Effectiveness of thiamphenicol glycinate acetilcysteinate in inhalation treatment of children with rhinosinusitis

The article evaluates the effectiveness of thiamphenicol glycinate acetylcysteinate for inhalation versus systemic antibiotic for oral administration in complex treatment of uncomplicated rhinosinusitis in the outpatient conditions.

Characteristics of children and research methods. The prospective, single-center, randomized, pilot, open-label comparative study included 61 patients from 3 to 9 years old with acute rhinosinusitis meeting the inclusion criteria. Group 1: children were prescribed thiamphenicol glycinate acetylcysteinate (0.125 mg per inhalation twice a day), Group 2: patients received amoxicillin clavulanate at an age-specific dosage of 40-45 mg/kg orally 2 or 3 times a day. At each visit (Day 0 and Day 7–8) the scientists assessed such symptoms as nasal breathing and rhinoscopy findings (edema, hyperemia of the mucous membrane and nasal discharge) on a 10-point visual analogue scale. At the repeated examination (Day 7-8), they assessed the effectiveness of the treatment (recovery/improvement/cure), the duration of treatment (in days) and the number of drugs taken simultaneously, as well as the tolerability of treatment by the presence/absence of undesirable or side effects. The Python language (Python 3.8.) was used for statistical processing of the obtained data. They used the built-in functions from the Scipy module for calculation.

Results. At the time of inclusion in the study (Day 0), the condition of the patients in both groups was comparable (p>0.05). When comparing condition of the patients on Day 0 and Day 7-8 there was a therapeutic effect in both groups for all studied symptoms (p<0.01) and for the duration of the treatment course (p=0.2302). Thiamphenicol glyceinate acetylcysteinate reduced the need for other drugs in the complex treatment of sinusitis (p<0.001). In most cases the result of treatment was assessed as recovery. None of the observed patients had undesirable side effects.

Conclusion. Thiamphenicol glycinate acetylcysteinate (Fluimucil-antibiotic IT) in the form of inhalation is as effective as amoxicillin clavulanate for the treatment of children with acute uncomplicated rhinosinusitis. A decrease in the need to take additional drugs (p<0.001) can be considered as the advantage of thiamphenicol glycinate acetylcysteinate in complex treatment for uncomplicated rhinosinusitis.

1. Fokkens W.J., Lund V.J., Mullol J., Bachert C., Alobid I., Baroody F. et al. EPOS 2012: European position paper on rhinosinusitis and nasal polyps 2012. A summary for otorhinolaryngologists. Rhinology 2012; 50(1): 1–12. DOI: 10.4193/Rhino50E2

2. Fokkens W.J., Lund V.J., Hopkins C., Hellings P.W., Kern R., Reitsma S. et al. European Position Paper on Rhinosinusitis and Nasal Polyps 2020. Rhinology 2020; 58(Suppl S29): 1–464. DOI: 10.4193/Rhin20.600

3. Bogomil’skij M.R., Chistjakova V.R. Children’s otorhinolaryngology. Textbook. Moscow: GЕOTAR-Media, 2012; 576. (in Russ.)

4. Diseases of the ear, nose and throat in children. National leadership. M.R. Bogomilsky, V.R. Chistyakova (eds). Moscow: GЕOTAR-Media, 2015; 544. (in Russ.)

5. Otorhinolaryngology. National leadership. V.T. Palchun (ed.). Moscow: GEOTAR-Media, 2016; 1012. (in Russ.)

6. Bogomil’skij M.R., Radcig E.Yu., Sel’kova E.P. Diseases of the ear, throat and nose in children with acute respiratory infections. Moscow: GEOTAR-Media, 2016; 128. (in Russ.)

7. Clinical recommendations of NMAO “Acute sinusitis”. Saint Petersburg: Poliforum-group, 2016. http://www.nmaoru.org/files/KR313%20Ostryj%20sinusit.pdf The link is active on 22.11.2020. in Russ.)]

8. Baljasinskaja G.L., Minasjan V.S., Kachkaeva E.D. Experience of using rhinofluimucil and fluimucil-an antibiotic in the treatment of sinusitis in children. In: Topical issues of children’s otorhinolaryngology and pharmacotherapy of ENT diseases. Proc. of the Department staff. Moscow, 2001; 162–164. (in Russ.)

9. Baljasinskaja G.L., Bogomil’skij M.R., Ljumanova S.R. Experience in the use of topical mucolytic drugs in the treatment of acute rhinosinusitis in children. Pediatriya. Zhurnal im. G.N. Speranskogo 2005; 84(6): 60–64. (in Russ.)

10. Geppe N.A., Maljavina U.S., Dronov I.A., Titova E.L. New technology in the treatment of rhinosinusitis in children. Doctor.ru 2010; 1(52): 7–10. (in Russ.)

11. Karpova E.P., Tulupov D.A. On the possibilities of nebulizer therapy in the treatment of acute rhinosinusitis in children. Rossijskaya otorinolaringologiya (Russian otorhinolaryngol) 2013; 4(65): 160–163. (in Russ.)