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仙林骨葆胶囊治疗绝经后骨质疏松症的疗效和安全性:系统评价和荟萃分析方案。

Efficacy and safety of Xianling Gubao capsule in treating postmenopausal osteoporosis: A protocol for systematic review and meta-analysis.

机构信息

People's Hospital of Nanchuan District Chongqing, Chongqing, Chongqing, China.

出版信息

Medicine (Baltimore). 2021 Jan 8;100(1):e23965. doi: 10.1097/MD.0000000000023965.

Abstract

BACKGROUND

postmenopausal osteoporosis is a systemic metabolic skeletal disease associated with menopause-related estrogen withdrawal. postmenopausal osteoporosis is characterized by low bone mass, bone microstructure destruction, leading to increased bone brittleness and be prone to fracture, resulting in disability and death. At present, the commonly used drugs are estrogen, calcium, bone formation promoter and bone resorption inhibitor, and the side effects are obvious. In Traditional Chinese medicine, kidney-tonifying differentiating medicine is guided by the whole concept, Xianling Gubao capsule as the representative, the treatment of postmenopausal osteoporosis has certain therapeutic advantages, but lacks evidence-based medicine evidence. The purpose of this study is to systematically study the efficacy and safety of Xianling Gubao capsule in the treatment of postmenopausal osteoporosis.

METHODS

use computer to search English databases (PubMed, Embase, Web of Science, the Cochrane Library) and Chinese databases (China Knowledge Network, Wanfang, Weipu, Chinese Biomedical Database), in addition manually search Baidu academic, Google academic, from the establishment of database to October 2020, for randomized controlled clinical study of postmenopausal osteoporosis in the Xianling Gubao capsule treatment. Two researchers independently did the data extraction and literature quality evaluation, using RevMan5.3 software to do meta-analysis of the included literature.

RESULTS

this study assessed the efficacy and safety of xianling gubao capsule in the treatment of postmenopausal osteoporosis by total effective rate, bone density after treatment, blood calcium level after treatment, blood phosphorus level after treatment, pain score, quality of life and so on.

CONCLUSION

this study will provide reliable evidence-based evidence for the clinical application of Xianling Gubao capsule in the treatment of postmenopausal osteoporosis.

OSF REGISTRATION NUMBER

DOI 10.17605/OSF.IO/TP394.

摘要

背景

绝经后骨质疏松症是一种与绝经相关的雌激素缺乏有关的全身性代谢性骨骼疾病。绝经后骨质疏松症的特征是骨量低、骨微观结构破坏,导致骨脆性增加,易发生骨折,导致残疾和死亡。目前,常用的药物是雌激素、钙、成骨促进剂和骨吸收抑制剂,副作用明显。在中医中,以整体观念为指导,以仙灵骨葆胶囊为代表的补肾辨治药物,对绝经后骨质疏松症的治疗具有一定的治疗优势,但缺乏循证医学证据。本研究旨在系统研究仙灵骨葆胶囊治疗绝经后骨质疏松症的疗效和安全性。

方法

用计算机检索英文数据库(PubMed、Embase、Web of Science、The Cochrane Library)和中文数据库(中国知网、万方、维普、中国生物医学数据库),此外还手动检索百度学术、谷歌学术,从数据库建立到 2020 年 10 月,检索仙灵骨葆胶囊治疗绝经后骨质疏松症的随机对照临床研究。两名研究人员独立进行数据提取和文献质量评价,采用 RevMan5.3 软件对纳入文献进行 meta 分析。

结果

本研究通过总有效率、治疗后骨密度、治疗后血钙水平、治疗后血磷水平、疼痛评分、生活质量等方面评估仙灵骨葆胶囊治疗绝经后骨质疏松症的疗效和安全性。

结论

本研究将为仙灵骨葆胶囊治疗绝经后骨质疏松症的临床应用提供可靠的循证医学证据。

OSF 注册号:DOI 10.17605/OSF.IO/TP394。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3673/7793410/976eff4442a1/medi-100-e23965-g001.jpg

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