Journal of Traditional Chinese Medicine
中医杂志(英文版)
ISSN 0255-2922,CN 11-2167/R
《Journal of Traditional Chinese Medicine》网络首发论文
题目： Interpretation of TCM part in Diagnosis and Treatment Protocol for COVID-19
(Trial Version 7)
作者： Ping Song，Linhua Zhao，Xiuyang Li，Jiansen Su，Zhaoyuan Jiang，Bin Song，
Wenke Liu，Shuang Tang，Ye Lei，Qiyou Ding，Ze Yang，Jiaran Lin，Yu Wei，
Xiaolin Tong
网络首发日期： 2020-03-25
引用格式： Ping Song，Linhua Zhao，Xiuyang Li，Jiansen Su，Zhaoyuan Jiang，Bin Song，
Wenke Liu，Shuang Tang，Ye Lei，Qiyou Ding，Ze Yang，Jiaran Lin，Yu Wei，
Xiaolin Tong．Interpretation of TCM part in Diagnosis and Treatment Protocol for
COVID-19 (Trial Version 7) ．Journal of Traditional Chinese Medicine.
http://kns.cnki.net/kcms/detail/11.2167.R.20200325.1623.002.html
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Interpretation of TCM part in Diagnosis
and Treatment Protocol for COVID-19 (Trial
Version 7)
Ping Song1* ，Linhua Zhao2* ， Xiuyang Li2 ， Jiansen Su3 ，Zhaoyuan
Jiang1 ， Bin Song4 ， Wenke Liu2 ， Shuang Tang5 ， Ye Lei6 ， Qiyou
Ding2,5，Ze Yang2,5，Jiaran Lin5，Yu Wei2,5，Xiaolin Tong2
1International Cooperation Division, China Academy of Chinese Medical Sciences, Beijing
100704, China
2Department of Endocrinology, Guang’anmen Hospital, China Academy of Chinese Medical
Sciences, Beijing 100053, China
3Tianjin Tasly Medical&Healthcare Investment Co., LTD4, Tianjin, 300410, China
4The Third Affiliated Hospital of Zunyi Medical University, Zunyi, 563099, China
5Beijing University of Chinese medicine,100029，China
6Department of Endocrinology and Metablism, the Second Affiliated Hospital of Shaanxi
University of Traditional Chinese Medicine, Xianyang, 712000, China
Correspondence should be addressed to Xiaolin Tong; tongxiaolin@vip.163.com
- These two authors contributed equally to this work.
Abstract
The TCM protocol in Diagnosis and Treatment Protocol for COVID-19
(Trial Version 7) is the update based on previous versions. The
formulation of this protocol is under the direct leadership of the National
Administration of Traditional Chinese Medicine, based on the expert
panels’ experience, and supported by evidence from fever clinics, EM
Published online：2020-03-25 16:30:00
URL：http://kns.cnki.net/kcms/detail/11.2167.R.20200325.1623.002.html
Observation Room and inpatients nationwide, especially in Wuhan,
Hubei province, combining with the latest scientific research results and
data. In order to guide and standardize its clinical application, this
interpretation is carried out from overall understanding, revised content
and protocol interpretation, etc., for clinician’s reference.
Keywords COVID-19；TCM；Protocol interpretation.
Traditional Chinese medicine (TCM) has a long history in the treatment
of acute infectious diseases. Since the Western Han Dynasty（more than
2000 years ago），321 large-scale epidemics have occurred in China. It
is the effective prevention and control of Chinese medicine that have
controlled the spread of the epidemics in limited areas and spaces. Back
to 2003, 11 cases of SARS patients cured by pure Chinese herbal
decoction therapy followed up with no sequelae such as osteonecrosis of
the femoral head, which was written into the WHO report. According to
studies, TCM prevents and treats plague mainly by regulating the whole
body, strengthening immunity, killing pathogens, eliminating
pathological products and restoring metabolism balance.
In order to contain Coronavirus Disease 2019 (COVID-19), the Chinese
government and society have taken strong measures, with a
comprehensive participation of TCM. A series of Diagnosis and
Treatment Protocol for COVID-19 were released by National Health
Commission and National Administration of Traditional Chinese
Medicine. The TCM treatment protocol was recommended in the third
Version for the first time[1], adjustment and supplement of disease
staging, prevention, dosage and Chinese patent medicine were added to
the fourth and fifth Version [2-3].In the sixth Version, the disease staging,
syndrome type and medicine recommendation were systematically
revised.
The TCM protocol in Diagnosis and Treatment Protocol for COVID-19
(Trial Version 7) is the update based on previous versions. Under the
direct leadership of the National Administration of Traditional Chinese
Medicine, this version based on the expert panels’ experience, and
supported by evidence from fever clinics, EM Observation Room and
inpatients nationwide, especially in Wuhan, Hubei province, combining
with the latest scientific research results and data. In order to guide and
standardize its clinical application, this interpretation is carried out from
overall understanding, revised content and protocol interpretation, etc.,
for clinician’s reference.
I. Overall analysis of protocol
1.1 The TCM classification of COVID-19 is consistent with modern
medicine.
The TCM treatment divides the disease period into medical observation
and clinical treatment (confirmed cases). During clinical treatment, there
are Mild case, Moderate case, Severe case and Critical case, which is
consistent with modern medicine. In addition, the treatment of recovery is
added for the patients who satisfy the discharge standard but still need
quarantine, health monitoring, and the discharge patients who have ended
quarantine but still have symptoms such as lung function injury,
pulmonary fibrosis and asthenia. Now the updated TCM protocol is
consistent with the classification of modern medicine, with stronger
practicability and operability, which is conducive to the integration of
diagnosis and treatment thinking of TCM and modern medicine.
1.2 Recommend TCM syndrome types and drugs based on expert
clinical experience and evidence
With the accumulation of experience in epidemic prevention and
treatment, the protocol analyzes the TCM diagnosis and treatment
protocols of different provinces and cities in China, selects the treatment
experience and prescriptions of many National TCM masters and doctors,
including Prof. Zhou Zhongying and Prof. Xiong Jibai, systematically
updates the part of TCM syndrome types and drug recommendation.
