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接受透析且希望接受移植的肾衰竭合并肥胖患者应用司美格鲁肽:一项前瞻性、观察性、开放标签研究。

Semaglutide in patients with kidney failure and obesity undergoing dialysis and wishing to be transplanted: A prospective, observational, open-label study.

机构信息

Department of Internal Medicine III, Clinical Division of Nephrology and Dialysis, Medical University of Vienna, Vienna, Austria.

Center for Public Health, Department of Epidemiology, Medical University of Vienna, Vienna, Austria.

出版信息

Diabetes Obes Metab. 2024 Dec;26(12):5931-5941. doi: 10.1111/dom.15967. Epub 2024 Oct 7.

DOI:10.1111/dom.15967
PMID:39375862
Abstract

AIMS

Chronic kidney disease (CKD) and obesity are major global health challenges, eventually leading to kidney replacement therapy (KRT), but body mass index (BMI) thresholds hinder kidney transplantation. Glucagon-like peptide-1 receptor agonists induce weight loss, thereby offering attractive treatment options; however, their safety and efficacy have not been systematically investigated in patients undergoing dialysis.

MATERIALS AND METHODS

We conducted a prospective 12-week, open-label trial with 13 patients who had a BMI ≥ 30.00 kg/m, were undergoing dialysis (12 haemodialysis and 1 peritoneal dialysis) and had not been listed for transplantation due to their weight. Semaglutide was administered once weekly subcutaneously, and the dose was increased from 0.25 mg to 0.5 mg and then to 1 mg. Study endpoints included change in body weight and BMI (primary - statistically evaluated by repeated measures analysis of variance [ANOVA]), side effects, adverse events, blood parameters and patient-reported outcomes (secondary).

RESULTS

At baseline, the mean age ± standard deviation of patients was 64.0 ± 6.4 years, the mean weight was 113.9 ± 16.6 kg, and the mean BMI was 37.3 ± 3.9 kg/m. At week 12, average weight reduction under semaglutide treatment was 4.6 ± 2.4 kg and ranged from 2.0 to 9.7 kg (p < 0.001 for weight and BMI reduction across the study period). One patient discontinued treatment due to nausea/vomiting, two patients died of unrelated causes and six patients reported side effects. Approximately 9 months after the treatment started, three patients were able to seriously reconsider being listed for transplantation.

CONCLUSIONS

Semaglutide treatment resulted in significant reduction in weight and BMI in patients with obesity undergoing dialysis, while maintaining an acceptable side effect profile comparable to that of the non-dialysis population.

摘要

目的

慢性肾脏病(CKD)和肥胖是全球主要的健康挑战,最终导致需要进行肾脏替代治疗(KRT),但体重指数(BMI)阈值阻碍了肾脏移植。胰高血糖素样肽-1 受体激动剂可诱导体重减轻,从而提供有吸引力的治疗选择;然而,它们在接受透析的患者中的安全性和疗效尚未得到系统研究。

材料和方法

我们进行了一项前瞻性、12 周、开放标签试验,纳入了 13 名 BMI≥30.00kg/m 的患者,他们正在接受透析(12 名血液透析和 1 名腹膜透析),由于体重原因未被列入移植名单。每周皮下注射一次司美格鲁肽,剂量从 0.25mg 增加到 0.5mg,然后增加到 1mg。研究终点包括体重和 BMI 的变化(主要终点 - 通过重复测量方差分析[ANOVA]进行统计学评估)、副作用、不良事件、血液参数和患者报告的结果(次要终点)。

结果

在基线时,患者的平均年龄±标准差为 64.0±6.4 岁,平均体重为 113.9±16.6kg,平均 BMI 为 37.3±3.9kg/m。在第 12 周,司美格鲁肽治疗下的平均体重减轻为 4.6±2.4kg,范围为 2.0 至 9.7kg(整个研究期间体重和 BMI 降低的差异均具有统计学意义,p<0.001)。一名患者因恶心/呕吐而停止治疗,两名患者因非相关原因死亡,六名患者报告了副作用。在开始治疗大约 9 个月后,三名患者能够重新认真考虑被列入移植名单。

结论

司美格鲁肽治疗可显著降低接受透析的肥胖患者的体重和 BMI,同时保持可接受的副作用谱,与非透析人群相当。

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