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ASSALAMUALAIKUM.WR.WB.
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DISUSUN OLEH:GITHA AYU ASTARIKA
01.208.5662
JOURNAL READINGChronic rhinosinusitis and emerging treatment
options
Pembimbing: Kolonel. CKM. dr. Budi W, Sp.THT-KL
FAKULTAS KEDOKTERAN UNIVERSITAS ISLAM SULTAN AGUNG
SEMARANG
2013
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JOURNAL IDENTITY
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This review describes the epidemiology and various treatments
in chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP) andCRS without nasal polyps (CRSsNP). Evidence for short-term useof systemic corticosteroids has been shown to be favorable inCRSwNP, but still limited in CRSsNP. Topical corticosteroidsimprove symptom scores in both CRS subgroups. The role ofmicrobes in CRS is still controversial. Culture-directedantibiotics are recommended for CRSsNP with exacerbation.Long-term use of low dosage antibiotics is recommended forCRSsNP for their anti-inflammatory effects. Other emergingtreatment options are also discussed.
Keywords: rhinosinusitis, chronic, nasal polyps, therapy, sinus
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Rhinosinusitis is an inflammatory disease of the
nasal and paranasal sinus mucosa
It is defined as chronic when it lasts longer than 3months without complete symptom resolution.
Diagnostic criteria consist of the presence of symptoms including purulent nasaldischarge, nasal obstruction, facial pain/pressure/fullness, and/or decreasedsense of smell plus either endoscopic findings of inflammation, purulentdischarge or edema of the middle meatus or ethmoid region, polyps in the nasalcavity or the middle meatus, and/or radiographic imaging showing inflammationof the paranasal sinuses.
Chronic rhinosinusitis (CRS) is further divided into CRS with nasalpolyps (CRSwNP) and CRS without nasal polyps (CRSsNP).
As for the use in epidemiologic studies, CRS is defined as the presence oftwo or more symptoms, one of which should be either nasalblockage/obstruction/congestion or nasal discharge (anterior/posteriornasal drip) and/or facial pain/pressure and/or reduction or loss of smell for
more than 12 weeks with validation by telephone or interview.
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CONT...
The pathogenesis of CRS remainscontroversial..
Multifactorial factors altering thehost-environment interaction such
as bacteria, fungi, viruses, allergens,or environmental toxins may trigger
the inflammatory process
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CRS is a common health problem whichsignificantly affects quality of life
Patients have significantly higher bodily pain anddecreased social function compared to other chronic
diseases (congestive heart failure, angina, chronicobstructive pulmonary disease, and back pain) ( P , 0.05)
An epidemiology study in Europe was conducted by TheGlobal Allergy and Asthma Network of Excellence
(GA2LEN) by sending questionnaires on The European
Position Paper on Rhinosinusitis and Nasal Polyps (EPOS)criteria to a random sample of adults aged 15 75 years.
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The etiology and pathogenesis of chronicrhinosinusitis are not clearly understood.
Traditionally, it was believed that thechronic inflammatory process is the end
stage of untreated or partially treated acuterhinosinusitis or severe atopy from nasal
polyps.
This hypothesis leadsto the use of
antibiotics and anti-inflammatory drugs,eg, corticosteroids
for treating CRSpatients.
Alternative hypotheses includeexcessive host response to fungi,aspirin intolerance due to defects
in the eicosanoid pathway,staphylococcal superantigenresulting in exotoxin effects
including tissue damage,coordinated mechanical barrier
and the innate immune responseof the sinonasal mucosa, defects in
the immune barrier and biofilmsformation.
There is a growing body ofevidence supporting an emerginghypothesis that a dysfunctionalhost environment interaction
involving various exogenousagents results in the sinonasalinflammation.
In concert with the definition ofCRS as an inflammatory disorder,there has been movement away
from pathogen-drivenhypotheses.
