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Lianhua Qingwen won a good reputation in three epidemics

Lianhua Qingwen is provided with the famous prescription and herbs for treating "epidemic diseases" in the past dynasties

Lianhua Qingwen is a compound traditional Chinese medicine developed by exploring exogenous febrile diseases, their spread and progression laws, and their treatment based on the TCM collateral disease theory, putting forward the therapeutic strategies of "active intervention", and then formulating the therapeutic method of "clearing pestilence and detoxicating, and ventilating lung and purging heat". Its prescription incorporates the essence of medications for the treatment of epidemic diseases by famous doctors in the past dynasties, mainly from Maxing Shigan Decoction described in the Shang Han Lun (Treatise on Cold-induced Disease) by Zhang Zhongjing, a famous doctor in the Han Dynasty, Yingqiao Powder variation described in the Wen Bing Tiao Bian (Detailed Analysis of Epidemic Warm Diseases) by Wu Jutong, a well-known doctor in the Qing Dynasty, and the Dahuang experience described in the Wen Yi Lun (Treatise on Pestilence) by Wu Youke, a noted doctor in the Ming Dynasty. Maxing Shigan Decoction is used for relieving cough & panting and Yingqiao Powder for clearing pestilence & removing toxic substances, and also releasing exterior syndrome and ventilating lung, both of which are indicated for fever, cough, dyspnea, and shortness of breath. Modern pharmacological studies have reported that both prescriptions have good effects of subsiding fever, relieving cough, anti-inflammation and anti-virus. The release of exterior syndrome and ventilation of lung can solve the problems of continuous high body temperature in COVID-19 patients; clearing of lung and relief of cough and panting can solve the problems of continuous cough and dyspnea in COVID-19 patients; anti-inflammatory and antiviral effect can inhibit the replication of Novel Coronavirus and also the systemic inflammatory response caused by virus infection. From the point of view of traditional Chinese medicine, the whole prescription allows for "treating defensive qi, relieving exterior and interior syndrome, medicating before syndromes, block disease tendency, and conducting systemic regulation and multi-target treatment".

Besides Maxing Shigan Decoction and Yinqiao Powder, the prescription of Lianhua Qingwen also has another three medication characteristics. First, Dahuang (Rhubarb) is used to relax fu-organs and purge lung so as to eliminate "epidemic toxin" via stool and relieve pathogenic factors since lung is interior-exteriorly related to large intestine. Moreover, Dahuang is to be administered before syndromes to block the disease tendency. Wu Youke pointed out that plague should be treated when healthy qi is not declining in human body, and the early treatment and elimination of pathogenic factors and the early use of Dahuang can block the diseases from progressing to the critical condition. In the epidemic in 2020, some patients with COVID-19 had thin sloppy stool, which was caused by the accumulation of pestilence and filth in the intestines and could not prevent Dahuang from clearing pestilence out. This is also a common method of TCM. Modern pharmacodynamical research has demonstrated that Dahuang can inhibit pulmonary inflammation and improve pulmonary function.

Second, Huoxiang (Wrinkled Gianthyssop Herb) is also a famous medicine for the treatment of epidemic diseases in the past dynasties, which can remove dampness by means of aromatics, avoid filth, and convert turbid substance. During this epidemic, a prominent condition of COVID-19 patients was heavy pathogenic dampness and turbid toxin. These patients had a poor appetite and unsmooth sticky stool. Huoxiang can avoid filth, convert turbid substance, and improve the conditions of poor appetite and dampness obstructing spleen and stomach. Moreover, Huoxiang is also the most important ingredient in Huoxiang Zhengqi Powder.

Third, Hongjingtian (Rhodiola Rosea), growing in cold and high altitude areas, is another key ingredient in Lianhua Qingwen and plays a role in tonifying lung, abating panting and activating blood circulation. It can improve the anti-fatigue and anti-hypoxia abilities of human bodies, so as to cope with the multi-organ damage due to fatigue, shortness of breath and low blood oxygen content, which are commonly seen in COVID-19 patients. Additionally, it can improve the immune functions of patients to correct their decline of disease resistance associated with low lymphocyte and subsets, and also the ability of the human body to recover from diseases.

