Davies Glenn M, Dasbach Erik J, Santanello Nancy C, Knorr Barbara A, Bratton Donna L
Merck Research Laboratories, Merck & Co., Inc., West Point, PO Box 4, BL2-3, West Point, PA 19486, USA.
Clin Ther. 2004 Nov;26(11):1895-904. doi: 10.1016/j.clinthera.2004.11.010.
Limited clinical data are available on the long-term effects of asthma controller therapy on the utilization of health care resources in pediatric patients with asthma.
The objective of this study was to compare the effects of long-term treatment with montelukast and usual care on health care resource use in children with asthma.
Pediatric patients aged 2 to 5 years with asthma who had completed a 3-month, double-blind, double-dummy clinical trial comparing montelukast 4 mg and placebo were asked to participate in an open-label, controlled extension study comparing montelukast 4 mg and usual care. Usual care was defined as cromolyn or inhaled corticosteroid therapy Health care resource utilization was measured in terms of oral corticosteroid use and numbers of physician visits, emergency department visits, and hospitalizations.
Of 618 patients who completed the primary phase of the study, 516 (83.5%) participated in the extension study Data from 506 patients (302 without previous asthma maintenance therapy, 204 with) were included in the analysis. During the extension phase, patients who received montelukast and had not used previous asthma maintenance therapy were followed for a mean of 329.5 days; those who received usual care and
In this open-label study, pediatric patients aged 2 to 5 years with mild to moderate persistent asthma receiving long-term therapy with montelukast had similar rates of asthma-related health care resource utilization compared with those receiving usual care with cromolyn or inhaled corticosteroids.
关于哮喘控制疗法对哮喘患儿医疗资源利用的长期影响,临床数据有限。
本研究的目的是比较孟鲁司特长期治疗与常规治疗对哮喘患儿医疗资源使用的影响。
年龄在2至5岁的哮喘患儿完成了一项为期3个月的双盲、双模拟临床试验,比较了4毫克孟鲁司特与安慰剂,之后邀请他们参加一项开放标签、对照的延长期研究,比较4毫克孟鲁司特与常规治疗。常规治疗定义为色甘酸钠或吸入性糖皮质激素治疗。医疗资源利用通过口服糖皮质激素的使用情况以及医生就诊次数、急诊就诊次数和住院次数来衡量。
在完成研究第一阶段的618名患者中,516名(83.5%)参加了延长期研究。分析纳入了506名患者的数据(302名未接受过哮喘维持治疗,204名接受过)。在延长期,接受孟鲁司特且未使用过哮喘维持治疗的患者平均随访329.5天;接受常规治疗的患者……
在这项开放标签研究中,年龄在2至5岁、患有轻至中度持续性哮喘且接受孟鲁司特长期治疗的患儿,与接受色甘酸钠或吸入性糖皮质激素常规治疗的患儿相比,哮喘相关医疗资源利用率相似。