Novel Coronavirus
Pneumonia Diagnosis and Treatment Plan (Provisional 6th Edition)
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Since December 2019, many cases of novel
coronavirus pneumonia have been found in Wuhan City, Hubei Province, and with
the spread of the epidemic, such cases have also been found in other regions of
China and overseas. As an acute respiratory infectious disease, the
disease has been listed as a Class B infectious disease as provided by the
"Law of the People's Republic of China on Prevention and Control of
Infectious Diseases", and is managed as a Class A infectious disease. With a deepened
understanding of the disease and accumulation of experience in diagnosis and
treatment, we revised "The Diagnosis and Treatment Plan for COVID-19
(Provisional 5th edition)" to make the "The Diagnosis and Treatment
Plan for COVID-19 (Provisional 6th edition)".
I. Epidemiological Characteristics
The Novel Coronavirus belonging to the genus of
betacoronavirus. The enveloped viral particles may appear spherical or oblong,
with a diameter of 60-140nm. The genetic characteristics are distinctively
different from SARS-CoV or MERS-CoV. Current research found
more than 85% homology between the sequences of 2019-nCoV and bat SARS-like
coronavirus (bat-SL-CoVZC4). When cultured in vitro, 2019-nCoV appears
after 96 hours in the inoculated human respiratory epithelial cells and after 6
days in VeroE6 or Huh-7 cell lines.
Most of the knowledge on physicochemical
properties of coronavirus comes from the research on SARS-CoV and MERS-CoV. 2019-nCoV is sensitive
to UV radiation and heat, and can be inactivated by heating (30 minutes at
56-degree celsius), diethyl ether, 75% ethanol, chlorine-containing
disinfectants, peracetic acid, and organic solvents including chloroform.
Chlorhexidine does not effectively inactivate the virus.
II. Epidemiological Characteristics
(1) Source of infection. At present, the
source of infection is mainly patients infected by the novel coronavirus. Those who are
asymptomatic but infected may also become a source of infection.
(2) Route of transmission. The main route
of transmission is respiratory droplets and close contact. There is the possibility
of aerosol transmission when exposed to high concentration aerosol for a long
time in a relatively closed environment.
(3) Susceptible populations.
The population is generally susceptible.
III. Clinical Characteristics
(1) Clinical presentation. Based on the
current epidemiological investigation, the incubation period is 1-14 days, and
most often between 3-7 days.
The primary presentations are fever, dry cough,
and fatigue. A minority of patients have symptoms such as nasal
congestion, nasal discharge, sore throat, muscle pain, and diarrhea. Severe patients often
suffer from dyspnea and/or hypoxemia one week after onset, and severe patients
can rapidly progress to acute respiratory distress syndrome, septic shock,
difficult to correct metabolic acidosis, coagulation dysfunction and multiple
organ failure. It is worth noting that severe and critical patients may
have moderate to low fever or even no obvious fever during the course of the
disease.
Patients with the mild form of the disease
present only as low fever, slight fatigue, and so forth, with no lung inflammation.
Judging from the current cases, most patients
have a good prognosis and a minority are in critical condition. The prognosis of the
elderly and those with chronic underlying diseases is more poor. The
symptoms of child cases are relatively mild.
(2) Laboratory examination.
In the early stage of the disease, the total
number of peripheral blood leukocytes is normal or decreased, and the
lymphocyte count was decreased, and some patients may have increased liver
enzyme, lactate dehydrogenase (LDH), myoenzyme and myoglobin, and some
critically ill patients may have elevated troponin. C-reactive protein (CRP)
and erythrocyte sedimentation rate increased in most patients, and
procalcitonin was normal. In severe cases, D- dimer increased and
peripheral blood lymphocytes progressively decreased. Inflammatory
cytokines often increase in severe and critical patients.
Novel coronavirus nucleic acid can be detected
in nasopharyngeal swabs, sputum and other lower respiratory tract secretions,
blood, feces and other samples.
In order to improve the positive rate of nucleic
acid detection, it is suggested that sputum be collected as much as possible,
collecting secretions from the lower respiratory tract of patients undergoing
tracheal intubation, and sending samples for examination as soon as possible
after collection.
(3) Chest Imaging.
In the early stage, there are multiple small
patches and interstitial changes, most notably in the outer lung. It
further develops into multiple ground-glass opacity and infiltration shadows in
both lungs; and in severe cases, consolidation of the lungs may occur, and
pleural effusion is rare.
IV. Diagnostic Standards
(1) Suspected cases.
Comprehensively analyze combinations of the
following epidemiological history and clinical presentations:
1.