Third, Hongjingtian (Rhodiola Rosea), growing in cold and high altitude areas, is another key ingredient in Lianhua Qingwen and plays a role in tonifying lung, abating panting and activating blood circulation. It can improve the anti-fatigue and anti-hypoxia abilities of human bodies, so as to cope with the multi-organ damage due to fatigue, shortness of breath and low blood oxygen content, which are commonly seen in COVID-19 patients. Additionally, it can improve the immune functions of patients to correct their decline of disease resistance associated with low lymphocyte and subsets, and also the ability of the human body to recover from diseases.

The research and development of Lianhua Qingwen started from SARS, and the anti-SARS virus effect was included in the package insert.

Lianhua Qingwen was developed as an innovative traditional Chinese medicine for the treatment of influenza during the SARS period in 2003. In the face of the SARS outbreak, the academician and expert team of Yiling Pharmaceutical Research Institute founded a scientific research organization targeting at traditional Chinese medicine against the SARS virus, which was committed to the research and development of Lianhua Qingwen by studying the incidence and progression laws of SARS in the epidemic centers including Guangzhou and other places, discovering the essence of traditional Chinese medicine to cure "epidemic diseases" over the past two thousand years, and formulating the prescription, process, and specifications of Lianhua Qingwen.

At that time, the P3 Laboratory of Chinese Academy of Military Medical Sciences found that Lianhua Qingwen could effectively inhibit SARS virus. Both influenza and SARS belong to the category of exogenous febrile diseases, also known as "plague" in traditional Chinese medicine. Can anti-SARS virus Lianhua Qingwen also control influenza virus? The basic studies achieved a positive conclusion. The Chinese Academy of Chinese Medical Sciences confirmed by experiments that Lianhua Qingwen had an inhibitory effect on influenza virus H3N2, Type I parainfluenza virus, respiratory syncytial virus, adenovirus and so on. Later, with the Guang'anmen Hospital of Chinese Academy of Chinese Medical Sciences as the group leader, Xiyuan Hospital of Chinese Academy of Chinese Medical Sciences, Dongzhimen Hospital of Beijing University of Chinese Medicine, the Second Hospital of Hebei Medical University and other participants carried out a multi-center clinical study on Lianhua Qingwen, and the results showed that Lianhua Qingwen was efficacious in the treatment of influenza. Therefore, Lianhua Qingwen was approved to be on the fast track for drug approval.

In May 2004, after 347 days of intensive research and development, Lianhua Qingwen Capsule passed the New Drug Application by the National Medical Products Administration (NMPA), obtained its new drug certificate and production permit, and became a new one among anti-influenza drugs in China. Also the inhibitory effect on SARS virus was clearly included in the package inser of Lianhua Qingwen Granules.

The research and development of Lianhua Qingwen started from SARS, and the anti-SARS virus effect was included in the package insert.

After Lianhua Qingwen was launched on the market, its in-depth research has not been stopped. The researches, conducted by the National Key Laboratory of Respiratory Diseases in Guangzhou and other scientific research institutes, has confirmed that Lianhua Qingwen has inhibitory effects on Types A/H1N1, H3N2, H5N1, H7N9, H9N2, and Influenza B virus, coronavirus, respiratory syncytial virus, hand-foot-and-mouth disease virus EV71, rhinovirus, herpes virus, Coxac virus, MERS, and etc.

