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目的:系统评价奥利司他对比二甲双胍降低超体质量或肥胖患者体质量的疗效和安全性,为临床提供循证参考.方法:计算机检索PubMed、Embase、Ovid、Web of Science、 Cochrane图书馆、中国期刊全文数据库(CJFD)、万方数据库及中文科技期刊数据库(VIP),收集奥利司他单用或联合二甲双胍方案(试验组)对比二甲双胍单用(对照组)降低超体质量或肥胖患者体质量、体质量指数(BMI)及不良反应发生率的随机对照试验(RCT),提取资料并按照改良后的Jadad进行质量评价后,采用Rev Man5.3统计软件进行Meta分析.结果:共纳入9项RCT,合计502例患者.Meta分析结果显示,奥利司他与二甲双胍联用时,试验组患者 BMI降低水平均显著优于对照组,差异有统计学意义[SMD=-0. 74,95％CI(-1. 22,-0. 26),P=0. 002];两组患者体质量降低水平[SMD=-0. 04,95％CI(-0. 27,0. 20),P=0. 76]、不良反应发生率[RR=1. 07,95％CI(0. 68,1. 68),P=0. 78]比较,差异均无统计学意义.结论:奥利司他、二甲双胍均可起到一定的降低体质量效果,且均有较高的安全性,联合使用可使BMI降低更显著.“,”OBJECTIVE: To evaluate therapeutic efficacy and safety of orlistat versus metformin in reducing body weight of overweight or obese patients, and to provide evidence-based reference.METHODS: Retrieved from PubMed, Embase, Ovid, Web of Science, Cochrane Library, Chinese Journal Full-text Database, Wanfang database and VIP, RCTs about orlistat alone or combined with metformin (trial group) versus metformin alone (control group) in reducing body weight, BMI and the incidence of ADR of overweight or obese patients were collected. Meta-analysis was performed by using Rev Man 5. 3 statistical software after data extraction and quality evaluation with modified Jadad scale. RESULTS: A total of 9 RCTs were included, involving 502 patients. The results of Meta-analysis showed that, when orlistat combined with metformin, the reduction of BMI in trial group was significantly better than control group, with statistical significance [SMD= -0. 74, 95％CI (- 1. 22,-0. 26),P=0. 002]. There was no statistical significance in the reduction of body weight [SMD= -0. 04, 95％CI (-0. 27,0. 20), P=0. 76] or the incidence of ADR [RR=1. 07, 95％CI (0. 68, 1. 68), P=0. 78] between 2 groups. CONCLUSIONS: Both orlistat and metformin can reduce body weight with good safety. Combined use of these two drugs can reduce body weight more significantly.