Wolthers O D, Pedersen S
Department of Paediatrics, Kolding Hospital, Denmark.
Allergy. 1994 Feb;49(2):96-9. doi: 10.1111/j.1398-9995.1994.tb00807.x.
Systemic activity of the intranasal glucocorticosteroid budesonide administered once daily from a dry-powder inhaler (Turbuhaler) was assessed by knemometry. Lower leg length was measured weekly in 38 children aged 7-15 (mean 11.3) years with allergic or perennial rhinitis. The design was a randomized, double-blind, parallel-group study. After 4 weeks' run-in, the children were allocated to 4 weeks' treatment with either budesonide 200 or 400 micrograms or placebo. Fourteen children in the budesonide 200-micrograms group, 13 in the 400-micrograms group, and 10 in the placebo group completed the study. In the placebo and budesonide 200-micrograms groups, growth velocities during run-in (0.36 and 0.28 mm/week, respectively) and treatment periods (0.34 and 0.27 mm/week, respectively) were almost identical. In the budesonide 400-micrograms group (run-in: 0.40 mm/week), a nonsignificant reduction in mean growth velocity of 0.18 mm/week was seen (P = 0.11). There were no statistically significant differences among the run-in mean lower leg growth velocities (F = 1.12; P = 0.34), among growth velocities during treatment (F = 1.10; P = 0.34), or among the run-in and treatment growth velocities in the three groups (F = 1.19; P = 0.32). These results provide good evidence that systemic activity is low in children with allergic or perennial rhinitis treated with once daily budesonide in doses of 200- and 400-micrograms administered intranasally from a dry-powder inhaler.
通过骨测量法评估了每日一次从干粉吸入器（都保）给予鼻内糖皮质激素布地奈德的全身活性。对38名年龄在7至15岁（平均11.3岁）患有过敏性或常年性鼻炎的儿童每周测量小腿长度。该设计为随机、双盲、平行组研究。经过4周的导入期后，将儿童分配接受4周的治疗，分别使用200微克或400微克布地奈德或安慰剂。布地奈德200微克组的14名儿童、400微克组的13名儿童和安慰剂组的10名儿童完成了研究。在安慰剂组和布地奈德200微克组中，导入期（分别为0.36和0.28毫米/周）和治疗期（分别为0.34和0.27毫米/周）的生长速度几乎相同。在布地奈德400微克组（导入期：0.40毫米/周），平均生长速度有0.18毫米/周的非显著性降低（P = 0.11）。导入期小腿平均生长速度之间（F = 1.12；P = 0.34）、治疗期间生长速度之间（F = 1.10；P = 0.34）或三组导入期和治疗期生长速度之间（F = 1.19；P = 0.32）均无统计学显著差异。这些结果提供了充分证据，表明对于患有过敏性或常年性鼻炎的儿童，每日一次从干粉吸入器鼻内给予200微克和400微克剂量的布地奈德时，全身活性较低。