During the pandemic of Type A H1N1 influenza in 2009, Beijing You’an Hospital Affiliated to Capital University of Medical Sciences, jointly with nine hospitals, to treat swine flu patients, carried out the evidence-based medical research on "the treatment of Type A H1N1 influenza with Lianhua Qingwen Capsule", where the patients of the treatment group received Lianhua Qingwen Capsule according to the standard treatment dosage, and while the ones of the control group received Oseltamivir Capsule. The research results were encouraging. First, there was no difference in antiviral effect between Lianhua Qingwen Capsule and Oseltamivir Capsule; second, Lianhua Qingwen Capsule is superior to Oseltamivir in relieving the symptoms of influenza, especially fever, cough, headache, muscular soreness and fatigue.

During the influenza A H1N1 pandemic in 2009, Lianhua Qingwen played an important role in the epidemic prevention and control. According to CCTV news, a total of 60 million boxes of Lianhua Qingwen were used in China during three months. It is because of its major role in this pandemic; Lianhua Qingwen was awarded the 2011 Annual National Second Prize of Scientific and Technological Progress, which is the significant scientific and technological innovation achievement no other drugs achieved.

Since being launched on the market 17 years ago, Lianhua Qingwen has been recommended by the national treatment regimens for more than 20 times and included in the Diagnosis and Treatment Guide for Influenza, Diagnosis and Treatment Scheme for Patients Infected with Type A H1N1 Influenza, Prevention and Treatment Scheme of Traditional Chinese Medicine for Type B Influenza, Diagnosis and Treatment Scheme for Patients Infected with H7N9 Avian Influenza, Diagnosis and Treatment Scheme for Influenza (2019), and Diagnosis and Treatment Scheme for Novel Coronavirus Pneumonia (COVID-19) (Interim Version #7), and the like during all the major public health events such as Type A H1N1, Type B influenza, avian influenza and COVID-19 in China. It has become a representative drug in response to viral infectious public health events in China.

Lianhua Qingwen has played an important role in the treatment of COVID-19 at home and abroad and won a reputation among experts and common citizens.

In the prevention and control of COVID-19, China has adhered to the principle of combining traditional Chinese and western medicine and also Chinese and western drugs, and achieved initial results in the fight against the epidemic. The fourth to seventh versions of the Diagnosis and Treatment Scheme for Novel Coronavirus Pneumonia (COVID-19) issued by the National Health Commission and the National Administration of Traditional Chinese Medicine all recommended Lianhua Qingwen Capsule (Granules), a Chinese patent medicine for the prevention and treatment for patients with fatigue and fever during the medical observation period. Lianhua Qingwen Capsule (Granules) has also been recommended in the prevention and treatment schemes for COVID-19 released successively in more than 20 provinces and cities, including Hubei, Guangzhou, Zhejiang, Shandong and Hebei. The "three medicines and three prescriptions" which are effective traditional Chinese medicines for the treatment of COVID-19 include Lianhua Qingwen Capsule (Granules). Up to now, it has been used by a million of people in Hubei Province and widely used in Leishenshan Hospital, Huoshenshan Hospital and all the mobile cabin hospitals in Wuhan. Lianhua Qingwen Capsule (Granules) has been also deemed as reserved medicine in many provinces and cities such as Hubei Province and Heilongjiang Province, and the Ministry of Industry and Information Technology has taken it as the emergency guarantee medical material in the List of Key Materials for Epidemic Prevention and Control.

In the face of the increasingly serious COVID-19 epidemic in the world, Lianhua Qingwen Capsule, as a representative of modern traditional Chinese medicine, has gradually won unanimous confirmation at home and abroad for its inhibitory and mitigation effects on COVID-19 epidemic. Lianhua Qingwen Capsule was distributed to overseas students as anti-epidemic medicine in the health kits distributed by Chinese embassies and consulates. Recently, Lianhua Qingwen Capsule has been registered at the national level in Thailand, Singapore and other countries, approved to be marketed in Hong Kong, Macao, Brazil, Indonesia, Canada, Mozambique, Romania and other countries, and also the United States has carried out a Phase II clinical study on Lianhua Qingwen Capsule in terms of the treatment of influenza. After the global outbreak of COVID-19, the demand for Lianhua Qingwen Capsule has doubled in the international market, and it has played an important role in the prevention and control of the global epidemic.

