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特立帕肽与利塞膦酸盐治疗骨质疏松症的效果比较:一项随机对照试验的荟萃分析

Effects of teriparatide compared with risedronate in the treatment of osteoporosis: A meta-analysis of randomized controlled trials.

作者信息

Yang Chengzhi, Le Guoping, Lu Changwei, Wei Renjie, Lan Wanjie, Tang Jingli, Zhan Xinli

机构信息

Department of spine osteopathic surgery, the first affiliated hospital of Guangxi medical University.

Trauma centers.

出版信息

Medicine (Baltimore). 2020 Feb;99(7):e19042. doi: 10.1097/MD.0000000000019042.

DOI:10.1097/MD.0000000000019042
PMID:32049802
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7035098/
Abstract

BACKGROUND

This meta-analysis was conducted to compare the effects and safety of teriparatide with risedronate in the treatment of osteoporosis.

MATERIAL AND METHODS

PubMed, Embase, Web of Science and Cochrane library database were systematically reviewed for studies published up to February 24, 2019. Eligible studies that compared the effects of teriparatide with risedronate in osteoporosis were included in this meta-analysis. The outcomes included percentage change in bone mineral density (BMD) of lumbar spine, femoral neck, and total hip, the incidence of clinical fractures, serum bone markers, and adverse events. A random-effects or fixed-effects model was used to pool the estimate, according to the heterogeneity among the included studies.

RESULTS

Seven studies were included in this meta-analysis. Compared with risedronate, teriparatide was associated with a significant increase in lumbar spine BMD [weight mean difference (WMD)=4.24, 95%CI: 3.11, 5.36; P < .001], femoral neck BMD (WMD=2.28, 95%CI: 1.39, 3.18; P < .001), and total hip BMD (WMD = 1.19, 95%CI: 0.47, 1.91; P = .001). Moreover, patients in teriparatide group had significantly lower incidences of clinical fracture (risk ratio [RR] = 0.48, 95%CI: 0.32, 0.72; P < .001), new vertebral fracture (RR = 0.45, 95%CI: 0.32, 0.63; P < .001), and non-vertebral fracture (RR = 0.63, 95%CI: 0.40, 0.98; P = .042) than those in risedronate group. There were significant differences between the 2 groups in serum change, including P1NP (WMD = 122.34, 95%CI: 68.89, 175.99; P < .001), CTx (WMD = 0.62, 95%CI: 0.29, 0.96; P < .001), and iPTH (WMD = -13.18, 95%CI: -15.04, -11.33; P < .001). The incidence of adverse events was similar between the 2 groups (RR = 0.93, 95%CI: 0.69, 1.25; P = .610).

CONCLUSION

This study suggested that teriparatide was more effective than risedronate for increasing the BMD in lumbar spine, femoral neck, and total hip, as well as reducing the incidences of clinical fracture, new vertebral fracture and non-vertebral fracture. There was no significant difference in incidence of adverse events between the 2 drugs. Considering the potential limitations in the present study, further large-scale, well-performed randomized trials are needed to verify our findings.

摘要

背景

本荟萃分析旨在比较特立帕肽与利塞膦酸盐治疗骨质疏松症的疗效和安全性。

材料与方法

系统检索了PubMed、Embase、Web of Science和Cochrane图书馆数据库中截至2019年2月24日发表的研究。本荟萃分析纳入了比较特立帕肽与利塞膦酸盐治疗骨质疏松症疗效的合格研究。结局指标包括腰椎、股骨颈和全髋部骨密度(BMD)的变化百分比、临床骨折发生率、血清骨标志物和不良事件。根据纳入研究之间的异质性,采用随机效应或固定效应模型汇总估计值。

结果

本荟萃分析纳入了7项研究。与利塞膦酸盐相比,特立帕肽可使腰椎BMD显著增加[加权均数差(WMD)=4.24,95%置信区间(CI):3.11,5.36;P<0.001],股骨颈BMD(WMD=2.28,95%CI:1.39,3.18;P<0.001),全髋部BMD(WMD=1.19,95%CI:0.47,1.91;P=0.001)。此外,特立帕肽组患者的临床骨折发生率(风险比[RR]=0.48,95%CI:0.32,0.72;P<0.001)、新发椎体骨折发生率(RR=0.45,95%CI:0.32,0.63;P<0.001)和非椎体骨折发生率(RR=0.63,95%CI:0.40,0.98;P=0.042)均显著低于利塞膦酸盐组。两组血清变化存在显著差异,包括I型前胶原N端前肽(P1NP)(WMD=122.34,95%CI:68.89,175.99;P<0.001)、I型胶原交联C端肽(CTx)(WMD=0.62,95%CI:0.29,0.96;P<0.001)和全段甲状旁腺激素(iPTH)(WMD=-13.18,95%CI:-15.04,-11.33;P<0.001)。两组不良事件发生率相似(RR=0.93,95%CI:0.69,1.25;P=0.610)。

结论

本研究表明,特立帕肽在增加腰椎、股骨颈和全髋部BMD以及降低临床骨折、新发椎体骨折和非椎体骨折发生率方面比利塞膦酸盐更有效。两种药物的不良事件发生率无显著差异。考虑到本研究的潜在局限性,需要进一步进行大规模、高质量的随机试验来验证我们的发现。

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