This overall concept is inagreement with the current
understanding of the etiologyand pathogenesis of chronic
mucosal inflammatory disordersin general, which describes a
balance of interactions betweenthe host, commensal flora,potential pathogens, and
exogenous stresses.
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RhinosinusitisChronic
Loss of Cilia
Inadequatereply Drenase
Changes ofmucosa
Infection
Pollution,Chemicalsubstances
Residual SepsisInadequate treatment
Mechanicalobstruction
Allergy, immunodeficiencies
Figure. Cycle of recurringevents on chronic rinosinusitis
(Hilger, 1997)
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inflammation of the nose andthe paranasal sinusescharacterized by two or moresymptoms, one of which should
be either nasalblockage/obstruction/congestion or nasal discharge(anterior/posterior nasal drip) facial pain/pressure reductionor loss of smell for $12 weeks.
CRS with or withoutnasal polyps in adults is
defined as:
nasal polyps, and/or
mucopurulent dischargeprimarily from middle meatusand/or edema/mucosalobstruction primarily in middlemeatus.
and/or
computed tomography (CT)changes: mucosal changeswithin the ostiomeatal complexand/or sinuses.
This should be supportedby demonstrable diseasewith endoscopic signs of:
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The aims of treatment in CRS include elimination of theinfection, reduced sinonasal inflammation, and maintainedpatent sinonasal passage drainage.
In addition, CRS may be associated with precipitating factorsincluding allergies, cystic fibrosis, gastroesophageal reflux,sinonasal anatomic obstruction in the ostiomeatal unit, andimmunologic disorders. Therefore, the management of theserisk factors should also be optimized.
Treatment of CRS includes medical and surgical therapy. Medicaltherapy often requires combining multiple medicationsincluding antibiotics, nasal decongestants, topical nasal steroidsand/or oral steroids, and saline irrigation.
The rationale of this regimen is to control precipitating factors,treat the infection, reduce mucosal edema, and facilitatedrainage.
However, some patients do not respond with full medical
treatment alone; in these cases treatment with endoscopicsinus surgery should be considered as an alternative.
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The aim of corticosteroidtherapy in CRS is to reduceinflammation via directly
reducing eosinophil viabilityand activation.
In addition, an indirecteffect can be to reduce thesecretion of chemotacticcytokines from the nasal
mucosa and polypsepithelial cells
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Systemic corticosteroid
Oral steroids have been introduced as asystemic form to control inflammation.They are administrated as part of amultidrug regimen. To date, noevidence advocates for their use alone
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Management scheme for chronicrhinosinusitis without nasal polyps
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Management scheme for chronicrhinosinusitis with nasal polyps.
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There is limitedevidence to support the
use of oral steroids inCRSsNP.
Tosca et al investigatedthe efficacy of oralsteroids as part of a
multidrug regimen inchildren with CRS and
asthma.
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Cont....
They demonstratedbetter outcomes andcytokine profiles aftertreatment including
improved nasal
endoscopic condition in
allergic children (87.5%)and nonallergic children
(85.7%),
statistically significantreduction of
inflammatoryinfiltration in all
children ( P , 0.05)
significant decrease ofinterleukin (IL)-4 in
allergic children (P =0.0002) and nonallergic
children (P = 0.0007),
significant increase ofinterferon-gamma in
allergic children (P =0.03), and
nonsignificant increasein nonallergic children.
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CRSwNP
According to a recentCochrane review,when
data of 166 patientswere pooled from threerandomized controlled
trials, the effectsfavored systemiccorticosteroids.
Prednisoloneand
methylprednisolone are most
commonly used.
Due to the side-effects of
corticosteroids, wedo not recommendsystemic form usage
for long-termtreatment.
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Safety and tolerability
Adversesystemic effects
of treatmentwith systemic
steroids
`includeCushings
syndrome,
steroidinduced
diabetes,
gastriculcers,
gastrointestinalbleeding,
andavascular
necrosis ofthe femoral
head.
l d
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Topical corticosteroids
Topical corticosteroids are usedas part of a multidrug regimen.
