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Comparative Efcacy and Safety

of Various Anti-Microbials in
Patients of Acute Rhinosinusitis at
Tertiary-Care Hospital in
Uttarakhand (UK)

Oleh : Wenty Arbayeni


Pembimbing : dr. Fauziah Henny Sp.THT-KL
Anatomy of Nasal
Anatomy of Sinuses
Introduction
Needed to know that in international
literature, sinusitis often called by
rhinosinusitis.
Because of nasal mucosa not separated
with mucosa in sinus paranasalis which is if
there is inflamation within sinus always be
followed with inflamation in nasal conca
Acute Rhinosinusitis is inflamation in nasal
mucosa and sinus paranasal happen not to
longger than 4 weeks.
It can be caused by various inciting factors
including allergens, environmental irritants,
and infection by viruses, bacteria, or fungi
Antibiotics were for 81% of adults with acute
rhinosinusitis despite the fact that
approximately 70% of patients improve
spontaneously in placebo
This journal to compare the efficacy and safety of
gatilfloxacin, azithromycin, amoxicilin in patients
of acute rhinosinusitis.

Study Design : An open randomized trial of


comparative the efficacy and safety of
gatilfloxacin, azithromycin, amoxicilin in patients
of acute rhinosinusitis.

Subject : Adults patients at HIMS during the


course of 1 year with primary diagnosis of
clinicaly and and radiologically documented acute
sinusistis of less then or equal to 4 weeks enrolled
with us.
Inclusion Criteria :
With symptoms for more than 1 week or
those with severe symptoms of
rhinosinusitis.
1. Nasal discharge
2. Facial pain is not related to trauma
3. Unilateral upper jaw pain
4. Toothache in the upper jaw or pain when
chewing.
5. Unilateral pain in the upper and lower
jaws of the eyes when bent forward.
Exclusion Criteria :
1. Patients with chronic symptoms (> 1 month)
2. Patients with immunocompromised
3. Patients with previous history of sinus surgery.
4. Pasein with previous antibiotic usage history for 1 week.
5. Comorbidity (diabetes, heart failure, immuno deficiency)
6. Pregnancy / breastfeeding mother.
7. The last anyibiotic intake for less than 4 weeks.
8. Other nose abnormalities (rice polyps)
9. Along with bronchitis, the current episode is more than 3
months old.
10. Known to have hypersensitivity in amoxicillin, macrolide, and
fluroquinolone.
11. Hepatic, renal and immunological disorders.
12. Coagulation abnormalities
13. Seizures or other conditions that require therapy in the form of
tranquilizers.
14. Patients who require either nasal or systemic steroids.
Study Protocol
Baseline Characteristic
Diagnostic Criteria
Based on presence of at least two major
diagnostic factors or one major and two minor
factors
Antimicrobial therapy and
Assessment
Patients were recruited to study protocol
and randomizid into three groups ( of
ten patient each) as under :
Group 1 : Patients on oral amoxicilin
500mg TDS for 10 days
Group 2 : Patients on oral azithromycin
500mg OD for 5 days
Group 3 : Patients on oral gatifloxacin
400mg OD for 10 days
Evaluation of Efficacy
Efficacy evaluation included assesment of
clinical signs and symptoms, overall clinical
response rating and radiographic findings
waters view before and after drug
treatment as primary end point and after
28 days as secondary end point.
Observation and Result
Conclusions
Gatifloxacin was found to be most effective
drug both in term of improvement in signs and
symptom on visual analogue scale and
radiographic scoring. It was associated with
least adverse events in comparison to rest of
three drugs under study.
Azithromycin was the second safest drug
associated with less adverse effects.
Thank You