摘要
目的:评价儿童使用吸入性糖皮质激素的安全性。方法计算机检索MEDLINE(1995～2007)、PUBMED(1995～2007)、Cochrane临床试验数据库(2008年第1期)、中国期刊全文数据库(CNKI)(1995～2007)、万方数据库等文献数据库,收集评价儿童使用吸入性糖皮质激素安全性的随机或半随机试验,对符合纳入标准的研究进行Meta分析。结果:共纳入23篇随机和半随机对照研究(n=2 112),其中中文16篇,英文7篇。根据Jadad量表评分,共有6篇文献为高质量文献。吸入性糖皮质激素组与对照组相比:(1)对肾上腺皮质功能的影响,评价指标尿游离皮质醇(Urinary-free cortisol,UFC)在3个月内显著升高[WMD合并=-11.67,95%CI(-19.68,-3.66),P=0.004],但1年后两组间差异无统计学意义[WMD合并=-3.45,95%CI(-9.08,2.18),P=0.23];(2)1年内[WMD合并=0.02,95%CI(-0.07,0.11),P=0.49]和1年以上[WMD合并=-0.22,95%CI(-0.53,0.09),P=1.40]的生长速率GV(Growth velocity,GV)两组间均无显著差异(P>0.05);(3)使用6个月[WMD合并=0,95%CI(-0.01,0.01),P=0.95]和1年[WMD合并=0.01,95%CI(-0.01,0.02),P=0.24]后的骨密度BMD(Bone mineral density,BMD),两组间差异也均无统计学意义(P>0.05);(4)反应骨形成的指标血清I型胶原吡啶交联终肽(C-terminal telopeptide region of type I collagen,ICTP),6个月内显著升高[WMD合并=-3.33,95%CI(-5.23,-1.42),P=0.0006]。纳入的研究中仅ICTP研究间具有异质性(异质性检验P<0.000 01,I2=96.4%),但敏感性分析结果表明:ICTP的分析结果较为稳定可信;其余指标的来源文献均为同质性。发表偏倚的分析结果显示UFC存在一定发表偏倚。结论:哮喘儿童吸入糖皮质激素长时期内(1年)对生长发育、骨密度和肾上腺皮质功能没有明显影响,安全性较高;而短时间内(6个月)影响骨形成和肾上腺皮质功能。
OBJECTIVE： To assess the safety of inhaled glucocorticosteoids in the treatment of childhood asthma. METHODS： MEDLINE （1995 - 2007）, PUBMED （1995 - 2007）, Cochrane Central Register of Controlled Trials （Issue 1, 2008）, CNKI （ 1995 - 2007 ） and Wanfang Data were searched by computer for randomized controlled trials or quasi- randomized controlled trials about the safety of inhaled glucocorticosteoids in the treatment of childhood asthma. A meta- analysis was performed on the included studies. RESULTS： A total of twenty three literatures were included （n = 2 112）, of which, 16 were written in Chinese and 7 in English. According to Jadad scale, 6 literatures were high in quality. In the inhaled glucocorticosteoids groups as compared with the control, （1） the urinary-free cortisol （UFC） （within 3 month） was higher than that for the control group [WMD： - 11.67,95% CI （ - 19.68, - 3.66）, P = 0.004], however, the UFC had no statistical difference over 1 year [WMD： - 3.45, 95%CI（ - 9.08,2.18）, P = 0.23] ; （2） Within 1 year and over 1 year, the growth velocity （GV） had no statistical difference （ P 〉 0.05） [WMD： 0.02, 95% CI （ - 0.07,0.11）, P = 0.49 versus WMD： -0.22,95%CI （ -0.53, 0.09）, P = 1.40]; （3） Similar results were also found in 6 month and 1 year for the bone mineral density （BMD） [ WMD ： 0, 95 % CI （ - 0.01,0.01 ）, P = 0.95 versus WMD ： 0.01, 95 % CI （ -0.01,0.02）, P = 0.24] ; （4） The C-terminal telopeptide region of type I （ICTP） collagen increased significantly within 6 months [WMD： -3.33, 95% CI（ -5.23, - 1.42）, P = 0.000 6]. Heterogeneity was only noted among literatures of ICTP （Heterogeneity test P 〈 0.000 01, I^2 = 96.4% ）, but sensitivity analysis showed that the analysis results of ICTP were stable and reliable. The literatures of other indexes were of homogenicity. The finding showed that the UFC of publication bias was existed. CONCLUSION： Although inhaled corticosteroids may have eff
出处
《中国医院用药评价与分析》
2009年第1期16-20,共5页
Evaluation and Analysis of Drug-use in Hospitals of China