There are numerous preparationsthat can be classified by systemicbioavailability as first generation
intranasal corticosteroids
beclomethasonedipropionate
triamcinoloneacetonide
flunisolide budesonidethe newer generation
includes
fluticasonepropionate
mometasone furoate ciclesonide
fluticasonefuroate
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The delivery method of topicalsteroids is an imperative factor.
Nose
nasal siteincludedrops,
sprays, andnebulizers.
Paranasalsinus
Paranasalsinus
deliveryrequiresdevices
cannulated
through thenose.
Volume
sprayvolume lessthan 1 mL,
or largevolume,which is
defined asany
significantvolume
more than60 mL (eg,
simpleirrigationsyringe,
irrigationdevices).
Pressure
low pressure(eg, spray,nebulizers,
instilledsolution
through atube, and
nonpressureirrigation)
highpressuremethods
(eg, positivpressure
irrigation).
C Lund et al37 reported that the use of budesonide 128 g twice a day
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CR
SsN
P
Numerous clinical controlledtrials have investigated the
efficacy of inhaled intranasalcorticosteroids.
p g ysignificantly improved symptom scores ( P , 0.05). Similarly, Qvarnberg etal38 reported the beneficial effects of budesonide 400 g daily. It reduced
nasal symptoms to a greater extent than placebo together with asignificantly greater reduction in facial pain. In addition, Lavigne et al39 found a decrease in CD-3 (P = 0.02) and eosinophils (P = 0.002), and a
decrease in the density of cells expressing IL-4 (P = 0.0001) and IL-5messenger RNA (P = 0.006) after treatment.
Hansen et al40 studied the efficacy of fluticasone 400 g twice a day via anOptiNose device (Optinose US Inc; Yardley, PA, USA). When compared with
placebo, it improved mucosal edema ( P = 0.015), increased peak nasalinspiratory airflow at 4 and 8 weeks (P = 0.006 and P = 0.03, respectively),improved magnetic resonance imaging (MRI) scores after 12 weeks (P =
0.039), and improved nasal rhinosinusitis outcome measure-31 (RSOM-31)subscale scores at 4 and 8 weeks (P , 0.009 and P , 0.016, respectively). Inaddition, it significantly improved symptoms including sense of smell and
nasal discomfort (P , 0.05). Conversely, Dijkstra et al41 compared the efficacyof two regimes of fluticasone nasal spray (400 g versus 800 g twice a day)and placebo. The results showed no significant difference in total symptomscore on the 0 100 scale. Similarly, Jorissen et al42 reported no significant
difference in endoscopic score when mometasone nasal spray was comparedwith placebo ( P = 0.905).
Regarding the method of delivery, a meta-analysis showed significantly greater effects insinus delivery methods (direct cannulation or
irrigation post-surgery) than nasal delivery
methods (drops, sprays, or nebulizer) ( P =0.04).36
Although, the significant benefitof using intranasal corticosteroids
is not shown by severalstudies,41,42 the evidence from ameta-analysis36 showed benefits
in symptom improvement.
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CRSwNP Thirty-eight randomized controlled trials were included
for a meta-analysis.
Nasal aerosols and turbuhalers were more effectivethan nasal sprays in symptom control but there was no
difference in polyp size reduction.
The steroid agents used werefluticasone propionate,
beclomethasone dipropionate,betamethasone sodium
phosphate, mometasone furoate,flunisolide, and budesonide.
When compared to placebo, the steroid
group could decrease symptom scoresby 0.46 (95% confidence interval [CI]0.27 0.65) and decrease polyp sizescore by 0.48 (95% CI 0.21 0.75).
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Safety and tolerability
Adverse effects reported were mostly mild ormoderate, consisting of local effects at the site ofapplication.
Giger et al presented side effects including epistaxis,dry nose, nasal burning, nasal itching, sinusitis,pharyngitis, otitis, change of taste, eczema,nausea/diarrheas, nasal irritation, and common cold.
