奥利司他治疗伴有心血管危险因素肥胖患者有效性和安全性的Meta分析

Efficacy and safety of Orlistat for obese patients with cardiovascular risk:a meta-analysis

目的系统评价奥利司他胶囊在伴有心血管危险因素(高脂血症、糖尿病及糖尿病前期、高血压)的肥胖患者中的疗效和安全性。方法计算机检索Sinomed、CNKI、Wan Fang Data、Pub Med、EMbase、The Cochrane Library、Clinical Trails.gov等数据库,搜集奥利司他胶囊治疗伴有心血管危险因素(高脂血症、糖尿病及糖尿病前期、高血压)的肥胖患者的随机临床对照试验(RCT),检索时限均为建库至2017年1月7日。由2名研究者独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用Stata 14.0软件进行Meta分析。结果最终纳入28个RCT。Meta分析结果显示:与安慰剂比较,奥利司他能够明显降低患者体重[MD=–2.85,95%CI(–3.47,–2.24),P=0.000]、腰围[MD=–2.45,95%CI(–3.07,–1.83),P=0.000]和BMI[MD=–1.29,95%CI(–2.08,–0.49),P=0.002],差异均有统计学意义。在控制血压、血糖等心血管危险因素方面也有益处。与空白对照比较,奥利司他对腰围和部分心血管危险因素的改善也具有优势(P<0.05)。奥利司他不良事件发生率稍高于安慰剂,但多数能够自愈。结论当前证据显示,相较于安慰剂和空白对照,奥利司他能够控制肥胖并改善患者的部分心血管疾病危险因素。受纳入研究数量和质量的限制,上述结论尚待更多高质量研究予以验证。

Objectives To systematically review the efficacy and safety of Orlistat for obese patients with cardiovascular risk including hyperlipidemia, hypertension, diabetes and prediabetes. Methods Sinomed, CNKI,Wan Fang Data, Pub Med, EMbase, The Cochrane Library and Clinical Trails.gov databases were electronically searched to collect randomized controlled trials（RCTs） of Orlistat for obese patients with cardiovascular risk such as hyperlipemia,diabetes, prediabetes and hypertension from inception to Jan 7^ th, 2017. Two reviewers independently screened literature,extracted data, and assessed the risk of bias of included studies. Then, meta-analysis was performed using Stata 14.0 software. Results A total of 28 RCTs were included. The results of meta-analysis showed that, compared with placebo,Orlistat could significantly reduce the weight（MD=–2.85, 95%CI –3.47 to –2.24, P=0.000）, waist（MD=–2.45, 95%CI–3.07 to –1.83, P=0.000） and BMI（MD=–1.29, 95%CI –2.08 to –0.49, P=0.002） of patients. Orlistat could also control the blood pressure, blood glucose and other cardiovascular risk factors well. Compared with the blank control, Orlistat could improve the waist and parts of cardiovascular risk factors（P〈0.05）. The incidence of adverse events of Orlistat was slightly higher than that of placebo, but most could be self-healing. Conclusions Current evidence shows that compared with placebo and blank control, Orlistat is effective for improving both weight loss and some cardiovascular risk factors. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.