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Article(id=1236731781232251260, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236731777142804746, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2025.17.014, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=1729094400000, acceptedDateStr=2024-10-17, onlineDate=1772789434010, onlineDateStr=2026-03-06, pubDate=1757865600000, pubDateStr=2025-09-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1772789434010, onlineIssueDateStr=2026-03-06, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1772789434010, creator=13701087609, updateTime=1772789434010, updator=13701087609, issue=Issue{id=1236731777142804746, tenantId=1146029695717560320, journalId=1235980733773295621, year='2025', volume='34', issue='17', pageStart='1793', pageEnd='1904', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=1, specialIssue=0, createTime=1772789433036, creator=13701087609, updateTime=1772801868692, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1236783936152596961, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236731777142804746, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1236783936152596962, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1236731777142804746, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1882, endPage=1890, ext={EN=ArticleExt(id=1236731781483909515, articleId=1236731781232251260, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=A systematic review of the efficacy and safety of ferrous succinate tablets in the treatment of iron deficiency anemia during pregnancy, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To systematically evaluate the efficacy and safety of ferrous succinate tablets in the treatment of iron deficiency anemia during pregnancy.

Methods:

Retrieved from PubMed, Embase, Cochrane Library, CNKI, Wanfang, randomized controlled trials (RCTs) about ferrous succinate versus polysaccharide iron complex capsules and ferrous sulfate tablets in the treatment of anemia during pregnancy and different dosage forms of ferrous succinate tablets for the treatment of iron-deficiency anemia in pregnancy were collected from January 2016 to April 2024. Meta-analysis was performed using RevMan 5.3 and Stata 17.0 software.

Results:

A total of 47 RCTs were retrieved with 6 655 patients. Results of meta-analysis showed that ferrous succinate tablets were significantly better than ferrous sulfate tablets in terms of overall efficacy [OR=4.65, 95%CI (3.68,5.88), P<0.000 01] and incidence of adverse reactions (P<0.05). There was no statistical significance in total response rate [OR=1.47，95％CI (0.45，4.79)，P=0.52] and specific adverse effect rates (P>0.05) between ferrous succinate tablets and polysaccharide iron complex capsules. The overall effectiveness and total incidence of adverse drug reactions in ferrous succinate sustained-release tablets were significantly better than that of ferrous succinate film-coated tablets.

Conclusion:

The efficacy and safety of ferrous succinate tablets in treating iron deficiency anemia in pregnancy are both good.

, correspAuthors=Mei-xing YAN, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, authorCompany=null, fund=null, authors=null, authorsList=Zhuo CHEN, Li GAO, Hui WANG, Lu LIU, Mei-xing YAN), CN=ArticleExt(id=1236731784336036346, articleId=1236731781232251260, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=琥珀酸亚铁片治疗妊娠期缺铁性贫血有效性和安全性的系统评价, columnId=1236331163573342670, journalTitle=中国新药杂志, columnName=药物安全与合理应用, runingTitle=null, highlight=null, articleAbstract=
目的:

系统评价琥珀酸亚铁片治疗妊娠期缺铁性贫血的有效性和安全性。

方法:

检索PubMed、Embase、Cochrane Library、中国知网、万方数据库等数据库，纳入琥珀酸亚铁片对比多糖铁复合物胶囊、硫酸亚铁片治疗妊娠期缺铁性贫血的随机对照试验（randomized controlled trials，RCT），以及不同剂型琥珀酸亚铁片治疗妊娠期缺铁性贫血的RCT，检索年限为2016年1月—2024年4月。采用RevMan 5.3和Stata 17.0进行Meta分析。

结果:

共纳入47项RCT，共计6 655例患者。Meta分析显示，琥珀酸亚铁片的总有效率[OR=4.65，95％CI（3.68，5.88），P<0.000 01]和不良反应发生率（P<0.05）显著优于硫酸亚铁片；与多糖铁复合物胶囊相比，二者的总有效率[OR=1.47，95％CI（0.45，4.79），P=0.52]和具体不良反应发生率（P>0.05）均无统计学差异。琥珀酸亚铁缓释片的总有效率和不良反应总发生率均显著优于琥珀酸亚铁薄膜衣片（P<0.05）。

结论:

琥珀酸亚铁片治疗妊娠期缺铁性贫血的有效性及安全性均较好。

, correspAuthors=闫美兴, authorNote=null, correspAuthorsNote=
*闫美兴，男，硕士生导师，主任药师，主要从事临床药学与医院药事管理的相关研究。联系电话：(0532)68661278，E-mail: 。
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陈卓，女，硕士研究生，主要从事临床药学的相关研究。E-mail: 。

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陈卓，女，硕士研究生，主要从事临床药学的相关研究。E-mail: 。

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陈卓，女，硕士研究生，主要从事临床药学的相关研究。E-mail: 。

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Anaemia and iron deficiency in pregnancy and adverse perinatal outcomes in Southern India[J]. Eur J Clin Nutr, 2020, 74(1): 112-125., articleTitle=Anaemia and iron deficiency in pregnancy and adverse perinatal outcomes in Southern India, refAbstract=null), Reference(id=1236792941369414576, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731781232251260, doi=null, pmid=null, pmcid=null, year=2022, volume=1512, issue=1, pageStart=114, pageEnd=125, url=null, language=null, rfNumber=［54］, rfOrder=53, authorNames=GOMES F, AGUSTINA R, BLACK RE, journalName=Ann N Y Acad Sci, refType=null, unstructuredReference=GOMES F, AGUSTINA R, BLACK RE, et al. Multiple micronutrient supplements versus iron-folic acid supplements and maternal anemia outcomes: an iron dose analysis[J]. 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第一作者及发表年份例数/n孕周/周干预措施疗程结局指标
试验组对照组试验组对照组试验组对照组
范林芬（2021）[6]151523.41±2.3723.54±2.31ac4周①
常蕊（2021）[7]4141——ac4周①
陈玲玲（2021）[8]444327.76±4.5227.57±4.37ac1月①②③④⑤
娄秀芳（2023）[9]505021.62±4.1721.80±4.44ac1月①②③④
强小祎（2021）[10]424221.08±3.5421.28±3.62ac4周①
李丽娜（2020）[11]28028022.4±5.921.5±5.0ac4周①
魏江华（2022）[12]3131——ac1月①②
李杰（2021）[13]17617622.05±2.4722.50±2.05ac4周①②④⑥⑦
吴勤练（2023）[14]484821.19±2.5421.64±2.31ac6周①②③⑤⑦
李颖（2020）[15]303018～37—ac4周①②③
郭英（2018）[16]2020——ac8周①②
陈羽（2018）[17]11011023.55±3.1923.62±2.52ad1月①②③④⑤⑦
王芙蓉（2023）[18]3030——ad1月①②④⑦
尹卫霞（2020）[19]60060022.6±1.222.8±1.1ad1月②③⑤⑥⑦
许培培（2017）[20]2525——ad1月①②
刘智慧（2020）[21]2523——ad8周②④⑤
冯丽君（2019）[22]10010024.21±2.5622.12±2.01ad1月②
陈锦寒（2017）[23]25025020.2±4.420.3±4.1ad1月①②③⑤⑦
孙伟（2023）[24]505026.16±2.7426.27±2.46ad1月①②③④⑤
田淑君（2022）[25]353533.51±2.2133.51±2.34ad1月①②③④⑦
高丽荣（2019）[26]6363——ad1月①②③⑦
马海涛（2021）[27]181835.24±1.8635.21±1.87ad6周①②④⑥
熊克平（2018）[28]383823.87±2.7124.01±3.01ad1月①②③⑥
龚红儿（2021）[29]363624.11±2.3524.02±2.27ad1月②
秦智娟（2019）[30]505023.7±2.523.9±2.4ad1月①
赵晓美（2019）[31]555523.1±1.521.3±1.7ad1月①②③④⑤⑦
刘善敏（2018）[32]454527.32±2.7122.19±2.10ad1月①②③⑤⑦
全晓瑜（2017）[33]505020.98±4.7020.42±4.78ad1月①②③⑤⑦
许春兰（2018）[34]494929.3±3.528.0±3.1ad1月①②③⑤⑦
丁晓静（2017）[35]343421.1±1.322.3±1.4ad1月①②③⑤⑦
于宏波（2017）[36]434321.52±1.9822.13±2.08ad—①②③④⑤⑥
范建敏（2021）[37]454539.68±0.6239.45±0.45ad1月①②③⑤⑦
王静（2019）[38]424226.8±2.527.6±2.7ad1月①②③④⑤⑦
袁申云（2021）[39]222221.34±4.0621.36±4.03ad—①
陈红丽（2017）[40]505023.54±8.6620.98±6.54ad1月①②③④⑤⑦
汪小玲（2021）[41]404027.9±3.125.5±2.3ad1月②③④⑤⑦
忻晓芬（2017）[42]272721.15±1.321.23±1.42ad1月②③④⑤⑦
曹瑛瑛（2017）[43]2020——ad5周①②③⑤⑥
杨普兰（2019）[44]3030——ad1月①
白莹（2022）[45]303026.30±4.2026.50±3.20ad4周①
陈萍（2018）[46]303022.20±1.1022.23±1.14ad1月①②③④⑤⑦
杨瑞雪（2017）[47]3131——ad1月①②③⑤⑦
王海侠（2021）[48]300300——ad1月①②③④⑤⑦
李春花（2021）[49]4040——bd1月①
张春凤（2020）[50]383820.62±2.4821.82±2.41bd6周①
张杏娟（2022）[51]505024.5±0.523.5±0.5ba—①②④⑦
徐军（2020）[52]505225.9±1.1625.32±1.24ba2月①②④⑦
), ArticleFig(id=1236792932657844923, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731781232251260, language=CN, label=表1, caption=