Using intranasal corticosteroid is generally safe. It does not provide increased incidence of infection or
candidiasis, or produce a change in morning serumcortisol level
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Antibiotics The role of microbes in CRS as causative agents or for
colonization is unclear. There is substantial evidence ofbacterial colonization in CRS, antibiotics still play amajor role for occurrences of acute exacerbation ofCRS.
Bacterial organisms of CRS differ from acute rhinosinusitis. The main organismsinclude Staphylococcus aureus, Enterobacteriaceae spp., and Pseudomonas spp., and less commonly Streptococcus pneumoniae, Haemophilus influenza, and beta hemolytic streptococci. In addition, anaerobes (eg, Peptostreptococcus, Prevotella, Porphyromonas,
Bacteroides, Fusobacterium species) are possible organisms in CRS.
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Systemic antibiotics
Systemic antibiotic treatment of CRSsNP can beadministrated as either short- or long-term treatment.
Short-term treatment is defined as the duration ofusage less than 4 weeks in order to eradicate theorganisms; conversely, long-term treatment is used foranti-inflammatory effects rather than anti-bacterialeffects. Although, infection is not well established to becausative, the expert committee recommended using
antibiotics as short-term treatment in CRSsNP withexacerbation with a positive culture.
CRS NP
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CRSsNP The appropriate antibiotic for short-term treatment is usually broad spectrum to control both
aerobic and anaerobic organisms. In addition, beta-lactamase-producing organisms andmethicillin-resistant S. aureus (MRSA) are possible pathogens, thus empiric antibiotics are
frequently prescribed for coverage of these organisms.
Extended spectrum antibiotics (eg, amoxicillin/clavulanic acid, fluoroquinolone) are commonlyused. Legent et al79 compared amoxicillin/clavulanic acid with ciprofloxacin. The results showed
no significant differences in clinical cure (51.2% versus 58.6%) and bacteriological eradicationrate (90.5% versus 88.9%) for amoxicillin/clavulanic acid and ciprofloxacin. This result wassimilar to the result of Namyslowski et al80 which showed no significant difference betweenamoxicillin/clavulanic acid and cefuroxime axetil in clinical response (95% versus 88%) andbacterial eradication (65% versus 68%). Ciprofloxacin and cefuroxime axetil may be a usefulalternative choice of therapeutic treatment.
Regarding long-term antibiotic treatment, the anti-inflammatory effects of macrolides havebeen investigated. Numerous studies have demonstrated the efficacy of macrolides in reducinginflammatory markers and an increasing ciliary beat frequency, indicating less stickysecretions.81 85 Furthermore, Wallwork et al86 showed a significant anti-inflammatory effectof roxithromycin on the sinonasal outcome test (SNOT)-20 score, nasal endoscopy, saccharintransit time, and IL-8 levels ( P , 0.05) in a randomized placebo-controlled trial for CRSsNP.Conversely, the result of Videler et al87 showed no significant anti-inflammatory effects onSNOT-22, patient response rating scale, visual analog score, and SF-36.
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CONT... These different outcomes between the two studies may be
explained by using different inclusion criteria. Wallwork etal86 included only patients with CRSsNP, whereas Videler etal87 included both CRSwNP and CRSsNP. Subgroup analysisin the study of Wallwork et al86 demonstrated that thesubpopulation of patients with normal immunoglobulin E(IgE) levels had a higher response rate to the macrolidetreatment than patients with elevated IgE. Therefore,serum IgE is a helpful indicator to identify responders tolong-term macrolide treatment.
The recent Cochrane review78 found that there was limitedgood quality evidence to compare using antibiotics versusplacebo in CRS; thus, future well-designed studies shouldbe conducted.
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CRSwNP
There were tworandomized placebocontrolled trials
For short-termantibiotics.
could significantly reducepolyp size and post-nasaldrip score, while otherantibiotics (quinolone,amoxicillin/clavulanate, orco-trimoxazole) had no
significant effect but had atrend towards benefit.