Epidemiological history
(1) Within 14 days prior to onset, had history
of travel or residence in Wuhan or surrounding regions, or other communities
reporting cases;
2. Within 14 days before onset had a history of
contact with those infected by the novel coronavirus (positive nucleic acid
testing);
(3) Within 14 days prior to onset, had contact
with patients who had a fever or respiratory tract symptoms that had come from
Wuhan, its surrounding regions, or other communities reporting cases.
(4) Aggregated onset.
1.
Clinical presentation:
(1) Fever and/or respiratory tract symptoms;
(2) Having the imaging features of novel
coronavirus pneumonia discussed above;
(3) The white blood cell count is normal or
decreased and lymphocyte count was decreased in the early stage of the disease.
Where there are any of the epidemiologic history
items, and any 2 of the clinical presentions are met. Where there is no
clear epidemiological history, and at least 3 of the clinical presentations are
met.
(2) Confirmed cases.
Suspected cases have one of the following
pathological evidence:
1.
Tests positive for
real-time fluorescence RT-PCR detection of novel coronavirus nucleic acid;
2.
The viral gene
sequencing is highly homologous with the known novel coronavirus.
V. Clinical Classification
(1) Mild form.
Clinical symptoms are minor, imaging does not
show signs of lung inflammation.
(2) Ordinary form.
Has fever and respiratory tract symptoms,
imaging shows visible lung inflammation.
(3) Severe form.
Meeting any of the following:
1.
Shortness of breath, RR
above 30 times/min;
2.
In resting state, oxygen
saturation is less than 93%;
3.
Arterial oxygen partial
pressure (Pa)/ oxygen concentration (Fio.) greater than 300mmHg
(ImmHg=0.133kPa).
For high altitude (altitude over 1000 meters),
(Pa0/F10) should be corrected according to the following formula: Pa0/F10 = 2x
[ atmospheric pressure (mmHg)/760]
Where lung imaging shows that the lesion has
progressed significantly more than 50% within 24-48 hours, it should be
re-classified as severe form.
(4) Critical form.
Meeting any of the following criteria:
1.
Respiratory failure
occurs and mechanical ventilation is required;
2.
Shock;
3.
other organ failure
requiring ICU monitoring;
VI. Differential diagnosis
(1) COVID-19 cases with mild presentations need
to be differentiated from other virus-induced upper respiratory tract
infections.
(2) COVID-19 is to be differentiated from
pneumonia caused by known viral agents such as influenza, adenovirus, and
respiratory syncytial virus, as well as mycoplasma pneumonia. Suspected cases
should be tested for common pathogens using methods such as rapid antigen test
and multiplex PCR nucleic acid test as much as possible.
(3) Also consider non-infectious diseases such
as vasculitis, dermatomyositis, and organizing pneumonia.
VII. Discovery and Reporting of Cases
When a suspected case is discovered by medical
workers at various level or type of medical institution, the patient should
receive treatment in isolation immediately. Consultations of specialists or
primary care clinicians should consider differential diagnosis and report the
case online within 2 hours. Samples should be collected for nCoV-19 nucleic
acid testing. The suspected case should then be transferred to designated
hospitals under safe transferring conditions immediately. It's recommended
that patients who tested positive for other respiratory antigens be tested also
for nCoV-19 if they had had close contact with nCoV-19 patients.
VIII. Treatment
(1) Determine the place of treatment based on
the patients' conditions.
1.
Suspected and confirmed
cases should be treated in quarantine, in designated hospitals with effective
isolation and disease control capacity. Suspected cases should be treated in
individual isolation. Confirmed cases can be treated with multiple patients in
the same isolation room.
2.
Critical cases shall be
put in ICU treatment as soon as possible.
(2) Regular treatment.
1.
Treatment for mild cases
includes bed rest, supportive treatments, and maintenance of caloric intake.
Pay attention to fluid and electrolyte balance and maintain homeostasis.
Closely monitor the patient's vitals and oxygen saturation.
2.
As indicated by clinical
presentations, monitor the hematology panel, routine urinalysis, CRP,
biochemistry (liver enzymes, cardiac enzymes, kidney function), coagulation,
arterial blood gas analysis, chest radiography, and so on. Cytokines can be tested
if possible.
3.
Administer effective
oxygenation measures promptly, including nasal catheter, oxygen mask, and high
flow nasal cannula.
4.
