中藥抗疫藥方 台灣清冠一號 根據《黃帝內經》等醫典的記載,古時抑制疫病的流行唯有中藥;2020年起新冠疫情全球大爆發,病毒傳播力之強、變異性之快、隱匿性之高,成為全球公衛醫師與傳染病學家的挑戰,中藥在此危機時刻亦扮演了重要的角色。 由台灣研發,治療新冠肺炎的中藥「清冠一號」,是全球率先合法行銷50多個國家的中藥製劑。在全球確診人數仍繼續攀升,並且病毒流感化的情勢下,與西藥相比,清冠一號價格平易,兼具多靶點治療之功效,提供全球抗疫更安心的解方。 A TCM Prescription for Covid Taiwan’s NRICM101 NRICM101 is a traditional Chinese medicine (TCM) developed in Taiwan to treat Covid-19, and is the first TCM formulation to be legally sold in more than 50 nations. Given Covid’s transmissibility, the still growing number of confirmed cases around the world, and the inexpensiveness of NRICM101 relative to Western medicines, the multi-target drug has the potential to be a Covid remedy for the whole planet. 2020年由台灣衛生福利部國家中醫藥研究所(以下簡稱「中醫藥研究所」)提供處方,同步進行基礎研究與技術授權的「清冠一號」,授權八家GMP中藥廠製造上市,卻先在海外聲名遠播,引發搶購熱潮,歐美針灸師、中西醫師與華人社團的群組,熱切地分享療效、哪裡可以買到等訊息。 清冠一號先在海外販售,並且從海外紅回台灣的原因,是因為2020年初台灣防疫做得好,疫情不嚴重,中醫藥研究所所長蘇奕彰在2020年1月底即完成的抗疫藥方,在國內「派不上用場」。 外感時疫,專藥專方 能這麼快寫成「臨床分期治療指引」,是因為蘇奕彰2003年時就有抗SARS的經驗。當時擔任中國醫藥大學中醫學系系主任的他,因為學生在醫院實習時被SARS患者的嘔吐物噴到,遭到院內感染。蘇奕彰說:「其實當時從中央到地方都是一團亂,但因為是自己的學生,又是B型肝炎帶原者,根據國際的統計,死亡率很高。」學生向老師求救,接受治療後,幸運地痊癒。 隨著SARS疫情的平息,當時擬定的「治療指引」並沒有走到授權藥廠商品化的地步。但此次新冠肺炎的肆虐非同小可,中醫藥研究所2020年初,在進行基礎研究同時,也展開技術授權給中藥廠的程序。2020年4月時,三軍總醫院有位重症的染疫患者在情況危急之際,啟動中西醫會診,蘇奕彰與三總中醫部所開的複方作成水煎藥,效果很不錯,接著在感染科醫師與病人的同意下進行中西醫合治,十多個病人順利出院,藉由臨床診治支持清冠一號的療效。 台灣一直到了2021年5月初時,每日本土確診人數升破三位數,清冠一號才由「外服」轉「內用」,由當時外銷的四家藥廠共捐了2,000份(一份十天的療程)給中醫藥研究所與15家醫院與檢疫所運用。 2021年5~8月初,15家救治醫院與中醫藥研究所研究小組成立臨床研究平台,同步會診524位患者,其中加護病房的重症患者超過100人。與沒有使用清冠一號的患者相比,使用清冠一號的輕症患者,轉重症比例下降80%;以清冠一號加減的清冠二號對重症死亡率下降超過50%。 清冠一號的處方基礎,來自具有470年歷史的老方子──荊防敗毒散,並且根據此次病毒的變異性與臨床的表現,進行處方的調整。看病30年的蘇奕彰,經常診治因流感、病毒性感染導致肺炎、腦膜炎的急重症患者,他認為,面對快速傳播、高傳染力的疫情,清冠一號目標就在「救命」,減少重症,並減輕醫院量能,雖然中醫界有人要求應該要辨證論治(個人化醫療),但疫情蔓延的速度這麼快,歷史上處理瘟疫也是以專病專方,讓醫生可以快速去照顧病人。 In 2020, the Ministry of Health and Welfare’s National Research Institute of Chinese Medicine (NRICM) came up with the formulation for NRICM101 and embarked on a program of research while also pursuing licensing of the formula to manufacturers. The institute subsequently authorized eight GMP-certified TCM drug makers to produce and sell the formulation. Overseas markets caught wind of NRICM101 early, triggering a buying frenzy that saw acupuncturists, doctors of Chinese and Western medicine, and Chinese communities in Europe and the US enthusiastically sharing information both on the product’s efficacy and on where to purchase it. The reason for NRICM101’s unusual progress from development in Taiwan, to sales abroad, and then back again to Taiwan was that Taiwan was managing the pandemic quite well in early 2020. NRICM director Su Yi-chang initially decided not to distribute it domestically because, given that we weren’t struggling with Covid when the formulation was finalized in late January 2020, he anticipated little local demand for the product. A broad solution NRICM advanced its research on the formulation in early 2020. In April of that year, Tri-Service General Hospital treated a critically ill Covid patient in its care with a combination of Western and Chinese medicine. When the decoction that Su and the TCM department at the hospital prescribed proved effective, with the consent of patients and of doctors in the infectious disease department and patients, they began to provide complementary TCM treatments to other Covid patients at the hospital. Their efforts resulted in a dozen or so patients being cured and released from the hospital, providing an initial clinical demonstration of the effectiveness of NRICM101. With the emergence of a major outbreak of Covid-19 in Taiwan in 2021, 15 hospitals and a NRICM research group created a platform for clinical trials. These institutions then conducted a study that ran from May to early August of that year and involved 524 patients, including more than 100 who were critically ill. The research found that patients given NRICM101 were 80% less likely to progress to serious illness than patients who did not receive the formulation. It further found that NRICM102, a variation on NRICM101, lowered the mortality rate of critically ill patients by more than 50%. NRICM101 is based on a 470-year-old TCM formulation known as jingfang baidusan, which NRICM adapted to address the variability of Covid-19 and its differences from SARS, as well as the preparation’s clinical performance. While some TCM practitioners argue for individualized treatment of every patient, Su notes that we are in the midst of a pandemic, and that doctors of TCM have long made broad use disease-specific formulations during epidemics as a means of treating people more quickly.
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