Doxycycline 100mg for 20 days
which showed adecrease in polypsize and patientsymptoms, but allwerenonrandomizedtrials.
macrolides
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Safety and tolerability
Common adverse effects of antibiotics include gastrointestinal symptoms,skin rash, and reversible elevation of liver enzymes. Adverse events fromantibiotic use in CRS were observed in an amoxicillin/clavulanic acid group(4.4%) and cefuroxime group (4.3%). These events were minorcomplications; diarrhea was the most common event. However, oneserious urticaria occurred in the cefuroxime group.
Resistant bacterial strains from long-term antibiotic treatment are ofconcern due to using the low dose form which does not reach the minimalinhibitory concentration. A controlled trial found that three of 50 cultureshad positive macrolide resistant strains before treatment, and four ofcultures had resistant strains after treatment. Although, there seems to be
no significant difference of resistant strains between before and aftertreatment, increased macrolide-resistant bacterial strains have beenreported. Therefore, development of resistant bacterial strains should bemonitored by nasal swab culture every 3 months.
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Topical antibiotics CRSsNP
Topical antibiotics have been administrated to treat CRS with the aimof providing higher concentrations of drug and acting directly on the
site of infection; however, placebo controlled trials showed onlyminimal benefit.
Desrosiers et al reported significant improvements in quality of life,symptoms, and sinonasal endoscopic appearance in both the saline
and tobramycin group ( P , 0.05).
Similarly, Videler et al compared bacitracin/colimycin topical spraywith placebo and reported improvements in both groups without
significant differences in SF-36 or sinonasal endoscopic appearance.These studies showed no significant additive effects of topicalantibiotics; therefore, topical antibiotics should not be used as first-
line management but may be prescribed in patients refractory totraditional topical steroids and oral antibiotics.
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There was no evidence regarding the useof topical antibiotics in CRSwNP.
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Safety and tolerability
The mostcommonadverseeffects
included
Intranasalstinging or
burningsensation
Moderatepain
Throatirritation
Cough
Dry skin
O h i i
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Other emerging optionsMany adjunctive agents have been utilized to control CRS including
Antimycotics,
Anti-ige,Anti-il5,Antihistamine,Aspirin desensitization,Bacterial lysates,Capsaicin,Complementary and alternative medicine,Decongestants,Furosemide,Immunosuppressants,Leukotriene antagonistsNasal irrigation,Mucolytic agents,
Phototherapy,Probiotics, andProton pump inhibitors (ppis).
There was limited evidence on the effect of these options. We will focus thistopic only on medications with positive effects.
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Anti-IgE
Several investigators found that CRSwNP patientshave higher IgE in polyps and serum than controls.
One randomized controlled trial used omalizumab for6 months compared with placebo in CRS patients.
They found improvement of sinus opacification in CT-scans and the SNOT-20, but there was not asignificant difference.
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Anti-IL-5
IL-5 is the key mediator in eosinophil activation.
Sejima et al found that patients with CRSwNP had higherlevels of IL-5 compared with patients with CRSsNP. There weresome small Phase II randomized controlled trials that found apositive effect of reslizumab and mepolizumab in decreasingpolyp size.
These drugs may have a possible role in treatment of CRSwNPin the future.
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Bacterial lysates
The mechanisms of bacterial lysates arehypothesized to enhance the process ofpostnatal maturation of T helper (Th)1function and dendritic cells.
The efficacy of bacterial lysates(Broncho-Vaxom, OM Pharma, Geneva,Switzerland) was investigated comparedwith placebo.
They found a significant improvement insymptoms including headache, purulentdischarge, cough, and expectoration inthe bacterial lysates group.
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Capsaicin
The calcitonin gene-related peptide (CGRP) is
a vasodilator agentpresent in sensory
nerves and may play amajor role in the
vascular component of
neurogenicinflammation.
