Peng Lihua, Luo Qian, Lu Hui
Department of Orthopaedics, The People's Hospital of Bishan District, Bishan Department of Radiation Oncology, Chongqing Cancer Institute & Hospital & Cancer Center Department of Orthopaedics, Jiangjin Central Hospital of Chongqing, Chongqing, P. R. China.
Medicine (Baltimore). 2017 Dec;96(49):e8659. doi: 10.1097/MD.0000000000008659.
Bazedoxifene may be promising to treat osteoporosis of postmenopausal women. We conducted a systematic review and meta-analysis to explore the efficacy and safety of bazedoxifene in postmenopausal women with osteoporosis.
PubMed, EMbase, Web of science, EBSCO, and Cochrane library databases were systematically searched. Randomized controlled trials (RCTs) assessing the effect of bazedoxifene on osteoporosis of postmenopausal women were included. Two investigators independently searched articles, extracted data, and assessed the quality of included studies. The primary outcomes were vertebral fracture and spine BMD at 3 and 7 years.
Four RCTs are included in the meta-analysis. Overall, compared with placebo intervention in postmenopausal women with osteoporosis, bazedoxifene intervention can significantly reduce the risk of vertebral fracture [risk risks (RRs) = 0.69; 95% confidence interval (95% CI) = 0.52-0.93; P = .01], and increase spine BMD at 3 years (Std. mean difference = 1.71; 95% CI = 1.55-1.87; P < .005) and 7 years (Std. mean difference = 8.31; 95% CI = 8.07-8.55; P < .005). Bazedoxifene intervention results in no increase in adverse events (RR = 1.00; 95% CI = 0.99-1.00; P = .34), serious adverse events (RR = 1.04; 95% CI = 0.97-1.12; P = .31), myocardial infarction (RR = 0.88; 95% CI = 0.51-1.52; P = .64), stroke (RR = 0.97; 95% CI = 0.64-1.46; P = .87), venous thromboembolic event (RR = 1.56; 95% CI = 0.92-2.64; P = .10), and breast carcinoma (RR = 1.03; 95% CI = 0.59-1.79; P = .92).
Compared with placebo intervention for the osteoporosis of postmenopausal women, bazedoxifene intervention is found to significantly reduce the incidence of vertebral fracture and increase spine BMD at 3 and 7 years, and results in no increase in adverse events, serious adverse events, myocardial infarction, stroke, venous thromboembolic event, and breast carcinoma.
巴多昔芬在治疗绝经后女性骨质疏松症方面可能具有前景。我们进行了一项系统评价和荟萃分析，以探讨巴多昔芬在绝经后骨质疏松症女性中的疗效和安全性。
系统检索了PubMed、EMbase、Web of science、EBSCO和Cochrane图书馆数据库。纳入评估巴多昔芬对绝经后女性骨质疏松症影响的随机对照试验（RCT）。两名研究者独立检索文章、提取数据并评估纳入研究的质量。主要结局为3年和7年时的椎体骨折和脊柱骨密度。
荟萃分析纳入了4项RCT。总体而言，与安慰剂干预相比，在绝经后骨质疏松症女性中，巴多昔芬干预可显著降低椎体骨折风险[风险比（RRs）=0.69；95%置信区间（95%CI）=0.52-0.93；P=0.01]，并在3年时增加脊柱骨密度（标准化均差=1.71；95%CI=1.55-1.87；P<0.005）以及7年时增加脊柱骨密度（标准化均差=8.31；95%CI=8.07-8.55；P<0.005）。巴多昔芬干预未导致不良事件增加（RR=1.00；95%CI=0.99-1.00；P=0.34）、严重不良事件增加（RR=1.04；95%CI=0.97-1.12；P=0.31）、心肌梗死增加（RR=0.88；95%CI=0.51-1.52；P=0.64）、中风增加（RR=0.97；95%CI=0.64-1.46；P=0.87）、静脉血栓栓塞事件增加（RR=1.56；95%CI=0.92-2.64；P=0.10）以及乳腺癌增加（RR=1.03；95%CI=0.59-1.79；P=0.92）。
与安慰剂干预绝经后女性骨质疏松症相比，发现巴多昔芬干预可显著降低椎体骨折发生率，并在3年和7年时增加脊柱骨密度，且未导致不良事件、严重不良事件、心肌梗死、中风、静脉血栓栓塞事件和乳腺癌增加。