Lung cleansing & detoxifying decoction is the key recommendation in
clinical treatment period as the general prescription, which is selected
from the “The Research on screening the effective prescription for
COVID-19″ program. In the treatment of severe and critical patients,
there are more detailed treatment methods and drugs combining with the
experience of panels. For example, the protocol added the TCM solution
for the desynchrony between ventilator and patient, targeting to reduce
the fatality rate of severe and critical patients. In addition, in order to
further guide the clinical TCM doctors and improve the operability, all
the recommended dose of TCM prescriptions is indicated in the protocol,
which enables the frontline doctors to fully use the TCM protocol, and
truly achieves the combination of TCM and modern medicine.
1.3 Provide TCM Prevention Protocol for patients in medical
observation period
Initiative quarantine and self-isolation are the effective measures to
contain the spread of epidemic. During medical observation period,
suspected cases or self-isolation patients stay at home, most of them may
have fever or not, and do not have an obvious respiratory symptoms.
Chinese patent medicine are recommended to these patients.
1.4 Provide the recommendation of Chinese patent medicine,
especially the intravenous TCM injection for severe and critical cases
Confronting sharp increasing new patients, single Chinese medicine
prescription astricts the flexible application of TCM clinicians and limits
the clinical choice of modern medicine doctors. Therefore, according to
the pathogenesis of patients in different stages, the recommendation of
Chinese patent medicine is diversified. For example, oral Chinese patent
medicine are recommended to the patients in medical observation period;
TCM injections, such as Xuebijing injection, Reduning injection,
Xingnaojing injection, Shenmai injection, etc, are recommended in the
treatment of severe and critical patients, with specific usage for the
convenience of clinicians.
II Program Interpretation
The TCM protocol in seventh version establishes medical observation
period and clinical treatment period, which corresponds to the treatment
of suspected cases, home isolated patients and confirmed cases
respectively. It recommends TCM prescriptions and Chinese patent
medicines for different syndrome types. The following is a detailed
interpretation of disease patterns and prescriptions based on different
stages and types. (Italics are the original text of Diagnosis and Treatment
Protocol for COVID-19 (Trial Version 7). Underline is not in TCM part.
The normal font is the interpretation.)
The COVID-19 belongs to plague in TCM with the etiology of epidemic
factor exposure. Different regions can refer to the following plans for
syndrome differentiation and treatment, according to the disease, local
climate characteristics and different constitutions. Prescriptions which
exceed maximum dose according to pharmacopoeia should be used under
the guidance of a physician.
“Yi” equals to plague, which is a general term of severe infectious
diseases in TCM. According to the available data, COVID-19 is oral and
nasal afferent with highly contagious. Therefore, it can be classified into
“Yi” from the TCM prospective. After the visit to fever clinics,
emergency patients and inpatients in Wuhan, Prof. Tong Xiaolin,
Academician of Chinese Academy of Sciences, leader of the expert group,
and Prof. Xue Boshou, National TCM Master, claimed that COVID-19
should be named as “Yi of cold-dampness” from the TCM perspective.
“Cold-dampness” is a qualitative analysis of COVID-19 from the
perspective of TCM etiology with the following pieces of evidence.
Firstly, the clinical manifestations of patients often show obvious clinical
characteristics of cold and dampness. Secondly, Wuhan is in cold and
humid climate during the outbreak of COVID-19. Besides, studies found
a suitable mean temperature (5-11 ℃ ) and relative humidity (RH,
47-79%) for the COVID-19 outbreak. The common points for different
infected areas were having similar average temperature, humidity, and
latitude. In addition, the outbreak point is at the lowest annual
temperature cycle. These pieces of evidence suggested that the cold and
damp environment is an important factor to the outbreak of COVID-19.
Although the disease is developed by cold and dampness, the course of
the disease will also change due to the influence of different regional
climates and patient physiques. The following protocol for the treatment
based on syndrome differentiation should be adopted according to the
actual clinical situation.
- During medical observation
This period is mainly aimed at the treatment of suspected cases. The
diagnostic criteria for suspected cases are combined with the following
epidemiological history and clinical manifestations:
Epidemiological history: 1)History of travel to or residence in Wuhan
and its surrounding areas, or in other communities where cases have
been reported, within 14 days prior to the onset of the disease; 2) In
contact with SARS-CoV-2 infected people (with positive results for the
RT-PCR test) within 14 days prior to the onset of the disease; 3)In
contact with patients who have fever or respiratory symptoms from
Wuhan and its surrounding area, or from communities where confirmed
cases have been reported, within 14 days before the onset of the disease;
or 4)Clustered cases (2 or more cases with fever and/or respiratory
symptoms in a small area such families, offices, schools etc. within 2
weeks).
Clinical manifestations: 1) Fever and/or respiratory symptoms; 2)The
aforementioned imaging characteristics of COVID-19(Thoracic imaging:
Multiple small patchy shadows and interstitial changes were present in
the early stage, especially in the extrapulmonary bands. Furthermore, it
develops into multiple ground-glass opacities and infiltrates in both lungs.
In severe case, pulmonary consolidation can occur. But pleural effusion is
rare.); 3) Normal or decreased WBC count, normal or decreased
lymphocyte count in the early stage of onset.
A suspect case has any of the epidemiological history plus any two
clinical manifestations or all three clinical manifestations if there is no
clear epidemiological history.
1.1 Clinical manifestation: fatigue with gastrointestinal discomfort
Recommended Chinese patent medicine: Huoxiang Zhengqi Capsule
(Pill, Liquid, Oral liquid)
1.2 Clinical manifestation: fatigue with fever
Recommended Chinese patent medicines: Jinhua Qinggan Granule,
Lianhua Qingwen Capsule (Granule), Shufeng Jiedu Capsule (Granule)
Interpretation: For suspected cases and home isolated patients
withfatigue and gastrointestinal discomfort, if the patient shows chest
oppression, abdominal distension, nausea, vomiting, diarrhea and other
symptoms, it is recommended to use Huoxiang Zhengqi Capsule (pill,
tincture, oral liquid). Huoxiang Zhengqi Capsule (pill, tincture, oral
liquid) is derived from Huoxiang Zhengqi San. The original formula
comes from “Formulas from the Imperial Pharmacy” (Tai Ping Hui Min
He Ji Ju Fang). Modern pharmacological research shows that the
medicinal effect of this Chinese patent medicine is regulating
gastrointestinal function, enhancing immunity and anti-inflammatory.[4-6]
For suspected cases and home isolated patients with fatigue and fever, it
is recommended to use Jinghua Qinggan Granule, Lianhua Qingwen
Capsule (granule), Shufeng Jiedu Capsule (granule). Jinghua Qinggan
Granule is developed during the outbreak of A/H1N1 Influenza.
