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小剂量氢化可的松防治极早产儿支气管肺发育不良有效性和安

          全性的Meta分析                 Δ



                 1*
          施慧玲 ,贾雁平 ,任 翼(1.海口市妇幼保健院儿童保健部,海口 570203;2.海口市妇幼保健院新生儿科,
                           2
                                   3
          海口 570203;3.海口市妇幼保健院儿内科,海口 570203)
          中图分类号  R974;R722.6      文献标志码  A      文章编号  1001-0408(2023)10-1252-06
          DOI  10.6039/j.issn.1001-0408.2023.10.19

          摘   要  目的  系统评价极早产儿早期预防性使用小剂量氢化可的松(HC)防治支气管肺发育不良(BPD)的有效性和安全性,为
          临床治疗提供循证参考。方法  计算机检索PubMed、Embase、Web of Science、Cochrane图书馆、中国期刊全文数据库、中文科技期
          刊数据库、万方数据,收集极早产儿早期预防性使用小剂量HC(试验组)对比安慰剂或多巴胺(对照组)的随机对照试验(RCT)。
          检索时限均为建库起至2022年6月。筛选文献、提取资料后采用Cochrane系统评价员手册推荐的6.2偏倚风险评估工具对纳入文
          献质量进行评价;采用RevMan 5.3软件进行Meta分析、敏感性分析和发表偏倚分析。结果  共纳入9篇RCT,总计1 437例极早产
          儿。Meta 分析结果显示,试验组患儿的 BPD 发生率[OR=0.75,95%CI(0.58,0.95),P=0.02]、病死率[OR=0.72,95%CI(0.54,
          0.97),P=0.03]均显著低于对照组,无BPD生存率[OR=1.36,95%CI(1.06,1.74),P=0.02]、胃肠道穿孔发生率[OR=2.23,95%CI
         (1.31,3.78),P=0.003]、败血症发生率[OR=1.27,95%CI(1.01,1.60),P=0.04]均显著高于对照组;两组患儿的坏死性小肠结肠
          炎、脑室旁白质软化、脑室内出血、动脉导管未闭、高血糖、气胸、早产儿视网膜病发生率比较,差异均无统计学意义(P>0.05)。敏
          感性分析结果显示,所得结果稳健。发表偏倚分析结果显示,本研究存在发表偏倚的可能性较小。结论  极早产儿早期预防性使
          用小剂量HC可减少BPD的发生,降低病死率,提高无BPD生存率,但需注意胃肠道穿孔和败血症的发生。
          关键词  极早产儿;氢化可的松;支气管肺发育不良;有效性;安全性;Meta分析

          Efficacy  and  safety  of  low-dose  hydrocortisone  for  the  prevention  and  treatment  of  bronchopulmonary
          dysplasia in very premature infants: a meta-analysis
          SHI Huiling ,JIA Yanping ,REN Yi(1.  Dept.  of  Child  Health,  Haikou  Maternal  and  Child  Health  Hospital,
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                     1
                                           3
          Haikou 570203, China;2. Dept. of Neonatology, Haikou Maternal and Child Health Hospital, Haikou 570203,
          China;3.  Dept.  of  Pediatric  Internal  Medicine,  Haikou  Maternal  and  Child  Health  Hospital,  Haikou  570203,
          China)

          ABSTRACT    OBJECTIVE  To  systematically  evaluate  the  efficacy  and  safety  of  prophylactic  use  of  low-dose  hydrocortisone
         (HC) for the prevention and treatment of bronchopulmonary dysplasia (BPD), and to provide evidence-based reference for clinical
          treatment.  METHODS  PubMed,  Embase, Web  of  Science,  Cochrane  Library,  CJFD, VIP  and Wanfang  databases  were  searched
          by computer; randomized controlled trials (RCT) about prophylactic use of low-dose HC (trial group) versus placebo or dopamine
         (control  group)  in  very  premature  infants  were  collected  from  the  establishment  of  the  database  to  Jun.  2022.  The  quality  of  the
          included literature was evaluated by using bias risk assessment tool recommended by Cochrane system evaluator’s manual (version
          6.2)  after  screening  the  literature  and  extracting  the  data.  Meta-analysis,  sensitivity  analysis  and  publication  bias  analysis  were
          carried out with RevMan 5.3 statistical software. RESULTS A total of 1 437 very premature infants were included in 9 RCTs. Meta-
          analysis  showed  that  the  incidence  of  BPD  [OR=0.75,  95%CI(0.58,0.95),  P=0.02]  and  fatality  [OR=0.72,  95%CI (0.54,
          0.97),  P=0.03]  in  trial  group  were  significantly  lower  than  control  group;  the  survival  rate  without  BPD  [OR=1.36,  95%CI
         (1.06,1.74), P=0.02], the incidences of gastrointestinal perforation [OR=2.23, 95%CI (1.31,3.78), P=0.003] and sepsis [OR=
          1.27,  95%CI (1.01,1.60),  P=0.04]  in  trial  group  were  all  significantly  higher  than  control  group.  There  was  no  significant
          difference  in  the  incidence  of  necrotizing  enterocolitis,  paraventricular  leukomalacia,  intraventricular  hemorrhage,  patent  ductus
          arteriosus,  hyperglycemia,  pneumothorax,  retinopathy  of  premature  infants  between  the  two  groups (P>0.05).  Results  of
          sensitivity analysis showed that study results were robust. Results of publication bias analysis showed that there was little possibility
          of  publication  bias  in  this  study.  CONCLUSIONS  The  early  prophylactic  use  of  low-dose  HC  can  reduce  BPD  in  very  premature
          infants, reduce fatality, and improve the survival rate without BPD, but we should pay attention to gastrointestinal perforation and
                                                              sepsis.
              Δ 基金项目 海南省自然科学基金面上项目(No.821MS0848)
             *第一作者 副主任医师。研究方向:儿童保健及临床。电话:                     KEYWORDS    very   premature   infants;   hydrocortisone;
          0898-65222333。E-mail:shihuiling0088@163.com         bronchopulmonary dysplasia; efficacy; safety; meta-analysis


          · 1252 ·    China Pharmacy  2023 Vol. 34  No. 10                            中国药房  2023年第34卷第10期
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