纳入文献基本信息

, figureFileSmall=null, figureFileBig=null, tableContent=
第一作者及发表年份例数/n孕周/周干预措施疗程结局指标
试验组对照组试验组对照组试验组对照组
范林芬（2021）[6]151523.41±2.3723.54±2.31ac4周①
常蕊（2021）[7]4141——ac4周①
陈玲玲（2021）[8]444327.76±4.5227.57±4.37ac1月①②③④⑤
娄秀芳（2023）[9]505021.62±4.1721.80±4.44ac1月①②③④
强小祎（2021）[10]424221.08±3.5421.28±3.62ac4周①
李丽娜（2020）[11]28028022.4±5.921.5±5.0ac4周①
魏江华（2022）[12]3131——ac1月①②
李杰（2021）[13]17617622.05±2.4722.50±2.05ac4周①②④⑥⑦
吴勤练（2023）[14]484821.19±2.5421.64±2.31ac6周①②③⑤⑦
李颖（2020）[15]303018～37—ac4周①②③
郭英（2018）[16]2020——ac8周①②
陈羽（2018）[17]11011023.55±3.1923.62±2.52ad1月①②③④⑤⑦
王芙蓉（2023）[18]3030——ad1月①②④⑦
尹卫霞（2020）[19]60060022.6±1.222.8±1.1ad1月②③⑤⑥⑦
许培培（2017）[20]2525——ad1月①②
刘智慧（2020）[21]2523——ad8周②④⑤
冯丽君（2019）[22]10010024.21±2.5622.12±2.01ad1月②
陈锦寒（2017）[23]25025020.2±4.420.3±4.1ad1月①②③⑤⑦
孙伟（2023）[24]505026.16±2.7426.27±2.46ad1月①②③④⑤
田淑君（2022）[25]353533.51±2.2133.51±2.34ad1月①②③④⑦
高丽荣（2019）[26]6363——ad1月①②③⑦
马海涛（2021）[27]181835.24±1.8635.21±1.87ad6周①②④⑥
熊克平（2018）[28]383823.87±2.7124.01±3.01ad1月①②③⑥
龚红儿（2021）[29]363624.11±2.3524.02±2.27ad1月②
秦智娟（2019）[30]505023.7±2.523.9±2.4ad1月①
赵晓美（2019）[31]555523.1±1.521.3±1.7ad1月①②③④⑤⑦
刘善敏（2018）[32]454527.32±2.7122.19±2.10ad1月①②③⑤⑦
全晓瑜（2017）[33]505020.98±4.7020.42±4.78ad1月①②③⑤⑦
许春兰（2018）[34]494929.3±3.528.0±3.1ad1月①②③⑤⑦
丁晓静（2017）[35]343421.1±1.322.3±1.4ad1月①②③⑤⑦
于宏波（2017）[36]434321.52±1.9822.13±2.08ad—①②③④⑤⑥
范建敏（2021）[37]454539.68±0.6239.45±0.45ad1月①②③⑤⑦
王静（2019）[38]424226.8±2.527.6±2.7ad1月①②③④⑤⑦
袁申云（2021）[39]222221.34±4.0621.36±4.03ad—①
陈红丽（2017）[40]505023.54±8.6620.98±6.54ad1月①②③④⑤⑦
汪小玲（2021）[41]404027.9±3.125.5±2.3ad1月②③④⑤⑦
忻晓芬（2017）[42]272721.15±1.321.23±1.42ad1月②③④⑤⑦
曹瑛瑛（2017）[43]2020——ad5周①②③⑤⑥
杨普兰（2019）[44]3030——ad1月①
白莹（2022）[45]303026.30±4.2026.50±3.20ad4周①
陈萍（2018）[46]303022.20±1.1022.23±1.14ad1月①②③④⑤⑦
杨瑞雪（2017）[47]3131——ad1月①②③⑤⑦
王海侠（2021）[48]300300——ad1月①②③④⑤⑦
李春花（2021）[49]4040——bd1月①
张春凤（2020）[50]383820.62±2.4821.82±2.41bd6周①
张杏娟（2022）[51]505024.5±0.523.5±0.5ba—①②④⑦
徐军（2020）[52]505225.9±1.1625.32±1.24ba2月①②④⑦
), ArticleFig(id=1236792932754313917, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731781232251260, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应纳入研究数异质性OR（95%CI）P
PI2/%
乏力30.7200.99(0.24, 4.05)0.99
恶心呕吐30.32131.37(0.45, 4.16)0.58
胃痛20.8502.37(0.34, 16.41)0.38
腹泻20.4503.07(0.73, 12.96)0.13
), ArticleFig(id=1236792932838200000, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731781232251260, language=CN, label=表2, caption=

