Department of Endocrinology, Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University, Huai'an, PR China; Department of Endocrinology, the Affiliated Nanjing Hospital of Nanjing Medical University, Nanjing, PR China.
Department of Information Statistics Center, Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University, Huai'an, PR China.
Diabetes Metab. 2019 Oct;45(5):436-445. doi: 10.1016/j.diabet.2019.01.010. Epub 2019 Feb 6.
To evaluate the association between sodium-glucose cotransporter-2 (SGLT2) inhibitors and risk of bone fractures in patients with type 2 diabetes mellitus (T2DM).
A systematic literature search conducted of PubMed, Embase, the Cochrane Library and Web of Science from inception up to 31 August 2018 identified all eligible randomized controlled trials (RCTs). The following data were extracted from each study: first author; year of publication; sample size; patient characteristics; study design; intervention drug; control drug; follow-up durations; and incident bone-fracture events. A meta-analysis was performed using Review Manager 5.3 software to calculate odds ratios (ORs) and 95% confidence intervals (CI) for dichotomous variables.
A total of 30 studies involving 23,372 patients with T2DM were included in our analysis. There were 387 incident bone-fracture cases (245 in the SGLT2 inhibitor group, 142 in the control group). Compared with patients who received placebo, those receiving SGLT2 inhibitor treatment had a pooled OR of bone fracture of 0.86 (95% CI: 0.70-1.06). Also, there was no evidence that individual SGLT2 inhibitors across different doses were associated with any increased risk of bone fracture. After stratification by follow-up duration, an SGLT2 inhibitor treatment period of ≤ 52 weeks appeared to have beneficial effects against bone fracture; however, when the treatment period exceeded 52 weeks, these beneficial effects for preventing bone fracture disappeared.
Our meta-analysis has indicated that SGLT2 inhibitors do not increase risk of bone fracture compared with placebo in patients with T2DM. However, these findings now need to be confirmed in well-designed RCT studies.
评估钠-葡萄糖共转运蛋白 2（SGLT2）抑制剂与 2 型糖尿病（T2DM）患者骨折风险的关系。
系统检索 PubMed、Embase、Cochrane 图书馆和 Web of Science 自成立以来至 2018 年 8 月 31 日的所有合格随机对照试验（RCT）。从每项研究中提取以下数据：第一作者；发表年份；样本量；患者特征；研究设计；干预药物；对照药物；随访时间；以及骨折事件。使用 Review Manager 5.3 软件进行荟萃分析，以计算二分类变量的比值比（OR）和 95％置信区间（CI）。
共纳入 30 项研究，涉及 23372 例 T2DM 患者。共发生 387 例骨折事件（SGLT2 抑制剂组 245 例，对照组 142 例）。与接受安慰剂的患者相比，接受 SGLT2 抑制剂治疗的患者骨折的汇总 OR 为 0.86（95％CI：0.70-1.06）。此外，没有证据表明不同剂量的 SGLT2 抑制剂与骨折风险增加有关。按随访时间分层后，SGLT2 抑制剂治疗≤52 周似乎对骨折有有益作用；然而，当治疗期超过 52 周时，预防骨折的这些有益作用消失。
我们的荟萃分析表明，与安慰剂相比，SGLT2 抑制剂不会增加 T2DM 患者的骨折风险。然而，这些发现现在需要在精心设计的 RCT 研究中得到证实。
