Background: The purpose of this study was to determine an appropriate period for macrolide antibiotic therapy, and to investigate whether this period could be shorter, for patients with chronicrhino sinusitis (CRS) after functional endoscopic sinus surgery (FESS). Methods: A retrospective analysis of 41 patients undergoing FESS for CRS was performed. All patients underwent pre-operative computed tomography (CT). Patients with fungal sinusitis, allergic fungal sinusitis, and eosinophilic sinusitis were excluded. After FESS, normalized sinus mucosa was confirmed by CT and endoscopy in all patients. Postoperative antibiotic therapy consisted of first-line and second-line regimens. Garenoxacin (GRNX), or clarithromycin (CAM, 400 mg/day) was used as the first-line regimens and low-dose macrolide therapy (CAM, 200 mg/day) was used as the second-line regimen and was prescribed at outpatient visits based on our clinical criteria. Results: Second-line antibiotic therapy (low-dose CAM) was not necessary in 12 of 41 (29%) patients, while it was prescribed in 29 of 41 (71%). The mean duration of low-dose CAM therapy after FESS was 36 days (range 7 to 122 days; median, 25 days). Patients who received second-line therapy (n = 29) were divided into two groups based on the choice of first-line therapy, a GRNX group (n = 13) and a non-GRNX group (n = 16). Those in the non-GRNX had longer periods of postoperative CAM therapy than those in the GRNX group. Conclusion: GRNX was associated with a shorter duration of low-dose macrolide therapy after FESS, and 29% of patients did not need any low-dose macrolide therapy postoperatively. Therefore, macrolide antibiotics should not be routinely prescribed after FESS.
Antibiotics are routinely used by otolaryngologists to reduce the risk of postoperative infection in patients undergoing functional endoscopic sinus surgery (FESS). Antibiotic containing nasal packing can reduce postoperative infections [
The purpose of this study is to examine the state of postoperative antibiotic treatment, especially low-dose macrolide therapy, and to determine the appropriate period of macrolide therapy after FESS for CRS.
The retrospective analysis included 41 patients (28 men, and 13 women) who underwent FESS for CRS at Kyushu University Hospital from April 2009 to October 2013. The mean age at the time of FESS was 59 years, with a range of 14 to 84 years. The diagnosis of CRS was based on a history of rhinosinusitis and the findings of endoscopy and computed tomography (CT) examinations. The patients were screened for allergy and cases with allergy were excluded. There were 20 patients who had sinusitis with polyp and 21 who had sinusitis without polyp. Cases of fungal sinusitis, allergic fungal sinusitis, eosinophil-related fungal rhinosinusitis including allergic fungal rhinosinusitis (AFRS) and eosinophilic sinusitis were not included in this study. All patients included in the study had responded poorly to medical treatments for more than 6 months. Preoperative CT was performed in all cases. The CT findings were summarized according to the Lund-Mackay score [
Nasal and sinus saline irrigation was performed at the end of the surgery. If patients required nasal packing, the nasal cavity was minimally packed with chitin-coated gauze (Beschitin® F, Unitika Co., Ltd., Kyoto, Japan), that was to be removed within 1 to 2 days after surgery. Septoplasty prior to FESS was performed in 8 patients with severe nasal septal deviation. Nasal and sinus saline irrigation using a bulb syringe was recommended after discharge. Antibiotic prophylaxis (piperacillin 2 g IV or cefazolin 2 g IV) was given during surgery to all patients. Postoperative antibiotic therapy consisted of a first-line regimen and a second-line regimen. Garenoxacin (GRNX, 400 mg/day), or clarithromycin (CAM, 400 mg/day) was used as the first-line regimen during hospitalization, and low-dose CAM (200 mg/day) therapy was used as the second-line regimen during the outpatient period. The surgeon decided whether or not to perform the second-line regimen (low-dose CAM therapy) based on the following conditions;
1) Long-term sinusitis (more than one year);
2) Sinusitis with granulomatous inflammation;
3) Sinusitis with bleeding disorders;
4) Patients on antiplatelet or anticoagulant treatment;
5) Excessive bleeding during or after FESS;
6) Postoperative nasal packing in place for more than four days;
7) Patients with diabetes mellitus;
8) Patients on steroid treatment for chronic disease.
All patients underwent postoperative CT examination at three or four months after the FESS. Normalized mucosa in sinuses was postoperatively confirmed by CT and endoscopy in all patients. Patients were followed for 3 to 12 months postoperatively; the follow-up period ranged from 4 to 24 months (average, 12 months).
Statistical analysis was performed using the Mann-Whitney U test or Fisher’s exact test for the duration of low-dose CAM. CT scores were compared using Cochran-Cox, Welch t, and Kruskal-Wallis H test. A P-value of <0.05 was considered statistically significant.