Pharmacological and clinical studies have shown that it has antipyretic
and antiviral effects, and has a good effect on influenza of wind-heat
invading the lung.[7-9] COVID-19 patients with slight fever, mild or no
aversion to cold, red and sore throat, nasal congestion, runny nose, thirst
and cough or cough with sputum is recommended to use Jinghua Qinggan
Granule based on their own situation. The formula of Lianhua Qingwen
Capsule (granule) is derived from Ma Xing Shi Gan Decoction and Yin
Qiao San. The medicine has a broad-spectrum antiviral, antipyretic and
anti-inflammatory effect. It is clinically used for a variety of viral
influenza and respiratory infections.[10-13] Clinical studies shows, with
combined application of Lianhua Qingwen Capsule for the treatment of
COVID-19, the effective rate of the main symptoms increased by 17.7%
compared with the control group, and the probability of exacerbation
during treatment reduced by 13.8%.[14] Shufeng Jiedu Capsule (granule)
is derived from Qu Du San, which helps clearing heat, resolving toxin,
soothing the liver and resolving constraint. Pharmacological studies
indicate that it has antiviral, anti-inflammatory, antipyretic and
immunoregulatory effects. It is clinically used for acute upper respiratory
infection with fever, community-acquired pneumonia, etc.[15-18] It is
recommended for COVID-19 patients with fever, aversion to wind, sore
throat, headache, nasal congestion, runny nose with turbid snivel and
cough. - Clinical treatment period (confirmed cases)
Suspect cases with one of the following etiological or serological
evidences: 1) Real-time fluorescent RT-PCR indicates positive for new
coronavirus nucleic acid; 2) Viral gene sequence is highly homologous to
known new coronaviruses. 3) SARS-CoV-2 specific Ig M and IgG are
detectable in serum; SARS-CoV-2 specific IgG is detectable or reaches a
titration of at least 4-fold increase during convalescence compared with
the acute phase. For these patients, a general therapy and classficaiton
therapy are recommended in the new guideline.
2.1 Qingfei Paidu Decoction Scope of Application: in accordance with
the clinical observations of doctors in various locations, it is suitable for
mild, moderate and severe cases, and can be used reasonably with the
consideration of the actual conditions of critically ill patients.
The Basic Formula: Ma Huang (Ephedrae Herba) 9g, Zhi Gan Cao
(Glycyrrhizae Radix) 6g, Xing Ren (Armeniacae Semen) 9g, Sheng Shi
Gao (Gypsum fibrosum) (decocted first) 15-30g, Gui Zhi (Cinnamomi
Ramulus) 9g, Ze Xie (Alismatis Rhizoma) 9g, Zhu Ling (Polyporus) 9g,
Bai Zhu (Atractylodis macrocephalae Rhizoma) 9g, Fu Ling (Poria) 15g,
Chai Hu (Bupleuri Radix) 16g, Huang Qin (Scutellariae Radix) 6g, Jiang
Ban Xia (Pinellinae Rhizoma Praeparatum) 9g, Sheng Jiang (Zingiberis
Rhizoma recens) 9g, Zi Wan (Asteris Radix) 9g, Kuan Dong Hua
(Farfarae Flos) 9g, She Gan (Belamcandae Rhizoma) 9g, Xi Xin (Asari
Radix et Rhizoma) 6g, Shan Yao (Dioscoreae Rhizoma) 12g, Zhi Shi
(Aurantii Fructus immaturus) 6g, Chen Pi (Citri reticulatae Pericarpium)
6g, Huo Xiang (Pogostemonis Herba) 9g.
Administration: traditional Chinese herbal pieces in decoction. One
package per day. Take warm twice (40 minutes after meal in the morning
and evening). One course of treatment is for three packages.
If possible, half bowl of rice soup after taking the decoction is advised.
For the patients with dry tongue due to fluid depletion, one bowl of rice
soup is suggested. (Note: If no fever, the dosage of gypsum should be
reduced. In case with fever or high fever, the amount of gypsum can be
increased. If the symptoms improve but not toally recovered, continue the
second course of treatment. If the patient has a special condition or other
underlying diseases, the formula can be modified according to the actual
situation in the second course. If the symptoms disappear, the drug
should be discontinued.
