Abstract
BACKGROUND:
Acute bacterial rhinosinusitis is one of upper respiratory tract infection that disturbs patient life and requires special consideration.
AIM:
To evaluate the efficiency of Ceftriaxone versus a high dose of Amoxicillin-clavulanic acid for the treatment of acute bacterial rhinosinusitis.
PATIENTS AND METHOD:
Observational retrospective study include120 patients of both sex classified into two groups equally conducted. G1 treated with Ceftriaxone 1 g intramuscular injection once daily while, G2 treated with oral Amoxicillin-clavulanic acid (875 mg/125 mg) twice daily for 3-4 days then, the outcome of treatment evaluated as a cure or failed at the fifth or fourth day of treatment.
RESULTS:
Significant cure response observed in Ceftriaxone treated patient’s P ≤ 0.05 and significant failure response observed in Amoxicillin-clavulanic acid-treated patients when groups compared with each other. About gender and age groups, no significant differences in number between group 1 and 2 P ≥ 0.05.
CONCLUSION:
Ceftriaxone found more effective in the treatment of acute bacterial sinusitis than Amoxicillin+ clavulanic acid. Amoxicillin+clavulanic acid associated with more male failure cases recorded than female.
Keywords: Acute bacterial rhinosinusitis, Amoxicillin+ clavulanic acid, Ceftriaxone
Introduction
Rhinosinusitis is an inflammation of the lining epithelia of paranasal sinuses and nasal cavity associated with nasal purulent secretion [1] [2]. Rhinosinusitis classified to acute and chronic infection according to the duration of symptoms and to viral and bacterial rhinosinusitis depending on the causative source [3]. Symptoms are nasal congestion, purulent secretion, facial pain or pressure, pain on bending forward, upper teeth pain, fever and headache [4][5]. Acute rhinosinusitis among the principal cause to millions of physician visits every year [5]. The common cold is the common upper respiratory tract disease that could be complicated with bacterial infection leading to acute bacterial rhinosinusitis [2] [6].
The inability of clinical criteria to distinguish between viral and bacterial rhinosinusitis cause inappropriate, excessive antibiotics prescription [6] [7].
Although most of the rhinosinusitis is of viral cause and self-limiting if symptoms persist for more than 10 days or worsen within 7 days regarded as acute bacterial rhinosinusitis [8]. According to that strategy of treatment changed to involve antibiotic treatments, topical corticosteroids, analgesics and/or decongestants [9].
However, proper antibiotics choice and duration are of great interest. Chose antibiotic prescription to depend on bacterial species, including Streptococcus pneumoniae, Haemophilus influenzae and, particularly in children, Moraxella catarrhalis [10].
Guidelines of treatment suggest Amoxicillin-clavulanate as a first-line empiric antibiotic for mild rhino sinusitis short course treatment [11] [12]. In case of no improvement or penicillin sensitivity Amoxicillin-clavulanate dose either increased or another antibiotic selected like respiratory fluoroquinolone such as moxifloxacin, levofloxacin or cephalosporin’s [12] [13].
Ceftriaxone is third-generation cephalosporin with strong wide range antibacterial profile, its β-lactam antibiotic act by inhibition of bacterial cell wall synthesis. Ceftriaxone half-life about eight hours allows single daily dose for treatment of infections caused by various bacterial species like Klebsiella, Providencia, Serratia, and Haemophilus species. It is the drug of choice for meningitis caused by Haemophilus influenza. Adverse reaction of Ceftriaxone is hypersensitivity responses that are indistinguishable from those of penicillin [14].
Previous studies show that Ceftriaxone is good replacements for amoxicillin in the treatment of acute tonsillopharyngitis due to its safety [15].
The current study aims to evaluate the efficiency of Ceftriaxone versus oral Amoxicillin-clavulanic acid for the treatment of acute bacterial rhinosinusitis.