Antiviral therapies:
Interferon-alpha (adult: 5 million units or equivalent can be added to 2ml
sterile water for injection and delivered with a nebulizer twice daily),
lopinavir/ritonavir (adult: 200mg/50mg/tablet, 2 tablets twice daily; the
length of treatment should not exceed 10 days), ribavirin (recommended in
combination with interferon or lopinavir/ritonavir, adult: 500mg twice or three
times daily via IV, the length of treatment should not exceed 10 days),
chloroquine phosphate (adult: 500mg twice daily; the length of treatment should
not exceed 10 days), umifenovir (adult: 200mg three times daily; the length of
treatment should not exceed 10 days). Pay attention to the
adverse effects associated with lopinavir/ritonavir, such as diarrhea, nausea,
vomiting and liver dysfunction, as well as interactions with other
medications. The efficacy of the current medications in use will be
evaluated in clinical application. Using 3 or more antiviral drugs is not
recommended. Corresponding medication should be discontinued should intolerable
side effects are present.
5.
Antibiotic therapies:
avoid unjustifiable or inappropriate usage of antibiotics, especially
combinatory use of broad-spectrum antibiotics.
(3) Treatment of severe and critical cases.
1.
Treatment principles: on
the basis of symptom management, proactively prevent and manage complications,
treat underlying diseases, prevent secondary infections, and prompt organ
function support.
2.
Respiratory support:
(1) Oxygen therapy: patients with severe
symptoms should be receiving oxygenation through nasal cannulas or oxygen
masks. Assess the patient timely to determine whether dyspnea and/or hypoxemia
have been alleviated.
(2) High flow nasal cannula or non-invasive
ventilation: when patients with dyspnea and/or hypoxemia do not respond to
regular oxygen therapy, consider using high flow nasal cannula or non-invasive
ventilation. If the symptoms do not improve or worsen within a short
period of time (1-2 hours), tracheal intubation and invasive mechanical
ventilation should be used.
(3) Invasive mechanical ventilation: using
lung-protective ventilation strategy (LPVS), i.e. low tidal volume of 4-8ml/kg
ideal body weight, and low inspiratory pressure (plateau pressure < 30cm
H2O) for mechanical ventilation in order to reduce ventilation-associated lung
injury. Patient-ventilator asynchrony is common. Sedation and muscle
relaxant should be used appropriately.
(4) Salvage therapy: for patients with severe
ARDS, a recruitment maneuver is recommended. When resources allow, prone
ventilation should be carried out for 12 hours per day. If prone
ventilation is ineffective, extracorporeal membrane oxygenation (ECMO) should
be considered if conditions allow.
1.
Circulatory support:
starting with sufficient fluid resuscitation and improve microcirculation. Use
vasoactive drugs, and monitor hemodynamics when necessary.
2.
Use of convalescent
plasma collected from recovered patients: indicated for patients with rapid
disease progression, and severe or critical cases For usage and dosage,
see "The Diagnosis and Treatment Plan for COVID-19 (Provisional 1st
edition)".
3.
Other treatment measures
For patients with progressively deteriorating
oxygenation index, rapid imaging progression, and overactive inflammatory
responses, short-term (3-5 days) glucocorticoid treatment may be used at the
clinician's discretion. It's recommended that the dosage should not exceed the
equivalence of methylprednisolone at 1-2mg/kg/day, since the immunosuppressive
function of high-dose glucocorticoid may delay the clearance of coronavirus
from the system. Xuebijing may be given intravenously at 100ml twice a day.
Probiotics can be given to maintain intestinal microbiome balance and to
prevent secondary bacterial infection. For severe and critical cases with
hyper-inflammation, extracorporeal blood purification techniques such as plasma
exchange, plasma absorption, plasma perfusion, and hemofiltration may be
considered.
Patients often have anxiety and fear, and
psychological counseling should be strengthened.
(4) Treatment by Chinese Medicine.
本病属于中医“疫”病范畴,病因为感受“疫民”之气,各地可根据病情、当地气候特点以及不同体质等情况,参照下列方案进行辨证论治。 涉及到超药典剂量,应当在医师指导下使用。
1.
Period of Medical
Observation
Clinical manifestation 1: lack of energy
accompanied by gastrointestinal discomfort
推荐中成药:藿香正气胶囊(丸、水、口服液)
Clinical Manifestation 2: Fatigue with Fever
推荐中成药:金花清感颗粒、连花清瘟胶囊(颗粒)、疏风解毒胶囊(颗粒)
1.
