Chen Wei-Tao, Sun Ce, Zhou Ying-Bin, Liu Dong-Hua, Peng Zhi-Long, Chen Jing, Xu Nuo, Lei Yan-Yan, He Jun, Tang Chun-Zhi, Lin Xin-Feng, Xu Neng-Gui, Xian Shao-Xiang, Lu Li-Ming
Intensive Care Unit, The First Affiliated Hospital of Guangzhou University of Chinese Medicine.
Ling-Nan Medical Research Center, Guangzhou University of Chinese Medicine.
Medicine (Baltimore). 2020 May 22;99(21):e20233. doi: 10.1097/MD.0000000000020233.
Sepsis-induced myopathy (SIM) is a disease that causes motor dysfunction in patients with sepsis. There is currently no targeted treatment for this disease. Acupuncture has shown considerable efficacy in the treatment of sepsis and muscle weakness. Therefore, our research aims to explore the effects of acupuncture on the improvement of muscle structure and function in SIM patients and on activities of daily living.
The ACU-SIM pilot study is a single-center, propensity-score stratified, assessor-blinded, prospective pragmatic controlled trial (pCT) with a 1-year follow-up period. This study will be deployed in a multi-professional critical care department at a tertiary teaching hospital in Guangzhou, China. Ninety-eight intensive care unit subjects will be recruited and assigned to either the control group or the acupuncture group. Both groups will receive basic treatment for sepsis, and the acupuncture group will additionally receive acupuncture treatment. The primary outcomes will be the rectus femoris cross-sectional area, the Medical Research Council sum-score and time-to-event (defined as all-cause mortality or unplanned readmission to the intensive care unit due to invasive ventilation). The activities of daily living will be accessed by the motor item of the Functional Independence Measure. Recruitment will last for 2 years, and each patient will have a 1-year follow-up after the intervention.
There is currently no research on the therapeutic effects of acupuncture on SIM. The results of this study may contribute to new knowledge regarding early muscle atrophy and the treatment effect of acupuncture in SIM patients, and the results may also direct new approaches and interventions in these patients. This trial will serve as a pilot study for an upcoming multicenter real-world study.
Chinese Clinical Trials Registry: ChiCTR-1900026308, registered on September 29th, 2019.
脓毒症诱导的肌病（SIM）是一种导致脓毒症患者运动功能障碍的疾病。目前该疾病尚无针对性治疗方法。针灸在脓毒症和肌肉无力的治疗中已显示出显著疗效。因此，我们的研究旨在探讨针灸对改善SIM患者肌肉结构和功能以及日常生活活动的影响。
ACU-SIM试点研究是一项单中心、倾向评分分层、评估者盲法、前瞻性实用对照试验（pCT），随访期为1年。本研究将在中国广州一家三级教学医院的多专业重症监护病房开展。将招募98名重症监护病房受试者并分配至对照组或针灸组。两组均接受脓毒症的基础治疗，针灸组还将接受针灸治疗。主要结局指标将是股直肌横截面积、医学研究委员会总评分和事件发生时间（定义为全因死亡率或因有创通气导致的计划外再次入住重症监护病房）。日常生活活动将通过功能独立性测量的运动项目进行评估。招募将持续2年，每位患者在干预后将有1年的随访期。
目前尚无关于针灸对SIM治疗效果的研究。本研究结果可能有助于获得关于早期肌肉萎缩以及针灸对SIM患者治疗效果的新知识，结果也可能为这些患者的新方法和干预措施提供指导。本试验将作为即将开展的多中心真实世界研究的试点研究。
中国临床试验注册中心：ChiCTR-1900026308，于2019年9月29日注册。
