神经肌肉电刺激和口服支链氨基酸预防活体肝移植后患者肌少症的效果比较研究：一项开放标签随机对照试验的研究方案。
Comparative study of the effect of neuromuscular electrical stimulation and oral administration of branched-chain amino acid on preventing sarcopenia in patients after living-donor liver transplantation: study protocol for an open-label randomized controlled trial.
机构信息
Department of Gastroenterology and Hepatology, Nagasaki University Graduate School of Biomedical Sciences, 1-7-1 Sakamoto, Nagasaki City, Nagasaki, 852-8501, Japan.
Department of Immunology and Rheumatology, Division of Advanced Preventive Medical Sciences, Nagasaki University Graduate School of Biomedical Sciences, Nagasaki City, Nagasaki, Japan.
出版信息
Trials. 2021 Feb 12;22(1):137. doi: 10.1186/s13063-021-05086-y.
BACKGROUND
Liver cirrhosis is the irreversible fibrosis of the liver and causes refractory ascites and hepatic encephalopathy, which might not respond to treatment. Living donor liver transplantation (LDLT) is an effective treatment for patients with cirrhosis. However, post-LDLT patients are prone to muscle atrophy and sarcopenia. Therefore, physiotherapy of post-LDLT patients is essential for preventing the progression of sarcopenia. Recently, rehabilitation using neuromuscular electrical stimulation (NMES) has been reported to be useful for preventing the progression of sarcopenia. Similarly, nutrition therapy is essential for post-LDLT patients because these patients frequently experience malnutrition. However, the effects of combined NMES and nutrition therapy on post-LDLT patients remain unknown.
METHODS/DESIGN: This open-label, randomized, parallel-group study will compare the effects of combined therapy with NMES and branched-chain amino acids (BCAA) with those of NMES alone in patients with decompensated cirrhosis after LDLT. After LDLT, 50 patients with decompensated cirrhosis will be randomly assigned to receive NMES with BCAA or NMES without BCAA. The duration of the intervention will be 3 months. To analyze the change in skeletal muscle mass, InBody 770 body composition and body water analysis and ultrasonography will be performed before LDLT and 4 weeks and 12 weeks post-LDLT. The primary endpoint is changes in the skeletal muscle mass from baseline to 3 months. Important secondary endpoints are the changes in the skeletal muscle mass from baseline to 1 month and changes in the quadriceps strength from baseline to 1 month.
DISCUSSION
The results of this study are expected to provide evidence regarding the effect of NMES combined with BCAA therapy on the skeletal muscle of post-LDLT patients.
TRIAL REGISTRATION
Japan Registry of Clinical Research jRCTs071190051 . Registered on February 26, 2020.
背景
肝硬化是肝脏的不可逆转纤维化，可导致难治性腹水和肝性脑病，且可能对治疗无反应。活体肝移植（LDLT）是治疗肝硬化患者的有效方法。然而，LDLT 后患者易发生肌肉萎缩和肌肉减少症。因此，对 LDLT 后患者进行物理治疗对于预防肌肉减少症的进展至关重要。最近，使用神经肌肉电刺激（NMES）的康复治疗已被证明对预防肌肉减少症的进展有用。同样，营养疗法对于 LDLT 后患者也是必不可少的，因为这些患者经常会出现营养不良。然而，NMES 和营养疗法联合治疗对 LDLT 后患者的影响尚不清楚。
方法/设计：这是一项开放标签、随机、平行组研究，将比较 NMES 联合支链氨基酸（BCAA）与 NMES 单独治疗 LDLT 后失代偿期肝硬化患者的效果。在 LDLT 后，将 50 例失代偿期肝硬化患者随机分为 NMES 联合 BCAA 组或 NMES 不联合 BCAA 组。干预时间为 3 个月。为了分析骨骼肌质量的变化，在 LDLT 前、LDLT 后 4 周和 12 周，使用 InBody 770 身体成分和身体水分分析以及超声进行检测。主要终点是从基线到 3 个月时骨骼肌质量的变化。重要的次要终点是从基线到 1 个月时骨骼肌质量的变化以及从基线到 1 个月时股四头肌力量的变化。
讨论
预计该研究的结果将为 NMES 联合 BCAA 治疗对 LDLT 后患者骨骼肌的影响提供证据。
试验注册
日本临床试验注册数据库 jRCTs071190051。注册于 2020 年 2 月 26 日。
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