Clinical treatment period
(confirmed cases)
2.1清肺排毒汤
适用范围:适用于轻型、普通型、重型患者,在危重型患者救治中可结合患者实际情况合理使用。
基础方剂:麻黄9g、炙甘草6g、杏仁9g、生石膏15~30g(先煎)、桂枝9g、泽泻9g、猪苓9g、白术9g、茯苓15g、柴胡16g、黄芩6g、姜半夏9g、生姜、紫菀9g、冬花9g、射千9g、细辛6g、山药12g、枳实6g、陈皮68、藿香9g。
服法:传统中药饮片,水煎服。 每天一付,早晚两次(饭后四十分钟),温服,三付一个疗程。
如有条件,每次服完药可加服大米汤半碗,舌干津液亏虚者可多服至一碗。 (注:如患者不发热则生石膏的用量要小,发热或壮热可加大生石膏用量)。 若症状好转而未痊愈则服用第二个疗程,若患者有特殊情況或其他基础病,第二疗程可以根据实际情况修改处方,症状消失则停药。
处方来源:国家卫生健康委办公厅国家中医药管理局办公室《关于推荐在中西医结合救治新型冠状病毒感染的肺炎中使用“清肺排毒汤”的通知》(国中医药办医政函〔2020)22号)。
2.2 Mild Form
(1)寒湿郁肺证
临床表现:发热,乏力,周身酸痛,咳嗽,咯痰,胸紧整气,纳呆,恶心,呕吐,大便粘膩不爽。 舌质淡胖齿痕或淡红,苔白厚腐腻或白腻,脉濡或滑。
推荐处方:生麻黄6g、生石膏15g、杏仁9g、羌活15g、尊劳子15g、贯众9g、地龙15g、徐长卿15g、藿香15g、佩兰9g、苍术15g、云苓45g、生白术30g、焦三仙各9g、厚朴15g、焦槟榔9g、喂草果9g、生姜15g。
服法:每日1剂,水煎600ml,分3次服用,早中晚各1次,饭前服用。
(2)湿热蕴肺证
临床表现:低热或不发热,微恶寒,乏力,头身困重,肌肉酸痛,干咳痰少,咽痛,口干不欲多饮,或伴有胸闷脘痞,无汗或汗出不畅,或见呕恶纳呆,便溏或大便粘滞不爽。 舌淡红,苔白厚腻或薄黄,脉滑数或需。
推荐处方:槟榔10g、草果10g、厚朴10g、知母10g、黄梦10g、柴胡10g、赤芍10g、连翘15g、青蒿10g(后下)、苍术10g、大青叶10g、生甘草5g。
服法:每日1剂,水煎400ml,分2次服用,早晚各1次。
2.3普通型
(1)湿毒郁肺证
临床表现:发热,咳嗽痰少,或有黄痰,憋闷气促,腹胀,便秘不畅。 舌质暗红,舌体胖,苔黄腻或黄燥,脉滑数或弦滑。
推荐处方:生麻黄6g、苦杏仁15g、生石膏30g、生薏苡仁30g、茅苍术10g、广藿香15g、青蒿草12g、虎杖20g、马鞭草30g、干芦根30g、孝子15g、化橘红15g、生甘草10g。
服法:每日1剂,水煎400ml,分2次服用,早晚各1次。
(2)寒湿阻肺证
临床表现:低热,身热不扬,或未热,干咳,少痰,倦怠乏力,胸闷,脘痞,或呕恶,便溏。 舌质淡或淡红,苔白或白腻,脉濡。
推荐处方:苍术15g、陈皮10g、厚朴10g、藿香10g、草果6g、生麻黄6g、羌活10g、生姜10g、槟榔10g。
服法:每日1剂,水煎400ml,分2次服用,早晚各1次。
2.4 Serious Form
(1)疫毒闭肺证
临床表现:发热面红,咳嗽,痰黄粘少,或痰中带血,喘憋气促,疲乏倦怠,口干苦粘,恶心不食,大便不畅,小便短赤。 舌红,苔黄腻,脉滑数。
推荐处方:生麻黄6g、杏仁9g、生石膏15g、甘草3g、灌香10g(后下)、厚朴10g、苍术15g、草果10g、法半夏9g、获苓15g、生大黄58(后下)、生黄芪10g、夢芹子10g、赤芍10g。
服法:每日1~2剂,水煎服,每次100ml~200ml,一日2~4次,口服或鼻饲。
(2)气营两燔证
临床表现:大热烦渴,喘憋气促,擔语神昏,视物错督,或发斑疹,或吐血、衄血,或四肢抽搐。 舌绛少苔或无苔,脉沉细数,或浮大而数。
推荐处方:生石膏30~60g(先煎)、知母30g、生地30~60g、水牛角30g(先煎)、赤芍30g、玄参30g、连翘15g、丹皮15g、黄连6g、竹叶12g、夢劳子15g、生甘草6g。
服法:每日1剂,水煎服,先煎石膏、水牛角后下诸药,每次100ml~200ml,每日2~4次,口服或鼻饲。
推荐中成药:喜炎平注射液、血必净注射液、热毒宁注射液、痰热清注射液、醒脑静注射液。 功效相近的药物根据个体情况可选择一种,也可根据临床症状联合使用两种。 中药注射剂可与中药汤剂联合使用。
2.5危重型(内闭外脱证)
临床表现:呼吸困难、动辄气喘或需要机械通气,伴神昏,烦躁,汗出肢冷,舌质紫暗,苔厚膩或燥,脉浮大无根。
推荐处方:人参15g、黑顺片10g(先煎)、山茱萸15g,送服苏合香丸或安宫牛黄丸。
推荐中成药:血必净注射液、热毒宁注射液、痰热清注射液、醒脑静注射液、参附注射液、生脉注射液、参麦注射液。 功效相近的药物根据个体情况可选择一种,也可根据临床症状联合使用两种。 中药注射剂可与中药汤剂联合使用。
注：重型和危重型中药注射剂推荐用法
中药注射剂的使用遵照药品说明书从小剂量开始、逐步辨证调整的原则,推荐用法如下:
病毒感染或合并轻度细菌感染:0.9%氯化钠注射液250ml加喜炎平注射液100mgbid,或0.9%氯化钠注射液250ml加热毒宁注射液20ml,或0.9%氯化钠注射液250ml加痰热清注射液40mlbid。
高热伴意识障碍:0.9%氯化钠注射液250ml加醒脑静注射液20mlbid。