Patients and Method
A retrospective observational study conducted in (ear, nose and throat) ENT consultant clinic of our teaching hospital at a period from October 2016 to December 2017 for patients diagnosed with acute bacterial rhinosinusitis under the approval of a responsible, ethical committee of surgical department
A group of 120 patients of both sexes with age 15-52 years attend ENT consultant clinic suffering from facial pain and pressure, nasal obstruction with purulent discharge (rhinorrhoea) and fever after flu-like reaction for more than 10 days included according to Infectious Disease Society of America (IDSA) guidelines [12].
Patients with a history of flu-like illness without complication within the first 7 days, patients with previous surgery on nasal sinuses, patients with diabetes mellitus or renal impairment, patients with allergy to penicillin groups or ceftriaxone, patients with traumatic nasal injury, and symptoms duration more than 12 weeks excluded.
All patients included clinically examined by nasal endoscope finding the followings:
Nasal septal deviation, bilateral hypertrophy of inferior turbinate, pus discharge from middle meatus with red nasal mucosa and postnasal drip (mucus pus), then sent to computerised coronal tomography to ensure no complications.
Patients with a positive sign and symptoms of acute bacterial rhinosinusitis treated as the following:
Group 1: 60 patients prescribed with Ceftriaxone 1g intramuscular injection every 24 hours.
Group 2: 60 patients prescribed with Amoxicillin-clavulanic acid orally 1000 mg (875 mg/125 mg) every 12 hours for 3-4 days.
Xylometazoline nasal decongestant and analgesia prescribed for both groups.
After antibiotic regimen, patients followed up on the fifth day to evaluate the following:
1 - cure: no sign and symptoms of acute bacterial rhinosinusitis clinically.
2 - failure: persistence of sign and symptoms of acute bacterial rhinosinusitis clinically or complicated.
3 - an adverse reaction to the antibiotic regimen.
(Amoxicillin + clavulanic acid) oral tablet 1000 mg (875 mg/125 mg) (Comox Acino, Acino Pharma., Switzerland).
Ceftriaxone vial for intravenous /intramuscular injection 1 g (TORLAN, Spain).
Data presented by the proportion of the total number. Statistical significant assessed by Fisher exact test at the level of ≤ 0.05 using SPSS version 21 from IBM.
Results
The current study results show patients treated with Ceftriaxone for short course treatment have significantly higher cure proportion than those treated with (Amoxicillin + clavulanic acid) during follow up period, P ≤ 0.05, Table 1.
Table 1.
Response to treatments among groups
| Treatments | Patients number | Gender | Cure cases | Failure cases | |
|---|---|---|---|---|---|
| Male | Female | ||||
| Ceftriaxone G1 | 60 | 34 (55.9%) | 26 (44.06%) | 50 (83.33%)* | 10 (16.66%) |
| (Amoxillin/clavulanic acid) G2 | 60 | 32 (53.3%) | 28 (46.6%) | 39 (65%) | 21 (35%)* |
p ≤ 0.05.
By gender, no significant differences in number between group 1 and 2, P ≥ 0.05. Cure cases about the gender of Ceftriaxone treated group show higher proportion among male than female, Table 2.
Table 2.
Response to treatments of group 1 about gender and age group
| Age group | Male | Female |
|---|---|---|
| 20-30 years | 25 (42.3%) | 19 (31.66%) |
| 30-40 | 5 (8.47%) | 5 (8.47%) |
| 40-60 | 3 (5%) | 3 (5%) |
| Cure cases | 27 (81.8%) | 23 (84.61%) |
| Failure cases | 6 (18.18%) | 4 (15.38%) |
While in-group 2 the proportions of male and female were comparable in cure response, Table 3.
Table 3.
Response to treatments of group 2 about gender and age group
| Age group | Male | Female |
|---|---|---|
| 20-30 years | 21 (35%) | 19(31%) |
| 30-40 | 8 (13.3%) | 6(10%) |
| 40-60 | 3 (5%) | 3(5%) |
| Cure cases | 19 (59.37%) | 20(71.4%) |
| Failure cases | 13 (40.6%) | 8(28.57%) |
On the other hand, failure of treatment was more in male than female in group 2, Table 3.
