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药物对预防继发性骨质疏松性椎体压缩性骨折、非椎体骨折和因不良事件停药的影响:一项随机对照试验的荟萃分析。

Effect of medications on prevention of secondary osteoporotic vertebral compression fracture, non-vertebral fracture, and discontinuation due to adverse events: a meta-analysis of randomized controlled trials.

机构信息

Department of Orthopedic Surgery, College of Medicine, Seoul National University, Seoul, 110-799, South Korea.

The First Hospital of Jilin University, Changchun City, 130021, China.

出版信息

BMC Musculoskelet Disord. 2019 Aug 31;20(1):399. doi: 10.1186/s12891-019-2769-8.

DOI:10.1186/s12891-019-2769-8
PMID:31472671
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6717630/
Abstract

BACKGROUND

Bone loss with aging and menopause increases the risk of fragile vertebral fracture, osteoporotic vertebral compression fracture (OVCF). The fracture causes severe pain, impedes respiratory function, lower the quality of life, and increases the risk of new fractures and deaths. Various medications have been prescribed to prevent a secondary fracture, but few study summarized their effects. Therefore, we investigated their effects on preventing subsequent OVCF via meta-analyses of randomized controlled trials.

METHODS

Electronic databases, including MEDLINE, EMBASE, CENTRAL, and Web of Science were searched for published randomized controlled trials from June 2015 to June 2019. The trials that recruited participants with at least one OVCF were included. We assessed the risk of bias of every study, estimated relative risk ratio of secondary OVCF, non-vertebral fracture, gastrointestinal complaints and discontinuation due to adverse events. Finally, we evaluated the quality of evidence.

RESULTS

Forty-one articles were included. Moderate to high quality evidence proved the effectiveness of zoledronate (Relative Risk, RR: 0.34; 95% CI, 0.17-0.69, p = 0.003), alendronate (RR: 0.54; 95% CI: 0.43-0.68; p < 0.0001), risedronate (RR: 0.61; 95% CI: 0.51-0.73; p < 0.0001), etidronate (RR, 0.50; 95% CI, 0.29-0.87, p < 0.01), ibandronate (RR: 0.52; 95% CI: 0.38-0.71; p < 0.0001), parathyroid hormone (RR: 0.31; 95% CI: 0.23-0.41; p < 0.0001), denosumab (RR, 0.41; 95% CI, 0.29-0.57; p < 0.0001) and selective estrogen receptor modulators (Raloxifene, RR: 0.58; 95% CI: 0.44-0.76; p < 0.0001; Bazedoxifene, RR: 0.66; 95% CI: 0.53-0.82; p = 0.0002) in preventing secondary fractures. Moderate quality evidence proved romosozumab had better effect than alendronate (Romosozumab vs. alendronate, RR: 0.64; 95% CI: 0.49-0.84; p = 0.001) and high quality evidence proved that teriparatide had better effect than risedronate (risedronate vs. teriparatide, RR: 1.98; 95% CI: 1.44-2.70; p < 0.0001).

CONCLUSION

Zoledronate, alendronate, risedronate, etidronate, ibandronate, parathyroid hormone, denosumab and selective estrogen receptor modulators had significant secondary prevention effects on OVCF. Moderate quality evidence proved romosozumab had better effect than alendronate. High quality evidence proved PTH had better effect than risedronate, but with higher risk of adverse events.

摘要

背景

随着年龄的增长和绝经,骨质流失会增加脆弱性椎体骨折(OVCF)、骨质疏松性椎体压缩骨折的风险。骨折会导致严重疼痛,阻碍呼吸功能,降低生活质量,并增加新骨折和死亡的风险。各种药物被开处来预防继发性骨折,但很少有研究总结它们的效果。因此,我们通过对随机对照试验的荟萃分析来研究它们在预防后续 OVCF 中的效果。

方法

我们检索了 2015 年 6 月至 2019 年 6 月发表的随机对照试验,包括 MEDLINE、EMBASE、CENTRAL 和 Web of Science。试验纳入了至少有一个 OVCF 的参与者。我们评估了每个研究的偏倚风险,估计了继发性 OVCF、非椎体骨折、胃肠道不良反应和因不良事件而停药的相对风险比。最后,我们评估了证据质量。

结果

41 篇文章被纳入。高质量证据证明唑来膦酸(RR:0.34;95% CI,0.17-0.69,p=0.003)、阿仑膦酸钠(RR:0.54;95% CI:0.43-0.68;p<0.0001)、利塞膦酸钠(RR:0.61;95% CI:0.51-0.73;p<0.0001)、依替膦酸二钠(RR:0.50;95% CI:0.29-0.87,p<0.01)、伊班膦酸钠(RR:0.52;95% CI:0.38-0.71;p<0.0001)、甲状旁腺激素(RR:0.31;95% CI:0.23-0.41;p<0.0001)、地舒单抗(RR:0.41;95% CI:0.29-0.57;p<0.0001)和选择性雌激素受体调节剂(雷洛昔芬,RR:0.58;95% CI:0.44-0.76;p<0.0001;巴多昔芬,RR:0.66;95% CI:0.53-0.82;p=0.0002)在预防继发性骨折方面有显著效果。高质量证据证明罗莫佐单抗比阿仑膦酸钠效果更好(罗莫佐单抗比阿仑膦酸钠,RR:0.64;95% CI:0.49-0.84;p=0.001),高质量证据证明特立帕肽比利塞膦酸钠效果更好(利塞膦酸钠比特立帕肽,RR:1.98;95% CI:1.44-2.70;p<0.0001)。

结论

唑来膦酸、阿仑膦酸钠、利塞膦酸钠、依替膦酸二钠、伊班膦酸钠、甲状旁腺激素、地舒单抗和选择性雌激素受体调节剂对 OVCF 有显著的二级预防作用。高质量证据证明罗莫佐单抗比阿仑膦酸钠效果更好。高质量证据证明甲状旁腺激素比利塞膦酸钠效果更好,但不良反应风险更高。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40f9/6717630/7a60b5f7d109/12891_2019_2769_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40f9/6717630/b4beb7c6a4cd/12891_2019_2769_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40f9/6717630/14c47c86bb29/12891_2019_2769_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40f9/6717630/7a60b5f7d109/12891_2019_2769_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40f9/6717630/b4beb7c6a4cd/12891_2019_2769_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40f9/6717630/14c47c86bb29/12891_2019_2769_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/40f9/6717630/7a60b5f7d109/12891_2019_2769_Fig3_HTML.jpg

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