英国儿童和青少年抗肥胖药物处方量上升：一项基于人群的研究。
Rise in antiobesity drug prescribing for children and adolescents in the UK: a population-based study.
机构信息
General & Adolescent Paediatrics Unit, UCL Institute of Child Health, University College London, London, UK.
出版信息
Br J Clin Pharmacol. 2009 Dec;68(6):844-51. doi: 10.1111/j.1365-2125.2009.03528.x.
WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT
- The antiobesity drugs sibutramine and orlistat are not licensed for use in children and adolescents in the UK or USA. * Clinical trials suggest antiobesity drugs are effective and well-tolerated in obese adolescents.
WHAT THIS STUDY ADDS
- Prescribing of unlicensed antiobesity drugs in children and adolescents has increased significantly in the past 8 years. * Most prescribed antiobesity drugs in children and adolescents are rapidly discontinued before patients can see clinical benefit, suggesting they are poorly tolerated or poorly efficacious.
AIMS
The international childhood obesity epidemic has driven increased use of unlicensed antiobesity drugs, whose efficacy and safety are poorly studied in children and adolescents. We investigated the use of unlicensed antiobesity drugs (orlistat, sibutramine and rimonabant) in children and adolescents (0-18 years) in the UK.
METHODS
Population-based prescribing data from the UK General Practice Research Database between 1 January 1999 and 31 December 2006.
RESULTS
A total of 452 subjects received 1334 prescriptions during the study period. The annual prevalence of antiobesity drug prescriptions rose significantly from 0.006 per 1000 [95% confidence interval (CI) 0.0007, 0.0113] in 1999 to 0.091 per 1000 (95% CI 0.07, 0.11) in 2006, a 15-fold increase, with similar increases seen in both genders. The majority of prescriptions were made to those >or=14 years old, although 25 prescriptions were made for children <12 years old. Orlistat accounted for 78.4% of all prescriptions; only one patient was prescribed rimonabant. However, approximately 45% of the patients ceased orlistat and 25% ceased sibutramine after only 1 month. The estimated mean treatment durations for orlistat and sibutramine were 3 and 4 months, respectively.
CONCLUSIONS
Prescribing of unlicensed antiobesity drugs in children and adolescents has dramatically increased in the past 8 years. The majority are rapidly discontinued before patients can see weight benefit, suggesting they are poorly tolerated or poorly efficacious when used in the general population. Further research into the effectiveness and safety of antiobesity drugs in clinical populations of children and adolescents is needed.
已知关于该主题的内容
在英国和美国，抗肥胖药物西布曲明和奥利司他未获准用于儿童和青少年。
临床试验表明，抗肥胖药物在肥胖青少年中有效且耐受良好。
本研究增加的内容
在过去的 8 年中，儿童和青少年中超适应证使用抗肥胖药物的情况显著增加。
儿童和青少年中最常开的抗肥胖药物在患者看到临床获益之前就迅速停药，这表明它们的耐受性差或疗效不佳。
目的
国际儿童肥胖症的流行导致未经许可的抗肥胖药物的使用增加，而这些药物在儿童和青少年中的疗效和安全性研究甚少。我们调查了英国（0-18 岁）儿童和青少年中超适应证使用（奥利司他、西布曲明和利莫那班）抗肥胖药物的情况。
方法
使用英国全科医学研究数据库 1999 年 1 月 1 日至 2006 年 12 月 31 日期间的基于人群的处方数据。
结果
在研究期间，共有 452 名患者接受了 1334 次处方。抗肥胖药物处方的年患病率显著上升，从 1999 年的 0.006/1000（95%置信区间 0.0007-0.0113）增加到 2006 年的 0.091/1000（95%置信区间 0.07-0.11），增加了 15 倍，两性均有类似的增加。大多数处方是给年龄大于或等于 14 岁的患者开具的，尽管有 25 张处方是给年龄小于 12 岁的患者开具的。奥利司他占所有处方的 78.4%；只有一名患者开了利莫那班。然而，大约 45%的患者在服用奥利司他 1 个月后停药，25%的患者在服用西布曲明 1 个月后停药。奥利司他和西布曲明的估计平均治疗持续时间分别为 3 个月和 4 个月。
结论
在过去的 8 年中，儿童和青少年中超适应证使用抗肥胖药物的情况显著增加。在患者看到体重获益之前，大多数药物迅速停药，这表明在一般人群中使用时，它们的耐受性差或疗效不佳。需要进一步研究抗肥胖药物在儿童和青少年临床人群中的有效性和安全性。
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