Reference: The General Office of the National Health Commission of the
people’s Republic of China The Office of the National Administration of
Traditional Chinese Medicine “Notice on Recommending the Use of
Qingfei Paidu Decoction in Pneumonia Treated with Integrated Chinese
and Western Medicine for the COVID-19 Infection” (National
Administration of Traditional Chinese Medicine Office Medical Letter
[2020] No.22)
Interpretation: This prescription is a general prescription for
COVID-19, which effectively relieves the main symptoms of patients on
mild, moderate and severe cases. It is a combination of Maxing Shigan
Decoction, Wuling Powder, Xiaochaihu Decoction, Shegan Mahuang
Decoction, and Sini Powder etc. with some adjustment, which is a
syncretive and innovative use of classical ancient prescriptions. Applied
on more than 1,100 confirmed patients in 10 provinces excluding Hubei,
effective on more than 90% cases, and more than half of the patients had
an effect after first time. A clinical retrospective analysis of 98 cases
showed that the percentage of lymphocytes, aspartate aminotransferase
(AST), alanine aminotransferase (ALT), and D-dimer returned to normal
status after taking Qingfei Paidu Decoction for 3 days (p <0.01), each observed laboratory index has returned to normal in over 70% of patients. After taking Qingfei Paidu Decoction for 6 days, the C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) returned to normal (p <0.01), and each observed laboratory index has returned to normal in over 80% of patients. After taking Qingfei Paidu Decoction for 9 days, each observed laboratory index has returned to normal in over 90% of patients. No drug-related adverse reaction were observed during the study. Besides, 79 patients’ computer tomography (CT) images improved after 6 days treatment, and the improvement rate was more than 80%. At present, preliminary findings have been made on the pharmacodynamic material basis that Toll-like receptors and T cell receptors may be the relevant pathways of this prescription gainst COVID-19. Additionally, it also showed that some core compounds of Qingfei Paidu decoction have a certain degree of affinity for the main protease (3C-like protease, 3CLpro) and angiotensin-converting enzyme 2 (ACE2) of SARS-CoV-2 [19]. 2.2Mild Case Mild patients have mild clinical symptoms and no manifestations of pneumonia in medical imaging. Depending on the syndromes, the guideline recommend two treatment regimens: 2.2.1 Cold-damp constraint in the lung pattern Clinical manifestation: fever, fatigue, generalized body aches, cough, expectoration, chest tightness and labored breathing, poor appetite, nausea, vomiting and sticky stool, pale enlarged tongue with tooth marks or light red tongue and coating which is white, thick, curd-like, and greasy or white and greasy, and soggy of slippery pulse. Recommended formula: Sheng Ma Huang (Ephedrae Herba) 6g, Sheng Shi Gao (Gypsum fibrosum) 15g, Xing Ren (Armeniacae Semen) 9g, Qiang Huo (Notopterygii Rhizoma seu Radix) 15g, Ting Li Zi (Lepidii/Descurainiae Semen) 15g, Guan Zhong (Cyrtomii Rhizoma) 9g, Di Long (Pheretima) 15g, Xu Chang Qing (Cynanchi paniculati Radix) 15g, Huo Xiang (Pogostemonis Herba) 15g, Pei Lan (Eupatorii Herba) 9g, Cang Zhu (Atractylodis Rhizoma) 15g, Yun Ling (Poria) 45g, Sheng Bai Zhu (Atractylodis macrocephalae Rhizoma) 30g, Jiao San Xian (Jiao Shan Zha (Crataegi Fructus), Jiao Shen Qu (Massa medicate fermentata), and Jiao Mai Ya (Hordei Fructus germinatus)) 9g each, Hou Po (Magnoliae officinalis Cortex) 15g, Jiao Bing Lang (Arecae Semen) 9g, Wei Cao Guo (Tsaoko Fructus) 9g, Sheng Jiang (Zingiberis Rhizoma recens) 15g.. Administration: one package daily, 600ml after decocting, divide into three times, equally in the morning, afternoon and evening, take before meal. Scope of application: It is suitable for patients with mild clinical symptoms such as fever, fatigue, generalized body aches, cough, poor appetite, and sticky stool. Interpretation: This prescription, also known as the Wuhan Anti-epidemic Formula, was developed by Academician Tong Xiaolin. It has applied to more than 50,000 patients, the vast majority of them are suspected patients and the confirmed patients with mild and ordinary symptoms. Preliminary results showed that it had a good effect on fever, cough, fatigue and muscle aches. The prescription is a combination of Maxing Shigan Decoction, Tingli Dazao Xiefei Decoction, Huopo Xialing Decoction, Shenzhu Powder, and Da Yuan Decoction, etc., has the functions of dispersing cold and dehumidifying, ventilating the lung to regulate the surface, invigorating spleen and replenishing qi, eliminating pathogenic factor from Moyuan, dispelling filth with aroma, activating blood to dredge collaterals. Studies have shown that Maxing Shigan decoction has the effect of anti-virus[20], inhibiting airway inflammation[21] and reducing colonic mucosal inflammation[22]. Huopo Xialing Decoction regulate gastrointestinal function and improve gastric mucosal defense[23]. Modified Shenzhu Powder can down-regulate the secretion levels of NLRP3 inflammatory corpuscles and its downstream factors IL-1β and IL-18, which probably have immune-protective effect on mice infected with influenza virus FM1[24]. The expression of NF-κB in bronchial mucosal epithelium and lung tissues of rats with acute lung injury was attenuated by Dayuan Decoction[25], and at the same time the pulmonary edema of lipopolysaccharide-induced acute lung injury was alleviated[26]. 