摘要
目的评价阿仑膦酸钠治疗合并II型糖尿病骨质疏松的疗效和安全性。方法计算机检索MEDLINE(1948/2012-05)、EMBASE(1966/2012-05)、Cochrane图书馆(2012年第5期)及中国生物医学数据库(1979/2012-05)、中国期刊全文数据库(1989/2015-05),万方数据库(1990/2012-05),并采用手工检索等方法收集会议文献。文献检索无语种限制。收集所有相关随机对照试验,采用Cochrane协作网提供的软件Revman 5.1进行Meta分析,以获得阿仑膦酸钠治疗合并II型糖尿病骨质疏松的疗效及其安全性有差异的相关证据。结果经全面检索及筛查后,共纳入5项随机对照试验,1项为B级,4项为C级。Meta分析表明,与对照组相比阿仑膦酸钠治疗合并II型糖尿病骨质疏松骨密度增幅[WMD=0.05,95%置信区间为(0.01,0.09),P=0.01],不良反应发生率[RR=1.25,95%置信区间为(0.99,1.58),P=0.06],退出研究发生率[RR=1.21,95%置信区间为(0.67,2.16),P=0.52]。结论与对照组相比,阿仑膦酸钠治疗能够有效改善合并II型糖尿病骨质疏松骨量,且与对照组安全性相近。鉴于本系统评价及纳入研究存在一定局限性,仍需设计良好、实施完善的大样本、多中心随机对照试验进一步研究。
Objective To evaluate the clinical efficacy and safety of alendronate for the treatment of osteoporosis in patients with type Ⅱ diabetes. Methods Literatures in Medline (1948/2012-05), Embase (1966/2012-05), the Cochrane Library (Issue 5, 2012) , Chinese Biomedical Literature Database (CBM, 1979/2012-05 ), Chinese National Knowledge Infrastructure (CNKI, 1989/2012-05 ), and Wanfang Data (1990/2012-05) were retrieved. Conference papers were retrieved manually. There was no limitation of language during the process of retrieval. All related randomized controlled trials (RCTs) in these literatures were selected. A Revman 5.1 software provided by the Cochrane Collaboration was used for Meta-analysis, in order to acquire the evidence of clinical efficacy and safety of alendronate for the treatment of osteoporosis with type Ⅱ diabetes. Results Five RCTs were selected after retrieval and screening. One was level B, and others were level C. Meta-analysis showed that compared with the control group, the increase of BMD was higher in alendronate group [WMD =0.05, CI (0.01, 0.09), P =0.01], while the rate of adverse effects had no difference between the 2 groups [ RR = 1.25, CI (0.99, 1.58), P = 0.06]. The rates of withdrawal in both groups were indicated [ RR = 1. 21, 95% CI (0. 67, 2. 16), P = 0. 52]. Conclusion Compared with the treatment in the control group, alendronate can effectively increase the BMD of osteoporosis patients with type Ⅱ diabetes. The safety in alendronate group is similar with that in the control group. Because of the limitation of selection bias and implementation bias in this study, the results need to be further studied through well-designed, well-conducted RCTs with larger samples and high quality.
出处
《中国骨质疏松杂志》
CAS
CSCD
北大核心
2013年第1期51-57,共7页
Chinese Journal of Osteoporosis