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地诺单抗与双膦酸盐治疗绝经后骨质疏松症有效性比较的综述

Review on the comparison of effectiveness between denosumab and bisphosphonates in post-menopausal osteoporosis.

作者信息

Benjamin Biju, Benjamin Mridula Ambwani, Swe Myint, Sugathan Sandheep

机构信息

Dept. of Orthopaedics, Royal College of Medicine Perak, University Kuala Lumpur, Malaysia.

Dept. of Obstetrics and Gynaecology, Quest International University, Perak, Malaysia.

出版信息

Osteoporos Sarcopenia. 2016 Jun;2(2):77-81. doi: 10.1016/j.afos.2016.03.003. Epub 2016 Apr 27.

Abstract

OBJECTIVES

Osteoporosis is a rapidly rising cause of concern for elderly patients. Various classes of drugs are available in the market. Bisphosphonates are considered as a first-line therapy for the prevention and treatment. Denosumab is an antiresorptive agent which is a RANK ligand inhibitor. There is a scarcity of comparison between these two classes of drugs. The aim of this study is to compare efficacy of Bisphosphonates and Denosumab in various parameters.

METHODS

Literature search was done for randomized controlled trials (RCTs) comparing bisphosphonates with denosumab. RCTs with a treatment period of at least one year with a baseline bone mineral density (BMD) and bone turnover markers (BTM) and follow up values at one year were included in the study. All included studies were also analysed for complications. The study has also been registered in PROSPERO International prospective register of systematic reviews.

RESULTS

A total of five RCTs were identified providing data on 3751 participants. In all five studies, the BMD changes at both hip and spine were statistically significant in favour of denosumab. Result was similar in three studies that studied BMD changes at the wrist. Denosumab also produced significant reduction in BTM as early as one month, but at one year there was no difference compared to the bisphosphonates. There was no statistically significant differences in the complication rates.

CONCLUSIONS

Though both bisphosphonates and denosumab were effective with similar side effects, the latter was statistically superior in increasing the BMD and reducing the BTM.

摘要

目的

骨质疏松症正迅速成为老年患者日益关注的问题。市场上有各类药物可供选择。双膦酸盐被视为预防和治疗的一线疗法。地诺单抗是一种抗吸收剂,是一种核因子κB受体活化因子配体(RANKL)抑制剂。这两类药物之间的比较较少。本研究的目的是比较双膦酸盐和地诺单抗在各项参数上的疗效。

方法

检索比较双膦酸盐与地诺单抗的随机对照试验(RCT)。纳入治疗期至少一年、有基线骨密度(BMD)和骨转换标志物(BTM)以及一年随访值的RCT。对所有纳入研究的并发症情况也进行了分析。该研究也已在国际前瞻性系统评价注册库PROSPERO中登记。

结果

共确定了五项RCT,提供了3751名参与者的数据。在所有五项研究中,髋部和脊柱的BMD变化在统计学上对地诺单抗有利。在三项研究腕部BMD变化的试验中结果类似。地诺单抗早在一个月时就能使BTM显著降低,但在一年时与双膦酸盐相比并无差异。并发症发生率在统计学上无显著差异。

结论

虽然双膦酸盐和地诺单抗都有效且副作用相似,但后者在提高BMD和降低BTM方面在统计学上更具优势。

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