2.2.2 Damp-heat accumulation in the lung patternClinical manifestation: low-grade fever or absence of fever, slight aversion to cold, fatigue, heavy sensation in the head and body, muscle soreness, dry cough with little sputum, sore throat, thirst without desire to drink, or accompanied with chest tightness and epigastric fullness, absence of sweating or disturbed hidrosis, or vomiting with anorexia, loose stool or sticky stool. The tongue is light red and coating is white, thick and greasy or thin and yellow. The pulse is slippery and rapid or soggy. Recommended formula: Bing Lang (Arecae Semen) 10g, Cao Guo (Tsaoko Fructus) 10g, Hou Po (Magnoliae officinalis Cortex) 10g, Zhi Mu (Anemarrhenae Rhizoma) 10g, Huang Qin (Scutellariae Radix) 10g, Chai Hu (Bupleuri Radix) 10g, Chi Shao (Paeoniae Radix rubra) 10g, Lian Qiao (Forsythiae Fructus) 15g, Qing Hao (Artemisiae annuae Herba) (added later) 10g, Cang Zhu (Atractylodis Rhizoma) 10g, Da Qjng Ye (Isatidis Folium) 10g, Sheng Gan Cao (Glycyrrhizae Radix) 5g.Administration: one pack daily, 400ml after decocting, divide into twice, and half in the morning and half in the evening. Scope of application: It is suitable for patients with mild clinical symptoms such as low-grade fever or not, fatigue, heavy sensation in head and body, dry cough with little sputum, sore throat, bad appetite, nausea, and sticky stool. Interpretation: The prescription made some adjustment of Dayuan Decoction, Xiaochaihu Decoction, and Haoqin Qingdan Decoction, etc., which has the effects of clearing heat and dampness, reconciling Shaoyang, eliminating pathogenic factor from Moyuan, dispelling filth and resolving turbidity, cooling blood and detoxifying. Studies have shown that Xiaochaihu Decoction has a certain protective effect on gastrointestinal mucosa[27,28] and a variety of its extracts have different degrees of antibacterial effect[29]. Haoqin Qingdan Decoction inhibits influenza virus proliferation by down-regulating the expression of influenza virus genes[30], while reducing immune damage caused by inflammatory factors, protecting lung tissue[31]. Besides, it also improves gastric mucosal inflammation and protect gastric mucosa of mice infected with H.pylori by down-regulating NF-KBP65[32], COX-2, TNF-α[33], adjusting the imbalance of Th1 / Th2 [34]. 2.3 Moderate case Moderate patients have symptoms such as fever and respiratory symptoms, the image demonstrates the appearance of pneumonia. Depending on the syndromes, the guideline recommend two treatment regimens: 2.3.1 Dampness and stagnation lung syndrome Clinical manifestations: fever, cough with little sputum or yellow sputum, chest tightness and shortness of breath, abdominal distension , and constipation with difficult defecation. The tongue body is dark-red, and tongue shape is enlarged. The cotaing is yellow greasy or yellow dry. The pulse is slippery and rapid or wiry and slippery. Recommended prescription: Sheng Ma Huang (Ephedrae Herba) 6g, Ku Xing Ren (Armeniacae Semen) 15g, Sheng Shi Gao (Gypsum fibrosum) 30g, Sheng Yi Yi Ren (Coicis Semen) 30g, Mao Cang Zhu (Atractylodis Rhizoma) 10g, Guang Huo Xiang (Pogostemonis Herba) 15g, Qing Hao Cao (Artemisiae annuae Herba) 12g, Hu Zhang (Polygoni cuspidati Rhizoma) 20g, Ma Bian Cao (Verbenae Herba) 30g, Gan Lu Gen (Phragmitis Rhizoma) 30g, Ting Li Zi (Lepidii/Descurainiae Semen) 15g, Hua Ju Hong (Citri grandis Exocarpium rubrum) 15g, Sheng Gan Cao (Glycyrrhizae Radix) 10g. Administration: one package daily, 400ml after decocting, and equally divide into twice, in the morning and evening. Scope of application: It is suitable for patients characterized by fever, cough with yellow sputum, chest distress, flatulence and constipation. Interpretation: This prescription is adjusted from Maxingshigan Decoction, Maxingyigan Decoction, Tinglidazaoxiefei Decoction and Shenshu Powder, etc., and has the functions of ventilating lung and removing dampness, clearing heat, relieving cough and asthma, and detoxification. The mechanism of action may be related to anti-inflammatory, antiviral, immune regulation[39] and protection of respiratory and gastrointestinal mucosa. 2.3.2 Cold-dampness Obstructing lung syndrome Clinical manifestations: low-grade fever, unsurfaced fever or no fever, dry cough with little sputum, lassitude and fatigue, chest tightness, stomach discomfort, or nausea, and loose stool. The tongue is pale or light red and coating is white or white greasy. The pulse is soggy. Recommended prescription:Cang Zhu (Atractylodis Rhizoma) 15g, Chen Pi (Citri reticulatae Pericarpium) 10g, Hou Po (Magnoliae officinalis Cortex) 10g, Huo Xiang (Pogostemonis Herba) 10g, Cao Guo (Tsaoko Fructus) 6g, ShengMa Huang (Ephedrae Herba) 6g, Qiang Huo (Notopterygii Rhizoma seu Radix) 10g, Sheng Jiang (Zingiberis Rhizoma recens) 10g, Bing Lang (Arecae Semen) 10g. Administration: one package daily, 400ml after decocting, and equally divide into twice, in the morning and evening. Scope of application: It is suitable for patients characterized by low fever or not, cough with less sputum, chest distress, flatulence and loose stool (mushy and sticky). Interpretation: This prescription is made of adjusted Shenzhu Powder, Dayuan Decoction and Pingwei Powder, etc., and has the functions of ventilating lung and relieving, dispersing cold and dehumidifying, regulating stomach and detoxification. Pingwei Powder promote the repair of intestinal barrier injury and has a benign effect on intestinal mucosal barrier[40]; regulate the expression of aquaporin (such as AQP2,AQP9) in gastric mucosal layer, so as to protect gastric mucosal layer[41].The mechanism of this prescription might be related to the reduction of bronchial mucosal damage and the repair of intestinal mucosa. 2.4 Severe Case Adult patients meeting any of the following criteria: 1) Respiratory distress (≧30 breaths/ min); 2) Oxygen saturation≤93% at rest; 3) Arterial partial pressure of oxygen (PaO2)/ fraction of inspired oxygen (FiO2)≤300mmHg (l mmHg=0.133kPa). In high-altitude areas (at an altitude of over 1,000 meters above the sea level), PaO2/ FiO2 shall be corrected by the following formula: PaO2/ FiO2 x[Atmospheric pressure (mmHg)/760]. Patients with chest imaging that shows obvious lesion progression within 24-48 hours >50% shall be managed as severe cases.
Depending on the syndromes, the guideline recommend two treatment
regimens of Common Case:
2.4.1 Epidemic toxin blocking the lung pattern
Clinical manifestations: fever with red face, cough with little yellow and
sticky sputum, or blood-stained sputum, chest tightness and short of
breath, lassitude, dryness, bitterness and stickiness in the mouth, nausea
and loss of appetite, difficult defecation, and scanty dark urine. The
tongue is red with yellow greasy coating. The pulse is slippery and rapid.
