临床儿科杂志 ›› 2017, Vol. 35 ›› Issue (6): 467-.doi: 10.3969/j.issn.1000-3606.2017.06.017

• 循证医学 • 上一篇    下一篇

吸入性糖皮质激素预防早产儿慢性肺疾病有效性和安全性的meta 分析

王小玲, 李雄, 雷小平, 康兰, 王胜会, 董文斌   

  1. 西南医科大学附属医院新生儿科(四川泸州 646000)
  • 收稿日期:2017-06-15 出版日期:2017-06-15 发布日期:2017-06-15

Meta-analysis of the efficacy and safety of inhaled corticosteroids for preventing chronic lung disease in preterm infants

WANG Xiaoling, LI Xiong, LEI Xiaoping, KANG Lan, WANG Shenghui, Dong Wenbin   

  1. Department of Neonatology, Affiliated Hospital of Southwest Medical University, Luzhou 646000, Sichuan, China
  • Received:2017-06-15 Online:2017-06-15 Published:2017-06-15

摘要:  目的 系统评价吸入性糖皮质激素预防早产儿慢性肺疾病(CLD)的有效性和安全性。方法 计算机检索 PubMed、EMBASE、CENTRAL、the ISI Web of Knowledge Databases、CBM、CNKI和VIP、WanFang Data,检索时限均为建 库至2016年10月,搜集所有研究吸入性糖皮质激素防治早产儿CLD的疗效和安全性的随机对照试验(RCT),并进行RCT 的筛选、资料提取和质量评价,应用RevMan 5.3软件进行meta分析。结果 共纳入12篇RCT,2 051例早产儿。与对照组 比较,28天组吸入糖皮质激素组,以及吸入布地奈德亚组、倍氯米松亚组和氟替卡松亚组,CLD发生率的差异无统计学意 义(P均>0.05)。与对照组比较,校正胎龄36周组吸入糖皮质激素组(RR=0.70,95%CI:0.61~0.80)、雾化吸入亚组(RR=0.74, 95%CI:0.63~0.87)、气管内给药亚组(RR=0.57,95%CI:0.43~0.76)以及布地奈德亚组(RR=0.67;95%CI:0.57~0.78) 和氟替卡松亚组(RR=0.58,95%CI:0.36~0.94),CLD发生率的差异有统计学意义(P均<0.05);而倍氯米松组CLD发 生率与对照组差异无统计学意义(P=0.90);总的病死率差异无统计学意义(P=0.55);雾化吸入亚组和气管内给药亚组 以及布地奈德亚组、倍氯米松亚组和氟替卡松亚组病死率与对照组比较差异无统计学意义(P均>0.05)。 结论 预防性使 用吸入性糖皮质激素能有效降低早产儿CLD的发病率,但对病死率无影响,与给药方式和给药类型无显著相关性。同时 推荐以校正胎龄36周为结局指标观察点,但相关研究数量有限,且缺乏长期随访结果,因此吸入性糖皮质激素的作用及 远期并发症,仍需大量的临床研究来评估,建议临床谨慎使用。

Abstract: Objective To evaluate the efficacy and safety of inhaled corticosteroids for preventing chronic lung disease (CLD) in preterm infants. Methods PubMed, EMBASE, CENTRAL, the ISI Web of Knowledge databases, CBM, CNKI, VIP and Wanfang Data were searched for the period up to Oct. 2016. All randomized controlled trials (RCTs) about inhaled corticosteroids for preventing CLD in preterm infants were collected. The RCTs had been screened, data were extracted and assessed. The mata-analysis was performed by RevMan 5.3 software. Result A total of 12 RCTs were included (a total of 2051 preterm neonates).  Compared with control group, in 28 day old group, the incidence of CLD was not significantly  different between experimental and control groups (RR=0.87, 95%CI:0.74-1.03, P=0.11) and (RR=1.19, 95%CI:0.59-2.43, P=0.63) and  no significant  difference among subgroups budesonide (α), beclomethasone (β), fluticasone (γ)  (RR=0.89, 95%CI:0.69-1.14, P=0.35), (RR=0.86, 95%CI:0.69-1.08, P=0.19) and (RR=0.91, 95%CI:0.60-1.38, P=0.19). In 36 wk postmenstrual age group,the incidence of CLD was decreased in experimental group and in subgroups inhalation (A), Intratracheal administration (B), α, γ (RR=0.70, 95%CI: 0.61-0.80, P<0.00001), (RR=0.74, 95%CI: 0.63-0.87, P=0.0003), (RR=0.57, 95%CI: 0.43-0.76, P=0.0002), (RR=0.67, 95%CI: 0.57-0.78, P<0.00001) and (RR=0.58, 95%CI: 0.36-0.94, P=0.03); but it is not significantly  different in  subgroup β (RR=0.98, 95%CI: 0.69-1.39, P=0.90); There was no difference in the motality in experimental and subgroups A ,B, α, β , γ (RR=1.07, 95%CI:0.86-1.33, P=0.55), (RR=1.24, 95%CI: 0.97-1.59, P=0.09), (RR=0.67, 95%CI: 0.43-1.03, P=0.07), (RR=1.04, 95%CI: 0.811.33, P=0.78), (RR=1.47, 95%CI: 0.79-2.74, P=0.22) and (RR=0.91, 95%CI: 0.47-1.74, P=0.77). No clinically significant adverse effects were observed during the study.  Conclusions This updated review indicated that early administration of inhaled steroids to very low birth weight preterm neonates was effective in reducing the incidence of CLD. There was no statistically significant effect of inhaled steroids on motality, and there was no significant correlation between the mode of administration and the type of drug delivery, It is recommended to observe the 36 week gestational age as the outcome index. More and larger randomised placebo-controlled trials including long-term follow up are needed to establish the efficacy  and safety of inhalation corticosteroids.
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