Safety monitoring of oral iron supplements in pregnant women with anemia: a multi-center observational clinical study
Aims: To investigate the safety of oral iron therapy in pregnant women with iron-deficiency anemia (IDA) in the real world. Methods: A retrospective analysis was performed on 1792 pregnant patients with IDA who received oral iron supplements from 12 hospitals in Shandong Province from 1 April to 31...
| Main Authors: | , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2023-06-01
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| Series: | Therapeutic Advances in Drug Safety |
| Online Access: | https://doi.org/10.1177/20420986231181335 |
| _version_ | 1797796229038473216 |
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| author | Chang Liu Qianqian Zhang Peiye Hui Yan Wang Guohui Li Guangchao Cao Zicheng Xue Jing Zhang Heng Zhang Xin Huang Jiyong Wu Fusehng Sun Meixing Yan |
| author_facet | Chang Liu Qianqian Zhang Peiye Hui Yan Wang Guohui Li Guangchao Cao Zicheng Xue Jing Zhang Heng Zhang Xin Huang Jiyong Wu Fusehng Sun Meixing Yan |
| author_sort | Chang Liu |
| collection | DOAJ |
| description | Aims: To investigate the safety of oral iron therapy in pregnant women with iron-deficiency anemia (IDA) in the real world. Methods: A retrospective analysis was performed on 1792 pregnant patients with IDA who received oral iron supplements from 12 hospitals in Shandong Province from 1 April to 31 June 2021; follow-up and adverse reactions were recorded. They were divided into six groups according to the treatment drugs. Results: The overall adverse reaction rate was 15.4%, and the main adverse reaction site was the digestive system. The incidence of all kinds of oral iron adverse reactions from high to low in order: compound ferrous sulfate and folic acid tablets (21.88%); iron proteinsuccinylate oral solution (20.90%); ferrous succinate tablets (19.76%); ferrous succinate sustained-release tablets (18.00%); iron polysaccharide complex capsule (12.06%); and iron dextran oral solution (6.94%). It was found that there was a significant difference in the incidence of adverse reactions among the six drugs ( p < 0.05). Pairwise comparison showed that the incidence of adverse reactions was higher in the iron proteinsuccinylate oral solution than that in the iron polysaccharide complex capsule ( p < 0.05). There was no significant difference in the incidence of adverse reactions in different ages ( p > 0.05), but there was a significant difference in the incidence of adverse reactions in different gestational ages ( p < 0.05). In Adverse Drug Reaction (ADR) patients, the adverse reaction result of most patients is recovery or improvement, and there was no serious adverse reaction outcome such as sequela and death. Conclusion: All the adverse reactions of oral iron were mainly gastrointestinal adverse reactions, and no heavy adverse reactions were found. Iron proteinsuccinylate oral solution has a higher incidence of adverse reactions than iron polysaccharide complex capsule. The results showed that oral iron was safer for anemia patients during pregnancy. |
| first_indexed | 2024-03-13T03:29:55Z |
| format | Article |
| id | doaj.art-fe8256aa526842baa48c81553db63462 |
| institution | Directory Open Access Journal |
| issn | 2042-0994 |
| language | English |
| last_indexed | 2024-03-13T03:29:55Z |
| publishDate | 2023-06-01 |
| publisher | SAGE Publishing |
| record_format | Article |
| series | Therapeutic Advances in Drug Safety |
| spelling | doaj.art-fe8256aa526842baa48c81553db634622023-06-25T02:33:44ZengSAGE PublishingTherapeutic Advances in Drug Safety2042-09942023-06-011410.1177/20420986231181335Safety monitoring of oral iron supplements in pregnant women with anemia: a multi-center observational clinical studyChang LiuQianqian ZhangPeiye HuiYan WangGuohui LiGuangchao CaoZicheng XueJing ZhangHeng ZhangXin HuangJiyong WuFusehng SunMeixing YanAims: To investigate the safety of oral iron therapy in pregnant women with iron-deficiency anemia (IDA) in the real world. Methods: A retrospective analysis was performed on 1792 pregnant patients with IDA who received oral iron supplements from 12 hospitals in Shandong Province from 1 April to 31 June 2021; follow-up and adverse reactions were recorded. They were divided into six groups according to the treatment drugs. Results: The overall adverse reaction rate was 15.4%, and the main adverse reaction site was the digestive system. The incidence of all kinds of oral iron adverse reactions from high to low in order: compound ferrous sulfate and folic acid tablets (21.88%); iron proteinsuccinylate oral solution (20.90%); ferrous succinate tablets (19.76%); ferrous succinate sustained-release tablets (18.00%); iron polysaccharide complex capsule (12.06%); and iron dextran oral solution (6.94%). It was found that there was a significant difference in the incidence of adverse reactions among the six drugs ( p < 0.05). Pairwise comparison showed that the incidence of adverse reactions was higher in the iron proteinsuccinylate oral solution than that in the iron polysaccharide complex capsule ( p < 0.05). There was no significant difference in the incidence of adverse reactions in different ages ( p > 0.05), but there was a significant difference in the incidence of adverse reactions in different gestational ages ( p < 0.05). In Adverse Drug Reaction (ADR) patients, the adverse reaction result of most patients is recovery or improvement, and there was no serious adverse reaction outcome such as sequela and death. Conclusion: All the adverse reactions of oral iron were mainly gastrointestinal adverse reactions, and no heavy adverse reactions were found. Iron proteinsuccinylate oral solution has a higher incidence of adverse reactions than iron polysaccharide complex capsule. The results showed that oral iron was safer for anemia patients during pregnancy.https://doi.org/10.1177/20420986231181335 |
| spellingShingle | Chang Liu Qianqian Zhang Peiye Hui Yan Wang Guohui Li Guangchao Cao Zicheng Xue Jing Zhang Heng Zhang Xin Huang Jiyong Wu Fusehng Sun Meixing Yan Safety monitoring of oral iron supplements in pregnant women with anemia: a multi-center observational clinical study Therapeutic Advances in Drug Safety |
| title | Safety monitoring of oral iron supplements in pregnant women with anemia: a multi-center observational clinical study |
| title_full | Safety monitoring of oral iron supplements in pregnant women with anemia: a multi-center observational clinical study |
| title_fullStr | Safety monitoring of oral iron supplements in pregnant women with anemia: a multi-center observational clinical study |
| title_full_unstemmed | Safety monitoring of oral iron supplements in pregnant women with anemia: a multi-center observational clinical study |
| title_short | Safety monitoring of oral iron supplements in pregnant women with anemia: a multi-center observational clinical study |
| title_sort | safety monitoring of oral iron supplements in pregnant women with anemia a multi center observational clinical study |
| url | https://doi.org/10.1177/20420986231181335 |
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