琥珀酸亚铁片和多糖铁复合物胶囊具体不良反应发生率Meta分析结果

, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应纳入研究数异质性OR（95%CI）P
PI2/%
乏力30.7200.99(0.24, 4.05)0.99
恶心呕吐30.32131.37(0.45, 4.16)0.58
胃痛20.8502.37(0.34, 16.41)0.38
腹泻20.4503.07(0.73, 12.96)0.13
), ArticleFig(id=1236792932905308868, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731781232251260, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应纳入研究数异质性OR（95%CI）P
PI2/%
乏力221.0000.33(0.23, 0.48)<0.000 01
恶心呕吐140.6800.58(0.35, 0.98)0.04
胃痛200.7200.30(0.18, 0.51)<0.000 01
腹痛50.07540.22(0.03, 1.52)0.13
腹泻190.8100.37(0.26, 0.53)<0.000 01
), ArticleFig(id=1236792933014360775, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731781232251260, language=CN, label=表3, caption=

琥珀酸亚铁片和硫酸亚铁片具体不良反应发生率Meta分析结果

, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应纳入研究数异质性OR（95%CI）P
PI2/%
乏力221.0000.33(0.23, 0.48)<0.000 01
恶心呕吐140.6800.58(0.35, 0.98)0.04
胃痛200.7200.30(0.18, 0.51)<0.000 01
腹痛50.07540.22(0.03, 1.52)0.13
腹泻190.8100.37(0.26, 0.53)<0.000 01
), ArticleFig(id=1236792933085663949, tenantId=1146029695717560320, journalId=1235980733773295621, articleId=1236731781232251260, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
不良反应纳入研究数异质性OR（95%CI）P
PI2/%
恶心呕吐20.5900.29(0.08, 1.07)0.06
腹泻20.9900.20(0.02, 1.71)0.14
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琥珀酸亚铁片和琥珀酸亚铁缓释片具体不良反应发生率Meta分析结果

