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【medical-news】大型前瞻性研究：左氧氟沙星引发
From the *Johnson and Johnson Pharmaceutical Research and Development, L.L.C., Raritan, NJ; †Childrenʼs Hospital and Health Center, San Diego, CA; ‡Childrenʼs Mercy Hospital, Kansas City, MO; §Montreal Childrenʼs Hospital and McGill University, Montreal, Quebec, Canada; ∥Boston Childrenʼs Hospital, Boston, MA; ¶Instituto de Atención Pediátrica, Neeman-ICIC, Universidad de Ciencias Médicas, San José, Costa Rica; and #Case Western Reserve University, Rainbow Babies Hospital and Childrenʼs Hospital, Cleveland, OH.
BACKGROUND:: Fluoroquinolones, including levofloxacin, have not been recommended for use in children largely because studies in juvenile laboratory animals suggest there may be an increased risk of fluoroquinolone-associated cartilage lesions. A large prospective trial is needed to assess the risks associated with using levofloxacin in children.
OBJECTIVE:: Assess the safety and tolerability of levofloxacin therapy in children based on observations for 1 year after therapy.
METHODS:: Safety data were collected in children who participated in 1 of 3 efficacy trials (N = 2523) and a subset of these children who also subsequently participated in a long-term 1-year surveillance trial (N = 2233). Incidence of adverse events in children randomized to receive levofloxacin versus nonfluoroquinolone antibiotics was compared. Based on assessments by treating physicians and an independent data safety monitoring committee, events related to the musculoskeletal system were further categorized as 1 of 4 predefined musculoskeletal disorders (arthralgia, arthritis, tendinopathy, gait abnormality) considered most likely clinical correlates of fluoroquinolone-associated cartilage lesions observed in laboratory animals.
RESULTS:: Levofloxacin was well tolerated during and for 1 month after therapy as evidenced by similar incidence and character of adverse events compared with nonfluoroquinolone antibiotics. However, incidence of at least 1 of the 4 predefined musculoskeletal disorders (largely due to reports of arthralgia) was greater in levofloxacin-treated compared with nonfluoroquinolone-treated children at 2 months (2.1% vs. 0.9%; P = 0.04) and 12 months (3.4% vs. 1.8%; P = 0.03) after starting therapy.
CONCLUSIONS:: The incidence of 1 or more of the 4 predefined musculoskeletal disorders identified in nonblinded, prospective evaluations, was statistically greater in levofloxacin-treated compared with comparator-treated children.
http://www.docguide.com/news/content.nsf/PaperFrameSet?OpenForm&newsid=852571020057CCF685257366003F7A80&topabstract=1&u=http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&dopt=Abstract&list_uids=17901792 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 请诸位战友指教！
Comparative Safety Profile of Levofloxacin in 2523 Children With a Focus on Four Specific Musculoskeletal Disorders.
大型前瞻性研究：左氧氟沙星引发儿童肌骨骼症状
From the *Johnson and Johnson Pharmaceutical Research and Development, L.L.C., Raritan, NJ; †Childrenʼs Hospital and Health Center, San Diego, CA; ‡Childrenʼs Mercy Hospital, Kansas City, MO; §Montreal Childrenʼs Hospital and McGill University, Montreal, Quebec, Canada; ∥Boston Childrenʼs Hospital, Boston, MA; ¶Instituto de Atención Pediátrica, Neeman-ICIC, Universidad de Ciencias Médicas, San José, Costa Rica; and #Case Western Reserve University, Rainbow Babies Hospital and Childrenʼs Hospital, Cleveland, OH.
BACKGROUND:: Fluoroquinolones, including levofloxacin, have not been recommended for use in children largely because studies in juvenile laboratory animals suggest there may be an increased risk of fluoroquinolone-associated cartilage lesions. A large prospective trial is needed to assess the risks associated with using levofloxacin in children.
背景：
包括左氧氟沙星在内的氟喹诺酮类药物尚未被广泛推荐用于儿童，因为幼小动物实验研究证实，其可能会增加氟喹诺酮相关的软骨损伤风险。为了评估儿童使用左氧氟沙星的相关风险需要进行大型前瞻性研究。
OBJECTIVE:: Assess the safety and tolerability of levofloxacin therapy in children based on observations for 1 year after therapy.
目的：
治疗后观察一年来评估儿童使用左氧氟沙星治疗的安全性及耐受性。
METHODS:: Safety data were collected in children who participated in 1 of 3 efficacy trials (N = 2523) and a subset of these children who also subsequently participated in a long-term 1-year surveillance trial (N = 2233).
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作者:admin@医学,生命科学 2011-05-27 17:11
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