特立帕肽对骨质疏松症患者髋部和上肢骨折的影响:系统评价和荟萃分析。
Effects of teriparatide on hip and upper limb fractures in patients with osteoporosis: A systematic review and meta-analysis.
机构信息
Hospital del Mar-IMIM-UAB, Department of Internal Medicine, Barcelona, Spain; CIBERFES, Institute Carlos III, Barcelona, Spain.
Lilly Research Center, Windlesham, United Kingdom.
出版信息
Bone. 2019 Mar;120:1-8. doi: 10.1016/j.bone.2018.09.020. Epub 2018 Sep 27.
In randomized clinical trials (RCTs) with teriparatide, the number of patients with incident hip fractures was small and insufficiently powered to show statistically significant differences between groups. We, therefore, conducted a systematic review and meta-analysis of the efficacy of teriparatide in the reduction of hip and upper limb fractures in women and men with osteoporosis. A comprehensive search of databases until 22 November 2017 was conducted for RCTs of at least 6-month duration that reported non-spine fractures (hip, humerus, forearm, wrist), either as an efficacy or safety endpoint. Only RCTs that included patients with the approved treatment indications and dose for use of teriparatide were included; trials with off-label use of teriparatide were excluded. Two independent reviewers performed study selection and data extraction. Statistical procedures included Peto's method and Mantel-Haenszel with empirical correction, as most of the RCTs reported zero events in at least one of the treatment arms. Study results are expressed as odds ratios (OR) with 95% confidence intervals (CI). Publication bias and heterogeneity were evaluated with standard statistical tests. Twenty-three RCTs were included, 19 with an active-controlled arm (representing 64.9% of the patients included in the control group) and 11 double-blind, representing data on 8644 subjects, 3893 of them treated with teriparatide. Mean age (SD) was 67.0 (4.5) years, median treatment duration 18 months (range: 6 to 24 months). A total of 34 incident hip, 31 humerus, 31 forearm, and 62 wrist fractures were included. Meta-analysis results showed an OR (95% CI) for hip fractures of 0.44 (0.22-0.87; p = 0.019) in patients treated with teriparatide compared with controls. The effects on the risk of humerus [1.02 (0.50-2.08)], forearm [0.53 (0.26-1.08)] and wrist fractures [1.21 (0.72-2.04)] were not statistically significant (p > 0.05). This meta-analysis provides evidence of efficacy of teriparatide in reducing hip fractures by 56% in patients with osteoporosis.
在特立帕肽的随机临床试验 (RCT) 中,发生髋部骨折的患者数量较少,且不足以显示组间有统计学意义的差异。因此,我们对特立帕肽在降低骨质疏松症女性和男性髋部和上肢骨折方面的疗效进行了系统评价和荟萃分析。我们对截至 2017 年 11 月 22 日的数据库进行了全面检索,以寻找至少持续 6 个月的 RCT,这些 RCT 报告了非脊柱骨折(髋部、肱骨、前臂、腕部)作为疗效或安全性终点。仅纳入了包含特立帕肽批准治疗适应证和剂量的 RCT;排除了特立帕肽标签外使用的试验。两名独立的审查员进行了研究选择和数据提取。统计程序包括 Peto 法和 Mantel-Haenszel 法,同时进行经验校正,因为大多数 RCT 报告在至少一个治疗组中出现了零事件。研究结果以比值比(OR)和 95%置信区间(CI)表示。使用标准的统计检验评估发表偏倚和异质性。共纳入 23 项 RCT,其中 19 项为活性对照臂(代表对照组中 64.9%的患者),11 项为双盲,共纳入 8644 例受试者,其中 3893 例接受特立帕肽治疗。平均年龄(SD)为 67.0(4.5)岁,中位治疗时间为 18 个月(范围:6 至 24 个月)。共纳入 34 例髋部、31 例肱骨、31 例前臂和 62 例腕部骨折。荟萃分析结果显示,与对照组相比,接受特立帕肽治疗的患者髋部骨折的 OR(95%CI)为 0.44(0.22-0.87;p=0.019)。特立帕肽对肱骨[1.02(0.50-2.08)]、前臂[0.53(0.26-1.08)]和腕部骨折[1.21(0.72-2.04)]的风险的影响无统计学意义(p>0.05)。这项荟萃分析提供了证据表明,特立帕肽可使骨质疏松症患者的髋部骨折风险降低 56%。