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不良反应纳入研究数异质性OR（95%CI）P
PI2/%
恶心呕吐20.5900.29(0.08, 1.07)0.06
腹泻20.9900.20(0.02, 1.71)0.14
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琥珀酸亚铁片治疗妊娠期缺铁性贫血有效性和安全性的系统评价
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陈卓 1 , 高丽 2 , 王辉 3 , 刘璐 2 , 闫美兴 2, *
中国新药杂志 | 药物安全与合理应用 2025,34(17): 1882-1890
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中国新药杂志 | 药物安全与合理应用 2025, 34(17): 1882-1890
琥珀酸亚铁片治疗妊娠期缺铁性贫血有效性和安全性的系统评价
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陈卓1 , 高丽2, 王辉3, 刘璐2, 闫美兴2, *
作者信息
  • 1中国海洋大学医药学院，青岛　266003
  • 2青岛市妇女儿童医院，青岛　266034
  • 3青岛大学药学院，青岛　266071

    • 陈卓，女，硕士研究生，主要从事临床药学的相关研究。E-mail: 。

通讯作者:

*闫美兴，男，硕士生导师，主任药师，主要从事临床药学与医院药事管理的相关研究。联系电话：(0532)68661278，E-mail: 。
A systematic review of the efficacy and safety of ferrous succinate tablets in the treatment of iron deficiency anemia during pregnancy
Zhuo CHEN1 , Li GAO2, Hui WANG3, Lu LIU2, Mei-xing YAN2, *
Affiliations
  • 1Ocean University of China, Qingdao 266003, China
  • 2Qingdao Women and Children's Hospital, Qingdao 266034, China
  • 3Qingdao University, Qingdao 266071, China
出版时间: 2025-09-15 doi: 10.20251/j.cnki.1003-3734.2025.17.014
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摘要
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目的:

系统评价琥珀酸亚铁片治疗妊娠期缺铁性贫血的有效性和安全性。

方法:

检索PubMed、Embase、Cochrane Library、中国知网、万方数据库等数据库，纳入琥珀酸亚铁片对比多糖铁复合物胶囊、硫酸亚铁片治疗妊娠期缺铁性贫血的随机对照试验（randomized controlled trials，RCT），以及不同剂型琥珀酸亚铁片治疗妊娠期缺铁性贫血的RCT，检索年限为2016年1月—2024年4月。采用RevMan 5.3和Stata 17.0进行Meta分析。

结果:

共纳入47项RCT，共计6 655例患者。Meta分析显示，琥珀酸亚铁片的总有效率[OR=4.65，95％CI（3.68，5.88），P<0.000 01]和不良反应发生率（P<0.05）显著优于硫酸亚铁片；与多糖铁复合物胶囊相比，二者的总有效率[OR=1.47，95％CI（0.45，4.79），P=0.52]和具体不良反应发生率（P>0.05）均无统计学差异。琥珀酸亚铁缓释片的总有效率和不良反应总发生率均显著优于琥珀酸亚铁薄膜衣片（P<0.05）。

结论:

琥珀酸亚铁片治疗妊娠期缺铁性贫血的有效性及安全性均较好。

琥珀酸亚铁片  /  妊娠期贫血  /  有效性  /  安全性  /  Meta分析
Objective:

To systematically evaluate the efficacy and safety of ferrous succinate tablets in the treatment of iron deficiency anemia during pregnancy.

Methods:

Retrieved from PubMed, Embase, Cochrane Library, CNKI, Wanfang, randomized controlled trials (RCTs) about ferrous succinate versus polysaccharide iron complex capsules and ferrous sulfate tablets in the treatment of anemia during pregnancy and different dosage forms of ferrous succinate tablets for the treatment of iron-deficiency anemia in pregnancy were collected from January 2016 to April 2024. Meta-analysis was performed using RevMan 5.3 and Stata 17.0 software.

Results:

A total of 47 RCTs were retrieved with 6 655 patients. Results of meta-analysis showed that ferrous succinate tablets were significantly better than ferrous sulfate tablets in terms of overall efficacy [OR=4.65, 95%CI (3.68,5.88), P<0.000 01] and incidence of adverse reactions (P<0.05). There was no statistical significance in total response rate [OR=1.47，95％CI (0.45，4.79)，P=0.52] and specific adverse effect rates (P>0.05) between ferrous succinate tablets and polysaccharide iron complex capsules. The overall effectiveness and total incidence of adverse drug reactions in ferrous succinate sustained-release tablets were significantly better than that of ferrous succinate film-coated tablets.

