布洛索单抗治疗绝经后骨质疏松症女性：一项系统评价和荟萃分析。

Blosozumab in the treatment of postmenopausal women with osteoporosis: a systematic review and meta-analysis.

作者信息

Su Yanlin, Wang Wenzhao, Liu Fei, Cai Yuli, Li Nianhu, Li Hao, Li Gang, Ma Liang

机构信息

Department of Orthopedics, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China; Department of Orthopaedics, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.

Department of Orthopedic, Qilu Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China.

出版信息

Ann Palliat Med. 2022 Oct;11(10):3203-3212. doi: 10.21037/apm-22-998.

DOI:10.21037/apm-22-998

PMID:36367007

Abstract

BACKGROUND

Postmenopausal women are one of the most vulnerable groups to osteoporosis. Romosozumab is a newly monoclonal drug that inhibits the activity of sclerostin. Since it has been on the market for only 3 years, there is a lack of systematic analysis on postmenopausal women and the efficacy is not clear. In this study, we compared randomized controlled trials to assess the effects of blosozumab versus placebo in perimenopausal and postmenopausal women.

METHODS

This meta-analysis has been registered in the PROSPERO registry (number CRD42020145839). The PubMed, Cochrane Library, ClinicalKey, and Embase databases were searched from inception date to July 01, 2021. We used the keywords "osteoporosis", "decreased bone mass", and "blosozumab" to retrieve studies on the relationship between blosozumab and osteoporosis in each database. The inclusion criteria were: (I) randomized controlled trials (RCTs) comparing the treatment of osteoporosis with blosozumab and a placebo or without treatment, (II) studies on postmenopausal women aged over 50 years, and (III) studies providing bone mineral density data. The quality of all randomized controlled trials included in this study was independently assessed by two researchers according to the Cochrane risk manual and was divided into high, medium and low quality. The main results analyzed were bone mineral density (BMD) and T-score. Our results mainly include BMD and procollagen type I N-terminal propeptide (P1NP), C-terminal telopeptide of type I collagen (CTX), bone-specific alkaline phosphatase (BSAP), and osteocalcin (OC).

RESULTS

Three RCTs with 105 patients were selected from 157 retrieved articles. Due to high heterogeneity [BMD: Tau2=2.79; Chi2=11.70, degrees of freedom (df) =1 (P=0.0006); I2=91%], we could not perform statistical analysis of BMD. The results of BMD were then evaluated systematically. Three RCT studies were included in the evaluation. Compared with that of the placebo, blosozumab increased levels of the BMD biomarker osteocalcin [mean deviation (MD) 12.55; 95% confidence interval (CI), 8.18, 16.91; P<0.00001]. None of the 3 RCTs presented a risk of bias during the meta-analysis.

CONCLUSIONS

The results suggested that blosozumab could be used as a target drug to improve BMD in postmenopausal women. This will provide a reference for the clinical treatment of postmenopausal women with osteoporosis.

摘要

背景

绝经后女性是骨质疏松症最脆弱的群体之一。罗莫索单抗是一种新型单克隆药物，可抑制硬化蛋白的活性。由于其上市仅3年，缺乏对绝经后女性的系统分析，疗效尚不明确。在本研究中，我们比较了随机对照试验，以评估罗莫索单抗与安慰剂对围绝经期和绝经后女性的影响。

方法

本荟萃分析已在PROSPERO注册库（注册号CRD42020145839）中注册。从创刊日期至2021年7月1日检索PubMed、Cochrane图书馆、ClinicalKey和Embase数据库。我们使用关键词“骨质疏松症”、“骨量减少”和“罗莫索单抗”检索各数据库中关于罗莫索单抗与骨质疏松症关系的研究。纳入标准为：（I）比较罗莫索单抗与安慰剂治疗骨质疏松症或不治疗的随机对照试验（RCT）；（II）对50岁以上绝经后女性的研究；（III）提供骨密度数据的研究。本研究纳入的所有随机对照试验的质量由两名研究人员根据Cochrane风险手册独立评估，并分为高、中、低质量。分析的主要结果是骨密度（BMD）和T值。我们的结果主要包括骨密度、I型前胶原N端前肽（P1NP）、I型胶原C端肽（CTX）、骨特异性碱性磷酸酶（BSAP）和骨钙素（OC）。

结果

从157篇检索到的文章中选择了3项随机对照试验，共105例患者。由于异质性高[骨密度：Tau2=2.79；Chi2=11.70，自由度（df）=1（P=0.0006）；I2=91%]，我们无法对骨密度进行统计分析。然后对骨密度结果进行系统评估。评估纳入了3项随机对照试验研究。与安慰剂相比，罗莫索单抗增加了骨密度生物标志物骨钙素的水平[平均偏差（MD）12.55；95%置信区间（CI），8.18，16.91；P<0.00001]。在荟萃分析中，3项随机对照试验均未出现偏倚风险。