Recommended prescription:Huashi Baidu Formula
The basic formula: Sheng Ma Huang (Ephedrae Herba) 6g, Xing Ren
(Armeniacae Semen) 9g, Sheng Shi Gao (Gypsum fibrosum) 15g, Gan
Cao (Glycyrrhizae Radix) 3g, Huo Xiang (Pogostemonis Herba) (added
later) 10g, Hou Po (Magnoliae officinalis Cortex) 10g, Cang Zhu
(Atractylodis Rhizoma) 15g, Cao Guo (Tsaoko Fructus) 10g, Fa Ban Xia
(Pinellinae Rhizoma Praeparatum) 9g, Fu Ling (Poria) 15g, Sheng Da
Huang (Rhei Radix et Rhizoma) (added later) 5g, Sheng Huang Qi
(Astragali Radix) 10g, Ting Li Zi (Lepidii/Descurainiae Semen) 10g, Chi
Shao (Paeoniae Radix rubra) 10g.
Administration: 1-2 packages daily, decoction, 100-200ml each time, 2-4
times per day, oral administration or nasal feeding.
Scope of application: It is suitable for patients characterized by fever,
cough with less sticky yellow sputum or blood-stained sputum + gasping,
fatigue, chest distress, tachypnoea, nausea, bad appetite and constipation.
Interpretation: This prescription is made of adjusted Maxingshigan
Decoction, Huoxiang Zhengqi Powder, Huangqi Chifeng Decoction,
Tinglidazao Xiefei Decoction, etc., and has the functions of clearing lung
and detoxication, relieving cough and asthma，removing dampness for
regulating stomach ， purging fu-organs to eliminate heat, enriching qi
and activating blood circulation. Huoxiang Zhengqi oral liquid effectively
restore the function of intestinal barrier in the rats of dampness
obstructing spleen-stomach syndrome, and may play a role in repairing
the mechanical barrier of intestinal mucosa. The mechanism of this
prescription might be related to the respiratory and gastrointestinal
mucosa[42].
2.4.2 Blazing of both qi and ying pattern
Clinical manifestations: high fever with polydipsia, tachypnoea and
shortness of breath, delirium and unconsciousness, blurred vision or
accompanied with macules and papules, or hematemesis, epistaxis or
convulsion of the four limbs. The tongue is crimson with little or no
coating. The pulse is deep, thready and rapid, or floating, large and
rapid pulse.
Recommended prescription: Sheng Shi Gao (Gypsum fibrosum)
(decocted first) 30-60g, Zhi Mu (Anemarrhenae Rhizoma) 30g, Sheng Di
(Rehmanniae Radix) 30-60g, Shui Niu Jiao (Bubali Cornu) (decocted
first) 30g, Chi Shao (Paeoniae Radix rubra) 30g, Xuan Shen
(Scrophulariae Radix) 30g, Lian Qiao (Forsythiae Fructus) 15g, Dan Pi
(Moutan Cortex) 15g, Huang Lian (Coptidis Rhizoma) 6g, Zhu Ye
(Phyllostachys nigrae Folium) 12g, Ting Li Zi (Lepidii/Descurainiae
Semen) 15g, Sheng Gan Cao (Glycyrrhizae Radix) 6g.
Administration: one pack daily, decoction, Shi Gao and Shui Niu Jiao
should be decocted first, 100-200 ml each time, 2-4 times per day, oral
administration or nasal feeding.
Scope of application: It is suitable for severe patients characterized by
high fever, gasping, fatigue, chest distress, shortness of breath,
obnubilation and hemorrhage symptoms, such as purpura, nosebleed or
spitting blood.
Interpretation: This prescription is adjusted from Qingwen Baidu
Decoction, which has the functions of eliminating heat and detoxicating,
cooling blood and hemostasis, purging lung, relieving asthma and
inducing resuscitation. Qingwen Baidu Decoction reduces systemic
inflammatory response in sepsis rabbits through the TLR4/NF-κB
signaling pathway[39];at the same time, it down-regulate IL-1β in the
spleen tissue of sepsis rats, so as to protect the spleen function of sepsis
rats[40];it also has potential active ingredients for interfering with cytokine
storms[41].
Recommended Chinese patent medicines: Xiyanping injection, Xuebijing
injection, Reduning injection, Tanreqing injection, and Xingnaojing
injection. Drugs with similar effects can be selected according to
individual conditions, or can be used in combination according to
clinical symptoms. Traditional Chinese medicine injection can be used
together with TCM decoction.
Severe case may develop polypnea, low blood oxygen saturation, obvious
progress of pulmonary imaging lesions and other clinical manifestations.
In this stage, except different treatments based on syndrome
differentiation of TCM, the guideline also recommends the following
TCM injections (Xiyanping injection, Xuebijing injection, Reduning
injection, Tanreqing injection, Xingnaojing injection), using one or two
of them, or combining with TCM decoction, for treatment and slow down
the disease development, prevent complications.
The main component of Xiyanping injection is the water
soluble andrographolidume sulfonated production, which could
eliminating heat and detoxicating, relieving cough and diarrhea.
Pharmacological studies indicate that it has certain effect on antiviral,
improve immunity, anti-inflammatory and antibacterial, etc., can be used
for the treatment of acute respiratory infection and other
diseases.[42]Xuebijing injection is derived from Xuefu Zhuyu Decoction,
which includes Danggui (Radix Angelicae Sinensis), Honghua
(Safflower), Chishao (Radix Paeoniae Rubra), Chuanxiong (Sichuan
Lovage Rhizome), Danshen ( The Root of Red-rooted Salvia), etc., has
the functions of promoting blood circulation and removing blood stasis,
eliminating heat and detoxification. It is often used as an adjuvant therapy
in the treatment of severe pneumonia.[43,44] Reduining injection is made of
Qinghao (Herba Artemisiae Annuae) , Jinyinhua (Flos Lonicerae), Zhizi
(Fructus Gardeniae),and has the functions of eliminating heat,
detoxicating, cooling bloodand dispelling wind. Pharmacological studies
indicate that the injection has antiviral and anti-inflammatory effects, can
be used to treat severe cases such as acute upper respiratory infection and
viral pneumonia.[45] Tanreqing injection is composed of Huangqin (Radix
Scutellariae), Bear Gall Powder, Cornu Gorais, Jinyinhua (Flos
Lonicerae), Lianqiao (Fructus Forsythiae), has the functions of
eliminating heat, resolving phlegm and detoxicating. It has a definite
effect on severe patients with acute viral pneumonia, COPD associated
with respiratory failure.[46] Studies indicate that the combination of
QingwenBaidu Decoction and Tanreqing injection significantly reduce
the inflammatory response of A/H1N1 viral pneumonia patients and
alleviate their symptoms, which may related to the prevention and
treatment of cytokine inflammatory storm[47]. Xingnaojing injection is
composed of Shexiang (Musk), Yujin (Radix Curcumae),
Zhizi(Gardenia), Bingpian (Borneol), and has the functions of eliminating
heat, detoxicating, cooling and activating blood, and refreshing mind. It
can be used for the continuous high fever and multiple organ functional
failure caused by sepsis[48].