全身炎症反应综合征或/和多脏器功能衰竭:0.9%氯化钠注射液250ml加血必净注射液100mlbid。
免疫抑制:0.9%氯化钠注射液250ml加参麦注射液100mlbid.
休克:0.9%氯化钠注射液250ml加参附注射液100mlbid。
2.6 Recovery Period
(1)肺脾气虚证
临床表现:气短,倦怠乏力,纳差呕恶,痞满,大便无力,便溏不爽。 舌淡胖,苔白腻。
推荐处方:法半夏9g、陈皮10g、党参15g、炙黄芪30g、1炒白术10g、茯苓15g、藿香10g、砂仁6g(后下)、甘草6g。
服法:每日1剂,水煎400ml,分2次服用,早晚各1次。
(2)气阴两虚证临床表现:乏力,气短,口干,口渴,心悸,汗多,纳差,低热或不热,干咳少痰。 舌干少津,脉细或虚无力。
推荐处方:南北沙参各10g、麦冬15g、西洋参6g,五味子6g、生石膏15g、淡竹叶10g、桑叶10g、芦根15g、丹参15g、生甘草6g。
服法:每日1剂,水煎400ml,分2次服用,早晚各1次。
IX. Matters for attention after release from isolation or
hospital.
(1) Criteria for release from isolation and hospital
discharge
1. Temperature returned to normal for 3 days or
more;
1.
Respiratory symptoms
have a clear turn for the better;
2.
Chest radiology findings
show substantial improvement of acute exudative lesions.
3.
Two consecutive negative
nucleic acid tests using respiratory tract samples (taken at least 24 hours
apart).
Those meeting the requirements above may be
released from isolation or hospital.
(2) Matters for attention after hospital
discharge.
1.
Designated hospitals
should communicate with primary care facilities at the patient's place of
residence and share medical records. Information on the discharged patients
should be forwarded to the relevant neighbourhood committees and primary care
facilities in a timely manner.
2.
Discharged patients are
at increased risk of acquiring other pathogens due to their reduced immune
functions during recovery. It's recommended that the patients: continue to
self-monitor for 14 days, wear masks, live in well-ventilated individual suites
if possible, reduce close contact with family members, eat separately, practice
good hand hygiene, and avoid going outside.
3.
Follow-up visits are
recommended at 2 and 4 weeks after discharge.
X. Transport Priniciples
Implement in accordance with the "Work Plan
for Transport of Novel Coronavirus Pneumonia Cases (Provisional)" released
by our Commission.
XI. Prevention and Control of Infection in Medical Establishments
严格按照我委《医疗机构內新型冠状病毒感染预防与控制技术指南(第一版)》、《新型冠状病毒感染的肺炎防护中常见医用防护用品使用范围指引(试行)》的要求执行。
抄送;各省、自治区、直辖市及新疆生产建设兵团应对新型冠状病毒肺炎疫情联防联控机制(领导小组、指挥部)。
General Office of the National Health Commission
Released February 18, 2020
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