Conclusion:

The efficacy and safety of ferrous succinate tablets in treating iron deficiency anemia in pregnancy are both good.

ferrous succinate  /  anemia in pregnancy  /  efficacy  /  safety  /  meta-analysis
陈卓, 高丽, 王辉, 刘璐, 闫美兴. 琥珀酸亚铁片治疗妊娠期缺铁性贫血有效性和安全性的系统评价. 中国新药杂志, 2025 , 34 (17) : 1882 -1890 . DOI: 10.20251/j.cnki.1003-3734.2025.17.014
Zhuo CHEN, Li GAO, Hui WANG, Lu LIU, Mei-xing YAN. A systematic review of the efficacy and safety of ferrous succinate tablets in the treatment of iron deficiency anemia during pregnancy[J]. Chinese Journal of New Drugs, 2025 , 34 (17) : 1882 -1890 . DOI: 10.20251/j.cnki.1003-3734.2025.17.014
正文
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贫血是世界范围内的一个重要公共卫生问题，影响着超过16亿患者。缺铁性贫血（iron deficiency anemia，IDA）是临床上最常见的贫血类型，也是妊娠期最常见的合并症[1]，临床上常表现为唇舌失色、神疲乏力、面色苍白、头晕头痛等症状，严重者可危及母婴健康，造成不良妊娠结局[2]。我国孕妇IDA总患病率为19.1%，妊娠早、中、晚期IDA患病率分别为9.6%，19.8%和33.8%[3]。目前，在针对妊娠期缺铁性贫血的治疗中，以常规的铁剂补充为主，硫酸亚铁、琥珀酸亚铁、多糖铁复合物等药物是临床常用的治疗孕期缺铁性贫血的药物，但现在大多为医生的经验用药，如何选择合适的补铁药物依旧是一大难题。
琥珀酸亚铁作为第2代铁剂，是当前临床防治缺铁性贫血的常用药物[4]。琥珀酸亚铁缓释片作为琥珀酸亚铁片的一种新型制剂，具有缓释的特点，能够很好地减轻铁剂常见的胃肠系统不良反应。目前尚未有研究对妊娠缺铁性贫血妇女使用琥珀酸亚铁片的安全性和有效性进行全面系统的评估，缺乏其与其他补铁药物比较的系统性的Meta分析。因此，本研究采用Meta分析方法系统评价琥珀酸亚铁片治疗妊娠期缺铁性贫血的有效性和安全性，旨在为妊娠期贫血女性安全合理使用口服铁剂提供参考。
资料与方法
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1　纳入与排除标准
1.1　研究类型
已公开发表的中文或英文随机对照试验。
1.2　研究对象
符合《妊娠期铁缺乏和缺铁性贫血诊治指南》中“妊娠合并贫血”诊断标准，诊断为妊娠期IDA的妊娠期贫血妇女。
1.3　干预措施
①琥珀酸亚铁片（琥珀酸亚铁薄膜衣片或琥珀酸亚铁缓释片）与其他可替代口服铁剂（多糖铁复合物胶囊、硫酸亚铁片）的比较。②琥珀酸亚铁缓释片与琥珀酸亚铁薄膜衣片的比较。
1.4　结局指标
本研究的结局指标包括总有效率、不良反应总发生率及具体不良反应发生率。其中，具体不良反应包括口服铁剂类药物常见不良反应：乏力、恶心呕吐、胃痛、腹痛、腹泻等。
1.5　排除标准
本研究的排除标准为：①综述性研究、个案报道。②重复发表的文献。③无法获得全文的文献。④非随机对照临床研究。⑤无相关数据、数据无法提取或存在明显错误的文献。
2　文献检索策略
计算机检索PubMed、Embase、Cochrane Library、Web of Science、中国知网、万方数据库、维普网、中国生物医学文献数据库。中文检索词包括“孕产妇”“妊娠”“缺铁性贫血”“贫血”“琥珀酸亚铁”“速力菲”；英文检索词包括“pregnant women”“iron deficiency anemia”“iron-deficiency”“IDA”“anemia”“ferrous succinate”。检索时限为2016年1月—2024年4月。以“主题词”+“自由词”结合作为检索策略。
