基于临床实践指南的韩国医学治疗急性周围性面瘫患者的有效性和安全性：一项多中心、前瞻性、观察性研究方案。
Effectiveness and safety of Korean medicine treatment based on the clinical practice guidelines in patients with acute peripheral facial palsy: A protocol for a multicenter, prospective, observational study.
机构信息
Department of Clinical Korean Medicine, Graduate School, Kyung Hee University, Seoul, Republic of Korea.
Department of Acupuncture and Moxibustion, Kyung Hee University Korean Medicine Hospital, Seoul, Republic of Korea.
出版信息
Medicine (Baltimore). 2022 Jul 8;101(27):e29864. doi: 10.1097/MD.0000000000029864.
INTRODUCTION
Peripheral facial palsy (PFP) results in weakness or paralysis of the affected side of the face. In Korea, there is a high demand for Korean medicine treatment for PFP. The clinical practice guidelines (CPGs) of Korean medicine for facial palsy were developed; however, there remains insufficient evidence to support the effectiveness and safety of Korean medicine treatment. Thus, this study aimed to evaluate the effectiveness and safety of Korean medicine treatment based on the CPGs in patients with acute PFP.
METHODS
This is a multicenter, prospective, observational study. The participants will be recruited from one Korean medicine hospital and eight Korean medicine clinics. The participants will receive Korean medicine treatments based on the CPGs, fill in survey questionnaires, and undergo electrophysiologic testing. The changes in House-Brackmann (H-B) grade, movement of the lip and eye, symptoms related to or accompanied by facial palsy, Facial Disability Index, EuroQol 5-dimension 5-level (EQ-5D-5L), and EuroQol Visual Analogue Scale (EQ-VAS), and the results of electromyography (EMG), electroneurography (ENoG), and Blink Reflex test will be analyzed. For the safety analysis, adverse events will be recorded, and for the feasibility analysis, the results of the Was It Worth It questionnaire will be assessed.
CONCLUSION
We expect to draw real-world clinical data on the effectiveness and safety of Korean medicine treatment based on the CPGs in patients with acute PFP from this study. It would be the basis for complementing and improving the CPGs and provide the basis of clinical and policy decision-making.
TRIAL REGISTRATION
This study was approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital (2021-06-005-001), and registered with the Korean Clinical Trial Registry (CRIS), Republic of Korea (KCT0006562).
简介
周围性面瘫（PFP）导致面部受影响一侧的无力或瘫痪。在韩国，对 PFP 的韩医学治疗需求很高。已经制定了韩医学面瘫的临床实践指南（CPGs）；然而，仍然没有足够的证据支持韩医学治疗的有效性和安全性。因此，本研究旨在根据 CPGs 评估急性 PFP 患者韩医学治疗的有效性和安全性。
方法
这是一项多中心、前瞻性、观察性研究。参与者将从一家韩医院和八家韩医学诊所招募。参与者将根据 CPG 接受韩医学治疗，填写问卷调查表，并进行电生理测试。House-Brackmann（H-B）分级、唇和眼运动的变化、与面瘫相关或伴随的症状、面部残疾指数、EuroQol 5 维度 5 级（EQ-5D-5L）和 EuroQol 视觉模拟量表（EQ-VAS），以及肌电图（EMG）、神经电图（ENoG）和眨眼反射测试的结果将进行分析。对于安全性分析，将记录不良事件，对于可行性分析，将评估“值得一试”问卷的结果。
结论
我们期望从这项研究中得出基于 CPG 的急性 PFP 患者韩医学治疗有效性和安全性的真实临床数据。这将是补充和改进 CPG 的基础，并为临床和决策提供依据。
试验注册
该研究得到了庆熙大学韩医院机构审查委员会的批准（2021-06-005-001），并在韩国临床试验注册处（CRIS，大韩民国）注册（KCT0006562）。
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