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·循证药学·


          多糖铁对比硫酸亚铁用于妊娠期贫血安全性的Meta分析                                                             Δ


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                 1*
          王广燕 ,刘 璐 ,王巧黎 ,闫美兴 ,刘 畅 (1.青岛大学附属妇女儿童医院药学部,山东 青岛 266034;
                                                   1 #
          2.青岛市中心医疗集团药学部,山东 青岛 266042)
          中图分类号  R973      文献标志码  A      文章编号  1001-0408(2023)13-1627-05
          DOI  10.6039/j.issn.1001-0408.2023.13.16


          摘  要  目的  比较多糖铁与硫酸亚铁用于妊娠期贫血的安全性。方法  计算机检索 the Cochrane Library、PubMed、Embase、
          SinoMed、中国知网、维普网、万方数据库,收集多糖铁(试验组)对比硫酸亚铁(对照组)用于妊娠期贫血的随机对照试验(RCT),检
          索时限为建库起至2022年5月20日。筛选文献、提取资料及质量评价后,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 13 项 RCT,共计 1 318 例患者。Meta 分析结果显示,试验组患者的不良反应总发生率[RR=0.11,
          95%CI(0.06,0.18),P<0.000 01]以及胃肠道不适[RR=0.08,95%CI(0.05,0.12) ,P<0.000 01]、厌食恶心[RR=0.21,95%CI(0.09,
          0.54),P=0.001]、腹痛[RR=0.18,95%CI(0.04,0.78),P=0.02]、腹泻[RR=0.18,95%CI(0.04,0.79),P=0.02]、呕吐[RR=0.24,
          95%CI(0.06,0.89),P=0.03]、牙龈黑染[RR=0.09,95%CI(0.03,0.28),P<0.000 1]发生率均显著低于对照组。敏感性分析结果显
          示,本研究所得结论较稳健。发表偏倚结果显示,本研究存在发表偏倚的可能性较大。结论  多糖铁用于妊娠期贫血的安全性优
          于硫酸亚铁。
          关键词  妊娠期贫血;多糖铁;硫酸亚铁;安全性;Meta分析


          Meta-analysis  of  the  safety  of  polysaccharide  iron  complex  versus  ferrous  sulfate  in  the  treatment  of
          anemia during pregnancy
                                                               1
          WANG Guangyan ,LIU Lu ,WANG Qiaoli ,YAN Meixing ,LIU Chang(1.  Dept.  of  Pharmacy,  Women  and
                                                 2
                         1
                                                                           1
                                  1
          Children’s Hospital of Qingdao University, Shandong Qingdao 266034, China;2. Dept. of Pharmacy, Qingdao
          Central Medical Group, Shandong Qingdao 266042, China)
          ABSTRACT   OBJECTIVE  To  compare  the  safety  of  polysaccharide  iron  complex  and  ferrous  sulfate  in  the  treatment  of  anemia
          during  pregnancy.  METHODS  Retrieved  from  Cochrane  Library,  PubMed,  Embase,  SinoMed,  CNKI,  VIP  and  Wanfang
          database,  randomized  controlled  trials (RCTs)  about  polysaccharide  iron  complex (trial  group)  versus  ferrous  sulfate (control
          group)  in  the  treatment  of  anemia  during  pregnancy  were  collected  from  the  inception  to  May  20th,  2022.  After  literature
          screening,  data  extraction  and  quality  evaluation,  meta-analysis,  sensitivity  analysis  and  publication  bias  analysis  were  conducted
          with  RevMan  5.3  software.  RESULTS  A  total  of  13  RCTs  were  included,  with  a  total  of  1  318  patients.  Results  of  meta-analysis
          showed that the total incidence of adverse drug reactions (ADR) [RR=0.11, 95%CI (0.06, 0.18), P<0 000 01], gastrointestinal
          adverse  reactions  [RR=0.08,  95%CI (0.05,  0.12),  P<0.000  01],  anorexia  and  nausea  [RR=0.21,  95%CI (0.09,  0.54),  P=
          0.001],  abdominal  pain  [RR=0.18,  95%CI (0.04,  0.78),  P=0.02],  diarrhea  [RR=0.18,  95%CI (0.04,  0.79),  P=0.02],
          vomiting [RR=0.24, 95%CI (0.06, 0.89), P=0.03] and gingival melanosis [RR=0.09, 95%CI (0.03, 0.28), P<0.000 1] in the
          trial  group  were  all  significantly  lower  than  the  control  group.  The  results  of  sensitivity  analysis  showed  that  the  conclusions
          obtained  in  this  study  were  relatively  robust.  The  results  of  publication  bias  analysis  indicated  that  there  was  a  high  possibility  of
          publication  bias  in  this  study.  CONCLUSIONS  The  polysaccharide  iron  complex  is  safer  than  ferrous  sulfate  for  treatment  of
          anemia during pregnancy.
                                                             KEYWORDS     anemia  during  pregnancy;  polysaccharide  iron
              Δ 基金项目 山东省第一批药品临床综合评价项目(No. 鲁卫函                complex; ferrous sulfate; safety; meta-analysis
         〔2021〕252号)
             *第一作者 主管药师,硕士。研究方向:妇产科临床药学。电
          话:0532-68661613。E-mail:gywang2017@163.com
                                                                 妊娠期妇女是缺铁性贫血的高发人群。妊娠期贫
             # 通信作者 副主任药师,博士。研究方向:临床药学、药品临床综
          合评价。电话:0532-68661613。E-mail:lch1001@yeah.net       血不仅会增加不良妊娠结局的发生风险,还会威胁母亲


          中国药房  2023年第34卷第13期                                              China Pharmacy  2023 Vol. 34  No. 13    · 1627 ·
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