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补血糖浆和补血XT片对育龄期缺铁性贫血女性血红蛋白水平的影响:一项随机、安慰剂对照、开放标签试验。

Effect of Hemocare Syrup and Hemocare XT Tablets on Hemoglobin levels in iron deficiency anemia among women of reproductive age: A randomized, placebo controlled, open label trial.

作者信息

Vijayakumar Thangavel Mahalingam, Priyadharshini Ananthathandavan, Ahalya Sivaguru Paramesh, Lakshmi Karunanidhi Santhana, Muthunarayanan Logaraj, Rama Srivatsan

机构信息

Department of Pharmacy Practice, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur, 603 203, Kanchipuram (Dt), Tamil Nadu, India.

Department of Community Medicine, SRM Medical College Hospital & Research Centre, SRM Institute of Science and Technology, Kattankulathur, 603 203, Kanchipuram (Dt), Tamil Nadu, India.

出版信息

Contemp Clin Trials Commun. 2019 Jul 23;15:100425. doi: 10.1016/j.conctc.2019.100425. eCollection 2019 Sep.

Abstract

BACKGROUND

Iron deficiency anemia is one of the important public health problems in developing countries among the women of reproductive age group. Hemocare formulation plays a significant role in Iron deficiency anemia because of its Iron content. The present study aimed to investigate the effect of Hemocare Syrup and Hemocare XT Tablets compared with placebo on Hemoglobin Levels in Iron Deficiency Anemia among Women of Reproductive Age.

METHODS

A prospective, interventional, randomized, open label, placebo controlled trial has been conducted with 126 patients. Eligible patients randomly received either Placebo 100 mg or Hemocare XT Tablet 100 mg or 10 ml of Hemocare Syrup once daily in the same manner for 4 weeks. Hemoglobin values were documented at the end of 15th day, 21st day and 30th day.

RESULTS

The baseline hemoglobin values were compared with each follow up and statistically significant difference was found at the end of 30th day of Hemocare Syrup and Hemocare XT treatment (P < 0.05) but there was no significant difference observed in the placebo group. The study results revealed that 30 days treatment of Hemocare Syrup and Hemocare XT Tablets increases the Hemoglobin levels to 12.46 ± 0.44 g/dl and 12.90 ± 0.98 g/dl from 9.08 ± 2.54 g/dl and 9.68 ± 2.04 g/dl respectively.

CONCLUSION

Hemocare Syrup and Hemocare XT Tablets treatment showed clinically significant improvement in hemoglobin levels from the baseline and placebo group.

摘要

背景

缺铁性贫血是发展中国家育龄妇女中重要的公共卫生问题之一。Hemocare制剂因其铁含量在缺铁性贫血中发挥着重要作用。本研究旨在调查与安慰剂相比,Hemocare糖浆和Hemocare XT片对育龄期缺铁性贫血女性血红蛋白水平的影响。

方法

对126例患者进行了一项前瞻性、干预性、随机、开放标签、安慰剂对照试验。符合条件的患者以相同方式随机接受100毫克安慰剂、100毫克Hemocare XT片或10毫升Hemocare糖浆,每日一次,共4周。在第15天、第21天和第30天结束时记录血红蛋白值。

结果

将基线血红蛋白值与每次随访结果进行比较,发现Hemocare糖浆和Hemocare XT治疗第30天结束时存在统计学显著差异(P<0.05),但安慰剂组未观察到显著差异。研究结果显示,30天的Hemocare糖浆和Hemocare XT片治疗分别使血红蛋白水平从9.08±2.54克/分升和9.68±2.04克/分升提高到12.46±0.44克/分升和12.90±0.98克/分升。

结论

Hemocare糖浆和Hemocare XT片治疗显示,与基线和安慰剂组相比,血红蛋白水平有临床显著改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7f87/6664097/e05835f55237/gr1.jpg

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