“ 在肥胖儿童(6至<12岁)中，利拉鲁肽治疗56周加生活方式干预比安慰剂加生活方式干预更能降低BMI。”
近年来肥胖话题火爆全球，各种药物在学术界和市场都掀起一阵热潮。然而，在现实中对治疗6 - 12岁以下儿童肥胖患者却存在一定的难度。
很多人会问：儿童肥胖患者能用药吗？
目前还没有药物被批准用于治疗12岁以下儿童的非单基因、非综合征性肥胖。虽然利拉鲁肽的使用已被证明可诱导成人和青少年肥胖患者体重减轻，但其在儿童中的安全性和有效性尚未确定。为了探究用药后的实际情况，研究人员对使用利拉鲁肽，进行了一项重要的随机试验。
研究结果发表在四大医学頂刊之一JAMA（2023年影响因子96.2）。
*详细数据可点击左下角“阅读原文”
先直接上“答案”：
在肥胖儿童(6至<12岁)中，利拉鲁肽治疗56周加生活方式干预比安慰剂加生活方式干预更能降低BMI。
再看看研究怎么做的：
在这项3a期试验中，包括56周的治疗期和26周的随访期，随机分配肥胖儿童(6至<12岁)，以2:1的比例接受每日一次的皮下利拉鲁肽3.0 mg(或最大耐受剂量)或安慰剂，外加生活方式干预。主要终点是身体质量指数(BMI;重量(公斤)除以高度(米)的平方。确定的次要终点是体重变化的百分比和BMI降低至少5%。
温馨提示：数据可参考原文；翻译可能有错漏，请以原文为准！
再看看结果：
共有82名参与者进行了随机化;56人被分配到利拉鲁肽组，26人被分配到安慰剂组。在第56周，利拉鲁肽组BMI较基线的平均百分比变化为-5.8%，安慰剂组为1.6%，估计差异为-7.4个百分点(95%可信区间[CI]， -11.6至-3.2;P < 0.001)。
利拉鲁肽组体重的平均百分比变化为1.6%，安慰剂组为10.0%，估计差异为-8.4个百分点(95% CI， -13.4至-3.3;P = 0.001)， 46%的利拉鲁肽组参与者和9%的安慰剂组参与者的BMI至少降低了5%(校正优势比为6.3 [95% CI, 1.4至28.8];P = 0.02)。
利拉鲁肽组和安慰剂组的不良事件发生率分别为89%和88%。利拉鲁肽组胃肠道不良事件更常见(80%对54%);利拉鲁肽组和安慰剂组分别有12%和8%的参与者报告了严重不良事件。
小编：很有前途啊！
Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial
附：英文摘要
Abstract
Background:
No medications are currently approved for the treatment of nonmonogenic, nonsyndromic obesity in children younger than 12 years of age. Although the use of liraglutide has been shown to induce weight loss in adults and adolescents with obesity, its safety and efficacy have not been established in children.
Methods:
In this phase 3a trial, which consisted of a 56-week treatment period and a 26-week follow-up period, we randomly assigned children (6 to <12 years of age) with obesity, in a 2:1 ratio, to receive either once-daily subcutaneous liraglutide at a dose of 3.0 mg (or the maximum tolerated dose) or placebo, plus lifestyle interventions. The primary end point was the percentage change in the body-mass index (BMI; the weight in kilograms divided by the square of the height in meters). The confirmatory secondary end points were the percentage change in body weight and a reduction in BMI of at least 5%.
Results:
A total of 82 participants underwent randomization; 56 were assigned to the liraglutide group and 26 to the placebo group. At week 56, the mean percentage change from baseline in BMI was -5.8% with liraglutide and 1.6% with placebo, representing an estimated difference of -7.4 percentage points (95% confidence interval [CI], -11.6 to -3.2; P<0.001). The mean percentage change in body weight was 1.6% with liraglutide and 10.0% with placebo, representing an estimated difference of -8.4 percentage points (95% CI, -13.4 to -3.3; P = 0.001), and a reduction in BMI of at least 5% occurred in 46% of participants in the liraglutide group and in 9% of participants in the placebo group (adjusted odds ratio, 6.3 [95% CI, 1.4 to 28.8]; P = 0.02). Adverse events occurred in 89% and 88% of participants in the liraglutide and placebo groups, respectively. Gastrointestinal adverse events were more common in the liraglutide group (80% vs. 54%); serious adverse events were reported in 12% and 8% of participants in the liraglutide and placebo groups, respectively.
Conclusions:
Among children (6 to <12 years of age) with obesity, treatment with liraglutide for 56 weeks plus lifestyle interventions resulted in a greater reduction in BMI than placebo plus lifestyle interventions. (Funded by Novo Nordisk; SCALE Kids ClinicalTrials.gov number, NCT04775082.).
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参考文献：Fox CK, Barrientos-Pérez M, Bomberg EM, Dcruz J, Gies I, Harder-Lauridsen NM, Jalaludin MY, Sahu K, Weimers P, Zueger T, Arslanian S; SCALE Kids Trial Group. Liraglutide for Children 6 to <12 Years of Age with Obesity - A Randomized Trial. N Engl J Med. 2024 Sep 10. doi: 10.1056/NEJMoa2407379. Epub ahead of print. PMID: 39258838.
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