Clin Exp Otorhinolaryngol.  2011 Jun;4(2):83-87.

A Randomized, Double-blinded, Open Label Study of the Efficacy and Safety of Cefcapene Pivoxil and Amoxicillin, Clavulanate in Acute Presumed Bacterial Rhinosinusitis

• Lee JE
• Han DH
• Won TB
• Rhee CS

Abstract

OBJECTIVES
Currently established first line therapy of acute (presumed bacterial) rhinosinusitis (ARS) consists of 10 to 14 days of oral amoxicillin or cephalosporins. This study compared the clinical efficacy and tolerance of cefcapene pivoxil (CP) and amoxicillin-clavulanate (AMC) in patients with ARS.
METHODS
A randomized, open labeled, double-blinded trial of ARS patients over 15 years of age was performed. Patients diagnosed with ARS received paranasal sinus X-rays and nasal endoscopies and 2 weeks of either CP (150 mg, 3 times/ day) or AMC (625 mg, amoxicillin 500 mg, 3 times/day). All patients revisited the clinic on days 7, 14, and 28 for evaluation of changes in symptoms, endoscopy, and monitoring of any adverse reactions. Demographics, clinical characteristics and drug efficacy were also compared between the two groups.
RESULTS
Among the 60 initially enrolled patients (CP 30, AMC 30), 5 patients in the CP group and 6 in the AMC group were excluded due to poor compliance. There were no significant differences in demographic data including age, sex, initial signs and symptoms, endoscopic and X-ray findings between the two groups. Rates of improvement after 2 weeks were 96% and 95.8% in the CP and AMC group, respectively. Sinus symptoms were changed significantly after 2 and 4 weeks, however, there was no difference between groups (P=0.41). The most common adverse reaction was gastrointestinal complication, diarrhea occurred in 1 patient in the CP group and 6 in the AMC group (P=0.04).
CONCLUSION
CP and AMC were both effective in treating ARS. The difference of treatment outcome was not found between the two groups, however, gastrointestinal complications were less prevalent in the CP group.

Keyword

Sinusitis; Bacterial infection; Cefcapene pivoxil hydrochloride; Amoxicillin potassium clavulanate combination; Comparative study; Double-blind method

MeSH Terms

Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Bacterial Infections
Cephalosporins
Clavulanic Acid
Compliance
Demography
Diarrhea
Double-Blind Method
Endoscopy
Humans
Sinusitis
Treatment Outcome
Amoxicillin
Amoxicillin-Potassium Clavulanate Combination
Cephalosporins
Clavulanic Acid

Reference

1. Anon JB, Jacobs MR, Poole MD, Ambrose PG, Benninger MS, Hadley JA, et al. Antimicrobial treatment guidelines for acute bacterial rhinosinusitis. Otolaryngol Head Neck Surg. 2004; 1. 130(1 Suppl):1–45. PMID: 14726904.

2. Wald ER. Microbiology of acute and chronic sinusitis in children. J Allergy Clin Immunol. 1992; 9. 90(3 Pt 2):452–456. PMID: 1527336.

3. Sakata H. Comparative study of 5-day cefcapene-pivoxil and 10-day amoxicillin or cefcapene-pivoxil for treatment of group A streptococcal pharyngitis in children. J Infect Chemother. 2008; 6. 14(3):208–212. PMID: 18574656.

4. Lanza DC, Kennedy DW. Adult rhinosinusitis defined. Otolaryngol Head Neck Surg. 1997; 9. 117(3 Pt 2):S1–S7. PMID: 9334782.

5. Anon JB, Berkowitz E, Breton J, Twynholm M. Efficacy/safety of amoxicillin/clavulanate in adults with bacterial rhinosinusitis. Am J Otolaryngol. 2006; Jul-Aug. 27(4):248–254. PMID: 16798401.

6. Tantimongkolsuk C, Pornrattanarungsee S, Chiewvit P, Visitsunthorn N, Ungkanont K, Vichyanond P. Pediatric sinusitis:symptom profiles with associated atopic conditions. J Med Assoc Thai. 2005; 11. 88(Suppl 8):S149–S155. PMID: 16856435.

7. Young J, De Sutter A, Merenstein D, van Essen GA, Kaiser L, Varonen H, et al. Antibiotics for adults with clinically diagnosed acute rhinosinusitis: a meta-analysis of individual patient data. Lancet. 2008; 3. 15. 371(9616):908–914. PMID: 18342685.

8. Rosenfeld RM, Andes D, Bhattacharyya N, Cheung D, Eisenberg S, Ganiats TG, et al. Clinical practice guideline: adult sinusitis. Otolaryngol Head Neck Surg. 2007; 9. 137(3 Suppl):S1–S31. PMID: 17761281.

9. Garbutt JM, Goldstein M, Gellman E, Shannon W, Littenberg B. A randomized, placebo-controlled trial of antimicrobial treatment for children with clinically diagnosed acute sinusitis. Pediatrics. 2001; 4. 107(4):619–625. PMID: 11335733.

10. Bottenfield GW, Burch DJ, Hedrick JA, Schaten R, Rowinski CA, Davies JT. Safety and tolerability of a new formulation (90 mg/kg/day divided every 12 h) of amoxicillin/clavulanate (Augmentin) in the empiric treatment of pediatric acute otitis media caused by drug-resistant Streptococcus pneumoniae. Pediatr Infect Dis J. 1998; 10. 17(10):963–968. PMID: 9802654.

11. Poachanukoon O, Kitcharoensakkul M. Efficacy of cefditoren pivoxil and amoxicillin/clavulanate in the treatment of pediatric patients with acute bacterial rhinosinusitis in Thailand: a randomized, investigator-blinded, controlled trial. Clin Ther. 2008; 10. 30(10):1870–1879. PMID: 19014842.

12. Kafetzis DA. Multi-investigator evaluation of the efficacy and safety of cefprozil, amoxicillin-clavulanate, cefixime and cefaclor in the treatment of acute otitis media. Eur J Clin Microbiol Infect Dis. 1994; 10. 13(10):857–865. PMID: 7889960.

13. Henry DC, Kapral D, Busman TA, Paris MM. Cefdinir versus levofloxacin in patients with acute rhinosinusitis of presumed bacterial etiology: a multicenter, randomized, double-blind study. Clin Ther. 2004; 12. 26(12):2026–2033. PMID: 15823766.

14. Benninger MS, Payne SC, Ferguson BJ, Hadley JA, Ahmad N. Endoscopically directed middle meatal cultures versus maxillary sinus taps in acute bacterial maxillary rhinosinusitis: a meta-analysis. Otolaryngol Head Neck Surg. 2006; 1. 134(1):3–9. PMID: 16399172.