[Results of the clinical study of the combination of flurbiprofen and cetylpyridinium chloride in patients with sore throat]. / Rezul'taty klinicheskogo issledovaniya kombinatsii flurbiprofena i tsetilpiridiniya khlorida u patsientov s bol'yu v gorle.

Sore throat is one of the most frequent complaints with which patients seek medical help from an otorhinolaryngologist, therapist and pediatrician. OBJECTIVE: To evaluate the efficacy and safety of a combined topical drug with flurbiprofen and cetylpyridinium chloride compared with a monocomponent drug in patients with sore throat associated with manifestations of acute pharyngitis, tonsillitis or with exacerbation of chronic forms of pharyngitis or tonsillitis. MATERIAL AND METHODS: A prospective, multicenter, open, randomized, comparative study in parallel groups included 266 adult patients aged 18 to 60 years with an established diagnosis of acute pharyngitis or acute tonsillitis with the main complaint of sore throat caused by viral infections of the upper respiratory tract. The patients included in the study were randomized into two groups of 133 participants each: the 1st group included patients who received the combined agent flurbiprofen 8.75 mg and cetylpyridinium chloride 1.0 mg in the form of tablets for resorption; the 2nd group included patients who received cetylpyridinium chloride 1.2 mg in the form of medicinal lozenges. The effectiveness was evaluated on three scales - STPIS, TPA, STPR, reflecting indicators of the dynamics of the disease. RESULTS: The studied combination turned out to be more effective than the monocomponent remedy and was characterized by a more pronounced decrease in the intensity of sore throat within 2 hours after taking the drug and a decrease in pharyngeal hyperemia. CONCLUSION: According to results of the study, the use of a drug based on the combination of flurbiprofen and cetylpyridinium chloride was accompanied by a rapid and pronounced decrease in the intensity of sore throat and pharyngeal hyperemia in patients with upper respiratory tract infections.

[Results of a clinical study of the combination of flurbiprofen and cetylpyridinium chloride in patients with sore throat]. / Rezul'taty klinicheskogo issledovaniya kombinatsii flurbiprofena i tsetilpiridiniya khlorida u patsientov s bol'yu v gorle.

Sore throat is one of the most frequent complaints with which patients seek medical help from an otorhinolaryngologist, therapist and pediatrician. OBJECTIVE: To evaluate the efficacy and safety of a combined topical drug with flurbiprofen and cetylpyridinium chloride in patients with sore throat caused by upper respiratory tract infections. MATERIAL AND METHODS: A prospective multicenter open randomized comparative study in parallel groups included 266 adult patients with an established diagnosis of acute pharyngitis or acute tonsillitis aged 18 to 60 years with the main complaint of sore throat caused by viral infections of the upper respiratory tract. The patients included in the study were randomized into two groups of 133 participants each: the 1st group included patients who received the combined agent flurbiprofen 8.75 mg and cetylpyridinium chloride 1.00 mg in the form of tablets for resorption, the 2nd group included patients who received cetylpyridinium chloride 1.2 mg in the form of medicinal lozenges. The effectiveness was evaluated on several scales (RADT, STPIS, TPA, STPR) reflecting subjective and objective indicators of the dynamics of the disease. RESULTS: The studied combination proved to be more effective than the monocomponent agent and was characterized by a more pronounced decrease in sore throat within 2 hours after taking the drug and a decrease in pharyngeal hyperemia. CONCLUSION: According to the results of the study, the use of a drug based on a combination of flurbiprofen and cetylpyridinium chloride was accompanied by a rapid and pronounced decrease in sore throat and pharyngeal hyperemia in patients with upper respiratory tract infections.

[Rengalin, a novel drug for treatment of cough in children. Intermediate data on multicentre, comparative randomized clinical trial].

