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一项比较赖氨酸钙与碳酸钙及柠檬酸苹果酸钙在骨质疏松症患者中的疗效、安全性和生物利用度的随机开放标签临床研究。

A Randomized Open-Label Clinical Study Comparing the Efficacy, Safety, and Bioavailability of Calcium Lysinate with Calcium Carbonate and Calcium Citrate Malate in Osteopenia Patients.

作者信息

Shankar Kanthi, M Sakthibalan, Raizada Priyanka, Jain Rashmi

机构信息

Quest Life Sciences, Thambaram, Chennai, Tamil Nadu. India.

Department of Pharmacology, Sri Venkateshwaraa Medical College Hospital and Research Centre, Puducherry. India.

出版信息

J Orthop Case Rep. 2018 Jul-Aug;8(4):15-19. doi: 10.13107/jocr.2250-0685.1138.

DOI:10.13107/jocr.2250-0685.1138
PMID:30687654
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6343570/
Abstract

INTRODUCTION

Many factors influence bone health, but osteoporosis is viewed as a calcium deficiency disorder in which bone is resorbed to maintain the serum calcium levels. Dietary calcium supplements have been recommended for the prevention of osteoporosis in the elderly. Many forms of dietary calcium supplements are widely available in market, but products containing calcium citrate and calcium carbonate are the most common. Calcium lysinate, a new form of calcium preparation, may have a better absorption and can be a better calcium supplement.

AIM

The aim of this study is to evaluate the efficacy, safety, and bioavailability of calcium lysinate in comparison to other calcium supplements in improving the bone mineral density (BMD) status in osteopenia patients.

METHODOLOGY

A total of 24 osteopenia patients were randomly divided into three groups of eight subjects in each. Anyone of the study drug, namely, calcium lysinate, calcium carbonate, or calcium citrate malate was administered to each group. Blood samples for the determination of serum calcium was taken, based on which the area under the curve (absorption profile) and relative bioavailability were calculated. BMD was assessed on the day 0 and at 8 weeks' post-treatment.

RESULTS

The relative oral bioavailability of calcium lysinate was 223.15%. There is a significant improvement in the T-score of BMD in all the groups. It was more significant in calcium lysinate group (P < 0.0004).

CONCLUSION

The high oral bioavailability of calcium lysinate, high percentage of calcium content, and a good clinical improvement in the BMD T-scores of osteopenia patients suggest that calcium lysinate will serve as a better dietary calcium supplement.

摘要

引言

许多因素会影响骨骼健康,但骨质疏松症被视为一种钙缺乏症,在此病症中,骨骼会被吸收以维持血清钙水平。已推荐膳食钙补充剂用于预防老年人的骨质疏松症。市场上广泛提供多种形式的膳食钙补充剂,但最常见的是含有柠檬酸钙和碳酸钙的产品。赖氨酸钙是一种新型钙制剂,可能具有更好的吸收性,并且可以成为更好的钙补充剂。

目的

本研究的目的是评估赖氨酸钙与其他钙补充剂相比,在改善骨质减少患者骨矿物质密度(BMD)状况方面的疗效、安全性和生物利用度。

方法

总共24名骨质减少患者被随机分为三组,每组八名受试者。向每组施用研究药物中的任何一种,即赖氨酸钙、碳酸钙或苹果酸柠檬酸钙。采集用于测定血清钙的血样,并据此计算曲线下面积(吸收曲线)和相对生物利用度。在治疗前第0天和治疗后8周评估骨密度。

结果

赖氨酸钙的相对口服生物利用度为223.15%。所有组的骨密度T值均有显著改善。在赖氨酸钙组中更为显著(P < 0.0004)。

结论

赖氨酸钙的高口服生物利用度、高钙含量百分比以及骨质减少患者骨密度T值的良好临床改善表明,赖氨酸钙将成为更好的膳食钙补充剂。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9c6/6343570/fc396311cdf3/JOCR-8-15-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9c6/6343570/d4950408a887/JOCR-8-15-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9c6/6343570/fc396311cdf3/JOCR-8-15-g007.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9c6/6343570/d4950408a887/JOCR-8-15-g006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f9c6/6343570/fc396311cdf3/JOCR-8-15-g007.jpg

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