Explain traditional Chinese medicine to the world in "international language"

The hard process of internationalization of traditional Chinese medicine has good news in the United States At the recent annual meeting of American liver diseases, a Chinese medicine "Fuzheng Huayu tablet" in Shanghai successfully completed the second phase clinical trial in the United States and actively prepared for the third phase clinical trial This not only makes it the first traditional Chinese medicine to appear at the international top academic conference, but also enables it to pass the second phase clinical trial of the US Food and Drug Administration (FDA), which is known as "the most stringent drug regulatory agency in the world", and makes the industry call directly that Fuzheng Huayu tablet is expected to become "the first modern traditional Chinese medicine to enter the mainstream drug market in western developed countries as a drug" Build a bridge between eastern and Western Medicine At the latest annual meeting of American liver disease, Professor Tara Hassani, liver disease center of University of California, San Diego, USA, introduced a Chinese traditional medicine "Fuzheng Huayu tablet", and reported the results of its second phase clinical trial in the United States to the world: it has good safety and tolerance for patients with refractory hepatitis C and liver fibrosis, stability and improvement of liver fibrosis Cheng has a good trend Liver fibrosis is the only way for all kinds of chronic liver diseases to develop into cirrhosis and end-stage liver diseases (including liver cancer) Up to now, there is no effective western medicine against liver fibrosis in the western world "Fuzheng Huayu tablet is the first Chinese traditional medicine in the field of liver disease treatment that has progressed to this research stage in the United States." Hassani is the main leader of clinical research of Fuzheng Huayu tablet in the United States In an interview with the U.S business news agency, the scientist made no secret of his confidence in this traditional Chinese medicine "The current research has convinced us of the previously reported effect of Fuzheng Huayu tablet in preventing liver fibrosis in China The study of Fuzheng Huayu tablet will be a bridge for mutual understanding between Oriental Medicine and Western medicine " The annual meeting of American hepatology is a top academic conference in the field of global Hepatology, attracting thousands of Hepatology experts How to explain to foreigners that the study of Fuzheng Huayu tablet started from the study of prevention and treatment of liver cirrhosis caused by schistosomiasis, which concentrated the efforts of three generations of liver disease experts from Shanghai University of traditional Chinese medicine "Traditional Chinese medicine believes that the key pathogenesis of liver fibrosis is Qi deficiency and blood stasis The prescription of strengthening the vital energy and removing blood stasis is to take Salvia miltiorrhiza, peach kernel and other" promoting blood circulation and removing blood stasis ", Cordyceps sinensis and other" tonifying the middle and benefiting the Qi ", strengthen the body immunity and improve the curative effect." Professor Liu Chenghai, director of Hepatology Research Institute of Shanghai University of traditional Chinese medicine and director of liver cirrhosis Department of Shuguang Hospital, told reporters In China, Fuzheng Huayu tablet is regarded as "star traditional Chinese medicine": it was successfully listed in China in 2002 and produced by Shanghai modern traditional Chinese Medicine Co., Ltd.; it has won 17 patents at home and abroad, and is the first Chinese medicine to win the national highest science and technology award, the second prize of national science and technology progress; it has been used by about 800000 patients in total, with an annual sales volume of nearly 250 million yuan But when it comes to the overseas market, the first problem facing the research team is: how to explain traditional Chinese medicine to foreigners? "Westerners don't know what the substance of" strengthening and removing blood stasis "is first of all? We have to explain that "promoting blood circulation and removing stasis" in traditional Chinese medicine is not the same as "promoting blood circulation" seen by the naked eye in western medicine, which is actually related to the philosophy of traditional Chinese medicine Liu Chenghai is the scientific research leader of Fuzheng Huayu tablet's listing in the United States He began his overseas listing process around 2006 His deepest feeling is that in addition to "good metaphor", he has to "tell evidence" A large number of clinical and basic mechanism researches on Fuzheng Huayu tablet have been carried out before and after its listing in China by combining the production, learning and research forces of Shanghai University of traditional Chinese medicine, East China University of science and technology, Shuguang Hospital, Ruijin Hospital, Zhongshan Hospital, and Shanghai Modern Chinese Medicine Co., Ltd "Hard evidence" will be rewarded when it goes to the United States In 2010, Fuzheng Huayu tablet was approved by the FDA of the United States It was exempted from the first phase of clinical trial and directly entered the second phase of clinical trial During this period, Liu also noticed the change of Western attitude towards traditional Chinese medicine "Our American counterparts tell us that 75% of patients with cirrhosis of hepatitis C have sought botanical therapy due to the lack of effective treatment in hospitals, and this huge market is in urgent need of supervision." In 2004, the US FDA issued the "Clinical Research Guide for application of botanical drugs", which is regarded as "the key document for FDA to enter the clinical trials of botanical drugs, including traditional Chinese medicine, and then enter the market as a drug" In the view of the industry, the opening of the US door by Fuzheng Huayu tablet is closely related to the new trend of the guide When designing the second phase of clinical trial, Fuzheng Huayu tablet encountered new challenges, which was proposed by the Americans to solve the problem of "hepatitis C patients who are unable to carry out or lose the opportunity of antiviral treatment" There are many patients with hepatitis C in the United States, but the FDA has not approved a drug for anti fibrosis Fuzheng Huayu tablet is approved to be listed in China, which is used to treat liver fibrosis caused by hepatitis B Can it be tested when it is first used in patients with refractory hepatitis C in the United States? The whole clinical trial was conducted under the strict supervision of FDA The research was led by Professor Hassani of the University of California, San Diego The units participating in the clinical trial were all famous medical schools or medical centers in the United States 249 patients with refractory hepatitis C fibrosis were enrolled in the trial, and 118 patients were finally enrolled in the group The experimental group was given Fuzheng Huayu tablet (4.8g / day), and the control group was given placebo for 48 weeks, followed up for 12 weeks The results showed that there was no drug-related adverse reactions in the patients Compared with the progress rate of liver fibrosis in the control group, Fuzheng Huayu tablet had a trend of improvement According to this, Fuzheng Huayu tablet passed the second phase clinical trial and entered the third phase clinical trial Once it passes the third phase, as soon as five years, it is expected to become the first modern Chinese medicine to enter the mainstream drug market in western developed countries as a drug Compared with the results, the "international rules" found by Fuzheng Huayu tablet overseas are more enlightening "There is still no example of the biggest difficulty we have so far How far can we go? We can give some hints to the latecomers " Liu Chenghai said At present, in addition to Fuzheng Huayu tablet, there are also compound Danshen dropping pills which have passed the second phase clinical trials in the United States This is also the "most in-depth" two traditional Chinese medicines in the world mainstream medical stage.