APORTE DESDE LO ACADÉMICO HACIA EL DESARROLLO

SwNP and CRSsNP are combined in this analysis and recommendation.

The goal of topical antibiotic therapy in CRS is to deliver a high concentration of antibiotics directly to the diseased sinonasal mucosa, thereby increasing efficacy and decreasing systemic absorption and associated side effects. Disadvantages to topical antibiotic therapy include user-dependent variations in delivery technique, topical absorption, local adverse effects, and limited long-term data. Studies on topical antibiotic delivery do not dis- tinguish between those with CRSwNP and CRSsNP.

TABLE VII-18. Evidence for CRSsNP and CRSwNP management with topical antibiotics

Study Year LOE Study design Study groups Clinical endpoint Conclusions

Jervis-Bardy341 _{2012 1b DBRCT 1. Mupirocin rinses (n=9); 2.}

Saline rinses (n=13) 1. Bacterial culture; 2. Symptoms; 3. QoL; 4. Endoscopy Short-term effect onS.

aureusclearance with

mupirocin, but no effect on long-term outcomes Wei787 _{2011 1b DBRCT 1. Saline plus gentamicin; 2.}

Saline alone

1. LM scoring of CT; 2. QoL No benefit seen with topical antibiotic Videler776 _{2008 1b DBRCT crossover pilot}

study

Total (n=14): 1.

Bacitracin-Colimycin with oral antibiotics; 2. Saline (placebo) with oral antibiotics

1. Symptoms (VAS); 2. QoL questionnaire; 3. Nasal endoscopy

No benefit seen with topical antibiotic Desrosiers777 _{2001 1b DBRCT 1. Tobramycin-saline} nebulization; 2. Saline nebulization 1. Symptoms; 2. QoL; 3. Histology

No benefit seen with topical antibiotic

Sykes709 _{1986 1b DBRCT 1. Neomycin, tramazoline,}

dexamethasone (n=20); 2. Tramazoline, dexamethasone (n=20); 3. Placebo (n=10) 1. Nasal MCC; 2. Sinus X-ray; 3. Nasal rhinomanometry; 4. Bacterial culture; 5. Nasal endoscopy

No benefit seen with topical antibiotic

Lee781 _{2014 2a Systematic review with}

heterogeneity

Topical antibiotic therapy not recommended as first-line therapy, but may be considered for recalcitrant CRS Huang780 _{2013 2a Systematic review with}

heterogeneity

Additional studies required to evaluate efficacy of topical antibiotics Rudmik702 _{2013 2a Systematic review with}

heterogeneity

Recommend against topical antibiotic due to insufficient clinical research Soler752 _{2013 2a Systematic review with}

heterogeneity

Use of topical antibiotics recommended against due to lack of evidence Woodhouse779 _{2011 2a Systematic review of RCT,}

with heterogeneity

Nebulized antibiotics cannot be

recommended due to lack of evidence Lim782 _{2008 2a Systematic review with}

heterogeneity

Topical antibiotics may be effective, but further high level studies are required

Additionally the majority of studies focus on the postsur- gical recalcitrant CRS patient. Studies have shown that ESS increases the penetration of topical irrigation therapy

from minimal absorption (<2%) to greater than 95%

absorption.717, 774, 775_{Four RCTs and 6 systematic reviews}

have examined topical antibiotics in CRS (Table VII-18).

Videler et al.776 _{conducted a randomized, placebo-}

controlled, double-blind, cross-over pilot study in 14 people with refractory CRS post-ESS. Recalcitrant disease

was defined by positive nasal cultures for Staphylococcus

aureus after 2 treatments of oral antibiotics (>2 weeks duration) and nasal saline irrigations. The patients were initially randomized into 1 of 2 groups, either high-dose nebulized bacitracin-colimycin (8 weeks) and oral lev- ofloxacin (2 weeks) or nebulized saline (control) and oral levofloxacin (2 weeks). Although the authors found that nebulization improved CRS symptoms, they did not find any added benefit of bacitracin/colimycin to the nebulized solution. The authors acknowledged the inadequate number of patients enrolled and calculated a minimum of

126 patients to achieve statistical significance. Moreover the use of oral levofloxacin may have confounded the results, although patients had failed prior oral antibiotics.

Sykes et al.709 _{investigated the additive effective of}

neomycin in conjunction with a nasal spray of trazoline and dexamethasone compared to saline placebo. They stud- ied 50 patients with symptoms of chronic purulent nasal drainage although there was no mention of prior surgical therapy. Their study utilized comprehensive outcome mea- sures, which included nasal MCC, imaging, rhinomanome- try, bacterial cultures, and endoscopy. Both therapy groups showed improvement in objective measures of disease and no added benefit was seen with topical neomycin.

Desrosiers and Salas-Prato777 _{looked at 20 patients}

with a history of post-ESS recalcitrant CRS who were randomized to nebulized tobramycin with saline compared to saline placebo alone for a total of 4 weeks. After a 4-week washout period, they found that both groups improved in symptoms, QoL, and histologic changes in sinonasal mucosa and were unable to detect a significant difference with the addition of tobramycin. Tobramycin was found to improve pain more quickly than saline, but also led to the side effect of nasal congestion.

One RCT investigated the use of mupirocin irrigations

in post-ESS patients to treat recalcitrantS. aureus. Jervis-

Bardy et al.341 _{performed a DBRCT study of 25 patients}

with either 1 month of mupirocin-saline irrigations or saline control irrigations. They found a short-term im-

provement in negative S. aureus cultures in those with

mupirocin, but no improvement in long-term outcomes in regard to objective or subjective measures of CRS im- provement. Interestingly, a subsequent study by the same group found a high failure rate of mupirocin in eradicating S.aureus and documented a case of mupirocin-resistanct

S.aureusin 1 of their patients following treatment.778 Six systematic reviews have summarized the evidence on

topical antibiotics in CRS. Woodhouse and Cleveland779

confined their review to the 4 published RCTs; however, the RCTs were heterogeneous and therefore topical antibiotic use could not be recommended. The 5 remaining systematic reviews included lower-level studies, and all consistently recommended against the use of topical

antibiotics because of the lack of evidence.702, 752,780–782

Existing high-level evidence of topical antibiotics in CRS fails to consistently demonstrate benefits. Their routine use cannot be recommended. Some case series have reported ef-

fectiveness, particularly in recalcitrant cases of CRS,783–786

suggesting there may be a role in unusual cases.

r

_{Aggregate Grade of Evidence: B (Level 1b: 4 studies;}

Level 2a: 6 studies; Level 4: 4 studies).

r

Benefit: RCTs failed to show any benefit from the use of

topical antibiotics.

r

Harm: Nasal congestion, irritation, epistaxis. The-

oretical possibility of systemic absorption with

topical aminoglycosides. Possibility of developing bac- terial resistance.

r

Cost: Moderate to high (US$2.64 to US$7.64) per dose,

depending on antibiotic and formulation.

r

_{Benefits-Harm Assessment: Relative harm over benefit.}

r

_{Value Judgments: Topical therapy may be a preferable}

alternative to IV therapy for infections caused by organ- isms resistant to oral antibiotics.

r

Policy Level: Recommendation against.

r

Intervention: Topical antibiotics are not recommended

for CRS.

VII.E.5. CRSsNP Management: Antifungals

In document Modelo de negocios para la empresa Home Deko en la ciudad de Cuenca para el periodo 2017 2020 (página 163-176)