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盐酸安非他酮/托吡酯治疗超重或肥胖成人的疗效和安全性:系统评价和荟萃分析。

Efficacy and Safety of Phentermine/Topiramate in Adults with Overweight or Obesity: A Systematic Review and Meta-Analysis.

机构信息

Geriatrics Department of Endocrinology and Metabolism, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.

Guangxi Key Laboratory of Precision Medicine in Cardio cerebrovascular Diseases Control and Prevention, The First Affiliated Hospital of Guangxi Medical University, Nanning, Guangxi, China.

出版信息

Obesity (Silver Spring). 2021 Jun;29(6):985-994. doi: 10.1002/oby.23152. Epub 2021 Apr 16.

Abstract

OBJECTIVE

The study objective was to examine the association between phentermine/topiramate therapy and weight loss and adverse events in adults with overweight or obesity by meta-analysis and systematic review.

METHODS

Medical Subject Headings and free-text terms were selected to search for eligible trials in PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Embase up to April 18, 2020. The quality of randomized controlled trials was evaluated by the Cochrane risk-of-bias tool. Meta-analysis was performed using random-effect models.

RESULTS

Phentermine/topiramate therapy resulted in an average weight loss of 7.73 kg (95% CI: 6.60-8.85) in general compared with placebo. The weight loss was related to the dose of phentermine/topiramate. Compared with placebo, the average weight loss was 3.55 kg (95% CI: 2.22-4.88) for 3.75/23 mg, 7.27 kg (95% CI: 6.40-8.13) for 7.5/46 mg, and 8.25 kg (95% CI: 6.92-9.79) for 15/92 mg. For phentermine/topiramate participants in different weight-loss subgroups, the weight loss of participants with ≥5%, ≥10%, and ≥15% baseline weight loss was 3.18 (95% CI: 2.75-3.67), 5.32 (95% CI: 4.53-6.25), and 5.65 (95% CI: 3.55-9.01), respectively. Compared with placebo, the adverse events associated with the treatment mainly included dysgeusia (odds ratio [OR] = 8.86, 95% CI: 5.65-13.89), paresthesia (OR = 8.51, 95% CI: 6.20-11.67), dry mouth (OR = 6.71, 95% CI: 5.03-8.94), disturbance in attention (OR = 4.48, 95% CI: 2.39-8.41), irritability (OR = 4.10, 95% CI: 2.29-7.33), hypoesthesia (OR = 3.81, 95% CI: 1.32-11.00), constipation (OR = 2.43, 95% CI: 2.02-2.93), and dizziness (OR = 2.26, 95% CI: 1.72-2.98). Phentermine/topiramate also reduced waist circumference, blood pressure, blood sugar levels, and lipid levels.

CONCLUSIONS

Phentermine/topiramate has considerable benefit in reducing body weight, and the efficacy was closely related to the dosage. However, it increased the risk of nervous system-related adverse events.

摘要

目的

通过荟萃分析和系统评价,研究目的是评估苯丁胺/托吡酯治疗与超重或肥胖成年人的体重减轻和不良事件之间的关联。

方法

使用医学主题词和自由文本术语,在 PubMed、Cochrane 对照试验中心注册库(CENTRAL)和 Embase 中搜索截至 2020 年 4 月 18 日的合格试验。使用 Cochrane 偏倚风险工具评估随机对照试验的质量。使用随机效应模型进行荟萃分析。

结果

与安慰剂相比,苯丁胺/托吡酯治疗可使总体平均体重减轻 7.73kg(95%CI:6.60-8.85)。体重减轻与苯丁胺/托吡酯的剂量有关。与安慰剂相比,3.75/23mg 的平均体重减轻为 3.55kg(95%CI:2.22-4.88),7.5/46mg 的平均体重减轻为 7.27kg(95%CI:6.40-8.13),15/92mg 的平均体重减轻为 8.25kg(95%CI:6.92-9.79)。对于不同体重减轻亚组的苯丁胺/托吡酯参与者,基线体重减轻≥5%、≥10%和≥15%的参与者的体重减轻分别为 3.18(95%CI:2.75-3.67)、5.32(95%CI:4.53-6.25)和 5.65(95%CI:3.55-9.01)。与安慰剂相比,与治疗相关的不良事件主要包括味觉障碍(OR=8.86,95%CI:5.65-13.89)、感觉异常(OR=8.51,95%CI:6.20-11.67)、口干(OR=6.71,95%CI:5.03-8.94)、注意力障碍(OR=4.48,95%CI:2.39-8.41)、易怒(OR=4.10,95%CI:2.29-7.33)、感觉迟钝(OR=3.81,95%CI:1.32-11.00)、便秘(OR=2.43,95%CI:2.02-2.93)和头晕(OR=2.26,95%CI:1.72-2.98)。苯丁胺/托吡酯还降低了腰围、血压、血糖水平和血脂水平。

结论

苯丁胺/托吡酯在减轻体重方面有相当大的益处,疗效与剂量密切相关。然而,它增加了与神经系统相关的不良事件的风险。

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