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. Pathogen 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) Regular 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 (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg (1mmHg=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 2019-nCoV 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 2019-nCoV if they have had close contact with 2019-nCoV 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) General 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. Concurrent usage of 3 or more antiviral drugs is not recommended. Corresponding medication should be discontinued should intolerable side effects appear.
  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 support organ functions promptly.
  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 "COVID-19 Clinical Treatment Plan Using Convalescent Plasma Collected from Recovered Patients (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 Traditional 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。

Note: Suggested use of Traditional Chinese Medicine Injections for Severe and Critical Cases

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。

Copy sent to:The joint mechanism (leading group, command department) for the prevention and control of the novel coronavirus pneumonia epidemic of each province, autonomous region, and directly governed municipality, as well as for the Xinjiang Construction and Production Corps.

General Office of the National Health Commission

Released February 18, 2020

Proofread: Qingyang Du

 

 

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