2018 Section 6 - Laryngology, Voice Disorders, and Bronchoesophalogy
TABLE I. Comparison of the Main Study Parameters Between Groups 1 and 2
Group 2 (OR 1 SILSI)
Group 1 (SILSI Alone)
Group 1 vs. Group 2
Mean age, yr (range)
50.3 (28–68)
44.4 (21–58)
P 5 .177, t test 52 8% (95% CI: 2 9.64% to 25.6%)
Mean starting %PEF
65.4%
57.4%
Mean ending %PEF
88.6%
82.5%
23.1% ( P 5 .007)
25.1% ( P 5 .002)
P 5 .569, t test 52 1.99% (95% CI: 2 25.71% to 21.72%)
Mean change in %PEF/round
Mean no. of treatment rounds
1.3
2.1
Mean injections/round
5.3 5.9
5.9 5.2
Mean no. of weeks between injections Mean change in %PEF/month active treatment
P 5 .406, t test 5 0.63 (95% CI: 2 4.85% to 6.11%)
4.4% (95% CI: 0.26% to 8.50%)
3.8% (95% CI: 0.21% to 7.29%)
Mean follow-up, yr
3.3
2.7
Subject 1
1 round, 2 injections
Subject 2
1 round, 3 injections
Subject 3 Subject 4
2 rounds, 23 injections
1 round, 7 injections
Subject 5
1 round, 4 injections
Subject 6 Subject 7
1 round, 7 injections
2 rounds, 7 injections
Subject 8
3 rounds, 21 injections
Subject 9
2 rounds, 13 injections
Subject 10
1 round, 10 injections
Subject 11
5 rounds, 25 injections
Subject 12 Subject 13
1 round, 6 injections 1 round, 4 injections
The number of rounds and injections of steroids given are listed for individual subjects. The 23.1% mean %PEF improvement in group 1 and the 25.1% mean %PEF improvement in group 2 represent statistically significant improvements ( P 5 .007 and P 5 .002, respectively). There was noted to be no significant differences between the mean starting %PEF ( P 5 .177), mean change in %PEF ( P 5 .569), and mean change in %PEF/month of active treatment ( P 5 .406) when comparing groups 1 and 2. CI 5 confidence interval; OR 5 operating room; PEF 5 peak expiratory flow; SILSI 5 serial intralesional steroid injections.
treatment aggressiveness to disease aggressiveness. We recommend a trial of steroids consisting of four to six injections, separated by 3 to 5 weeks. If we suspect very aggressive disease from prior surgical failures, we decrease the dosing interval (every week to 2 weeks) and potentially increase the total number of injections beyond six. Figure 4 outlines our clinical protocol. Endo- scopic airway surgery is performed when clinically nec- essary to open the airway quickly, with initiation of an office-based SILSI regimen 1 to 3 weeks postprocedure for a total of six to seven steroid injections. There is evidence in the dermatologic literature that intralesional injection is more efficacious, because topical steroids do not work in the skin scar (keloid) model to eradicate scar. In a randomized prospective study, topical steroids failed to decrease scar formation in burn-related deformities, 13 and were found to be inef- fective with nonburn wounds too. 14 The finding that subglottic scars would be modified by steroid injections in the same way that steroid injec- tions modify skin scars should not be surprising, because those processes that disrupt scarring in the skin should also work in laryngeal scars.
Office-Based Spirometry as an Objective Means to Track Subject Progress In the current study, each subject’s progress was monitored using objective PFT data. Spirometry allowed us to quantify the degree of obstruction and make com- parisons between subjects by using the normalized %PEF values. We can compare women of different ages and sizes directly using the %PEF values, whereas the absolute changes in liters/second would not be compara- ble. As a way to track outcomes, forced spirometry data are more objective and relate to the airway obstruction more directly than the subjective categorization found in most articles describing iSGS treatments. Can Steroids Alone Modulate iSGS? As a profession, we should consider revising our think- ing that iSGS might be dealt with as a chronic medical con- dition that can be managed with medications and sometimes surgery. The Dermatologic literature warns of the dismal results when surgery alone is used as the defini- tive treatment for scar, with failure rates from 45% to 100%. 15 In our study, in-office SILSI alone objectively
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Franco et al.: Intralesional Steroid Injections for iSGS
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