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地舒单抗与双磷酸盐类药物在改善绝经后骨质疏松症患者骨强度方面的疗效和安全性比较:系统评价。

Efficacy and safety of denosumab compared to bisphosphonates in improving bone strength in postmenopausal osteoporosis: a systematic review.

机构信息

St Andrew's Community Hospital, Singapore.

Department of Infectious Diseases, Singapore General Hospital, Singapore.

出版信息

Singapore Med J. 2019 Jul;60(7):364-378. doi: 10.11622/smedj.2019028. Epub 2019 Mar 11.

Abstract

INTRODUCTION

Osteoporosis is the main cause of fractures among women after menopause. This study aimed to evaluate the efficacy and safety of denosumab compared to bisphosphonates in treating postmenopausal osteoporosis.

METHODS

Databases including PubMed and the Cochrane Central Register of Controlled Trials were systematically searched for randomised controlled trials (RCTs) that directly compared denosumab and bisphosphonates. RCTs that studied both denosumab and bisphosphonates in postmenopausal women with osteoporosis and had a Jadad score ≥ 3 were included.

RESULTS

Nine studies were eligible for inclusion. They were further categorised into six cohort groups. All studies had denosumab with oral bisphosphonates as the active comparator. Four out of six cohort studies showed significant improvements in bone strength (p < 0.001) at the distal radius, tibia, total hip, femoral neck, lumbar spine and trochanter at 12 months for patients on denosumab compared to the bisphosphonate group. Serum C-telopeptide of cross-linked collagen, a bone turnover marker, was consistently lower in the denosumab group in all studies. There were no significant differences in hypocalcaemia, atypical fractures, fragility fractures, osteonecrosis of the jaw, all infections (including fever or influenza-like symptoms), gastrointestinal side effects or dermatological conditions in all studies, except for one that did not document side effects.

CONCLUSION

Denosumab can be used both as a first-line agent and an alternative to bisphosphonate in the treatment of postmenopausal osteoporosis. There is currently insufficient data to show that denosumab is not inferior to bisphosphonates in fracture prevention.

摘要

简介

骨质疏松症是绝经后女性骨折的主要原因。本研究旨在评估地舒单抗与双磷酸盐类药物治疗绝经后骨质疏松症的疗效和安全性。

方法

系统检索了包括 PubMed 和 Cochrane 对照试验中心注册在内的数据库,以查找直接比较地舒单抗和双磷酸盐类药物的随机对照试验(RCT)。纳入的 RCT 研究了绝经后骨质疏松症女性使用地舒单抗和双磷酸盐类药物,Jadad 评分≥3 分。

结果

9 项研究符合纳入标准。进一步将其分为 6 个队列组。所有研究均将地舒单抗与口服双磷酸盐类药物作为活性对照。6 个队列研究中有 4 个研究表明,与双磷酸盐类药物组相比,地舒单抗组在 12 个月时远端桡骨、胫骨、全髋、股骨颈、腰椎和转子间的骨强度显著改善(p<0.001)。所有研究中,地舒单抗组的血清 C 端肽交联胶原(一种骨转换标志物)均持续较低。除了一项未记录副作用的研究外,所有研究在地舒单抗组中低钙血症、非典型骨折、脆性骨折、颌骨骨坏死、所有感染(包括发热或流感样症状)、胃肠道副作用或皮肤病况方面均无显著差异。

结论

地舒单抗可作为绝经后骨质疏松症一线治疗药物和双磷酸盐类药物的替代药物。目前尚无足够的数据表明地舒单抗在预防骨折方面不如双磷酸盐类药物。

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