This research received no specific grant from any funding agency, commercial, or not-for-profit entity. The authors assert that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional guidelines on human experimentation and with the Helsinki Declaration of 1975, as revised in 2008.
The study of the patients was summarized in
Post-Ope therapy | Gender | Polyp | Total | |||
---|---|---|---|---|---|---|
First-line | Second-line | Man | Women | With | Without | No. of case |
CAM (200 mg/day) | CAM (100 mg/day) | 8 | 5 | 3 | 10 | 13 |
GRNX | CAM (100 mg/day) | 10 | 6 | 8 | 8 | 16 |
GRNX | None | 4 | 1 | 4 | 1 | 5 |
None | None | 6 | 1 | 5 | 2 | 7 |
Total | 28 | 13 | 20 | 21 | 41 |
Abbreviations: CAM, clarithromycin; GRNX, garenoxacin.
Post-Ope therapy | No. of case | CT Score | ||||||
---|---|---|---|---|---|---|---|---|
First-line | Second-line | Min | Max | Median | Mean | SD | SE | |
CAM (200 mg/day) | CAM (100 mg/day) | 13 | 2 | 15 | 6 | 7 | 4.5 | 1.2 |
GRNX | CAM (100 mg/day) | 16 | 4 | 15 | 6 | 6.8 | 3.1 | 0.8 |
GRNX | None | 5 | 2 | 11 | 6 | 6.2 | 3.5 | 1.6 |
None | None | 7 | 3 | 10 | 6 | 6.1 | 2.4 | 0,9 |
Total | 41 | 2 | 15 | 6 | 6.1 | 3.1 | 0.4 |
P > 0.05. Abbreviations: CAM, clarithromycin; GRNX, garenoxacin; CT, computed tomography (CT scores are by the Lund-Mackay System); SD, standard deviation; SE, standard error.
Post-Ope therapy | No. of case | Low-CAM period (days) | ||||||
---|---|---|---|---|---|---|---|---|
First-line | Second-line | Min | Max | Median | Mean | SD | SE | |
CAM (200 mg/day) | CAM (100 mg/day) | 13 | 7 | 122 | 21 | 46 | 46.9 | 13 |
GRNX | CAM (100 mg/day) | 16 | 14 | 60 | 28 | 28 | 12 | 3 |
GRNX | None | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
None | None | 7 | 0 | 0 | 0 | 0 | 0 | 0 |
Total | 41 |
Abbreviations: CAM, clarithromycin; GRNX, garenoxacin; SD, standard deviation; SE, standard error.
Postoperative low-dose CAM therapy was not necessary in 12 of 41 (29%) patients, all of whom exhibited normalized sinuses mucosa within 3 months.
The second-line, low-dose CAM therapy patients (n = 29) were divided into two groups based on the first-line antibiotic choice, a GRNX group (n = 16) and a non-GRNX group (n = 13).
The duration of low-dose CAM therapy ranged from 14 to 60 days (mean, 28 days) in the GRNX group and from 7 to 122 days (mean 46 days) in the non-GRNX group (
It has been found that prophylactic administration of antibiotics for patients undergoing FESS can decrease postoperative morbidity and reduce the risk of infection [
In the early 1990s in Japan, long-term low-dose erythromycin treatment was used primarily. Since then, the anti-inflammatory effect of macrolides in vitro has been well-documented [
In this retrospective study, first-line (CAM or GRNX) and second-line (low-dose CAM) postoperative antibiotic treatment regimens were established. Low-dose CAM therapy was prescribed as the second-line treatment at outpatient visits after FESS in patients for whom, the first-line may not work adequately, and it was not necessary in 29% of patients. The sinus mucosa was normalized within 3 months in all of those patients. This result indicates that patients should not routinely be given a prescription for CAM after FESS. Although previous reports have recommended a duration of 3 to 6 months for low-dose macrolide therapy [
Garenoxacin (GRNX), a synthetic des-F (6)-quinolone, has been available since 2007 in Japan [
line therapy after FESS had shorter periods of low-dose CAM therapy as outpatients, and 5 of 21 (24%) patients who received GRNX therapy received no low-dose CAM therapy. There were no patients in the GRNX group who received low-dose CAM therapy for more than 60 days. These results suggest that GRNX could be useful for permitting shorter durations of low-dose CAM therapy postoperatively in CRS patients undergoing FESS.
Because of a small number of patients and the retrospective study, this report was a preliminary result, but it showed that 29% of patients did not need low-dose CAM therapy after FESS. Therefore, CAM antibiotics should not be prescribed routinely after FESS. GRNX was associated with shorter durations of low-dose CAM therapy postoperatively. The duration of CAM therapy after GRNX ranged from 14 to 60 (mean, 28) days.