Kemp James P, Osur Scott, Shrewsbury Stephen B, Herje Nancy E, Duke Susan P, Harding Stuart M, Faulkner Kenneth, Crim Courtney C
Allergy and Asthma Medical Group and Research Center APC, San Diego, Calif 92123, USA.
Mayo Clin Proc. 2004 Apr;79(4):458-66. doi: 10.4065/79.4.458.
To evaluate the effects of treatment with fluticasone propionate vs placebo on bone, hypothalamic-pituitary-adrenal (HPA) axis function, and the eyes in patients with asthma.
This randomized, double-blind, placebo-controlled study of 160 patients with asthma who had minimal previous exposure to corticosteroids was conducted from July 1994 through June 1997. Patients received fluticasone at 88 microg twice daily, fluticasone at 440 microg twice daily, or placebo twice daily for 2 years. Bone mineral density (BMD) was evaluated every 6 months by lumbar spine, proximal femur, and total body scans. Measurements of HPA axis function and ophthalmic evaluations were conducted at similar intervals.
Among the 3 groups, no significant differences were observed in BMD at week 104 (at any anatomical site). Mean percent change from baseline in the lumbar spine was less than 1% for all 3 groups. At all time points, HPA axis function was similar in the 88-microg fluticasone group compared with the placebo group. For mean change from baseline in corticotropin-stimulated peak cortisol (P = .003 and P = .02 at weeks 24 and 52, respectively) and area under the stimulated plasma cortisol vs time curve (P = .002 and P = .02 at weeks 24 and 52, respectively), statistically significant reductions from baseline were observed in the 440-microg fluticasone group compared with the placebo group. These reductions of 10% to 13% from baseline were not accompanied by other signs of systemic effect and did not persist with continued treatment (at weeks 76 and 104). No important ocular changes were observed.
Long-term treatment with 88 microg of fluticasone twice daily was comparable to placebo in all skeletal, ophthalmic, and HPA axis function assessments. Treatment with fluticasone at 440 microg twice daily resulted in no significant effects on BMD and a statistically significant but not clinically important temporary reduction in cortisol production.
评估丙酸氟替卡松与安慰剂治疗对哮喘患者骨骼、下丘脑 - 垂体 - 肾上腺（HPA）轴功能及眼部的影响。
这项随机、双盲、安慰剂对照研究于1994年7月至1997年6月进行，纳入160例既往极少接触皮质类固醇的哮喘患者。患者接受每日两次88微克丙酸氟替卡松、每日两次440微克丙酸氟替卡松或每日两次安慰剂治疗，为期2年。每6个月通过腰椎、股骨近端及全身扫描评估骨密度（BMD）。以相似的间隔进行HPA轴功能测量及眼科评估。
在第104周时（在任何解剖部位），3组之间的骨密度未观察到显著差异。所有3组腰椎骨密度相对于基线的平均变化百分比均小于1%。在所有时间点，88微克丙酸氟替卡松组与安慰剂组的HPA轴功能相似。对于促肾上腺皮质激素刺激的皮质醇峰值相对于基线的平均变化（在第24周和第52周时分别为P = 0.003和P = 0.02）以及刺激后的血浆皮质醇与时间曲线下面积（在第24周和第52周时分别为P = 0.002和P = 0.02），与安慰剂组相比，440微克丙酸氟替卡松组观察到相对于基线有统计学显著降低。这些相对于基线降低10%至13%的情况未伴有其他全身效应迹象，且在持续治疗时（第76周和第104周）未持续存在。未观察到重要的眼部变化。
在所有骨骼、眼科及HPA轴功能评估中，每日两次88微克丙酸氟替卡松的长期治疗效果与安慰剂相当。每日两次440微克丙酸氟替卡松治疗对骨密度无显著影响，且导致皮质醇分泌有统计学显著但临床上无重要意义的暂时降低。