Complementary and alternative
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Complementary and alternativemedicine
The complementary and alternativemedicines used to treat CRS includeherbal medicine, vitamins, homeopathy,acupuncture, massage, reflexology, yoga,and chiropractics.
Richstein and Mann compared the herbal preparation(European elder, common sorrel, cowslip, European vervainand gentian) with placebo, and found improvement of theoverall clinical status and possible improvement on theradiological findings in the herbal preparation group (12/16patients) and placebo group (6/15 patients).
Another study reported a significant effect on nasal mucosainflammation reduction and overall rating in the herbalpreparation group, but no significant difference in othersymptoms including nasal mucosa edema, nasal discharge,
and breathing difficulties.
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Furosemide
Furosemide couldinduce cell shrinkageby mediating the net
influx of osmoticallyactive ions and
hypothetically haveimmunomodulatory
and anti-inflammatory effects
in hyperactiveairway disease.
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Nasal irrigation
removal of mucus,
infectivepathogens
inflammatorymediators and
promotes ciliarybeat frequency.
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Cont....
Freeman et al studied the efficacy of saline irrigation post-endoscopic sinus surgery.
At 3 weeks postoperatively, the outcomes showed a significantimprovement of discharge in the saline douching group
compared with no treatment ( P = 0.046).
However, at 3 months postoperatively, there was only aminimal difference with crusting (P = 0.18) and edema (P =
0.32), and no difference with adhesions, discharge, and polyps.
Khianey et al also found a small clinical benefit of the nasalsaline irrigation with minimal side effects.
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Mucolyticagents
Some studies usedmucolytic agentsas an adjunctivedrug for treating
patients withtenacious mucus.
Majima et al assessed theefficacy ofScarboxymethylcysteine inCRS patients without nasalpolyps or with small nasal
polyps.
After 12 weeks oftreatment, the nasal
discharge and post-nasal discharge weresignificantly
improved in the S-carboxymethylcystein
e group ( P = 0.008and P = 0.002,
respectively).
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Esophagealreflux was
considered apotentialcause of CRS.
Using PPIs todecrease acid
reflux may reducesinonasal mucosal
damage.
An uncontrolledtrial evaluating
PPIs in CRSpatients reportedimprovement insinus symptoms
(nasal congestion,
nasal drainage,sinus pressure,facial headache,
malaise) and globalsatisfaction (25%
89% and 91%,respectively).
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Near-infrared laserillumination (NILI),
with or without
photo-activated (PA)agents, hasbactericidal andwound healing
promoting effectswhich may have a
potential role inmanaging CRS.
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Surgery CRSsNP
The aim of surgery includesclearing diseased mucosa,
eliminating infection, relievingdrainage obstruction, and
restoring ventilation.
Two randomized controlledtrials compared the efficacy
between surgery andmedication in CRS. Hartog et al
showed no significantdifference in overall cure ratesbetween the medication group
(sinus irrigation plusloracarbef) and surgical group
(sinus irrigation plus loracarbefplus endoscopic sinus surgery).
The Cochrane reviewsuggested that functional
endoscopic sinus surgery hasnot been demonstrated toconfer additional benefits tothose obtained by medicaltreatment. We recommendsurgical intervention only
when there is no response tomaximal medical treatment.
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Surgical intervention involvesclearance of polyps and abnormalmucosa and opening of the sinusopenings. There was limited evidencebased on nonrandomized controlledtrials which found that endoscopic
sinus surgery was safe and effective.
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Conclusion
Several therapieshave been proven
by studies with ahigh level ofevidence to
improve clinicalsymptoms and
objectiveoutcomes.
Some therapies still need
validation through well-conducted studies, inwhich randomized
controlled trials may be adifficult task due to
confounding factors andtrial participation.
Even though itremains achallenge to curethe root cause of
CRS, an algorithmof multidrugregimen and
endoscopic sinussurgery after fullyimplemented
medication canhelp to decrease
the diseaseburden andimprove the
quality of life ofthis group of
patients.
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