【摘要】 目的 系统评价极低热量生酮饮食（VLCKD）对超重/肥胖人群减重干预的有效性和安全性。方法 计算机检索PubMed、EMbase、Web of Science、The Cochrane Library、CNKI、WanFang Data、VIP和CBM数据库，搜集超重/肥胖患者使用VLCKD干预的随机对照试验（RCT），检索时限均从建库至2021年8月。由2位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后，采用Stata 16.0软件进行Meta分析。结果 共纳入5个RCT，包括245例超重/肥胖症患者。Meta分析结果显示：当基线BMI≥30 kg/m2时，与对照组饮食相比，VLCKD能够降低超重/肥胖患者的身体质量指数（BMI）[MD=-2.92,95%CI（-4.33，-1.50）,P<0.05]、体质量[MD=-7.00,95%CI（-10.48，-3.53）,P<0.05]和腰围[MD=-7.40,95%CI（-12.68，-2.12）,P<0.05]。亚组分析结果显示，VLCKD与对照组相比，可降低超重/肥胖且患有糖尿病人群的血糖[MD=-9.60,95%CI（-17.52，-1.69）,P<0.05]、糖化血红蛋白[MD=-0.24,95%CI（-0.39，-0.08）,P<0.05]、胰岛素抵抗指数[MD=-0.90,95%CI（-1.08，-0.73）,P<0.05]和甘油三酯水平[MD=-41.42,95%CI（-53.78，-29.06）,P<0.05]；干预时间达到12个月后，可提高超重/肥胖人群的高密度脂蛋白水平[MD=8.60,95%CI(0.17,17.03),P<0.05]。但VLCKD对超重/肥胖患者的胰岛素水平、总胆固醇、低密度脂蛋白、尿素、肌酸酐和尿酸水平无明显作用。VLCKD组不良事件发生率高于对照组，但4个月后，两组在不良事件发生率方面的差异无统计学意义。结论 现有证据表明，VLCKD可明显降低超重/肥胖人群的BMI、体质量和腰围。对患有糖尿病的超重/肥胖人群，还可改善其血糖、糖化血红蛋白、胰岛素抵抗指数和甘油三酯水平。但对超重/肥胖人群的胰岛素水平、总胆固醇、尿素、肌酸酐和尿酸水平无明显作用。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。更多还原

【Abstract】 Objective To systematically review the efficacy and safety of a very low-calorie ketogenic diet(VLCKD) in patients who were overweight or obese. Methods From inception to August 2021, the electronic databases PubMed, EMbase, Web of Science, The Cochrane Library, CNKI, WanFang Data, VIP, and CBM were searched for randomized controlled trials(RCTs) of VLCKD in patients with overweight or obesity. Two reviewers independently screened the literature, extracted data, and evaluated the risk of bias of the included studies. Then, meta-analysis was performed using Stata 16.0 software. Results A total of 5 RCTs involving 245 patients were included. Among patients with baseline body mass index(BMI) ≥30 kg/m2, the meta-analysis showed that compared with the control group,VLCKD could significantly reduce the BMI(MD=-0.24, 95%CI-0.39 to-0.08, P<0.05), weight(MD=-7.00, 95%CI-10.48 to-3.53, P<0.05) and waist circumference(MD=-7.40, 95%CI-12.68 to-2.12, P<0.05). The subgroup analysis results showed that compared with the control diet, VLCKD could significantly reduce the glucose(MD=-9.60, 95%CI-17.52 to-1.69, P<0.05), glycated hemoglobin(MD=-0.24, 95%CI-0.39 to-0.08, P<0.05), insulin resistance index(MD=-0.90, 95%CI-1.08 to-0.73, P<0.05) and triglycerides(MD=-41.42, 95%CI-53.78,-29.06, P<0.05) in patients with type 2 diabetes and with obesity or overweight. In patients with obesity or overweight, VLCKD could increase highdensity lipoprotein cholesterol(MD=8.60, 95%CI 0.17 to 17.03, P<0.05) when the intervention lasted longer than12 months. In patients with obesity or overweight, VLCKD had no effect on insulin, total cholesterol, low-density lipoprotein, urea, creatinine, or uric acid. Patients with VLCKD had a higher rate of adverse events than those in the control groups; however, there was no significant difference in the rate when the intervention lasted longer than 4 months.Conclusion The current evidence shows that VLCKD can reduce BMI, weight, and waist circumference and reduce fasting glucose, HbA1c, insulin resistance index, and triglycerides among patients with type 2 diabetes and with obesity or overweight. However, VLCKD has no effect on insulin, total cholesterol, low-density lipoprotein, urea, creatinine, or uric acid. Due to the limited quantity and quality of the included studies, more high-quality studies are needed to verify the above conclusion.更多还原