Wang Ya-Kang, Qin Si-Qing, Ma Tao, Song Wei, Jiang Ren-Qi, Guo Jian-Bin, Li Kun, Zhang Yu-Min
Department of Joint Surgery, Hong-Hui Hospital, Xi'an Jiaotong University College of Medicine, Xi'an, China.
Medicine (Baltimore). 2017 May;96(21):e6970. doi: 10.1097/MD.0000000000006970.
Osteoporosis remains a clinical challenge. Teriparatide is an anabolic drug and alendronate is an antiresorptive agent; both are used in the treatment of osteoporosis. Comprehensive reviews investigating the comparative safety and efficacy of teriparatide versus alendronate are scarce. Therefore, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the safety and efficacy of teriparatide versus alendronate for the treatment of postmenopausal osteoporosis.
We conducted a comprehensive literature review of the PubMed, EMBASE, Cochrane Controlled Trials Registry, and the China Academic Journal Network Publishing databases for relevant RCTs of teriparatide versus alendronate in postmenopausal osteoporosis patients. Outcome measures were percentage change in lumbar spine and femoral neck bone mineral density (BMD) and incidence of vertebral and nonvertebral fractures. Effect size was reported as weighted mean differences (WMDs) for continuous outcomes and odds ratios (OR) for dichotomous outcomes, with associated 95% confidence intervals (CIs).
Six trials involving 618 patients were included. The meta-analysis demonstrated a significant increase in lumbar spine BMD (WMD: 3.46, 95% CI: 2.15-4.77, P < .00001), but not femoral neck BMD (WMD = 1.50, 95% CI: 0.04-2.95, P = .04), in postmenopausal osteoporosis patients treated with teriparatide compared with alendronate for 6 to 18 months. These beneficial effects were apparent in the lumbar spine at 12 months of treatment (WMD: 4.49, 95% CI: 2.57-6.40, P < .01). Teriparatide was not superior to alendronate in reducing fracture risk (OR: -0.03, 95% CI: -0.12 to 0.07; P = .52).
Teriparatide may be superior to alendronate for increasing lumbar spine BMD in postmenopausal osteoporosis. The efficacy and safety of long-term teriparatide and alendronate treatment in postmenopausal osteoporosis should be further investigated in clinical trials.
骨质疏松症仍然是一项临床挑战。特立帕肽是一种促合成药物，阿仑膦酸钠是一种抗吸收药物；二者均用于治疗骨质疏松症。关于特立帕肽与阿仑膦酸钠比较安全性和疗效的综合性综述较少。因此，我们对随机对照试验（RCT）进行了系统评价和荟萃分析，以评估特立帕肽与阿仑膦酸钠治疗绝经后骨质疏松症的安全性和疗效。
我们对PubMed、EMBASE、Cochrane对照试验注册库和中国学术期刊网络出版总库进行了全面的文献检索，查找有关特立帕肽与阿仑膦酸钠治疗绝经后骨质疏松症患者的相关RCT。结局指标为腰椎和股骨颈骨密度（BMD）的百分比变化以及椎体和非椎体骨折的发生率。效应量以连续性结局的加权均数差（WMD）和二分性结局的比值比（OR）表示，并伴有95%置信区间（CI）。
纳入了6项涉及618例患者的试验。荟萃分析表明，与阿仑膦酸钠相比，特立帕肽治疗6至18个月的绝经后骨质疏松症患者，腰椎BMD显著增加（WMD：3.46，95%CI：2.15 - 4.77，P <.00001），但股骨颈BMD未增加（WMD = 1.50，95%CI：0.04 - 2.95，P = 0.04）。这些有益效果在治疗12个月时在腰椎明显（WMD：4.49，95%CI：2.57 - 6.40，P <.01）。特立帕肽在降低骨折风险方面并不优于阿仑膦酸钠（OR： - 0.03，95%CI： - 0.12至0.07；P = 0.52）。
在增加绝经后骨质疏松症患者的腰椎BMD方面，特立帕肽可能优于阿仑膦酸钠。长期使用特立帕肽和阿仑膦酸钠治疗绝经后骨质疏松症的疗效和安全性应在临床试验中进一步研究。