2.5 Critical case (Internal blockage and external desertion pattern)
Cases meeting any of the following criteria: 1) Respiratory failure and
requiring mechanical ventilation; 2) Shock; 3) With other organ failure
that requires ICU care.
Clinical manifestation: dyspnea, panting on exertion or mechanical
ventilation required, accompanied with unconsciousness and dysphoria,
sweating, cold extremities.The tongue is dark and purple with thick
greasy or dry coating. The pulse is floating and large without root.
Recommended formula: Take Su He Xiang Wan or Angong Niuhuang
Wan with the following decoction composed of Ren Shen (Ginseng
Radix) 15g, Hei Shun Pian(Aconiti Radix lateralis praeparata)(decocted
first) 10g, Shan Zhu Yu ( Corni Fructus) 15g.
If there is mechanical ventilation with abdominal distension, constipation
or difficult defecation, 5-10g of Sheng Da Huang(Rhei Radix et Rhizoma)
can be considered.If patient–ventilator asynchrony occurs, 5-10g of
Sheng Da Huang and 5-10g of Mang Xiao (Natrii Sulfas)can be used
together with sedationand muscle relaxants.
Scope of application: It is suitable for critical patients characterized by
breathing difficulty, asthma or ventilator needing + coma, irritable,
sweaty and cold limbs.
Interpretation: This prescription is adjusted from Shenfu Decoction and
LaiFu Decoction, has functions of reinforce vital energy, restoring Yang
to rescue collapse. According to hot or cold nature of disearse, take
Suhexiang Pill to warm or Angong Niuhuang Pill to cool, to break open
the epidemic toxin blockage of lung Qi. Shenfu Decoction prolonging the
hypoxia tolerance of animal, protecting myocardium protection,
promoting coronary blood flow, immunoregulation, improving
hemorheology and stimulating pituitary-adrenocortical function, and also
has the function of anti-arrhythmia, anti-shock, anti-lipid peroxidation,
etc[49].
Patients need mechanical ventilator may have symptoms such as
abdominal distension, inhibited defecation, even patient-ventilator
desynchrony, due to the effect of organ functional failure or the
utilization of sedative and muscle relaxant, use Dahuang (Rheum
officinale) and Mangxiao (Mirabilite) immediately to expel harmful
metabolites and toxins, maintain internal environment stability, and also
helpful for ventilator using[49].
Recommended Chinese patent medicines: Xuebijing injection, Reduning
injection, Tanreqing injection, Xingnaojing injection, Shenfu injection,
Shengmai injection, Shenmai injection. Drugs with similar effects can be
selected according to individual conditions, or can be used in
combination according to clinical symptoms. Traditional Chinese
medicine injection can be used together with TCM decoction.
Note: Recommended usage of TCM injections for severe and critical
cases.
The use of TCM injections follows the principle of starting from a small
dose and modifying based on pattern indentification in the instructions.
The recommended usage is as follows:
Viral infection or combined mild bacterial infection: 0.9% sodium
chloride injection 250ml with Xiyanping injection 100mg
(bid), or 0.9% sodium chloride injection 250mlwith Reduning injection
20ml, or 0.9% sodium chloride injection with Tanreqing injection 40ml
(bid).
High fever with disturbance of consciousness:0.9% sodium chloride
injection 250ml with Xingnaojing injection 20ml (bid).
Systemic inflammatory response syndrome (SIRS) or/and multiple organ
failure (MOF): 0.9% sodium chloride injection 250mlwith Xuebijing
injection 100ml (bid).
Immunosuppression: glucose injection 250ml with Shenmai injection
100ml or Shengmai injection 20-60ml (bid).
Critical patients may have respiratory failure, shock, or combine with
other organ failure because of the severe lung infection and
complications. Except the first-aid decoction and oral Chinese patent
medicine, it can also choose one or two kinds of intravenous injection of
Chinese medicine recommended according to individual situation. The
protocol recommends Xuebijing injection, Reduning injections ，
Tanreqing injection, Xingnaojing injection, Shenfu Injection, Shengmai
injection and Shenmai injection. Apart from the four Chinese medicine
injection for severe cases, Shenfu injection is originated from Shenfu
Decoction; its main components are Hongshen (red ginseng) and
Fuzi(radix aconiti carmichaeli ) extractions ， which rescuing from
collapse by restoring Yang, tonifying Qi and preventing exhaustion. It
also has pharmacological actions of anti-shock, improve hemorheology,
regulate immune function and improve cardiac function etc[50]. Shengmai
injection is designed based on the Shengmai Powder which contain the
extracts from Hongshen Red Ginseng, Maidong(ophiopogonis) , and
Wuweizi (schisandra). It can tonifying Qi and Yin, restoring the pulse for
relieving desertion, and has remarkable clinical effects on cardiovascular
system, immune system and hemorheology[51]. Shenmai injection is made
from Hongshen(Red Ginseng), Maidong(ophiopogonis), which tonifying
Qi, preventing exhaustion, nourishing Yin and generating body fluid.
Pharmacological studies indicate that it has anti-inflammatory,
anti-ischemia-reperfusion injury, anti-shock and enhance immune
function[52].
Attention: Application of the injection of Chinese medicine for severe
and critical cases must follows the principle of starting from a small dose
and gradually adjusting the dosage according to the drug instructions.
