Este estudio demuestra que la azitromicina, administrada en dosis de 10 mg/kg durante tres días, da como resultado una respuesta clínica y bacteriológica comparable a la de la penicilina G benzatínica en el tratamiento de niños con faringoamigdalitis causada por el EBHGA. La tasa de reinfección también es similar entre los grupos después de 26-38 días de tratamiento. La seguridad y tolerabilidad fueron excelentes en ambos grupos de tratamiento. Los datos de eficacia y seguridad de este estudio se encuentran dentro de los rangos encontrados en otras publicaciones.
Summary
Objectives: to compare effi cacy, safety of 3-day course of azithromycin (AZM) oral suspension vs single intramuscular dose of penicillin-G-benzathine (PGB) for the treatment of acute pharyngitis/tonsillitis caused by Group A â -hemolytic streptococci (GABHS).
Design: randomized, open label, multicenter, comparative study. Ethics committee approval and written informed consent of legal guardians were obtained. After a positive immunoassay test, a clinical evaluation, leukocytes count, erythrosedimentation rate (ESR), Anti – Streptolysin – O (ASO) titers, culture and in-vitro sensitivity were performed at days 0,10-16 and 26 – 38.
Drug: AZM: 10 mg/kg/day. PGB: 600,000 units in patients
Subjects: a total of 192 Colombian children were included, 68%males, aged 2 to 15 years (mean=7.8). Forty subjects were discontinued from the study (21 of AZM and 19 of PGB).
Efficacy: the GABHS eradication at 10-16 day was 84% for AZM and 84% for PGB (p=0.883). Good Clinical response was 99% for AZM and 100% for PGB (p=1). At 26-38 day, the GABHS re-infection rate was 11 % for AZM (95%CI:1.6-20.2 ) and 6% for PGB (95% CI: 4.3 – 25.3) (p=0.306). The laboratory parameters had similar progression between groups. The ITT analysis showed similar trends.
Safety: two children suffered diarrhea and one abdominal pain in the AZM group. In the PGB group, all children had pain at injection site and one suffered hemoglobin decrease. No one was discontinued due to adverse events and there were not significant laboratory test abnormalities related to both treatments.
Conclusions: 1) There were not safety, clinical and bacteriological statistical differences between AZM and PGB.2) The re-infection rates at day 26-38 were not different.
Referencias
1. Committee on Rheumatic Fever. A statement for health professionals by the Committee on Rheumatic Fever, Endocarditis and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, the American Heart Association. Circulation 1988; 78: 1082-1086
2. Committee on Rheumatic Fever. A statement for health professionals by the Committee on Rheumatic Fever, Endocarditis and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, the American Heart Association.Circulation 1988; 78: 1082-1086
3. Bisno, et al. Diagnosis and Management of Group A Streptococcal pharyngitis: a practice guideline. Clin Infect Dis 1997; 25: 574-583.
4. Facklam RR. Specificity study of kits for detection of group A streptococci directly from throat swabs. J Clin Microbiol 1987; 25: 504-508.
5. Pichichero ME. Group A Beta-hemolytic Streptococcal Infections Pediatr Rev -1998 Sep; 19 (9): 291-302
6. Markowitz M, Gerber MA, Kaplan EL. Treatment of streptococcal pharyngotonsillitis: reports of penicillin ’s demise are premature. J Pediatr 1993; 123: 679-85.
7. Gilbert D, Moellering R, Sande M. The Sanford Guide of Antimicrobial Therapy. Antimicrobial Therapy Inc. 29th, 1999. Ed. p.7.
8. Tarlow et al. Macrolides in the management of streptococcal pharyngitis/tonsillitis. Pediatr Infect Dis J1997; 16: 444-448.
9. Bisno AL, Gerber MA, Gwaltney JM Jr, at al. Diagnosis and Management of group A streptococcal pharyngitis: a practice guideline. Infectious Diseases Society of America. Clin Infect Dis 1997; 25: 574-583.
10. Schito et al. The role of macrolides in Streptococcus pyogenes pharyngitis. J Antimicrob Chemother 1997; 39: 562-565.
11. Neu HC. Clinical microbiology of azithromycin. Am J Med 1991; 91 (Suppl 3): 12S-18S.
12. Zuckerman JM. The Newer Macrolides: Azithromycin and Clarithromycin. Infect Dis Clin North Am 2000; 14: 449-462.
13. Stevens et al. Pharmacokinetics of azithromycin after single-and multiple-doses in children. Pharmacotherapy 1997; 17: 874-880.
14. Vaudaux BP, Cherpillod J, Dayer P.Tonsillar/adenoid tissue concentrations of azithromycin (Eng). 19th International Congress of Chemotherapy (ICC), Montreal, Canada, 16-22 Jul 1995. In: Program and Abstracts of the 19th International Congress of Chemotherapy, 1995.
