Comparison of once- with twice-daily dosing of fluticasone propionate in mild and moderate asthma.

OBJECTIVES: Two 12-week, randomized, double-blind, parallel-group studies were performed to compare the efficacy and safety of once- and twice-daily dosing of fluticasone propionate (FP) in the treatment of mild to moderate asthma, considered to require the equivalent of either 200 or 500 microg of FP daily. PATIENTS AND METHODS: In study A, 461 patients with asthma received FP either 200 microg once daily or 100 microg twice daily. In study B, 443 patients with asthma received FP, either 500 microg once daily or 250 microg twice daily. RESULTS: In both studies, regardless of the treatment regimen to which patients were randomly assigned, small improvements over baseline were observed in morning peak expiratory flows (PEF) and forced expiratory volume in 1 s (FEV1) following 12 weeks of treatment. In study A, the mean morning PEF improved by 2.4% and 4.3% (once daily versus twice daily, P=0.008). In study B, the mean morning PEF improvement was 0.2% and 3.7% (once daily versus twice daily, P<0.001). For both studies, the increases observed in FEV1 were not significantly different between the two groups (P = not significant). The incidence of exacerbations of asthma and related events was 13% and 5%, respectively, in the patients with mild asthma for the once-daily group versus the twice-daily group; these exacerbations were 12% and 10%, respectively, in patients with moderate asthma. Otherwise, the incidence and types of adverse events were comparable for the two treatment regimens. Although twice-daily dosing demonstrated small but statistically significant improvements over once-daily dosing, patients of both groups generally maintained a good level of asthma control on both regimens according to current treatment guidelines. CONCLUSIONS: Twice-daily dosing of FP is more effective than once-daily dosing, although the latter can maintain asthma control in most patients.

Alteration in facial sensibility in adolescents following sagittal split and chin osteotomies of the mandible.

Static two-point discrimination, pressure, and vibratory threshold values were measured bilaterally at standard coordinates in the area of the face innervated by the mental nerve in 115 adolescents (230 nerves). The patients were divided into four groups: normal adolescents who had not undergone any orthognathic surgery (group I controls, n = 134 nerves, mean age 18 years, SD = 3), those 1 year after undergoing bilateral sagittal split osteotomies of the mandible (group II, n = 14 nerves, mean age 19 years, SD = 2), those 1 year after undergoing an osteoplastic genioplasty (group III, n = 40, mean age 19 years, SD = 3), and those 1 year after undergoing a combination of bilateral sagittal split osteotomies and an osteoplastic genioplasty (group IV, n = 42 nerves, mean age 19 years, SD = 3). Subjective residual numbness at the 1 year postoperative interval was reported by 2 of 7 patients in group II, 2 of 20 patients in group III, and 14 of 21 patients (67 percent) in group IV. Long-term subjective numbness involved only the chin skin in 16 of 18 patients experiencing residual numbness and was perceived as problematic in the remaining 2 (group IV) patients whose subjective numbness also was measured objectively in the chin, lower lip (mucosa and skin), and gingiva. Objectively, the mean threshold values of the three sensory modalities tested were higher in group IV patients than in the remaining groups at all coordinates tested, but significant differences (p < 0.05) were found only between the mean two-point discrimination of group IV patients and the control group in the region of the chin skin. The high percentage of patients documented to have subjective and objective sensory disturbance after undergoing a combination of sagittal split osteotomies of the mandible and an osteoplastic genioplasty (group IV) may be explained by the "double crush syndrome."