allergic asthma;
IgE;
omalizumab;
children;
quality of life;
asthma;
D O I:
10.1542/peds.110.5.e55
中图分类号:
R72 [儿科学];
学科分类号:
100202 ;
摘要:
Background and Objective. Omalizumab is a recombinant, humanized, monoclonal anti-immunoglobulin E (IgE) antibody, developed for the treatment of IgE-mediated diseases. In children with allergic asthma, it was shown to reduce the requirement for inhaled corticosteroids while protecting against disease exacerbation. Here we report the effects of treatment with omalizumab on asthma-related quality of life (AQoL) in children with allergic asthma. Methods. This evaluation was part of a previously reported 28-week, randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of omalizumab (at least 0.016 mg/kg/IgE [IU/mL] per 4 weeks) in children with allergic asthma who were well controlled on daily treatment with inhaled corticosteroids. Dosage of beclomethasone dipropionate was kept constant for 16 weeks (steroid-stable phase), then reduced over 8 weeks to the minimum effective dose (steroid-reduction phase). This dose was then maintained for the final 4 weeks. The Pediatric Asthma Quality of Life Questionnaire (PAQLQ) was administered at baseline, week 16, and week 28. Results. Baseline demographics, PAQLQ scores, and other data were comparable for the 2 treatment groups. At the end of the steroid-reduction phase, patients in the omalizumab-treated group reported significant improvements in the "activities" and "symptoms" domain scores as well as overall AQoL compared with placebo. More patients in the omalizumab group achieved clinically relevant (greater than or equal to0.5) changes in PAQLQ scores during the course of the study, and this difference was significant for activities and overall AQoL. Conclusion. Omalizumab improves AQoL in children with allergic asthma.
机构:
Columbia Univ Coll Phys & Surg, New York Presbyterian Hosp, Gen Pediat Inpatient Serv, New York, NY 10032 USAColumbia Univ Coll Phys & Surg, New York Presbyterian Hosp, Gen Pediat Inpatient Serv, New York, NY 10032 USA
Subramony, Anupama
Hall, Matthew
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机构:
Childrens Hosp Assoc, Overland Pk, KS USAColumbia Univ Coll Phys & Surg, New York Presbyterian Hosp, Gen Pediat Inpatient Serv, New York, NY 10032 USA
Hall, Matthew
Thomas, Cherie
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h-index: 0|
机构:
Childrens Hosp Assoc, Overland Pk, KS USAColumbia Univ Coll Phys & Surg, New York Presbyterian Hosp, Gen Pediat Inpatient Serv, New York, NY 10032 USA
Thomas, Cherie
Chiang, Vincent W.
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机构:
Boston Childrens Hosp, Inpatient Serv, Boston, MA USA
Boston Childrens Hosp, Finance, Dept Med, Boston, MA USA
Harvard Med Sch, Pediat, Boston, MA USAColumbia Univ Coll Phys & Surg, New York Presbyterian Hosp, Gen Pediat Inpatient Serv, New York, NY 10032 USA
Chiang, Vincent W.
McClead, Richard E.
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机构:
Ohio State Univ, Dept Pediat, Columbus, OH 43210 USA
Nationwide Childrens Hosp, Qual Improvement Serv, Columbus, OH USAColumbia Univ Coll Phys & Surg, New York Presbyterian Hosp, Gen Pediat Inpatient Serv, New York, NY 10032 USA
McClead, Richard E.
Macias, Charles G.
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机构:
Texas Childrens Hosp, Pediat, Houston, TX 77030 USA
Texas Childrens Hosp, Evidence Based Outcomes Ctr, Houston, TX 77030 USA
Texas Childrens Hosp, Ctr Clin Effectiveness, Houston, TX 77030 USA
Baylor Coll Med, Houston, TX 77030 USAColumbia Univ Coll Phys & Surg, New York Presbyterian Hosp, Gen Pediat Inpatient Serv, New York, NY 10032 USA
Macias, Charles G.
Frank, Gary
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机构:
Childrens Healthcare Atlanta, Qual & Med Management, Atlanta, GA USA
Emory Univ, Sch Med, Pediat, Atlanta, GA 30322 USAColumbia Univ Coll Phys & Surg, New York Presbyterian Hosp, Gen Pediat Inpatient Serv, New York, NY 10032 USA
Frank, Gary
Simon, Harold K.
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机构:
Emory Univ, Dept Pediat, Childrens Healthcare Atlanta, Atlanta, GA 30322 USAColumbia Univ Coll Phys & Surg, New York Presbyterian Hosp, Gen Pediat Inpatient Serv, New York, NY 10032 USA
Simon, Harold K.
Mann, Keith
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机构:
Childrens Mercy Hosp & Clin, Kansas City, MO USA
Univ Missouri Kansas City, Pediat, Sch Med, Kansas City, MO USAColumbia Univ Coll Phys & Surg, New York Presbyterian Hosp, Gen Pediat Inpatient Serv, New York, NY 10032 USA
Mann, Keith
Morse, Rustin
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机构:
Childrens Med Ctr, Dallas, TX USA
Univ Texas Southwestern, Dallas, TX USAColumbia Univ Coll Phys & Surg, New York Presbyterian Hosp, Gen Pediat Inpatient Serv, New York, NY 10032 USA
机构:
Guangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R ChinaGuangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R China
Li, Jing
Kang, Jian
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机构:
Guangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R ChinaGuangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R China
Kang, Jian
Wang, Changzheng
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机构:
Guangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R ChinaGuangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R China
Wang, Changzheng
Yang, Jing
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h-index: 0|
机构:
Guangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R ChinaGuangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R China
Yang, Jing
Humphries, Michael
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机构:
Guangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R ChinaGuangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R China
Humphries, Michael
Greenberg, Steven
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h-index: 0|
机构:
Guangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R ChinaGuangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R China
Greenberg, Steven
Zhong, Nanshan
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h-index: 0|
机构:
Guangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R ChinaGuangzhou Med Univ, State Key Lab Resp Dis, Guangzhou, Guangdong, Peoples R China