15. Dunn and Barradell. Azithromycin: a review of its pharmacological properties and use as 3-day therapy in respiratory tract infections. Drugs 1996; 51: 483-505.
16. Bergogne-Berezin E. Azithromycin: tissue pharmacology (Fre). Pathol Biol (Paris) 1995; 43: 498-504.
17. Dajani AS. Adherence to Physicians’ Instructions as a factor in Managing Streptococcal Pharyngitis. Pediatrics 1996; 97: 976-980.
18. López LP, ed. Consenso para el manejo de enfermedades infecciosas en pediatría. Asociación Colombiana de Infectología. 1a Edición. Colombia, 1997.
19. Moyer NP, Quinn PJ, Showalter CA. Evaluation of the Directigen 1, 2, 3 Group A Strep Test for diagnosis of streptococcal pharyngitis. J Clin Microbiol 1990; 28: 1661-1663.
20. Reed BD, Huck W, French T. Diagnosis of group A beta-hemolytic Streptococcus using clinical scoring criteria, directigen 1 – 2 – 3 group A streptococcal test, and culture. Arch Intern Med 1990; 150: 1727-1732.
21. Hamill J. Multicentre evaluation of azithromycin and penicillin V in the treatment of acute streptococcal phariyngitis and tonsillitis in children. J Antimicrob Chemother. 1993; 31 (Suppl E): 89-94.
22. O ’Doherty B. The Paediatric Azithromycin Study Group. Azithromycin versus penicillin V in the treatment of paediatric patients with acute streptococcal pharyngitis/tonsillitis. Eur J Clin Mícrobiol Infect Dis 1996; 15: 718-724.
23. Pacifico L, Scopetti F, Ranucci A, et al. Comparative efficacy and safety of 3-day azithromycin and 10-day penicillin V treatment of group A beta-hemolytic streptococcal infection in children. Antimicrob Agents Chemother 1996; 40: 1005-1008.
24. Schaad, et al. Evaluation of the efficacy, safety, and toleration of azithromycin vs. penicillin V in the treatment of acute streptococcal pharyngitis in children: results of a multicenter, open comparative study. Pediatr Infect Dis J 1996; 15: 791-795.
25. Pichichero ME, Margolis PA. A comparison of cephalosporins and penicillins in the treatment of Group A beta-hemolytic streptococcal pharyngitis:a metaanalysis supporting the concept of microbial copathogenicity. Pediatr lnfect Dis J 1991; 10: 275-281.
26. Gerber MA. A comparison of cefadroxil and penicillin V in the treatment of streptococcal pharyngitis in children. Drugs 1986; 32 (Suppl): 29-36.
27. Tong RR, Shulman ST. Streptococcal pharyngitis. Postgrad Med 1988; 84: 203-214.
28. Cremer J, Walirauch C, Milatovic D, et al. Azithromycin versus cefacior in the treatment of pediatric patients with acute group A beta-hemolytic streptococcal tonsillopharyngitis. Eur J Clin Microbiol lnfect Dis 1998; 17: 235-239.
29. Weippl G. Multicentre comparison of azithromycin versus erythromycin in the treatment of paediatric pharyngitis or tonsillitis caused by group A streptococci.J Antimicrob Chemother 1993; 32 (Suppl E): 95-101.
30. Ece A, Iscan A, Sengil AZ, Balkan C,Cetinkaya Z .A comparative study of azithromycin, cephalexin and penicil l in V for the treatment of streptococcal pharyngitis and tonsillitis in children (Tur). Mikrobiyol Bul 1996; 30: 233-238.
31. Rodríguez AF, Arguedas A, Urruela R, Loniza C. Efficacy and safety of azithromycin (AZI) in the treatment of pediatric patients with acute pharyngitis (AP) due to group a beta-hemolytic streptococci (GABHS) (abstract no. P 563) (Eng). 8th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Lausanne, Switzerland, 25-28 May 1997. In: Program and Abstracts of the 8th European Congress of Clinical Microbiology and Infectious Diseases, 1997: 132-133.
32. Treadway G, Pontani D. Paediatric safety of azithro-mycin: worldwide experience In: Finc RG et al, eds. Azithromycin: Further Clinical Experience (Eng). J Antimicrob Chemother 1996; 37 (Suppl C): 143-149.
33. Pichicero ME. Pharyngitis: When to treat. Consultant 2000; 40: 1669-1674.
34. Shulman ST. Evaluation of penicillins, cephalosporins, and macrolides for theraphy of streptococcal pharyngitis. Pediatrics 1996; 97 (6 II Suppl): 955-959.
Correspondencia: Hugo Trujillo. Calle 2 Sur N° 46–55.
Clínica Las Vegas Fase I. Consultorio 434
E-mail:hugot@colomsat.net.co Medellín,Colombia