CAJ | 학술논문

目的应用系统评价的方法探讨噻唑烷二酮类药物(TZDs)对糖尿病患者骨折发生率的影响.方法计算机检索MedLine、Cochrane Library、中国生物医学文献数据库(CBM)、中国学术期刊全文数据库(CNKI)、维普中文科技期刊数据库(VIP)、万方数据库,同时筛查纳入文献的参考文献,按纳入与排除标准纳入TZDs类药物对糖尿病患者骨折影响的随机对照试验(RCT).由2名评价员独立评价文献质量、提取资料并交叉核对,而后采用RevMan 5.0软件进行分析.结果共纳入7项临床试验,16350例研究对象.研究发现,女性患者(平均年龄范围52 ～ 62岁),TZDs组总骨折发生率(观察时间3年)显著高于安慰剂组(RR=1.99,95％ CI:1.21 ～2.37,P＜0.05)；TZDs组总骨折发生率(观察时间1～3年)略高于双胍类或磺脲类药物组[1.32(0.29～5.87),P＞0.05]；TZDs组总骨折发生率(观察时间＞3年)显著高于双胍类或磺脲类药物组[1.94(1.55 ～2.43),P＜0.05].男性患者(平均年龄52～ 62岁),TZDs组总骨折发生率与对照组相比差异均无统计学意义(P＞0.05). TZDs组女性上肢[1.85(1.33 ～2.59),P ＜0.05]和下肢[2.74(1.88～3.97),P＜0.05]骨折发生率(观察时间＞3年)均显著高于双胍类或磺脲类药物组；脊柱骨折发生率(观察时间＞3年)略高于双胍类或磺脲类药物组[1.72(0.60 ～4.95),P ＞0.05].结论现有证据表明长期服用TZDs类药物具有潜在致女性糖尿病患者骨折的风险,尤其对于绝经后女性患者.
목적 응용계통평개적방법탐토새서완이동류약물(TZDs)대당뇨병환자골절발생솔적영향.방법 계산궤검색MedLine、Cochrane Library、중국생물의학문헌수거고(CBM)、중국학술기간전문수거고(CNKI)、유보중문과기기간수거고(VIP)、만방수거고,동시사사납입문헌적삼고문헌,안납입여배제표준납입TZDs류약물대당뇨병환자골절영향적수궤대조시험(RCT).유2명평개원독립평개문헌질량、제취자료병교차핵대,이후채용RevMan 5.0연건진행분석.결과 공납입7항림상시험,16350례연구대상.연구발현,녀성환자(평균년령범위52 ～ 62세),TZDs조총골절발생솔(관찰시간3년)현저고우안위제조(RR=1.99,95％ CI:1.21 ～2.37,P＜0.05)；TZDs조총골절발생솔(관찰시간1～3년)략고우쌍고류혹광뇨류약물조[1.32(0.29～5.87),P＞0.05]；TZDs조총골절발생솔(관찰시간＞3년)현저고우쌍고류혹광뇨류약물조[1.94(1.55 ～2.43),P＜0.05].남성환자(평균년령52～ 62세),TZDs조총골절발생솔여대조조상비차이균무통계학의의(P＞0.05). TZDs조녀성상지[1.85(1.33 ～2.59),P ＜0.05]화하지[2.74(1.88～3.97),P＜0.05]골절발생솔(관찰시간＞3년)균현저고우쌍고류혹광뇨류약물조；척주골절발생솔(관찰시간＞3년)략고우쌍고류혹광뇨류약물조[1.72(0.60 ～4.95),P ＞0.05].결론 현유증거표명장기복용TZDs류약물구유잠재치녀성당뇨병환자골절적풍험,우기대우절경후녀성환자.
Objective To evaluate the effect of thiazolidinediones on the risk of bone fracture in patients with type 2 diabetes.Methods We searched for randomized controlled trials (RCTs) in the following electronic databases:MedLine,the Cochrane Library,Chinese BioMedical Literature Database (CBM),National Knowledge Infrastructure Database (CNKI),Chongqing VIP Information Database (VIP),Wanfang Data and collect all clinical controlled trials according to selection criteria.Quality assessment and data extraction were conducted by two reviewers independently.Disagreement were resolved through discussion.All data were analyzed by using Review Manager 5.0 software.Results Seven studies involving 16350 participants were selected in this analysis.The main results of meta-analysis showed that:thiazolidinediones significantly increased the risk of bone fractures among women (duration of treatment:three years) compared with that in placebo group(RR =1.99,95％ CI:1.21-2.37,P ＜0.05);thiazolidinediones increased the risk of fractures among women (duration of treatment:one to three years)compared with biguanides or sulfonylureas (1.32 (0.29-5.87),P ＞ 0.05) ; thiazolidinediones significantly increased the risk of fractures among women (duration of treatment:more than three years)compared with biguanides or sulfonylureas (1.94 (1.55-2.43),P ＜ 0.05).No significant difference was found in the risk of bone fracture among men treated with thiazolidinediones and men treated with control drugs (P ＞ 0.05).Thiazolidinediones significantly increased the risk of fractures of upper limb (1.85 (1.33-2.59),P ＜ 0.05) and distal lower limb (2.74 (1.88-3.97),P ＜ 0.05) among women (duration of treatment:more than three years) compared with biguanides or sulfonylureas; but there was no significant differences in the risk of fractures of spine among women treated with thiazolidinediones (duration of treatment:more than three years) compared with biguanides or sulfonylureas (1.72 (0.60-4.95),P ＞0.05).Conclusion Based on the current studies,thiazolidinediones might cause bone fracture in female patients with type 2 diabetes mellitus,especially in postmenopausal female patients.