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利拉鲁肽增强腹腔镜袖状胃切除术减肥效果:一项随机、双盲、安慰剂对照研究。

Liraglutide Augments Weight Loss After Laparoscopic Sleeve Gastrectomy: a Randomised, Double-Blind, Placebo-Control Study.

机构信息

Department of Gastro-intestinal Surgery, PGIMER, Chandigarh, Chandigarh, India.

Department of Endocrinology, PGIMER, Chandigarh, Room-1011, Nehru Hospital Extension Block, Chandigarh, 160012, India.

出版信息

Obes Surg. 2021 Jan;31(1):84-92. doi: 10.1007/s11695-020-04850-4. Epub 2020 Jul 12.

Abstract

PURPOSE

Both laparoscopic sleeve gastrectomy (LSG) and liraglutide cause a significant weight loss. We evaluated the effect of liraglutide in comparison with placebo on total weight loss (TWL) and excess body weight loss (EWL) and when added in initial weight loss period after LSG in obese individuals.

MATERIAL AND METHODS

Participants with BMI > 30 kg/m undergoing LSG were randomised to receive either liraglutide (subcutaneous) in increasing does of 0.6 mg/day until maximum tolerated dose of 3.0 mg (L-L group) or placebo (L-P group) from 6 weeks post-operative until 6 months. Weight, BMI, %TWL, %EWL, HbA1c, fasting plasma glucose, HOMA-IR, resolution of type 2 diabetes mellitus, hypertension, dyslipidaemia, sleep apnea and quality of life were evaluated. Primary end point was %TWL and % EWL at post-operative 6 months.

RESULTS

Thirty participants underwent LSG, and 23 were randomised to receive liraglutide (n = 12) or placebo (n = 11).The mean dose of liraglutide in L-L group was 1.41 ± 0.49 mg/day. Patients in L-L group had %TWL of 28.2 ± 5.7 and %EWL of 58.7 ± 14.3 as compared with 23.2 ± 6.2 (p = 0.116) and 44.5 ± 8.6 (p = 0.043) in L-P group at 24 weeks, respectively. BMI decreased by 11.7 ± 3.5 in L-L group compared with 9.5 ± 4.0 in L-P group (p = 0.287). All patients with diabetes or pre-diabetes had resolution of dysglycemia in the L-L group as compared with 50% in L-P group. However, there was no significant difference in resolution of other obesity-related comorbidities between two groups at 24-week follow-up.

CONCLUSION

Liraglutide added early after LSG significantly augments weight loss from LSG in obese individuals.

TRIAL REGISTRATION

The study protocol was registered at clinical trials.gov.in with NCT: 04325581.

摘要

目的

腹腔镜袖状胃切除术(LSG)和利拉鲁肽均能显著减轻体重。我们评估了利拉鲁肽与安慰剂相比,在肥胖患者 LSG 术后初始减重期添加利拉鲁肽对总减重(TWL)和多余体重减轻(EWL)的影响。

材料和方法

BMI>30kg/m2的参与者接受 LSG 后,随机接受皮下注射利拉鲁肽(逐渐增加剂量,从 0.6mg/天直至最大耐受剂量 3.0mg)或安慰剂(L-P 组),从术后 6 周持续到 6 个月。评估体重、BMI、%TWL、%EWL、HbA1c、空腹血糖、HOMA-IR、2 型糖尿病缓解、高血压、血脂异常、睡眠呼吸暂停和生活质量。主要终点是术后 6 个月的%TWL 和%EWL。

结果

30 名参与者接受了 LSG,其中 23 名随机接受利拉鲁肽(n=12)或安慰剂(n=11)治疗。L-L 组利拉鲁肽的平均剂量为 1.41±0.49mg/天。与 L-P 组相比,L-L 组患者的%TWL 为 28.2±5.7,%EWL 为 58.7±14.3,而 L-P 组分别为 23.2±6.2(p=0.116)和 44.5±8.6(p=0.043)。与 L-P 组相比,L-L 组的 BMI 降低了 11.7±3.5,而 L-P 组则降低了 9.5±4.0(p=0.287)。所有糖尿病或糖尿病前期患者在 L-L 组的血糖异常均得到缓解,而 L-P 组仅为 50%。然而,在 24 周随访时,两组之间其他肥胖相关合并症的缓解情况无显著差异。

结论

LSG 术后早期添加利拉鲁肽可显著增加肥胖患者的 LSG 减重效果。

试验注册

研究方案在 clinicaltrials.gov.in 注册,注册号为 NCT: 04325581。

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