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국문

급성기 안면신경마비 환자를 대상으로 한의표준임상진료지침에 따른 치료를 시행하여 효과, 안전성 및 실현가능성을 확인하여 이를 바탕으로 양질의 공익적 임상연구 근거를 창출 및 공공보건 정책 수립 지원을 통한 한의의료서비스 보장성을 강화하고자 함.
안면신경마비의 경우 국내 한의치료에 대한 비중이 높음. 환자들의 한의치료에 대한 수요가 많기 때문에 현 의료체계에 있어서 한의 치료의 효과, 효율성, 형평성 등의 확인이 필요함. 기존 개발된 한의표준임상진료지침을 바탕으로 임상현장자료의 수집을 통해 한의치료에 대한 근거를 지속적으로 수립해야하며 환자 중심의 공적 가치의 생산으로 보장성을 강화할 필요가 있음.
본 연구는 공익적 임상연구로 실제 임상현장에서 이루어지고 있는 한의치료의 효과성과 안전성에 대한 보건의료현장의 근거를 만들어내기 위한 연구임. 해당 치료의 기준이 되는 안면신경마비 한의임상표준진료지침을 근거로 하여 침, 전침 및 한약치료를 포함하여 환자의 증상에 따라 한의사 재량껏 시행하고 경과에 대한 평가를 시행하는 관찰연구임.

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The purpose of the study is to increase the coverage of Korean medical services by providing Korean medicine treatment based on the standard clinical practice guideline to the patients with acute facial palsy and identifying the effectiveness, safety and feasibilty to create a good evidence for public benefit clinical research and support public health policies.
Korean medicine treatment takes a large proportion in facial palsy. Because there is a high demand for Korean medicine treatment, it is necessary to identify the effectiveness, efficiency, and equity of Korean medicine treatment in the current medical system. Based on the previously developed standard clinical practice guidelines, more evidence for Korean medicine treatment should be established through the collection of real-world data and the coverage of Korean medicine treatment should be increased by producing patient-centered public values.
This study is intended to establish a basis for the effectiveness and safety of Korean medicine treatment conducted at the real-world. The patients are treated by Korean medicine doctors based on the standard clinical practice guidelines for facial palsy. Treatments include acupuncture, eletroacupuncture, and herbal medicine, and other treatments which are necessary depending on the individual symptoms. Evaluation on the progression of facial palsy is conducted every week.

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The patients with acute facial palsy which occurred within 7 days, are treated by Korean medicine doctors based on the standard clinical practice guidelines for facial palsy. Treatments include acupuncture, eletroacupuncture, and herbal medicine, and other treatments which are necessary depending on the individual symptoms. Evaluation is conducted every week from the first visit to 6 weeks later. ENoG, blink reflex, needle EMG are conducted within 2-3 weeks from the occurrence.

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Adult outpatients with facial palsy who are over the age of 19

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Among adult outpatients with facial palsy who has visited the research institution for the first time, after receiving consent from the eligible patients who has decided to participate in the study, the patients are registered as study subjects.

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(G51.0) Bell’s palsy
(G51.8) Other disorders of facial nerve
(G51.9) Disorder of facial nerve, unspecified
(B02.2) Zoster with other nervous system involvement

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House-Brackmann grading system, Measurement of eyebrow and lip movement, Pre-occurrence symptoms and accompanying symptoms related to facial palsy

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First visit, 1 week later, 2 weeks later, 3 weeks later, 4 weeks later, 5 weeks later, 6 weeks later

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Facial Disability Index(FDI), EQ-5d-5l, EQ-VAS

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First visit, 6 weeks later

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Was it Worth it (WIWI) questionnaire

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6 weeks later