摘要
目的评价沙格列汀（5 mg/d）致尿路感染（UTI）和上呼吸道感染（URTI）的风险。方法检索国内外相关数据库（截至2016年6月），收集以单用沙格列汀5 mg/d 或联用其他降糖药的2型糖尿病患者为试验组、以安慰剂代替沙格列汀的患者为对照组、主要结局指标包括UTI和URTI发生率的所有RCT（文种限中文和英文）。对纳入文献进行数据提取和质量评价后，采用RevMan 5.3软件进行Meta分析，结果用RR及其95%CI表示。结果共16篇文献纳入分析，包括17项RCT，患者共6 236例，试验组3 226例，对照组3 010例，疗程12～206周。沙格列汀5 mg/d 致 UTI 风险和致 URTI 风险的研究分别纳入患者6 088例（试验组3 152例，对照组2 936例）和4 851例（试验组2 461例，对照组2 390例）；沙格列汀5 mg/d 联合二甲双胍致 URTI 风险的研究纳入患者1 741例（试验组879例，对照组862例）。16篇文献质量评价结果为 A 级13篇、B级 3 篇。Meta分析结果显示，沙格列汀5 mg/d 单用或与其他降糖药联用致 UTI 和 URTI 的风险均与安慰剂相似，试验组与对照组 UTI 发生率差异无统计学意义［6.66%（210/3 152）比5.82%（171/2 936），RR=1.15, 95%CI： 0.94～1.40, P=0.17］，URTI发生率差异无统计学意义［8.00%（197/2 461）比7.66%（183/2 390），RR=1. 04, 95%CI： 0.86～1.26, P=0.71］；沙格列汀5 mg/d 联用二甲双胍致 URTI 的风险与安慰剂相似，试验组与对照组 URTI 发生率差异无统计学意义［7.17%（63/879）比6.15%（53/862），RR=1.16, 95%CI： 0.82～1.65, P=0.40］。结论本研究结果未显示 2 型糖尿病患者使用沙格列汀5 mg/d能提高致 UTI 和 URTI 的风险。
Objective To evaluate the risk of urinary tract infection （UTI）and upper respiratory tract infection （UPI） induced by saxagliptin 5 mg/d. Methods The related databases were searched （ until June 2016） for randomized controlled trials （RCTs）. The RCT about the risk of urinary tract infection and upper respiratory tract infection induced by saxagliptin between the patients with type 2 diabetes using saxagliptin 5 mg/d alone or with other hypoglycemic agents （test group） and the patients using placebo （ control group） were collected. The main outcome of all RCTs were UTI and URTI rates. The literature was in Chinese and English only. The data and the quality of the enrolled literature was extracted and evaluated, respectively. The soft ware RevMan 5.3 was used for the Meta-analysis. The results were expressed as relative risk （RR） and 95% confidence interval （CI）. Results A total of 16 reports which included 17 RCTs comprised 6 236 patients [3 226 cases in the test group （T）, 3 010 cases in the control group （C） ] with a course of treatment from 12 to 206 weeks were enrolled into the Meta-analysis. The studies on the risk of UTI and URTI which were induced by saxagliptin 5 mg/d comprised 6 088 patients （T： 3 152, C： 2 936） and 4 851 patients （T： 2 461, C： 2 390） , respectively. The studies about the risk of UTI and URTI which were induced by saxagliptin 5 mg/d plus mefformin comprised 1 741 patients （T： 879, C： 862）. The results of quality evaluation of 16 articles showed 13 of Grade A and 3 of Grade B. Meta-analysis showed that there were no significant differences between saxagliptin 5 mg/d monotherapy or combined with other antidiabetic drugs and the placebo in the risk of UTI [ 6.66% （210/3 152）vs. 5.82% （171/2 936）, RR = 1.15, 95%CI： 0.94-1.40, P=0.17） andURTI [8.00% （197/2 461） vs. 7.66% （183/2 390）,RR=1. 04, 95% CI： 0. 86-1.26, P = 0.71 ） ]. There was no significant difference between saxagliptin 5 mg/d combined with metfo
出处
《药物不良反应杂志》
CSCD
2017年第1期37-43,共7页
Adverse Drug Reactions Journal
关键词
泌尿道感染
呼吸道感染
META分析
沙格列汀
Urinary tract infections
Respiratory tract infections
Meta-analysis
Saxagliptin