3　文献筛选与资料提取
由2位研究者按照纳入与排除标准独立筛选文献，若出现分歧，则由第3位研究者参与共同讨论。资料提取的内容包括第一作者、发表年份、患者基线信息、干预措施、结局指标等。
4　纳入文献质量评价
采用Cochrane偏倚风险评价手册进行质量评价，具体包括：随机序列的产生、分配隐藏、盲法、结果数据完整性、选择性报告结果、其他偏倚来源等七方面。每个条目评价按照低风险、不清楚和高风险3个等级进行评价。
5　统计学方法
采用RevMan 5.3和Stata 17.0软件进行Meta分析。二分类资料采用比值比及95％置信区间（confidence interval, CI）表示。对纳入研究采用Q检验和I2检验分析各研究间的异质性，若I2≤50%，采用固定效应模型分析，反之采用随机效应模型[5]。采用倒漏斗图进行发表偏倚分析。检验水准α=0.05。
结果
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1　文献筛选结果与纳入研究基本信息
经文献检索及筛选后，最终纳入47篇文献，共计6 655例患者。文献筛选流程见图1，纳入研究基本信息见表1。
2　纳入文献质量评价结果
47项研究均为RCT[6-52]。所有研究均提及随机，其中，13项研究提及采用随机数字表法进行分组[6,8,10,13,16,25,27,30,44-45,48,50-51]；1项研究描述了盲法[14]；所有研究均未提及分配隐藏方案及对研究结局的盲法评价，均无选择性报告结果，均不清楚其他偏倚来源。
3　Meta分析结果
3.1　总有效率
共纳入39个RCT研究[6-18,20,23-28,30-40,43-50]，各研究间存在统计学差异（P<0.000 01，I2=61％），采用随机效应模型进行分析。Meta分析结果显示，试验组患者的总有效率显著高于对照组[OR=3.83，95％CI（2.64，5.57），P<0.000 01]，差异有统计学意义，见图2。
按照对照组干预措施的不同，对两组患者的总有效率进行亚组分析：①琥珀酸亚铁片vs多糖铁复合物胶囊，共纳入11项研究均对总有效率进行了描述[6-16]。各研究间存在统计学差异（P<0.000 01，I2=84％），采用随机效应模型进行Meta分析，见图3A。结果显示，两组患者的总有效率的比较，差异无统计学意义[OR=1.47，95％CI（0.45，4.79），P=0.52]。②琥珀酸亚铁片vs硫酸亚铁片，28项研究对总有效率进行了描述[17-18,20,23-28,30-40,43-50]。各研究间无统计学差异（P=0.97，I2=0％），采用固定效应模型进行Meta分析，见图3B。结果显示琥珀酸亚铁片总有效率显著高于硫酸亚铁片，差异有统计学意义[OR=4.65，95％CI（3.68，5.88），P<0.000 01]。
2项研究对琥珀酸亚铁缓释片与薄膜衣片的总有效率进行了描述[51-52]。各研究间无统计学差异（P=0.50，I2=0％），采用固定效应模型进行Meta分析，见图3C。结果显示，琥珀酸亚铁片总有效率显著低于琥珀酸亚铁缓释片，差异有统计学意义[OR=7.35，95％CI（2.11，25.65），P=0.002]。
3.2　不良反应总发生率
35项研究对不良反应总发生率进行了报道[8-9,12-29,31-38,40-44,46-48]，各研究间存在统计学差异（P<0.000 01，I2=78％），采用随机效应模型进行分析。结果显示，试验组患者的不良反应总发生率显著低于对照组[OR=0.47，95％CI（0.29，0.77），P=0.002]，差异有统计学意义，见图4。
2项研究报道了琥珀酸亚铁缓释片与薄膜衣片的不良反应总发生率[51-52]，结果显示，缓释片的不良反应总发生率显著低于薄膜衣片[OR=0.14，95％CI（0.04，0.51），P=0.003]，差异有统计学意义，见图5。
3.3　具体不良反应发生率
琥珀酸亚铁片vs多糖铁复合物胶囊：两组患者的乏力、恶心呕吐、胃痛、腹泻等具体不良反应发生率比较，差异均无统计学意义（P>0.05），见表2。
琥珀酸亚铁片vs硫酸亚铁片：琥珀酸亚铁片的乏力、恶心呕吐、胃痛、腹泻等具体不良反应发生率显著低于硫酸亚铁片（P<0.05），腹痛的发生率与硫酸亚铁片比较无显著差异（P>0.05），见表3。
琥珀酸亚铁薄膜衣片vs琥珀酸亚铁缓释片：琥珀酸亚铁缓释片的腹泻发生率和恶心呕吐发生率与薄膜衣片相比差异均无统计学意义（P>0.05），见表4。