About age group, no differences in numbers of patients observed between treatments groups, Table 2 and 3.
Three patients develop skin rash adverse reaction to Ceftriaxone while only one patient develop a skin reaction to Amoxicillin+ clavulanic acid treatment recorded during the study period.
Failure cases treated by the change of antibiotic regimen or surgical treatment for those complicated during the study period according to clinical examination at follow up visit.
Discussion
Acute bacterial rhinosinusitis among the higher complaints of patients attends ENT outpatient clinics in our region. It disturbs the patient’s normal life with serious complication if not treated properly [16].
The current study was a retrospective observational study that aimed to evaluate the response of patients with acute bacterial rhinosinusitis to two regimens of antibiotics including first-line oral (Amoxicillin + clavulanic acid) drug in high dose and Ceftriaxone.
Short antibiotic treatment decided to avoid an adverse reaction, development of bacterial resistance and decrease cost; depending on previous studies that found no dependable differences in response between short and long antibiotic treatment [12] [17].
The choice of Ceftriaxone was following recent guidelines that suggest β-lactam agent rather than a respiratory fluoroquinolone for empiric antimicrobial therapy [12].
Beside to Ceftriaxone efficiency against Haemophilus species and other pathogenic bacteria which are mostly isolated species from swaps of acute bacterial rhinosinusitis patients and its recorded safety for short course treatments that decrease patients hospitalisation and cost [18].
The study results show significant high cure response to Ceftriaxone than (Amoxicillin + clavulanic acid) as observed at the end of 3-4 days of treatments according to guidelines of short course antibiotic treatments. This result proves the efficiency of Ceftriaxone for acute bacterial rhinosinusitis. Although its parenteral drug, it’s well tolerated with broad spectrum efficiency that made Ceftriaxone good alternative antibiotic. This explanation goes with Seaton and Barr [18] study that evaluate outpatient parenteral antibiotic therapy to decrease hospital admission and cost. Also, agree with Duncan and colleague study [15] that found Ceftriaxone excellent broad-spectrum antibiotic for various clinical infection states including upper respiratory tract infection.
Moreover, high failure response to (Amoxicillin + clavulanic acid) observed in this study even though it regarded as the first-line drug for acute bacterial rhinosinusitis could be explained by the development of non B- lactamase type of resistance in certain pathogenic species like Streptococcus pneumonia making Ceftriaxone more efficient replacement [19] [20].
However, it required future microbiological study to look for the most common causative microorganism for acute bacterial rhinosinusitis in our region.
This finding unlike Muhammad and colleague [21] finding that demonstrate the effectiveness of high dose Amoxicillin + clavulanic acid in the treatment of acute bacterial rhinosinusitis as compared to levofloxacin for 10 days treatment, Which may be due to the dissimilarity of treatment period that lasts for 3-4 days in the current study.
About gender response to treatment, male treated with Ceftriaxone show more resolution of symptoms (cure) as compared to female patients, that probably due to differences in some included cases. While, in group 2, male patients show more failure response than the female of the same group that could be due to the variation of an inhabitant of a respiratory microorganism or due to variation in immune response and tolerance between male and female [22] [23].
The antibiotic-related adverse reaction was predicted for the types of antibiotic used with more adverse reaction recorded in group 1 [24] although, it is not serious reactions.
Nasal decongestant and analgesics prescribed for both treatment groups to decrease nasal obstruction and relief painful symptoms associated with acute bacterial rhinosinusitis.
In conclusion, Ceftriaxone found to be more effective than Amoxicillin + clavulanic acid in the treatment of acute bacterial sinusitis. Amoxicillin + clavulanic acid associated with more male failure cases than female.
Footnotes
Funding: This research did not receive any financial support
Competing Interests: The authors have declared that no competing interests exist
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