RESUMO
OBJECTIVE: Evaluation of the therapeutic efficacy, safety and tolerability of the drug Alental cream for external use (VERTEX, LLS, Russia) compared with the original drug - Aertal cream for external use (Gedeon Richter, LLS, Hungary) for local therapy of acute nociceptive pain syndrome in patients who have suffered traumatic ankle injury. MATERIAL AND METHODS: The study included 131 patients who had suffered an injury to the soft tissues of the ankle joint. The 1st comparison group received the drug Alental cream, the 2nd group - Aertal cream. The duration of therapy was 7 days. The effectiveness of the drugs was evaluated during treatment based on the dynamics of the intensity of pain syndrome and other symptoms of trauma, as well as the assessment of these changes by the doctor and the patient. The safety analysis included the registration of adverse events according to clinical and laboratory studies. RESULTS: Alental cream in terms of therapeutic efficacy was equivalent to the registered original preparation Aertal cream. The analysis of the assessment of the dynamics of clinical and laboratory parameters, the safety of treatment, including the frequency of adverse events, did not reveal significant differences between the two drugs. CONCLUSIONS: Alental cream can be used as a means for local therapy of acute nociceptive pain syndrome in traumatic soft tissue injuries.