The research team led by Academician Zhong Nanshan recently published a paper titled "Lianhua Qingwen has antiviral and anti-inflammatory effects on Novel Coronavirus" in the Pharmacology Research, an international journal, as the first basic research article about an effective Chinese patent medicine against novel coronavirus SARS-Cov-2. The study reported that Lianhua Qingwen could significantly inhibit the replication of novel coronavirus in cells and significantly reduce the expression of viral particles in cells. As an excessive immune response of the body to external stimuli such as viruses and bacteria, inflammatory storm becomes an important node for the progression of COVID-19 from mild type to severe and critical ones. The cells infected by novel coronavirus could remarkably inhibit the overexpression of the inflammatory factors TNF-a, IL-6, MCP-1 and IP-10 genes. This study revealed the pharmacological basis of the exact therapeutic effect of Lianhua Qingwen on COVID-19, confirmed that Lianhua Qingwen can inhibit viral replication and the expression of inflammatory factors in host cells, thus playing the role of preventing COVID-19 activity and providing an experimental basis for the application of Lianhua Qingwen in the treatment of COVID-19. The paper indicated that Lianhua Qingwen has antagonistic effect on a series of influenza viruses as a traditional Chinese medicine prescription.

With Academicians Zhong Nanshan, Li Lanjuan, and Zhang Boli as the consultants, a prospective, multicenter, randomized, and controlled clinical study on the treatment of novel coronavirus pneumonia with traditional Chinese medicine Lianhua Qingwen was conducted jointly in more than 20 hospitals, including the People's Hospital of Wuhan University, Wuhan Jinyintan Hospital, and First Affiliated Hospital of Guangzhou Medical University. The related research results were published in the Phytomedicine, with a higher impact factor in the field of international plant medicine. This is the first large-scale clinical study of Chinese patent medicine involving hospitals participating in the treatment of COVID-19 in China, and also the first prospective, randomized, controlled, multicenter clinical study on traditional Chinese medicine for COVID-19 released in an international journal. The study included 284 eligible COVID-19 patients and its results showed that after 14 days of treatment with Lianhua Qingwen Capsule, the cure rates of main clinical symptoms (fever, fatigue, and cough) in the treatment group reached 57.7% on the 7th day after treatment, 80.3% on the 10th day after treatment, and 91.5% on the 14th day after treatment, significantly higher than those in the control group, respectively. The study results showed that the combined oral administration of Lianhua Qingwen Capsule for 14 days on the basis of conventional treatment can significantly improve the elimination rates of fever, fatigue, cough and other clinical symptoms of COVID-19, remarkably reduce the pulmonary lesions indicated in imaging, shorten the duration of the symptoms, improve the clinical cure rate of COVID-19, and restrict the deterioration of COVID-19 conditions. This indicates that Lianhua Qingwen Capsule can eliminate the clinical symptoms and outcomes in patients with COVID-19.

The publication of the results of this clinical study in an international journal institutes the international recognition and affirmation for the prevention and control of COVID-19 with Chinese traditional medicine, which is of great significance in promoting the internationalization of Chinese traditional medicine.

Because of such confirmed basic experimental and clinical research evidence, the National Medical Products Administration (NMPA) approved the increase of a new indication, the treatment of "mild and common COVID-19", for Lianhua Qingwen Capsule/Granules, on the basis of the originally approved indications on April 12, 2020.

Since its marketing in 2003, Lianhua Qingwen has always played an important role in every epidemic prevention and control. It has been highly praised by clinicians and patients from many hospitals and pharmacies across China, awarded the title of Medicine for Treating Cold Commonly Prepared by Families by the Beijing Evening News for successive 8 years, and become one of the representative medicines in response to public health events associated with viral infection.

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