發佈日期：2022/05/11
衛生福利部國家中醫藥研究所
有關民眾對臺灣清冠一號（NRICM101）的疑問說明： (FAQs on NRICM101)
一、什麼是《新型冠狀病毒病(COVID-19)中醫臨床分期治療指引》
說明：
《新型冠狀病毒病中醫臨床分期治療指引》(簡稱《臨床指引》)是由衛生福利部國家中醫藥研究所蘇奕彰所長於2020年1月31日研擬完成分期治療草案，並於2020年3月31日定稿供三軍總醫院中醫部、台中榮總傳統醫學科及其他教學醫院進行「中醫會診治療COVID-19患者」之依據。
本指引乃針對西醫隔離病房收治 COVID-19患者，採用「中西合作照護、中醫會診」模式。臨床實務上，醫師穿戴隔離衣及手套無法操作脈診，重症患者進行插管亦無法操作舌診。因此，為控管感染及防疫醫療物資消耗，並加速診療效率，中醫臨床上不對患者進行接觸診察，只要確定西醫臨床分期資訊及臨床醫護紀錄資料，並透過視訊進行確認後即可開立治療處方。此外針對具高風險因子患者（心腦血管疾病、肺病、糖尿病、肥胖等），臨床上為截斷病勢，醫師得超前用藥（使用更嚴重分期用方）。
由於兩個醫學中心依照《臨床指引》治療COVID-19危重症、重症、輕症患者臨床成效顯著，為了預防疫情擴散的需要，衛生福利部中醫藥司於2020年5月6日召開專家會議通過該《臨床指引》做為教學醫院中醫會診治療COVID-19患者之臨床依據；6月1日國家中醫藥所上網公告，以提供全球中醫治療COVID-19患者之參考。
1、What are the Traditional Chinese Medicine Treatment Guidelines for COVID-19 in Traditional Chinese Medicine?
The Traditional Chinese Medicine Treatment Guidelines for COVID-19 (TCMTG) were developed based on research by the National Research Institute of Chinese Medicine (NRICM) led by Director Yi-Chang Su on January 31, 2020 and finalized on March 31, 2020. These guidelines serve as the basis for Chinese medicine treatment for COVID-19 at the Tri-Service General Hospital, Taichung Veterans General Hospital, and other teaching hospitals in Taiwan.
These guidelines are designed for patients in isolation wards, using both Western and traditional Chinese medicine (TCM) approaches. In clinical practice, because physicians wear protective clothing and gloves, they have difficulty performing pulse diagnoses and tongue diagnoses for patients undergoing fluids transfusions or tracheal intubation. TCM physicians are not required to have direct physical contact in order to prevent infection, limit the consumption of medical supplies, and accelerate treatment. After a western medicine physician confirms clinical staging information, a TCM physician can prescribe treatment after assessing the condition through video communications and clinical data. In addition, for patients with high risk factors (cardiovascular diseases, pulmonary diseases, diabetes, obesity, etc.), the TCM physician may prescribe advanced medication (using the prescriptions for the next stage) in order to halt the progression of disease.
Given the significant clinical outcomes seen in COVID-19 patients treated with TCMTG at the two medical centers, the Tri-Service General Hospital and Taichung Veterans General Hospital, the Department of Chinese Medicine and Pharmacy, Ministry of Health and Welfare adopted these guidelines on May 6, 2020 to serve as the basis for Chinese medicine treatment for COVID-19 in medical centers. On June 1, 2020, the NRICM released “Traditional Chinese Medicine Treatment Guidelines for COVID-19” online for global TCM physicians to follow.
二、什麼是「臺灣清冠一號；NRICM101」？
說明：
2020年4月3日三軍總醫院中醫部與感染科合作建立「COVID-19患者中西醫共治模式」，開始為加護病房危重症、重症病患進行診治，因治療成效顯著，隨即擴及輕症患者，隨後台中榮民總醫院、高雄長庚紀念醫院陸續加入中醫會診治療。患者在中藥標準方介入後，發燒症狀緩解，心跳、血壓及生理徵象明顯穩定，平均中位數9天即能獲得三採陰性檢驗結果，且無任何副作用或中西藥交互作用。
因為醫學中心中藥局調製之中藥水煎劑無法因應大量病患，為了能迅速、大量提供品質穩定之標準化治療藥物，國家中醫藥研究所於2020年4月20日選擇《臨床指引》中以「抗病毒」與「免疫調節」藥物組成為主的「輕症方」作為治療患者之核心標準方劑（國家中醫藥研究所命名為「臺灣清冠一號；NRICM101」），並著手探討這個中藥標準複方水煎劑的作用機轉及處方組成化合物，以便作為製劑品質控制之基礎。
經過一系列生物分子及細胞層次的研究，以及P3實驗室直接針對 SARS-CoV-2的細胞感染研究，證實複方臺灣清冠一號具有多靶點的作用機轉，包括：
抑制新冠病毒棘蛋白(Spike Protein)與宿主細胞膜上ACE2的結合，阻止病毒入侵細胞。
抑制3CL蛋白酶的活性，阻斷病毒在細胞內的複製。
抑制肺泡巨噬細胞分泌的細胞激素TNF-α、IL-6，來調控所產生的發炎風暴，減少肺部的破壞及降低肺纖維化的發展。
為了能夠對臺灣社會及國際疫情有所幫助，國家中醫藥研究所已為「臺灣清冠一號」申請相關商標及專利，並採用「非專屬授權」來擴大組成「中醫藥國家隊」，目前已有八家GMP中藥廠取得授權(順天堂藥廠、莊松榮製藥廠、勸奉堂製藥、立康生物、天一藥廠、漢聖製藥、勝昌製藥及華陀扶元堂)，其中四間藥廠製劑產品已經通過衛生福利部外銷專用藥品許可證審查，並進行量產與出口來協助疫情嚴峻之國家（包括歐、美、亞、非洲及澳洲）。
2、What is NRICM101?
The Tri-Service General Hospital’s TCM and Infectious Disease departments collaborated to develop the "Chinese and Western Medicine Co-Treatment Model for COVID-19 Patients" on April 3, 2020, which was initially used to treat critically ill patients in the intensive care unit (ICU). Its use was immediately extended to less severely ill patients due to the treatment’s success. Soon after, the Taichung Veterans General Hospital and Kaohsiung Chang-Geng Memorial Hospital, also adopted the model. COVI
資料來源：衛生福利部國家中醫藥研究所