2.6 Convalescence
This protocol mainly aims at patients who already satisfy the discharge
standards need quarantine and health monitoring, and the patient ended
quarantine but still have sequelae such as pulmonary function injury,
pulmonary fibrosis or uncomfortable symptoms like fatigue. Two types of
clinical syndrome involved:
2.6.1 Lung and spleen qi deficiency pattern
Clinical manifestation: shortness of breath, lassitude and fatigue, poor
appetite with nausea and vomiting, abdominal fullness, a sense of
incomplete evacuation, and sticky loose stool. The tongue is pale and
enlatged with white and greasy coating.
Recommended formula: Fa Ban Xia ( Pinellinae Rhizoma Praeparatum)
9 g, Chen Pi (Citri reticulatae Pericarpium) 10 g ， Dang Shen
(Codonopsis Radix) 15 g, Zhi Huang Qi(Astragali Radix) 30 g, Chao Bai
Zhu (Atractylodis macrocephalae Rhizoma) 10 g, Fu Ling (Poria) 15 g,
Huo Xiang (Pogostemonis Herba) 10 g, Sha Ren(AmomiFructus)(added
later)6g, Gan Cao(Glycyrrhizae Radix) 6g.
Administration: one package daily, 400ml after decoctiong, and equally
divide into twice in the morning and evening.
Scope of application: It is suitable for convalescent patient with panting,
fatigue and bad appetite, nausea, fullness of abdomen, poor bowel
movement with loose stool.
Interpretation: This prescription is modified from Liujunzi Decoction,
reinforces spleen and strengthen Qi, expels phlegm, eliminates dampness
and turbid pathogen. It improves symptoms of patients with COPD in the
stable stage. It also improves the life quality, regulate the expression of
inflammatory cytokines. Helping patients with the recovery from poor
digestion function and fatigue. It might have a certain effect on the
prevention of disease reoccurrence [53].
2.6.2 Deficiency of both qi and yin pattern
Clinical manifestation: Fatigue, shortness of breath, dry mouth, thirst,
heart palpitations, profuse sweating, poor appetite, low-grade fever or no
fever, dry cough with little sputum. The tongue is dry with scanty fluid.
The pulse is thread or weak and forceless.
Recommended formula: Nan Sha Shen ( Adenophorae Radix) 10 g, Bei
Sha Shen（Glehniae Radix） 10 g, Mai Dong (Ophiopogonis Radix) 15
g, Xi Yang Shen (Panacis quinquefolii Radix) 6 g, Wu Wei Zi
(Schisandrae Fructus) 6 g,Shen Shi Gao (Gypsum fibrosum) 15 g, Dan
Zhu Ye (Lophatheri Herba) 10 g, SangYe (Mori Folium) 10 g, Lu Gen
(Phragmitis Rhizoma) 15 g, Dan Shen (Salviae miltiorrhizae Radix) 15
g,Shen Gan Cao (Glycyrrhizae Radix) 6 g.
Administration: one package daily, 400ml after decocting, and equally
divide into twice in the morning and evening.
Clinical indication: Individual under recovery but still present mild
symptoms of: fatigue, coughing without phlegm and dry mouth, bad
appetite, palpitation and sweaty.
Interpretation: This prescription is constructed from the combination of
Shashen Maidong Decoction, Shengmai Decoction and Zhuye Shigao
Decoction. Featured by the actions of benefiting Qi, nourishing Yin,
eliminating heat, moistening dryness, activating blood circulation to
dissipate blood stasis. Shashen Maidong Decoction improves the
symptom including cough variant asthma and chronic bronchitis which
might be related to its action on the IL-6 and SIgA regulation and the
improvement on the damage of oxygen radical[54,55]. For Shengmai
Decoction, it has an anti-effect on the pulmonary fibrosis and injury of
vascular endothelial cell [56].
Prevention of disease relapse is one of the major concerns and advantage
of TCM. In order to prevent reoccurrence of discharge patients, the
problem of pulmonary fibrosis and impaired lung function of severe
cases, apart from the above recommendations, a Suggestive Guidance
based on Chinese medicine for rehabilitation of COVID-19 was issued by
the National Health Commission of the People’s Republic of China and
National Administration of Traditional Chinese Medicine on February 22, - This is a medical approach specifically designed for discharge
patients for the very first time on a national standard. As an instruction
for both clinician and patients, it has recommended a comprehensive
strategy on the interventions which has focused on the Chinese medicine,
conventional non-pharmaceutical therapy, psychology, diet management
and physical exercise. - Epilogue
China is now facing the critical stage of confronting the COVID-19. The
number of newly confirmed and suspected cases are showing a tendency
of continuously declining. Unfortunately, COVID-19 cases are rising
globally. On March 11th, the outbreak of COVID-19 has been confirmed
a “pandemic” by Dr. Tedros Adlhanom Ghebreyesus, Director General of
WHO ， on the press conference in WHO headquarter, Geneva. The
number of cases outside China has increased 13 times， and numbers of
outbreak countries is tripled in the past two weeks. It is reported that, by
21:00 on March 12, 2020, a total of 129,146 cases has been confirmed
worldwide; 68,673 cases cured, 4,727 of death; and still 55,746 cases
under treatment.
Duiring the epidemic prevention and control in China, TCM plays an
important role with early intervention, fully participation and
comprehensively contribution. The continuously updating protocol of
clinical guideline thanks to the support of research data and the
experiences of clinical practice from the frontline. Under this
circumstance, Chinese medicine offering a complement for the
therapeutic approach of mild cases in the lack of specific medicine at the
early stage, helping with the immunity adjustment and decreasing the
transmission to sever cases. The combined approach of TCM and modern
medicine for severe cases, not only reliefing the disease symptoms, but
also effectively lowering the fatality rate and stopping disease from
developing [57]. The latest version of TCM clinical protocol for
COVID-19 provides a practical and effective approach, hopefully it could
be a reference for the international societies.
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Conflicts of Interest
The authors declared that they have no conflicts of interest.
Authors’ Contributions
Dr. Ping Song and Linhua Zhao contributed equally to this work.
Acknowledgments
This work was financially supported by the National Key Research and
Development Project “Public security risk prevention and control and
emergency technical equipment” special item “Clinical evaluation of
traditional Chinese medicine intervention in convalescence of
COVID-19” (No. 2020YFC0845000).