Akhter Shakib, Qureshi Abdul Rehman, El-Khechen Hussein Ali, Bozzo Anthony, Khan Moin, Patel Rakesh, Bhandari Mohit, Aleem Ilyas
Department of Health Research Methods, Evidence, and Impact, McMaster University, Canada.
Department of Orthopaedic Surgery, McMaster University, Canada.
Bone Rep. 2020 Oct 16;13:100728. doi: 10.1016/j.bonr.2020.100728. eCollection 2020 Dec.
Teriparatide has been increasingly utilized in the management of osteoporosis. The efficacy of low and high dose teriparatide on lumbar spine bone mineral density, vertebral fracture incidence and pain is unknown. We sought to determine the efficacy of teriparatide on these patient-important outcomes using a systematic review and meta-analysis.
A systematic search of electronic databases (MEDLINE, EMBASE, CENTRAL, CINAHL) was performed to identify randomized controlled trials (RCTs) that evaluate teriparatide to any comparator for the treatment of osteoporosis in postmenopausal women. The Grades of Recommendation Assessment, Development and Evaluation (GRADE) criteria were used by two independent reviewers to assess the strength and quality of evidence.
A total of 20 studies (n = 6024) were included in this review, with 2855 patients receiving teriparatide and 3169 patients receiving placebo or control treatment. A teriparatide dose of 20 μg/day increased lumbar spine bone mineral density (BMD) (standardized mean difference (SMD) 0.34 standard deviation (SD) units higher (95% CI 0.19-0.48 SDs higher) in comparison to placebo. Relative to anti-resorptive agents, 20 μg/day of teriparatide had a range from 0.14 SD units to 0.96 SD units higher (95% CI, 0.08 SDs lower to 0.36 SDs higher, CI, 0.33-1.59 SDs higher, respectively). 20 μg/day teriparatide had a significant effect on pain severity to placebo or control (SMD 0.80, 95% CI, 1.16-0.43 SDs lower) and also decreased the incidence of vertebral fractures compared to placebo (relative risk 0.31, 95% CI 0.21 to 0.46). Arthralgia and extremity pain incidence were also calculated; there were 15 and 8 fewer events per 1000 patients with the use of 20 μg/day of teriparatide compared to placebo or control, respectively.
High quality evidence supports the utilization of teriparatide 20 μg/day dose to significantly improve lumbar spine BMD and decrease incidence of vertebral fractures and pain severity relative to all comparators. 40 μg/day dose of teriparatide demonstrated significantly better results with prolonged treatment. This data is valuable for clinicians involved in the care of this growing demographic of patients. Further investigation on the safety and efficacy of teriparatide in higher doses for the long-term treatment of osteoporosis in postmenopausal women should be conducted through high-quality clinical trials.
特立帕肽在骨质疏松症管理中的应用日益广泛。低剂量和高剂量特立帕肽对腰椎骨密度、椎体骨折发生率及疼痛的疗效尚不清楚。我们试图通过系统评价和荟萃分析来确定特立帕肽对这些对患者重要的结局指标的疗效。
对电子数据库（MEDLINE、EMBASE、CENTRAL、CINAHL）进行系统检索，以识别评估特立帕肽与任何对照药物治疗绝经后妇女骨质疏松症的随机对照试验（RCT）。两名独立 reviewers 使用推荐分级评估、制定和评价（GRADE）标准来评估证据的强度和质量。
本评价共纳入 20 项研究（n = 6024），其中 2855 例患者接受特立帕肽治疗，3169 例患者接受安慰剂或对照治疗。与安慰剂相比，20μg/天的特立帕肽剂量可提高腰椎骨密度（标准化均数差（SMD）高 0.34 个标准差（SD）单位（95%CI 高 0.19 - 0.48 个 SD 单位）。相对于抗吸收药物，20μg/天的特立帕肽比抗吸收药物高 0.14 至 0.96 个 SD 单位（95%CI，分别为低 0.08 个 SD 单位至高 0.36 个 SD 单位，CI，高 0.33 - 1.59 个 SD 单位）。20μg/天的特立帕肽对安慰剂或对照的疼痛严重程度有显著影响（SMD 0.80，95%CI，低 1.16 - 0.43 个 SD 单位），与安慰剂相比，椎体骨折发生率也降低（相对风险 0.31，95%CI 0.21 至 0.46）。还计算了关节痛和肢体疼痛发生率；与安慰剂或对照相比，使用 20μg/天特立帕肽的每 1000 例患者中，关节痛和肢体疼痛事件分别减少 15 例和 8 例。
高质量证据支持使用 20μg/天剂量的特立帕肽相对于所有对照药物显著改善腰椎骨密度、降低椎体骨折发生率和疼痛严重程度。40μg/天剂量的特立帕肽在延长治疗时显示出显著更好的结果。这些数据对参与照料这一不断增长的患者群体的临床医生很有价值。应通过高质量临床试验进一步研究特立帕肽更高剂量用于绝经后妇女骨质疏松症长期治疗的安全性和疗效。