UNLABELLED: Rengalin liquid formulation on the basis of antibodies to bradikinin histamine and morphine was specially designed for the treatment of cough in children. The three-component combination in therapeutically active against both dry and wet cough due to effect on diverse pathogenetic aspects of the cough reflex. The aim of the multicenter, comparative, randomized clinical trial was to estimate the efficacy and safety of rengalin in the treatment of cough in patients with acute respiratory infection (ARI) of the upper respiratory tract. METHODS: One hundred forty six patients at the age of 3 to 17 years (the average age of 8.2 ± 3.6 years) from 14 medical centres of Russia were observed. The patients suffered from dry/nonproductive, frequent, sore cough preventing from day-time activity and/or night sleep (≥ 4 by the Cough Severity Scale). The cough duration ranged from 12 hours to 3 days. For 3 days the patients of group 1 (n = 71) and group 2 (n = 75) were treated with rengalin and sinekod (butamirate) respectively. For the following 4 days the patients (in case of viscid expectoration were treated with ambroxole in the age doses. The results of the Per Protokol Analysis (n = 67 rengalin group and n = 73 sinekod group) with an account of the Non-Infectiority Design are presented. RESULTS: In 3 days the number of the group 1 patients with significant improvement/recovery by the day and night estimates amounted to 90% and 88% respectively (vs. 81% and 88% in the group 2 patients, no night opisodes of cough after 3-days rengalin use being recorded in 52% of the patients vs. 34% in the sinekod group patients (p = 0.0003). On the 7th day of the treatment with rengalin the number of the children with significant improvement of or recovery from day-time cought amounted to 99%and that of the patients with significant improvement of or recovery from night-time cough amounted to 93%, in 90% of them no night-time cough being recorded (p = 0.0008). As for the patients of the reference group, the respective values were 93% and 90%, no night-time cough being recorded in 81% of the patients. The time required for development of productive/moist cough during the 3-day treatment course in the patients of both the group was the same (2.9 ± 0.3 days in the patients of group 1 and 2.9 ± 0.4 days in the group 2 patients. Moreover, in 34% of the rengalin dry cough became residual (as rare episode of tussiculation with scantly exudation). After 3-day course of the rengalin therapy, 66% of the patients was treated with ambroxole (versus 95% in sinecod group (p < 0.0001) based on comparative analysis and χ2 = 17.7, p > 0.0001 by the results of the frequency analysis). The total duration of cough in the patients of groups 1 and 2 was 6.5 ± 0.8 and 6.7 ± 0.7 days respectively (the comparability truth, p = 0.0001). The severity of the day-time cough by the area under the curve estimates for 7 days of the treatment in the rengalin group patients was equel to 14.3 ± 5.6 numbers--days and that of the patients of the sinekod? group was equal to 15.9?6.1 numbers - days. The severity of the night-time cough was equal to 4.2 ± 2.7 number--days respectively. In 2 patients (3%) treated with sinekod signs of ARI generalization was observed after the 3-day treatment (p > 0.0001). The research physicians-investigators (CGI-EL Scale) the combination of the anti- and protussive activities in one drug to be efficient and absolutely safe for the chilgren. The therapeutic efficacy in the patients of the rengalin group was higher in 3 days (2.1 ± 0.5 numbers) and even in 7 days (2.7 ± 0.5 numbers). The results value in the patients of the sinekod group being 1.8 ± 0.4 and 2.5 ± 0.6 numbers (one-wayANOVA for repeated estimates ANOVA: Visit - F(1/138) = 146, p < 0.0001, TREATMENT--F(1/138) = 9.0, p = 0.003). The factor of the side effects in the patients of the rengalin group was zero (no side effects due to the treatment were recorded in the patients), whereas in the patients treated with sinekod for 3 days the respective value was 0.1 ± 0.3 (true superiority of rengalin by the ANOVA data. TREATMENT--F(1/138) = 4.7, p = 0.03). The efficacy factor of the rengalin was also in its favour (ANOVA: Visit--F(1/138) = 182, p < 0.0001, TREATMENT--F(1y138) = 7.3, p = 0.008). In the patients treated with rengalin there were defected no deviations in the biochemical and general clinical analyses of blood and urine, no adverse reactions characteristic of antitussive drugs of the action. 100-percent adherence to the therapy was stated. CONCLUSION: He antitussive effect of rengalin in the treatment of frequent dry day-time and night-time cough was observed earlier and proved to be comparable with that of butamirate (sinekod). Rengalin prevented significant exudation and viscid expectoration in many patients, promoted rapid residual in the patients with dry cough and the patients recovery. The use of rengalin for 3 days significantly lowered the percentage of the patients requiring treatment with mucolytics at the subsequent stages of ARI.