treatment of patients with low back pain. Methods. A total of 100 patients with low back pain (LBP), who received a single intramuscular injection of Ambenium® parenteral, were included in the study. The follow-up period was 3 days. The change in pain severity on VAS (mm) was selected as a primary outcome measure for efficacy. The pain syndrome severity was estimated before administration of the drug (visit 1) and 4, 6, 8 and 12 h after the drug administration, as well as during visits 2 (day 2) and 3 (day 4). The McGill Pain Questionnaire, muscle syndrome index (MSI), Roland-Morris Disability Questionnaire pain estimates were used as the secondary diagnostic criteria. The percentage of patients with the positive response relative to baseline (the decrease in pain severity on VAS by more than 50%) was also determined. Results. The dynamics of the primary efficacy measure (pain severity on VAS) was as follows: 7.4 ± 0.92 cm (mean ± standard deviation) during visit 1, 5.6 ± 1.49 cm after 2 h, 4.6 ± 1.74 cm after 4 h, 3.0 ± 1.79 cm after 8 h; the VAS score was 2.3 ± 1.70 cm after 12 h (р
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