4　发表偏倚
绘制漏斗图对本次研究中纳入研究数>10的亚组的发表偏倚情况进行分析，结果显示，琥珀酸亚铁片vs硫酸亚铁片亚组总有效率的漏斗图各研究点散落分布，对称性一般，存在一定的发表偏倚（Egger's test得出P<0.000 1），见图6。其余研究漏斗图对称性较好，存在发表偏倚的可能性较小（P>0.05）。
讨论
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妊娠期贫血是一种常见的妊娠期并发症，严重影响母婴健康。铁元素在妊娠女性贫血症的发生、发展过程中具有重要作用，补铁治疗可促进红细胞的生成，有效缓解妊娠期贫血症状的发生[53]。目前临床应用较广的口服铁剂分为3代，琥珀酸亚铁作为第2代铁剂，已上市剂型包括薄膜衣片及缓释片2种，均为临床常用的防治妊娠期贫血的药物。
本研究共纳入47项RCT，对琥珀酸亚铁片与其他常用口服铁剂以及琥珀酸亚铁片2种不同剂型的有效性和安全性进行分析。结果显示，琥珀酸亚铁片与多糖铁复合物胶囊的总有效率及具体不良反应发生率均无明显差异，二者疗效相当。琥珀酸亚铁片为一种二价铁剂，口服进入胃肠道后会在胃酸环境下实现亚铁离子解离，并积极参与人体的血红蛋白合成，能够使妊娠期妇女血红蛋白水平提高[54]；琥珀酸亚铁片的总有效率和具体不良反应发生率均优于硫酸亚铁片，这可能是因为琥珀酸亚铁片作为一种有机酸盐类，与无机铁剂相比有更高的生物利用度，并且减少了胃肠道刺激和铁锈味，更容易被大家接受。琥珀酸亚铁缓释片的总有效率和不良反应总发生率均显著优于薄膜衣片，琥珀酸亚铁缓释片具有缓释的特性，经口服后能够延缓药物的释放速率，降低药物的吸收速率，避免胃肠道亚铁离子峰浓度过大，同时能保证长时间持续释放，刺激性极小，极大减少恶心呕吐、胃疼、腹泻等不良反应[52]。与此同时，该药物口感较好，没有金属异味，更有利于提升患者的依从性[51]。发表偏倚分析结果表明，本研究存在一定发表偏倚。
综上所述，琥珀酸亚铁片总有效率和不良反应发生率明显优于第1代铁剂硫酸亚铁片，与第3代铁剂多糖铁复合物胶囊治疗妊娠期缺铁性贫血的疗效和安全性相当。琥珀酸亚铁缓释片在疗效和安全性方面较薄膜衣片存在明显的优势。反思本研究的局限性：①纳入文献均为中文文献且大多集中在琥珀酸亚铁薄膜衣片与硫酸亚铁片的比较，其他药物的研究较少；琥珀酸亚铁缓释片作为一种新型剂型，相关研究较少。②研究异质性较高，可能与铁剂的生产厂家、剂量、服用周期等不同有关。③各个研究间试验人数差异较大，个别研究样本人数较少，代表性较差。故本研究所得结论仍需多中心、大样本、高质量RCT进行证实。
基金
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  • 山东省药学会科研项目(SDSYXH-KY-202307)
文献
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2025年第34卷第17期
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doi: 10.20251/j.cnki.1003-3734.2025.17.014
  • 首发时间：2026-03-06
  • 出版时间：2025-09-15
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  • 录用日期：2024-10-17
基金
山东省药学会科研项目(SDSYXH-KY-202307)
作者信息
    1中国海洋大学医药学院，青岛　266003
    2青岛市妇女儿童医院，青岛　266034
    3青岛大学药学院，青岛　266071

通讯作者:

*闫美兴，男，硕士生导师，主任药师，主要从事临床药学与医院药事管理的相关研究。联系电话：(0532)68661278，E-mail: 。
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https://castjournals.cast.org.cn/joweb/zgxyzz/CN/10.20251/j.cnki.1003-3734.2025.17.014
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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