今日药学

2020, v.30(01) 67-72

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利拉鲁肽治疗超重或肥胖超药品说明书用法的循证评价
Evidence-Based Evaluation of the Use of Liraglutide in the Treatment of Overweight or Obesity

陈泽鹏;朱建红;伍俊妍;郑志华;
CHEN Zepeng;ZHU Jianhong;WU Junyan;ZHENG Zhihua;Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University;Guangdong Pharmaceutical Association;

摘要(Abstract):

目的运用循证药学的方法评价利拉鲁肽用于治疗超重或肥胖的临床证据,为超说明书用药循证评价提供参考。方法系统检索Pub Med、EMBASE、Cochrane Library、CNKI、万方数据库,国外药品说明书及MICROMEDEX~?循证数据库,由两名评价者独立的根据纳入排除标准筛选文章,评价文献质量,提取数据并分析。结果共纳入FDA与EMA药品说明书、循证数据库MICROMEDEX~?、5项国内外指南与6篇系统评价/Meta分析。利拉鲁肽与安慰剂相比可以显著降低肥胖患者的体重和BMI、提高体重减轻至少5%的患者比例。安全性方面利拉鲁肽由于不良反应而停止治疗的比率显著高于安慰剂,其中胃肠道不良反应发生率较高。结论利拉鲁肽用于治疗BMI>27 kg·m~(-2)合并至少一项肥胖并发症、或者BMI>30 kg·m~(-2)的单纯性肥胖的患者具有较好的疗效,但是需要注意患者胃肠道不良反应。
OBJECTIVE To evaluate the evidence of liraglutide in the treatment of overweight or obesity. METHODS Studies investigated the effect of liraglutide on overweight or obesity were searched using the following database:Pub Med,EMBASE,Cochrane Library,CNKI,Wanfang database,foreign drug instruction website and MICROMEXEX~? evidence-based database. Two reviewers selected articles based on inclusion and exclusion criteria,evaluated study quality,extracted and analyzed data independently.RESULTS The FDA and EMA package insert,data from MICROMEX~? and 6 systematic reviews/Meta analysis were included.Liraglutide significantly reduced the body weight and BMI of obese patients,and increased the proportion of patients with at least 5%weight loss compared with placebo. In terms of safety,the ratio of stopped treatment due to adverse reactions in liraglutide group was significantly higher than that of the placebo group,and the incidence of gastrointestinal adverse reactions was higher liraglutide group.CONCLUSION Liraglutide was effective in the treatment of patients with BMI > 27 kg·m~(-2) with at least one obesity complication,or simple obesity with BMI >30 kg·m~(-2),but attention should be paid to the gastrointestinal reactions.

关键词(KeyWords): 利拉鲁肽;超说明书;有效性;安全性;循证评价
liraglutide;off-label;effective;safety;evidence-based evaluation

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作者(Author): 陈泽鹏;朱建红;伍俊妍;郑志华;
CHEN Zepeng;ZHU Jianhong;WU Junyan;ZHENG Zhihua;Sun Yat-Sen Memorial Hospital,Sun Yat-Sen University;Guangdong Pharmaceutical Association;

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